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Aprovel belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body which binds to receptors in blood vessels causing them to tighten. This results in an increase in blood pressure. Aprovel prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower. Aprovel slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes. Aprovel is used *to treat high blood pressure (essential hypertension) *to protect the kidney in patients with high blood pressure, type 2 diabetes and laboratory evidence of impaired kidney function.

Do not take Aprovel *if you are allergic (hypersensitive) to irbesartan or any other ingredients of Aprovel *during the last 6 months of pregnancy, see section Pregnancy and breastfeeding *if you are breast-feeding Aprovel should not be given to children and adolescents (under 18 years).

Take special care with Aprovel
Tell your doctor if any of the following apply to you: *if you get excessive vomiting or diarrhoea *if you suffer from kidney problems *if you suffer from heart problems *if you receive Aprovel for diabetic kidney disease. In this case your doctor may perform regular blood tests, especially for measuring blood potassium levels in case of poor kidney function *if you are going to have an operation (surgery) or be given anaesthetics You must tell your doctor if you think that you are (or might become) pregnant. Aprovel is not recommended in early pregnancy and may cause serious harm to your baby after 3 months of pregnancy, see section Pregnancy and breastfeeding.

Using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Aprovel does not usually interact with other medicines. You may need to have blood checks if you take: *potassium supplements *salt substitutes containing potassium *potassium-sparing medicines (such as certain diuretics) *medicines containing lithium If you take certain painkillers, called non-steroidal anti-inflammatory drugs, the effect of irbesartan may be reduced.

Taking Aprovel with food and drink
Aprovel can be taken with or without food.

Pregnancy and breast-feeding
You must tell your doctor if you think that you are (or might become) pregnant. Usually, your doctor will advise you to take another medicine instead of Aprovel, as Aprovel is not recommended in early pregnancy, and may cause serious harm to your baby if it is used after 3 months of pregnancy. Appropriate antihypertensive drug must usually replace Aprovel before starting a pregnancy. The product should not be used during the 2nd and 3rd trimester of pregnancy, or while breast-feeding. Your doctor will normally advise you to stop taking Aprovel as soon as you know you are pregnant. If you become pregnant during therapy with Aprovel, please inform and see your doctor without delay.

Driving and using machines
No studies on the effects on the ability to drive and use machines have been performed. Aprovel is unlikely to affect your ability to drive or use machines. However, occasionally dizziness or weariness may occur during treatment of high blood pressure. If you experience these, talk to your doctor before attempting to drive or use machines. Important information about some of the ingredients of Aprovel Aprovel contains lactose. If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose), contact your doctor before taking this medicine.

Always take Aprovel exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Method of administration Aprovel is for oral use. Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water). You can take Aprovel 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 Aprovel until your doctor tells you otherwise. Patients with high blood pressure The usual dose is 150 mg once a day. The dose may later be increased to 300 mg once daily depending on blood pressure response. Patients with high blood pressure and type 2 diabetes with kidney disease In patients with high blood pressure and type 2 diabetes, 300 mg once daily is the preferred maintenance dose for the treatment of associated kidney disease. The doctor may advise a lower dose, especially when starting treatment in certain patients such as those on haemodialysis, or those over the age of 75 years. The maximal blood pressure lowering effect should be reached 4-6 weeks after beginning treatment.

If you take more Aprovel than you should:

If you accidentally take too many tablets, contact your doctor immediately. Children should not take Aprovel Aprovel should not be given to children under 18 years of age. If a child swallows some tablets, contact your doctor immediately.

If you forget to take Aprovel:
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 product, ask your doctor or pharmacist.

Like all medicines, Aprovel 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 Aprovel and contact your doctor immediately. Side effects reported in clinical studies for patients treated with Aprovel were: Very common: if you suffer from high blood pressure and type 2 diabetes with kidney disease, blood tests may show an increased level of potassium. Common: dizziness, feeling sick/vomiting, fatigue and blood tests may show raised levels of an enzyme that measures the muscle and heart function (creatine kinase enzyme). In patients with high blood pressure and type 2 diabetes with kidney disease, dizziness when getting up from a lying or sitting position, low blood pressure when getting up from a lying or sitting position, pain in joints or muscles and decreased levels of a protein in the red blood cells (haemoglobin) were also reported. Uncommon: heart rate increased, flushing, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (problems with sexual performance), chest pain. Some undesirable effects have been reported since marketing of Aprovel but the frequency for them to occur is not known. These undesirable effects are: headache, taste disturbance, ringing in the ears, muscle cramps, pain in joints and muscles, abnormal liver function, increased blood potassium levels, impaired kidney function, and inflammation of small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis). If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children. Do not use Aprovel after the expiry date which is stated on the carton and on the blister after EXP. The expiry date refers to the last day of that month. Do not store above 30°C. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

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