Perindopril Tert-Butylamine 8mg 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 because it contains
important information for you.
- Keep this leaflet. Y ou 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.
In this leaflet:
1. What Perindopril tert-butylamine is and what it is used for
2. What you need to know before you take Perindopril tert-butylamine
3. How to take Perindopril tert-butylamine
4. Possible side effects
5. How to store Perindopril tert-butylamine
6. Contents of the pack and other information
1. WHAT PERINDOPRIL TERT-BUTYLAMINE IS AND WHAT IT IS USED FOR
Perindopril is an angiotensin converting enzyme (ACE) inhibitor. These work by widening the blood
vessels, which makes it easier for your heart to pump blood through them.
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. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PERINDOPRIL TERT-
BUTYLAMINE
Do not take Perindopril tert-butylamine
- if you are allergic to perindopril tert-butylamine or 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 rash 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)
- 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 you have diabetes or impaired kidney function and you are treated with a blood pressure
lowering medicine containing aliskiren.
Warnings and precautions
If any of the following apply to you please talk to your doctor or pharmacist or nurse before taking Perindopril tert-butylamine:
- 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),
- if you have any other heart problems,
- if you have liver problems,
- if you have 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 erythematosus or scleroderma,
- if you have diabetes,
- if you are on a salt restricted diet or use salt substitutes which contain potassium,
- if you are to undergo anaesthesia and/or major surgery,
- if you are to undergo LDL apheresis (which is removal of cholesterol from your blood by a machine),
- if you are going to have desensitisation treatment to reduce the effects of an allergy to bee or wasp stings,
- if you have recently suffered from diarrhoea or vomiting, or are dehydrated,
- if you have been told by your doctor that you have an intolerance to some sugars,
- 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 tert-butylamine”
- 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.
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 tert-butylamine. This may occur at any time during treatment. If you develop such symptoms, you should stop taking Perindopril tert-butylamine and see a doctor immediately. See also section 4.
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).
Children and adolescents
Perindopril tert-butylamine Tablets should not be given to children and adolescents.
Other medicines and Perindopril tert-butylamine
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Treatment with Perindopril tert-butylamine Tablets can be affected by other medicines. Your doctor may need to change your dose and/or to take other precautions. These include:
- other medicines for high blood pressure, including angiotensin II receptors blockers (ARB),
aliskiren (see also information under the headings “Do not take Perindopril tert-butylamine Tablets” and “Warning and precautions” or diuretics (medicines which increase the amount of urine produced by the kidneys),
- potassium-sparing drugs (e.g.triamterene, amiloride), potassium supplements or potassium-containing salt substitutes,
- potassium-sparing drugs used in treatment of heart failure: eplerenone and spironolactone at doses between 12.5 mg and 50 mg per day,
- lithium for mania or depression,
- non-steroidal anti-inflammatory drugs (e.g. ibuprofen) for pain relief or high dose aspirin,
- medicines to treat diabetes (insulin or metformin and gliptins such as linagliptin, saxagliptin, sitagliptin, vildagliptin),
- baclofen (used to treat muscle stiffness in diseases such as multiple sclerosis),
- medicines to treat mental disorders such as depression, anxiety, schizophrenia etc. (e.g. tricyclic antidepressants, antipsychotics),
- immunosupressants (medicines which reduce the defence mechanism of the body) used for the treatment of auto-immune disorders or following after transplant surgery (e.g. ciclosporin, tacrolimus),
- trimethoprim (for the treatment of infections),
- estramustine (used in cancer therapy),
- allopurinol (for the treatment of gout),
- procainamide (for the treatment of an irregular heartbeat),
- vasodilators including nitrates (medicines that make the blood vessels wider)
- heparin (medicines used to thin the blood),
- medicines used for the treatment of low blood pressure, shock or asthma (e.g.ephedrine, noradrenaline or adrenaline),
- gold salts especially with intravenous administration (used to treat symptoms of rheumatoid arthritis).
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.It is preferable to take your Perindopril tert-butylamine Tablets 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 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.
Driving and using machines
Perindopril tert-butylamine 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 tert-butylamine tablets contains 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.
3. HOW TO TAKE PERINDOPRIL TERT-BUTYLAMINE
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, before a meal. Your doctor will decide on the correct dose for you.
The recommended dosages are as follows:
High blood pressure: 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.
If you are 65 or older, 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: the usual 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 usual starting dose is 4 mg once daily. After two weeks, this can be increased to 8 mg once daily, which is the maximum recommended dose in this indication.
If you are 65 or older, the usual 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.
Use in children and adolescents
Use in children and adolescent is not recommended
If you take more Perindopril tert-butylamine Tablets 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 tert-butylamine Tablets
It is important to take your medicine every day as regular treatment works better. However, if you forget to take a dose of Perindopril tert-butylamine, take the next dose at the usual time. Do not take a double dose to make up for a forgotten tablet.
If you stop taking Perindopril tert-butylamine Tablets
As the treatment with Perindopril tert-butylamine 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.
Stop taking the medicine and see a doctor immediately, if you experience any of the following side effects that can be serious:
- swelling of the face, lips, mouth, tongue or throat difficulty in breathing (angioedema) (See section 2 “Warnings and precautions"),
- severe dizziness or fainting due to low blood pressure,
- unusual fast or irregular heartbeat or chest pain (angina) or heart attack,
- weakness of arms or legs, or problems speaking which could be sign of a possible stroke,
- sudden wheeziness, chest pain, shortness of breath, or difficulty in breathing (bronchospasm),
- inflamed pancreas which may cause severe abdominal and back pain accompanied with feeling very unwell,
- yellowing of the skin or eyes (jaundice) which could be a sign of hepatitis,
- skin rash which often starts with red itchy patches on your face, arms or legs (erythema multiforme).
Stop taking the medicine and tell your doctor if you notice any of the following side effects:
- kidney problems,
- changes in blood tests such as high levels of potassium reversible on discontinuation or low levels of sodium,
- chest infection (eosinophilic pneumonia),
- unexplained bruising or bleeding
- recurring fevers or infections
- feeling tired or breathless more than usual
- changes in blood values such as a lower number of white and red blood cells, lower haemoglobin, lower number of blood platelets.
Other side effects:
Common (may affect up to 1 in 10 people):
- headache,
- dizziness,
- vertigo,
- pins and needles,
- vision disturbances,
- tinnitus (sensation of noises in the ears),
- cough,
- shortness of breath (dyspnoea),
- gastro-intestinal disorders (nausea, vomiting, abdominal pain, taste disturbances, dyspepsia or difficulty of digestion, diarrhoea, constipation),
- allergic reactions (such skin rashes, itching),
- muscle cramps,
- feeling of weakness.
Uncommon (may affect up to 1 in 100 people):
- mood swings,
- sleep disturbances,
- dry mouth,
- intense itching or severe skin rashes,
- formation of blister clusters over the skin,
- impotence,
- sweating,
- excess of eosinophils (a type of white blood cells),
- somnolence,
- fainting,
- 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: 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 10,000people):
- confusion,
- rhinitis (blocked up or runny nose),
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE PERINDOPRIL TERT-BUTYLAMINE
Keep this medicine out of the sight and reach of children.
Store below 25°C and in the original package
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.
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 protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Perindopril tert-butylamine Tablets contains
- 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, biconvex 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
Distributor
Distributed by: Apotex UK Ltd, 6 Ridgeway Court, Grovebury Road, Leighton Buzzard, Bedfordshire, LU7 4SF, United Kingdom