Allegra Telfast 180

Package Leaflet: Information for the User

Warning! Keep the leaflet, the information on the immediate packaging is 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 package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your 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. 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 of age for the treatment of symptoms of chronic skin allergic reactions (chronic idiopathic urticaria) such as itching, swelling, and hives.

2. Important information before taking Allegra Telfast 180

When not to take Allegra Telfast 180:

• if you are 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 extra careful when taking Allegra Telfast 180:

• if you have kidney or liver problems,
• if you have a heart condition, as this medicine may cause fast or irregular heartbeat,
• if you are elderly. If any of these apply to you, or if you are not sure, consult your doctor before taking this medicine.

Allegra Telfast 180 and other medicines

Tell your doctor about all the medicines you are taking now or have taken recently, and about any medicines you plan to take.
If you are taking apalutamide (a medicine used to treat prostate cancer), the effect of fexofenadine may be reduced.
Taking antacids that contain aluminum and magnesium may affect the action of Allegra Telfast 180 by reducing the amount of medicine absorbed. Therefore, it is recommended to leave a 2-hour interval between taking these antacids and taking Allegra Telfast 180.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.
Do not take Allegra Telfast 180 during pregnancy, unless it is clearly 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 your ability to drive or use machines. However, before driving or using machines, make sure that the medicine does not cause drowsiness or dizziness.

Allegra Telfast 180 contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is essentially sodium-free.

3. How to take Allegra Telfast 180

Always take this medicine exactly as your doctor has told you.
In case of doubt, consult your 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 meals, with water.

Overdose of Allegra Telfast 180

If you have taken more than the recommended dose, seek medical advice immediately. Symptoms of overdose are: dizziness, drowsiness, fatigue, and dry mouth.

Missed dose of Allegra Telfast 180

Do not take a double dose to make up for a forgotten dose.
Take the next dose at the scheduled time.

Stopping Allegra Telfast 180 treatment

If you want to stop taking Allegra Telfast 180, talk to your doctor first.
If you stop taking Allegra Telfast 180 earlier than recommended, the symptoms of your disease may return.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Allegra Telfast 180 can cause side effects, although not everybody gets them.
Seek medical attention immediately and stop taking Allegra Telfast 180 if you experience 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): 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 are: difficulty sleeping (insomnia), sleep disturbances, vivid dreams/nightmares, nervousness, blurred vision, fast or irregular heartbeat, diarrhea, skin rash, and itching, hives, 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 get serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Reporting of side effects
If you experience any side effects, including any side effects not listed in the leaflet, please tell your doctor, pharmacist, or nurse. 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Allegra Telfast 180

Keep this medicine out of the 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 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, which corresponds to 168 mg of fexofenadine.
• The other ingredients are: Core tablet:microcrystalline cellulose, maize starch, sodium croscarmellose, magnesium stearate Coating:hypromellose, 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 with "018" on one side and "e" on the other side.
Allegra Telfast 180 tablets are packaged in PVC/PE/PVDC/Al or PVC/PVDC/Al blisters in a cardboard box.
The pack contains 20, 50, or 100 film-coated tablets.
For more detailed information, please contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Spain, the 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

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorization number in Spain, the country of export: 663351.9

Parallel import authorization number: 182/24

Date of approval of the leaflet: 06.05.2024

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