Telfast 30
Poland
Table of Contents
Package leaflet: Information for the patient
Telfast 30, 30 mg, film-coated tablets
Fexofenadini hydrochloridum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.
- Keep this leaflet, so that you can read it again if necessary.
- If you have any doubts, please 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 someone else, even if their symptoms are the same.
- If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
Table of contents
- What Telfast 30 is and what it is used for
- Important information before taking Telfast 30
- How to take Telfast 30
- Possible side effects
- How to store Telfast 30
- Contents of the pack and other information
1. What Telfast 30 is and what it is used for
Telfast 30 contains fexofenadine hydrochloride, an antihistamine that does not cause drowsiness.
Telfast 30 is used in children aged 6 to 11 years for the treatment of symptoms of hay fever (seasonal allergic rhinitis), such as sneezing, runny or itchy nose, nasal congestion, and itchy, red, watery eyes.
2. Information before using Telfast 30
When not to use Telfast 30:
- if the child is allergic to fexofenadine or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Before starting to use Telfast 30, consult a doctor or pharmacist if:
- the child has kidney or liver function disorders
- the child currently has or has previously had a heart condition, as this medicine may cause rapid or irregular heartbeat.
If any of the above conditions apply to the child or if there are any doubts,
consult a doctor before administering Telfast 30 to the child.
Telfast 30 and other medicines
Tell the doctor or pharmacist 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 aluminium and magnesium, which neutralize gastric acid, may affect the action of Telfast 30 by reducing the amount of medicine absorbed.
It is recommended to maintain a two-hour interval between taking the above-mentioned antacids that neutralize gastric acid and taking Telfast 30.
Pregnancy and breastfeeding
This medicine is indicated for use in children aged 6–11 years. However, for safety reasons, please review the following information.
Before giving any medicine to a child, consult a doctor or pharmacist.
Telfast 30 should not be used during pregnancy unless absolutely necessary.
Use of Telfast 30 is not recommended during breastfeeding.
Driving and operating machinery
It is unlikely that Telfast 30 will affect the ability to drive or operate machinery. However, check whether the medicine causes drowsiness or dizziness in the child.
If such symptoms occur, the child should not be allowed to drive or operate machinery.
Telfast 30 contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet; therefore, the medicine is considered "sodium-free".
3. How to use Telfast 30
This medicine should always be used as directed by a physician.
If in doubt, consult a doctor or pharmacist.
Children aged 6 to 11 years
The recommended dose is 1 tablet (30 mg) twice daily.
The tablets should be taken orally with water.
Taking more Telfast 30 than recommended
If a child takes more than the recommended dose, seek medical advice immediately from a doctor or go to the nearest hospital. Symptoms of overdose include dizziness, drowsiness, fatigue, and dry mouth.
If you miss a dose of Telfast 30
Do not give a double dose to make up for the missed dose.
Give the next dose according to the dosing schedule recommended by the doctor.
Stopping Telfast 30 treatment
Inform the doctor if you intend to stop giving Telfast 30 to the child before the recommended treatment period has ended. If treatment with Telfast 30 is stopped earlier than recommended, symptoms of the illness may return.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
You should immediately contact a doctor and stop using Telfast 30 if the child develops:
- swelling of the face, lips, tongue, or throat, and breathing difficulties. These may be symptoms of a severe allergic reaction.
In clinical studies involving children aged 6 to 11 years, the most commonly reported adverse effect was headache.
In adults, the following adverse effects have been observed (in clinical trials, the frequency of these adverse effects was similar to that observed in patients who received placebo):
Common adverse effects (occurring in fewer than 1 in 10 people):
- headache
- drowsiness
- nausea
- dizziness
Uncommon adverse effects (occurring in fewer than 1 in 100 people):
- fatigue
- drowsiness
Other adverse effects (frequency unknown: cannot be estimated from available data) may include:
- difficulty sleeping (insomnia)
- sleep disturbances
- nightmares
- 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, sudden skin redness, chest tightness, and breathing difficulties.
Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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.
Adverse effects can also be reported to the marketing authorisation holder or its representative in Poland.
Reporting adverse effects helps to provide more information on the safety of the medicine.
- How to store Telfast 30
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following the abbreviation: EXP. The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.
6. Contents of the pack and other information
What Telfast 30 contains
- The active substance is fexofenadine hydrochloride. Each coated tablet contains 30 mg of fexofenadine hydrochloride.
- The other ingredients are:
o Core composition: sodium croscarmellose, pregelatinized starch, microcrystalline cellulose, magnesium stearate.
o Coating composition: hypromellose E-15, hypromellose E-5, povidone, titanium dioxide (E171), anhydrous colloidal silicon dioxide, macrogol 400, pink colouring mixture [red iron oxide (E172), titanium dioxide (E171)], and yellow colouring mixture [yellow iron oxide (E172), titanium dioxide (E171)].
What Telfast 30 looks like and contents of the pack
Telfast 30 tablets are round, peach-coloured, film-coated tablets, marked with
“03” on one side and “e” on the other side.
Telfast 30 tablets are packed in blisters and cardboard boxes.
The pack contains 30 or 60 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Opella Healthcare Poland Sp. z o.o.
ul. Marcina Kasprzaka 6
01-211 Warsaw
Tel.: +48 22 280 00 00
Manufacturers:
Sanofi-Aventis S.p.A.
Strada Statale 17 km 22
67019 Scoppito (L’Aquila)
Italy
Sanofi Winthrop Industrie
30-36 avenue Gustave Eiffel
37100 Tours
France
This medicinal product is authorised in the European Economic Area member states under the following names:
Belgium: Telfast 30 mg filmomhulde tabletten
Denmark: Telfast, filmovertrukne tabletter 30 mg
Finland: Telfast 30 mg tabletti, kalvopäällysteinen
Ireland: Telfast 30 mg film coated tablets
Iceland: Telfast 30 mg filmuhúðaðar töflur
Luxembourg: Telfast 30 mg filmomhulde tabletten
Norway: Telfast 30 mg filmdrasjerte tabletter
Poland: Telfast 30
Portugal: Telfast 30, comprimidos revestidos por película
United Kingdom: Telfast 30 mg film coated tablets
Italy: Telfast 30 mg compresse rivestite con film