IRBESARTAN TARBIS FARMA 300 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Irbesartan Tarbis Farma 75 mg film-coated tablets EFG

Irbesartan Tarbis Farma 150 mg film-coated tablets EFG

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

1. What is Irbesartan Tarbis Farma and what is it used for

Irbesartan belongs to a group of medicines called angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body that constricts blood vessels, leading to an increase in blood pressure.

Irbesartan prevents angiotensin-II from binding to its receptors, relaxing blood vessels and lowering blood pressure. Irbesartan slows the progression of kidney disease in patients with high blood pressure and type 2 diabetes.

Irbesartan 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 disease.

2. What you need to know before you take Irbesartan Tarbis Farma

Do not take Irbesartan Tarbis Farma

• 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 beginning of your pregnancy – see section “Pregnancy”)
• if you have diabetes or kidney problemsand are being treated with a blood pressure medicine containing aliskiren.

Warnings and precautions

Talk to your doctor before starting to take irbesartan and if any of the following apply 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 can include sweating, weakness, hunger, dizziness, trembling, headache, flushing, or pallor, numbness, rapid 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 given anesthetics
• 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 Tarbis Farma”.

Talk to 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. It is not recommended to use irbesartan at the start of pregnancy (first 3 months), and in any case, it 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 medicine should not be used in children and adolescents, as the safety and efficacy have not been fully established.

Taking Irbesartan Tarbis Farma with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Your doctor may need to change 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 Tarbis Farma” and “Warnings and precautions”).

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

• potassium supplements
• potassium-containing salt substitutes
• potassium-sparing diuretics (such as certain water pills)
• lithium-containing medicines
• repaglinide (a medicine used to reduce blood sugar levels).

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

Taking Irbesartan Tarbis Farma with food and drink

Irbesartan Tarbis Farma can be taken with or without food.

Pregnancy and breastfeeding

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.

Breastfeeding

Inform your doctor if you are about to start or are already breastfeeding. It is not recommended to take irbesartan while breastfeeding. Your doctor may decide to prescribe a different treatment if you want to breastfeed, especially if you are breastfeeding a newborn or premature baby.

Driving and using machines

It is unlikely that irbesartan will affect your ability to drive or use machines. However, during treatment for high blood pressure, dizziness or fatigue may occasionally occur. If you experience these symptoms, talk to your doctor before driving or using machines.

3. How to take Irbesartan Tarbis Farma

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Method of administration

Irbesartan Tarbis Farma is taken orally. The tablets should be swallowed with a sufficient amount of liquid (e.g., a glass of water). Irbesartan Tarbis Farma 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.

• Patients with high blood pressure

The usual 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 disease

In patients with high blood pressure and type 2 diabetes, the recommended maintenance dose for the treatment of kidney disease is 300 mg once daily.

Your doctor may advise a lower dose, especially when starting treatment, in certain patients, such as those on hemodialysisor aged 75 years or older.

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

Use in children and adolescents

Irbesartan Tarbis Farma should not be given to children under 18 years. If a child swallows several tablets, contact your doctor immediately.

If you take more Irbesartan Tarbis Farma than you should

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Irbesartan Tarbis Farma

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 forgotten doses.

If you have any further questions on the use of this product, 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 require 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 a reaction of this type or experience shortness of breath, stop taking Irbesartan Tarbis Farma and go immediately to a medical center.

The following side effects are grouped by frequency:

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

Rare: may affect up to 1 in 1,000 people

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

• Very common(may affect more than 1 in 10 people): if you have high blood pressure and type 2 diabetes with kidney disease, blood tests may show an increase in potassium levels.
• Common(may affect up to 1 in 10 people): 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 disease, 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 people): rapid heartbeat, flushing, cough, diarrhea, indigestion/heartburn, sexual dysfunction (sexual function disorders), and chest pain.
• Rare(may affect up to 1 in 1,000 people): Intestinal angioedema: swelling in the intestine that presents with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Since the marketing of irbesartan, the following side effects have been reported. The frequency of these side effects is not known: feeling of spinning, headache, altered taste, ringing in the ears, muscle cramps, muscle and joint pain, decreased number of red blood cells (anemia - symptoms can include fatigue, headaches, difficulty breathing when exercising, dizziness, and pallor), reduced number of platelets, abnormal liver function, increased potassium levels in the blood, impaired kidney function, 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. There have also been rare cases of jaundice (yellowing of the skin and/or whites of the eyes).

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Surveillance System for Human Use: www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Irbesartan Tarbis Farma

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

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

This medicine does not require any special storage conditions.

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 Tarbis Farma

The active substance is irbesartan.

Each film-coated tablet contains 75 mg of irbesartan.

Each film-coated tablet contains 150 mg of irbesartan.

Each film-coated tablet contains 300 mg of irbesartan.

The other ingredients are

Core:microcrystalline cellulose, sodium croscarmellose, povidone (kollidon 30), colloidal silicon dioxide, calcium stearate.

Coating:hypromellose, titanium dioxide, talc (E553b).

Appearance and packaging

Irbesartan Tarbis Farma 75 mg film-coated tablets EFG

White to off-white, film-coated tablets (approximately 9.10 mm x 4.60 mm), capsule-shaped, biconvex, engraved with "158" on one side and "H" on the other.

Irbesartan Tarbis Farma 150 mg film-coated tablets EFG

White to off-white, film-coated tablets (approximately 11.59 mm x 5.58 mm), capsule-shaped, biconvex, engraved with "159" on one side and "H" on the other.

Irbesartan Tarbis Farma 300 mg film-coated tablets EFG

White to off-white, film-coated tablets (approximately 15.12 mm x 6.58 mm), capsule-shaped, biconvex, engraved with "160" on one side and "H" on the other.

Irbesartan Tarbis Farma film-coated tablets are available in blisters of 28, 30, 56, 90, 98, and 500 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer

Amarox Pharma B.V.

Rouboslaan 32

Voorschoten, 2252TR

Netherlands

This medicine is authorized in the Member States of the European Economic Area under the following names:

Germany: Irbesartan Amarox 75 mg/150 mg/300 mg film-coated tablets

Netherlands: Irbesartan Amarox 75 mg/150 mg/300 mg film-coated tablets

Spain: Irbesartán Tarbis Farma 75 mg/150 mg/300 mg film-coated tablets EFG

Date of last revision of this leaflet: December 2024

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