Coversyl 10 mg Film-Coated Tablets

Each Coversyl 5 mg, film-coated tablet contains 5 mg perindopril arginine salt. Each Coversyl 10 mg, film-coated tablet contains 10 mg perindopril arginine salt. Coversyl 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 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).

Do not take Coversyl if

• you are allergic to perindopril, or to any other ACE-inhibitor or to any of the ingredients of Coversyl (listed in Section 6).
• you are pregnant or trying to become pregnant.
• you are breastfeeding or plan to breastfeed.
• 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 (This rare condition is known as angioedema).
• If you have porphyria.
• if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.
• if you are having dialysis or any other type of blood filtration. Depending on the machine that is used, Coversyl may not be suitable for you,
• if you have kidney problems where the blood supply to your kidneys is reduced (renal artery stenosis).
• if you are being treated with sacubitril/valsartan, a medicine for heart failure as the risk of angioedema (rapid swelling under the skin in an area such as the throat) is increased (see (see Take special care and Taking other medicines and Coversyl).
• If you take fluoroquinolones (antibiotics).

Warnings and precautions

Take special care

• If you are undergoing desensitisation treatment, or have had an allergic reaction during previous desensitisation treatment (e.g. treatments using bee, wasp or ant venom).
• are to undergo LDL apheresis (which is removal of cholesterol from your blood by a machine),
• If you are to undergo anaesthesia and/or surgery.
• if you have recently suffered from diarrhoea or vomiting, or are dehydrated,
• You have any other health problems, including: Kidney disease or if you are receiving dialysis. Liver disease. Diabetes. Heart disease.
• Contact your doctor to re-evaluate your treatment if you are treated with ACE-inhibitors/Angiotensin receptor blockers together with a fluoroquinolone antibiotic,
• if you have abnormally increased levels of a hormone called aldosterone in your blood (primary aldosteronism),
• 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 been told by your doctor that you have an intolerance to some sugars.

If you suffer from a collagen vascular disease such as systemic lupus erythematosus or scleroderma.

if you are on a salt restricted diet or use salt substitutes which contain potassium,

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.

if you are taking aliskiren (medicines used to treat hypertension). Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.

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,

if you are taking any of the following medicines, the risk of angioedema is increased:

• racecadotril (used to treat diarrhoea),
• sirolimus, everolimus, temsirolimus and other drugs belonging to the class of so-called mTor inhibitors (used to avoid rejection of transplanted organs and for cancer),
• sacubitril (available as fixed-dose combination with valsartan), used to treat long-term heart failure.
• linagliptin, saxagliptin, sitagliptin, vildagliptin and other drugs belonging to the class of also called gliptins (used to treat diabetes).

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. This may occur at any time during treatment. If you develop such symptoms, you should stop taking Coversyl and see a doctor immediately (see Possible side effects). (Also see section 4).

Do not share medicines prescribed for you with any other person. Always take Coversyl exactly as your doctor has instructed you. You should check with your doctor if you are unsure. Swallow your tablet(s) with a glass of water, preferably in the morning before a meal. The dose of Coversyl you may need each day will be decided and adjusted by your doctor. The usual dosages are as follows:

Dosage in high blood pressure

The recommended dosage is 5 mg orally taken in the morning before breakfast, which can be increased to a single daily dose of 10 mg if necessary, after one month of treatment.

Dosage in elderly patients and heart failure

In elderly patients and patients with heart failure, treatment should be started at a dose of 2.5 mg, which may progressively be increased to 5 mg after one month, then to 10 mg if necessary, depending on kidney function.

Use in children and adolescent Use in children and adolescent is not recommended.

Coversyl can have side effects. Not all side effects reported for this medicine are included in this leaflet. Should your general health worsen, or you experience any untoward effects while taking this medicine, please consult your doctor, pharmacist or other healthcare professional for advice. 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 (angioedema) (See section 2 “Warnings and precautions”),
• severe dizziness or fainting, due to low blood pressure,
• unusual fast or irregular heartbeat, chest pain (angina), heart attack.
• weakness of arms or legs, or problems speaking which could be a 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).
• skin rash which often starts with red itchy patches on your face, arms or legs (erythema multiforme)

In decreasing order of frequency, side effects can include:

Frequent

• 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 as skin rashes, itching),
• muscle cramps,
• feeling of tiredness.

Less Frequent

• depression
• mood swings,
• sleep disturbances,
• dry mouth,
• intense itching or severe skin rashes),
• formation of blister clusters over the skin,
• kidney problems,
• 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,
• peripheral oedema,
• fever,
• fall,
• change in laboratory parameters: high blood level of potassium reversible on discontinuation, low level of sodium, hypoglycaemia (very low blood sugar level) in case of diabetic patients, increased blood urea, and increased blood creatinine.
• acute renal failure,
• dark urine, feeling sick (nausea) or being sick (vomiting), muscle cramps, confusion and seizures. These may be symptoms of a condition called SIADH (inappropriate antidiuretic hormone secretion).

decreased or absent urine output,

flushing,

worsening of psoriasis,

changes in laboratory parameters: Increased level of liver enzymes, high level of serum bilirubin.

confusion,

eosinophilic pneumonia (a rare type of pneumonia),

rhinitis (blocked up or runny nose),

changes in blood values such as a lower number of white and red blood cells, lower haemoglobin, lower number of blood platelets.

If you have these symptoms contact your doctor as soon as possible.

Frequency not known (cannot be estimated from available data): Discoloration, numbness and pain in fingers or toes (Raynaud’s phenomenon). If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of 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 to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form” found online under SAHPRA’s publications https//www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of Coversyl.

Store at or below 30 °C in a dry place. Store all medicine out of reach of children. Do not use after the expiry date stated on the blister.

Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains and sewerage systems (e.g. toilets).