Allegra Telfast 180

Leaflet attached to the packaging: patient information

Allegra Telfast 180, 180 mg, film-coated tablets

Fexofenadine hydrochloride

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

• Please keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not give it to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform 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. 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 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, the patient should discuss it with their 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 they have doubts, they should consult their doctor before taking the medicine.

Allegra Telfast 180 and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan 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 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, 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 patient should consult their doctor or pharmacist.
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 a meal, 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 patient should immediately consult their doctor or go to the nearest hospital. Symptoms of overdose include dizziness, drowsiness, fatigue, and dry mouth.

Missing a dose of Allegra Telfast 180

The patient should not take a double dose to make up for a missed dose.
The next dose of the medicine should be taken according to the dosage schedule recommended 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 any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Allegra Telfast 180 can cause side effects, although not everybody gets them.
The patient should immediately consult their doctor and stop taking Allegra Telfast 180 if they 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): 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, vivid dreams/nightmares, 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 pressure in the chest, sudden flushing of the skin.
If any of the side effects worsen or if the patient experiences any side effects not listed in the leaflet, they should inform their doctor or pharmacist.
Reporting side effects
If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their 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.
Side effects can also be reported to the marketing authorization holder or its representative in Poland.
By reporting side effects, more information can be gathered 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 expiration date stated on the carton after:
"Expiration date (EXP):". The expiration date refers to the last day of the specified month.
Store at a temperature below 25°C.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist 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: Core tablet ingredients:sodium croscarmellose, maize starch, microcrystalline cellulose, magnesium stearate. Coating ingredients:hypromellose E-15, hypromellose E-5, povidone, titanium dioxide (E171), colloidal anhydrous silica, macrogol 400, iron oxide mixture (E172).

What Allegra Telfast 180 looks like and what the package contains

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 blisters and a carton.
The package contains 20, 30, 50, or 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:
Opella Healthcare Poland Sp. z o.o.
ul. Marcina Kasprzaka 6
01-211 Warsaw
Manufacturer:
Sanofi Winthrop Industrie
30-36 avenue Gustave Eiffel
37100 Tours
France
Opella Healthcare International SAS
56, Route de Choisy
60200 Compiègne
France
To obtain more detailed information, the patient should contact the representative of the marketing authorization holder:
Opella Healthcare Poland Sp. z o.o.
ul. Marcina Kasprzaka 6
01-211 Warsaw
Phone: +48 22 280 00 00
Date of last revision of the leaflet:May 2025