Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Allegra (Fexofenadina Opella Healthcare), 120 mg, film-coated tablets
Fexofenadini hydrochloridum
Allegra and Fexofenadina Opella Healthcare are different trade names for the same medicine.
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as
directed by your doctor or pharmacist.

Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, consult your pharmacist.
If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.
If there is no improvement or if you feel worse after 5 days, consult your doctor.

Table of contents of the leaflet

What Allegra is and what it is used for
Important information before taking Allegra
How to take Allegra
Possible side effects
How to store Allegra
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 medicine.
Allegra is used in adults and adolescents aged 12 years and older to treat symptoms of
allergic rhinitis (e.g. hay fever), such as sneezing, runny or itchy nose, nasal congestion,
and itchy, red, watery eyes.

2. Important information before taking Allegra

When not to use 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 starting to take Allegra, discuss this with your doctor or pharmacist.
When to exercise special caution when taking Allegra:

if the patient has impaired kidney or liver function,
if the patient currently has or has previously had a cardiovascular disorder, as this medicine may cause rapid or irregular heartbeat,
if the patient is elderly.

If any of the above situations apply to the patient or if the patient has any doubts,
the patient should consult a doctor or pharmacist before taking Allegra.
Allegra and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
If the patient is taking apalutamide (a medicine used to treat prostate cancer), the effect of fexofenadine may be reduced.
Taking antacids containing aluminium or magnesium may affect the action of Allegra by reducing the amount of medicine absorbed.
Therefore, it is recommended to maintain an interval of approximately 2 hours between taking the above-mentioned antacids and administration of Allegra.
Allegra with food and drink
Allegra tablets should be taken before a meal, with water.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before taking this medicine.
Allegra should not be used during pregnancy unless clearly necessary.
Use of Allegra is not recommended during breastfeeding.
Driving and operating machinery
It is unlikely that Allegra will affect the ability to drive or operate machinery. This means that patients may drive motor vehicles and perform tasks requiring concentration. However, before driving or operating mechanical equipment, ensure that the medicine does not cause drowsiness or dizziness. If such symptoms occur, do not drive or operate machinery.
Allegra contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Allegra

This medicine should always be taken exactly as described in the patient leaflet or as directed by
your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The following instructions apply if your doctor has not advised otherwise.
For adults and adolescents aged 12 years and older
The recommended dose is 1 tablet (120 mg) once daily.
The tablets should be taken orally, before a meal, with water.
If symptoms do not improve within 5 days of starting treatment, consult your doctor.
Taking more Allegra than recommended
If you take more than the recommended dose, seek medical advice immediately or go to the nearest hospital. Symptoms of overdose include dizziness, drowsiness, fatigue, and dry mouth.
Missed dose of Allegra
Do not take a double dose to make up for a missed dose.
Take the next dose at the usual scheduled time.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You should contact a doctor immediately and stop taking Allegra if you experience swelling
of the face, lips, tongue or throat and have difficulty breathing. These may be symptoms of a severe
allergic reaction.
Common adverse reactions (occurring in less than 1 in 10 but more than 1 in 100 patients):
headache, drowsiness, nausea, and dizziness.
Uncommon adverse reactions (occurring in less than 1 in 100 but more than 1 in 1,000 patients):
fatigue/drowsiness.
Other adverse reactions (frequency unknown – frequency cannot be estimated from the available data)
which may occur include: difficulty falling asleep (insomnia), sleep disturbances, nightmares/vivid dreams,
nervousness, blurred vision, rapid or irregular heartbeat, diarrhoea, skin rash, itching, urticaria, severe
allergic reactions which may cause swelling of the face, lips, tongue and throat, difficulty breathing,
feeling of chest tightness, sudden redness of the skin.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor,
pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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 adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Allegra

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard packaging.
The expiry date refers to the last day of the specified month.
Store below 25°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Allegra contains

The active substance in Allegra is fexofenadine hydrochloride. Each tablet contains 120 mg of fexofenadine hydrochloride.
The other ingredients are:
Tablet core ingredients: sodium croscarmellose, pregelatinized corn starch, microcrystalline cellulose, magnesium stearate.
Coating ingredients: 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 coated tablets are peach-coloured, capsule-shaped, measuring 6.1 mm x 15.8 mm, and are marked with "012" on one side and "e" on the other.
Allegra coated tablets are packed in PVC/PVDC/Al or PVC/PE/PVDC/Al blisters in a cardboard carton.
The pack contains 20 coated tablets.
For more detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.

Marketing Authorisation 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, Poland

Repackaged by:
InPharm Sp. z o.o. Services sp. k., ul. Chełmżyńska 249, 04-458 Warsaw, Poland

Marketing Authorisation Number in Italy, the country of export: 033304078
Parallel Import Licence Number: 60/25