Perindopril 8mg Tablets
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:
What Perindopril tablets are and what they are used for What you need to know before you take Perindopril tablets _3| How to take Perindopril tablets Possible side effects _5 How to store Perindopril tablets
Contents of the pack and other information
J What Perindopril tablets are and what they are used for
Perindopril contains the active substance perindopril tert-butylamine which 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.
What you need to know before you take Perindopril tablets
Do not take Perindopril tablets:
- If you are allergic to perindopril or any of the other ingredients of this medicine (listed in section 6) or to any other ACE inhibitor.
- 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).
- 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 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)
• have recently had a kidney transplant
• have any other heart or liver or kidney problems, or if you are having dialysis
• have diabetes
• have been told to limit the salt in your diet or to use a salt-substitute containing potassium
• have a collagen disease such as systemic lupus erythematosus or scleroderma.
• are going to have or are having treatment to reduce the effects of an allergy to bee or wasp stings
• are going to have cholesterol removed from your blood by a machine (LDL apheresis)
• 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
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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).
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 tablets"
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 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)
Children and adolescents
Perindopril tablets are not recommended for use in children and adolescents.
Other medicines and Perindopril tablets
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, talk to your doctor before taking Perindopril 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.
• medicines to treat certain types of cancer or tumours (Temsirolimus).
• 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)
• therapy with injectable gold (sodium aurothiomalate)
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 tablets"and"Warnings and precautions').
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.
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:
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
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.
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
Perindopril tablets usually do 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 abilities to drive or to operate machinery may be impaired.
Perindopril 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.
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3| How to take Perindopril 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 this medicine exactly as described in this leaflet or as your doctor has told you. 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 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 recommended dose is:
High blood pressure:
• Starting dose 4mg Perindopril 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. This is to prevent a fall in your blood pressure.
• if needed, you can start taking water tablets again after you have started Perindopril.
• if it is not possible to stop your water tablets, then you can take 2mg of Perindopril as well.
Your doctor or pharmacist will tell you exactly what you should do.
The doctor may start you with 2mg Perindopril 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 each day.
• after 2 weeks, this may be raised to 4mg each day.
Stable coronary artery disease:
• the usual starting dose is 4mg Perindopril 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.
Use in children and adolescents
Perindopril is not for use in children and adolescents.
If you take more Perindopril tablets than you should
Immediately contact your doctor or nearest accident and emergency department 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.
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 tablets
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 tablets
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.
^ Possible Side Effects
Like all medicines, this medicine 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 (may affect up to 1 in 10 people)
• cough, shortness of breath
• feeling faint due to low blood pressure (especially when you start Perindopril, 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 (may affect up to 1 in 100 people)
• 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 (may affect up to 1 in 10,000 people)
• 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
Not Known (frequency cannot be estimated form the available data)
• In case of diabetic patients, hypoglycaemia (very low blood sugar level) can occur
• Vasculitis (inflammation of the blood vessels) have been reported
Reporting 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 www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
How to store Perindopril tablets
• Keep this medicine out of the sight and reach of children.
• Do not store above 30°C.
Do not use this medicine after the expiry date which is stated on the carton after"do not use after"or"exp" The expiry date refers to the last day of that month.
Do not throw away any medicines 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.
Contents of the pack and other 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.
The 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
Actavis Group PTC ehf, Reykjavikurvegur 76-78, 220 Hafnarfjordur, Iceland Manufacturers
Tillomed Laboratories Ltd, 3 Howard Road, Eaton Socon, St Neots Cambridgeshire PE19 8ET United Kingdom
Glenmark Pharmaceuticals s.r.o Fibichova 143, 566 17 Vysoke Myto, Czech Republic Actavis BV, Baarnsche Dijk 1,3741 LN Baarn, The Netherlands Actavis Group PTC ehf, Reykjavikurvegur 76-78, 220 Hafnarfjordur, Iceland This leaflet was last revised in November 2014
Actavis, Barnstaple, EX32 8NS, UK
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