Perindopril Erbumine 2 Mg Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
PERINDOPRIL ERBUMINE 2 mg TABLETS PERINDOPRIL ERBUMINE 4 mg TABLETS
(perindopril fe/T-butylamine)
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. 1 2 3 4 5 6 7
You must tell your doctor if you think that you are (or might become) pregnant. Perindopril Erbumine 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).
Children and adolescents
Perindopril Erbumine is not recommended for use in children and adolescents.
Other medicines and Perindopril Erbumine Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Perindopril Erbumine can affect the way some other medicines work and some medicines can have an effect on Perindopril Erbumine. In particular, tell your doctor if you are using any of the following medicines:
• Other medicines for high blood pressure, including diuretics (medicines which increase the amount of urine produced by the kidneys).
• Potassium-sparing diuretics (spironolactone, triamterene or amiloride), potassium supplements or potassium-containing salt substitutes.
• Lithium (a medicine for mental health problems).
• Non-steroidal anti-inflammatory drugs
(e.g. ibuprofen) for pain relief or high dose aspirin.
• Medicines to treat diabetes (such as insulin or metformin).
• Medicines to treat mental disorders such as depression, anxiety or schizophrenia (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).
• Medicines for the treatment of gout (e.g. allopurinol).
• Medicines for the treatment of an irregular heart beat (e.g. procainamide).
• Products that make the blood vessels become wider (i.e. vasodilators, including nitrates).
• medicines used to thin blood (e.g. heparin)
• Medicines used for the treatment of low blood pressure, shock or asthma (e.g. ephedrine, noradrenaline or adrenaline).
Taking Perindopril Erbumine with food and drink
It is recommended to take Perindopril Erbumine before a meal.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, thinkyou maybe 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 thinkyou are (or might become) pregnant. Your doctor will normally advise you to stop taking Perindopril Erbumine before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Perindopril Erbumine.
Perindopril Erbumine 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 Erbumine 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 Erbumine 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.
Perindopril Erbumine contains lactose
Perindopril Erbumine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, such as lactose, contact your doctor before taking this medicine.
3.HOWTOTAKE PERINDOPRIL ERBUMINE
Always take this medicine exactly as your doctor or pharmacist has told you. 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 and before a meal. Your doctor will decide on the correct dose for you.
The recommended dose for Perindopril Erbumine is: High blood pressure
The recommended starting and maintenance dose is 4 mg once daily. After one month, this can be increased to 8 mg once a day if required. The maximum recommended dose for high blood pressure is 8 mg a day.
If you are 65 years old or older, the recommended 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 recommended 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 recommended starting dose is 4 mg once daily. After two weeks, this can be increased to 8 mg once a day, which is the maximum recommended dose for this indication. If you are 65 years old or older, the recommended 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 Erbumine 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 Erbumine
It is important to take your medicine every day as regular treatment works better. However, if you forget to take a dose of Perindopril Erbumine, 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 Erbumine
As the treatment with Perindopril Erbumine 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.
4.POSSIBLE SIDE EFFECTS
Like all medicines, this medicine 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 (may affect up to 1 in 10 people):
• 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 -difficulty of digestion, diarrhoea, constipation)
• allergic reactions (such as skin rashes, itching)
• muscle cramps
• tiredness.
Uncommon (may affect up to 1 in 100 people):
• mood swings or sleep disturbances
• tightening of the chest, wheezing and shortness of breath (bronchospasm)
• 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 (may affect up to 1 in 10,000 people):
• 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) has been reported.
If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
5. HOW TO STORE PERINDOPRIL ERBUMINE
Keep this medicine out of the sight and reach of children. Do not store above 25°C. Do not use this medicine after the expiry date, which is stated on the carton and blister after 'EXP2. 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.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Perindopril Erbumine contains
The active substance is perindopril ferf-butylamine. One 2 mg tablet contains 2 mg of perindopril ferf-butylamine, equivalent to 1.669 mg of perindopril. One 4 mg tablet contains 4 mg of perindopril ferf-butylamine, equivalent to 3.338 mg of perindopril.
The other ingredients are:
Lactose anhydrous, magnesium stearate, silica, hydrophobic colloidal, cellulose, microcrystalline, sodium hydrogen carbonate, aluminium lake of sodium copper chlorophyllin E141.
What Perindopril Erbumine looks like and contents of the pack
Perindopril Erbumine 2 mg tablets are green mottled, round, tablets debossed with 'PT' over '2' on one side of the tablet and 'M' on the other side.
Perindopril Erbumine 4 mg tablets are green mottled, capsule shaped, tablets with side notch, debossed with 'PT4' on one side of the tablet and 'M' on the other side. The tablet can be divided into equal halves.
Perindopril Erbumine is available in blisters of 14,30, 60, 90 and 100 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom.
Manufacturers
Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland.
Generics [UK] Limited, Potters Bar, Hertfordshire,
EN6 1TL, United Kingdom.
This leaflet was last revised in: February 2012
Code No.: MH/DRUGS/25/NKD/89 10003750
What is in this leaflet:
What Perindopril Erbumine is and what it is used for.
What you need to know before you take Perindopril Erbumine.
How to take Perindopril Erbumine.
Possible side effects.
How to store Perindopril Erbumine.
Contents of the pack and other information.
1. WHAT PERINDOPRIL ERBUMINE IS AND WHAT IT IS USED FOR
Perindopril Erbumine belongs to a group of medicines known as angiotensin converting enzyme (ACE) inhibitors. These work by making your blood vessels wider, which makes it easier for your heart to pump blood through them.
Perindopril Erbumine 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.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PERINDOPRIL ERBUMINE
Do not take Perindopril Erbumine:
• If you are allergic (hypersensitive) to perindopril, to any other ACE inhibitor or to any of the other ingredients of this medicine (listed in Section 6).
• 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).
Warnings and precautions
Talk to your doctor or pharmacist before taking Perindopril Erbumine 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).
• Have any other heart problems.
• Have liver problems.
• Have kidney problems or if you are receiving dialysis
• Suffer from a collagen vascular disease (disease of the connective tissue) such as systemic lupus erythematosus or scleroderma.
• Have diabetes
• Are on a salt restricted diet or use salt substitutes which contain potassium.
• Are to undergo anaesthesia and/or major surgery.
• Are to undergo LDL apheresis (which is removal of cholesterol from your blood by a machine).
• Are going to have desensitisation treatment to reduce the effects of an allergy to bee or wasp stings.
• Have recently suffered from diarrhoea or vomiting, or are dehydrated.