Coversyl Arginine 5mg Film-Coated Tablets
1. What Coversyl Arginine is and what it is used for
2. What you need to know before you take Coversyl Arginine
3. How to take Coversyl Arginine
PACKAGE LEAFLET: INFORMATION FOR THE USER Coversyl® Arginine 5mg Film-Coated Tablets Coversyl® Arginine 10mg Film-Coated Tablets
(perindopril arginine)
Your medicine is available as either of the above names but will be referred to as Coversyl Arginine throughout this leaflet.
Other strengths of this product are available.
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, pharmacist or nurse.
• 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 or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Coversyl Arginine is and what it is used for
2. What you need to know before you take Coversyl Arginine
3. How to take Coversyl Arginine
4. Possible side effects
5. How to store Coversyl Arginine
6. Content of the pack and other information
Coversyl Arginine 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.
Coversyl Arginine 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 Coversyl Arginine
• 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 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).
• if you are more than 3 months pregnant (it is also better to avoid Coversyl Arginine 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 Coversyl Arginine 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,
• have been told by your doctor that you have an intolerance to some sugars,
• are taking any of the following medicines used to treat high blood pressure:
- an “angiotensin ll 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 Coversyl Arginine”.
• 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 Coversyl Arginine. This may occur at any time during treatment. If you develop such symptoms, you should stop taking Coversyl Arginine and see a doctor immediately. See also section 4.
You must tell your doctor if you think you are (or might become) pregnant. Coversyl Arginine 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
The use of perindopril in children and adolescents up to the age of 18 years is not recommended.
Other medicines and Coversyl Arginine
Please tell your doctor or pharmacist if you are taking, or have recently taken or might take any other medicines.
Treatment with Coversyl Arginine 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 ll receptor blockers (ARB), aliskiren (see also information under the headings “Do not take Coversyl Arginine” and “Warnings 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 the treatment of heart failure: eplerenone and spironolactone at doses between 12.5mg to 50mg 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 (such as insulin or metformin),
• 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),
• 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, 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 heart beat),
• vasodilators including nitrates (products that make the blood vessels become wider),
• heparin (medicines used to thin 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).
Coversyl Arginine with food and drink
It is preferable to take Coversyl Arginine 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 Coversyl Arginine before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Coversyl Arginine. Coversyl Arginine 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
T ell your doctor if you are breast-feeding or about to start breastfeeding. Coversyl Arginine 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
Coversyl Arginine 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.
Coversyl Arginine contains lactose
Coversyl Arginine 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.
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 5mg once daily. After one month, this can be increased to 10mg once a day if required. 10mg a day is the maximum recommended dose for high blood pressure.
If you are 65 or older, the usual starting dose is 2.5mg once a day. After a month this can be increased to 5mg once a day and then if necessary to 10mg once daily.
