Aprovel 300mg film-coated tablets

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Aprovel is and what it is used for
2. What you need to know before you take Aprovel
3. How to take Aprovel
4. Possible side effects
5. How to store Aprovel
6. Contents of the pack and other information

Do not take Aprovel

• if you are allergic to irbesartan or any other ingredients of this medicine (listed in section 6)
• if you are more than 3 months pregnant. (It is also better to avoid Aprovel in early pregnancy - see pregnancy section)
• if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren

Warnings and precautions

Talk to your doctor before taking Aprovel 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 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
• 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.

See also information under the heading “Do not take Aprovel”.

You must tell you 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).

Children and adolescents

This medicinal product should not be used in children and adolescents because the safety and efficacy have not yet been fully established.

Other medicines and Aprovel

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

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

If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Aprovel” and “Warnings and precautions”).

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 non-steroidal anti-inflammatory drugs, the effect of irbesartan may be reduced.

Aprovel with food and drink

Aprovel can be taken with or without food.

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 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.

Breast-feeding

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

Aprovel is unlikely to affect your ability to drive or use machines. However, occasionally dizziness or weariness may occur during the treatment of high blood pressure. If you experience these, talk to your doctor before attempting to drive or use machines.

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 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 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.

What Aprovel contains

• The active substance is irbesartan. Each tablet of Aprovel 300 mg contains 300 mg irbesartan.
• The other ingredients are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromellose, silicon dioxide, magnesium stearate, titanium dioxide, macrogol 3000, carnauba wax. Please see section 2 “Aprovel contains lactose”.

What Aprovel looks like and contents of the pack

Aprovel 300 mg film-coated tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2873 engraved on the other side.

Aprovel 300 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 film-coated tablets. Unidose blister packs of 56 x 1 film-coated tablet for delivery in hospitals are also available.

Not all pack sizes may be marketed.

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