Irbesartan Sun 300 mg film-coated tablets EFG

Package leaflet: Information for the user

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, 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. It could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects 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 side effects
5. How to store Irbesartan SUN

Pack contents and other information

1. What Irbesartan 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 in the body that binds to receptors, causing blood vessels to constrict. This results in an increase in blood pressure.

Irbesartan prevents angiotensin-II from binding to these receptors, relaxing blood vessels and thereby reducing blood pressure. Irbesartan slows down the worsening 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 Irbesartán SUN

Do not take Irbesartán 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 (use of Irbesartán is also advised to be avoided 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 Irbesartán SUN and if any of the following apply to you:

• if you have excessive vomiting or diarrhea

  • if you have kidney problems

• if you have heart problems

  • if you are taking Irbesartán SUN for diabetic kidney disease. In this case, your doctor may carry out regular blood tests, especially to measure potassium levels in case of impaired kidney function

• if you have low blood sugar levels (symptoms may include sweating, weakness, hunger, dizziness, trembling, headache, flushing or paleness, numbness, rapid and strong heartbeat)

• if you are scheduled for surgery or will be receiving anesthetics

  • if you are taking any of the following medicines used to treat high blood pressure (hypertension):
    • an angiotensin-converting enzyme inhibitor (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 Irbesartán SUN”.

If you are pregnant, suspect you may be pregnant, or plan to become pregnant, inform your doctor. The use of Irbesartán/Hydrochlorothiazide is not recommended at the beginning of pregnancy and must not be administered after the third month of pregnancy 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 Irbesartán SUN. Your doctor will decide whether treatment should continue. Do not stop taking Irbesartán SUN on your own.

Children and adolescents

Irbesartán SUN must not be used in children and adolescents, as its safety and efficacy have not been fully established.

Taking Irbesartán SUN with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Your doctor may need to adjust your dose and/or take other precautions if you are taking an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also information under the headings “Do not take Irbesartán 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 Irbesartán SUN with food and drink

Irbesartán SUN can be taken with or without food.

Pregnancy and breastfeeding

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

Pregnancy

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 Irbesartán SUN before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. The use of Irbesartán 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

Inform your doctor if you are breastfeeding or about to start breastfeeding. The use of Irbesartán SUN is not recommended 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 Irbesartán 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, talk to your doctor before driving or operating machinery.

Irbesartán SUN contains lactose

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

3. How to take Irbesartan SUN

Follow exactly the administration instructions for this medicine as 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). 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 taking this medicine until 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 haemodialysis or patients 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 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 next dose at the usual time. Do not take a double dose to make up for missed doses.

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

4. Possible adverse effects

Like all medicines, Irbesartán SUN may cause adverse effects, although not everyone will experience them.

However, some of these adverse effects can be serious and may require medical attention. As occurs with similar medicines, rare cases of skin allergic reactions (rash, urticaria) as well as localized swelling of the face, lips and/or tongue have been reported in patients treated with irbesartan. If you think you may be experiencing such a reaction or have difficulty breathing, stop taking Irbesartán SUN and seek immediate medical attention.

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 Irbesartán 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): palpitations, skin redness, cough, diarrhoea, indigestion/acid reflux, sexual dysfunction (disturbances in sexual function), and chest pain.

Since the marketing of Irbesartán SUN, some adverse effects have been reported. Adverse effects observed with unknown frequency include: sensation of spinning, 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, shortness of breath during exercise, dizziness and paleness), reduction in the number of platelets, abnormal liver function, increased blood potassium levels, impaired kidney function, inflammation of small blood vessels, mainly in the skin (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 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 through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es.

5. Storage of Irbesartán SUN

Keep out of sight and reach of children.

Do not use Irbesartán SUN after the expiry date stated on the carton and blister after EXP. The expiry date refers to 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 must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. If you are unsure, please ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Irbesartan SUN

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

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

Appearance of the product and contents of the pack

The film-coated tablets are white or almost white, biconvex and oval-shaped, marked with "I5" on one side and smooth on the other.

Irbesartan SUN 300 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 medicine is authorized in the following EU Member States under the following names:

France Irbesartan SUN 300 mg film-coated tablet

Greece PIESITON 300 mg Επικαλυμμ?να με λεπτ? υμ?νιο δισκ?α

Italy Irbesartan SUN 300 mg compresse rivestite con film

Netherlands Irbesartan SUN 300 mg filmomhulde tabletten

Romania Irbesartan Terapia 300 mg, comprimate filmate

Spain Irbesartán SUN 300 mg comprimidos recubiertos con película EFG

This leaflet has been reviewed in January 2025

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