Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Allegra Telfast 180 (Fexofenadina Opella 180 mg), 180 mg, film-coated tablets
Fexofenadini hydrochloridum
Allegra Telfast 180 and Fexofenadina Opella 180 mg are different trade names for the same
medicinal product.
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet so that you can read it again if necessary.
If you have any doubts, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

What is Allegra Telfast 180 and what is it used for
Important information before taking Allegra Telfast 180
How to take Allegra Telfast 180
Possible side effects
How to store Allegra Telfast 180
Contents of the pack and other information

1. What is Allegra Telfast 180 and what is it used for

Allegra Telfast 180 contains fexofenadine hydrochloride, which is an antihistamine medicine.
Allegra Telfast 180 is used in adults and children over 12 years of age for the treatment of symptoms of chronic allergic skin reactions (chronic idiopathic urticaria), such as itching, swelling, and rashes.

2. Important information before using the medicine Allegra Telfast 180

When not to use the medicine Allegra Telfast 180:

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 treatment with Allegra Telfast 180, discuss it with your doctor.
When to exercise special caution when using Allegra Telfast 180:

if the patient has impaired kidney or liver function,
if the patient currently has or has previously had cardiovascular disease, as this medicine may cause rapid or irregular heartbeat,
if the patient is elderly. If any of the above situations apply, or if the patient has any doubts, they should consult a doctor before taking the medicine.

Allegra Telfast 180 and other medicines
Tell your doctor about all medicines currently taken or recently taken, as well as any medicines the patient plans to use.
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 Telfast 180 by reducing the amount of medicine absorbed. Therefore, it is recommended to maintain a 2-hour interval between taking the above-mentioned antacids and administration of Allegra Telfast 180.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a baby, she should consult her doctor before using this medicine.
Allegra Telfast 180 should not be used during pregnancy unless absolutely necessary.
Use of Allegra Telfast 180 during breastfeeding is not recommended.

Driving and operating machinery
It is unlikely that Allegra Telfast 180 will affect the ability to drive or operate machinery. However, before driving or operating mechanical equipment, ensure that the medicine does not cause drowsiness or dizziness.

Allegra Telfast 180 contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Allegra Telfast 180

This medicine should always be used as directed by the physician. In case of doubt, consult a
physician or pharmacist.
For adults and children over 12 years of age
The recommended dose is 1 tablet (180 mg) once daily.
Tablets should be taken orally, before a meal, with water.
Taking more than the recommended dose of Allegra Telfast 180
If more than the recommended dose is taken, seek immediate medical advice from a physician or
go to the nearest hospital. Symptoms of overdose include: dizziness, drowsiness,
fatigue, and dry mouth.
Missed dose of Allegra Telfast 180
Do not take a double dose to make up for a missed dose.
Take the next dose according to the dosing schedule recommended by the physician.
Stopping treatment with Allegra Telfast 180
If the patient wishes to discontinue treatment with Allegra Telfast 180, they should inform the
physician beforehand. If treatment with Allegra Telfast 180 is stopped earlier than recommended,
symptoms of the disease may recur.
In case of any further doubts regarding the use of this medicine, consult a
physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You should seek immediate medical attention and stop taking Allegra Telfast 180 if you experience swelling of the face, lips, tongue or throat, or have difficulty breathing. These may be symptoms of a severe allergic reaction.
Frequent adverse reactions (occurring less often than in 1 in 10 but more often than in 1 in 100 patients): headache, drowsiness, nausea, and dizziness.
Uncommon adverse reactions (occurring less often than in 1 in 100 but more often than in 1 in 1000 patients): fatigue.
Other adverse reactions (frequency not known) which may occur include: difficulty sleeping (insomnia), sleep disturbances, nightmares/vivid dreams, nervousness, blurred vision, rapid or irregular heartbeat, diarrhoea, skin rash and itching, urticaria, severe allergic reactions which may cause swelling of the face, lips, tongue and throat, difficulty breathing (shortness of breath), feeling of chest tightness, sudden reddening of the skin.
If any of the adverse effects worsen or if any adverse effects not listed in this leaflet occur, inform your doctor or pharmacist.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of 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 Telfast 180

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

6. Contents of the pack and other information

What Allegra Telfast 180 contains

The active substance in Allegra Telfast 180 is fexofenadine hydrochloride. Each tablet contains 180 mg of fexofenadine hydrochloride.
The other components are:
Tablet core composition: sodium croscarmellose, pregelatinized corn starch, microcrystalline cellulose, magnesium stearate.
Coating composition: hypromellose E-15, hypromellose E-5, povidone, titanium dioxide (E 171), colloidal anhydrous silica, macrogol 400, iron oxide mixture (E 172).

What Allegra Telfast 180 looks like and contents of the pack
Allegra Telfast 180 tablets are peach-coloured, capsule-shaped, and marked with
“018” on one side and “e” on the other.
Allegra Telfast 180 tablets are packed in blisters and placed in cardboard cartons.
Pack sizes contain 20, 50 or 100 coated tablets.
For more detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.

Marketing Authorisation Holder in Spain, country of export:
Opella Healthcare Spain, S.L.
C/ Rosselló i Porcel, 21
08016 Barcelona
Spain

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

Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland

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

Spanish Marketing Authorisation Number (country of export): 663351.9
Parallel Import Licence Number: 157/23