Irbesartan Sun 150 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

IRBESARTAN SUN 150 mg FILM-COATED TABLETS EFG

irbesartan

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

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if such effects are not listed in this leaflet. See section 4.

Leaflet contents:

1. What Irbesartan SUN is and what it is used for
2. What you need to know before taking Irbesartan SUN
3. How to take Irbesartan SUN
4. Possible adverse effects
5. How to store Irbesartan SUN

Pack contents and additional information

1. What IRBESARTÁN SUN is and what it is used for

Irbesartan belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced by the body that binds to receptors, causing blood vessels to constrict. This leads to an increase in blood pressure.

Irbesartan prevents angiotensin-II from binding to these receptors, thereby relaxing blood vessels and reducing blood pressure. Irbesartan slows the decline of kidney function 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 clinical evidence of impaired kidney function.

2. WHAT YOU NEED TO KNOW BEFORE TAKING IRBESARTAN SUN

Do not take Irbesartan SUN

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

Warnings and precautions

Talk to your doctor or pharmacist before taking 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 perform regular blood tests, especially to measure potassium levels if kidney function is impaired
  • if you have low blood sugar levels (symptoms may include sweating, weakness, hunger, dizziness, trembling, headache, flushing or paleness, numbness, rapid and strong heartbeat), especially if you are being treated for diabetes

• if you are scheduled for surgery (surgical procedure) or if you are to receive anaesthetics

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

  • an angiotensin-converting enzyme (ACE) inhibitor (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
  • aliskiren

Your doctor may monitor 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, suspect you may be pregnant, or plan to become pregnant, you must inform your doctor. The use of Irbesartan/Hydrochlorothiazide is not recommended at the beginning of pregnancy, and must in no case be administered from the third month of pregnancy onwards, as it may cause severe harm to your baby (see section Pregnancy).

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

This medicine should not be used in children and adolescents, as its safety and efficacy have not yet been fully established.

Use of Irbesartan SUN with other medicines

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

Your doctor may need to adjust your dose and/or take other precautions if you are taking an angiotensin-converting enzyme (ACE) inhibitor or aliskiren (see also 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
• salt substitutes containing potassium
• potassium-sparing medicines (such as certain diuretics)
• medicines containing lithium
• repaglinide (a medicine used to lower blood sugar levels)

If you are taking a type of painkiller known as non-steroidal anti-inflammatory drugs (NSAIDs), the effect of irbesartan may be reduced.

Taking Irbesartan SUN with food and drink

Irbesartan SUN can be taken with or without food.

Pregnancy and breastfeeding

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

Pregnancy

You must inform your doctor if you are pregnant, suspect you may be pregnant, or plan to become pregnant. Your doctor will generally advise you to stop taking Irbesartan SUN before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. The use of Irbesartan SUN is not recommended during early pregnancy (first 3 months) and must not be used after the first 3 months of pregnancy, as it may cause severe harm to your baby if used beyond the third month of pregnancy.

Breastfeeding

You must inform your doctor if you are breastfeeding or about to start breastfeeding. Irbesartan SUN is not recommended for use in breastfeeding mothers. If you wish to continue breastfeeding, your doctor will recommend an alternative 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 operate machinery. However, during treatment for high blood pressure, dizziness or fatigue may occasionally occur. If you experience these symptoms, discuss them with your doctor before driving or operating machinery.

Irbesartan SUN contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Irbesartán SUN

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. Consult your doctor or pharmacist if you have any doubts.

Method of administration

This medicine is administered orally. The tablets should be swallowed with a sufficient amount of liquid (e.g. a glass of water). Irbesartán may 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 taking this medicine unless your doctor advises you otherwise.

• Patients with high blood pressure

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

• 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 300 mg once daily.

Your doctor may recommend a lower dose, especially at the beginning of treatment, in certain patients, such as those undergoing hemodialysis or those over 75 years of age.

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

Use in children and adolescents

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

If you take more Irbesartán SUN than you should

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

If you forget to take Irbesartán SUN

If you accidentally miss a dose, simply take your next dose at the scheduled time. Do not take a double dose to make up for missed doses.

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

4. Possible adverse effects

Like all medicines, Irbesartan SUN may produce adverse effects, although not everyone experiences them. However, some of these adverse effects may be serious and may require immediate medical attention.

As with similar medicines, rare cases of skin allergic reactions (rash, urticaria) and localized swelling of the face, lips and/or tongue have been reported in patients treated with irbesartan. If you think you may be having such a reaction or experience shortness of breath, stop taking Irbesartan SUN and go immediately to a medical centre.

The adverse effects listed below are grouped according to their frequency as follows:

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

Adverse effects reported in clinical trials conducted 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 impairment, blood tests may show increased 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 enzyme). 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 (haemoglobin).

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

Since the marketing of Irbesartan SUN, some additional adverse effects have been reported. Adverse effects observed with unknown frequency include: sensation of spinning (vertigo), headache, taste disturbances, tinnitus (ringing in the ears), muscle cramps, muscle and joint pain, reduction in the number of red blood cells (anaemia – symptoms may include tiredness, headaches, difficulty breathing during exercise, dizziness and paleness), reduction in the number of platelets, abnormal liver function, increased blood potassium levels, kidney function impairment, inflammation of small blood vessels, mainly in the skin area (a condition known as leukocytoclastic 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 presenting with symptoms such as abdominal pain, nausea, vomiting, and diarrhoea.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es.

5. Storage of Irbesartan SUN

Keep out of sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date is the last day of the month indicated.

Store in the original packaging to protect from light.

This medicine does not require any special storage conditions regarding temperature.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Irbesartán SUN

• The active substance is irbesartan. Each Irbesartán SUN 150 mg tablet contains 150 mg of irbesartan.

The other components are monohydrate lactose, microcrystalline cellulose, hypromellose, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate, and Opadry White (composition: hypromellose, polyethylene glycol 4000, titanium dioxide, and monohydrate lactose).

Appearance of the medicinal product and contents of the container

The film-coated tablets are white or almost white, biconvex and oval, marked with "I4" on one side and smooth on the other.

Irbesartán SUN 150 mg is available in PVC/PE/PVdC/Aluminum blister packs containing 1, 14, 28, 30, 56, 60, 84, 90 or 98 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87, 2132 JH,

Hoofddorp,

The Netherlands

Manufacturer

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87,

2132 JH, Hoofddorp,

The Netherlands

Or

Demo Sa Pharmaceutical Industry,

21st km National Road Athens – Lamia, Krioneri Attiki,

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 medicinal product is authorized in the following EU Member States under the following names:

France Irbesartan SUN 150 mg comprimé pelliculé
Greece PIESITON 150 mg Επικαλυμμ?να με λεπτ? υμ?νιο δισκ?α
Italy Irbesartan SUN 150 mg compresse rivestite con film
Netherlands Irbesartan SUN 150 mg filmomhulde tabletten
Romania Irbesartan Terapia 150 mg, comprimate filmate
Spain Irbesartán SUN 150 mg comprimidos recubiertos con película EFG

This leaflet has been revised in January 2025

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