Perindopril 2 Mg Film-Coated Tablets
Package leaflet: Information for the user
Perindopril 2 mg, 4 mg & 8 mg Film-coated Tablets
Perindopril Erbumine Monohydrate The name of this medicine is Perindopril 2 mg, 4 mg & 8 mg Film-coated Tablets, which will be referred to as Perindopril throughout this leaflet.
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Perindopril is and what it is used for
2. What you need to know before you take Perindopril
3. How to take Perindopril
4. Possible side effects
5. How to store Perindopril
6. Contents of the pack and other information
1. What Perindopril is and what it is used for
Perindopril is the active substance of this medicine. Perindopril belongs to a group of medicines called ACE inhibitors. 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.
2. What you need to know before you take Perindopril
Do not take Perindopril:
- if you are allergic (hypersensitive) to perindopril or to any of the other ACE inhibitors or to any of the other ingredients of this medicine (listed in section 6)
- if you have experienced symptoms such as wheezing, swelling of the face, tongue or throat, intense itching or severe skin rasheswith 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)
- if you are more than 3 months pregnant. (it is also better to avoid Perindopril in early pregnancy - see
section “Pregnancy and breast-feeding”).
- if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.
Warnings and precautions
Talk to your doctor or pharmacist before taking Perindopril.
- if you have narrowing of the main blood vessel leading from the heart (aortic stenosis) or cardiac muscle disease (hypertrophic cardiomyopathy) or narrowing of the artery supplying the kidney with blood (renal artery stenosis);
- if you have any other heart problems or liver problems or kidney problems, or if you are receiving dialysis;
- if you suffer from a collagen vascular disease (disease of the connective tissue) such as systemic lupus erythema tosus or scleroderma;
- if you are on a salt restricted diet or use salt substitutes which contain potassium;
- if you suffer from diabetes;
- if you are of black origin since you may have a higher risk of angioedema and this medicine may be less effective in lowering your blood pressure than in non-black patients.
- if you are taking any of the following medicines used to treat high blood pressure:
* An angiotensin II receptor blocker (ARBs) (also known as sartans-for example valsartan, telmisartan, irbesartan), in particular if you have diabetes-related kidney problems.
* Aliskiren
Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.
See also information under the heading ‘Do not take Perindopril’
You should also inform your doctor or the medical staff that you are taking Perindopril:
- if you are to undergo anaesthesia and/or surgery;
- if you have suffered from recent diarrhoea or vomiting or are dehydrated;
- if you are going to have desensitisation treatment to reduce the effects of an allergy to bee or wasp stings;
- if you are to undergo LDL apheresis (which is removal of cholesterol from your blood by a machine).
You must tell your doctor if you think 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).
Angioedema
Angioedema (a severe allergic reaction with swelling of the face, lips, tongue or throat with difficulty in swallowing or breathing) has been reported in patients treated with ACE inhibitors, including Perindopril. This may occur at any time during treatment. If you develop such as symptoms, you should stop taking Perindopril and see a doctor immediately. See section 4.
Children and adolescents
The use of Perindopril in children and adolescents up to the age of 18 years is not recommended.
Other medicines and Perindopril
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Treatment with Perindopril can be affected by other medicines. Your doctor may need to change your dose and/or to take other precautions. These include:
- other medicine for high blood pressure, including angiotensin II receptor blocker (ARB), aliskiren (see also information under headings "Do not take Perindopril" and Warnings and precautions") or diuretics (medicines which increase the amount of urine produced by the kidneys),
- potassium-sparing drugs (e.g. triamterene or amiloride), potassium supplements or potassium-containing salt substitutes;
- medicines for the treatment of diabetes (insulin or tablets such as metformin) to lower blood sugar;
- lithium for mania or depression;
- medicines for the treatment of mental disorders such as depression, anxiety, schizophrenia or other psychoses;(e.g. tricyclic antidepressants, antipsychotics),
- allopurinol used for the treatment of gout;
- 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, tacrolimus),
- procainamide, a treatment for irregular heartbeat;
- non-steroidal anti-inflammatory drugs (e.g. ibuprofen) for pain relief or aspirin;
- medicines used for the treatment of low blood pressure, shock or asthma (e.g. ephedrine, noradrenaline or adrenaline);
- vasodilators including nitrates (products that make the blood vessels become wider);
- heparin (used to thin the blood).
- potassium-sparing drugs used in the treatment of heart failure: eplerenone and spironolactone at doses between 12.5 mg to 50 mg a day,
- baclofen (used to treat muscle stiffness in diseases such as multiple sclerosis),
- trimethoprim (for the treatment of infections),
- estramustine (used in cancer therapy),
- gold salts, especially with intravenous administration (used to treat symptoms of rheumatoid arthritis).
Your doctor may need to change your dose and/or to take other precautions:
If you are taking an angiotensin II receptor blocker (ARB) or aliskiren (see also information under the headings ‘Do not take Perindopril’ and ‘Warnings and precautions’)
Perindopril with food and drink
It is recommended that Perindopril should be taken before a meal.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this 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 beforeyou 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 at that stage.
Breastfeeding
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.
3. How to take Perindopril
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The score line is only there to help you break the tablet if you have difficulty swallowing it whole.
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 recommended dosages are as follows:
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High blood pressure:
- Adults: 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.
- Older (65 years or over): 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:
- Adults & Older: treatment should be started under close medical supervision with 2 mg once a day. After two weeks, it can be increased to 4 mg once a day which is the maximum recommended dose for heart failure.
Stable coronary artery disease:
- Adults: the usual starting dose is 4 mg once daily. After two weeks and if 4 mg is well tolerated, this can be increased to 8 mg once daily which is the maximum recommended dose in this indication.
- Older (65 years or over): the usual starting dose is
2 mg once daily. After one week, this can be increased to 4 mg once daily and after a further week to 8 mg once daily.
Your doctor may give you a blood test to check that your kidneys are working properly before increasing the dose to 8 mg. Treatment for these conditions is usually life-long. Use in children and adolescents
Use in children and adolescents is not recommended.
If you take more Perindopril than you should
If you take too many tablets, contact your nearest hospital accident and emergency department or tell your doctor immediately. The most likely effect of an overdose is low blood pressure which can make you feel faint or dizzy. If this happens, laying down on your back with your 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 one or more doses, take the next dose at the usual time. Do not take a double dose to make up for a dose which you forgot.
If you stop taking Perindopril
The taking of perindopril is usually life-long; you should discuss stopping taking your tablets with your doctor before you stop taking your medicine.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, perindopril can cause side effects,
although not everybody gets them.
Stop taking the medicinal product and see a doctor
immediately, if you experience any of the following
effects:
- swelling of the face, lips, mouth, tongue or throat, difficulty in breathing (angioedema) (See section 2 “Warnings and precautions”) (Uncommon - may affect up to 1 in 100 people),
- severe dizziness or fainting due to low blood pressure (Common - may affect up to 1 in 10 people),
- unusual fast or irregular heartbeat , chest pain (angina) or heart attack (Very rare - may affect up to 1 in 10,000 people),
- weakness of arms or legs, or problems speaking which could be a sign of a possible stroke (Very rare - may affect up to 1 in 10,000 people),
- sudden wheeziness, chest pain, shortness of breath, or difficulty in breathing (bronchospasm) (Uncommon -may affect up to 1 in 100 people),
- inflamed pancreas which may cause severe abdominal and back pain accompanied with feeling very unwell (Very rare - may affect up to 1 in 10,000 people),
- yellowing of the skin or eyes (jaundice) which could be a sign of hepatitis (Very rare - may affect up to 1 in 10,000 people),
- skin rash which often starts with red itchy patches on your face, arms or legs (erythema multiforme) (Very rare
- may affect up to 1 in 10,000 people).
Other side effects that may occur:
• Common (may affect up to 1 in 10 people)
- cough, shortness of breath
- headache, dizziness, vertigo, tiredness, pins and needles, muscle cramps, visual disturbances (e.g. blurred vision, eye pain), sensation of noises in the ears (tinnitus)
- nausea, vomiting, abdominal pain, changes in your sense of taste, feeling of indigestion, diarrhoea, constipation
- feeling of weakness
- skin rashes, itching
• Uncommon (may affect up to 1 in 100 people)
- changes in mood or sleep
- dry mouth
- kidney problems
- impotence
- sweating
- intense itching or severe skin rashes,
- formation of blister clusters over the skin,
- an excess of eosinophils (a type of white blood cells),
- palpitations,
- tachycardia,
- vasculitis (inflammation of blood vessels),
- photosensitivity reaction (increased sensitivity of the skin to sun),
- arthralgia (joint pain),
- myalgia (muscle pain),
- chest pain,
- malaise,
- oedema peripheral,
- fever,
- fall,
- change in laboratory parameters: high blood level of potassium reversible on discontinuation, low level of sodium, hypoglycaemia (very low blood sugar level) in case of diabetic patients, increased blood urea, and increased blood creatinine.
• Rare (may affect up to 1 in 1,000 people)
- Changes in laboratory parameters: Increased level of liver enzymes, high level of serum bilirubin.
• Very rare (may affect up to 1 in 10,000 people)
- confusion
- somnolence,
- fainting,
- rare type of pneumonia called eosinophilic pneumonia
- blocked up or runny nose (rhinitis)
- kidney failure
- changes in blood values such as a lower number of white and red blood cells,
- lower haemoglobin,
- lower number of blood platelets,
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not
listed in this leaflet. You can also report side effects directly
via the Yellow Card Scheme at:
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Perindopril
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton after “Exp”. The expiry date refers to the last day of that month.
Store in original package in order to protect from moisture. Store below 30°C.
Do not throw away any medicine via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Perindopril Tablets contain
• The active substance is perindopril erbumine monohy drate. Each tablet contains 2, 4 or 8 mg of Perindopril Erbumine.
The other ingredients are:
• Tablet core: mannitol (E421), sodium starch glycolate (Type A), sodium carbonate anhydrous, hypromellose (HPMC E-15), macrogol-6000, talc, simeticone, magnesium stearate.
• Tablet coating: hypromellose 6cps, polyvinyl alcohol, titanium dioxide (E171), talc, lecithin (Soya), xanthan gum.
What Perindopril Tablets look like and contents of the pack
Perindopril 2 mg tablets are white to off-white circular, biconvex film coated tablets plain on both sides.
Perindopril 4 mg tablets are white to off-white, barrel shaped, biconvex film coated tablets, debossed with ‘PE4’ on one side and a central scoreline on the other. The scoreline is only to enable a tablet to be broken in half for ease of swallowing, and not to divide into equal doses. Perindopril 8 mg tablets are white to off-white, barrel shaped, biconvex film coated tablets,debossed with ‘PE8’ on one side and a central scoreline on the other. The scoreline is only to enable a tablet to be broken in half for ease of swallowing, and not to divide into equal doses.
The tablets are supplied in blister packs (Aluminium laminated foil) of 7, 10, 14, 15, 20, 28, 30, 50, 56, 60, 90, 100, 112, 120, 500 tablets per pack.
Not all pack sizes may be marketed
Marketing Authorisation Holder:
Cipla (EU) Limited, Hillbrow House, Hillbrow Road, Esher, Surrey, KT10 9NW, United Kingdom.
Manufacturer:
Cipla (EU) Limited, 4th Floor, 1 Kingdom Street, London, W2 6BY, United Kingdom
This leaflet was last revised in 12/2015.
Cipla
Date : 02-12-15