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Irbesartan 150 Mg Tablets Your doctor may check your kidney function, blood Package leaflet: pressure, and the amount of electrolytes (e.g. Information for the user potassium) in your blood at regular intervals. Irbesartan 75 mg tablets See also information under the heading “Do not take Irbesartan 150 mg tablets Irbesartan” Irbesartan 300 mg tablets You must tell your doctor if you think you are (or might become) pregnant. Irbesartan is not Irbesartan 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). Read all of this leaflet carefully before you Children and adolescents start taking this medicine because it contains This medicinal product should not be used in children important information for you. and adolescents because the safety and efficacy - Keep this leaflet. You may need to read it again. have not yet been fully established. - If you have any further questions, ask your doctor or pharmacist. Other medicines and Irbesartan - This medicine has been prescribed for you only. Tell your doctor or pharmacist if you are taking, have Do not pass it on to others. It may harm them, recently taken or might take any other medicines. even if their signs of illness are the same as Your doctor may need to change your dose and/or to yours. take other precautions: - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side If you are taking an ACE-inhibitor or aliskiren (see effects not listed in this leaflet. See section 4. also information under the headings “Do not take Irbesartan” and “Warnings and precautions”) What is in this leaflet 1. What Irbesartan is and what it is used for You may need to have blood checks if you take: 2. What you need to know before you take • potassium supplements Irbesartan • salt substitutes containing potassium 3. How to take Irbesartan • potassium-sparing medicines (such as certain 4. Possible side effects diuretics) 5. How to store Irbesartan • medicines containing lithium 6. Contents of the pack and other information • repaglinide (medication used for lowering blood sugar levels) 1. What Irbesartan is and what it is used for If you take certain painkillers, called non-steroidal anti-inflammatory drugs, the effect of irbesartan may Irbesartan belongs to a group of medicines known be reduced. as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body which binds to Irbesartan with food and drink receptors in blood vessels causing them to tighten. Irbesartan can be taken with or without food. This results in an increase in blood pressure. Pregnancy and breast-feeding Irbesartan prevents the binding of angiotensin-II to Pregnancy these receptors, causing the blood vessels to relax You must tell your doctor if you think you are (or and the blood pressure to lower. Irbesartan slows might become) pregnant. Your doctor will normally the decrease of kidney function in patients with high advise you to stop taking Irbesartan before you blood pressure and type 2 diabetes. become pregnant or as soon as you know you Irbesartan is used in adult patients are pregnant and will advise you to take another • to treat high blood pressure (essential medicine instead of Irbesartan. Irbesartan is not hypertension) recommended in early pregnancy, and must not be • to protect the kidney in patients with high taken when more than 3 months pregnant, as it may blood pressure, type 2 diabetes and laboratory cause serious harm to your baby if used after the evidence of impaired kidney function. third month of pregnancy. Breast-feeding 2. What you need to know before you take Tell your doctor if you are breast-feeding or about to Irbesartan start breast-feeding. Irbesartan is not recommended Do not take Irbesartan for mothers who are breast-feeding, and your doctor • if you are allergic to irbesartan or any other may choose another treatment for you if you wish to ingredients of this medicine (listed in section 6) breast-feed, especially if your baby is newborn, or • if you are more than 3 months pregnant. (It is was born prematurely. also better to avoid Irbesartan in early pregnancy Driving and using machines – see pregnancy section) Irbesartan is unlikely to affect your ability to drive or • if you have diabetes or impaired kidney function use machines. However, occasionally dizziness or and you are treated with a blood pressure weariness may occur during treatment of high blood lowering medicine containing aliskiren pressure. If you experience these, talk to your doctor Warnings and precautions before attempting to drive or use machines Talk to your doctor or pharmacist before taking This medicine contains less than 1 mmol sodium Irbesartan and if any of the following apply to you: (23 mg) per tablet, that is to say essentially ‘sodium- • if you get excessive vomiting or diarrhoea free’. • if you suffer from kidney problems • if you suffer from heart problems 3. How to take Irbesartan • if you receive Irbesartan for diabetic kidney disease. In this case your doctor may perform Always take this medicine exactly as your doctor has regular blood tests, especially for measuring told you. Check with your doctor or pharmacist if you blood potassium levels in case of poor kidney are not sure. function Method of administration • if you develop low blood sugar levels Irbesartan is for oral use. Swallow the tablets with a (symptoms may include sweating, weakness, sufficient amount of fluid (e.g. one glass of water). hunger, dizziness, trembling, headache, flushing You can take Irbesartan with or without food. Try or paleness, numbness, having a fast, pounding to take your daily dose at about the same time heart beat), particularly if you are being treated each day. It is important that you continue to take for diabetes. Irbesartan until your doctor tells you otherwise. • if you are going to have an operation (surgery) Patients with high blood pressure or be given anaesthetics The usual dose is 150 mg once a day. The dose • if you are taking any of the following medicines may later be increased to 300 mg once daily used to treat high blood pressure: depending on blood pressure response. - an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems. - aliskiren N13656 Black Version: 11 Date & Time: 29.04.2021 & 6:10 PM Submission Code: N13656 Patients with high blood also been reported. pressure and type 2 diabetes Reporting of side effects with kidney disease If you get any side effects, talk to your doctor, In patients with high blood pressure pharmacist or nurse. This includes any possible side and type 2 diabetes, 300 mg once effects not listed in this leaflet. You can also report daily is the preferred maintenance side effects directly dose for the treatment of associated kidney disease. Malta ADR Reporting The doctor may advise a lower Website: www.medicinesauthority.gov.mt/adrportal dose, especially when starting treatment in certain patients such The United Kingdom as those on haemodialysis, or Yellow Card Scheme those over the age of 75 years. Website: www.mhra.gov.uk/yellowcard The maximal blood pressure lowering effect should By reporting side effects you can help provide more be reached 4-6 weeks after beginning treatment. information on the safety of this medicine. If you take more Irbesartan than you should 5. How to store Irbesartan If you accidentally take too many tablets, contact your doctor immediately. Keep this medicine out of the sight and reach of Use in children and adolescents children. Irbesartan should not be given to children under This medicine does not require any special storage 18 years of age. If a child swallows some tablets, conditions. contact your doctor immediately. Do not use this medicine after the expiry date which If you forget to take Irbesartan is stated on the carton and on the blister after EXP. If you accidentally miss a daily dose, just take the The expiry date refers to the last day of that month. next dose as normal. Do not take a double dose to Do not throw away any medicines via wastewater or make up for a forgotten dose. household waste. Ask your pharmacist how to throw If you have any further questions on the use of this away medicines you no longer use. These measures medicine, ask your doctor or pharmacist. will help protect the environment. 4. Possible side effects 6. Contents of the pack and other information Like all medicines, this medicine can cause side What Irbesartan contains effects, although not everybody gets them. Some • The active substance is irbesartan. of these effects may be serious and may require Each tablet contains 75 mg of irbesartan. medical attention. Each tablet contains 150 mg of irbesartan. As with similar medicines, rare cases of allergic Each tablet contains 300 mg of irbesartan. skin reactions (rash, urticaria), as well as localised • The other ingredients are: Microcrystalline swelling of the face, lips and/or tongue have been cellulose 101, calcium hydrogen phosphate reported in patients taking irbesartan. If you get dihydrate, sodium starch glycolate (Type A), any of these symptoms or get short of breath, hypromellose (5cp), polysorbate 80, talc, silica stop taking Irbesartan and contact your doctor colloidal anhydrous, sodium stearyl fumarate. immediately. What Irbesartan looks like and contents of the The frequency of the side effects listed below is pack defined using the following convention: Tablets Very common: may affect more than 1 in 10 people: Irbesartan 75 mg tablets: Common: may affect up to 1 in 10 people White to off-white, biconvex oval shaped uncoated Uncommon: may affect up to 1 in 100 people tablets debossed with ‘H 28’ on one side and plain on Side effects reported in clinical studies for patients other side.
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