Allegra

Package Leaflet: Information for the User

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Allegra (Fexofenadine Opella Healthcare), 120 mg, film-coated tablets

Fexofenadine hydrochloride
Allegra and Fexofenadine Opella Healthcare are different trade names for the same medicine.

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the package leaflet for the patient or as directed by a doctor or pharmacist.

• The package leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the package leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 5 days or the patient feels worse, they should contact their doctor.

Table of Contents of the Package Leaflet

• 1. What Allegra is and what it is used for
• 2. Important information before taking Allegra
• 3. How to take Allegra
• 4. Possible side effects
• 5. How to store Allegra
• 6. Contents of the pack and other information

1. What Allegra is and what it is used for

Allegra contains fexofenadine hydrochloride, which is an antihistamine.
Allegra is used in adults and in adolescents aged 12 years and older to treat symptoms of allergic rhinitis (such as hay fever), including sneezing, nasal itching, runny or itchy nose, and itchy, red, or watery eyes.

2. Important information before taking Allegra

When not to take Allegra:

• if the patient is allergic to fexofenadine hydrochloride or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before taking Allegra, the patient should discuss it with their doctor or pharmacist.
When to be particularly cautious when taking Allegra:

• if the patient has kidney or liver problems,
• if the patient currently has or has had a heart condition, as this medicine may cause a fast or irregular heartbeat,
• if the patient is elderly.

If any of these cases apply to the patient or if they have any doubts, they should consult their doctor or pharmacist before taking Allegra.

Allegra with other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take.
If the patient is taking apalutamide (a medicine used to treat prostate cancer), the effect of fexofenadine may be reduced.
Taking antacids that contain aluminum or magnesium may affect the action of Allegra by reducing the amount of medicine absorbed.
Therefore, it is recommended to leave a 2-hour interval between taking the above-mentioned antacids and taking Allegra.

Allegra with food and drink

Allegra tablets should be taken before a meal, with a glass of water.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
Allegra should not be taken during pregnancy unless it is absolutely necessary.
It is not recommended to take Allegra during breastfeeding.

Driving and using machines

It is unlikely that Allegra will affect the ability to drive or use machines.
This means that patients can drive vehicles and perform tasks that require concentration.
However, before driving or operating machinery, the patient should make sure that the medicine does not cause drowsiness or dizziness.
If such symptoms occur, the patient should not drive or operate machines.

Allegra contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is considered "sodium-free".

3. How to take Allegra

This medicine should always be taken exactly as described in the package leaflet for the patient or as directed by a doctor or pharmacist.
In case of doubts, the patient should consult their doctor or pharmacist.
The following instructions apply if the doctor has not prescribed a different way of taking Allegra.
For adults and adolescents aged 12 years and older
The recommended dose is 1 tablet (120 mg) once a day.
The tablets should be taken orally, before a meal, with a glass of water.
If the symptoms do not improve after 5 days of taking the medicine, the patient should contact their doctor.

Overdose of Allegra

In case of an overdose, the patient should immediately consult their doctor or go to the nearest hospital.
Symptoms of an overdose include dizziness, drowsiness, fatigue, and dry mouth.

Missing a dose of Allegra

A double dose should not be taken to make up for a missed dose.
The next dose should be taken at the usual time.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Allegra can cause side effects, although not everybody gets them.
The patient should immediately consult their doctor and stop taking Allegra if they experience swelling of the face, lips, tongue, or throat, and difficulty breathing.
These may be symptoms of a severe allergic reaction.
Common side effects (occurring in less than 1 in 10 but more than 1 in 100 patients): headache, drowsiness, nausea, and dizziness.
Uncommon side effects (occurring in less than 1 in 100 but more than 1 in 1,000 patients): fatigue/drowsiness.
Other side effects (frequency not known - frequency cannot be estimated from the available data) that may occur include: difficulty sleeping (insomnia), sleep disorders, nightmares/vivid dreams, nervousness, blurred vision, fast or irregular heartbeat, diarrhea, skin rash, itching, hives, severe allergic reactions that may cause swelling of the face, lips, tongue, and throat, difficulty breathing, feeling of tightness in the chest, sudden flushing of the skin.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in this package leaflet, they should inform their doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Allegra

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the carton.
The expiry date refers to the last day of the month stated.
The medicine should be stored below 25°C.
Medicines should not be disposed of via wastewater or household waste.
The patient should ask their pharmacist how to dispose of medicines that are no longer needed.
This will help protect the environment.

6. Contents of the pack and other information

What Allegra contains

• The active substance of Allegra is fexofenadine hydrochloride.
  Each tablet contains 120 mg of fexofenadine hydrochloride.
• The other ingredients of the medicine are: Core tablet:croscarmellose sodium, maize starch, microcrystalline cellulose, magnesium stearate.Coating:hypromellose E-5, hypromellose E-15, povidone, titanium dioxide (E 171), colloidal anhydrous silica, macrogol 400, yellow iron oxide (E 172), red iron oxide (E 172).

What Allegra looks like and contents of the pack

Allegra film-coated tablets are peach-colored, have a capsule shape with dimensions of 6.1 mm x 15.8 mm, and are marked with "012" on one side and "e" on the other side.
Allegra film-coated tablets are packaged in PVC/PVDC/Al or PVC/PE/PVDC/Al blisters, in a carton box.
The pack contains 20 film-coated tablets.
For more detailed information, the patient should consult the marketing authorization holder or the parallel importer.

Marketing authorization holder in Italy, the country of export:

Opella Healthcare Italy S.r.l.
Viale L Bodio, 37/B
20158 Milan, Italy

Manufacturer:

Sanofi Winthrop Industrie
30-36 Avenue Gustave Eiffel
37100 Tours, France
Opella Healthcare International SAS
56, Route de Choisy
60200 Compiègne, France

Parallel importer:

InPharm Sp. z o.o., ul. Strumykowa 28/11, 03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k., ul. Chełmżyńska 249, 04-458 Warsaw
Marketing authorization number in Italy, the country of export:033304078
033304041

Parallel import authorization number: 60/25

Date of revision of the package leaflet: 11.02.2025

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