Cosyrel 5 mg Film-Coated Tablets

Cosyrel contains two active ingredients, bisoprolol fumarate and perindopril arginine in one tablet.

• Bisoprolol fumarate belongs to a group of medicines called beta-blockers. Beta-blockers slow down the heart rate and make the heart more efficient at pumping blood around the body.
• Perindopril arginine is an angiotensin converting enzyme (ACE) inhibitor. It works by widening the blood vessels, which makes it easier for your heart to pump blood through them.

Cosyrel is used to treat high blood pressure (hypertension) and/or stable chronic heart failure (a condition where the heart is unable to pump enough blood to meet the body’s needs resulting in breathlessness and swelling) and/or 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. Instead of taking bisoprolol fumarate and perindopril arginine as separate tablets, you will take only one tablet of Cosyrel which contains both active ingredients in the same strength.

Do not take Cosyrel if you

• are allergic to bisoprolol or any other beta-blocker, to perindopril or any other ACE-inhibitor, or to any of the other ingredients of this medicine (listed in section 6),
• have heart failure that suddenly becomes worse and/or that may require hospital treatment,
• have a cardiogenic shock (a serious heart condition caused by very low blood pressure),
• have a heart disease characterised by a slow or irregular heart rate (atrioventricular block second or third degree, sinoatrial block, sick sinus syndrome),
• have a slow heart rate,
• have very low blood pressure,
• have severe asthma or severe chronic lung disease,
• have severe blood circulation problems in your limbs (such as Raynaud’s syndrome), which may cause your fingers and toes to tingle or turn pale or blue,
• have an untreated phaeochromocytoma, which is a rare tumour of the adrenal gland (medulla),
• have metabolic acidosis, a condition where your blood contains too much acid,
• have experienced symptoms such as wheezing, swelling of the face, tongue or throat, with or without breathing difficulty, 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),
• are pregnant or breastfeeding your baby (see pregnancy section),
• have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren,
• are having dialysis or any other type of blood filtration. Depending on the machine that is used, Cosyrel may not be suitable for you,
• have kidney problems where the blood supply to one or both of your kidneys is reduced (renal artery stenosis), or you have only one kidney with a reduced blood supply to the kidney,
• if you are being treated with sacubitril/valsartan, a medicine for heart failure (see “Warning and Precaution” and “Other medicines and Cosyrel”).

Do not share medicines prescribed for you with any other person. Always take Cosyrel exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are not sure. The recommended dose is one tablet once daily. Swallow your tablet with a glass of water in the morning before a meal. In some cases, your doctor may prescribe one half tablet of Cosyrel once daily in the morning before a meal.

Patient with kidney disease

Your doctor may prescribe one half tablet of Cosyrel if you suffer from moderate kidney disease. Cosyrel is not recommended if you suffer from severe kidney disease.

Use in children and adolescents

Cosyrel should not be used in children and adolescents less than 18 years of age.

Cosyrel can have side effects. Not all side effects reported for Cosyrel are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking Cosyrel, please consult your healthcare provider for advice.

Stop taking Cosyrel and see a doctor immediately, if you experience any of the following side effects

• severe dizziness or fainting due to low blood pressure,
• worsening of heart failure causing increased breathlessness and /or retention of fluid (swelling),
• swelling of the face, lips, mouth, tongue or throat, difficulty in breathing (angioedema),
• sudden wheeziness, chest pain, shortness of breath, or difficulty in breathing (bronchospasm),
• unusual fast or irregular heart beat, chest pain (angina) or 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,
• skin rash which often starts with red itchy patches on your face, arms or legs (erythema multiforme).

Cosyrel is usually well tolerated but, you can experience different side effects, particularly when treatment is first started. If you notice any of the side effects listed below or any not listed, please tell your doctor or pharmacist immediately

• Frequent
• slow heart beat.
• headache,
• dizziness,
• vertigo,
• taste disturbances,
• pins and needles,
• tingling or numbness of the hands of feet,
• vision disturbances,
• tinnitus (sensation of noises in the ears),
• feeling of coldness in hands or feet,
• cough,
• shortness of breath,
• gastro-intestinal disorders such as nausea, vomiting, abdominal pain, difficulty of digestion or dyspepsia, diarrhoea, constipation,
• allergic reactions such as skin rashes, itching,
• muscle cramps,
• feeling of tiredness,
• fatigue,
• mood swings,
• sleep disturbances,
• depression,
• dry mouth,
• intense itching or severe skin rashes,
• formation of blister clusters over the skin,
• increased sensitivity of the skin to sun (photosensitivity reaction),
• sweating,
• kidney problems,
• impotence,
• an excess of eosinophils (a type of white blood cells),
• somnolence,
• fainting,
• palpitations,
• tachycardia (fast heart/pulse rate),
• irregular heart rate (AV - conduction disturbances inflammation of blood vessels (vasculitis),
• dizziness when standing up,
• muscle weakness,
• arthralgia (joint pain),
• myalgia (muscle pain),
• chest pain,
• malaise,
• localised swelling (oedema peripheral),
• fever,
• fall,
• changes in laboratory parameters high blood level of potassium reversible on discontinuation, low level of sodium, very low blood sugar level (hypoglycaemia) in case of diabetic patients, increased blood urea, increased blood creatinine.
• Less frequent
• 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 antidiu-retic hormone secretion).
• decreased or absent urine output,
• flushing,
• nightmares, hallucinations,
• reduced tear flow (dry eyes),
• hearing problems,
• erection problems,
• inflammation of the liver which can cause yellowing of the skin or the whites of the eyes,
• allergic runny nose, sneezing,
• allergy-like reactions such as itching, flush, rash,
• psoriasis worsening,
• changes in laboratory parameters increased level of liver enzymes, high level of serum bilirubin, fat levels differing from normal.
• confusion,
• irritation and redness of the eye (conjunctivitis),
• eosinophilic pneumonia (a rare type of pneumonia),
• inflammation of the pancreas (which causes severe pain in the abdomen and the back),
• hair loss,
• appearance or worsening of scaly skin rash (psoriasis), psoriasis-like rash,
• acute renal failure,
• changes in blood values such as a lower number of white and red blood cells, lower haemoglobin, lower number of blood platelets.
• discoloration, numbness and pain in fingers or toes (Raynaud’s phenomenon).

If you have these symptoms contact your doctor as soon as possible. If you notice any side effects not mentioned 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 SA HPRA 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 Cosyrel.

Store at or below 30 °C. Store all medicine out of reach of children. Do not store in bathrooms. Do not use this medicine after the expiry date stated on the outer carton and blister. The expiry date refers to the last day of that month. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains and sewerage systems (e.g. toilets). Once opened, Cosyrel should be used within 60 days.