Allegra Telfast 180

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. 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
medicinal product.

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

• The leaflet should be kept in case it needs to be read again.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their disease are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. 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. Package contents 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 of age to treat symptoms of
chronic skin allergic reactions (chronic idiopathic urticaria) such as itching, swelling, and rashes.

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, the doctor should be consulted.
When to exercise special caution 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 rate,
• 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

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The doctor should be informed 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 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 the above-mentioned 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, the patient should make sure 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, 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, the doctor or pharmacist should be consulted.
For adults and children over 12 years of age
The recommended dose is 1 tablet (180 mg) once a day.
Tablets should be taken orally, before meals, with water.

Taking a higher dose of Allegra Telfast 180 than recommended

In case of taking a higher dose of the medicine than recommended, the doctor or the nearest hospital should be consulted immediately. Symptoms of overdose include dizziness, drowsiness, fatigue, and dry mouth.

Missing a dose of Allegra Telfast 180

A double dose should not be taken to make up for a missed dose.
The next dose of the medicine should be taken according to the dosage schedule prescribed by the doctor.

Stopping Allegra Telfast 180 treatment

If the patient wants to stop taking Allegra Telfast 180, they should inform their doctor first. If the treatment is stopped earlier than recommended, the symptoms of the disease may recur.
In case of any further doubts about taking this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, Allegra Telfast 180 can cause side effects, although not everybody gets them.
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The doctor should be consulted immediately and the treatment with Allegra Telfast 180 should be stopped if the patient experiences 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): headaches, 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 rate, 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 pressure in the chest, sudden flushing of the skin.
If any of the side effects worsen or if any side effects not listed in the leaflet occur, the doctor or pharmacist should be informed.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor, pharmacist, or nurse should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181 C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder or its representative in Poland.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Allegra Telfast 180

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

6. Package contents 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:

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Core tablet ingredients:sodium croscarmellose, maize starch, microcrystalline cellulose, magnesium stearate.
Coating ingredients:hypromellose E-15, hypromellose E-5, povidone, titanium dioxide (E 171), colloidal anhydrous silica, macrogol 400, iron oxide (E 172).

What Allegra Telfast 180 looks like and what the package contains

Allegra Telfast 180 tablets are peach-colored, have a capsule shape, and are marked with "018" on one side and "e" on the other side.
Allegra Telfast 180 tablets are packaged in blisters and a cardboard box.
The package contains 20, 50, or 100 film-coated tablets.
For more detailed information, the marketing authorization holder or the parallel importer should be consulted.

Marketing authorization holder in Spain, the country of export:

Opella Healthcare Spain, S.L., C/ Rosselló i Porcel, 21, 08016 – Barcelona, Grupo Sanofi, 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:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Spanish export authorization number: 663351.9

Parallel import authorization number: 102/24

Date of leaflet approval: 13.03.2024

[Information about the trademark]
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