VIBRAMYCIN 50 CAPSULES

VIBRAMYCIN 50 CAPSULES

(doxycycline)

Please read this leaflet

This leaflet tells you about Vibramycin. Please read it before you start to take the medicine. It will help you. If you do not understand or you want to know more, ask your doctor or pharmacist (chemist). Keep this leaflet, you may want to read it again.

The name of this medicine is Vibramycin 50 mg Capsules.

The active ingredient in the capsules is doxycycline hyclate.

What is in your medicine?

50 mg Capsules Each green/ivory capsule contains 50 mg doxycycline as doxycycline hyclate. Inactive ingredients are: alginic acid, lactose, magnesium stearate, maize starch and sodium lauryl sulphate. The gelatin capsule shell is coloured with indigotine (E132), patent blue V (E131), quinoline yellow (E104), titanium dioxide (E171) and yellow iron oxide (E172).

50 mg capsules come in calendar packs of 28.

Product Licence Holder and Manufacturer

Pfizer Limited

Sandwich

Kent

CT13 9NJ

What type of medicine is Vibramycin?

Vibramycin is one of a group of medicines called tetracycline antibiotics. It is used to treat many different types of infections.

What is your medicine for?

You may be given Vibramycin by your doctor to treat infections such as:

• Chest, lung or nasal infections e.g. bronchitis, pneumonia, sinusitis.


• Urinary tract infections e.g. cystitis, urethritis.


• Acne which is a skin infection.


• Eye infections.


• Sexually transmitted diseases e.g. gonorrhoea, syphilis, chlamydia.


• Fevers associated with louse or tick bites.


• Malaria, when chloroquine is not effective.

Vibramycin is also used to prevent certain infections developing, these are scrub typhus, travellers’ diarrhoea, malaria and leptospirosis.

Your doctor may want you to take Vibramycin to treat another infection not listed above. You may also be prescribed an additional medicine to take with Vibramycin to treat your infection. If in doubt talk to your doctor.

Before you take your medicine

If the answer is YES to any of the questions below DO NOT TAKE VIBRAMYCIN.

• Have you been told you are allergic to Vibramycin or any other tetracycline antibiotic?


• Are you allergic to any of the other ingredients in Vibramycin Capsules listed above?


• Are you pregnant or trying to become pregnant?


• Are you breast feeding?


• Is this medicine prescribed for a child under the age of 12 years?

Tetracyclines should not be used during tooth development (during pregnancy, infancy and children below 12 years old) as such use may lead to permanent discolouration or underdevelopment of the teeth (yellow-grey-brown).

Avoid exposure to strong sunlight while taking this medicine. Your skin may be more sensitive to sunburn than normal. If you get a skin rash, itching, redness or severe sunburn when out in strong sunlight or under ultraviolet light (e.g. on a sun bed) stop taking the medicine and check with your doctor.

If the answer is YES to any of the following questions tell your doctor before you start Vibramycin.

• Are you likely to be exposed to strong sunlight or ultraviolet light (e.g. on a sun bed)?


• Do you have liver problems?


• Do you have myasthenia gravis (a disease which causes unusual tiredness and weakness of certain muscles, particularly in the eyelid)?


• Do you have porphyria (a rare disease of blood pigments)?


• Do you have (or have you ever had) systemic lupus erythematosus? This condition may be worsened by taking Vibramycin.

If you are suspected as having syphilis, your doctor will continue to monitor you after your treatment has stopped.

Can Vibramycin be taken with other medicines?

Some medicines may interfere with Vibramycin. You should tell your doctor if you are taking any of the medicines listed below. Also check with your doctor if you are taking any other medicines:

• Antacids (indigestion remedies), iron preparations, oral zinc or bismuth. If you take these at the same time of day as Vibramycin it may stop this medicine from working properly.



• Warfarin or coumarins (used to prevent blood clots). Tetracyclines may increase the action of these drugs.



• Oral contraceptives (birth control pills). Use of birth control pills with tetracyclines may impair the effect of the birth control pill and increase the chance of unwanted pregnancy.



• Penicillin antibiotics (used to treat infections). Vibramycin may reduce the effect of these antibiotics.



• Alcohol. Alcohol may reduce the effect of Vibramycin.



• Carbamazepine, phenytoin (medicines used to control epilepsy) and barbiturates (used to control epilepsy or as a sedative).



• Cyclosporin (used to affect the body’s immune response).



• Methoxyflurane (an anaesthetic). If you are going to have a general anaesthetic for an operation or dental surgery you must tell your anaesthetist or dentist that you are taking doxycycline.

Can you drive whilst taking this medicine?

This medicine should not affect your ability to drive.

How to take your medicine

Vibramycin should only be taken by mouth.

Usual Dose (Respiratory, Urinary tract, Ophthalmic and other infections):

• 200 mg on the first day then 100 mg daily. The duration of treatment is dependent on the infection being treated.

Acne:

• 50 mg daily for 6-12 weeks, with food or fluid.
  

Sexually Transmitted Diseases:

• 100 mg twice daily for 7-10 days.
  

Primary and Secondary Syphilis:

• 200 mg twice daily for 2 weeks.
  

Fevers associated with louse or tick bites:

• Single dose of 100 mg or 200 mg depending on severity.
  

Treatment of malaria, when chloroquine is not effective:

• 200 mg daily for at least 7 days.
  

Prevention of malaria:

• 100 mg daily from 1-2 days before travelling until 4 weeks after returning.
  

Prevention of scrub typhus:

• Single dose of 200 mg.
  

Prevention of travellers’ diarrhoea:

• 
  
  100 mg twice daily on the first day of travel, followed by 100 mg daily throughout the stay in the area. If you are planning to take these capsules for more than 21 days, please consult your doctor.
  

Prevention of leptospirosis:

• 200 mg once each week during the stay in the area; 200 mg on completion of the trip. If you are planning to take these capsules for more than 21 days, please consult your doctor.
  

Doctors may prescribe different doses to these depending on the infection being treated. Check with your doctor if you are not sure why you have been prescribed the medicine.

The label on the pack will tell you what dose YOU should take, how often and for how long to take it. If you are still not sure, ask your doctor or pharmacist.

• Take Vibramycin capsules with a full glass of water.



• It is best to take your capsules at the same time(s) each day, when standing or while sitting.



• It is important not to lie down for at least thirty minutes after taking Vibramycin capsules, so that the capsule can move as swiftly as possible into the stomach and prevent irritation of the throat or oesophagus (canal taking food from the mouth to the stomach).



• If your stomach is upset, Vibramycin can be taken with milk or a meal.



• Take the capsules for the full time of treatment, even when you begin to feel better. If you stop taking the capsules too soon, the infection may return.

What if you take too many capsules?

An occasional extra dose taken by accident is unlikely to be a problem, but if a large overdose has been taken contact your doctor or your nearest hospital Casualty Department immediately.

What if you miss a dose?

Do not worry. If you forget to take a capsule take it as soon as you can. Take your next capsule at the right time.

How quickly will the treatment start to work?

You should start to feel better within a few days. If you have been given Vibramycin for acne it may be a few weeks before you start to see an improvement.

What if you do not feel better?

If your infection gets worse or you do not start to feel better within a few days (except for acne), or a new infection develops, go back and see your doctor.

YOU WILL FIND MORE ABOUT VIBRAMYCIN ON THE BACK OF THIS LEAFLET

Does this medicine cause undesirable effects?

Vibramycin may cause some undesirable effects.

The undesirable effects listed below are infrequent:

• Upset stomach


• Feeling or being sick


• Stomach pain


• Heartburn


• Diarrhoea


• Difficulty in swallowing


• Sore or painful tongue or mouth


• Loss of appetite


• Flushing


• A ringing or buzzing noise in the ear


• Soreness and itching of the rectal and/or genital area.

These undesirable effects are usually mild. If they are troublesome, severe, or do not wear off as treatment goes on tell your doctor.

Other undesirable effects which may occur include:

• Skin rash.


• Flaking or peeling of the skin.


• Severe skin reactions which may cause you to feel very unwell.


• Your skin may be more sensitive to sunlight than it is normally when taking tetracyclines.


• Very severe headache which may be associated with visual disturbance such as blurred vision.


• Inflammation and/or ulcers of the gullet. These are very unlikely if you take the capsules with water while standing or when sitting (See ‘How to take your medicine’).


• Blood disorders. These are due to an imbalance in numbers of different cell types in the blood. Symptoms may include tiredness, easy bruising or susceptibility to infection.


• Low blood pressure.


• Increased heart rate.


• Aches in the joints or muscles.


• Worsening of a disease called systemic lupus erythematosus (SLE). This is a disease affecting a number of organs.

If any of these undesirable effects occur, consult with your doctor.

All medicines can cause allergic reactions. Serious allergic reactions are very rare. Any sudden wheeziness, difficulty in breathing, chest pain, fever, sudden swellings, rash or itching (especially affecting the whole body) should be reported to a doctor immediately.

The following have also been reported:

• Discolouration of thyroid tissue when given for long periods. But the medicine does not impair thyroid function.


• Inflammation of the bowel


• Bulging fontanelles (soft spot on head) of infants.


• Abnormal liver function tests, inflammation of the liver, jaundice and inflammation of the pancreas.


• Pericarditis (inflammation of the membrane surrounding the heart).


• Discolouration and underdevelopment of teeth.

It is important to tell your doctor or pharmacist if you suffer any other undesirable effects which are not listed above.

Look after your medicine

This treatment is for YOU. Do not give it to others.

Do not take this medicine after the date stamped on the pack.

Where to keep your medicine

• Keep your medicine below 25ºC.


• Keep all medicines out of the reach of children.

Further information

This leaflet does not contain all the information about this medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

The information in this leaflet is about Vibramycin Capsules.

June 2007

© Pfizer Limited

Company Ref: VM6_0