FEXOFENADINE OPELLA 180 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Fexofenadina Opella 180 mg film-coated tablets

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

1. What is Fexofenadina Opella and what is it used for

Fexofenadina Opella contains fexofenadina hydrochloride, which is a non-drowsy antihistamine.

Fexofenadina Opella 180 mg is used in adults and adolescents aged 12 years and older to relieve the symptoms associated with skin allergy reactions (chronic idiopathic urticaria) such as itching, inflammation, and hives.

2. What you need to know before you take Fexofenadina Opella

Do not take Fexofenadina Opella

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

Warnings and precautions

Consult your doctor or pharmacist before taking Fexofenadina Opella if:

• you have liver or kidney problems.
• you have or have had heart disease, as this medicine may cause a fast or irregular heartbeat.

• you are an elderly patient.

If you are in any of these situations or if you are not sure, consult your doctor before taking Fexofenadina Opella.

Taking Fexofenadina Opella with other medicines

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

If you are taking apalutamide (a medicine for prostate cancer), as the effect of fexofenadina may be reduced.

Indigestion remedies containing aluminum and magnesium may affect the action of Fexofenadina Opella, reducing the amount of medicine absorbed.

It is recommended to leave an interval of about 2 hours between taking Fexofenadina Opella and the indigestion remedy.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before taking any medicine.

Do not take Fexofenadina Opella if you are pregnant, unless it is necessary.

Fexofenadina Opella is not recommended during breastfeeding.

Driving and using machines

It is very unlikely that Fexofenadina Opella will affect your ability to drive or use machines. However, you should make sure that when taking these tablets you do not feel drowsy or dizzy before driving or using machines.

Fexofenadina Opella contains sodium.

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

3. How to take Fexofenadina Opella

Follow exactly the administration instructions of this medicine given by your doctor. If you are not sure, consult your doctor or pharmacist.

Adults and children from 12 years

The recommended dose is 1 tablet (180 mg) once daily.

Take the tablet with water before a meal.

The effect of the medicine starts within 1 hour and lasts 24 hours.

If you take more Fexofenadina Opella than you should

If you take many tablets, consult your doctor or pharmacist, or go to the nearest hospital emergency department. The symptoms of overdose in adults are dizziness, drowsiness, fatigue, and dry mouth.

In case of overdose or accidental ingestion, consult the Toxicological Information Service (telephone 91 562 04 20).

If you forget to take Fexofenadina Opella

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

Take the next dose at the usual time indicated by your doctor.

If you stop taking Fexofenadina Opella

Consult your doctor if you want to stop taking Fexofenadina Opella before finishing the treatment. If you stop taking Fexofenadina Opella before it is due, you may have the symptoms again.

If you have any further questions on 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.

Consult your doctor immediately and stop taking Fexofenadina Opella if you notice that:

• your face, lips, tongue, or throat swell and you have difficulty breathing, as these may be symptoms of a severe allergic reaction.

The following unwanted effects have been reported in clinical trials, with an incidence similar to that observed in patients who did not receive the medicine (placebo).

Common side effects(may affect up to 1 in 10 people):

• headache
• dizziness
• drowsiness
• nausea.

Uncommon side effects(may affect up to 1 in 100 people):

• fatigue
• drowsiness.

Other side effects(frequency not known: cannot be estimated from the available data) that may occur are:

• difficulty sleeping (insomnia)
• sleep disorders
• nightmares
• nervousness
• fast or irregular heartbeat
• diarrhea, skin rash, and itching
• hives
• severe allergic reactions that may cause swelling of the face, lips, tongue, or throat, shortness of breath, chest tightness, and difficulty breathing
• blurred vision.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through 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 Fexofenadina Opella

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 pack after EXP. The expiry date is 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 further information

Composition of Fexofenadina Opella 180 mg

The active substance is fexofenadina hydrochloride. Each tablet contains 180 mg of fexofenadina hydrochloride.

The other ingredients are:

Core ingredients: microcrystalline cellulose, pregelatinized corn starch, sodium croscarmellose, magnesium stearate.

Coating ingredients: hypromellose, povidone, titanium dioxide (E171), colloidal anhydrous silica, macrogol 400, and iron oxide (E172).

Appearance and pack contents

Fexofenadina Opella 180 mg are film-coated tablets, oblong in shape, and pale orange in color, engraved with “018” on one side and an “e” on the other side.

Fexofenadina Opella is presented in blisters. Each tablet is inside the blister.

Fexofenadina Opella is available in packs of 2 (only samples), 10, 15, 20, 30, 50, 100, and 200 (10x20) tablets per pack.

Not all pack sizes are marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Opella Healthcare Spain, S.L.

C/ Roselló i Porcel, 21

08016 - Barcelona

Sanofi Group

Manufacturer

Sanofi-Winthrop Industrie

Avenue Gustave Eiffel, 30 – 36

37100 Tours (France)

or

Opella Healthcare International SAS

56, route de Choisy

60200 Compiègne (France)

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

Belgium: Telfast 180 mg filmomhulde tabletten

Denmark: Telfast filmovertrukne tabletter 180 mg

Finland: Telfast 180 mg tabletti, kalvopäällysteinen

Germany: Telfast 180 mg Filmtabletten

Ireland: Telfast 180 mg film-coated tablets

Italy: Telfast 180 mg compresse rivestite con film

Luxembourg: Telfast 180 mg filmomhulde tabletten

Malta: Telfast 180 mg film-coated Tablets

Portugal: Telfast 180, comprimidos revestidos por película

Spain: Fexofenadina Opella 180 mg comprimidos recubiertos con película

Sweden: Telfast 180 mg filmdragerade tabletter

United Kingdom: Telfast 180 mg film-coated tablets

This leaflet was approved in June 2023

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.es/