Telfast 30mg Film-coated Tablets

• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as your child's.
• If your child gets any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Telfast is and what it is used for
2. What you need to know before your child uses Telfast
3. How to use Telfast
4. Possible side effects
5. How to store Telfast
6. Content of the pack and other information

• if your child is allergic to fexofenadine or any of the other ingredients of this medicine (listed in section 6)

Talk to your doctor or pharmacist before using Telfast if:

• if your child has liver or kidney problems
• 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.

Tell your doctor or pharmacist if your child is taking, has recently taken or might take any other medicines.

If you are taking apalutamide (a medicine to treat prostate cancer), as the effect of fexofenadine may be decreased.

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.

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 to your child.

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

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 use machines if they are affected.

Telfast contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free'.

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

The tablet should be taken with water.

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.

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.

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.

• 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.

The following undesirable effects have been reported in clinical trials, with an incidence similar to those observed in patient who did not receive the drug (placebo).

In adults, the following side effects have been reported:

Common side effects (may affect up to 1 in 10 people):

• headache,
• drowsiness,
• feeling sick (nausea)
• dizziness.

Uncommon side effects (may affect up to 1 in 100 people):

• tiredness
• sleepiness.

Additional side effects (Not known: frequency cannot be estimated from the available data) 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.
• blurred vision

If your child gets any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the yellow card scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

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

• The other ingredients are:
  • Tablet core: microcrystalline cellulose, pregelatinised 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.

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:

Manufacturer:

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

Belgium: Telfast 30 mg filmomhulde tabletten

Denmark: Telfast, filmovertrukne tabletter 30 mg

Finland: Telfast 30 mg tabletti, kalvopäällysteinen

Iceland: Telfast 30 mg filmuhúðaðar töflur

Ireland: Telfast 30 mg film coated tablets

Italy: Telfast 30 mg compresse rivestite con film

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