Perindopril 2mg, 4mg and 8mg Tablets
Perindopril tert-butylamine
Read all of this leaflet carefully before you start taking this medicine
- Keep this leaflet. You may need to read it again.
- If you have any further questions, consult your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others.
It may harm them, even if their symptoms are the same as yours. - If any of the side effects becomes serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
- 1. What are Perindopril tablets and what they are used for?
- 2. What you should know before you take Perindopril tablets.
- 3. How is Perindopril tablets taken?
- 4. Possible side effects.
- 5. How to store Perindopril tablets.
- 6. Further information.
What are Perindopril tablets and what they are used for
Perindopril belongs to a group of medicines called ACE inhibitors. These work by widening the blood vessels. This makes it easier for your heart to pump blood through the body.
Perindopril 2mg or 4mg tablets are used to:
- treat high blood pressure (hypertension)
- treat heart failure (a condition where the heart is unable to pump enough blood to meet the body’s needs)
- reduce the risk of cardiac events, such as heart attack, in patients with stable coronary artery disease (a condition where the blood supply to the heart is reduced or blocked) and who have already had a heart attack and/or an operation to improve the blood supply to the heart by widening the vessels that supply it.
Perindopril 8mg tablets are used to:
- treat high blood pressure (hypertension)
- reduce the risk of cardiac events, such as heart attack, in patients with stable coronary artery disease (a condition where the blood supply to the heart is reduced or blocked) and who have already had a heart attack and/or an operation to improve the blood supply to the heart by widening the vessels that supply it.
Before you take Perindopril tablets
Do not take Perindopril tablets:
- If you are allergic (hypersensitive) to perindopril or to any of the other ingredients of Perindopril tablets or to any other ACE inhibitor (see Further Information, section 6),
- if you have in the past suffered from acute swelling of the face, tongue or larynx (angioneurotic syndrome), regardless of whether or not it has been caused by treatment with a similar medicine (ACE inhibitor).
- If you are more than 3 months pregnant. (it is also better to avoid Perindopril tablets in early pregnancy (see pregnancy section).
Children
Perindopril tablets are not for use in children.
Take special care with Perindopril tablets
Talk to your doctor before taking Perindopril tablets if:
- you have narrowing of the heart valves (aortic or mitral stenosis) or heart muscle disease (hypertrophic cardiomyopathy) or narrowing of the artery supplying the kidney with blood (renal artery stenosis)
- if you have recently had a kidney transplant
- you have any other heart or liver or kidney problems, or if you are having dialysis
- you have diabetes which is not well controlled
- you have been told to limit the salt in your diet or to use a salt-substitute containing potassium
- you have a collagen disease such as systemic lupus erythematosus or scleroderma.
- you are going to have or are having treatment to reduce the effects of an allergy to bee or wasp stings
- you are going to have cholesterol removed from your blood by a machine (LDL apheresis).
- You must tell your doctor if you think you are (or might become) pregnant.
Perindopril tablets are not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after that stage (see pregnancy section).
In the event of the occurrence of a feeling of tightness in the chest and swelling of the face and tongue (angioneurotic oedema), you should immediately notify your doctor and stop the treatment with Perindopril tablets 2mg, 4mg or 8mg. This applies to all ACE inhibitors.
Tell the doctor or pharmacist that you are taking Perindopril tert-butylamine if:
- you are about to have an operation or a general anaesthetic
- you have recently had diarrhoea or vomited
- your blood pressure is not sufficiently lowered due to ethnic affiliation
(particularly in patients with black skin colour)
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without prescription.
In particular, talk to your doctor before taking Perindopril tert-butylamine if you are taking:
- medicines for high blood pressure including water tablets (diuretics)
- water tablets (diuretics) which affect potassium, such as spironolactone, triamterene or amiloride
- medicines to increase your level of potassium
- heparin (for thinning the blood) can also affect potassium levels in your blood
- medicines for diabetes (insulin or tablets)
- lithium (for mania or depression)
- medicines for mental illness such as depression, anxiety, schizophrenia or other psychosis
- allopurinol for gout
- medicines to treat auto-immune disorders (such as rheumatoid arthritis) or given after transplant surgery. These are called immunosupressants.
- procainamide (for irregular heartbeat)
- non-steroidal anti-inflammatory drugs (NSAIDs such as ibuprofen, diclofenac), including aspirin for pain
- medicines for low blood pressure, shock or asthma (including ephedrine, noradrenaline or adrenaline)
- medicines that make the blood vessels wider (vasodilators, such as nitrates).
Ask your doctor if you are not sure what these medicines are. Tell the doctor if you have taken any of the medicines listed above in the past, but have now stopped.
Taking Perindopril tablets with food and drink
It is recommended to take Perindopril tablets in the morning before a meal to reduce the influence of food on the way in which the medicine works. Potassium containing food additives or salt substitutes should not be used if you use Perindopril.
Pregnancy and Breastfeeding:
Ask your doctor or pharmacist for advice before taking any medicine
Pregnancy:
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Perindopril tablets before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Perindopril tablets. Perindopril tablets are not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Breastfeeding:
Tell your doctor if you are breast-feeding or about to start breast-feeding. Perindopril tablets are not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.
Driving and using machines
You may feel dizzy or tired when taking Perindopril tert-butylamine, just as with other ACE inhibitors. If this happens, do not drive or use machines. You must talk to your doctor about this
Important information about some of the ingredients of Perindopril tablets
The tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine
How to take Perindopril tablets
Your doctor will decide on the amount of perindopril tert-butylamine you should start to take. This may be increased depending on your condition and other medicines you are taking. Always take Perindopril tert-butylamine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Do not change the amount of medicine you take unless your doctor tells you. Perindopril tert-butylamine may be used on its own, or with other medicines which lower blood pressure.
- Take Perindopril tablets by mouth only.
- Take them in the morning, before a meal.
- It is best to take your tablet(s) with a glass of water at the same time each day.
Perindopril tert-butylamine is not for use in children.
The usual dose is:
High blood pressure:
- Starting dose - 4mg Perindopril tert-butylamine each day
- after a month, this may be raised to 8mg each day.
8mg each day is the highest amount normally used.
In older people with high blood pressure the daily amounts are usually:
- 2mg each day
- after a month, this may be raised to 4mg each day.
8mg each day is the highest amount used.
Perindopril tert-butylamine 2mg, 4mg or 8mg should only be used with other medicines for high blood pressure which are not also ACE inhibitors.
If you are taking water tablets (diuretics):
- your doctor may stop them 2 to 3 days before you start taking Perindopril tert-butylamine. This is to prevent a fall in your blood pressure.
- if needed, you can start taking water tablets again after you have started Perindopril tert-butylamine.
- if it is not possible to stop your water tablets, then you can take 2mg of perindopril tert-butylamine as well.
Your doctor or pharmacist will tell you exactly what you should do.
The doctor may start you with 2mg perindopril tert-butylamine if:
- your blood pressure is very high
- you do not have enough water in your body (dehydrated).
- you have a low level of salt in your blood.
- you have a heart problem which means that it has difficulty in pumping blood through the body (cardiac decompensation).
- you have high blood pressure due to the blood vessels in the kidneys being blocked (constriction of the arteries).
- you have an excessive drop in blood pressure following the initial dose.
Heart failure:
The 8mg strength is not suitable for treatment of this condition.
- Starting dose 2mg Perindopril tert-butylamine each day.
- after 2 weeks, this may be raised to 4mg each day.
Stable coronary artery disease:
- the usual starting dose is 4mg Perindopril tert-butylamine once daily
- after two weeks, this may be raised to 8mg each day.
In older people with stable coronary artery disease the daily amounts are usually:
- 2mg each day
- after one week, this may be raised to 4mg each day
- and after a further week to 8mg each day which is the highest amount used.
If you take more perindopril tert-butylamine than you should
Immediately contact your doctor if you have taken too high a dose.
The following effects may happen: low blood pressure, shock, kidney problems, fast breathing, fast heartbeat, uneven heartbeat (palpitations), slow heartbeat, feeling dizzy or anxious and cough.
If you forget to take perindopril tert-butylamine
Do not take a double dose to make up for a forgotten dose.
If you have forgotten to take one or more tablets, you should skip the tablets which you have forgotten. Contact your doctor if in doubt.
If you stop taking perindopril tert-butylamine
Do not stop taking Perindopril tablets without talking to your doctor.
Medicines for high blood pressure or heart failure will normally have to be taken for the rest of your life. If you stop taking Perindopril tablets your condition may get worse.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Perindopril Tablets Side Effects
Like all medicines, perindopril tert-butylamine can cause side effects, although not everyone gets them.
If any of the following effects happen, stop taking your tablets and tell your doctor immediately:
- swelling of the face, lips, mouth, tongue or throat
- difficulty in breathing
- feeling dizzy or faint
- very fast or uneven heartbeat.
This is a very rare but serious reaction called angioedema, which can happen with all medicines of this type (ACE inhibitors). You must get treatment immediately, usually in hospital.
Common (affecting 1 or more than 1 in 100 but less than 1 in 10 patients)
- cough, shortness of breath
- feeling faint due to low blood pressure (especially when you start Perindopril tert-butylamine, or when the amount is increased, or when you also take water tablets)
- headache, feeling dizzy or tired, feeling dizzy with a spinning sensation (vertigo), pins and needles, muscle cramps, blurred vision, eye pain, sensation of noises in the ears (tinnitus)
- feeling or being sick, stomach pain or indigestion,
- changes in your sense of taste, diarrhoea, constipation, skin rash, itching.
Uncommon (affecting 1 or more than 1 in 1000 but less than 1 in 100 patients)
- changes in mood or sleep
- tight feeling in the chest, wheezing and short of breath (bronchospasm)
- dry mouth
- kidney problems
- unable to get an erection
- sweating
- wheezing, swelling of the face, tongue or throat, intense itching, skin rash, fainting or feeling dizzy (angioedema).
Very rare (affecting less than 1 in 10,000 patients)
- feeling confused
- uneven heartbeat, chest pain that happens in heart disease (angina), heart attack and stroke (these have happened with ACE inhibitors in people with low blood pressure)
- chest infection (eosinophilic pneumonia), blocked up or runny nose (rhinitis)
- inflamed pancreas (pancreatitis)
- inflamed liver (hepatitis)
- skin reaction like an allergy (erythema multiforme)
- changes in the blood. Your doctor may carry out blood tests to check for this.
- acute kidney problems
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
How to store Perindopril tablets
- Keep out of the reach and sight of children.
- Do not store above 30°C.
Do not use Perindopril tablets after the expiry date which appears on the packet after “do not use after” or “exp”. The first 2 figures show the month, while the last figures show the year.
Medicines should not be disposed of via wastewater or in the household refuse. Ask your pharmacist what you should do with medicines which are no longer required. These measures will help to protect the environment.
Further information
What Perindopril tablets contains
The active substance is: perindopril tert-butylamine.
Each Perindopril 2mg tablet contains 2mg of perindopril tert-butylamine salt equivalent to 1.669mg of perindopril.
Each Perindopril 4mg tablet contains 4mg of perindopril tert-butylamine salt equivalent to 3.338mg of perindopril.
Each Perindopril Tablets 8mg tablet contains 8mg of perindopril tert-butylamine salt equivalent to 6.676mg perindopril.
Other ingredients (excipients) are:
Hydrophobic colloidal silica, microcrystalline cellulose, lactose and magnesium stearate.
What Perindopril tablets looks like and contents of the pack
2 mg: White, round, biconvex tablets, plain on both sides.
4 mg: White, oblong tablets with a break line on both sides, ‘PP’ on one side and ‘4’ on the other.
8 mg: White, round, biconvex tablets with ‘PP’ on one side and ‘8’ on the other.
Each strength of tablet is available in packaging containing 14, 20, 28, 30, 56, 60 and 90 tablets in alu-alu blister packaging.
Not all pack sizes may be marketed.
Marketing Authorisation holder and Manufacturer
Marketing Authorisation holder
Manufacturers
This leaflet was last approved in June 2009
GLEPL003
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