Allegra telfast 180

Package leaflet: Information for the user

Warning! Keep the leaflet, information on the immediate packaging 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 of the same
medicinal product.
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, 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 others, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

1. What Allegra Telfast 180 is and what it is used for
2. What you need to know before taking Allegra Telfast 180
3. How to take Allegra Telfast 180
4. Possible side effects
5. How to store Allegra Telfast 180
6. Contents of the pack and other information

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

Allegra Telfast 180 contains fexofenadine hydrochloride, which is an antihistamine.
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 Allegra Telfast 180

When not to use 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 a cardiovascular disease, 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, they should consult a doctor before using this medicine.

Allegra Telfast 180 and other medicines
Inform your doctor about all medicines currently 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.
Antacids containing aluminium and 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 may be pregnant, or is planning to have a child, 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 affects 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 a physician. If in doubt, consult a doctor or pharmacist.
For adults and children over 12 years of age
The recommended dose is 1 tablet (180 mg) once daily. The tablets should be taken orally, before a meal, with water.
Taking more than the recommended dose of Allegra Telfast 180
If an overdose is taken, seek immediate medical attention from a doctor or go to the nearest hospital. Symptoms of overdose may include dizziness, drowsiness, fatigue, and dry mouth.
Missing a 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 doctor.
Stopping treatment with Allegra Telfast 180
If the patient wishes to discontinue treatment with Allegra Telfast 180, they should consult their doctor beforehand. Discontinuing treatment earlier than recommended may result in the return of disease symptoms.
If there are any further questions regarding the use of this medicine, consult a doctor 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 develop 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 fewer than 1 in 10 but more than 1 in 100 patients): headache, drowsiness, nausea, and dizziness.

Uncommon adverse reactions (occurring in fewer than 1 in 100 but more than 1 in 1000 patients): fatigue.

Other adverse reactions (frequency unknown) that may occur include: difficulty falling asleep (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 tightness in the chest, sudden redness of the skin.

If any of the adverse reactions worsen, or if any adverse reactions not listed in this leaflet occur, inform your doctor or pharmacist.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can also be reported directly to the Department for Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181 C
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 provide more information on the safety of this 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 stated 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. This will 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, equivalent to 168 mg of fexofenadine.
• Other components are:
  Tablet core composition: microcrystalline cellulose, maize starch gelatinized, sodium croscarmellose, magnesium stearate
  Coating composition: hypromellose, povidone, titanium dioxide (E 171), colloidal anhydrous silica, polyethylene glycol 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
“018” on one side and “e” on the other side.
Allegra Telfast 180 tablets are packed in PVC/PE/PVDC/Al or PVC/PVDC/Al blisters,
contained in a cardboard box.
Pack sizes: 20, 50 or 100 film-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/ Roselló i Porcel 21
08016 Barcelona
Spain

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

Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged by:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Spanish Marketing Authorisation Number (country of export): 663351.9
Parallel Import Authorisation Number: 182/24