Perindopril Tert-Butylamine 2mg Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Perindopril tert-butylamine 2 mg Tablets Perindopril tert-butylamine 4 mg Tablets Perindopril tert-butylamine 8 mg 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, 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 tert-butylamine Tablets are and what they are used for
2. Before you take Perindopril tert-butylamine Tablets
3. How to take Perindopril tert-butylamine Tablets
4. Possible side effects
5. How to store Perindopril tert-butylamine Tablets
6. Further information
1. WHAT PERINDOPRIL TERT-BUTYLAMINE TABLETS ARE 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 tert-butylamine 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.
2. BEFORE YOU TAKE PERINDOPRIL TERT-BUTYLAMINE TABLETS
Do not take Perindopril tert-butylamine Tablets
- if you are allergic (hypersensitive) to perindopril or any of the other ingredients of Perindopril tert-butylamine Tablets (see Further Information, section 6).
- if you have had symptoms such as wheezing, swelling of the face, tongue or throat, intense itching, skin rash, fainting or feeling dizzy.
If you have had these symptoms when you have taken an ACE inhibitor in the past or at any other time, this may be angioedema. If so, do not take Perindopril tert-butylamine Tablets.
- if you are more than 3 months pregnant (It is also better to avoid Perindopril tert-butylamine Tablets in early pregnancy - see pregnancy section.)..
If any of the above applies to you, talk to your doctor and do not take Perindopril tert-butylamine Tablets. Take special care with Perindopril tert-butylamine Tablets
Talk to your doctor before taking Perindopril tert-butylamine 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)
- 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.
Tell the doctor or pharmacist that you are taking Perindopril tert-butylamine Tablets if:
- you are about to have an operation or a general anaesthetic
- you have recently had diarrhoea or vomitted
- you are going to have 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).
Tell the doctor if any of the situations above have happened to you in the past.
You must tell your doctor if you think you are (or might become) pregnant. Perindopril tert-butylamine 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).
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, talk to your doctor before taking Perindopril tert-butylamine Tablets 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 tert-butylamine Tablets with food and drink
Drinking alcohol with Perindopril tert-butylamine Tablets may make you feel dizzy. Check with your doctor whether you can drink alcohol when taking this medicine.
Take your Perindopril tert-butylamine Tablets in the morning before a meal.
Pregnancy and breast-feeding
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 tert-butylamine 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 tert-butylamine Tablets. Perindopril tert-butylamine 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.
Breastfeeding
Tell your doctor if you are breast-feeding or about to start breast-feeding. Perindopril tert-butylamine 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.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
You may feel dizzy or tired when taking Perindopril tert-butylamine Tablets. 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 tert-butylamine 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 medicinal product.
Information on special patient groups
Perindopril tert-butylamine Tablets should not be given to children.
3. HOW TO TAKE PERINDOPRIL TERT-BUTYLAMINE TABLETS
Your doctor will decide on the amount of perindopril you should start to take. This may be increased depending on your condition and other medicines you are taking. Always take Perindopril tert-butylamine Tablets 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 may be used on its own, or with other medicines which lower blood pressure.
- Take Perindopril tert-butylamine 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.
The usual dose is:
High blood pressure:
- 4 mg each day
- after a month, this may be raised to 8 mg each day.
8 mg each day is the highest amount normally used.
In older people with high blood pressure the daily amounts are usually:
- 2 mg each day
- after a month, this may be raised to 4 mg each day.
8 mg each day is the highest amount used.
If you are taking water tablets (diuretics):
- your doctor may stop them 2 to 3 days before you start taking Perindopril tert-butylamine Tablets. 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 Tablets.
- if it is not possible to stop your water tablets, then you can take 2 mg of perindopril as well.
Your doctor or pharmacist will tell you exactly what you should do.
The doctor may start you with 2 mg perindopril if:
- your blood pressure is very high
- you have not 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).
Heart failure:
- 2 mg each day to start
- after 2 weeks, this may be raised to 4 mg each day. Stable coronary artery disease:
- the usual starting dose is 4 mg once daily
- after two weeks, this may be raised to 8 mg each day. In older people with stable coronary artery disease the daily amounts are usually:
- 2 mg each day
- after one week, this may be raised to 4 mg each day
- and after a further week to 8 mg each day which is the highest amount used.
If you take more Perindopril tert-butylamine Tablets than you should, talk to a doctor or pharmacist straight away.
The following effects may happen:
Low blood pressure, shock, kidney problems, fast breathing, fast heartbeat, uneven heartbeat (palpitations), slow heartbeat, feeling dizzy or anxious, cough.
If you forget to take Perindopril tert-butylamine Tablets
It is important to take your medicine every day. If you forget to take your tablets, take another as soon as you remember. Then take the normal amount the next day. Do not take a double dose to make up for a forgotten tablet.
If you stop taking Perindopril tert-butylamine Tablets
Do not stop taking Perindopril tert-butylamine 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 tert-butylamine Tablets your condition may get worse. 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 tert-butylamine Tablets can cause side effects, although not everybody 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 less than 1 person in 10):
- cough, shortness of breath
- feeling faint due to low blood pressure (especially when you start Perindopril tert-butylamine Tablets, 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 less than 1 person in 100):
- 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).
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Very rare (affecting less than 1 person in 10,000):
- 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.
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.
5. HOW TO STORE PERINDOPRIL TERT-BUTYLAMINE TABLETS
- Keep out of the reach and sight of children.
- Store below 25°C and in the original package Use-by date
Do not use Perindopril tert-butylamine Tablets after the expiry date which is stated on the packet after EXP. The expiry date refers to the last day of that month. 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.
- The active substance is perindopril tert-butylamine.
- The other ingredients are lactose anhydrous and magnesium stearate.
What Perindopril tert-butylamine Tablets look like and contents of the pack
Perindopril tert-butylamine 2 mg Tablets are white, round tablets, engraved “APO" on one side and “PE2" on the other.
Perindopril tert-butylamine 4 mg Tablets are white, capsule shaped tablets, engraved “APO" on one side and “PE" bisect “4" on the other. The tablets can be divided into equal halves.
Perindopril tert-butylamine 8 mg Tablets are white, capsule shaped tablets, engraved “APO" on one side and “PE" bisect “8" on the other. The tablets can be divided into equal halves.
Each strength of Perindopril tert-butylamine Tablets is available in cartons of 4, 7, 14, 15, 28, 30, 50, 56, 60, 90, 100, 112, 120, 500 tablets.
Not all pack sizes may be available.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Apotex Europe B.V., Darwinweg 20, 2333 CR Leiden,
The Netherlands.
Manufacturer Apotex Nederland B.V.,
Archimedesweg 2, 2333 CN Leiden, The Netherlands Distributed by: LPC Medical (UK) Limited 30 Chaul End Lane, Luton, Bedfordshire, LU4 8EZ, United Kingdom
6. FURTHER INFORMATION
What Perindopril tert-butylamine Tablets contain
This leaflet was last approved in April 2009.
06/10
APOTEX UK LTD.
Code: 015728