PERINDOPRIL 2 mg, 4mg and 8mg tablets
perindopril tert-butylamine salt
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, ask 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
- 1. What PERINDOPRIL is and what it is used for
- 2. Before you take PERINDOPRIL
- 3. How to take PERINDOPRIL
- 4. Possible side effects
- 5. How to store PERINDOPRIL
- 6. Further information
What Perindopril Is And What It Is Used For
PERINDOPRIL is an angiotensin converting enzyme (ACE) inhibitor. These work by widening the blood vessels, which makes it easier for your heart to pump blood through them.
PERINDOPRIL is used:
- to treat high blood pressure (hypertension),
- to treat heart failure (a condition where the heart is unable to pump enough blood to meet the body’s needs),
- to 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
Do not take PERINDOPRIL
- if you are allergic (hypersensitive) to perindopril, to any other ACE inhibitor or to any of the other ingredients of PERINDOPRIL,
- if you are more than 3 months pregnant. (It is also better to avoid PERINDOPRIL in early pregnancy – see pregnancy section.),
- if you have experienced symptoms such as wheezing, swelling of the face, tongue or throat, intense itching or severe skin rashes with previous ACE inhibitor treatment or if you or a member of your family have had these symptoms in any other circumstances (a condition called angioedema).
Take special care with PERINDOPRIL
If any of the following apply to you please talk to your doctor before taking PERINDOPRIL:
- if you have aortic stenosis (narrowing of the main blood vessel leading from the heart) or hypertrophic cardiomyopathy (heart muscle disease) or renal artery stenosis (narrowing of the artery supplying the kidney with blood),
- if you have any other heart problems,
- if you have liver problems,
- if you have kidney problems or if you are receiving dialysis,
- if you suffer from a collagen vascular disease such as systemic lupus erythematosus or scleroderma,
- if you have diabetes,
- if you are on a salt restricted diet or use salt substitutes which contain potassium,
- if you are going to have a general anaesthetic and/or major surgery,
- if you are to undergo LDL apheresis (which is removal of cholesterol from your blood by a machine),
- if you are going to have desensitisation treatment to reduce the effects of an allergy to bee or wasp stings,
- if you have recently suffered from diarrhoea or vomiting, or are dehydrated,
- if you have been told by your doctor that you have an intolerance to some sugars,
You must tell your doctor if you think that you are (or might become) pregnant. PERINDOPRIL is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).
PERINDOPRIL is not recommended for use in children and adolescents.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Treatment with PERINDOPRIL can be affected by other medicines. These include:
- other medicines for high blood pressure, including diuretics (medicines which increase the amount of urine produced by the kidneys),
- potassium-sparing diuretics (spironolactone, triamterene, amiloride), potassium supplements or potassium-containing salt substitutes,
- lithium for mania or depression,
- non-steroidal anti-inflammatory drugs (e.g. ibuprofen) for pain relief or high dose aspirin,
- medicines to treat diabetes (such as insulin or metformine),
- medicines to treat mental disorders such as depression, anxiety, schizophrenia etc (e.g. tricyclic antidepressants, antipsychotics),
- immunosuppressants (medicines which reduce the defence mechanism of the body) used for the treatment of auto-immune disorders or following transplant surgery (e.g. ciclosporin),
- allopurinol (for the treatment of gout),
- procainamide (for the treatment of an irregular heart beat),
- vasodilators including nitrates (products that make the blood vessels become wider),
- heparin (medicines used to thin blood),
- medicines used for the treatment of low blood pressure, shock or asthma (e.g. ephedrine, noradrenaline or adrenaline).
Taking PERINDOPRIL with food and drink
It is preferable to take PERINDOPRIL before a meal.
Pregnancy and breast-feeding
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 before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of PERINDOPRIL. PERINDOPRIL is 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.
Breast-feeding
Tell your doctor if you are breast-feeding or about to start breast-feeding. PERINDOPRIL is 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
PERINDOPRIL usually does not affect alertness but dizziness or weakness due to low blood pressure may occur in certain patients. If you are affected in this way, your ability to drive or to operate machinery may be impaired.
Important information about some of the ingredients of PERINDOPRIL
PERINDOPRIL contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
How To Take Perindopril
Always take PERINDOPRIL exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Swallow your tablet with a glass of water, preferably at the same time each day, in the morning, before a meal. Your doctor will decide on the correct dose for you.
The usual dosages are as follows:
High blood pressure: the usual starting and maintenance dose is 4 mg once daily. After one month, this can be increased to 8 mg once a day if required. 8 mg a day is the maximum recommended dose for high blood pressure.
If you are 65 or older, the usual starting dose is 2 mg once a day. After a month this can be increased to 4 mg once a day and then if necessary to 8 mg once daily.
Heart failure: the usual starting dose is 2 mg once daily. After two weeks, this can be increased to 4 mg once a day, which is the maximum recommended dose for heart failure.
Stable coronary artery disease: the usual starting dose is 4 mg once daily. After two weeks, this can be increased to 8 mg once daily, which is the maximum recommended dose in this indication.
If you are 65 or older, the usual starting dose is 2 mg once a day. After a week this can be increased to 4 mg once a day and after a further week to 8 mg once daily.
If you take more PERINDOPRIL than you should
If you take too many tablets, contact your nearest accident and emergency department or tell your doctor immediately. The most likely effect in case of overdose is low blood pressure which can make you feel dizzy or faint. If this happens, lying down with the legs raised can help.
If you forget to take PERINDOPRIL
It is important to take your medicine every day as regular treatment works better. However, if you forget to take a dose of PERINDOPRIL, take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.
If you stop taking PERINDOPRIL
As the treatment with PERINDOPRIL is usually life-long, you should discuss with your doctor before stopping this medicinal product.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible Side Effects
Like all medicines, PERINDOPRIL can cause side effects, although not everybody gets them.
If you experience any of the following, stop taking the medicinal product at once and tell your doctor immediately:
- swelling of the face, lips, mouth, tongue or throat, difficulty in breathing,
- severe dizziness or fainting,
- unusual fast or irregular heart beat.
In decreasing order of frequency, side effects can include:
- Common (occur in fewer than 1 in 10 users but in more than 1 in 100 users): headache, dizziness, vertigo, pins and needles, vision disturbances, tinnitus (sensation of noises in the ears), light-headedness due to low blood pressure, cough, shortness of breath, gastro-intestinal disorders (nausea, vomiting, abdominal pain, taste disturbances, dyspepsia or difficulty of digestion, diarrhoea, constipation), allergic reactions (such as skin rashes, itching), muscle cramps, feeling of weakness,
- Uncommon (occur in fewer than 1 in 100 users but in more than 1 in 1000 users): mood swings, sleep disturbances, bronchospasm (tightening of the chest, wheezing and shortness of breath), dry mouth, angioedema (symptoms such as wheezing, swelling of the face, tongue or throat, intense itching or severe skin rashes), kidney problems, impotence, sweating,
- Very rare (occur in fewer than 1 in 10,000 users): confusion, cardiovascular disorders (irregular heart beat, angina, heart attack and stroke), eosinophilic pneumonia (a rare type of pneumonia), rhinitis (blocked up or runny nose), erythema multiforme, disorders of the blood, pancreas or liver.
- In case of diabetic patients, hypoglycaemia (very low blood sugar level) can occur.
- Vasculitis (inflammation of blood vessels) have been reported.
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
Keep out of the reach and sight of children.
Do not use PERINDOPRIL after the expiry date which is stated on the carton and blister. The expiry date refers to the last day of that month.
Do not store above 30° C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Further Information
What PERINDOPRIL contains
- The active substance is perindopril tert-butylamine. One tablet contains 2 mg, 4 mg or 8 mg perindopril tert-butylamine corresponding to 1.669, 3.338 and 6.676 mg perindopril respectively.
- The other ingredients are: microcrystalline cellulose, lactose monohydrate, hydrophobic colloidal silica, magnesium stearate.
What PERINDOPRIL looks like and contents of the pack
PERINDOPRIL 2 mg Tablets are white, round, biconvex tablets.
PERINDOPRIL 4 mg Tablets are white, oblong tablets half-scored on both sides. The tablet can be divided into equal halves.
PERINDOPRIL 8 mg Tablets are white, round, convex tablets.
The tablets are available in blister packs (PVC/Aluminium) of 5, 7, 10, 14, 15, 20, 28, 30, 50, 56, 60, 84, 90, 100, 112, 120 or 500 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder :
Local Contact:
Slough
Manufacturer:
and
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This leaflet was last approved in April 2009
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