IRBESARTAN 150 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

Method of administration

Irbesartan is for oral use. Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water). You can

take Irbesartan 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 until your doctor tells you otherwise.

• ■ Patients with high blood pressure

The usual dose is 150 mg once a day (e.g. two 75 mg tablets a day, or one 150 mg tablet a day).

The dose may later be increased to 300 mg (e.g. four 75 mg tablets, or two 150 mg tablets, or one 300 mg tablet) once daily depending on blood pressure response.

• ■ Patients with high blood pressure and type2 diabetes with kidney disease

In patients with high blood pressure and type 2 diabetes, 300 mg (e.g. four 75 mg tablets, or two 150 mg tablets, or one 300 mg tablet) 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.

Irbesartan 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. Irbesartan prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower. Irbesartan slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes.

Irbesartan is used in adult patients:

• – in the treatment of high blood pressure (essential hypertension)

• – to protect the kidney in patients with high blood pressure, type 2 diabetes and known impaired kidney function.

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Use in children and adolescents

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

If you take more Irbesartan than you should

If you accidentally take too many tablets, contact your doctor immediately. The most likely manifestations of overdosage are expected to be hypotension and tachycardia; bradycardia might also occur from overdose.

If you forget to take Irbesartan

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.

The frequency of the side effects listed below is defined using the following convention:

Very common: may affect more than 1 in 10 people

Common: may affect up to 1 in 10 people

Uncommon: may affect up to 1 in 100 people

Other side effects reported in clinical studies for patients treated with Irbesartan were:

• Very common (may affect more than 1 in 10 people): if you suffer from high blood pressure and type 2 diabetes with kidney disease, blood tests may show an increased level of potassium.
• Common (may affect up to 1 in 10 people): 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 (may affect up to 1 in 100 people): heart rate increased, flushing (skin becomes red and hot), cough, diarrhoea, indigestion/he­artburn, sexual dysfunction (problems with sexual performance), chest pain and uncommon cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been reported
• Not known: frequency cannot be estimated from the available data: feeling of spinning, headache, taste disturbance, ringing in the ears, muscle cramps, pain in joints and muscles, reduced number of red blood cells (anaemia – symptoms may include tiredness, headaches, being short of breath when exercising, dizziness and looking pale), reduced number of platelets, abnormal liver function, increased blood potassium levels, impaired kidney function, inflammation of small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis) and low blood sugar levels.

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 Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store.

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 Irbesartan before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Irbesartan. Irbesartan 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. Irbesartan 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

Irbesartan 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, you should consult your doctor before attempting such activities.

Information on sodium content

This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially ‘sodium-free’.

By reporting side effects you can help provide more information on the safety of this medicine.

8086746–7803

150 mm

150 mm

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