IRBESARTAN CINFA 300 mg TABLETS

Introduction

Package Leaflet: Information for the User

Irbesartan Cinfa 300 mg film-coated tablets EFG

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

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

Contents of the pack

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

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

Irbesartan Cinfa 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 results in an increase in blood pressure. Irbesartan prevents angiotensin-II from binding to these receptors, relaxing blood vessels and reducing blood pressure. Irbesartan slows the progression of kidney damage in patients with high blood pressure and type 2 diabetes.

Irbesartan Cinfa is 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 evidence of kidney function impairment.

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

Do not take Irbesartan Cinfa

• If you are allergicto irbesartan or any of the other ingredients of this medicine (listed in section 6).
• If you are pregnant more than 3 months. (In any case, it is better to avoid taking this medicine also at the start of your pregnancy – see section “Pregnancy”).
• If you have diabetesor kidney insufficiencyand are being treated with a blood pressure-lowering medicine that contains aliskiren

Warnings and precautions

Consult your doctor or pharmacist before starting to take Irbesartan Cinfa and if any of the following applies to you:

• If you have excessive vomiting or diarrhea.
• If you have kidney problems.
• If you have heart problems.
• If you are taking Irbesartan 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 have low blood sugar levels(symptoms may include sweating, weakness, hunger, dizziness, trembling, headache, flushing or pallor, numbness, rapid and strong heartbeat), especially if you are being treated for diabetes.
• If you are going to have surgery(surgical intervention) or if you are going to be givenanesthetics.
• If you are taking any of the following medicines used to treat high blood pressure:
• • an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), especially 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 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, think you may be pregnant, or plan to become pregnant, inform your doctor. Irbesartan is not recommended during the first trimester of pregnancy and must not be used after the third month of pregnancy, as it may cause serious harm to your baby (see section “Pregnancy”).

Children and adolescents

This medicine must not be used in children and adolescents as the safety and efficacy have not been fully established.

Other medicines and Irbesartan Cinfa

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

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

If you are taking an angiotensin-converting enzyme inhibitor (ACE inhibitor) 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
• potassium-containing salt substitutes
• potassium-sparing medicines (such as certain diuretics)
• medicines containing lithium
• repaglinide (a medicine used to reduce blood sugar levels).

If you are taking a type of painkiller called non-steroidal anti-inflammatory medicines, 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 breast-feeding

Pregnancy

You should inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. Your doctor will normally advise you to stop taking Irbesartan before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine to treat your high blood pressure. Irbesartan is not recommended during the first trimester of pregnancy and must not be used after the third month of pregnancy, as it may cause serious harm to your baby.

Breast-feeding

Inform your doctor if you are about to start or are already breast-feeding. Irbesartan is not recommended for use in women who are breast-feeding, and your doctor may decide to give you a different treatment, especially if you are breast-feeding a newborn or premature baby.

Driving and using machines

Irbesartan is unlikely to affect your ability to drive or use machines. However, occasionally, dizziness or fatigue may occur during treatment of high blood pressure. If you experience these symptoms, consult your doctor before driving or using machines.

Irbesartan Cinfa contains lactose.

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

Irbesartan Cinfa contains hydrogenated castor oil.

This medicine may cause stomach upset and diarrhea because it contains hydrogenated castor oil.

Irbesartan Cinfa contains sodium.

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

3. How to take Irbesartan Cinfa

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

Method of administration

Irbesartan is taken orally. 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 each day. It is important that you continue to take this medicine until your doctor tells you to stop.

The tablet can be divided into equal doses.

• Patients 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.

• Patients 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 when starting treatment, in certain patients, such as those on hemodialysisor 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

Irbesartan should not be given to children under 18 years. 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 Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Irbesartan Cinfa

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

As with similar medicines, in rare cases, the following have been reported for patients treated with irbesartan: allergic skin reactions (rash, urticaria), as well as localized swelling in the face, lips, and/or tongue. If you think you may have an allergic reaction or experience difficulty breathing, stop takingIrbesartanand seek medical attention immediately.

The following side effects have been reported:

Very common:may affect more than 1 in 10 people.

Common:may affect up to 1 in 10 people.

Uncommon:may affect up to 1 in 100 people.

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

• Very common (may affect more than 1 in 10 patients): if you have high blood pressure and type 2 diabetes with kidney damage, blood tests may show an increase in potassium levels.
• Common (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 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 (may affect up to 1 in 100 patients): rapid heartbeat, flushing, cough, diarrhea, indigestion/heartburn, sexual dysfunction (sexual function disorders), and chest pain.

Since the marketing of irbesartan, the following side effects have been reported: feeling of spinning, headache, altered taste, ringing in the ears, muscle cramps, muscle and joint pain, decreased number of red blood cells (anemia - symptoms may include tiredness, headaches, difficulty breathing when exercising, dizziness, and pallor), reduced number of platelets, abnormal liver function, increased potassium levels in the blood, kidney function impairment, and inflammation of small blood vessels, mainly in the skin area (a condition known as leucocytoclastic vasculitis), severe allergic reactions (anaphylactic shock), and low blood sugar levels. Rare cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been reported. Rarely: intestinal angioedema: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Irbesartan Cinfa

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

Store in the original package to protect from light.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Irbesartan Cinfa

• The active substance is irbesartan. Each tablet contains 300 mg of irbesartan.
• The other ingredients are: povidone (E-1201), magnesium stearate (E-470b), microcrystalline cellulose (E-460), lactose monohydrate, croscarmellose sodium, colloidal anhydrous silica, hydrogenated castor oil, and maize starch.

Appearance of the product and pack contents

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

Available in PVC-PVDC/Aluminum blister packs. Each pack contains 28 tablets.

Marketing authorization holder and manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Date of last revision of this leaflet:February 2025

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

You can access detailed and up-to-date 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