516582_Nt TELFAST 30MG GB.qxp_FORMAT 210x170mm-RL.qxd 19/06/14 11:46 Pagel

PACKAGE LEAFLET:

INFORMATION FOR THE USER

30 mg

film-coated tablets

Fexofenadine hydrochloride

SANOFlO

Is this leaflet hard to see or read? Phone 0845 372 7101

Read all of this leaflet carefully before your child starts

taking this medicine.

•    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 your child. Do not pass it on to others. It may harm them, even if their symptoms are the same as your child’s.

•    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Telfast is and what it is used for

2.    Before you use Telfast

3.    How to use Telfast

4.    Possible side effects

5.    How to store Telfast

6.    Further information

1. What Telfast is and what it is used for

Telfast contains fexofenadine hydrochloride, which is an antihistamine.

Telfast 30 mg is used in children 6 to 11 years old to relieve the symptoms that occur with hay fever (seasonal allergic rhinitis) such as sneezing, itchy, runny or blocked nose and itchy, red and watery eyes.

2. Before you use Telfast

Do not use Telfast

X if your child is allergic (hypersensitive) to fexofenadine or any of the other ingredients of Telfast (see section 6 for a full list of ingredients)

Take special care with Telfast

A if your child has liver or kidney problems A if your child has or ever had heart disease, since this medicine may lead to a fast or irregular heart beat If any of these apply to your child, or if you are not sure, always tell your doctor before giving Telfast to your child.

EH Taking other medicines

Please tell your doctor or pharmacist if your child is taking or has recently taken any other medicines, including medicines obtained without a prescription.

Indigestion remedies containing aluminium and magnesium may affect the action of Telfast, by lowering the amount of medicinal product absorbed.

It is recommended that 2 hours are left between the time that your child takes Telfast and the indigestion remedy.

Pregnancy and breast-feeding

This medicine is for use in children 6 - 11 years of age. However, the following information should be noted regarding the safe use of this medicine.

Ask your doctor or pharmacist for advice before giving any medicine.

Telfast should not be taken during pregnancy, unless necessary. Telfast is not recommended during breast-feeding.

Driving and using machines

Telfast is unlikely to affect ones ability to drive or use machines. However, you should check that these tablets do not make your child feel sleepy or dizzy.

Do not let your child drive or operate machinery if they are affected.

3. How to use Telfast

Always use Telfast exactly as the doctor has told you. You should check with your doctor or pharmacist if you are not sure.

For children aged 6 to 11 years of age

The recommended dose is one tablet (30 mg) twice daily.

The tablet should be taken with water.

If you use more Telfast than you should

If your child takes too many tablets, contact your doctor or the nearest hospital emergency department immediately. Symptoms of an overdose are dizziness, drowsiness, fatigue and dry mouth.

If you forget to use Telfast

Do not give a double dose to make up for a forgotten tablet. Give the next dose at the usual time as prescribed by the doctor.

If you stop using Telfast

Tell your doctor if you want your child to stop taking Telfast before the course of treatment has finished.

If treatment with Telfast is stopped earlier than planned, the symptoms may return.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Telfast can cause side effects, although not everybody gets them.

Tell your doctor immediately and stop treatment with Telfast if your child experiences swelling of the face, lips, tongue or throat and difficulty breathing, as these may be signs of a serious allergic reaction.

In clinical trials in children 6 to 11 years of age, the most common side effect was headache.

In adults, the following side effects have been reported: Common side effects (occurring in less than 1 in 10 but more than 1 in 100 patients): headache, drowsiness, feeling sick (nausea) and dizziness.

Uncommon side effects (occurring in less than 1 in 100 but more than 1 in 1,000 patients): tiredness/sleepiness. Additional side effects (frequency unknown) which may occur are: difficulty sleeping (insomnia), sleeping disorders, bad dreams, nervousness, fast or irregular heart beat, diarrhoea, skin rash and itching, hives, serious allergic reactions which can cause swelling of the face, lips, tongue or throat, flushing, chest tightness and difficulty breathing.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. How to store Telfast

Keep out of the reach and sight of children.

Do not use Telfast after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage condition. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Further information

What Telfast 30 mg looks like and contents of the pack

Telfast 30 mg film coated tablets are round and peach coloured, marked with “03” on one side and a scripted “e” on the other.

Telfast is presented in blister packs. Each tablet is blistered. Telfast is available in packs of 1,2, 4, 8, 10, or 15 (sample only), 20, 30, 40, 50, 60, and 100 tablets per package.

Not all pack sizes are marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Sanofi, One Onslow Street, Guildford,

Surrey, GU1 4YS, UK Tel: 0845 372 7101

email: uk-medicalinformation@sanofi.com Manufacturer:

Sanofi Winthrop Industrie,

30-36 Avenue Gustave Eiffel,

37 100 Tours, France

This medicinal product is authorised in the Member states of the EEA under the following names:

Belgium: Telfast 30 mg filmomhulde tabletten Cyprus: Telfast

Denmark: Telfast, filmovertrukne tabletter 30 mg Finland: Telfast 30 mg tabletti, kalvopaallysteinen Germany: Telfast 30 mg Filmtabletten Iceland: Telfast 30 mg filmuhuSaSar toflur Ireland: Telfast 30 mg film coated tablets Italy: Telfast 30 mg compresse rivestite con film Luxembourg: Telfast 30 mg filmomhulde tabletten Malta: Telfast 30 mg film coated tablets Norway: Telfast 30 mg filmdrasjerte tabletter Poland: Telfast 30

Portugal: Telfast 30, comprimidos revestidos por pelicula Spain: Telfast 30 mg comprimidos recubiertos con pelicula Sweden: Telfast 30 mg filmdragerade tabletter United Kingdom: Telfast 30 mg film coated tablets

This leaflet was last revised in June 2014 © Sanofi, 2014

What Telfast 30 mg film-coated tablets contains

The active substance of Telfast is fexofenadine hydrochloride. Each tablet contains 30 mg of fexofenadine hydrochloride.

The other ingredients are:

Tablet core: microcrystalline cellulose, pregelatinised maize starch, croscarmellose sodium, magnesium stearate.

Film coating: hypromellose, povidone, titanium dioxide (E171), colloidal anhydrous silica, macrogol, pink iron oxide (E172) blend and yellow iron oxide (E172) blend.

516582