Patient Information Leaflet: Information for the Patient

Irbesartán Combix 300 mg Film-Coated Tablets

Read 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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have similar symptoms to you, as it may harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4

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

2.What you need to know before you start taking Irbesartán Combix

3.How to take Irbesartán Combix

4.Possible side effects

5.Storage of Irbesartán Combix

6. Contents of the pack and additional information

Irbesartán Combix belongs to a group of medications known as angiotensin-II receptor antagonists.Theangiotensin-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.

Irbesartán Combix prevents the binding of angiotensin-II to these receptors, relaxing blood vessels and reducing blood pressure. Irbesartán slows the deterioration of renal 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 kidneys in patients with high blood pressure, type 2 diabetes, and clinical evidence of altered renal function.

Do not take Irbesartán Combix

• if you areallergic(hypersensitive) to irbesartán or any of the other components of Irbesartán Combix.
• if you aremore than 3 months pregnant.(In any case, it is better to avoid taking this medication also at the beginning of your pregnancy – see Pregnancy section).
• if you have diabetes or kidney failure and are being treated with a medication to lower blood pressure that contains aliskirén.

Irbesartán Combix should not be administered to children and adolescents (under 18 years).

Warnings and precautions

You must inform your doctorin any of the following cases:

• if you haveexcessive vomiting or diarrhea
• if you havekidney problems
• if you haveheart problems
• if you are taking Irbesartán Combix fordiabetic nephropathy. In this case, your doctor may perform regular blood tests, especially to measure potassium levels in case of impaired renal function
• if you are to be operated(surgical intervention) orif you are to be administered anesthetics.
• if you are taking any of the following medications used to treat high blood pressure (hypertension):

• a converting enzyme inhibitor (ACEI) (for example enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
• aliskirén.

Your doctor may monitor your renal function, blood pressure, and electrolyte levels in the blood (e.g., potassium), at regular intervals.

See also the information under the heading “Do not take Irbesartán Combix”.

If you are pregnant, if you suspect that you may be, orif you plan to become pregnant, you must inform your doctor. Irbesartán Combix is not recommended for use at the beginning of pregnancy (first 3 months) and should not be administered at all after the third month of pregnancy, as it may cause serious harm to your baby (see Pregnancy section).

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

Interaction of Irbesartán 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.

Irbesartán Combix does not present interactions with other medications.

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

If you are taking an ACEI or aliskirén (see also the 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
• potassium-sparing salt substitutes
• potassium-saving medications (such as certain diuretics)
• medications containing lithium

If you are using a type of analgesic, known as nonsteroidal anti-inflammatory drugs (NSAIDs), the effect of irbesartán may be reduced.

Irbesartán Combix with food and drinks

Irbesartán Combix can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Pregnancy

You must inform your doctor if you are pregnant, if you suspect that you may beor if you plan to become pregnant. Your doctor will usually advise you to stop taking Irbesartán Combix before becoming pregnant or as soon as you become pregnant and recommend taking another antihypertensive medication instead. Irbesartán Combix is not recommended for use at the beginning of pregnancy and should not be administered at all after the third month of pregnancy, as it may cause serious harm to your baby when administered from that time.

Breastfeeding

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

Driving and operating machinery

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

Irbesartán Combix contains lactose.If your doctor has indicated that you have a certain sugar intolerance, consult with him before taking this medication.

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

Administration Method

Irbesartán Combix is administeredorally. 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 essential to continue taking this medication until your doctor advises you otherwise.

-Patients with High Blood Pressure

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

-Patients with High Blood Pressure and Type 2 Diabetes with Renal Impairment

In patients with high blood pressure and type 2 diabetes, the recommended maintenance dose for the treatment of associated renal impairment is 300 mg once a day.

Your doctor may advise a lower dose, especially at the beginning of treatment, in certain patients, such as those undergoinghemodialysisor thoseover 75 years old.

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 Irbesartán Combix

Irbesartán Combix should not be administered to children under 18 years old. If a child 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, phone 91 562 04 20 indicating the medication and the amount ingested.

If You Forget to Take Irbesartán Combix

If you accidentally forget to take a dose, simply take your regular dose when it is due. Do not take a double dose to compensate for the missed doses.

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

Like all medications, Irbesartán Combix may cause side effects, although not everyone will experience them.

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

Like with similar medications, in rare cases, skin allergic reactions (skin rash, urticaria) and localized inflammation on the face, lips, and/or tongue have been reported in patients treated with irbesartán. If you think you may be having this type of reaction or experience shortness of breath,stop taking Irbesartán Combix and seek immediate medical attention.

The side effects listed below 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 conducted in patients treated with irbesartán were:

• Very common:If you have high blood pressure and type 2 diabetes with kidney impairment, 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 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 (hemoglobin).

• Uncommon:Tachycardia, skin redness, cough, diarrhea, indigestion/heartburn, sexual dysfunction (alteration of sexual function), and chest pain.
• Rare: Angioedema intestinal: Intestinal swelling that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Since the marketing of irbesartán, some side effects have been reported. The side effects observed with unknown frequency are: feeling of spinning, headache, altered taste, 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 (condition known as leukocytoclastic vasculitis). Cases of jaundice (yellowing of the skin and/or white of the eyes) have also been observed.

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this prospectus, 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 prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep out of reach and sight of children.

Do not use Irbesartán Combix after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above30°C.

Medicines should not be disposed of through drains or inthe trash. Disposeof the packaging and medicines that you no longer need at the SIGRE collection pointofthe pharmacy. Incase of doubt, ask your pharmacist how to dispose of the packaging and medicines that you no longer need. By doing so, you will help protect the environment.

Composition of Irbesartán Combix:

-The active ingredient is irbesartan. Each Irbesartán Combix 300 mg tablet contains 300 mg of irbesartan.

- Theother components are: Lactose monohydrate, maize pregelatinized starch, sodium croscarmellose, Poloxamero 188, microcrystalline cellulose (E460i), calcium stearate, coating agent (hypromellose (E464), titanium dioxide (E171), macrogol 3600 and talc (E553b))

Appearance of the product and content of the packaging

The Irbesartán Combix 300 mg tablets arefilm-coated white or almost white, biconvex, capsule-shaped, marked with “ZE55”on one face and smooth on the other.

They are presented in blister-type packaging containing 28 tablets.

Irbesartán Combix is also available in film-coated tablets of 75 mg and 150 mg, in packaging containing 28 film-coated tablets.

Holder of the marketing authorization

Combix Laboratories, S.L.U.

C/ Badajoz 2. Building 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Responsible for manufacturing

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

Last review of this leaflet was in: February 2025

Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/