What Avapro is and what it is used for
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 in adult patients
• 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.
How to take Avapro
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. The dose may later be increased to 300 mg (two 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 (two 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.
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 Aprovel and contact your doctor
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. 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, 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 severe allergic reactions (anaphylactic shock).
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 United Kingdom 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. Ireland You can also report side effects directly via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: [email protected] By reporting side effects you can help provide more information on the safety of this medicine.
How to Store Avapro
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.
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