Allegra Telfast 180

Leaflet attached to the packaging: patient information

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

Allegra Telfast 180 (Fexofenadine Opella 180 mg), 180 mg, film-coated tablets

Fexofenadine hydrochloride
Allegra Telfast 180 and Fexofenadine Opella 180 mg are different trade names for the same
medicine.

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if their illness symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Allegra Telfast 180 and what is it used for
• 2. Important information 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 is Allegra Telfast 180 and what is it used for

Allegra Telfast 180 contains fexofenadine hydrochloride, which is an antihistamine.
Allegra Telfast 180 is used in adults and children over 12 years old to treat symptoms of
chronic skin allergic reactions (chronic idiopathic urticaria) such as itching, swelling, and rash.

2. Important information before taking Allegra Telfast 180

When not to take 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 taking Allegra Telfast 180, discuss it with your doctor.
When to be particularly careful when taking Allegra Telfast 180:

• if the patient has kidney or liver function disorders,
• if the patient currently has or has had cardiovascular disease in the past, as this medicine may cause rapid or irregular heart rhythm,
• if the patient is elderly. If any of these cases apply to the patient or if the patient has doubts, they should consult their doctor before taking the medicine.

Allegra Telfast 180 and other medicines

Tell your doctor about all medicines the patient is 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 aluminum 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 these antacids and taking Allegra Telfast 180.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine.
Allegra Telfast 180 should not be taken during pregnancy unless it is absolutely necessary.
It is not recommended to take Allegra Telfast 180 during breastfeeding.

Driving and using machines

It is unlikely that Allegra Telfast 180 will affect the ability to drive or use machines. However, before driving or operating machinery, make sure 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, which means the medicine is considered "sodium-free".

3. How to take Allegra Telfast 180

This medicine should always be taken as directed by the doctor. In case of doubts, consult the doctor or pharmacist.

For adults and children over 12 years old

The recommended dose is 1 tablet (180 mg) once a day.
Tablets should be taken orally, before a meal, with water.

Taking a higher dose of Allegra Telfast 180 than recommended

If a higher dose of the medicine is taken than recommended, consult a doctor or go to the nearest hospital immediately. Symptoms of overdose 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 of the medicine according to the dosing schedule prescribed by the doctor.

Stopping Allegra Telfast 180

If the patient wants to stop taking Allegra Telfast 180, they should tell their doctor first. If the patient stops taking Allegra Telfast 180 earlier than recommended, the symptoms of the disease may recur.
In case of further doubts about taking this medicine, consult the doctor or pharmacist.

4. Possible side effects

Like all medicines, Allegra Telfast 180 can cause side effects, although not everybody gets them.
Consult a doctor and stop taking Allegra Telfast 180 immediately if swelling of the face, lips, tongue, or throat and difficulty breathing occur. 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 1000 patients): fatigue
Other side effects (frequency not known) that may occur include: difficulty sleeping (insomnia), sleep disorders, nightmares/vivid dreams, nervousness, blurred vision, rapid or irregular heart rhythm, diarrhea, skin rash and itching, urticaria, severe allergic reactions that may cause swelling of the face, lips, tongue, and throat, difficulty breathing (dyspnea), feeling of chest tightness, sudden skin redness.
If any of the side effects worsen or if side effects not listed in the leaflet occur, tell the doctor or pharmacist.

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, tell the doctor or pharmacist. 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 gather more information on the safety of the medicine.

5. How to store Allegra Telfast 180

Keep the 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 in a temperature 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 pack and other information

What Allegra Telfast 180 contains

• The active substance of Allegra Telfast 180 is fexofenadine hydrochloride. Each tablet contains 180 mg of fexofenadine hydrochloride.
• Other ingredients are: Core tablet: croscarmellose sodium, maize starch, microcrystalline cellulose, magnesium stearate. Coating: 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-colored, capsule-shaped, and marked "018" on one side and "e" on the other side.
Allegra Telfast 180 tablets are packaged in blisters and a cardboard box.
The pack contains 20, 50, or 100 film-coated tablets.
For more detailed information, consult the marketing authorization holder or parallel importer.

Marketing authorization holder in Spain, the 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

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Spanish export authorization number:663351.9

Parallel import authorization number: 157/23

Date of leaflet approval: 08.08.2023

[Information about the trademark]