5Mg/6Mg Tablets for Example Valsartan, Telmisartan, Irbesartan, Etc.), in Particular Ramipril 5Mg If You Have Diabetes-Related Kidney Problems, • Aliskiren
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PACKAGE LEAFLET: INFORMATION FOR THE USER • 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 - 5mg/6mg Tablets for example valsartan, telmisartan, irbesartan, etc.), in particular Ramipril 5mg if you have diabetes-related kidney problems, • aliskiren. Piretanide 6mg Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals. See information under the heading ’Do not take Trialix Tablets’. • You have gout Is this leaflet hard to see or read? • You feel dizzy or dehydrated. This can happen if you have lost a Phone 01 403 5600 for help lot of body salts or fluids (through being sick (vomiting), having Read all of this leaflet carefully before you start using this diarrhoea, sweating more than usual, being on a low salt diet, medicine because it contains important information for you. passing water very often or having had dialysis. It can also happen • Keep this leaflet. You may need to read it again if you are having trouble drinking or eating • If you have any further questions, ask your doctor or pharmacist • If you have been pre-treated with diuretics (drugs to increase • This medicine has been prescribed for you only. Do not pass it the rate of urination) on to others. It may harm them, even if their signs of illness are • You are going to receive an anaesthetic. This may be given for an the same as yours. operation or any dental work. You may need to stop your Trialix • If you get any side effects, talk to your doctor or pharmacist. Tablets treatment one day beforehand; ask your doctor for advice This includes any possible side effects not listed in this leaflet. • You have high levels of potassium in your blood (shown in blood What is in this leaflet: test results) 1. What Trialix Tablets are and what they are used for • You have collagen vascular disease such as scleroderma or systemic 2. What you need to know before you take Trialix Tablets lupus erythematosus 3. How to take Trialix Tablets • You must tell your doctor if you think that you are (or might become) 4. Possible side effects pregnant. Trialix Tablets should not be used during pregnancy. 5. How to store Trialix Tablets If you are not sure if any of the above apply to you, talk to your 6. Contents of the pack and other information doctor or pharmacist before taking Trialix Tablets. Other medicines and Trialix Tablets 1. What Trialix Tablets are and what they are used for Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. What Trialix Tablets are This includes medicines you buy without a prescription, including The name of your medicine is Trialix 5mg/6mg Tablets (called Trialix herbal medicines. Tablets throughout this leaflet). Trialix Tablets contain two medicines This is because Trialix Tablets can affect the way some other medicines called ramipril and piretanide. work. Also, some medicines can affect the way Trialix Tablets work. Your Trialix is a combination product with one ingredient belonging to doctor may need to change your dose and/or take other precautions. a group of medicines called ACE (Angiotensin Converting Enzyme) If you are taking an angiotensin II receptor blocker (ARB) or aliskiren Inhibitors which act on the heart and blood vessels. It also contains a see also information under the headings ’Do not take Trialix Tablets’ diuretic which helps you to pass more water (urine) than you usually do. and ’Warnings and Precautions’. What Trialix Tablets are used for In particular, tell your doctor if you are taking any of the Trialix Tablets can be used: following: • To continue treatment of high blood pressure (hypertension) in • Sacubitril/valsartan – used for treating a type of long term (chronic) those patients who are insufficiently controlled with monotherapy heart failure in adults (see section 2 ‘Do not take Trialix Tablets’). (treatment with ramipril or piretanide alone). There is an increased risk of angioedema in patients taking ACE How Trialix Tablets work inhibitors with sacubitril/valsartan. Trialix Tablets work by: • Medicines used to relieve pain and inflammation (e.g. Non-Steroidal • Decreasing your body’s production of substances that could raise Anti-Inflammatory Drugs (NSAIDS)) such as indomethacin, aspirin. your blood pressure. • Medicines used for the treatment of high and low blood pressure, • Making your blood vessels relax and widen shock, cardiac failure, asthma or allergies. Your doctor will need • Making it easier for your heart to pump blood around your body to check your blood pressure. • Helping you to pass more water (urine) than you usually do • Medicines containing aliskiren used to treat hypertension. 2. What you need to know before you take Trialix Tablets • Medicines which suppress the immune response such as corticoids, cytostatics & antimetabolites. Do not take Trialix Tablets: • Medicines which can increase the amount of potassium in your • If you are allergic (hypersensitive) to ramipril, piretanide, any other blood such as spironolactone, potassium salts and heparin (for ACE inhibitor medicine or any of the other ingredients of Trialix thinning blood). Tablets (listed in Section 6 below). Signs of an allergic reaction • Medicines used to lower the uric acid in your blood such as include: a rash, swallowing or breathing problems, swelling of Allopurinol. your lips, face, throat or tongue • Medicines used as a general anaesthetic for relaxing your muscles • If you are allergic to sulphonamides. during surgery. • If you have ever had a serious allergic reaction called ‘angioedema’. • If you are going to have treatment to reduce your allergy to bee The signs include itching, hives (urticaria), red marks on the hands, or wasp stings (desensitisation). feet and throat, swelling of the throat and tongue, swelling around • Medicines for diabetes. These may not work as well when you the eyes and lips, difficulty breathing and swallowing. are using Trialix Tablets. • If you have ever had a serious allergic reaction called ‘intestinal • Vildagliptin - a medicine for diabetes. There has been an increased angioedema’. The signs include abdominal pain (with or without incidence of angioedema in patients taking Vildagliptin and ACE inhibitors. nausea or vomiting). • Lithium – used for mental illnesses. To help stop side effects your • If you have taken or are currently taking sacubitril/valsartan, a medicine doctor may need to change the dose of your lithium and check used to treat a type of long-term (chronic) heart failure in adults. the amount of lithium in your blood. • If you have heart problems such as heart failure • Medicines used for heart problems including digitalis preparations. • If you have hypertension and are taking medicine, containing Your doctor may need to change the dose of your medicine. aliskiren, to treat it. • Medicines used for depression. • If you are having dialysis or any other type of blood filtration. • Medicines used for sleeping disorders. Depending on the machine that is used, Trialix Tablets may not • mTOR Inhibitors e.g. temsirolimus, a medicine used to treat certain be suitable for you. types of cancer. • If you have diabetes or impaired kidney function and you are treated • Trimethoprim and co-trimoxazole (for infections) with a blood pressure lowering medicine containing aliskiren. • Everolimus (for prevention of graft rejection) • If you have kidney problems where the blood supply to your • Corticosteroids – used for inflammation. kidney is reduced (renal artery stenosis). • Carbenoxolene – used for ulcers of the foodpipe (gullet) • If you have severe kidney problems. Including history of kidney • Liquorice – often used in cough medicines if taken in large amounts. transplantation. • Probenecid. • If you have severe liver problems. • Procainamide (for heart rhythm problems). • If you are not passing any water. • Neprilsysin (NEP) inhibitors e.g. racecadotril (a medicine used • If you have too little sodium, potassium, calcium, uric acid, and to treat diarrhoea).There is an increased risk of angioedema in glucose in your blood (shown in blood tests). patients taking ACE inhibitors and NEP inhibitors. • If you have a low white blood cell count. • Medicines for infections (e.g. aminoglycoside antibiotics). It is recommended that the white blood cell count be monitored • Medicines used for constipation (laxatives) if used for a long time. to permit detection of a possible leucopenia. • Potassium salts, potassium retaining diuretics (e.g. spironolactone, • If your blood pressure is abnormally low or unstable. Your doctor amiloride, triamterene) or other medicines which may increase kalaemia. will need to make this assessment. • Glucocorticoids (‘steroids’) • If you are pregnant or breast-feeding (see “Pregnancy and breast- • Diuretics (water tablets) such as amiloride. feeding” section below). Trialix Tablets with food and alcohol • Trialix Tablets should never be given to children. Drinking alcohol with Trialix Tablets may make you feel dizzy or light • Trialix Tablets does not represent treatment of choice for primary headed. If you are concerned about how much you can drink while hyperaldosteronism. taking Trialix Tablets discuss this with your doctor as taking medicines Do not take Trialix Tablets if any of the above apply to you. If you are used to reduce blood pressure and alcohol can have additive effects. not sure, talk to your doctor or pharmacist before taking Trialix Tablets. Trialix Tablets may be taken with or without food. You should avoid Warnings and Precautions too much salt in your diet. Take special care with Trialix Tablets Pregnancy, breast-feeding and fertility Talk to your doctor or pharmacist before taking Trialix Tablets if: Do not take Trialix Tablets if you are pregnant. Talk to your doctor • You are elderly before taking this medicine if you are pregnant, might become • You have heart, liver or kidney problems pregnant, or think you might be pregnant.