IRBESARTAN COMBIX 75 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Irbesartan Combix 75 mg Film-Coated Tablets EFG

Read the entire package leaflet carefully before starting to take this medication because it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms of illness as you, as it may harm them.
• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are 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 taking Irbesartan Combix
3. How to take Irbesartan Combix
4. Possible side effects
5. Storage of Irbesartan Combix
6. Package Contents and Additional Information

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

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

Irbesartan Combix prevents the binding of angiotensin-II 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 clinical evidence of altered kidney function.

2. What you need to know before taking Irbesartan Combix

Do not take Irbesartan Combix

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

Irbesartan Combix should not be administered to children and adolescents (under 18 years of age).

Warnings and Precautions

You must inform 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 medications used to treat high blood pressure:

• a converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), especially if you have diabetes-related kidney problems.
• 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 Combix”.

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

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 medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

Irbesartan Combix does not interact with other medications.

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 medications (such as certain diuretics)
• medications containing lithium

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

Irbesartan Combix with food and beverages

Irbesartan Combix can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Pregnancy

You must inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. Your doctor will advise you to stop taking Irbesartan Combix before becoming pregnant or as soon as you become pregnant and recommend taking another blood pressure medication instead. Irbesartan Combix is not recommended during the first trimester of pregnancy and should not be taken after the third month of pregnancy, as it may cause serious harm to your baby.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to breastfeed, as Irbesartan Combix is not recommended for women during this period. Your doctor may decide to administer a treatment that is more suitable if you want to breastfeed, especially for newborns or premature babies.

Driving and using machines

No studies have been conducted on the effects on the ability to drive and use machinery. It is unlikely that Irbesartan Combix will affect your ability to drive vehicles or use machines. However, during hypertension treatment, 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 certain sugars, consult your doctor before taking this medication.

3. How to take Irbesartan Combix

Follow your doctor's instructions for taking Irbesartan Combix exactly. Consult your doctor or pharmacist if you have any questions.

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 every day at the same time. It is essential that you continue taking this medication until your doctor advises you otherwise.

• Patient with high blood pressure

The usual dose is 150 mg once a day (two tablets a day). Later, and depending on the response to blood pressure, this dose may be increased to 300 mg once a day (four tablets a day).

• 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 associated kidney damage is 300 mg once a day (four tablets a day).

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

The maximum blood pressure-reducing 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 administered to children under 18 years of age. 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 medication and the amount ingested.

If you forget to take Irbesartan Combix

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

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

4. Possible side effects

Like all medications, Irbesartan Combix can cause side effects, although not everyone will experience them.

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

As with similar medications, rare cases of allergic skin reactions (skin rash, hives) and localized inflammation 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 Combix and go to a medical center immediately.

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, some side effects have been reported. The side effects with unknown frequency are: feeling of spinning, headache, taste alteration, ringing in the ears, muscle cramps, muscle and joint pain, abnormal liver function, increased potassium levels in the blood, reduced platelet count, kidney function impairment, 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 is serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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 packaging after CAD. The expiration date is the last day of the month indicated.

Do not store above 30°C.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need in the SIGRE Point of your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Irbesartan Combix:

• The active ingredient is irbesartan. Each Irbesartan Combix 75 mg tablet contains 75 mg of irbesartan.
• The other ingredients are: lactose monohydrate, pregelatinized cornstarch, 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

The Irbesartan Combix 75 mg tablets are film-coated, white or almost white, biconvex, capsule-shaped, marked with “ZE 53” on one side and smooth on the other.

They are available in blister packs containing 28 tablets.

Irbesartan Combix is also available in 150 mg and 300 mg film-coated tablets, in packages 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 updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/