How does it work?

Coversyl arginine tablets contain the active ingredient perindopril,which is a type of medicine called an ACE inhibitor. (NB. Perindopril is alsoavailable without a brand name, ie as thegeneric medicine.)

ACE inhibitors work by blocking the action of a compound in thebody called angiotensin converting enzyme (ACE). Normally ACE produces anothercompound called angiotensin II, as part of the body's natural control of bloodpressure. Angiotensin II causes blood vessels to constrict and narrow, whichincreases the pressure within the blood vessels.

As perindopril blocks the action of ACE, it reduces theproduction of angiotensin II. This means that the blood vessels are allowed torelax and widen. The overall effect of this is a drop in blood pressure, henceperindopril can be used to lower high blood pressure.

The reduced pressure within the blood vessels means that theheart doesn't have to work as hard to pump the blood around the body. Thismeans that ACE inhibitors can be used to improve the symptoms of heart failure,where the heart is not pumping as efficiently, and to improve survivalfollowing a heart attack.

It is recommended that Coversyl arginine tablets are taken in the morningbefore breakfast.

What is it used for?

• Heart failure.
• High blood pressure (hypertension).
• Reducing the risk of further heart attacks in people with stable coronary heart disease who have had a heart attack or heart bypass surgery.

Warning!

• Coversyl arginine tablets replaced Coversyl tablets in April 2008. Coversyl arginine tablets contain a different salt of perindopril to the old Coversyl tablets (perindopril arginine instead of perindopril tert-butylamine). This new salt has an extended shelf-life and greater stability. Coversyl arginine is equivalent to the old Coversyl in terms of safety and effectiveness, and the action of the medicine has not changed. However, the new tablets come in different packaging and in different strengths to the old Coversyl tablets. Coversyl arginine 2.5mg tablets are equivalent to the old Coversyl 2mg tablets. Coversyl arginine 5mg tablets are equivalent to the old Coversyl 4mg tablets and Coversyl arginine 10mg tablets are equivalent to the old Coversyl 8mg tablets. Generic perindopril tablets remain available; these contain the tert-butylamine salt. Coversyl arginine 2.5mg tablets are equivalent to generic perindopril 2mg tablets. Coversyl arginine 5mg tablets are equivalent to generic perindopril 4mg tablets and Coversyl arginine 10mg tablets are equivalent to generic perindopril 8mg tablets. If you have any questions or concerns about this change you should talk to your pharmacist.
• Some people may experience dizziness caused by low blood pressure in the first few days of taking this medicine and in particular the first dose. For this reason, the first dose should preferably be taken at bedtime. Your doctor may want you to take the first dose of this medicine under medical supervision in hospital if you are aged over 70 years, have low blood pressure, low levels of fluids or salt in your blood (eg due to dehydration), severe or unstable heart failure, kidney problems, or are taking high doses of diuretic medicines, multiple diuretic medicines, or certain other medicines that dilate your blood vessels.
• If you feel dizzy during treatment this can be relieved by lying down until the symptoms pass. If affected you should avoid performing potentially hazardous tasks such as driving or operating machinary. If you frequently feel dizzy you should let your doctor know, as your dose may need reducing.
• Alcohol may enhance the blood pressure lowering effect of this medicine, which can increase dizziness and may increase the risk of fainting.
• ACE inhibitors can sometimes cause an allergic reaction called angioedema. Stop taking this medicine and consult your doctor immediately if you experience difficulty breathing or swallowing, or swelling of your face, lips, tongue, throat, hands, feet or ankles while taking this medicine. This type of allergic reaction has been reported more frequently in people of Afro-Caribbean origin.
• Your blood pressure, kidney function and the amount of potassium in your blood should be regularly monitored while you are taking this medicine.

Use with caution in

• Elderly people.
• Decreased liver function.
• Decreased kidney function.
• Narrowing of the arteries that supply blood to the kidneys (renal artery stenosis).
• High blood pressure caused by compression or blockage of the arteries that carry blood to the kidneys (renovascular hypertension).
• People with low fluid volume or salt levels in the body, eg due to diuretic therapy, low-sodium diet, diarrhoea or vomiting.
• People taking other medicines for high blood pressure, particularly diuretics (see end of factsheet).
• People with hardening of the arteries (athersclerosis) in the heart (cardiovascular disease), brain (cerebrovascular disease) or legs (peripheral vascular disease).
• Narrowing of the main artery of the body (aortic stenosis).
• Heart valve disease (mitral valve stenosis).
• Heart disease characterised by thickening of the internal heart muscle and a blockage inside the heart (hypertrophic obstructive cardiomyopathy).
• Diseases affecting connective tissue, eg scleroderma, systemic lupus erythematosus or rheumatoid arthritis (collagen vascular diseases).
• Diabetes.
• People with kidney failure requiring a certain type of haemodialysis (high-flux membrane).
• People undergoing therapy to decrease allergy to bee or wasp stings (desensitisation).
• People receiving therapy to remove certain types of fat from the blood using a machine (LDL apheresis).

Not to be used in

• Allergy to other ACE inhibitor medicines.
• History of swelling of the lips, face or tongue (angioedema) with no known cause, or caused by previous use of an ACE inhibitor medicine.
• Hereditary angioedema (angioneurotic oedema).
• Pregnancy.
• Breastfeeding.
• Rare hereditary problems of galactose intolerance, glucose-galactose malabsorption, or the Lapp lactase deficiency (Coversyl arginine tablets contain lactose).
• The safety and efficacy of this medicine in children have not been studied. It is not recommended for children.

This medicine should not be used if you are allergic to one orany of its ingredients. Please inform your doctor or pharmacist if you havepreviously experienced such anallergy.If you feel you haveexperienced an allergic reaction, stop using this medicine and inform yourdoctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy orbreastfeeding. However, other medicines may be safely used in pregnancy orbreastfeeding providing the benefits to the mother outweigh the risks to theunborn baby. Always inform your doctor if you are pregnant or planning apregnancy, before using any medicine.

• This medicine must not be used during pregnancy, particularly during the second and third trimesters, as it may be harmful to the unborn baby. Seek further medical advice from your doctor. If you get pregnant while taking this medicine, stop taking it and consult your doctor immediately.
• This medicine passes into breast milk. The manufacturer states that it should not be taken by women who are breastfeeding. Seek further medical advice from your doctor.

Side effects

Medicines and their possible side effects can affect individualpeople in different ways. The following are some of the side effects that areknown to be associated with this medicine. Just because a side effect is statedhere does not mean that all people using this medicine will experience thator any side effect.

Common (affect between 1 in 10 and 1 in 100 people)

• Headache.
• Pins and needles sensations.
• Low blood pressure (hypotension).
• Dizziness.
• Visual disturbances.
• Sensation of ringing or other noise in the ears (tinnitus).
• Dry cough.
• Shortness of breath.
• Disturbances of the gut such as diarrhoea, constipation, indigestion, nausea, vomiting or abdominal pain.
• Alteration in taste.
• Rash or itching.
• Muscle cramps.
• Feeling of weakness.

Uncommon (affect between 1 in 100 and 1 in 1000 people)

• Sleep disturbances.
• Changes in mood.
• Impotence.
• Sweating.
• Dry mouth.
• Severe swelling of lips, face, tongue or throat (angioedema - see warning above).
• Problems with kidney function.

Very rare (affect less than 1 in 10,000 people)

• Chest pain.
• Confusion.
• Inflammation of the pancreas (pancreatitis).
• Disturbances in the normal levels of blood cells in the blood (tell you doctor if you get a sore throat, mouth ulcers, high temperature (fever), or feel tired or generally unwell while taking this medicine).
• Problems with liver function, including jaundice or hepatitis (consult your doctor promptly if you develop unexplained itching, yellowing of the skin or eyes, unusually dark urine, nausea and vomiting, abdominal pains, loss of appetite or flu-like symptoms while taking this medicine).

The side effects listed above may not include all of the sideeffects reported by the medicine'smanufacturer.For moreinformation about any other possible risks associated with this medicine,please read the information provided with the medicine or consult your doctoror pharmacist.

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicinesyou are already taking, including those bought without a prescription andherbal medicines, before you start treatment with this medicine. Similarly,check with your doctor or pharmacist before taking any new medicines whiletaking this one, to ensure that thecombination is safe.

This medicine will have an additive effect with other medicinesthat decrease blood pressure, particularly other medicines used to treat highblood pressure (antihypertensives). In people taking antihypertensive medicinesit may cause a large drop in blood pressure with the first dose or after anydose increases, particularly in people taking diuretic medicines such asfurosemide. This may cause dizziness, which can usually be relieved by lyingdown until the symptoms pass. If you aretaking a diuretic medicine, your doctor may reduce your dose or ask you to stoptaking it for a few days before starting perindopril. This is to prevent yourblood pressure from dropping too low. If you frequently feel dizzy while taking thismedicine in combination with other blood pressure lowering medicines you shouldlet your doctor know, as your doses may need adjusting. Other medicines thatdecrease blood pressure include the following:

• ACE inhibitors such as enalapril
• alpha-blockers such as prazosin
• alprostadil
• angiotensin II receptor antagonists such as losartan
• antipsychotics
• baclofen
• benzodiazepines, eg diazepam, temazepam
• beta-blockers such as propranolol
• calcium channel blockers such as nifedipine, diltiazem
• clonidine
• diazoxide
• diuretics, eg furosemide, bendroflumethiazide
• dopamine agonists, eg bromocriptine, apomorphine
• hydralazine
• levodopa
• MAOI antidepressants, eg phenelzine
• methyldopa
• minoxidil
• moxonidine
• nicorandil
• nitrates, eg glyceryl trinitrate.

Non-steroidal anti-inflammatory drugs (NSAIDs, eg indometacin,aspirin, ibuprofen) may reduce the blood pressure lowering effect ofperindopril, and may increase the risk of a decline in kidney function.

There may be a risk of raised potassium levels in the blood(hyperkalaemia) if any of the following medicines are taken with perindopril,hence these are not normally recommended for use in combination withperindopril. If you are taking any of the following with this medicine youshould have regular blood tests to monitor the amount of potassium in yourblood:

• angiotensin II receptor antagonists, eg losartan
• ciclosporin
• drospirenone
• heparin
• potassium-containing salt substitutes (eg Lo-Salt)
• potassium salts, eg potassium citrate for cystitis
• potassium-sparing diuretics (eg spironolactone, triamterene, amiloride)
• potassium supplements.

Perindopril may increase the blood level of the medicine lithiumand for this reason, it is not normally recommended for people taking lithium.People taking this medicine in combination with lithium should have the levelof lithium in their blood closely monitored.

Perindopril may enhance the blood sugar lowering effect ofinsulin and oral antidiabetic medicines, and may increase the risk of low bloodsugar (hypoglycaemia). People with diabetes should therefore carefully monitortheir blood sugar while taking this medicine, particularly in the first fewweeks of treatment.

There may be an increased risk of a drop in the normal numbersof blood cells in the blood if this medicine is used in combination with any ofthe following medicines:

• allopurinol
• azathioprine
• immunosuppressant therapy
• procainamide.

If you are taking any of these in combination with thismedicine, you should have regular blood tests to monitor the levels of yourblood cells, particularly if you also have any kidney problems or diseasesaffecting connective tissue, eg scleroderma, systemic lupus erythematosusor rheumatoid arthritis (collagen vascular diseases). Tell your doctor if you experience any signs ofinfection, such as fever, sore throat or mouth ulcers, as these could be signsof problems with your white blood cells.

Other medicines containing the same active ingredient

Perindopril tablets are also available without a brand name, ieas thegeneric medicine. Generic perindopril tablets contain the tert-butylamine salt. As a result, Coversyl arginine 2.5mg tablets are equivalent to generic perindopril 2mg tablets. Coversyl arginine 5mg tablets are equivalent to generic perindopril 4mg tablets and Coversyl arginine 10mg tablets are equivalent to generic perindopril 8mg tablets.

Coversyl arginine pluscontains perindopril arginine in combination with the diuretic indapamide.