Irbesartan Tarbis Farma 300 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Irbesartán Tarbis Farma 75 mg film-coated tablets EFG

Irbesartán Tarbis Farma 150 mg film-coated tablets EFG

Irbesartán Tarbis Farma 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you. It could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

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

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

Irbesartan 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 thereby lowering blood pressure. Irbesartan slows the progression of renal impairment 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 clinical evidence of impaired kidney function.

2. What you need to know before starting to take Irbesartán Tarbis Farma

Do not take Irbesartán Tarbis Farma

• if you are allergic to irbesartan or to any of the other ingredients of this medicine (listed in section 6)
• if you are more than 3 months pregnant. (In any case, it is better to avoid taking this medicine also during early pregnancy – see section “Pregnancy”)
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering 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 perform regular blood tests, especially to measure potassium levels if kidney function is impaired

• if you have low blood sugar levels (symptoms may include sweating, weakness, hunger, dizziness, trembling, headache, flushing or paleness, numbness, rapid and strong heartbeat), especially if you are being treated for diabetes

• if you are going to have surgery (surgical procedure) or if you are going to receive anesthetics

• 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 Tarbis Farma”.

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, suspect you may be pregnant, or plan to become pregnant, you must inform your doctor. Use of irbesartan is not recommended during early pregnancy (first 3 months), and in no case should it be administered from the third month of pregnancy onward, 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 safety and efficacy have not yet been fully established.

Taking Irbesartán Tarbis Farma with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any 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 the information under the headings “Do not take Irbesartán Tarbis Farma” 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
• repaglinide (a medicine used to lower blood sugar levels).

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

Taking Irbesartán Tarbis Farma with food and drink

Irbesartán Tarbis Farma can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy

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 irbesartan before becoming pregnant or as soon as you become pregnant, and will recommend an alternative antihypertensive medicine. Irbesartan is not recommended during early pregnancy and must not be used from the third month of pregnancy onward, as it may cause serious harm to your baby when administered from that time.

Breastfeeding

Inform your doctor if you are planning to breastfeed or are currently breastfeeding, as irbesartan is not recommended for women during this period. Your doctor may decide to prescribe a treatment more suitable if you wish to breastfeed, especially if your baby is a newborn or premature.

Driving and using machines

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

3. How to take Irbesartan Tarbis Farma

Follow exactly the administration instructions for this medicine as indicated by your doctor.

If in doubt, consult your doctor or pharmacist again.

Method of administration

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

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

Use in children and adolescents

Irbesartán Tarbis Farma must not be given to children under 18 years of age. If a child swallows several tablets, contact your doctor immediately.

If you take more Irbesartán Tarbis Farma 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 or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Irbesartán Tarbis Farma

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

As with other similar medicines, rare cases of skin allergic reactions (rash, urticaria) as well as localized swelling of the face, lips and/or tongue have been reported in patients treated with irbesartan. If you think you may be experiencing such a reaction or have difficulty breathing, stop taking Irbesartán Tarbis Farma immediately and go to a medical facility right away.

The adverse effects listed below are grouped according to their frequency as follows:

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

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

• Very common (may affect more than 1 in 10 people): if you have high blood pressure and type 2 diabetes with kidney impairment, blood tests may show increased 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 enzyme). 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 (may affect up to 1 in 100 people): tachycardia, skin flushing, cough, diarrhea, indigestion/acid reflux, sexual dysfunction (disturbances in sexual function), and chest pain.

• Rare (may affect up to 1 in 1,000 people): 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 (ringing in the ears), muscle cramps, muscle and joint pain, reduction in the number of red blood cells (anemia – symptoms may include tiredness, headaches, shortness of breath during exercise, dizziness, and paleness), reduced platelet count, abnormal liver function, increased blood potassium levels, kidney function impairment, inflammation of small blood vessels, mainly in the skin (a condition known as leukocytoclastic 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 observed.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, 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: www.notificaRAM.es.

By reporting adverse 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 stated on the carton and blister after EXP/CAD. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, 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 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 components are

Core: microcrystalline cellulose, sodium croscarmellose, povidone (Kollidon 30), colloidal silica, calcium stearate.

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

Appearance of the product and contents of the container

Irbesartán Tarbis Farma 75 mg film-coated tablets EFG

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

Irbesartán Tarbis Farma 150 mg film-coated tablets EFG

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

Irbesartán Tarbis Farma 300 mg film-coated tablets EFG

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

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

Only certain 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

The Netherlands

This medicinal product is authorized in the European Economic Area (EEA) member states under the following names:

Germany: Irbesartan Amarox 75 mg/150 mg/300 mg Filmtabletten

The Netherlands: Irbesartan Amarox 75 mg/150 mg/300 mg, filmomhulde tabletten

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

Date of the most recent revision of this leaflet: December 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/