Introduction

Package Leaflet: Information for the User

Irbesartan Cinfa 300 mg Tablets EFG

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 or pharmacist.
This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms as you, as it may harm them.
If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What is irbesartán cinfa and what is it used for

irbesartán cinfabelongs 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.Irbesartánprevents the binding of angiotensin-II to these receptors, relaxing blood vessels and reducing blood pressure.Irbesartándelays the deterioration of renal function in patients with high blood pressure and type 2 diabetes.

irbesartán cinfais 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 altered renal function.

2. What you need to know before starting to take irbesartan cinfa

Do not take irbesartan cinfa

If you areallergicto irbesartan or any of the other components of this medication (listed in section 6).
If you aremore than 3 months pregnant. (In any case, it is best to avoid taking this medication also at the beginning of your pregnancy – see section “Pregnancy”).
If you have diabetesor kidney insufficiencyand are being treated with a medication to lower blood pressure that contains aliskiren

Warnings and precautions

Consult your doctor or pharmacist before starting to take irbesartan cinfaandif any of the following aspects affect you:

If you haveexcessive vomiting or diarrhea.
If you havekidney problems.
If you haveheart problems.
If you are takingirbesartanfordiabetic nephropathy. In this case, your doctor may perform regular blood tests, especially to measure potassium levels in case of impaired renal function.
If you presentlow blood sugar levels(symptoms may include sweating, weakness, hunger, dizziness, tremors, headache, flushing or pallor, numbness, rapid and strong heartbeats), especially if you are being treated for diabetes.
Ifyou are to be operated(surgical intervention) orif you are to receiveanesthetics.
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.
- Aliskiren.

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

See also the information under the heading “Do not take irbesartan cinfa”.

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.

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

Children and adolescents

This medication should not be used in children and adolescents as its safety and efficacy have not been fully established.

Other medications and irbesartan cinfa

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

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

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

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

Potassium supplements
Substitutes for salt that contain potassium
Medications that save potassium (such as certain diuretics)
Lithium-containing medications
Repaglinide(a medication used to reduce blood sugar levels).

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

Taking irbesartan cinfa with food and drinks

The tablets can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy

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

Breastfeeding

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

Driving and operating machinery

It is unlikely that irbesartan will affect your ability to drive vehicles or operate machinery. However, during hypertension treatment, occasional dizziness or fatigue may occur. If you experience these symptoms, discuss them with your doctor before driving or operating machinery.

Irbesartan cinfa contains lactose.

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Irbesartan cinfa contains hydrogenated ricin oil.

This medication may cause stomach discomfort and diarrhea due to the presence of hydrogenated ricin oil.

Irbesartan cinfa contains sodium.

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially “sodium-free”.

3. How to take irbesartan cinfa

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Administration method

Irbesartan is administeredorally. 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 every day. It is essential that you continue taking this medication until your doctor advises you otherwise.

The tablet can be divided into equal doses.

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 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 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

Irbesartanshould not be administered to children under 18 years old.If a child swallows several tablets, contact your doctor immediately.

If you take more irbesartan cinfa than you should

If you accidentally take too many tablets, contact your doctor immediately.

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

If you forget to take irbesartan cinfa

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

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

4. Possible Adverse Effects

Like all medicines, this medicinemay cause side effects, although not everyone will experience them.

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

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

The side effects mentioned below are grouped by frequency:

Very frequent:may affect more than 1 in 10 patients.

Frequent:may affect up to 1 in 10 patients.

Infrequent:may affect up to 1 in 100 patients.

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

Very frequent (may affect more than 1 in 10 patients): if you have high blood pressure and type 2 diabetes with kidney impairment, blood tests may show an increase in potassium levels.
Frequent (may affect up to 1 in 10 patients): 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).
Infrequent (may affect up to 1 in 100 patients): tachycardia, skin redness, cough, diarrhea, indigestion/heartburn, sexual dysfunction (sexual function alterations), and chest pain.

Since the marketing of irbesartán, some side effects have been reported. The side effects observed with unknown frequency (cannot be estimated from available data) are:feeling of spinning, headache, taste alteration, ringing in the ears, muscle cramps, muscle and joint pain,decreased number of red blood cells (anemia - symptoms may include fatigue, headaches, difficulty breathing during exercise, dizziness, and paleness),reduced number of platelets, abnormal liver function, increased potassium levels in blood, kidney function impairment, and inflammation of small blood vessels, mainly in the skin area (condition known as leukocytoclastic vasculitis),severe allergic reactions (anaphylactic shock) and low blood sugar levels. Cases of rare frequency of jaundice (yellowing of the skin and/or white of the eyes) have also been observed.With rare frequency: intestinal angioedema: intestinal swelling presenting symptoms such as abdominal pain, nausea, vomiting, and diarrhea

Reporting of side effects

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

5. Conservation of irbesartan cinfa

Keep this medication out of the sight and reach of children.

Store in the original packaging to protect it from light.

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

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

6. Contents of the packaging and additional information

Composition of irbesartan cinfa

The active ingredient is irbesartan. Each tablet contains 300 mg of irbesartan.
The other components are: povidone (E-1201), magnesium stearate (E-470b), microcrystalline cellulose (E-460), lactose monohydrate, sodium croscarmellose, anhydrous colloidal silica, hydrogenated ricin oil, and cornstarch.

Appearance of the product and contents of the packaging

White, oblong, biconvex, scored on one face, and marked with the code “Ir3” on the other face.

Presented in PVC-PVDC/Aluminum blisters. Each package contains 28 tablets.

Holder of the marketing authorization and responsible manufacturer

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Areta Industrial Estate

31620 Huarte (Navarra) – Spain

Date of the last review of this leaflet:February 2025

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

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/70120/P_70120.html

QR code to:https://cima.aemps.es/cima/dochtml/p/70120/P_70120.html