Package Insert: Information for the User

Fexofenadine Opella 180 mg Film-Coated Tablets

Fexofenadine hydrochloride

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Fexofenadina Opella contains fexofenadine hydrochloride, which is an antihistaminethat does not cause drowsiness.

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

Do not takeFexofenadina Opella

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Fexofenadina Opella if:

• You have problems with your liver or kidneys.
• You have or have had cardiovascular disease, as this medicine may cause a rapid or irregular heartbeat.

- You are an elderly patient.

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

Taking Fexofenadina Opella with other medicines

Inform your doctor or pharmacist if you are taking or have taken recently or may have to take any other medicine.

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

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

It is recommended to leave a gap of about 2 hours between taking Fexofenadina Opella and the antacid.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

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

The use of Fexofenadina Opella during breastfeeding is not recommended.

Driving and operating machinery

It is highly unlikely that Fexofenadina Opella will affect your ability to drive or operate machinery. However, you must ensure that you do not feel drowsy or dizzy before driving or operating machinery.

Fexofenadina Opella contains sodium.

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

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist.

Adults and children 12 years and older

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

Take the tablet with water before a meal.

The effect of the medication begins after 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 service. 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 (phone 91 562 04 20).

If you forgot to take Fexofenadina Opella

Do not take a double dose to compensate for the missed doses.

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

If you interrupt treatment with Fexofenadina Opella

Consult your doctor if you want to stop taking Fexofenadina Opella before completing the treatment. If you interrupt treatment with Fexofenadina Opella before the scheduled time, you may experience the symptoms again.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

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

• Your face, lips, tongue, or throat become swollen 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 medication (placebo).

Frequent Adverse Effects(may affect up to 1 in 10 people):

• Headache
• Dizziness
• Drowsiness
• Nausea.

Less Frequent Adverse Effects(may affect up to 1 in 100 people):

• Fatigue
• Drowsiness.

Other Adverse Effects(frequency unknown: cannot be estimated from available data) that may occur are:

• Difficulty sleeping (insomnia)
• Sleep disorders
• Nightmares
• Anxiety
• Fast or irregular heartbeat
• Diarrhea, skin rash, and itching
• Urticaria
• Severe allergic reactions that may cause facial, lip, tongue, or throat inflammation, shortness of breath, chest tightness, and difficulty breathing
• Blurred vision.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Fexofenadine Opella 180 mg Composition

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

The other components are:

Core Components: microcrystalline cellulose, pregelatinized cornstarch, sodium croscarmellose, magnesium stearate.

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

Product Appearance and Packaging Content

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

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

Fexofenadine Opella is available in packaging of 2 (only samples), 10, 15, 20, 30, 50, 100, and 200 (10x20) tablets per package.

Not all presentations are for sale.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

Opella Healthcare Spain, S.L.

C/ Roselló i Porcel, 21

08016 - Barcelona

Grupo Sanofi

Responsible Manufacturer

Sanofi-Winthrop Industrie

Avenue Gustave Eiffel, 30 – 36

37100 Tours (France)

or

Opella Helathcare International SAS

56, route de Choisy

60200 Compiègne (France)

This medicine is authorized in the member states of the European Economic Area with 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: Fexofenadine Opella 180 mg comprimidos recubiertos con película

Sweden: Telfast 180 mg filmdragerade tabletter

United Kingdom: Telfast 180 mg film-coated tablets

This prospectus was approved in June 2023

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.es/