Telfast 120mg 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 you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get 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 you take Telfast
3. How to take Telfast
4. Possible side effects
5. How to store Telfast
6. Contents of the pack and other information

• if you are allergic to fexofenadine or any of the other ingredients of this medicine (listed in section 6)

Talk to your doctor or pharmacist before taking Telfast if:

• you have problems with your liver or kidneys
• you have or ever had heart disease, since this kind of medicine may lead to a fast or irregular heart beat
• you are elderly

If any of these apply to you, or if you are not sure, tell your doctor before taking Telfast.

Other medicines and Telfast

Tell your doctor or pharmacist if you are taking, have 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 you leave about 2 hours between the time that you take Telfast and your indigestion remedy.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not take Telfast if you are pregnant, unless necessary.

Telfast is not recommended during breast-feeding.

Driving and using machines

Telfast is unlikely to affect your ability to drive or operate machinery. However, you should check that these tablets do not make you feel sleepy or dizzy before driving or operating machinery.

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 (120 mg) daily.

Take your tablet with water before a meal.

This medicine starts to relieve your symptoms within 1 hour and lasts for 24 hours.

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

If you forget to take Telfast

Do not take a double dose to make up for a forgotten tablet.

Take the next dose at the usual time as prescribed by your doctor.

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

If you stop taking Telfast earlier than planned, your symptoms may return.

• swelling of the face, lips, tongue or throat and difficulty breathing, as these may be signs of a serious allergic reaction.

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).

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 (frequency not known: 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 you get any side effects, talk to your doctor, pharmacist or nurse. 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 film-coated tablet contains 120 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, red iron oxide (E172) and yellow iron oxide (E172).

Telfast 120 mg film-coated tablets of 6.1 x 15.8 mm are peach coloured, capsule shaped tablets marked with “012” 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 2 (sample only), 7, 10, 15, 20, 30, 50, 100 and 200 (as 10x20) tablets per package.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Manufacturer

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

Austria: Allegra 120 mg Filmtabletten

Belgium: Allegra tab 120 mg filmomhulde tablette

Croatia: Allegra 120 mg filmom obložene tablete

Czech Republic: Allegra 120 mg

Denmark: Telfast, filmovertrukne tabletter 120 mg

Estonia: Allegra

Finland: Telfast 120 mg tabletti, kalvopäällysteinen

Germany: Telfast 120 mg-Filmtabletten

Greece: Allegra

Ireland: Telfast 120 mg film-coated tablets

Italy: Telfast 120 mg compresse rivestite con film

Latvia: Allegra 120 mg apvalkotās tabletes

Lithuania: Allegra 120 mg plėvele dengtos tabletės

Luxembourg: Allegra tab 120 mg comprimés pelliculés

Malta: Telfast 120 mg film-coated Tablets

Portugal: Telfast 120, comprimidos revestidos por película

Romania: Telfast 120 mg comprimate filmate

Slovenia: Telfast 120 mg filmsko obložene tablete

Slovakia: Allegra 120 mg

Spain: Telfast 120 mg comprimidos recubiertos con película

Sweden: Allegra

United Kingdom: Telfast 120 mg film-coated tablets