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Edarbi contains an active substance called azilsartan medoxomil and belongs to a class of medicines called angiotensin II receptor antagonists (AIIRAs). Angiotensin II is a substance which occurs naturally in the body and which causes the blood vessels to tighten, therefore increasing your blood pressure. Edarbi blocks this effect so that the blood vessels relax, which helps lower your blood pressure. This medicine is used for treating high blood pressure (essential hypertension) in adult patients (over 18 years of age). A reduction in your blood pressure will be measureable within 2 weeks of initiation of treatment and the full effect of your dose will be observed by 4 weeks. How to use Edarbi is for oral use. Take the tablet with plenty of water. You can take this medicine with or without food. The usual starting dose is 40 mg once a day. Your doctor may increase this dose to a maximum of 80 mg once a day depending on blood pressure response. For patients such as the very elderly (75 years and above) your doctor may recommend a lower starting dose of 20 mg once a day. If you suffer from mild or moderate liver disease your doctor may recommend a lower starting dose of 20 mg once a day. For patients who recently have lost body fluids e.g. through vomiting or diarrhoea, or by taking water tablets, your doctor may recommend a lower starting dose of 20 mg once a day. If you suffer from other coexisting illnesses such as severe kidney disease or heart failure your doctor will decide on the most appropriate starting dose. Warnings and precautions Do not take Edarbi if you Are allergic to azilsartan medoxomil or any of the other ingredients of this medicine (listed in section 6). Are more than 3 months pregnant. (It is also better to avoid this medicine in early pregnancy - see pregnancy section). Have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren. Warnings and Precautions Talk to your doctor before taking Edarbi, especially if you Have kidney problems. Are on dialysis or had a recent kidney transplant. Have severe liver disease. Have heart problems (including heart failure, recent heart attack). Have ever had a stroke. Have low blood pressure or feel dizzy or lightheaded. Are vomiting, have recently had severe vomiting, or have diarrhoea. Have raised levels of potassium in your blood (as shown in blood tests). Have a disease of the adrenal gland called primary hyperaldosteronism. Have been told that you have a narrowing of the valves in your heart (called “aortic or mitral valve stenosis”) or that the thickness of your heart muscle is abnormally increased (called “obstructive hypertrophic cardiomyopathy”). Are taking any of the following medicines used to treat high blood pressure: Side Effects Like all medicines, this medicine can cause side effects, although not everybody gets them. Stop taking Edarbi and seek medical help immediately if you have any of the following allergic reactions, which occur rarely (may affect up to 1 in 1,000 people): Difficulties in breathing, or swallowing, or swelling of the face, lips, tongue and/or throat (angioedema) Itching of the skin with raised lumps. Other possible side effects include: Common side effects (may affect up to 1 in 10 people): Dizziness Diarrhoea Increased blood creatine phosphokinase (an indicator of muscle damage). Storage Information Do not store above 30°C. Store in the original package in order to protect from light and moisture. Drug Interactions In particular, tell your doctor if you are taking any of the following medicines: Lithium (a medicine for mental health problems) Non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, diclofenac or celecoxib (medicines to relieve pain and inflammation) Acetylsalicyclic acid if taking more than 3 g per day (medicine to relieve pain and inflammation) Medicines that increase the amount of potassium in your blood; these include potassium supplements, potassium-sparing medicines (certain ‘water tablets’) or salt substitutes containing potassium Heparin (a medicine for thinning the blood) Diuretics (water tablets) Aliskiren or other medicines to lower your blood pressure (angiotensin converting enzyme inhibitor or angiotensin II receptor blocker, such as enalapril, lisinopril, ramipril or valsartan, telmisartan, irbesartan). Ingredients The active substance is azilsartan medoxomil (as potassium).
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