Coversyl Plus Tablets

Coversyl Plus is a combination of two active ingredients, perindopril and indapamide. It is an anti-hypertensive and is used in the treatment of high blood pressure (hypertension) in adults. Perindopril belongs to a class of medicines called ACE-inhibitors. These work by widening the blood vessels, which makes it easier for your heart to pump blood through them. Indapamide is a diuretic. Diuretics increase the amount of urine produced by the kidneys. However, indapamide is different from other diuretics, as it only causes a slight increase in the amount of urine produced. Each of the active ingredients reduces blood pressure and they work together to control your blood pressure. Coversyl Plus is used to treat high blood pressure.

Do not take Coversyl Plus:

• if you are hypersensitive (allergic) to perindopril or any other ACE-inhibitor, or to indapamide or any other sulphonamides or any of the other ingredients of Coversyl Plus,
• if you have experienced symptoms such as wheezing, swelling of the face or tongue, 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 have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren,
• if you have severe liver disease or suffer from a condition called hepatic encephalopathy (degenerative disease of the brain),
• if you have a severe kidney disease where the blood supply to your kidneys is reduced (renal artery stenosis),
• if you are receiving dialysis, or any other type of blood filtration. Depending on the machine that is used, Coversyl Plus may not be suitable for you.
• if you have low or high blood potassium,
• if you are suspected of having untreated decompensated heart failure (severe water retention, difficulty in breathing),
• if you are pregnant or trying to become pregnant,
• if you are breastfeeding,
• If you have porphyria,
• 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 take lithium or potassium-sparing diuretics (spironolactone, triamterene, amiloride) or potassium salts (see Taking other medicines),
• If you are being treated with sacubitril/valsartan, a medicine for heart failure (see “Warnings and Precautions” and “Taking other medicines with Coversyl Plus”).
• If you take fluoroquinolones (antibiotics)

Do not share medicines prescribed for you with any other person. Always take Coversyl Plus exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. The recommended dosage is one tablet orally taken in the morning before breakfast. Your doctor will tell you how long your treatment with Coversyl Plus will last. Do not stop treatment early because this could cause your blood pressure to increase. If you have the impression that the effect of Coversyl Plus is too strong or too weak, tell your doctor or pharmacist. Your doctor may decide to modify the dosage regimen if you suffer from kidney function impairment.

If you take more Coversyl Plus than you should: The most likely effect in case of overdose is low blood pressure. If marked low blood pressure occurs (symptoms such as dizziness or faintness), lying down with the legs raised can help. In the event of overdosage, consult your doctor or pharmacist. If neither is available seek help at the nearest hospital or poison control centre.

If you forget to take Coversyl Plus: It is important to take Coversyl Plus every day as regular treatment is more effective. However, if you forget to take a dose of Coversyl Plus, take the next dose at the usual time. Do not take a double dose to make up for forgotten individual doses.

If you stop taking Coversyl Plus: As the treatment for high blood pressure is usually life-long, you should discuss with your doctor before stopping Coversyl Plus.

Coversyl Plus can have side effects. Not all side effects reported for Coversyl Plus are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking this medicine, please consult your doctor, pharmacist or other health care professional for advice. If any of the following happen stop taking Coversyl Plus and tell your doctor immediately or go to your nearest casualty department at your nearest hospital:

• Severe dizziness or fainting due to low blood pressure,
• Bronchospasm (tightening of the chest, wheezing and shortness of breath),
• Swelling off the face, lips, mouth, tongue or throat, difficulty in breathing (angioedema) (See section 2 “Warnings and precautions”),
• Severe skin reactions including erythema multiforme (a skin rash which often starts with red itchy patches on your face, arms or legs) or intense skin rash, hives, reddening of the skin over your whole body, severe itching, blistering, peeling and swelling of the skin, inflammation of mucous membranes (Stevens Johnson Syndrome) or other allergic reactions,
• Cardiovascular disorders (irregular heartbeat, angina pectoris (pains to the chest, jaw and back, brought on by physical effort), heart attack)
• Weakness of arms or legs, or problems speaking which could be a sign of a possible stroke,
• 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,
• Life-threatening irregular beat,
• Disease of the brain caused by liver illness (Hepatic encephalopathy),

In decreasing order of frequency, other side-effects of Coversyl Plus can include:

• Frequent: Skin reactions in subjects predisposed to allergic and asthmatic reactions, 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, abdominal pain, anorexia, vomiting, stomach pain, taste disturbances, dry mouth, dyspepsia or difficulty of digestion, diarrhoea, constipation, allergic reactions (such as skin rash, itching), cramps, feeling of tiredness.
• Less frequent: Mood swings, sleep disturbances, urticaria (hives – raised itchy red spots), purpura (red pinpoints on skin), formation of blisters, kidney problems, impotence, sweating, an excess of eosinophils (a type of white blood cells), change in laboratory parameters: high blood level of potassium reversible on discontinuation, low blood level of sodium, somnolence (sleepiness), fainting, palpitations (awareness of your heartbeat), tachycardia (fast heartbeat), hypoglycaemia (very low blood sugar level) in case of diabetic patients, vasculitis (inflammation of blood vessels), dry mouth, photosensitivity reactions (increased sensitivity of the skin to sun), arthralgia (joint pain), myalgia (muscle pain), chest pain, malaise, peripheral oedema, fever, increased blood urea, increased blood creatinine, fall. Worsening of psoriasis, changes in laboratory blood tests (increased level of liver enzymes, high level of serum bilirubin, high level of calcium in the blood), fatigue. Confusion, eosinophilic pneumonia (a rare type of pneumonia), blocked up or runny nose, severe kidney problems, changes in blood values such as a lower number of white and red blood cells, lower haemoglobin, lower number of blood platelets, high level of calcium in the blood, abnormal hepatic function. If you suffer from systemic lupus erythematosus (a type of collagen disease), this might get worse. Abnormal ECG heart tracing, changes in laboratory parameters: low potassium levels, high uric acid levels and high sugar levels in the blood, short sightedness (myopia), blurred vision, visual impairment, discolouration, numbness and pain in fingers or toes (Raynaud’s phenomenon). Disorders of the blood, kidney, liver or pancreas and changes in laboratory parameters (blood tests) can occur. Your doctor may need to give you blood tests to monitor your condition. Concentrated urine (dark in colour), feel or are sick, have muscle cramps, confusion and fits which may be due to inappropriate ADH (anti-diuretic hormone) secretion can occur with ACE-inhibitors. If you have these symptoms contact your doctor as soon as possible. If you notice any side effects not listed in this leaflet, please inform 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 Plus.

Store all medicine out of reach of children. Store at or below 25 °C in a dry place. Keep the container tightly closed. Do not store in bathrooms. Do not use after the expiry date stated on the carton. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains and sewerage systems (e.g. toilets).