Product Details

Product Information of Micardis 80mg Tablets

What you need to know before you take Micardis

Do not take Micardis · if you are allergic to telmisartan or any of the other ingredients of this medicine (listed in section 6). · if you are more than 3 months pregnant. (It is also better to avoid Micardis in early pregnancy – see pregnancy section.) · if you have severe liver problems such as cholestasis or biliary obstruction (problems with drainage of the bile from the liver and gall bladder) or any other severe liver disease. · if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren. If any of the above applies to you, tell your doctor or pharmacist before taking Micardis. 2 M3a;80mg/GB/PL/1 Warnings and precautions Talk to your doctor before taking Micardis if you are suffering or have ever suffered from any of the following conditions or illnesses: · Kidney disease or kidney transplant. · Renal artery stenosis (narrowing of the blood vessels to one or both kidneys). · Liver disease. · Heart trouble. · Raised aldosterone levels (water and salt retention in the body along with imbalance of various blood minerals). · Low blood pressure (hypotension), likely to occur if you are dehydrated (excessive loss of body water) or have salt deficiency due to diuretic therapy (‘water tablets’), low-salt diet, diarrhoea, or vomiting. · Elevated potassium levels in your blood. · Diabetes. Talk to your doctor before taking Micardis: · if you are taking any of the following medicines used to treat high blood pressure: – an ACE-inhibitor (for example enalapril, lisinopril, ramipril), 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 Micardis”. · if you are taking digoxin. You must tell your doctor if you think you are (or might become) pregnant. Micardis 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). In case of surgery or anaesthesia, you should tell your doctor that you are taking Micardis. Micardis may be less effective in lowering the blood pressure in black patients. Children and adolescents The use of Micardis in children and adolescents up to the age of 18 years is not recommended. Other medicines and Micardis Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Your doctor may need to change the dose of these other medications or take other precautions. In some cases you may have to stop taking one of the medicines. This applies especially to the medicines listed below taken at the same time with Micardis: · Lithium containing medicines to treat some types of depression. · Medicines that may increase blood potassium levels such as salt substitutes containing potassium, potassium-sparing diuretics (certain ‘water tablets’), ACE inhibitors, angiotensin II receptor antagonists, NSAIDs (non steroidal anti-inflammatory medicines, e.g. aspirin or ibuprofen), heparin, immunosuppressives (e.g. cyclosporin or tacrolimus), and the antibiotic trimethoprim. · Diuretics (‘water tablets’), especially if taken in high doses together with Micardis, may lead to excessive loss of body water and low blood pressure (hypotension). · If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Micardis” and “Warnings and precautions”). · Digoxin. 3 M3a;80mg/GB/PL/1 The effect of Micardis may be reduced when you take NSAIDs (non steroidal anti-inflammatory medicines, e.g. aspirin or ibuprofen) or corticosteroids. Micardis may increase the blood pressure lowering effect of other medicines used to treat high blood pressure or of medicines with blood pressure lowering potential (e.g. baclofen, amifostine). Furthermore, low blood pressure may be aggravated by alcohol, barbiturates, narcotics or antidepressants. You may notice this as dizziness when standing up. You should consult with your doctor if you need to adjust the dose of your other medicine while taking Micardis. Pregnancy and breast-feeding Pregnancy You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Micardis before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Micardis. Micardis 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. Micardis is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely. Driving and using machines Some people feel dizzy or tired when taking Micardis. If you feel dizzy or tired, do not drive or operate machinery. Micardis contains sorbitol. This medicine contains 337.28 mg sorbitol in each tablet. Sorbitol is a source of fructose. If your doctor has told you that you have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you take or receive this medicine. Micardis contains sodium This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodiumfree