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 if you are more than 3 months pregnant. (It is also better to avoid Aprovel in early pregnancy – see pregnancy section)
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 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 pregnancy section).
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:
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 you are ( or might become) pregnant. Your doctor will normally advise you to stop taking Aprovel before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Aprovel. Aprovel 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.
Tell your doctor if you are breast-feeding or about to start breast-feeding. Aprovel 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
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 (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.
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.
The frequency of the side effects listed below is defined using the following convention: Very common: at least 1 in 10 patients or more
Common: at least 1 in 100 and less than 1 in 10 patients
Uncommon: at least 1 in 1000 and less than 1 in 100 patients
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.
Aprovel is a medicine that contains the active substance irbesartan. It is available as white, oval tablets (75, 150 and 300 mg).
Aprovel is used in patients who have essential hypertension (high blood pressure). ‘Essential’ means that the hypertension has no obvious cause. Aprovel is also used to treat kidney disease in patients with hypertension and type 2 diabetes (non-insulin-dependent diabetes). Aprovel is not recommended for use in patients below 18 years of age, because of a lack of information on safety and effectiveness in this age group.
The medicine can only be obtained with a prescription.
Aprovel is taken by mouth, with or without food. The usual recommended dose is 150 mg once a day. If the blood pressure is not sufficiently controlled, the dose can be increased to 300 mg a day or other medicines for hypertension can be added, such as hydrochlorothiazide. A starting dose of 75 mg can be used in patients receiving haemodialysis (a blood clearance technique) or in patients over 75 years of age.
In patients with hypertension and type 2 diabetes, Aprovel is added to other treatments for hypertension. Treatment is started at 150 mg once a day and is usually increased to 300 mg once a day.
The active substance in Aprovel, irbesartan, is an ‘angiotensin II receptor antagonist’, which means that it blocks the action of a hormone in the body called angiotensin II. Angiotensin II is a powerful vasoconstrictor (a substance that narrows blood vessels). By blocking the receptors to which angiotensin II normally attaches, irbesartan stops the hormone having an effect, allowing the blood vessels to widen. This allows the blood pressure to drop, reducing the risks associated with high blood pressure, such as having a stroke.
Aprovel was originally studied in 11 trials for its effects on blood pressure. Aprovel was compared with placebo (a dummy treatment) in 712 patients and with other medicines for hypertension (atenolol, enalapril or amlodipine) in 823 patients. Its use in combination with hydrochlorothiazide was also examined in 1,736 patients. The main measure of effectiveness was the reduction in diastolic blood pressure (the blood pressure measured between two heartbeats).
For the treatment of kidney disease, Aprovel was studied in two large studies involving a total of 2,326 patients with type 2 diabetes. Aprovel was used for two years or more. One study looked at markers of kidney damage by measuring whether the kidneys were releasing the protein albumin into the urine. The second study looked at whether Aprovel increased the time taken until the patients’ blood creatinine levels had doubled (a marker of kidney disease), until they needed a kidney transplant or dialysis, or until they died. In this study, Aprovel was compared with placebo and with amlodipine.
In the blood pressure studies, Aprovel was more effective than placebo at reducing diastolic blood pressure and had similar effects to the other medicines for hypertension. When used with hydrochlorothiazide, the effects of the two medicines were additive.
In the first kidney disease study, Aprovel was more effective than placebo at reducing the risk of developing kidney damage as measured by protein excretion. In the second kidney disease study, Aprovel reduced the relative risk of a doubling of blood creatinine levels, needing a kidney transplant or dialysis, or death during the study by 20% in comparison with placebo. There was a 23% relative risk reduction compared with amlodipine. The main benefit was on the effect on blood creatinine levels.
The most common side effects with Aprovel (seen in between 1 and 10 patients in 100) are dizziness, nausea (feeling sick) or vomiting, fatigue (tiredness) and increases in blood creatine kinase levels (an enzyme found in muscles). In addition, more than 1 patient in 100 with type 2 diabetes and kidney disease has the following side effects: hyperkalaemia (high blood potassium levels), orthostatic dizziness (dizziness when standing up), musculoskeletal (joint) pain and orthostatic hypotension (low blood pressure when standing up). For the full list of all side effects reported with Aprovel, see the Package Leaflet.
Aprovel should not be used in people who may be hypersensitive (allergic) to irbesartan or any of the other ingredients. It must not be used in women who are more than three months pregnant. Its use during the first three months of pregnancy is not recommended.
The Committee for Medicinal Products for Human Use (CHMP) decided that Aprovel’s benefits are greater than its risks for the treatment of essential hypertension and of renal disease in patients with hypertension and type 2 diabetes mellitus. The Committee recommended that Aprovel be given marketing authorisation.
The European Commission granted a marketing authorisation valid throughout the European Union for Aprovel to Sanofi Pharma Bristol-Myers Squibb SNC on 27 August 1997. The marketing authorisation was renewed on 27 August 2002 and on 27 August 2007.