Fexofenadine Opella 180 mg film-coated tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Fexofenadina Opella 180 mg film-coated tablets

Fexofenadine hydrochloride

Read the entire leaflet carefully before you start taking this medicine, as 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, since 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 Fexofenadina Opella is and what it is used for
2. What you need to know before taking Fexofenadina Opella
3. How to take Fexofenadina Opella
4. Possible side effects
5. How to store Fexofenadina Opella
6. Contents of the pack and other information

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

Fexofenadina Opella contains fexofenadine hydrochloride, which is a non-sedating antihistamine.

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

2. What you need to know before starting to take Fexofenadine Opella

Do not take Fexofenadine Opella

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Fexofenadine Opella if:

• you have liver or kidney problems.
• you have or have had cardiovascular disease, as this medicine may cause rapid or irregular heartbeat.
• you are an elderly patient.

If you are in any of these situations or if you are unsure, consult your doctor before taking Fexofenadine Opella.

Taking Fexofenadine Opella with other medicines

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

If you are taking apalutamide (a medicine used to treat prostate cancer), the effect of fexofenadine may be reduced.

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

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

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

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

The use of Fexofenadine Opella is not recommended during breastfeeding.

Driving and using machines

It is very unlikely that Fexofenadine Opella will affect your ability to drive or operate machinery. However, you should ensure that you do not experience drowsiness or dizziness after taking these tablets before driving or operating machinery.

Fexofenadine Opella contains sodium.

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

3. How to take Fexofenadine Opella

Follow exactly the instructions for use provided by your doctor. If in doubt, consult your doctor or pharmacist.

Adults and children aged 12 years and older

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 for 24 hours.

If you take more Fexofenadine Opella than you should

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

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

If you forget to take Fexofenadine Opella

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

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

If you stop taking Fexofenadine Opella

Consult your doctor if you wish to stop taking Fexofenadine Opella before completing the treatment. If you stop treatment with Fexofenadine Opella earlier than planned, your symptoms may return.

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.

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

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

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

Frequent adverse effects (may affect up to 1 in 10 people):

• headache
• dizziness
• drowsiness
• nausea

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

• fatigue
• drowsiness

Other adverse effects (frequency not known: cannot be estimated from available data) that may occur include:

• difficulty sleeping (insomnia)
• sleep disorders
• nightmares
• nervousness
• rapid or irregular heartbeat
• diarrhoea, skin rash, and itching
• urticaria
• severe allergic reactions that may cause swelling of the face, lips, tongue, or throat, flushing, chest tightness, and difficulty breathing
• blurred vision

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish System for Pharmacovigilance of Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Fexofenadine Opella Storage

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

Do not use this medicine after the expiry date stated on the packaging after EXP. 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 containers and unused medicines at a SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Fexofenadina Opella 180 mg

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

The other components are:

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

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

Appearance of the product and contents of the pack

Fexofenadina Opella 180 mg are film-coated tablets, oblong in shape and pale orange in colour, marked with "018" on one side and an "e" on the other.

Fexofenadina Opella is presented in blisters. Each tablet is contained within the blister.

Fexofenadina Opella is available in pack sizes of 2 (samples only), 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/ Rosselló i Porcel, 21

08016 Barcelona,

Spain

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 medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Germany: Telfast 180 mg Filmtabletten

Austria: Allegra Hives 180 mg filmtabletten

Belgium: Telfast 180 mg filmomhulde tabletten

Cyprus: Allegra Hives 180 mg επικαλυμμ?να με λεπτ? υμ?νιο δισκ?α

Denmark: Telfast filmovertrukne tabletter 180 mg

Greece: Allegra Hives 180 mg επικαλυμμ?να με λεπτ? υμ?νιο δισκ?α

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

Date of the most recent review of this leaflet: November 2025

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.es/