Product Details

Product Information of Tritace

What you need to know before you take TRITACE

Do not take TRITACE: ± If you are allergic to ramipril, any other ACE inhibitor medicine or any of the ingredients of this medicine listed in section 6. Signs of an allergic reaction may include a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue ± If you have ever had a serious allergic reaction called “angioedema”. The signs include itching, hives (urticaria), red marks on the hands, feet and throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty breathing and swallowing ± If you have taken or are currently taking sacubitril/ valsartan, a medicine used to treat a type of longterm (chronic) heart failure in adults. ± If you are having dialysis or any other type of blood filtration. Depending on the machine that is used, TRITACE may not be suitable for you ± If you have kidney problems where the blood supply to your kidney is reduced (renal artery stenosis) ± During the last 6 months of pregnancy (see section below on “Pregnancy and breast-feeding”) ± If your blood pressure is abnormally low or unstable. Your doctor will need to make this assessment ± If you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren Do not take TRITACE if any of the above apply to you. If you are not sure, talk to your doctor before taking TRITACE. Warnings and precautions Talk to your doctor or pharmacist before taking TRITACE: S If you have heart, liver or kidney problems S If you have lost a lot of body salts or fluids (through being sick (vomiting), having diarrhoea, sweating more than usual, being on a low salt diet, taking diuretics (water tablets) for a long time or having had dialysis) S If you are going to have treatment to reduce your allergy to bee or wasp stings (desensitization) S If you are going to receive an anaesthetic. This may be given for an operation or any dental work. You may need to stop your TRITACE treatment one day beforehand; ask your doctor for advice S If you have high amounts of potassium in your blood (shown in blood test results) S If you are taking medicines or have conditions which may decrease sodium levels in your blood. Your doctor may carry out regular blood tests, particularly for checking the levels of sodium in your blood especially if you are elderly. S If you are taking medicines that may increase the risk of angioedema, a serious allergic reaction, such as mTOR inhibitors (e.g. temsirolimus, everolimus, sirolimus), vildagliptin, neprilysin (NEP) inhibitors (such as racecadontril) or sacubitril/valsartan. For sacubitril/valsartan, see section 2 “Do not take TRITACE”. S If you have collagen vascular disease such as scleroderma or systemic lupus erythematosus S You must tell your doctor if you think that you are (or might become) pregnant. TRITACE is not recommended in the first 3 months of pregnancy and may cause serious harm to your baby after 3 months of pregnancy (see section below on “Pregnancy and breast-feeding”). S 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 814904 – 89036594 2/4 814904 – 89036594 3/4 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 TRITACE”. Children and adolescents TRITACE is not recommended for use in children and adolescents below 18 years of age because the safety and efficacy of TRITACE in children has not yet been established. If any of the above apply to you (or you are not sure), talk to your doctor before taking TRITACE. Other medicines and TRITACE Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because TRITACE can affect the way some other medicines work. Also some medicines can affect the way TRITACE works. Tell your doctor if you are taking any of the following medicines. They can make TRITACE work less well: • Medicines used to relieve pain and inflammation (e.g. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as ibuprofen or indometacin and aspirin) • Medicines used for the treatment of low blood pressure, shock, cardiac failure, asthma or allergies such as ephedrine, noradrenaline or adrenaline. Your doctor will need to check your blood pressure. Tell your doctor if you are taking any of the following medicines. They can increase the chance of getting side effects if you take them with TRITACE: • Sacubitril/valsartan – used for treating a type of long term (chronic) heart failure in adults (see section 2 ‘Do not take TRITACE’) • Medicines used to relieve pain and inflammation (e.g. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as ibuprofen or indometacin and aspirin) • Medicines for cancer (chemotherapy) • Medicines to stop the rejection of organs after a transplant such as ciclosporin • Diuretics (water tablets) such as furosemide • Medicines which can increase the amount of potassium in your blood such as spironolactone, triamterene, amiloride, potassium salts, trimethoprim alone or in combination with sulfamethoxazole (for infections) and heparin (for thinning blood) • Steroid medicines for inflammation such as prednisolone • Allopurinol (used to lower the uric acid in your blood) • Procainamide (for heart rhythm problems) • Temsirolimus (for cancer) • Sirolimus, everolimus (for prevention of graft rejection) • Vildagliptin (used for treating type 2 diabetes) • Racecadotril (used against diarrhoea) • Your doctor may need to change your dose and/ or to take other precautions if you are taking an angiotensin II receptor blocker (ARB) or aliskiren (see also information under the headings “Do not take TRITACE” and “Warnings and precautions”). Tell your doctor if you are taking any of the following medicines. They may be affected by TRITACE: • Medicines for diabetes such as oral glucose lowering medicines and insulin. TRITACE may lower your blood sugar amounts. Check your blood sugar amounts closely while taking TRITACE • Lithium (for mental health problems). TRITACE may increase the amount of lithium in your blood. Your lithium amount will need to be closely checked by your doctor. If any of the above apply to you (or you are not sure), talk to your doctor before taking TRITACE. TRITACE with food and alcohol • Drinking alcohol with TRITACE may make you feel dizzy or light-headed. If you are concerned about how much you can drink while you are taking TRITACE, discuss this with your doctor as medicines used to reduce blood pressure and alcohol can have additive effects. • TRITACE may be taken with or without food. Pregnancy and breast-feeding Pregnancy You must tell your doctor if you think that you are (or might become) pregnant. You should not take TRITACE in the first 12 weeks of pregnancy and you must not take them at all from the 13th week as their use during pregnancy may possibly be harmful to the baby. If you become pregnant while on TRITACE, tell your doctor immediately. A switch to a suitable alternative treatment should be carried out in advance of a planned pregnancy. Breast-feeding You should not take TRITACE if you are breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines You may feel dizzy, while taking TRITACE. This is more likely to happen when you start taking TRITACE or start taking a higher dose. If this happens, do not drive or use any tools or machines. TRITACE contains sodium This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.