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WHAT YOU NEED TO KNOW BEFORE YOU TAKE ENALAPRIL MALEATE TABLETS

Do not take Enalapril maleate Tablets • if you are allergic (hypersensitive) to enalapril maleate or any of the other ingredients of this medicine (listed in section 6) • if you have ever had an allergic reaction to a type of medicine similar to this medicine called an ACE inhibitor • if you have ever had swelling of your face, lips, mouth, tongue or throat which caused difficulty in swallowing or breathing (angioedema) when the reason why was not known or it was inherited • if you are more than 3 months pregnant. (It is also better to avoid Enalapril maleate tablets in early pregnancy – see Pregnancy section) • If you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren • If you have taken or are currently taking sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure in adults, as the risk of angioedema (rapid swelling under the skin in an area such as the throat) is increased. Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Enalapril maleate Tablets. Warnings and precautions Talk to your doctor or pharmacist before taking Enalapril maleate Tablets: – if you have a heart problem – if you have a condition involving the blood vessels in the brain – 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 a liver problem – if you have a kidney problem (including kidney transplantation), are on a saltrestricted diet, are taking potassium supplements, potassium-sparing agents, potassium-containing salt substitutes, or other drugs that may increase potassium in your blood (e.g., heparin [a medicine used to prevent blood clots], trimethoprimcontaining products such as cotrimoxazole [medicines used to treat infections]). These may lead to higher levels of potassium in your blood which can be serious. Your doctor may need to adjust your dose of Enalapril maleate Tablets or monitor your blood level of potassium. See also information under the heading “Other medicines and Enalapril maleate Tablets” – if you are having dialysis – if you have been very sick (excessive vomiting) or had bad 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 have ever had an allergic reaction with swelling of the face, lips, tongue or throat with difficulty in swallowing or breathing. You should be aware that black patients are at increased risk of these types of reactions to ACE inhibitors – if you have low blood pressure (you may notice this as faintness or dizziness, especially when standing) – if you have collagen vascular disease (e.g. lupus erythematosus, rheumatoid arthritis or scleroderma), are on therapy that suppresses immune system, are taking drugs allopurinol or procainamide, or any combinations of these – if you are taking any of the following medicines, the risk of angiodema may be increased: • Racecadotril, a medicine used to treat diarrhoea; • Medicines used to prevent organ transplant rejection or for cancer (e.g., temsirolimus, sirolimus, everlimus) • Vildagliptin, a medicine used to treat diabetes. – 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. – 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 Enalapril maleate Tablets”. PACKAGE LEAFLET: INFORMATION FOR THE USER Enalapril maleate 2.5mg Tablets Enalapril maleate 5mg Tablets Enalapril maleate 10mg Tablets Enalapril maleate 20mg Tablets enalapril maleate You must tell your doctor if you think you are (or might become) pregnant. This medicine is not recommended in early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see Pregnancy section). You should be aware that this medicine lowers the blood pressure in black patients less effectively than in non-black patients. If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking this medicine. If you are about to have a procedure: If you are about to have any of the following, tell your doctor that you are taking Enalapril maleate Tablets: • any surgery or receive anesthetics (even at dentist) • a treatment to remove cholesterol from your blood called ‘LDL apheresis’ • a desensitisation treatment, to lower the effect of an allergy to bee or wasp stings If any of the above applies to you, talk to your doctor or dentist before the procedure. Other medicines and Enalapril maleate Tablets Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes herbal medicines. This is because Enalapril maleate Tablets can affect the way some medicines work. Also, some other medicines can affect the way Enalapril maleate Tablets work. Your doctor may need to change your dose and/or to take other precautions. In particular tell your doctor or pharmacist if you are taking any of the following medicines: • an angiotensin II receptor blocker (ARB) or aliskiren (see also information under the headings “Do not take Enalapril maleate Tablets” and “Warnings and precautions”) • other medicines that lower blood pressure, such as beta blockers or water tablets (diuretics) • Potassium supplements (including salt substitutes), potassium-sparing diuretics and other medicines that can increase the amount of potassium in your blood (e.g. trimethoprim and co-trimoxazole for infections caused by bacteria; ciclosporin, an immunosuppressant medicine used to prevent organ transplant rejection; and heparin, a medicine used to thin blood to prevent clots). See also information under the heading “Warnings and precautions”. • medicines for diabetes (including oral antidiabetic medicines and insulin) • lithium (a medicine used to treat a certain kind of depression) • medicines for depression called ‘tricyclic antidepressants’ • medicines for mental problems called ‘antipsychotics’ • certain cough and cold medicines and weight reducing medicines which contain substances called ‘sympathomimetic agents’ • certain pain or arthritis medicines including gold therapy. • non-steroidal anti-inflammatory drugs (NSAIDs), 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) • an mTOR inhibitor (e.g., temsirolimus, sirolimus, everolimus; medicines used to treat certain types of cancer or to prevent the body’s immune system from rejecting a transplanted organ). See also information under the heading “Warnings and precautions” • a medicine containing a neprilysin inhibitor such as sacubitril (available as fixed-dose combination with valsartan), racecadotril or vildagliptin. The risk of angioedema (swelling of the face, lips, tongue or throat with difficulty in swallowing or breathing) may be increased. See also information under the headings “Do not take Enalapril maleate Tablets”. • alcohol If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Enalapril maleate Tablets. Enalapril maleate Tablets with food, drink and alcohol Enalapril maleate tablets can be taken with or without food. Most people take Enalapril maleate Tablets with a drink of water. Pregnancy and breast-feeding Pregnancy If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Your doctor will normally advise you to stop taking Enalapril maleate Tablets before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Enalapril maleate Tablets. This medicine is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy. Breast-feeding Tell your doctor if you are breast-feeding or about to start breast-feeding. Breast-feeding newborn babies (first few weeks after birth), and especially premature babies, is not recommended whilst taking Enalapril maleate Tablets. In the case of an older baby your doctor should advise you on the benefits and risks of taking Enalapril maleate Tablets whilst breast-feeding, compared to other treatments. Driving and using machines You may feel dizzy or sleepy while taking this medicine. If this happens, do not drive or use any tools or machines. Enalapril maleate Tablets contain lactose This product contains lactose which is a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine.