Avalide
(Irbesartan/Hydrochlorothiazide)

What Avalide is and what it is used for

Irbesartan Hydrochlorothiazide tablets are a combination of two active substances, irbesartan and hydrochlorothiazide. Irbesartan belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body that binds to receptors in blood vessels causing them to tighten. This results in an increase in blood pressure. Irbesartan prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower. Hydrochlorothiazide is one of a group of medicines (called thiazide diuretics) that causes increased urine output and so causes a lowering of blood pressure The two active ingredients in Irbesartan Hydrochlorothiazide tablets work together to lower blood pressure further than if either was given alone. Irbesartan Hydrochlorothiazide tablets are used in the treatment for high blood pressure (essential hypertension), when treatment with irbesartan or hydrochlorothiazide alone did not provide adequate control of your blood pressure.

How to take Avalide

Hydrochlorothiazide tablets Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Dosage The recommended dose is one 150mg/12.5mg, 300mg/12.5mg or 300mg/25mg tablet a day or two 150mg/12.5mg tablets a day. Irbesartan Hydrochlorothiazide tablets will usually be prescribed by your doctor when your previous treatment for high blood pressure did not provide appropriate blood pressure reduction. Your doctor will instruct you on how to switch from the previous treatment to Irbesartan Hydrochlorothiazide tablets. Method of administration Irbesartan Hydrochlorothiazide tablets are for oral use. Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water). You can take Irbesartan Hydrochlorothiazide tablets with or without food. Try to take your daily dose at about the same time each day. It is important that you continue to take Irbesartan Hydrochlorothiazide tablets until your doctor tells you otherwise. The maximal blood pressure lowering effect should be reached 6-8 weeks after beginning treatment. Use in children and adolescents Irbesartan Hydrochlorothiazide tablets should not be given to children and adolescents under 18 years of age. If a child swallows some tablets, contact your doctor immediately. If you take more Irbesartan Hydrochlorothiazide tablets than you should If you accidentally take too many tablets, contact your doctor immediately. If you forget to take Irbesartan Hydrochlorothiazide tablets If you accidentally miss a daily dose, just take the next dose as normal. Do not take a double dose to make up for a forgotten dose. If you have any further questions on the use of this medicine, ask your doctor or pharmacist

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Some of these effects may be serious and may require medical attention. As with similar medicines, rare cases of allergic skin reactions (rash, urticaria), as well as localised swelling of the face, lips and/or tongue have been reported in patients taking irbesartan. If you get any of these symptoms or get short of breath, stop taking Irbesartan Hydrochlorothiazide tablets and contact your doctor immediately. Side effects reported in clinical studies for patients treated with Irbesartan Hydrochlorothiazide tablets were:
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Common (may affect up to 1 in 10 people): nausea/vomiting, abnormal urination, fatigue and dizziness (including when getting up from a lying or sitting position) and blood tests may show raised levels of an enzyme that measures the muscle and heart function (creatine kinase) or raised levels of substances that measure kidney function (blood urea nitrogen, creatinine).
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Uncommon (may affect up to 1 in 100 people): diarrhoea, low blood pressure, fainting, heart rate increased, flushing, swelling and sexual dysfunction (problems with sexual performance). Blood tests may show lowered levels of potassium and sodium in your blood, yellowing of the skin and/or whites of the eyes (jaundice).
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Not known (frequency cannot be estimated from the available data): headache, ringing in the ears, cough, taste disturbance, indigestion, pain in joints and muscles, liver function abnormal, inflammation of the liver causing yellowing of the skin or eyes, impaired kidney function, kidney failure, increased level of potassium in your blood and allergic reactions such as rash, hives, swelling of the face, lips, mouth, tongue or throat. As for any combination of two active substances, side effects associated with each individual component cannot be excluded. In patients taking irbesartan alone, in addition to the side effects listed above the following has also been reported:
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Uncommon (may affect up to 1 in 100 people): chest pain.
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Not known (frequency cannot be estimated from the available data): decrease in the number of platelets (a blood cell essential for the clotting of the blood). Additional side effects associated with the other component of Irbesartan Hydrochlorothiazide tablets (hydrochlorothiazide) alone are:
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Not known (frequency cannot be estimated from the available data): loss of appetite; stomach irritation; diarrhoea; constipation; jaundice seen as yellowing of the skin and/or whites of the eyes; inflammation of the pancreas characterised by severe upper stomach pain, often with nausea and vomiting; sleep disorders; depression; yellow vision; blurred vision; lack of white blood cells,which can result in frequent infections, fever; decrease in the number of platelets (a blood cell essential for the clotting of the blood), decreased number of red blood cells (anaemia) characterised by tiredness, headaches, being short of breath when exercising, dizziness and looking pale; kidney disease; lung problems including pneumonia or build-up of fluid in the lungs; increased sensitivity of the skin to the sun; inflammation of blood vessels; a skin disease characterised by the peeling of the skin all over the body; cutaneous lupus erythematosus, which is identified by a rash that may appear on the face, neck, and scalp; allergic reactions; weakness and muscle spasm; altered heart rate; reduced blood pressure after a change in body position; swelling of the salivary glands; high sugar levels in the blood; sugar in the urine; increases in some kinds of blood fat; high uric acid levels in the blood, which may cause gout; dizziness at height; numbness, tingling or pins and needles; lightheadedness; restlessness; electrolyte imbalance (including hypokalaemia and hyponatraemia); changes in vision or pain in one or both eyes. It is known that side effects associated with hydrochlorothiazide may increase with higher doses of hydrochlorothiazide.

Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

How to Store Avalide

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the tablet container, carton and on the blister after EXP. The expiry date refers to the last day of that month. Al/PVDC/PVC blister packaging: Do not store above 25°C HDPE tablet containers with desiccant: This medicinal product does not require any special storage conditions. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.