IRBESARTAN COMBIX 300 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Irbesartan Combix 300 mg Film-Coated Tablets EFG

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

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• 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, pharmacist, or nurse. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet:

1. What is Irbesartan Combix and what is it used for
2. What you need to know before you take Irbesartan Combix
3. How to take Irbesartan Combix
4. Possible side effects
5. Storage of Irbesartan Combix
6. Package contents and further information

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

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

Irbesartan Combix prevents angiotensin-II from attaching to these receptors, relaxing blood vessels and reducing blood pressure. Irbesartan slows down the deterioration of kidney function in patients with high blood pressure and type 2 diabetes.

Irbesartan Combix is used in adult patients:

• For the treatment of high blood pressure (essential hypertension)
• To protect the kidneys in patients with high blood pressure, type 2 diabetes, and evidence of altered kidney function.

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

Do not take Irbesartan Combix

• if you are allergic(hypersensitive) to irbesartan or any of the other ingredients of Irbesartan Combix.
• if you are pregnant for more than 3 months.(In any case, it is best to avoid taking this medicine at the start of your pregnancy – see section Pregnancy).
• if you have diabetes or kidney insufficiency and are being treated with a blood pressure-lowering medicine that contains aliskiren.

Irbesartan Combix should not be given to children and adolescents (under 18 years).

Warnings and precautions

You should tell your doctorin any of the following cases:

• if you have excessive vomiting or diarrhea
• if you have kidney problems
• if you have heart problems
• if you are taking Irbesartan Combix 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 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:

• a 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 Combix”.

If you are pregnant, think you may be pregnant, or are planning to become pregnant, inform your doctor. The use of Irbesartan Combix is not recommended at the start of pregnancy (first 3 months) and should not be taken after the third month of pregnancy, as it may cause serious harm to your baby (see section Pregnancy).

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

Interaction of Irbesartan Combix with other medicines

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription.

Irbesartan Combix does not interact with other medicines.

Your doctor may need to adjust your dose and/or take other precautions:

If you are taking a converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also the information under the headings “Do not take Irbesartan Combix” and “Warnings and precautions”).

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

• potassium supplements
• potassium-containing salt substitutes
• potassium-sparing medicines (such as certain diuretics)
• medicines that contain lithium

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

Irbesartan Combix with food and drinks

Irbesartan Combix can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Pregnancy

Inform your doctor if you are pregnant, think you may be pregnant, or are planning to become pregnant. Your doctor will advise you to stop taking Irbesartan Combix before you become pregnant or as soon as you find out you are pregnant and will recommend that you take another blood pressure-lowering medicine instead. The use of Irbesartan Combix is not recommended at the start of pregnancy (first 3 months) and should not be taken after the third month of pregnancy, as it may cause serious harm to your baby.

Breastfeeding

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not recommended to take Irbesartan Combix while breastfeeding. Your doctor may decide to give you a different treatment that is more suitable if you want to breastfeed, especially for newborns or premature babies.

Driving and using machines

No studies have been performed on the effects on the ability to drive and use machines. It is unlikely that Irbesartan Combix 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 Combix 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 Combix

Follow the instructions for administration of Irbesartan Combix exactly as indicated by your doctor. Ask your doctor or pharmacist if you have any doubts.

Method of administration

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

• Patient with high blood pressure

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

• Patient 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 at the start of treatment, in certain patients, such as hemodialysispatients or 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

Children should not take Irbesartan Combix

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

If you take more Irbesartan Combix than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Irbesartan Combix

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

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

4. Possible side effects

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

However, some effects may be serious and may require medical attention.

As with similar medicines, in rare cases, the following have been reported for patients treated with irbesartan: skin allergic reactions (rash, urticaria), as well as localized swelling in the face, lips, and/or tongue. If you think you may have a reaction of this type or experience shortness of breath, stop taking Irbesartan Combix and go immediately to a medical center.

The following side effects are grouped by frequency:

Very common: May affect more than 1 in 10 patients.

Common: May affect between 1 and 10 in 100 patients.

Uncommon: May affect between 1 and 10 in 1,000 patients.

The side effects reported in clinical trials in patients treated with irbesartan were:

• Very common: if you have high blood pressure and type 2 diabetes with kidney damage, blood tests may show an increase in potassium levels.
• Common: 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: rapid heartbeat, skin flushing, cough, diarrhea, indigestion/heartburn, sexual dysfunction (sexual function disorder), and chest pain.
• Rare: intestinal angioedema: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Since the marketing of irbesartan, the following side effects have been reported. The side effects with unknown frequency are: feeling of spinning, headache, taste disturbance, ringing in the ears, muscle cramps, muscle and joint pain, abnormal liver function, increased potassium levels in the blood, decreased platelet count, kidney function insufficiency, and inflammation of small blood vessels, mainly in the skin area (a condition known as leucocytoclastic vasculitis). Cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been observed.

If you think any of the side effects you are experiencing are serious, or if you notice any side effects not listed in this package leaflet, tell your doctor or pharmacist.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible that the side effects are not listed in this package leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Irbesartan Combix

Keep out of the reach and sight of children.

Do not use Irbesartan Combix after the expiration date stated on the package after EXP. The expiration date is the last day of the month indicated.

Do not store above 30°C.

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

6. Package contents and further information.

Composition of Irbesartan Combix:

• The active ingredient is irbesartan. Each Irbesartan Combix 300 mg tablet contains 300 mg of irbesartan.
• The other ingredients are: lactose monohydrate, pregelatinized corn starch, sodium croscarmellose, Poloxamer 188, microcrystalline cellulose (E460i), calcium stearate, coating agent (hypromellose (E464), titanium dioxide (E171), macrogol 3600, and talc (E553b))

Appearance of the product and package contents

Irbesartan Combix 300 mg film-coated tablets are white or almost white, biconvex, capsule-shaped, marked with “ZE 55” on one face and smooth on the other.

They are available in blister packs containing 28 tablets.

Irbesartan Combix is also available in 75 mg and 150 mg film-coated tablets, in packs containing 28 film-coated tablets.

Marketing authorization holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2. Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Zydus France

ZAC Les Hautes Patures

Parc d'activités des Peupliers

25 Rue des Peupliers

92000 Nanterre

France

or

Centre Spécialités Pharmaceutiques

ZAC des Suzots

35 Rue de la Chapelle

63450 Saint Amant Tallende

France

This package leaflet was last revised in: February 2025

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