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
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 get 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
The name of your medicine is Perindopril 2 mg or 4 mg or 8 mg Film-coated Tablets. The tablets are available in three strengths. In the rest of this leaflet your medicine is called Perindopril.
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.
Do not take Perindopril:
- if you are allergic (hypersensitive) to perindopril or any of the other ACE inhibitors or to any of the other ingredients in the tablets (see section 6 Further information).
- if you have had symptoms such as wheezing, swelling of the face, tongue or throat, intense itching, skin rashes, fainting or dizziness with previous ACE inhibitor treatment or 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 are breastfeeding (see section “Pregnancy and breast-feeding”)
Perindopril should not be given to children.
If you think any of the above situations applies to you do not
take the tablets. Consult your doctor and take his/her advice.
Take special care with Perindopril
You should check with your doctor 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 disease such as systemic lupus erythematosus or scleroderma;
- if you are on a salt restricted diet or use salt substitutes which contain potassium;
- if you suffer from diabetes;
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).
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. In particular, you should check with your doctor if you are taking any of the following to be sure that it is safe to take Perindopril at the same time:
- other medicines for treating high blood pressure including diuretics (water tablets);
- potassium-sparing diuretics (e.g. spironolactone, triamterene or amiloride); potassium supplements and 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 used for the treatment of auto-immune disorders (e.g. rheumatoid arthritis) or following transplant surgery;
- 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).
Ask your doctor if you are not sure what these medicines are. If you go into hospital, let the medical staff know you are taking perindropil.
Taking Perindopril with food and drink
It is recommended that Perindopril should be taken 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 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
Do not drive or use machinery if you experience dizziness or weariness while taking Perindopril. If this occurs you should talk to your doctor.
Always take Perindropil exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Your doctor will decide on the right starting dose for you and on any increase in the dose depending on your condition and whether you are taking any other medicines. Do not change your dosage unless your doctor tells you to do so. Perindopril may be used on their own or with other medicines which lower blood pressure.
Method of administration:
Take your tablet(s) with a glass of water, preferably at the same time each day, in the morning, before a meal. If you are taking water tablets (diuretics), your doctor may decide to reduce or even discontinue these at the beginning of your treatment with Perindopril.
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The usual dosages for Perindopril Tablets are as follows:
High blood pressure:
- Adults: the usual starting and maintenance dose for treatment is 4 mg once daily. After a month, this can be increased to 8 mg a day which is the maximum recommended dose.
- Elderly (65 years or over): the usual starting dose is 2 mg once a day. After a month, this can be increased to 4 mg a day and if necessary to 8 mg a day.
Heart failure:
- Adults & the elderly: 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.
- Elderly (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
Perindopril Tablets are not suitable for use in children.
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 as your doctor has told you. However, if you forget to take one or more doses, take the next dose at the usual time and then carry on as normal. 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.
• Very rare (affects less than 1 user in 10,000)
- confusion
- irregular heartbeat, angina, heart attack and stroke (these have been reported with ACE inhibitors in association with low blood pressure)
- rare type of pneumonia called eosinophilic pneumonia
- blocked up or runny nose (rhinitis)
- inflammation of the pancreas (pancreatitis)
- inflammation of the liver (hepatitis)
- skin reaction like an allergy called erythema multiforme
- kidney failure
- changes in the blood: your doctor may decide to carry out blood tests at intervals to monitor for this.
- in case of diabetic patients, hypoglycaemia (very low blood sugar level) can occur.
- vasculitis (inflammation of blood vessels) has 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.
Keep out of the reach and sight of children.
Do not use Perindopril 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.
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.
Like all medicines, perindopril can cause side effects, although not everybody gets them.
Do not be alarmed by the list below, you may not get any of them.
Stop taking your tablets at once and TELL YOUR DOCTOR IMMEDIATELY if you experience any of the following effects of angioedema:
- swelling of the face, lips, mouth, tongue or throat
- difficulty in breathing, dizziness or fainting
- unusual fast or irregular heart beat.
This is a serious reaction which can occur with all drugs of this type (ACE inhibitors). It must be treated immediately, usually in hospital.
Other side effects that may occur:
• Common (affects 1 to 10 users in 100)
- cough, shortness of breath
- light-headedness due to low blood pressure (particularly after the first few doses, if the dose is increased or when water tablets are also taken)
- 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 (affects 1 to 10 users in 1,000)
- changes in mood or sleep
- tightening of the chest, wheezing and shortness of breath (bronchospasm)
- dry mouth
- kidney problems
- impotence
- sweating
- serious allergic reaction which cause swelling of face, tongue or throat (angioedema)
What Perindopril Tablets contain
• The active substance is Perindopril Erbumine Monohydrate. 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.
Manufacturer:
APC Pharmaceuticals & Chemicals (Europe) Limited,
9th Floor, CP House,
97-107 Uxbridge Road,
Ealing,
London W5 5TL.
Distributed By:
APC Pharmaceuticals & Chemicals (Europe) Limited,
9th Floor, CP House,
97-107 Uxbridge Road,
Ealing, S
London W5 5TL
This leaflet was last revised in October 2012.
G L O B A Li