Irbesartan Combix 300 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Irbesartán Combix 300 mg film-coated tablets EFG

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, pharmacist or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Irbesartán Combix is and what it is used for
2. What you need to know before taking Irbesartán Combix
3. How to take Irbesartán Combix
4. Possible side effects
5. How to store Irbesartán Combix
6. Contents of the pack and other information

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

Irbesartán Combix 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 leads to an increase in blood pressure.

Irbesartán Combix prevents angiotensin-II from binding to these receptors, relaxing the blood vessels and thereby reducing blood pressure. Irbesartan slows the decline in kidney function in patients with high blood pressure and type 2 diabetes.

Irbesartán Combix is used in adult patients:

• For the treatment of high blood pressure (essential hypertension)
• To protect the kidney 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 Combix

Do not take Irbesartán Combix

• if you are allergic (hypersensitive) to irbesartan or to any of the other components of Irbesartán Combix.
• if you are more than 3 months pregnant. (In any case, it is better to avoid taking this medicine also during early pregnancy – see Pregnancy section).
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.

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

Warnings and precautions

You must inform your doctor in any of the following cases:

• if you have excessive vomiting or diarrhoea

• if you have kidney problems

• if you have heart problems

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

• if you are going to undergo surgery or if you are to be given anaesthetics.

• 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 Combix”.

If you are pregnant, suspect you may be pregnant, or plan to become pregnant, you must inform your doctor. The use of Irbesartán Combix is not recommended during the first trimester of pregnancy (first 3 months), and it must not be administered from the third month of pregnancy onwards, as it may cause serious harm to your baby (see section Pregnancy).

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhoea after taking irbesartan. Your doctor will decide whether to continue treatment. Do not stop taking irbesartan monotherapy without medical advice.

Interaction of Irbesartán Combix with other medicines

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

Irbesartán Combix does not have interactions with 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 Combix” 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

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

Irbesartán Combix with food and drink

Irbesartán Combix can be taken with or without food.

Pregnancy, breastfeeding and fertility

Pregnancy

You must inform your doctor if you are pregnant, suspect you may be pregnant, or plan to become pregnant. Generally, your doctor will advise you to stop taking Irbesartán Combix before becoming pregnant or as soon as pregnancy occurs, and will recommend an alternative antihypertensive treatment. The use of Irbesartán Combix is not recommended during early pregnancy and must not be used from the third month of pregnancy onwards, as it may cause serious harm to your baby when administered from this stage.

Breast-feeding

Inform your doctor if you are breast-feeding or plan to breast-feed, as Irbesartán Combix is not recommended for women during this period. Your doctor may choose a treatment more suitable for you if you wish to breast-feed, especially if your baby is a newborn or premature.

Driving and using machines

No studies have been conducted on the effects on the ability to drive and use machines. It is unlikely that Irbesartán Combix will affect the ability to drive vehicles or operate machinery. However, during treatment for hypertension, dizziness or fatigue may occasionally occur. If you experience these symptoms, consult your doctor before driving or operating machinery.

Irbesartán Combix 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 Combix

Follow exactly the administration instructions for Irbesartán Combix provided by your doctor. Consult your doctor or pharmacist if you have any doubts.

Method of administration

Irbesartán Combix is administered orally. The tablets should be swallowed with a sufficient amount of liquid (e.g. a glass of water). Irbesartán 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 advises you otherwise.

- Patients with high blood pressure

The usual dose is 150 mg once daily. Subsequently, 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 haemodialysis patients or patients over 75 years of age.

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

Use in children and adolescents

Children must not take Irbesartán Combix.

Irbesartán Combix must not be administered to children under 18 years of age. If a child accidentally swallows several tablets, contact your doctor immediately.

If you take more Irbesartán Combix than you should

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

If you forget to take Irbesartán Combix

If you accidentally miss a dose, simply take your next scheduled 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, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Irbesartán Combix may cause adverse effects, although not everyone experiences them.

However, some 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 experiencing a reaction of this type or develop shortness of breath, stop taking Irbesartán Combix 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 patients.

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

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

Adverse effects reported in clinical trials conducted in patients treated with irbesartan were:

• Very common: If you have high blood pressure and type 2 diabetes with kidney impairment, blood tests may show increased 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 enzyme). In patients with high blood pressure and type 2 diabetes with kidney impairment, dizziness (especially upon standing), low blood pressure (especially upon standing), muscle or joint pain, and decreased levels of a protein present in red blood cells (hemoglobin).

• Uncommon: Tachycardia, skin redness, cough, diarrhea, indigestion/acid reflux, sexual dysfunction (impairment of sexual function), and chest pain.

• Rare: Intestinal angioedema: swelling in the intestine causing symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Since the marketing of irbesartan, additional adverse effects have been reported. Adverse effects observed with unknown frequency include: sensation of spinning (vertigo), headache, taste disturbances, tinnitus, muscle cramps, muscle and joint pain, abnormal liver function, increased blood potassium levels, reduced platelet count, impaired kidney function, and inflammation of small blood vessels, primarily in the skin (a condition known as leukocytoclastic vasculitis). Rare cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been observed.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Irbesartán Combix

Keep out of the reach and sight of children.

Do not use Irbesartán Combix after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you have any doubts, 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 Irbesartán Combix:

• The active substance is irbesartan. Each Irbesartán Combix 300 mg tablet contains 300 mg of irbesartan.
• The other components are: monohydrate lactose, 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 contents of the pack

Irbesartán Combix 300 mg tablets are white or almost white, biconvex, capsule-shaped, film-coated tablets, marked with "ZE 55" on one side and smooth on the other.

They are supplied in blister packs containing 28 tablets.

Irbesartán Combix is also available as 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

The latest revision of this leaflet was in: February 2025

Detailed and up-to-date 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/