Leaflet: information for the user
Aprovel 150 mg film-coated tablets
Irbesartán
Read this leaflet carefully before you start taking the medicine, because it contains important information for you.
Although they may have similar symptoms to yours, do not give your medicine to others.
If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
1. What Aprovel is and what it is used for
2.What you need to know before you start taking Aprovel
3.How to take Aprovel
4.Possible side effects
5.Storage of Aprovel
6.Contents of the pack and additional information
Aprovel belongs to a group of medications known as angiotensin II receptor antagonists.‑II. Angiotensin‑II is a substance produced in the body that binds to receptors, causing blood vessels to constrict. This results in an increase in blood pressure. Aprovel prevents the binding of angiotensin‑II to these receptors, relaxing blood vessels and reducing blood pressure. Aprovel slows the deterioration of renal function in patients with high blood pressure and type2 diabetes.
Aprovel is used in adult patients:
Do not take Aprovel
Warnings and precautions
Consult your doctor before starting to take Aprovel andif any of the following aspects affect you:
- an angiotensin-converting enzyme inhibitor (ACEI) (for example enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
- aliskiren.
Your doctor may monitor your renal function, blood pressure, and electrolyte levels in the blood (such as potassium), at regular intervals.
See also the information under the heading “Do not take Aprovel”.
If you are pregnant, if you suspect you may be pregnantor if you plan to become pregnant, you mustinform your doctor. It is generally recommended that you stop taking Aprovel before becoming pregnant or as soon as you become pregnant and your doctor will recommend taking another antihypertensive medication instead. Aprovel is not recommended for use at the beginning of pregnancy and should not be administered at all after the third month of pregnancy, as it may cause serious harm to your baby(see section “Pregnancy”).
Children and adolescents
This medication should not be used in children and adolescents as its safety and efficacy have not been fully established.
Taking Aprovel with other medications
Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.
Your doctor may need to modify your dose and/or take other precautions:
if you are taking an angiotensin-converting enzyme inhibitor (ACEI) or aliskiren (see also the information under the headings “Do not take Aprovel” and “Warnings and precautions”).
You may need to have blood tests if you are taking:
If you are using a type of pain reliever, known as nonsteroidal anti-inflammatory drugs (NSAIDs), the effect of irbesartan may be reduced.
Taking Aprovel with food and drinks
Aprovel can be taken with or without food.
Pregnancy and breastfeeding
Pregnancy
You mustinform your doctorif you are pregnant, if you suspect you may be pregnantor if you plan to become pregnant. It is generally recommended that you stop taking Aprovel before becoming pregnant or as soon as you become pregnant and your doctor will recommend taking another antihypertensive medication instead. Aprovel is not recommended for use at the beginning of pregnancy and should not be administered at all after the third month of pregnancy, as it may cause serious harm to your baby when administered from that point on.
Breastfeeding
Inform your doctor if you plan to start or are breastfeeding, as Aprovel is not recommended for use during this period. Your doctor may decide to administer a more suitable treatment if you want to breastfeed, especially for newborns or premature babies.
Driving and operating machinery
It is unlikely that Aprovel will affect your ability to drive vehicles or operate machinery. However, during hypertension treatment, occasional dizziness or fatigue may occur. If you experience these symptoms, discuss them with your doctor before driving or operating machinery.
Aprovel contains lactose. If your doctor has told you that you have an intolerance to certain sugars (such as lactose), consult with them before taking this medication.
Aprovel contains sodium. This medication contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially “sodium-free”.
Followexactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.
Administration Method
Aprovel is administeredby mouth. The tablets should be swallowed with a sufficient amount of liquid (e.g. a glass of water). Aprovel can be taken with or without food. You should try to take your daily dose at the same time every day. It is essential that you continue taking this medication until your doctor advises you otherwise.
The usual dose is 150mg once a day. Subsequently, and depending on the blood pressure response, this dose may be increased to 300mg once a day (two tablets a day).
In patients with high blood pressure and type2 diabetes, the recommended maintenance dose for the treatment of associated renal impairment is 300mg once a day (two tablets a day).
Your doctor may advise a lower dose, especially at the beginning of treatment, in certain patients, such as those undergoinghemodialysisor thoseover 75years old.
The maximum blood pressure-lowering effect should be achieved within 4‑6weeks after starting treatment.
Use in Children and Adolescents
Aprovel should not be administered to children under 18years old. If a child swallows several 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 forget to take a dose, simply take your usual dose when it is due. Do not take a double dose to make up for the missed dose.
If you have any other questions about the use of this medication, ask your doctor or pharmacist.
Like all medicines, this medicine may cause side effects, although not everyone will experience them.
However, some of these side effects can be serious and may require medical attention.
Like with similar medicines, in rare cases, cases of skin allergic reactions (skin rash, urticaria) have been reported, as well as localized inflammation in the face, lips, and/or tongue in patients treated with irbesartan. If you think you may have this type of reaction or experience shortness of breath,stop takingAproveland seek immediate medical attention.
The side effects mentioned below are grouped by frequency:
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
The side effects reported in clinical trials conducted in patients treated withAprovelwere:
Since the marketing ofAprovel, some side effects have been reported.The side effects observed with unknown frequency are: feeling of spinning, headache, taste alteration, ringing in the ears, muscle cramps, muscle and joint pain, decreased number of red blood cells (anemia - symptoms may include fatigue, headaches, difficulty breathing during exercise, dizziness, and paleness), reduced number of platelets, abnormal liver function, increased potassium levels in blood, kidney function impairment, inflammation of small blood vessels, mainly in the skin area (condition known as leukocytoclastic vasculitis), severe allergic reactions (anaphylactic shock)and low blood sugar levels. Cases of rare ictericia (yellowing of the skin and/or white of the eyes) have also been observed.
Reporting side effects
If you experienceany type of side effect, consult your doctor or pharmacist, even if it is apossibleside effect that does not appear in this prospectus.You can also report them directly through the national notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.
Keep out of the sight and reach of children.
Do not use this medicine after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.
Do not store above 86°F (30°C).
Dispose of medications through a proper disposal method, not through drains or regular trash. Ask your pharmacist how to dispose of unused packaging and medications. This will help protect the environment.
irbesartan.
sodium, hypromellose, colloidal silicon dioxide, magnesium stearate, titanium dioxide, macrogol
3000, carnauba wax. See section 2 “Aprovel contains lactose”.
Appearance of the product and contents of the pack
The film-coated tablets of Aprovel150mg are white or off-white, biconvex, oval-shaped, with a trochee in one face and the number2872 engraved on the other face.
The Aprovel150mg tablets are available in blister packs of 14, 28, 30, 56, 84, 90ó 98film-coated tablets. They are also available in packs of 56x1film-coated tablet containing single-dose blisters for hospital supply.
Only some pack sizes may be marketed.
Marketing authorisation holder:
Sanofi Winthrop Industrie
82 avenue Raspail
94250 Gentilly
France
Responsible for manufacturing:
SANOFIWINTHROPINDUSTRIE
1, rue de la Vierge
Ambarès & Lagrave
F‑33565Carbon Blanc Cedex‑France
SANOFIWINTHROPINDUSTRIE
30-36Avenue Gustave Eiffel, BP7166
F-37071ToursCedex2‑France
Sanofi-Aventis, S.A.
Ctra. C-35 (La Batlloria-Hostalric), km. 63.09
17404 Riells i Viabrea (Girona)
Spain
For further information about this medicinal product, please consult the representative of the marketing authorisation holder in your country.
België/Belgique/Belgien Sanofi Belgium Tél/Tel:+32 (0)2 710 54 00 | Luxembourg/Luxemburg Sanofi Belgium Tél/Tel:+32 (0)2 710 54 00 (Belgique/Belgien) | |
Magyarország SANOFI-AVENTIS Zrt. Tel.: +36 1505 0050 | ||
Ceská republika Sanofi, s.r.o. Tel: +420 233 086 111 | Malta Sanofi S.r.l. Tel: +39 02 39394275 | |
Danmark Sanofi A/S Tlf: +45 45 16 70 00 | Nederland Sanofi B.V. Tel:+31 20 245 4000 | |
Deutschland Zentiva Pharma GmbH Tel: 0800 52 52 010 Tel. aus dem Ausland:+49 69 305 21 131 | Norge sanofi-aventis Norge AS Tlf: +47 67 10 71 00 | |
Eesti Swixx Biopharma OÜ Tel: +372 640 10 30 | Österreich sanofi-aventis GmbH Tel: +43 1 80 185 – 0 | |
Ελλ?δα Sanofi-Aventis Μονοπρ?σωπη AEBE Τηλ: +30 210 900 16 00 | Polska Sanofi Sp.z o.o. Tel.: +48 22280 00 00 | |
España sanofi-aventis, S.A. Tel: +34 93 485 94 00 | Portugal Sanofi - Produtos Farmacêuticos, Lda Tel: +351 21 35 89 400 | |
France Sanofi Winthrop Industrie Tél: 0 800 222 555 Appel depuis l’étranger : +33 1 57 63 23 23 Hrvatska Swixx Biopharma d.o.o. Tel: +385 12078 500 | România Sanofi Romania SRL Tel: +40(0) 21 317 31 36 | |
Ireland sanofi-aventis Ireland Ltd. Tel: +353 (0) 1 403 56 00 | Slovenija Swixx Biopharma d.o.o. Tel: +386 1 235 51 00 | |
Ísland Vistor hf. Sími: +354 535 7000 | Slovenská republika Swixx Biopharma s.r.o. Tel: +421 2208 33 600 | |
Italia Sanofi S.r.l. Tel: 800.536389 | Suomi/Finland Sanofi Oy Puh/Tel: +358 (0) 201 200 300 | |
Κ?προς C.A. Papaellinas Ltd. Τηλ: +357 22 741741 | Sverige Sanofi AB Tel: +46 (0)8 63450 00 | |
Latvija Swixx Biopharma SIA Tel: +371 6616 47 50 | United Kingdom (Northern Ireland) sanofi-aventis Ireland Ltd. T/A SANOFI Tel: +44 (0) 800 035 2525 | |
Lietuva Swixx Biopharma UAB Tel: +370 5 236 91 40 |
Last update of this leaflet:
The detailed information on this medicinal product is available on the website of the European Medicines Agencyhttp://www.ema.europa.eu/
The average price of Aprovel 150 mg comprimidos recubiertos con pelicula in June, 2025 is around 7.74 EUR. Prices may vary depending on the region, pharmacy, and whether a prescription is required. Always check with a local pharmacy or online source for the most accurate information.
Have questions about this medication or your symptoms? Connect with a licensed doctor for guidance and personalized care.