Covenap 5 mg/10 mg Tablets

The active substance is enalapril maleate. COVENAP tablets are used to treat high blood pressure. COVENAP tablets are also used in the treatment of heart failure after a heart attack. Enalapril decreases the blood vessel resistance by relaxing the muscles in the blood vessels and that reduces the blood pressure. This also helps improve heart function.

Do not take COVENAP

• If you are allergic (hypersensitive) to enalapril or any of the other ingredients in the formulation of COVENAP (listed in section 6).
• If you are pregnant of breastfeeding
• If you have porphyria
• If you take other blood pressure medicines such as those that increase urine formation (water pills)
• If you have a kidney disease
• If you have a history of intolerance of similar medicines
• Any member of your family has had an allergic reaction to these medicines or you have ever had swelling of your face, eyelids, lips, mouth, tongue or throat which caused difficulty in swallowing or breathing (angioedema) when the reason why was not known or it was inherited
• You have diabetes or impaired kidney function and are treated with a blood pressure lowering medicine containing aliskiren
• If you are taking lithium
• If you have a narrowing of your arteries that carry blood to one or both of your kidneys
• If you have an obstruction of blood flow across the aortic valve in the heart
• if you have moderate to severe renal disorder and you are taking blood pressure medicines called ACE inhibitors like enalapril

Warnings and precautions

Take special care with COVENAP

• Tell your doctor immediately if you are planning to get pregnant or expect that you are pregnant
• If you should become pregnant while taking COVENAP tablets. Stop taking the tablets immediately and contact your doctor
• If you have low blood pressure (you may notice this as faintness or dizziness, especially when standing)
• If you have a condition involving the blood vessels in the brain
• If you have a heart problem
• If you have kidney disease, including narrowed blood vessels in your kidneys (renal artery stenosis) or recently had a kidney transplant. These may lead to higher levels of potassium in your blood which can be serious. Your doctor may need to adjust your dose of COVENAP or monitor your blood level for potassium
• If you have a liver problem
• If you have a blood problem such as low or lack of white blood cells (neutropenia/agranulocytosis), low blood platelet count (thrombocytopenia) or a decreased number of red blood cells (anaemia)
• If you have ever had an allergic reaction, ‘angioneurotic oedema’ or ‘angioedema’. The signs include itching, red marks on the hands, feet and throat, swelling of the face, around the eyes, lips, tongue or throat with difficulty in swallowing or breathing. You should be aware that black patients are at increased risk of these type of reactions to ACE inhibitors
• If you are a dialysis patient, are taking diuretics (water tablets), are on a salt restriction diet, or have suffered from excessive vomiting or diarrhoea recently
• If you have diabetes. You should monitor your blood for low blood glucose levels, especially during the first month of treatment. The level of potassium in your blood can also be higher
• If you take extra potassium in your diet or a salt substitute that contains potassium
• If you have collagen vascular disease (e.g. lupus erthematosus, rheumatoid arthritis or scleroderma), are on therapy that suppresses your immune system, are taking the drugs allopurinol or procainamide, or any combinations of these
• 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, etc.), 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 COVENAP"

• You should be aware that ‘COVENAP’ lowers the blood pressure in black patients less effectively than in non-black patients
• If you have developed a cough
• If you are undergoing surgery

If you are about to have any of the following, tell your doctor that you are taking ‘COVENAP’

• Any surgery or receive anaesthetics (even at the dentist)
• A treatment to remove cholesterol from your blood called 'LDL apheresis'
• if you are taking blood pressure medicines called ACE inhibitors like enalapril since taking them together with COVENAP may decrease kidney function.

If any of the above applies to you, talk to your doctor or dentist before the procedure.

Children and adolescents

Safety and efficacy in children has not been established.

Other medicines and COVENAP

Always tell your healthcare professional if you are taking any other medicine. (This includes complementary or traditional medicines.) “Tell your doctor or pharmacist if you are taking any of the following medicines”

• Medicines containing potassium (including dietary salt substitutes), other drugs which can increase potassium in your body (such as heparin and co-trimoxazole also known as trimethoprim/sulfamethoxazole)
• Water tablets (potassium sparing diuretics) such as spironolactone, eplerenone, triamterene or amiloride
• Other medicines to lower blood pressure, such as beta-blockers, angiotensin-receptor-blockers, water tablets (diuretics) such as thiazides, furosemide, bumetanide, a medicine called aliskiren or medicines for chest pain (angina) such as nitroglycerine
• If you are taking an angiotensin II receptor blocker (ARB) or aliskiren (see also information under the headings "Do not take COVENAP if" and "Take Special care with COVENAP")
• Lithium (for some types of mental illness)
• Medicines used for stiffness and inflammation associated with painful conditions, particularly those affecting your muscles, bones and joints: non-steroidal anti-inflammatory drugs, including COX-2-inhibitors (medicines that reduce inflammation, and can be used to help relieve pain)
• Aspirin (acetylsalicylic acid)
• Medicines used to dissolve blood clots (thrombolytics)
• Medicines used to treat abnormal blood glucose levels (antidiabetics)
• Injectable gold (sodium aurothiomalate) - medicines used to block inflammation in the body.

Do not share medicines prescribed for you with any other person. Always take COVENAP tablets exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.

Duration of administration

Your doctor will tell you how long your treatment with COVENAP will last. Do not stop treatment early. If you have the impression that the effect of COVENAP is too strong or too weak, tell your doctor or pharmacist.

Method of administration

The dose of COVENAP tablets might be different for different patients. The number of doses you take each day, the time allowed between doses, and the length of time you take this medicine depend on the medical problem for which you are taking COVENAP. COVENAP, unless otherwise prescribed, should be used as follows: COVENAP is to be taken once daily at the same time of the day with a half a glass of liquid during or after meals.

If you take more COVENAP than you should: In the event of overdosage you may experience dizziness and lightheadedness (very low blood pressure). Consult your doctor or pharmacist, if neither is available, seek help at the nearest hospital or poison control centre. Take this leaflet and the rest of the remaining tablets with you so the doctor will know what you have taken.

If you forget to take COVENAP: Take the missed dose as soon as possible. However, if it is almost time for your next dose, continue to take the next tablets at the usual time. Do not take a double dose.

If you stop taking COVENAP: If you interrupt or end treatment early with COVENAP, your condition may return.

COVENAP can have side effects. Not all side effects reported for COVENAP 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 healthcare professional for advice.

If any of the following happens, stop taking COVENAP and tell your doctor immediately or go to the casualty department at your nearest hospital:

• If you begin to itch, develop a raised red skin rash (hives), get short of breath or wheezy and develop swelling of the hands, feet or ankles, face, eyes, mouth, lips, tongue or throat, which may cause difficulty in breathing or swallowing
• Fainting (syncope)
• Severe abdominal pain (may be caused by inflammation of the pancreas)
• Jaundice (yellowing of the skin or eyes)
• If you get a rash which looks like targets, blisters, skin peeling off in sheets, which may appear also on the lips, eyes, mouth, nose and/or genitals. You may also have a high temperature or joint pain (erythema multiforme)
• If you get severe skin reaction of which symptoms may be reddening of the skin, skin scaling, blistering or raw sores, detachment of the top layer of the skin from bottom layers (‘Steven-Johnson Syndrome’, 'toxic epidermal necrolysis')

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to COVENAP. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Frequent: chest pain
• heart attack (myocardial infarction), stroke (cerebrovascular accident)
• angina pectoris (squeezing, heaviness or pain in the chest caused by decreased blood flow to the muscles of the heart)
• difficulty breathing
• increased blood potassium level, increased levels of creatinine in your blood (both are usually detected by a test).

Less frequent:

• vertigo (spinning sensation)
• Blood disorders which affect the cells or elements in the blood and are usually diagnosed by blood tests (symptoms may be tiredness, weakness, shortness of breath, inability to exercise, feeling run down, having constant or re-occurring colds, fever, chills, prolonged bleeding, bruising where cause is unknown, red or purple spots)
• decreased red blood cells (bone marrow depression) picked up by a blood test
• swollen glands in neck, armpit or groin.
• changes in the way your heart beats, for example if you notice it beating faster (palpitations)
• sudden fall in blood pressure (hypotension)
• a bloating feeling and cramping pain in the abdomen (may be caused by an obstruction of the gut)
• lower back pain and reduction in the volume of urine passed (this may indicate reduced kidney function or kidney failure)
• high level of proteins in the urine (usually detected by a blood test).
• high level of blood urea, low level of sodium, high levels of liver enzymes and serum bilirubin (all measured in a blood test)

These are all serious side effects. You may need urgent medical attention. Tell your doctor if you notice any of the following:

• Frequent: headache
• depression
• blurred vision
• cough
• feeling sick (nausea)
• diarrhoea
• pain around your stomach area (abdominal pain)
• change in sense of taste
• weakness
• tiredness (fatigue)
• rash.

Less Frequent:

• tiredness (which may be due to anaemia or decrease in haemoglobin
• low blood sugar which may cause you to feel shaky
• sleepiness
• pins and needles
• confusion and nervousness
• insomnia, abnormal dreams, sleep disorders
• small arteries, usually in the fingers and toes, go into spasm causing the skin to become pale or patchy red to blue colour and very cold - ('Raynaud's phenomenon')
• flushing
• runny nose and hayfever
• sore throat and hoarseness
• wheeze when you breathe (asthma)
• inflammation of your nose
• pneumonia (signs may be cough, high temperature and difficulty breathing)
• vomiting, indigestion
• constipation, loss of appetite
• stomach irritation, dry mouth
• symptoms may be burning, aching pain with an empty feeling and hunger, particularly when the stomach is empty (peptic ulcer)
• pain, inflammation and/or ulceration of the gums, cheeks, tongue, lips, throat
• excessive sweating
• hair loss
• difficulty getting an erection (impotence)
• enlargement of breasts in men
• muscle cramps and inflammation
• ringing in the ears (tinnitus)
• fever and generally feeling unwell

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor or pharmacist. 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 COVENAP.

Store at or below 25 °C. Protect from light. Do not remove blisters from the carton until required for use. Do not use the medication after the expiry date printed on the container. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets) STORE ALL MEDICINE OUT OF REACH OF CHILDREN.