APROVEL 300MG 28 TABLETS

Aprovel 300mg film coated tablets (sanofi-aventis)
Package leaflet: Information for the user
APROVEL® 300 mg film-coated tablets
irbesartan
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
1. WHAT APROVEL 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.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE APROVEL
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 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.