Aprovel

Do not take it if

From the package leaflet in EMA’s product information, p. 103–104.

How to take it

These directions are for this exact strength and form. Another one is different.

• Always take this medicine exactly as your doctor has told you. 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 (two tablets a day). The dose may later be increased to 300 mg (four tablets a day) 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 (four tablets a day) 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.
• Use in children and adolescents Aprovel 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 Aprovel than you should If you accidentally take too many 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 medicine, ask your doctor or pharmacist.

From the package leaflet in EMA’s product information, p. 105.

Pregnancy and breastfeeding

From the package leaflet in EMA’s product information, p. 104.

Other medicines

From the package leaflet in EMA’s product information, p. 104.

Driving and using machines

• 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.
• 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 medicinal product.
• Aprovel contains sodium. This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

From the package leaflet in EMA’s product information, p. 105.

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 Aprovel and contact your doctor immediately.
• 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 Side effects reported in clinical studies for patients treated with Aprovel 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, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (problems with sexual performance), chest pain.
• Rare (may affect up to 1 in 1,000 people): intestinal angioedema: a swelling in the gut presenting with symptoms like abdominal pain, nausea, vomiting and diarrhoea.
• 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, decreased 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), severe allergic reactions (anaphylactic shock) and low blood sugar levels.
• Uncommon cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been reported.
• 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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

From the package leaflet in EMA’s product information, p. 105–106.

How to store it

• 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 carton and on the blister after EXP. The expiry date refers to the last day of that month.
• Do not store above 30°C.
• 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.

From the package leaflet in EMA’s product information, p. 106.

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

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Details

Source: European Medicines Agency — medicine data · 2026-09-30 · not reviewed by a clinician

Source: European Medicines Agency (EMA). Product information as published by EMA. Reuse terms: EMA legal notice (reproduction authorised).

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Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

See every product with Irbesartan