IRBESARTAN SUN 300 mg FILM-COATED TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

IRBESARTAN SUN 300 mg FILM-COATED TABLETS EFG

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.

Contents of the pack and other information:

1. What is Irbesartan Sun and what is it used for
2. What you need to know before you take Irbesartan Sun
3. How to take Irbesartan Sun
4. Possible side effects
5. Storage of Irbesartan Sun

Contents of the pack and further information

1. What is Irbesartan Sun and what is it used for

Irbesartan belongs to a group of medicines called angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body that causes blood vessels to constrict. This leads to an increase in blood pressure.

Irbesartan blocks the action of angiotensin-II at its receptor, relaxing blood vessels and lowering blood pressure. Irbesartan slows the progression of kidney disease in patients with high blood pressure and type 2 diabetes.

Irbesartan is used in adult patients

• to treat high blood pressure (essential hypertension)
• to protect the kidneys in patients with high blood pressure, type 2 diabetes, and evidence of clinical kidney function impairment.

2. What you need to know before you take Irbesartan Sun

Do not takeIrbesartanSun

• if you are allergic to irbesartan or any of the other ingredients of this medicine (listed in section 6).
• if you are more than 3 months pregnant (it is also recommended to avoid the use of Irbesartan during the first months of pregnancy (see pregnancy and lactation).
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Irbesartan Sun and if any of the following apply to you:

• if you have severe vomiting or diarrhea
• if you have kidney problems

• if you have heart problems
• if you are taking Irbesartan Sun for diabetic kidney disease. In this case, your doctor may regularly perform blood tests, especially to measure potassium levels in case of impaired kidney function.

• if you have low blood sugar levels (symptoms can include sweating, weakness, hunger, dizziness, trembling, headache, flushing, or paleness, numbness, rapid heartbeat), especially if you are being treated for diabetes.
• if you are going to have surgery (surgical intervention) or if you are going to be given anesthetics.
• if you are taking any of the following medicines used to treat high blood pressure:
• • an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
  • aliskiren

Your doctor may check your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium) at regular intervals.

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

If you are pregnant, think you may be pregnant, or are planning to become pregnant, inform your doctor. It is not recommended to start taking Irbesartan Sun during pregnancy, and in any case, it should not be taken after the third month of pregnancy, as it may cause serious harm to your baby (see pregnancy section).

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Irbesartan Sun. Your doctor will decide whether you should continue treatment. Do not stop taking Irbesartan Sun on your own.

Children and adolescents

Irbesartan Sun should not be used in children and adolescents, as its safety and efficacy have not been fully established.

Using Irbesartan Sun with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Your doctor may need to adjust your dose and/or take other precautions if you are taking an ACE inhibitor or aliskiren (see also the information under the headings “Do not take Irbesartan Sun” and “Warnings and precautions”)

You may need to have blood tests if you are taking:

• potassium supplements
• potassium-containing salt substitutes
• potassium-sparing diuretics (such as certain water pills)
• lithium-containing medicines
• repaglinide (a medicine used to lower blood sugar levels).

If you are using a type of pain reliever known as non-steroidal anti-inflammatory medicines, the effect of irbesartan may be reduced.

Taking Irbesartan Sun with food and drinks

Irbesartan Sun can be taken with or without food.

Pregnancy and lactation

If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

You should inform your doctor if you are pregnant, think you may be pregnant, or are planning to become pregnant. Your doctor will normally advise you to stop taking Irbesartan Sun before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Irbesartan Sun. It is not recommended to start taking Irbesartan Sun during pregnancy, and in any case, it should not be taken after the third month of pregnancy, as it may cause serious harm to your baby, if used beyond the third month of pregnancy.

Lactation

You should inform your doctor if you are breastfeeding or about to start breastfeeding. It is not recommended to use Irbesartan Sun in breastfeeding mothers, if you wish to continue breastfeeding, your doctor will recommend another medicine, especially if your baby is newborn or premature.

Driving and using machines

It is unlikely that Irbesartan Sun will affect your ability to drive or use machines. However, during treatment for high blood pressure, dizziness or fatigue may occasionally occur. If you experience these symptoms, consult your doctor before driving or using machines.

Irbesartan Sun contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

3. How to take Irbesartan Sun

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Method of administration

This medicine is taken by mouth. The tablets should be swallowed with a sufficient amount of liquid (e.g., a glass of water). Irbesartan can be taken with or without food. You should try to take your daily dose at the same time each day. It is important that you continue to take this medicine until your doctor tells you to stop.

• Patients with high blood pressure

The usual dose is 150 mg once daily. Depending on the response to blood pressure, this dose may be increased to 300 mg once daily.

• Patients with high blood pressure and type 2 diabetes with kidney damage

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

Your doctor may advise a lower dose, especially when starting treatment, in certain patients, such as those on hemodialysis or elderly patients over 75 years.

The maximum blood pressure-lowering effect should be achieved within 4-6 weeks after starting treatment.

Use in children and adolescents

This medicine should not be given to children under 18 years. If a child swallows several tablets, contact your doctor immediately.

If you take more Irbesartan Sun than you should

If you accidentally take too many tablets, contact your doctor immediately.

If you forget to take Irbesartan Sun

If you accidentally miss a dose, simply take your normal dose when it is due. Do not take a double dose to make up for forgotten doses.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Irbesartan Sun can cause side effects, although not everybody gets them.

However, some of these side effects can be serious and may need medical attention. As with similar medicines, in rare cases, allergic skin reactions (skin rash, urticaria) and localized swelling in the face, lips, and/or tongue have been reported in patients treated with irbesartan. If you think you may have a reaction of this type or experience shortness of breath, stop taking Irbesartan Sun and go immediately to a medical center.

The following side effects 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 in patients treated with Irbesartan Sun were:

• Very common (may affect more than 1 in 10 people): if you have high blood pressure and type 2 diabetes with kidney damage, 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 damage, 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): rapid heartbeat, flushing of the skin, cough, diarrhea, indigestion/heartburn, sexual dysfunction (sexual function disorders), and chest pain.

Since the marketing of Irbesartan Sun, some side effects have been reported. The side effects 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 can include tiredness, headaches, difficulty breathing when exercising, dizziness, and paleness), reduced number of platelets, abnormal liver function, increased potassium levels in the blood, impaired kidney function, inflammation of small blood vessels, mainly in the skin area (a condition known as leucocytoclastic vasculitis), severe allergic reactions (anaphylactic shock), and low blood sugar levels. Rare cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been observed.

• Rare (may affect up to 1 in 10,000 people)

intestinal angioedema: swelling in the intestine that presents with symptoms such as abdominal pain, nausea, vomiting, and diarrhea

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es.

5. Storage of Irbesartan Sun

Keep out of the sight and reach of children.

Do not use Irbesartan Sun after the expiry date which is stated on the carton and blister after EXP. The expiry date is the last day of the month stated.

Store in the original package to protect from light.

This medicine does not require any special storage conditions.

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 protect the environment.

6. Contents of the pack and further information

Composition of Irbesartan Sun

• The active substance is irbesartan. Each Irbesartan Sun 300 mg tablet contains 300 mg of irbesartan.

The other ingredients are lactose monohydrate, microcrystalline cellulose, hypromellose, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate, white opadry (composition: hypromellose, macrogol 4000, titanium dioxide, and lactose monohydrate).

Appearance and packaging

The film-coated tablets are white or almost white, biconvex, and oval, engraved with “I5” on one side and smooth on the other side.

Irbesartan Sun 300 mg is available in PVC/PE/PVdC/Aluminum blister packs of 1, 14, 28, 30, 56, 60, 84, 90, or 98 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87, 2132 JH,

Hoofddorp,

Netherlands

Manufacturer

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87,

2132 JH, Hoofddorp,

Netherlands

Or

Demo Sa Pharmaceutical Industry,

21st km National Road Athens – Lamia, KrioneriAttiki,

14568, Greece

Or

S.C.Terapia S.A.

124 Fabricii Street,

400 632 Cluj Napoca,

Romania.

Local representative

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya 53-55

08007 - Barcelona

Spain

Tel: + 34 93 342 78 90

This medicine is authorized in the following EU member states with the following names:

France Irbesartan SUN 300 mg film-coated tablets

Greece PIESITON 300 mg film-coated tablets

Italy Irbesartan SUN 300 mg film-coated tablets

Netherlands Irbesartan SUN 300 mg film-coated tablets

Romania Irbesartan Terapia 300 mg film-coated tablets

Spain Irbesartán SUN 300 mg film-coated tablets EFG

This leaflet was last revised in January 2025

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es