IRBESARTAN TARBIS 75 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Irbesartan Tarbis 75 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 experience 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 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 which binds to receptors, causing blood vessels to constrict. This results in an increase in blood pressure. Irbesartan Tarbis prevents angiotensin-II from binding to these receptors, relaxing blood vessels and reducing blood pressure. Irbesartan slows the progression of renal impairment 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 kidney in patients with high blood pressure, type 2 diabetes and evidence of clinically overt renal disease.

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 recommended to avoid taking this medicine during the first few months of pregnancy – see section “Pregnancy”).
• if you havediabetes or kidney impairmentand you are 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 you start taking Irbesartan Tarbis.

• if you have severe vomiting or diarrhoea
• 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 check your blood for signs of kidney damage, particularly if you have existing kidney problems.
• if you are going to have surgery or are going to receive anaesthetics.
• 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 associated with diabetes.
• aliskiren

Your doctor may check your kidney function, blood pressure and levels of potassium in your blood 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 are planning to have a baby, ask your doctor for advice before taking this medicine.

Children and adolescents

This medicine should not be given to children and adolescents because the safety and efficacy have not been 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-sparing diuretics (certain “water tablets”)
• potassium-containing salt substitutes
• lithium (a medicine used to treat some types of depression)

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

Pregnancy and breast-feeding

Pregnancy

Ask your doctor for advice if you are pregnant, think you may be pregnant or are planning to have a baby.

Irbesartan should not be used during the first few months of pregnancy and should not be used at all after the third month of pregnancy because it may cause serious harm to your baby.

Breast-feeding

Ask your doctor for advice if you are breast-feeding or about to start breast-feeding.

Irbesartan is not recommended for mothers who are breast-feeding, and your doctor may choose a different treatment for you if you want to breast-feed, especially if your baby is a newborn or premature.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed. It is unlikely that irbesartan will affect your ability to drive vehicles or operate machines. However, during treatment with this medicine, occasional dizziness or fatigue may occur. If this happens, talk to your doctor before driving or using machines.

Irbesartan Tarbis contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

This medicine contains less than 23 mg sodium (1mmol) per tablet, i.e. it 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. Check with your doctor or pharmacist if you are not sure.

Method of administration

Irbesartan Tarbis is taken by mouth, with a sufficient amount of water (e.g. one glass of water). You can take Irbesartan Tarbis with or without food. Try to take your daily dose at about the same time each day.

Patient with high blood pressure

The usual dose is 150 mg once daily (two 75 mg tablets of Irbesartan Tarbis). The dose can be increased to 300 mg once daily.

Patient with high blood pressure and type 2 diabetes with renal disease

For patients with high blood pressure and type 2 diabetes, the recommended maintenance dose is 300 mg once daily.

Your doctor may advise a lower dose, especially when you start taking the medicine, if you have kidney problems or are over 75 years old.

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

Use in children and adolescents

Irbesartan should not be given to children under 18 years.

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, contact your doctor or pharmacist or go to the emergency department immediately. Inform them of the amount taken.

If you forget to take Irbesartan Tarbis:

If you accidentally miss a dose, just take your normal dose at the next scheduled time. 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, rare cases of allergic reactions to the skin (rash, urticaria) as well as localised swelling (oedema), particularly of the face, lips and/or tongue have been reported in patients taking irbesartan.

If you get any of these symptoms or get short of breath, 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 following side effects have been reported by patients taking irbesartan:

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

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

Uncommon (may affect up to 1 in 100 people): fast heart beat, reddening of the skin, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (problems with sexual function), chest pain.

Some side effects have been reported since the marketing of irbesartan. The frequency of these effects is not known:

vertigo, headache, altered taste, ringing in the ears, muscle cramps, pain in the muscles and joints, low platelet count, abnormal liver function, high levels of potassium in the blood, kidney failure and inflammation of small blood vessels, mainly in the skin (a condition known as leucocytoclastic vasculitis). Rare cases of yellowing of the skin and/or the whites of the eyes (jaundice) have been reported.

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 Agency (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 which is stated on the carton after EXP. The expiry date refers to the last day of that month.

No special storage precautions 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 to protect the environment.

6. Contents of the pack and further information

What Irbesartan Tarbis contains

• The active substance is irbesartan. Each tablet of Irbesartan Tarbis contains 75 mg of irbesartan.
• The other ingredients are: anhydrous colloidal silica, croscarmellose sodium (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 75 mg film-coated tablets are white, biconvex, oblong tablets, approximately 10.6 x 5.0 mm in size.

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 tablet for hospital use.

Not all pack sizes may be marketed.

Marketing authorisation 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 authorised in the Member States of the European Economic Area under the following names:

NL: Irbesartan Farmaprojects 75 mg, filmomhulde tabletten

DE: Irbesartan Farmaprojects 75 mg, Filmtabletten

EL: IRBESARTÁN FARMAPROJECTS

ES: Irbesartán Tarbis 75 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 Medicines Agency (AEMPS) http://www.aemps.gob.es/