Norethindrone/Ethinyl Estradiol (HRT)

Pronunciation: nor-eth-IN-drone/ETH-in-il ess-tra-DYE-ole
Generic Name: Norethindrone/Ethinyl Estradiol (HRT)
Brand Name: Femhrt

Do not use Norethindrone/Ethinyl Estradiol (HRT) to prevent heart disease, heart attacks, strokes, or dementia. Norethindrone/Ethinyl Estradiol (HRT) may increase the risk of heart disease (including heart attack), stroke, dementia, serious blood clots in the lung or leg, or breast cancer. Talk with your doctor regularly about whether you still need treatment with Norethindrone/Ethinyl Estradiol (HRT).

Norethindrone/Ethinyl Estradiol (HRT) is used for:

Treating hot flashes, night sweats, and other symptoms associated with menopause. It is also used to prevent thinning bones (osteoporosis) in women past menopause.

Norethindrone/Ethinyl Estradiol (HRT) is an estrogen and progestin combination. It helps maintain 2 female sex hormone levels that fall as a woman reaches menopause.

Do NOT use Norethindrone/Ethinyl Estradiol (HRT) if:

• you are allergic to any ingredient in Norethindrone/Ethinyl Estradiol (HRT)


• you have a history of heart attack, stroke, aneurysm, or heart disease


• you have or have had certain cancers, including cancer of the breast, uterus, cervix, or vagina, or an estrogen-dependent tumor


• you have unexplained vaginal bleeding


• you have or have a history of blood clots in the legs, lungs, heart, or other parts of the body


• you are or suspect you are pregnant

Contact your doctor or health care provider right away if any of these apply to you.

Before using Norethindrone/Ethinyl Estradiol (HRT):

Some medical conditions may interact with Norethindrone/Ethinyl Estradiol (HRT). Tell your health care provider if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines or other substances


• if you have breast nodules, disease of the breast, an abnormal breast x-ray or mammogram, a strong family history of breast cancer or hypercalcemia (high level of calcium in the blood)


• if you have or have a history of endometriosis, endometrial cancer, or inflammation of the pancreas


• if you have diabetes, lupus, or gallbladder, heart, liver, or kidney problems


• if you have high blood pressure, vision problems, or yellowing of the skin or eyes


• if you are obese or scheduled to have surgery


• if you use tobacco, have migraines, other headaches, or epilepsy


• if you have high protein, cholesterol, triglycerides, or calcium levels in your blood

Some MEDICINES MAY INTERACT with Norethindrone/Ethinyl Estradiol (HRT). Tell your health care provider if you are taking any other medicines, especially any of the following:

• Acitretin, aprepitant, azole antifungals (eg, ketoconazole), barbiturates (eg, phenobarbital), bosentan, carbamazepine, felbamate, griseofulvin, HIV protease inhibitors (eg, ritonavir), hydantoins (eg, phenytoin), modafinil, nevirapine, penicillins (eg, amoxicillin), rifampin, St. John's wort, tetracyclines (eg, doxycycline), topiramate, or troglitazone because they may decrease Norethindrone/Ethinyl Estradiol (HRT)'s effectiveness. If you are taking Norethindrone/Ethinyl Estradiol (HRT) for birth control, an alternative form of birth control (eg, condoms) will be needed while on these medicines, and until your next period after stopping these medicines.


• Oral anticoagulants (eg, warfarin), beta-blockers (eg, metoprolol), corticosteroids (eg, hydrocortisone), cyclosporine, theophyllines, or troleandomycin because the risk of their side effects may be increased by Norethindrone/Ethinyl Estradiol (HRT)


• Oral anticoagulants (eg, warfarin) or lamotrigine because their effectiveness may be decreased by Norethindrone/Ethinyl Estradiol (HRT). If you are taking lamotrigine, stopping Norethindrone/Ethinyl Estradiol (HRT) needs to be done under close monitoring. When Norethindrone/Ethinyl Estradiol (HRT) is stopped, it may cause increased levels of lamotrigine, which may lead to toxic effects, including nausea, dizziness, and visual disturbances.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Norethindrone/Ethinyl Estradiol (HRT) may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Norethindrone/Ethinyl Estradiol (HRT):

Use Norethindrone/Ethinyl Estradiol (HRT) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Norethindrone/Ethinyl Estradiol (HRT). Talk to your pharmacist if you have questions about this information.


• Take Norethindrone/Ethinyl Estradiol (HRT) by mouth with or without food.


• Take Norethindrone/Ethinyl Estradiol (HRT) at the same time every day.


• If you miss a dose, take it as soon as you remember. Take your next dose at the regular time. This means you may take 2 doses on the same day. If you miss more than 1 dose of Norethindrone/Ethinyl Estradiol (HRT), refer to the patient information that came with Norethindrone/Ethinyl Estradiol (HRT) or contact your health care provider or pharmacist.

Ask your health care provider any questions you may have about how to use Norethindrone/Ethinyl Estradiol (HRT).

Important safety information:

• Your health care provider should reevaluate you every 3 to 6 months to make sure you still need to take Norethindrone/Ethinyl Estradiol (HRT).


• You should have a complete physical exam, including blood pressure measurement, a Pap test, and breast and pelvic exams at least once per year.


• You should have regular breast examinations by a health care provider and examine your breasts monthly. Report any lumps to your doctor immediately. Ask your doctor to show you how to do a breast exam yourself. If you are over 50 years of age you should have a mammogram every year.


• If you are scheduled for surgery or you will be confined to a chair or bed for a long period of time (eg, a long plane flight), notify your doctor 3 to 4 weeks beforehand. Special precautions may need to be taken in these circumstances while you are taking Norethindrone/Ethinyl Estradiol (HRT).


• If you take calcium supplements as part of your treatment to help prevent bone thinning (osteoporosis), ask your doctor about the recommended amount. A daily intake of 1,500 milligrams of calcium is often recommended for women past menopause. Vitamin D (400 Units) may help your body absorb and use more calcium.


• Norethindrone/Ethinyl Estradiol (HRT) does not stop the spread of HIV or sexually transmitted diseases (STDs) to others through blood or sexual contact. Use barrier methods of birth control (eg, condoms) if you have an HIV infection or an STD. Do not share needles, injection supplies, or items like toothbrushes or razors.


• Diabetes patients - Norethindrone/Ethinyl Estradiol (HRT) may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.


• Norethindrone/Ethinyl Estradiol (HRT) may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Norethindrone/Ethinyl Estradiol (HRT).


• Lab tests, including liver function, kidney function, lung function, blood pressure, fasting blood glucose, and blood cholesterol, may be performed while you use Norethindrone/Ethinyl Estradiol (HRT). These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Norethindrone/Ethinyl Estradiol (HRT) with caution in the ELDERLY; they may be more sensitive to its effects


• Norethindrone/Ethinyl Estradiol (HRT) should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Norethindrone/Ethinyl Estradiol (HRT) while you are pregnant. Norethindrone/Ethinyl Estradiol (HRT) is found in breast milk. Do not breast-feed while taking Norethindrone/Ethinyl Estradiol (HRT).

Possible side effects of Norethindrone/Ethinyl Estradiol (HRT):

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; headache; irregular vaginal bleeding or spotting; mild breast pain; mild hair loss; nausea; stomach upset, cramps, or bloating; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); breast lumps; chest pain; confusion; coughing up blood; dark urine or pale stools; dizziness or fainting; fever; heaviness in the chest; lack of energy or fatigue; loss of appetite; mental or mood change; numbness in arm or leg; pain or tenderness in the calf; persistent or recurrent abnormal vaginal bleeding; severe or persistent breast pain; shortness of breath; sleeping problems; speech problems; stomach pain or tenderness; sudden or severe headache or vomiting; swelling of the fingers or ankles; unusual vaginal discharge, itching, or odor; vision problems or changes (including partial or complete loss of vision); weakness or one-sided weakness; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include vaginal bleeding; vomiting.

Proper storage of Norethindrone/Ethinyl Estradiol (HRT):

Store Norethindrone/Ethinyl Estradiol (HRT) at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Norethindrone/Ethinyl Estradiol (HRT) out of the reach of children and away from pets.

General information:

• If you have any questions about Norethindrone/Ethinyl Estradiol (HRT), please talk with your doctor, pharmacist, or other health care provider.


• Norethindrone/Ethinyl Estradiol (HRT) is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Norethindrone/Ethinyl Estradiol (HRT). If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Norethindrone/Ethinyl Estradiol (HRT) resources

• Norethindrone/Ethinyl Estradiol (HRT) Use in Pregnancy & Breastfeeding
• Norethindrone/Ethinyl Estradiol (HRT) Drug Interactions
• Norethindrone/Ethinyl Estradiol (HRT) Support Group
• 654 Reviews for Norethindrone/Ethinyl Estradiol (HRT) - Add your own review/rating

Compare Norethindrone/Ethinyl Estradiol (HRT) with other medications

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• Acne
• Birth Control
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• Menstrual Disorders
• Polycystic Ovary Syndrome
• Postmenopausal Symptoms
• Prevention of Osteoporosis

Panadol Original Tablets

1. Name Of The Medicinal Product

Panadol Original Tablets

2. Qualitative And Quantitative Composition

Each tablet contains Paracetamol Ph Eur 500.0 mg

3. Pharmaceutical Form

Tablet

4. Clinical Particulars

4.1 Therapeutic Indications

Panadol Original Tablets is a mild analgesic and antipyretic, and is recommended for the treatment of most painful and febrile conditions, for example, headache including migraine and tension headaches, toothache, backache, rheumatic and muscle pains, dysmenorrhoea, sore throat, and for relieving the fever, aches and pains of colds and flu. Also recommended for the symptomatic relief of pain due to non-serious arthritis.

4.2 Posology And Method Of Administration

Adults:

Two tablets up to four times daily as required.

Children:

6 - 12 years: Half to one tablet three or four times daily as required. Not suitable for children under six years of age. Children should not be given Panadol Original Tablets for more than 3 days without consulting a doctor.

These doses should not be repeated more frequently than every four hours nor should more than four doses be given in any 24 hour period.

Oral administration only.

4.3 Contraindications

Hypersensitivity to paracetamol or any of the other constituents.

4.4 Special Warnings And Precautions For Use

Care is advised in the administration of paracetamol to patients with renal or hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.

Do not exceed the stated dose.

Patients should be advised to consult their doctor if their headaches become persistent.

Patients should be advised not to take other paracetamol-containing products concurrently.

Patients should be advised to consult a doctor if they suffer from non-serious arthritis and need to take painkillers every day.

If symptoms persist consult your doctor.

Keep out of the reach and sight of children.

Pack Label:

Immediate medical advice should be sought in the event of an overdose, even if you feel well.

Do not take with any other paracetamol-containing products.

Patient Information Leaflet:

Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by colestyramine. The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.

4.6 Pregnancy And Lactation

Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol used in the recommended dosage, but patients should follow the advice of their doctor regarding its use. Paracetamol is excreted in breast milk but not in a clinically significant amount. Available published data do not contraindicate breast feeding.

4.7 Effects On Ability To Drive And Use Machines

None.

4.8 Undesirable Effects

Adverse events of paracetamol from historical clinical trial data are both infrequent and from small patient exposure. Accordingly, events reported from extensive post-marketing experience at therapeutic/labelled dose and considered attributable are tabulated below by system class. Due to limited clinical trial data, the frequency of these adverse events is not known (cannot be estimated from available data), but post-marketing experience indicates that adverse reactions to paracetamol are rare and serious reactions are very rare.

Post marketing data

Body System	Undesirable effect
Blood and lymphatic system disorders	Thrombocytopenia Agranulocytosis
Immune system disorders	Anaphylaxis Cutaneous hypersensitivity reactions including skin rashes, angiodema and Stevens Johnson syndrome/toxic epidermal necrolysis
Respiratory, thoracic and mediastinal disorders	Bronchospasm*
Hepatobiliary disorders	Hepatic dysfunction

* There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs.

4.9 Overdose

Liver damage is possible in adults who have taken 10g or more of paracetamol. Ingestion of 5g or more of paracetamol may lead to liver damage if the patient has risk factors (see below).

Risk factors

If the patient

a, Is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John's Wort or other drugs that induce liver enzymes.

Or

b, Regularly consumes ethanol in excess of recommended amounts.

Or

c, Is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.

Symptoms

Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema, and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.

Management

Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines, see BNF overdose section.

Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of paracetamol, however, the maximum protective effect is obtained up to 8 hours post-ingestion. The effectiveness of the antidote declines sharply after this time. If required the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside hospital. Management of patients who present with serious hepatic dysfunction beyond 24h from ingestion should be discussed with the NPIS or a liver unit.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Paracetamol is an antipyretic analgesic. The mechanism of action is probably similar to that of aspirin and dependant on the inhibition of prostaglandin synthesis. This inhibition appears, however to be on a selective basis.

5.2 Pharmacokinetic Properties

Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. The concentration in plasma reaches a peak in 30 to 60 minutes and the plasma half-life is 1 - 4 hours after therapeutic doses. Paracetamol is relatively uniformly distributed throughout most body fluids. Binding of the drug to plasma proteins is variable; 20 to 30% may be bound at the concentrations encountered during acute intoxication. Following therapeutic doses 90 - 100% of the drug may be recovered in the urine within the first day. However, practically no paracetamol is excreted unchanged and the bulk is excreted after hepatic conjugation.

5.3 Preclinical Safety Data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Maize starch, potassium sorbate, purified talc, stearic acid, polyvidone, starch pre-gelatinised, hypromellose, and triacetin.

6.2 Incompatibilities

None.

6.3 Shelf Life

48 months.

6.4 Special Precautions For Storage

None.

6.5 Nature And Contents Of Container

PVC 250µm / aluminium foil 30µm blister packs in an outer cardboard carton, containing 4, 6, 12, 16, 24, 30 or 32 tablets, or PVC 300 μm/aluminium foil 30 μm blister packs in a cardboard/PVC wallet containing 16 tablets.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

SmithKline Beecham (SWG) Limited

980 Great West Road

Brentford

Middlesex

TW8 9GS

United Kingdom

Trading as GlaxoSmithKline Consumer Healthcare, Brentford, TW8 9GS.

8. Marketing Authorisation Number(S)

PL 00071/5074R

9. Date Of First Authorisation/Renewal Of The Authorisation

29.05.84

10. Date Of Revision Of The Text

01.04.10

Ipaligo

Ipaligo may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Ipaligo

Magnesium Chloride

Magnesium Chloride is reported as an ingredient of Ipaligo in the following countries:

• France

Zinc Oxide

Zinc is reported as an ingredient of Ipaligo in the following countries:

• France

International Drug Name Search

Platinol-AQ

Generic Name: cisplatin (Intravenous route)

sis-PLA-tin

Intravenous route(Powder for Solution)

Administer under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Cumulative renal toxicity associated with cisplatin is severe and other major dose-related toxicities include myelosuppression, nausea, and vomiting. Ototoxicity, which may be more pronounced in children, is significant. Anaphylactic-like reactions to cisplatin such as facial edema, bronchoconstriction, tachycardia, and hypotension have been reported and may occur within minutes of cisplatin administration. Exercise caution to prevent inadvertent cisplatin overdose as doses greater than 100 mg/m(2)/cycle once every 3 to 4 weeks are rarely used. Avoid inadvertent cisplatin overdose due to confusion with carboplatin or prescribing practices that fail to differentiate daily doses from total dose per cycle .

Commonly used brand name(s)

In the U.S.

• Platinol-AQ

Available Dosage Forms:

• Powder for Solution


• Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Platinum Coordination Complex

Uses For Platinol-AQ

Cisplatin belongs to the group of medicines known as alkylating agents. It is used to treat cancer of the bladder, ovaries, and testicles. It may also be used to treat other kinds of cancer, as determined by your doctor.

Cisplatin interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected by cisplatin, other effects will also occur. Some of these may be serious and must be reported to your doctor. Other effects may not be serious but may cause concern. Some effects may not occur for months or years after the medicine is used.

Before you begin treatment with cisplatin, you and your doctor should talk about the good this medicine will do as well as the risks of using it.

Cisplatin is to be administered only by or under the immediate supervision of your doctor.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, cisplatin is used in certain patients with the following medical conditions:

• Cancer of the outside layer of the adrenal gland


• Cancer of the breast


• Cancer of the cervix


• Cancer of the endometrium


• Cancer of the fallopian tube or lining of the abdomen (spreading from the ovary)


• Cancer of the esophagus


• Cancer of the stomach


• Cancer of the lung


• Neuroblastoma (a certain type of cancer in nerve tissues that occurs in children)


• Cancer of the prostate


• Cancers of the head and neck


• Cancer of the liver


• Cancer of the thyroid


• Cancer of the anus


• Cancer of the vulva


• Cancer of the bile duct


• Cancer of the skin, including types that spread to other parts of the body


• Cancer of unknown primary site


• Cancer of the lymph system


• Hepatoblastoma (a certain type of liver cancer that occurs in children)


• Thymoma (a cancer of the thymus, which is a small organ that lies under the breastbone)


• Tumors in the ovaries


• Gestational trophoblastic tumors (tumors in the uterus or womb)


• Wilms' tumor (a cancer of the kidneys occurring mainly in children)


• Retinoblastoma (a cancer of the eye occurring mainly in children)


• Cancer of the bones (in children)


• Cancer of the muscles, connective tissues (tendons), vessels that carry blood or lymph, joints, and fat.


• Autoimmune deficiency syndrome (AIDS)–associated Kaposi's sarcoma (a type of cancer of the skin and mucous membranes that is more common in patients with AIDS)

Before Using Platinol-AQ

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Hearing problems and loss of balance are more likely to occur in children, who are usually more sensitive to the effects of cisplatin.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of cisplatin in the elderly with use in other age groups.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Rotavirus Vaccine, Live

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adenovirus Vaccine Type 4, Live


• Adenovirus Vaccine Type 7, Live


• Bacillus of Calmette and Guerin Vaccine, Live


• Doxorubicin Hydrochloride


• Doxorubicin Hydrochloride Liposome


• Furosemide


• Influenza Virus Vaccine, Live


• Measles Virus Vaccine, Live


• Mumps Virus Vaccine, Live


• Paclitaxel


• Rituximab


• Rotavirus Vaccine, Live


• Rubella Virus Vaccine, Live


• Smallpox Vaccine


• Tacrolimus


• Thioctic Acid


• Topotecan


• Typhoid Vaccine


• Varicella Virus Vaccine


• Vinorelbine


• Yellow Fever Vaccine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aldesleukin


• Docetaxel


• Fosphenytoin


• Phenytoin


• Tobramycin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Chickenpox (including recent exposure) or


• Herpes zoster (shingles)—Risk of severe disease affecting other parts of the body

• Gout (history of) or


• Kidney stones (history of)—Cisplatin may increase levels of uric acid in the body, which can cause gout or kidney stones

• Hearing problems—May be worsened by cisplatin

• Infection—Cisplatin decreases your body's ability to fight infection

• Kidney disease—Effects of cisplatin may be increased because of slower removal from the body

Proper Use of Platinol-AQ

This medicine is sometimes given together with certain other medicines. If you are using a combination of medicines, it is important that you receive each one at the proper time. If you are taking some of these medicines by mouth, ask your health care professional to help you plan a way to take them at the right times.

While you are receiving this medicine, your doctor may want you to drink extra fluids so that you will pass more urine. This will help prevent kidney problems and keep your kidneys working well.

This medicine usually causes nausea and vomiting that may be severe. However, it is very important that you continue to receive the medicine, even if you begin to feel ill. Ask your health care professional for ways to lessen these effects, especially if they are severe.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Precautions While Using Platinol-AQ

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

While you are being treated with cisplatin, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval. Cisplatin may lower your body's resistance and there is a chance you might get the infection the immunization is meant to prevent. In addition, other persons living in your household should not take oral polio vaccine since there is a chance they could pass the polio virus on to you. Also, avoid persons who have taken oral polio vaccine within the last several months. Do not get close to them, and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth.

Cisplatin can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.


• Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in urine or stools; or pinpoint red spots on your skin.


• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.


• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.


• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.


• Avoid contact sports or other situations where bruising or injury could occur.

If cisplatin accidentally seeps out of the vein into which it is injected, it may damage some tissues and cause scarring. Tell the doctor or nurse right away if you notice redness, pain, or swelling at the place of injection.

Platinol-AQ Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Also, because of the way cancer medicines act on the body, there is a chance that they might cause other unwanted effects that may not occur until months or years after the medicine is used. These delayed effects may include certain types of cancer, such as leukemia. Discuss these possible effects with your doctor.

Check with your doctor immediately if any of the following side effects occur:

Less common

• Black, tarry stools


• blood in urine or stools


• cough or hoarseness accompanied by fever or chills


• dizziness or faintness (during or shortly after a dose)


• fast heartbeat (during or shortly after a dose)


• fever or chills


• lower back or side pain accompanied by fever or chills


• painful or difficult urination accompanied by fever or chills


• pain or redness at place of injection


• pinpoint red spots on skin


• swelling of face (during or shortly after a dose)


• unusual bleeding or bruising


• wheezing (during or shortly after a dose)

Check with your doctor as soon as possible if any of the following side effects occur:

More common

• Joint pain


• loss of balance


• ringing in ears


• swelling of feet or lower legs


• trouble in hearing


• unusual tiredness or weakness

Less common

• Convulsions (seizures)


• loss of reflexes


• loss of taste


• numbness or tingling in fingers or toes


• trouble in walking

Rare

• Agitation or confusion


• blurred vision


• change in ability to see colors (especially blue or yellow)


• muscle cramps


• sores in mouth and on lips

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Nausea and vomiting (severe)

Less common

• Loss of appetite

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

• Black, tarry stools


• blood in urine or stools


• convulsions (seizures)


• cough or hoarseness


• decrease in urination


• fever or chills


• loss of balance


• loss of reflexes


• loss of taste


• lower back or side pain


• numbness or tingling in fingers or toes


• painful or difficult urination


• pinpoint red spots on skin


• ringing in ears


• swelling of feet or lower legs


• trouble in hearing


• trouble in walking


• unusual bleeding or bruising

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Platinol-AQ side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

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Ambien CR Extended-Release Tablets

Pronunciation: zole-PI-dem
Generic Name: Zolpidem
Brand Name: Ambien CR

Ambien CR Extended-Release Tablets are used for:

Treating insomnia (trouble falling asleep or staying asleep).

Ambien CR Extended-Release Tablets are a sedative-hypnotic, or sleep medicine. It works by helping to increase certain natural chemicals in the brain that cause sleep. Ambien CR is a dual-layer tablet - the first layer is designed to dissolve quickly to help you get to sleep and the second layer is designed to dissolve slowly, to help you stay asleep.

Do NOT use Ambien CR Extended-Release Tablets if:

• you are allergic to any ingredient in Ambien CR Extended-Release Tablets


• you are taking sodium oxybate (GHB)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Ambien CR Extended-Release Tablets:

Some medical conditions may interact with Ambien CR Extended-Release Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have kidney or liver problems, lung or breathing problems (eg, chronic obstructive pulmonary disease [COPD], sleep apnea), myasthenia gravis, metabolism problems, heart or blood pressure problems, or very poor health


• if you have a history of mood or mental problems (eg, depression), suicidal thoughts or behaviors, or alcohol or substance abuse or addiction


• if you are a child or teenager with a history of attention deficit hyperactivity disorder (ADHD)

Some MEDICINES MAY INTERACT with Ambien CR Extended-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

• HIV protease inhibitors (eg, ritonavir), ketoconazole, or sodium oxybate (GHB) because they may increase the risk of Ambien CR Extended-Release Tablets's side effects


• Rifampin because it may decrease Ambien CR Extended-Release Tablets's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Ambien CR Extended-Release Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Ambien CR Extended-Release Tablets:

Use Ambien CR Extended-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Ambien CR Extended-Release Tablets comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Ambien CR Extended-Release Tablets refilled.


• Take Ambien CR Extended-Release Tablets by mouth on an empty stomach at least 2 hours after a meal.


• Swallow Ambien CR Extended-Release Tablets whole. Do not break, crush, or chew before swallowing.


• Ambien CR Extended-Release Tablets works very quickly; use Ambien CR Extended-Release Tablets right before going to sleep.


• Use Ambien CR Extended-Release Tablets only when you are able to get a full night's sleep (7 to 8 hours).


• If you miss a dose of Ambien CR Extended-Release Tablets, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. Do not take more than your total daily dose in any 24-hour period.

Ask your health care provider any questions you may have about how to use Ambien CR Extended-Release Tablets.

Important safety information:

• Ambien CR Extended-Release Tablets may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Ambien CR Extended-Release Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Ambien CR Extended-Release Tablets; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• When you first start taking Ambien CR Extended-Release Tablets, it may have a "carryover" effect on you the next day. Use extreme care while doing anything that requires complete alertness (eg, driving a car).


• If your symptoms do not get better within 7 to 10 days or if they get worse, check with your doctor.


• Sleep medicines may cause a special type of memory loss or amnesia. To prevent memory problems, be sure to use Ambien CR Extended-Release Tablets only when you are able to get a full night's sleep (7 to 8 hours) before you need to be active again. Be sure to talk to your health care provider if you think you are having memory problems.


• Some patients taking Ambien CR Extended-Release Tablets have performed certain activities while they were not fully awake. These have included sleep-driving, making and eating food, making phone calls, and having sex. Patients often do not remember these events after they happen. Such an event may be more likely to occur if you use a high dose of Ambien CR Extended-Release Tablets. It may also be more likely if you drink alcohol or take other medicines that may cause drowsiness while you use these medicine. Tell your doctor right away if such an event happens to you.


• Use Ambien CR Extended-Release Tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially dizziness or drowsiness.


• Ambien CR Extended-Release Tablets should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed. Children may be more sensitive to Ambien CR Extended-Release Tablets's side effects, especially dizziness, headache, and hallucinations.


• PREGNANCY and BREAST-FEEDING: If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Ambien CR Extended-Release Tablets while you are pregnant. Ambien CR Extended-Release Tablets may cause prolonged sleep or severe breathing problems in the newborn if you take it during the last weeks of pregnancy, especially if you take it with certain other medicines. Ambien CR Extended-Release Tablets are found in breast milk. If you are or will be breast-feeding while you take Ambien CR Extended-Release Tablets, check with your doctor. Discuss any possible risks to your baby.

When sleep medicines are used every night for more than a few weeks, they may lose their effectiveness to help you sleep. This is known as TOLERANCE. Sleep medicines should usually be used only for short periods of time, such as a few days and generally no longer than 1 or 2 weeks. If your sleep problems continue, contact your doctor.

When used for longer than a few weeks or at high doses, some people develop a need to continue taking Ambien CR Extended-Release Tablets. This is known as DEPENDENCE or addiction. Be sure to tell your doctor if you have been dependent on alcohol, prescription medicines, or street drugs in the past.

If you stop taking Ambien CR Extended-Release Tablets suddenly, you may have WITHDRAWAL symptoms. These may include unpleasant feelings. In more severe cases, you may have stomach and muscle cramps, vomiting, sweating, and shakiness. Seizures may rarely occur. If you take Ambien CR Extended-Release Tablets for more than 1 to 2 weeks, do not stop taking it without talking to your doctor.

Possible side effects of Ambien CR Extended-Release Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; drowsiness (including daytime drowsiness); "drugged" feeling; dry mouth; headache; muscle aches; nausea; nose or throat irritation; sluggishness; stomach upset; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the hands, legs, mouth, face, lips, eyes, throat, or tongue; throat closing; unusual hoarseness); abnormal thinking; behavior changes; chest pain; confusion; decreased coordination; difficulty swallowing or breathing; fainting; fast or irregular heartbeat; hallucinations; memory problems (eg, memory loss); mental or mood changes (eg, aggression, agitation, anxiety); new or worsening depression; severe dizziness; shortness of breath; suicidal thoughts or actions; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Ambien CR side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include severe drowsiness or coma.

Proper storage of Ambien CR Extended-Release Tablets:

Store Ambien CR Extended-Release Tablets at room temperature, between 59 and 77 degrees F (15 and 25 degrees C). Brief storage at temperatures up to 86 degrees F (30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Ambien CR Extended-Release Tablets out of the reach of children and away from pets.

General information:

• If you have any questions about Ambien CR Extended-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.


• Ambien CR Extended-Release Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is summary only. It does not contain all information about Ambien CR Extended-Release Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

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DAKTARIN Sugar Free 2% Oral Gel

1. Name Of The Medicinal Product

DAKTARIN Sugar Free 2% Oral Gel

2. Qualitative And Quantitative Composition

Each gram of Daktarin Sugar Free 2% Oral Gel contains 20 mg of miconazole.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Oral gel.

White gel with orange taste.

4. Clinical Particulars

4.1 Therapeutic Indications

Oral treatment and prevention of fungal infections of the oropharynx and of superinfections due to Gram-positive bacteria.

4.2 Posology And Method Of Administration

For oral administration

For topical treatment of the oropharynx

Treatment should be continued for up to 2 days after the symptoms have cleared.

Adult, Elderly and Children aged 6 years and over

Apply a small amount of gel directly to the affected area with a clean finger four times a day. The gel should be kept in the mouth for as long as possible.

For oral candidosis, dental prostheses should be removed at night and brushed with the gel.

Children aged 4 months – 6 years:

Apply a small amount of gel directly to the affected area with a clean finger twice daily. The gel should be kept in the mouth for as long as possible.

The lower age limit should be increased by 1-2 months for infants who are pre-term, or infants exhibiting slow neuromuscular development.

4.3 Contraindications

Known hypersensitivity to miconazole or to any of the excipients.

In infants less than 4 months of age or in those whose swallowing reflex is not yet sufficiently developed.

In patients with liver dysfunction.

Coadministration of the following drugs that are subject to metabolism by CYP3A4: (See Section 4.5 Interactions with Other Medicinal Products and Other Forms of Interaction)

- Substrates known to prolong the QT-interval e.g., astemizole, cisapride, dofetilide, mizolastine, pimozide, quinidine, sertindole and terfenadine

- Ergot alkaloids

- HMG-CoA reductase inhibitors such as simvastatin and lovastatin

- Triazolam and oral midazolam

4.4 Special Warnings And Precautions For Use

If the concomitant use of Daktarin and oral anticoagulants such as warfarin is envisaged, the anticoagulant effect should be carefully monitored and titrated (see section 4.5).

It is advisable to monitor miconazole and phenytoin levels, if these two drugs are used concomitantly.

In patients using certain oral hypoglycaemics such as sulphonylureas, an enhanced therapeutic effect leading to hypoglycaemia may occur during concomitant treatment with miconazole and appropriate measures should be considered (See Section 4.5 Interactions with Other Medicinal Products and Other Forms of Interaction).

Particularly in infants and young children, caution is required to ensure that the gel does not obstruct the throat. Hence, the gel should not be applied to the back of the throat and each dose should be divided into smaller portions. Observe the patient for possible choking.

The lower age limit should be increased by 1-2 months for infants who are pre-term, or infants exhibiting slow neuromuscular development.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

When using any concomitant medication the corresponding label should be consulted for information on the route of metabolism. Miconazole can inhibit the metabolism of drugs metabolised by the CYP3A4 and CYP2C9 enzyme systems. This can result in an increase and/or prolongation of their effects, including adverse effects.

Oral miconazole is contraindicated with the coadministration of the following drugs that are subject to metabolism by CYP3A4 (See Section 4.3 Contraindications);

- Substrates known to prolong the QT-interval e.g., astemizole, cisapride, dofetilide, mizolastine, pimozide, quinidine, sertindole and terfenadine

- Ergot alkaloids

- HMG-CoA reductase inhibitors such as simvastatin and lovastatin

- Triazolam and oral midazolam

When coadministered with oral miconazole the following drugs should be used with caution because of a possible increase or prolongation of the therapeutic outcome and/or adverse events. If necessary, their dosage should be reduced and, where appropriate, plasma levels monitored:

Drugs subject to metabolism by CYP2C9 (see Section 4.4 Special Warnings and Precautions for Use);

- Oral anticoagulants such as warfarin,

- Oral hypoglycaemics such as sulphonylureas

- Phenytoin

Other drugs subject to metabolism by CYP3A4;

- HIV Protease Inhibitors such as saquinavir;

- Certain antineoplastic agents such as vinca alkaloids, busulfan and docetaxel;

- Certain calcium channel blockers such as dihydropyridines and verapamil;

- Certain immunosuppressive agents: cyclosporin, tacrolimus, sirolimus (= rapamycin)

- Others: carbamazepine, cilostasol, disopyramide, buspirone, alfentanil, sildenafil, alprazolam, brotizolam, midazolam IV, rifabutin, methylprednisolone, trimetrexate, ebastine and reboxetine.

4.6 Pregnancy And Lactation

In animals, miconazole has shown no teratogenic effects but is foetotoxic at high oral doses. The significance of this to man is unknown. However, as with other imidazoles, Daktarin Sugar Free 2% Oral Gel should be avoided in pregnant women if possible. The potential hazards should be balanced against the possible benefits.

It is not known whether miconazole is excreted in human milk. Caution should be exercised when prescribing Daktarin Sugar Free 2% Oral Gel to nursing mothers.

4.7 Effects On Ability To Drive And Use Machines

Daktarin should not affect alertness or driving ability.

4.8 Undesirable Effects

The safety of DAKTARIN Sugar free 2% Oral Gel was evaluated in 111 patients with oral candidiasis or oral mycoses who participated in 5 clinical trials. Of these 111 patients, 88 were adults with oral candidiasis or oral mycoses who participated in 1 randomised, active

Based on the pooled safety data from these 5 clinical trials (adult and paediatric), the most commonly reported (

Table A includes all identified ADRs, including those that that have been reported from post-marketing experience.

The frequency categories use the following convention: very common (

Adult Patients

Based on the pooled safety data from the 4 clinical trials in adults, common ADRs reported included nausea (4.5%), product taste abnormal (4.5%), oral discomfort (3.4%), dry mouth (2.3%), dysgeusia (1.1%), and vomiting (1.1%).

Paediatric Patients

In the 1 paediatric clinical trial, the frequency of nausea (13.0%) and vomiting (13.0%) was very common, and regurgitation (8.7%) was common. As identified through post-marketing experience, choking may occur in infants and young children (See Section 4.3 Contraindications and Section 4.4 Special Warnings and Special Precautions). The frequency, type, and severity of other ADRs in children are expected to be similar to that in adults.

Table A : Adverse Drug Reactions in Patients Treated with DAKTARIN Sugar free 2% Oral Gel

System Organ Class	Adverse Drug Reactions
Frequency Category
Common (	Uncommon (	Not Known
Immune System Disorders			Anaphylactic reaction, Angioedema, Hypersensitivity
Nervous System Disorders		Dysgeusia
Respiratory, Thoracic and Mediastinal Disorders			Choking
Gastrointestinal Disorders	Dry mouth, Nausea, Oral discomfort, Vomiting, Regurgitation		Diarrhoea, Stomatitis, Tongue discolouration
Hepatobiliary Disorders			Hepatitis
Skin and Subcutaneous Tissue Disorders			Toxic epidermal necrolysis, Stevens-Johnson syndrome, Urticaria, Rash
General Disorders and Administration Site Conditions	Product taste abnormal

4.9 Overdose

Symptoms:

In the event of accidental overdose, vomiting and diarrhoea may occur.

Treatment:

Treatment is symptomatic and supportive. A specific antidote is not available.

In the event of accidental ingestion of large quantities of Daktarin an appropriate method of gastic emptying may be used, if considered necessary (See Section 4.5 Interactions with Other Medicinal Products and Other Forms of Interaction.)

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

ATC Code: A01A B09 and A07A C01

Miconazole possesses an antifungal activity against the common dermatophytes and yeasts as well as an antibacterial activity against certain gram-positive bacilli and cocci.

Its activity is based on the inhibition of the ergosterol biosynthesis in fungi and the change in the composition of the lipid components in the membrane, resulting in fungal cell necrosis.

5.2 Pharmacokinetic Properties

Absorption:

Miconazole is systemically absorbed after administration as the oral gel. Administration of a 60 mg dose of miconazole as the oral gel results in peak plasma concentrations of 31 to 49 ng/mL, occurring approximately two hours post-dose.

Distribution:

Absorbed miconazole is bound to plasma proteins (88.2%), primarily to serum albumin and red blood cells (10.6%).

Metabolism and Elimination:

The absorbed portion of miconazole is largely metabolized; less than 1% of an administered dose is excreted unchanged in the urine. The terminal half-life of plasma miconazole is 20 to 25 hours in most patients. The elimination half-life of miconazole is similar in renally impaired patients. Plasma concentrations of miconazole are moderately reduced (approximately 50%) during hemodialysis. About 50% of an oral dose may be excreted in the faeces partly metabolized and partly unchanged.

5.3 Preclinical Safety Data

Preclinical data reveal no special hazard for humans based on conventional studies of local irritation, single and repeated dose toxicity, genotoxicity, and toxicity to reproduction.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Purified water

Pregelatinised potato starch

Ethanol (96%)

Polysorbate 20

Sodium saccharin

Cocoa flavour

Orange flavour

Glycerol

6.2 Incompatibilities

Not applicable

6.3 Shelf Life

3 years.

6.4 Special Precautions For Storage

Do not store above 30°C.

6.5 Nature And Contents Of Container

Aluminium tubes containing 5* g or 15 g gel.

* not marketed

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

7. Marketing Authorisation Holder

McNeil Products Limited

Foundation Park

Roxborough Way

Maidenhead

Berkshire

SL6 3UG

United Kingdom

8. Marketing Authorisation Number(S)

PL 15513/0296

9. Date Of First Authorisation/Renewal Of The Authorisation

15/10/2008

10. Date Of Revision Of The Text

25/08/2010

SANOMIGRAN Elixir

1. Name Of The Medicinal Product

SANOMIGRAN Elixir 0.25mg/5ml

2. Qualitative And Quantitative Composition

The active ingredient is : 4-(1-methyl-4-piperidylidene)-9,10-dihydro-4H-benzo-[4,5]cyclohepta [1,2-b] thiophene hydrogen maleate (= pizotifen hydrogen malate).

The syrup contains 0.365mg of pizotifen hydrogen malate B.P. in every 5mls.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Syrup

4. Clinical Particulars

4.1 Therapeutic Indications

Prophylactic treatment of recurrent vascular headaches, including classical migraine, common migraine and cluster headaches (periodic migrainous neuralgia).

The International Classification of Headache Disorders 2^nd edition (ICHD-II) are standard classifications of headache used by health professionals and describe the above-mentioned disorders as follows: prophylactic treatment of recurrent migraine headache with or without aura and of cluster headache.

It is not effective in relieving migraine attacks once in progress.

4.2 Posology And Method Of Administration

Adults

Usually 1.5mg daily. This may be taken as a single dose at night or in three divided doses. Dosage should be adjusted to individual patient requirements up to a maximum of 4.5mg daily. Up to 3mg may be given as a single dose.

Children and adolescents from 2 years of age

Up to 1.5mg daily, usually as a divided dose, although up to 1mg has been given as a single dose at night.

Use in the elderly

Clinical work with SANOMIGRAN has not shown elderly patients to require different dosages from younger patients.

Special populations

Renal and hepatic impairment

Caution is required in patients with renal or hepatic impairment and dosage adjustment may be necessary (see section 5.2).

Method of administration

Oral.

4.3 Contraindications

Known hypersensitivity to pizotifen or any of the excipients (see section 6.1 List of excipients).

4.4 Special Warnings And Precautions For Use

SANOMIGRAN Elixir does not contain sucrose nor tartrazine. The sweetening agent in SANOMIGRAN Elixir is maltitol liquid at a concentration of 4g in 5ml. Maltitol liquid contains 45% readily absorbable carbohydrate. This should be considered if prescribing the drug for diabetic patients.

Hepatic injury has been reported, ranging from transaminase elevations to severe hepatitis. Pizotifen treatment should be discontinued if there is any clinical evidence of hepatic dysfunction during treatment and until the cause of the liver abnormality is determined.

Although the anticholinergic activity of SANOMIGRAN is relatively weak, caution is required in the presence of closed angle glaucoma and in patients with a predisposition to urinary retention. Dosage adjustment may be necessary in patients with kidney insufficiency.

Pizotifen should be used with caution in patients with epilepsy (see section 4.8 Undesirable effects).

Withdrawal symptoms like depression, tremor, nausea, anxiety, malaise, dizziness, sleep disorder and weight decrease have been reported following abrupt cessation of pizotifen, therefore gradual withdrawal is recommended.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

The following drugs may exhibit drug interactions with pizotifen upon concomitant administration.

Anticipated drug interactions to be considered

Pizotifen is extensively metabolized in the liver, primarily by N-glucuronidation. Increased plasma concentration of pizotifen upon concomitant administration of drugs which exclusively undergo glucuronidation can not be excluded.

Central nervous system agents

The central effects of sedatives, hypnotics, antihistamines (including certain common cold preparations) and alcohol may be enhanced by SANOMIGRAN.

SANOMIGRAN antagonises the hypotensive effect of adrenergic neurone blockers.

4.6 Pregnancy And Lactation

Pregnancy

As clinical data with SANOMIGRAN in pregnancy are very limited it should only be administered during pregnancy under compelling circumstances.

Breast-feeding

Although the concentrations of SANOMIGRAN measured in the milk of treated mothers are not likely to affect the infant, its use in nursing mothers is not recommended.

4.7 Effects On Ability To Drive And Use Machines

Pizotifen may cause drowsiness, somnolence, dizziness and other CNS effects. Therefore, caution should be exercised when driving or using machines.

Patients being treated with pizotifen and presenting with drowsiness and/or somnolence episodes must be instructed to refrain from driving or engaging in activities where impaired alertness may put themselves or others at risk.

4.8 Undesirable Effects

The most common side-effects are appetite stimulating effect, increase in body weight and drowsiness (including somnolence and fatigue).

Adverse reactions are ranked under headings of frequency, the most frequent first, using the following convention: Very common ( (

Immune system disorders
	Rare:	Hypersensitivity reactions, face oedema
Metabolism and nutrition disorders
	Very common:	Increased appetite weight increased
Psychiatric disorders
	Rare:	Depression, CNS stimulation (e.g. aggression, agitation), hallucination, insomnia, anxiety
Nervous system disorders
	Common:	Sedation (including somnolence), dizziness
	Rare:	Paraesthesia
	Very rare:	Seizures
Gastrointestinal disorders
	Common:	Nausea, dry mouth
	Uncommon	Constipation
Hepatobiliary disorders
	Unknown:	Hepatic enzyme increased, jaundice, hepatitis*1
Skin and subcutaneous tissue disorders
	Rare:	Urticaria, rash
Musculoskeletal and connective tissue disorders
	Rare: Unknown:	Myalgia, arthralgia Muscle cramps*1
General disorders and administration site conditions
	Common	Fatigue

^*1 These adverse events were reported in patients treated with pizotifen based on post-marketing spontaneous reports.

Withdrawal symptoms

Withdrawal reactions have been reported following abrupt cessation of pizotifen, therefore gradual withdrawal is recommended (see section 4.4 Special warnings and precautions for use). Withdrawal symptoms may include: depression, tremor, nausea, anxiety, malaise, dizziness, sleep disorder and weight decrease.

4.9 Overdose

Symptoms: drowsiness, dizziness, pyrexia, hypotension, dryness of the mouth, confusion, excitatory states (in children), ataxia, nausea, vomiting, dyspnoea, cyanosis, tachycardia, convulsions (particularly in children), coma and respiratory paralysis.

Treatment: Administration of activated charcoal is recommended; in case of very recent uptake, gastric lavage may be considered. Severe hypotension must be corrected (CAVE: adrenaline may produce paradoxical effects). If necessary, symptomatic treatment should be given including monitoring of the cardiovascular and respiratory symptoms. Excitatory states or convulsions may be treated with short acting benzodiazepines.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: antimigraine drug, ATC code: N02C X01

Pharmacodynamic studies demonstrate pizotifen to have powerful anti-serotonin and anti-tryptaminic properties, marked anti-histaminic effects and some antagonistic activity against kinins. It also possesses weak anti-cholinergic effects and sedative properties.

Pizotifen also possesses appetite-stimulating properties.

The prophylactic effect of SANOMIGRAN in migraine is associated with its ability to modify the humoral mechanisms of headache.

It inhibits the permeability-increasing effect of serotonin and histamine on the affected cranial vessels, thereby checking the transudation of plasmakinin so that the pain threshold of the receptors is maintained at 'normal' levels. In the sequence of events leading to migraine attack, depletion of plasma serotonin contributes to loss of tone in the extracranial vessels. Pizotifen inhibits serotonin re-uptake by the platelets, thus maintaining plasma serotonin and preventing the loss of tone and passive distension of the extracranial arteries.

5.2 Pharmacokinetic Properties

Absorption

Absorption of pizotifen in man is fast (absorption half life 0.5 to 0.8 hours) and nearly complete. The absolute bioavailablility is 78%. Maximum blood levels are reached 5 hours after a single 2mg oral administration of pizotifen (parent compound and N-glucuronide-conjugate measured together).

Biotransformation

Pizotifen is extensively metabolised Glucuronidation is the main route of biotransformation and the main metabolite (N-glucuronide-conjugate) accounting for at least 50% of the plasma and 60-70% of urinary excreted radioactivity.

Distribution

Protein binding of pizotifen in human plasma in vitro amounts to 91%. The distribution volume in man is 833 L and 70 L for pizotifen and its N-glucuronide, respectively.

Elimination

About one-third of an orally applied dose is excreted via the biliary route into the faeces, a significant proportion, corresponding to about 18% of the applied dose, representing parent drug, likely produced in the intestine after biliary excretion of the N-glucuronide-conjugate. Less than 1% of the administered dose of pizotifen is excreted unchanged in the urine, whereas up to 55% is excreted as metabolites.

Pizotifen is eliminated with a half life of approximately 23 hours (total radioactivity). Unchanged pizotifen and the N-glucuronide have, as estimated from the excretion in the urine, a comparable elimination half-life.

Special patient groups

In patients with kidney insufficiency dosage adjustment may be necessary.

5.3 Preclinical Safety Data

There are no pre-clinical data of relevance to the prescriber, which are additional to that already included in other sections of the SPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

The syrup contains raspberry flavour 50969, maraschino flavour, methyl hydroxybenzoate, propyl hydroxybenzoate, citric acid (anhydrous), disodium phosphate (anhydrous), maltitol liquid, ethanol 96% and purified water.

6.2 Incompatibilities

None.

6.3 Shelf Life

60 months.

6.4 Special Precautions For Storage

None.

6.5 Nature And Contents Of Container

The syrup is clear, colourless liquid, with a fruity odour and taste and comes in amber glass bottles with a polypropylene closure or polypropylene child resistant, tamper evident cap (polythene wad faced with PP, PVDC or PET lining) in a 300ml pack size.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

Novartis Pharmaceuticals UK Limited

(trading as Sandoz Pharmaceuticals)

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

8. Marketing Authorisation Number(S)

PL 00101/0163

9. Date Of First Authorisation/Renewal Of The Authorisation

06 June 1983 / 11 March 2009

10. Date Of Revision Of The Text

11 October 2011

LEGAL CATEGORY

POM