Below is a text only representation of the Patient Information Leaflet (ePIL).
The text only version may be available in large print, Braille or audio CD.
For further information call emc accessibility on
0800 198 5000.
The product code(s) for this leaflet is: PL 53886/0064.
Read all of this leaflet carefully before your child starts taking this medicine because it contains important information for you.
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.
What is in this leaflet:
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
1. What Telfast is and what it is used for
Telfast contains fexofenadine hydrochloride, which is a non-drowsy 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. What you need to know before your child uses Telfast
Do not use Telfast
if your child is allergic to fexofenadine or any of the other ingredients of this medicine (listed in section 6)
Warnings and precautions
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.
Other medicines and Telfast
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.
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 to your child.
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 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'.
3. How to use Telfast
Always use this medicine exactly as your doctor or pharmacist has told you. 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 medicine, ask your doctor or pharmacist.
4. Possible side effects.
Like all medicines, this medicine 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.
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
Reporting of side effects
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.
5. How to store Telfast
Keep this medicine out of the sight and reach of children.
Do not use this medicine 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.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Telfast 30 mg film-coated tablets contains
The active substance is fexofenadine hydrochloride. Each tablet contains 30 mg of fexofenadine hydrochloride.