Label: information for the user

Aprovel 300 mg film-coated tablets

Irbesartan

Read this label carefully before starting to take the medicine, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

1.What Aprovel is and for what it is used

2.What you need to know before starting to take Aprovel

3.How to take Aprovel

4.Possible adverse effects

5.Storage of Aprovel

6.Contents of the package 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:

• to treat high blood pressure (essential hypertension)
• to protect the kidneys in patients with high blood pressure, type2 diabetes, and clinical evidence of altered renal function.

Do not take Aprovel

• if you areallergicto irbesartan or any of the other components of this medication (listed in section 6)
• if you aremore than 3 months pregnant.(In any case, it is better to avoid taking this medication also at the beginning of your pregnancy – see section “Pregnancy”)

• if you havediabetes or kidney failureandare being treated witha blood pressure medication that contains aliskiren

blood pressure medication that contains aliskiren.

Warnings and precautions

Consult your doctor before starting to take Aprovel andif any of the following aspects affect you:

• if you haveexcessive vomiting or diarrhea
• if you havekidney problems
• if you haveheart problems
• if you are taking Aprovel fordiabetic nephropathy. In this case, your doctor may perform regular blood tests, especially to measure potassium levels in case of impaired renal function
• if you presentlow blood sugar levels(symptoms may include sweating, weakness, hunger, dizziness, tremors, headache, flushing or paleness, numbness, rapid and strong heartbeats), especially if you are being treated for diabetes
• if you are to be operated(surgical intervention) orif you are to receiveanesthetics

• if you are taking any of the following medications used to treat high blood pressure (hypertension):

- 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.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Aprovel. Your doctor will decide whether to continue treatment. Do not stop taking Aprovel in monotherapy.

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 not recommended to use Aprovelat the beginning of pregnancy (first three months), and in any case, it should not be administered 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:

• potassium supplements
• potassium-sparing salt substitutes
• potassium-saving medications (such as certain diuretics)
• litium-containing medications
• repaglinide (a medication used to reduce blood sugar levels).

If you are taking 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. Generally, your doctor will advise you to stop taking Aprovel before becoming pregnant or as soon as you become pregnant and recommend taking another antihypertensive medication instead. It is not recommended to use Aprovel at the beginning of pregnancy and in any case, it should not be administered after the third month of pregnancy as it may cause serious harm to your baby when administered from that point onwards.

Breastfeeding

Inform your doctor if you plan to start or are breastfeeding as it is not recommended to administer Aprovel to women during this period. Your doctor may decide to administer a more suitable treatment if you want to breastfeed, especially in 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, inform 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”.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Administration Method

Aprovel is administeredorally. 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.

• Patients with High Blood Pressure

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.

• Patients with High Blood Pressure and Type 2 Diabetes with Kidney Impairment

In patients with high blood pressure and type 2 diabetes, the recommended maintenance dose for the treatment of associated kidney impairment is 300mg once a day.

Your doctor may advise a lower dose, especially at the beginning of treatment, in certain patients, such as those undergoinghemodialysisor those75 years or older.

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. 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 next 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 may 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:

• Very common (may affect more than 1 in 10 people): if you have high blood pressure and type 2 diabetes with kidney impairment, blood tests may show an increase in potassium levels.

• Common (may affect up to 1 in 10 people): dizziness, nausea/vomiting, fatigue, and blood tests may show elevated levels of an enzyme that measures muscle and heart function (creatine kinase). In patients with high blood pressure and type 2 diabetes with kidney impairment, dizziness (especially when standing up), low blood pressure (especially when standing up), muscle or joint pain, and decreased levels of a protein present in red blood cells (hemoglobin).

• Uncommon (may affect up to 1 in 100 people): tachycardia, skin redness, cough, diarrhea, indigestion/heartburn, sexual dysfunction (sexual function alterations), and chest pain.

• Rare (may affect up to 1 in 1,000 people): intestinal angioedema: intestinal swelling that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Since the marketing ofAprovel, some side effects have been reported.The side effects observed with unknown frequency are: feeling of spinning, headache, altered taste, 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 of 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.

Composition of Aprovel

• The active ingredient is irbesartan. Each Aprovel tablet300mg contains 300mg of

irbesartan.

• The other components are lactose monohydrate, microcrystalline cellulose, croscarmellose

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 Aprovel300mg are white or off-white, biconvex, oval-shaped, with a trochee in one face and the number2873 engraved on the other face.

The Aprovel300mg 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.

Date of the last revision of this leaflet:

The detailed information on this medicinal product is available on the website of the European Medicines Agencyhttp://www.ema.europa.eu/