IRBESARTAN TARBIS 300 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Irbesartan Tarbis 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 experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack and other information:

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

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

Irbesartan Tarbis belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body that attaches to receptors, causing blood vessels to constrict. This results in an increase in blood pressure. Irbesartan Tarbis prevents angiotensin-II from attaching to these receptors, relaxing blood vessels and reducing blood pressure. Irbesartan slows the deterioration of kidney function in patients with high blood pressure and type 2 diabetes.

Irbesartan Tarbis 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 altered kidney function.

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

Do not take Irbesartan Tarbis:

• if you are allergic to Irbesartan or 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 at the start of pregnancy – see section “Pregnancy”)
• if you have diabetes or kidney insufficiency and are being treated with a blood pressure-lowering medicine containing aliskiren

Irbesartan Tarbis should not be given to children and adolescents (under 18 years).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Irbesartan Tarbis.

• if you have severe vomiting or diarrhea
• if you have kidney problems
• if you have heart problems
• if you are taking Irbesartan Tarbis for diabetic kidney disease. In this case, your doctor may regularly perform blood tests, especially to measure potassium levels in the blood in case of poor kidney function.
• 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 (hypertension):
  • 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 check 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”.

If you are pregnant, think you may be pregnant, or plan to become pregnant, inform your doctor. Irbesartan Tarbis 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 and Breastfeeding).

Children and adolescents

This medicine should not be given to children and adolescents because the safety and efficacy have not been fully established.

Using Irbesartan Tarbis 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 ACE inhibitor or aliskiren (see also the information under the headings “Do not take Irbesartan Tarbis” and “Warnings and precautions”).

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

• potassium supplements
  • potassium-containing salt substitutes
  • potassium-sparing diuretics (certain water tablets)

• medicines containing lithium

If you are using a type of painkiller called non-steroidal anti-inflammatory medicines, the effect of irbesartan may be reduced.

Pregnancy and breastfeeding

Pregnancy

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.

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 give you a different treatment that is more suitable if you want to breastfeed, especially if you are breastfeeding a newborn or premature baby.

If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor before taking this medicine.

Driving and using machines

No studies have been performed on the effects of Irbesartan Tarbis on the ability to drive and use 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.

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

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

3. How to take Irbesartan Tarbis

This medicine is available in 3 strengths: 75 mg, 150 mg, and 300 mg

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 Tarbis is taken by mouth. Swallow the tablets with a sufficient amount of liquid (e.g., a glass of water). You can take Irbesartan Tarbis with or without food. Try to take your daily dose at the same time each day. It is important that you continue to take the medicine until your doctor tells you to stop.

Patient 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 (one Irbesartan Tarbis 300 mg tablet).

Patient with high blood pressure and type 2 diabetes with altered kidney function

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

Your doctor may advise a lower dose, especially when starting treatment, in certain patients, such as hemodialysis patientsor patients 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 any tablets, contact your doctor immediately.

If you take more Irbesartan Tarbis 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 Tarbis:

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 product, ask your doctor or pharmacist.

4. Possible side effects

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

Some of these side effects can be serious and require medical attention.

As with similar medicines, in patients taking irbesartan, rare cases of allergic reactions in the skin (rash, urticaria) and localized swelling in the face, lips, and/or tongue have been reported.

If you experience any of these symptoms or experience difficulty breathing, stop taking this medicine and contact your doctor 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 taking irbesartan were:

Very common (may affect more than 1 in 10 people): if you have high blood pressure and type 2 diabetes with altered kidney function, you may experience high levels of potassium in the blood.

Common (may affect up to 1 in 10 people): dizziness, nausea/vomiting, fatigue, and high levels of the enzyme that measures muscle and heart function (creatine kinase) in blood tests. In patients with high blood pressure and type 2 diabetes with altered kidney function, dizziness or low blood pressure, especially when standing up from a lying or sitting position, muscle or joint pain, and decreased hemoglobin levels (a protein in red blood cells) have also been reported.

Uncommon (may affect up to 1 in 100 people): rapid heartbeat, flushing, cough, diarrhea, indigestion/heartburn, sexual dysfunction (sexual function disorders), chest pain.

Some side effects have been reported since irbesartan has been marketed. The frequency of these side effects is not known: dizziness, headache, altered taste, ringing in the ears, muscle cramps, muscle and joint pain, reduced platelet count, abnormal liver function, high levels of potassium in the blood, kidney function impairment, and inflammation of small blood vessels, mainly in the skin area (a condition known as leucocytoclastic vasculitis). Rare cases of jaundice (yellowing of the skin and/or the whites of the eyes) have been reported.

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet.

Reporting of side effects

If you get 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 Vigilance 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

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

Do not use Irbesartan Tarbis after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month shown.

No special storage conditions are required.

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 further information

Composition of Irbesartan Tarbis

• The active substance is Irbesartan. Each Irbesartan Tarbis tablet contains 300 mg of Irbesartan
• The other ingredients are: anhydrous colloidal silica, sodium croscarmellose (E468), lactose monohydrate, magnesium stearate (E572), microcrystalline cellulose (E460), povidone K-30 (E1201), pregelatinized corn starch, and talc (E553b), hypromellose (E464), macrogol 400, titanium dioxide (E171)

Appearance and packaging

Irbesartan Tarbis 300 mg film-coated tablets are white, biconvex, and oblong, engraved with “300” on one side, approx. 18.8 x 9.0 mm.

Irbesartan Tarbis is available in blister packs of 14, 28, 30, 56, 84, 90, or 98 film-coated tablets.

It is also available in unit-dose blister packs of 56 x 1 film-coated tablets for hospital use.

Not all pack sizes may be marketed.

Marketing authorization holder:

Tarbis Farma, S.L.

Gran Vía Carlos III, 94

08028 Barcelona (Spain)

Manufacturer:

Ferrer Internacional, S.A.

Joan Buscallá, 1-9

08173 - Sant Cugat del Vallés, Barcelona – Spain

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

NL: Irbesartan Farmaprojects 300 mg, filmomhulde tabletten

DE: Irbesartan Farmaprojects 300 mg, Filmtabletten

EL: IRBESARTAN FARMAPROJECTS

ES: Irbesartán Tarbis 300 mg, comprimidos recubiertos con película EFG

PL: Irbesartan Farmaprojects

Date of last revision of this leaflet: November 2020

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/