APROVEL Tablet

In adult patients

- to treat high blood pressure (essential hypertension)

- to protect the kidney in patients with high blood pressure, type2 diabetes and laboratory evidence of impaired kidney function.

Method of administration

For oral use. Swallow the tablets with a sufficient amount of fluid (e.g. 1 glass of water). You can take this medicine 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 this medicine until your doctor tells you otherwise.

See the package insert about the details below:

- Patients with high blood pressure

- Patients with high blood pressure and type 2 diabetes with 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 4-6weeks after beginning treatment.

Use in children and adolescents

This medicine should not be given to children under 18 years of age. If a child swallows some tablets, contact your doctor immediately.

- if you are allergic to irbesartan or any other ingredients of this medicine

- if you are more than 3 months pregnant. (It is also better to avoid this medicine in early pregnancy)

- if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.

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 this medicine 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. Undesirable effects where the frequency is not known are: feeling of spinning, 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). Uncommon cases of jaundice (yellow of the skin and/or whites of the eyes) have also been reported.

Your doctor may need to change your dose and/or to take other precautions:

If you are taking an ACE-inhibitor or aliskiren.

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 NSAIDs, the effect of irbesartan may be reduced.

Aprovel with food and drink

Aprovel can be taken with or without food.

Pregnancy

You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking this medicine before you become pregnant or as soon as you know you are pregnant and will advise you to taken another medicine instead of Aprovel. This medicine 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. This medicine 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.

Talk to your doctor before taking this medicine and 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 this medicine 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,

- 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.

You must tell your doctor if you think you are (or might become) pregnant. Aprovel 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 the package insert about the details: Children and adolescents.

Aprovel belongs to a group of medicines known as angiotensin-Ⅱreceptor antagonists. Angiotensin-Ⅱis 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-Ⅱto 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.