MEBEVERINE TARBIS 135 mg FILM-COATED TABLETS

Introduction

Patient Information: Summary of Product Characteristics

Mebeverina Tarbis 135 mg film-coated tablets EFG

mebeverine hydrochloride

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

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

Mebeverina 135 mg film-coated tablets contain the active substance mebeverine hydrochloride, which belongs to a group of medicines called antispasmodics, which act on the intestine.

This medicine is used to relieve the symptoms of irritable bowel syndrome (IBS) and other similar conditions such as irritable colon in adults.

Irritable bowel syndrome (IBS) is a very common condition that causes spasms and pain in the intestine.

The intestine is a long muscular tube through which food passes to be digested. If a spasm occurs in the intestine and the pressure is too strong, it causes pain.

The symptoms vary from person to person, but may include:

• stomach pain and colic
• feeling of abdominal distension and gas
• diarrhea, constipation, or a combination of both

small, hard, fragmented, or pellet-like stools

Your diet and lifestyle can also help treat irritable bowel syndrome (IBS):

A high-fiber diet may be helpful, but consult your doctor or pharmacist for more information.

Relaxation can help reduce IBS symptoms.

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

Do not take Mebeverina

• If you are allergic to mebeverine hydrochloride or any of the other ingredients of this medicine (listed in section 6).

If you have intestinal obstruction (paralytic ileus)

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine.

If you develop new symptoms or if your symptoms worsen

Other medicines and Mebeverina Tarbis

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

Pregnancy and breastfeeding

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

Mebeverine is not recommended during pregnancy or breastfeeding.

Driving and using machines

This medicine is unlikely to affect your ability to drive or use tools or machines.

Mebeverina Tarbis contains lactose

Each film-coated tablet contains 97 mg of lactose (as lactose monohydrate).

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

Mebeverina Tarbis contains sodium

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

3. How to take Mebeverina Tarbis

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist again.

Taking this medicine

• Mebeverine is indicated in adults

• Take the tablet whole, without dividing it into smaller pieces or chewing it, with a full glass of water, approximately 20 minutes before meals.
• Try to take your tablets at the same time each day. This will help you remember when to take them.

Use in adults

The recommended dose is one tablet (135 mg of mebeverine hydrochloride) 3 times a day. Do not take more than 3 tablets per day and space the doses evenly throughout the day.

Use in children and adolescents

This medicine is not recommended for use in children and adolescents under 18 years, as there are not enough data available.

If you take more Mebeverina Tarbis than you should

If you have taken more mebeverine than you should or have accidentally ingested the contents of the pack, consult your doctor or pharmacist immediately or contact the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount ingested. It is recommended to take the pack and the leaflet of the medicine to the healthcare professional.

If you forget to take Mebeverina Tarbis

Do not take a double dose to make up for forgotten doses.

If you stop taking Mebeverina Tarbis

Do not stop taking this medicine without consulting your doctor, even if you feel better.

If you have any other questions about 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.

Stop taking this medicine and consult a doctor immediately if you experience any of the following serious side effects, as you may need urgent medical treatment:

• Difficulty breathing, swelling of the face, neck, lips, tongue, or throat. You may be experiencing a severe allergic reaction (hypersensitivity) to this medicine.

Other side effects are:

• You may experience a milder allergic reaction (hypersensitivity) to the medicine: for example, skin rash, redness, and itching.
• Very rare cases of dizziness, drowsiness, confusion, and nausea have been reported.

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 through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Mebeverina Tarbis

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the pack after "EXP". The expiry date is 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 Mebeverina Tarbis

The active substance is mebeverine hydrochloride.

Each film-coated tablet contains 135 mg of mebeverine hydrochloride.

The other excipients are:

Core of the tablet: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate (type A, potato), povidone, talc, magnesium stearate

Coating of the tablet: hypromellose, macrogol, titanium dioxide

Appearance of the product and contents of the pack

White, round, biconvex, and smooth film-coated tablets on both sides.

Diameter: 10.0 mm and thickness: 4.3 mm

Mebeverina Tarbis 135 mg film-coated tablets EFG are available in Al/PVC and PVC/PVDC-aluminum blisters in packs of 60 tablets.

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

Or

Meiji Pharma Spain S.A.

Avda. de Madrid 94 – Alcalá de Henares

28802 – Spain

Date of last revision of this leaflet: May 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/