Telfast Childrens Elixir and 30mg tablets
NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.
TELFAST®ORAL LIQUID AND 6 – 11 YEARS TABLETS
Oral Liquid and 6 – 11 Years tablets
Fexofenadine hydrochloride
Consumer Medicine Information (CMI)
What is in this leaflet
This leaflet answers some common questions about Telfast. Please read the information carefully before giving your child Telfast.
This leaflet provides a summary of the information available, it does not contain all the available information.
It does not take the place of talking to your pharmacist or doctor, who have more detailed information.
If you have any questions about Telfast, or if your child experiences any problems while being given Telfast, speak to your pharmacistor doctor.
All medicines have benefits and risks, so please discuss these with your pharmacist or doctor to make sure that the benefits of your child taking Telfast outweigh any possible risks.
Keep this leaflet with the medicine.
You may need to read it again.
What Telfast is used for
Telfast contains an active ingredient called fexofenadine hydrochloride. It is one of a group of medicines called antihistamines.
Antihistamines help reduce allergic symptoms by preventing the effects of a substance called histamine, which your body produces when exposed to certain substances.
Telfast is a non-sedating antihistamine which means it has been shown to not cause drowsiness.
Telfast is used to relieve the symptoms of:
hayfever (seasonal allergic rhinitis) and year round allergies (perennial allergic rhinitis). Symptoms include runny, itchy, blocked nose, sneezing anditchy, watery, red eyes.
hives or nettle rash (chronic idiopathic urticaria). Symptoms include pink to red, itchy swellings on the skin.
Your pharmacist or doctor may have recommended this medicine for another reason.
Ask your pharmacist or doctor if you have any questions about why this medicine has been recommended for your child.
Before giving it to your child
When it must not be given
Telfast must not be given to your child if your child has had an allergic reaction to fexofenadine, terfenadine (Teldane®) or any of the other ingredients in Telfast. These are listed at the end of this leaflet.
Do not give Telfast to a child under 2 years of age for allergies (allergic rhinitis) or 6 months of age for hives (chronic idiopathic urticaria).
There is currently not enough information available to recommend Telfast for use in children under 2 years of age for allergies and 6 months of age for hives.
Do not give Telfast after the expiry date (EXP) printed on the pack or bottle or if the packaging is torn or shows signs of tampering.
If you give your child this medicine after the expiry date has passed, it may not work as well. If it has expired or is damaged, return it to your pharmacist for disposal.
Before giving it
You should inform your pharmacist or doctor if your child has any allergies to any other medicines, foods, preservatives or dyes.
Your pharmacist or doctor will consider these points when recommending Telfast.
Taking other medicines
Tell your pharmacist or doctor if your child is being given any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food store.
Some medicines and Telfast may interfere with each other.
Your pharmacist or doctor has more information on medicines to be careful with or to avoid while your child is being given this medicine.
How to give it to your child
How much to give your child
For Hayfever/Allergic Rhinitis:
Children 2 – 5 years old:
5 mL (equivalent to 30 mg) of Telfast Oral Liquid, twice daily, when required.
Children 6 – 11 years old:
5 mL (equivalent to 30 mg) of Telfast Oral Liquid or one 6 – 11 Years tablet#, twice daily, when required.
For Hives/Nettle Rash:
Children 6 – 23 months old:
2.5 mL (equivalent to 15 mg) of Telfast Oral Liquid twice daily, when required.
Children 2 – 5 years old:
5 mL (equivalent to 30 mg) of Telfast Oral Liquid twice daily, when required.
Children 6 – 11 years old:
5 mL (equivalent to 30 mg) of Telfast Oral Liquid or one 6 – 11 Years tablet#, twice daily, when required.
For children 12 years of age or older and adults, please refer to Telfast’s 60 mg, 120 mg and 180 mg tablets CMI.
Talk to your pharmacist or doctor if you are unsure what dose to give your child.
The dosage directed by your pharmacist or doctor may be different to the recommended dose.
Do not give your child more than the dose your pharmacist or doctor has directed.
How to give it to your child
Measure Telfast Oral Liquid with the measuring device included in the package and give to your child.
Give Telfast tablets to your child with a glass of water or as directed by your pharmacist or doctor.
Telfast may be taken with or without food.
How long should it be given for
The duration of treatment depends on the type and duration of your complaint.
Talk to your pharmacistor doctor about how long to give Telfast to your child.
Talk to your pharmacist or doctor if Telfast does not relieve your child’s symptoms. Do not give extra oral liquid or tablets to your child.
If too much is taken (overdose)
If you think that your child or someone else may have taken too much Telfast immediately telephone your doctor, or the Poisons Information Centre (telephone Australia 13 11 26 or New Zealand 0800 POISON or 0800 764766), or go to Accident and Emergency at your nearest hospital. Do this even if there are no signs of discomfort or poisoning.
While your child is being given Telfast
Things you must do
Tell all the doctors, dentists and pharmacists who are treating your child that your child is being given Telfast.
If your child is about to be started on any new medicine, tell your pharmacist or doctor that your child is being given Telfast.
If your child is to have surgery that needs a general anaesthetic, tell the doctor or dentist that your child is being given this medicine.
Things you must not do
Do not give your child more than the recommended dose unless your pharmacist or doctor tells you to.
Do not give this medicine to anyone else, even if they have the same symptoms as your child’s.
Do not use this medicine to treat any other complaints unless your pharmacist or doctor tells you to.
Side effects
Tell your pharmacist or doctor as soon as possible if your child does not feel well while taking Telfast, even if you do not think the problem is connected with the medicine or is not listed in this leaflet.
All medicines can cause side effects. Sometimes they are serious, most of the time they are not. Your child may need medical treatment if they get some of the side effects. Although most children will not experience any, some of the side effects that may occur with Telfast are:
headache
tiredness
nausea
dizziness
drowsiness.
These same effects were seen in patients taking dummy or placebo fexofenadine during the clinical studies.
Ask your pharmacist or doctor to answer any questions you may have.
After giving it to your child
Storage
Keep the tablets in the blister pack until it is time to use them.
If you take the tablets out of the box or blister pack they may not keep well.
Store in a cool, dry place at room temperature below 30°C for the bottle and below 25°C for the tablets.
Do not store Telfast or any other medicine in the bathroom or near a sink.
Do not leave Telfast in the car or on window sills.
Heat and dampness can destroy some medicines.
Keep Telfast where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
Disposal
If your pharmacist or doctor tells you to stop giving Telfast to your child, or if the product has passed its expiry date, ask your pharmacist what to do with any left over product.
Product description
What Telfast looks like
Telfast Oral Liquid is a white liquid and is available in 60ml and 150 mL bottles.
Telfast 6 – 11 Years tablets# are round, peach coloured tablets with 03 embossed on one side and ‘e’ on the other.
They are available in blister packs of 20 tablets.
Ingredients
Active Ingredients
Each 5 mL of oral liquid contains 30 mg of fexofenadine.
Each tablet contains 30 mg of fexofenadine hydrochloride.
Inactive Ingredients
The oral liquid also contains:
butyl hydroxybenzoate
edetate disodium
poloxamer 407
polypropylene glycol
propyl hydroxybenzoate
purified water
raspberry cream flavour
sodium phosphate dibasic heptahydrate
sodium phosphate monobasic monohydrate
sucrose
titanium dioxide
xanthan gum
xylitol
The 6 – 11 Years tablets# also contain:
colloidal anhydrous silica
croscarmellose sodium
hypromellose
iron oxide.
macrogol 400
magnesium stearate
microcrystalline cellulose
povidone
pregelatinised maize starch
titanium dioxide
Telfast 6 – 11 Years tablets# do not contain any gluten, lactose or preservatives.
#Not marketed in New Zealand
Sponsor
Telfast is supplied in Australia by:
sanofi-aventis australia pty ltd
12-24 Talavera Road
Macquarie Park NSW 2113
Australia
Telfast is supplied in New Zealand by:
sanofi-aventis new zealand limited
Level 8, 56 Cawley Street
Ellersie, Auckland
New Zealand
This leaflet was prepared in March 2019
tel-ccdsv5-cmiv3-mar19
Australian Registration Numbers
Telfast Oral Liquid – AUST R 156262
Telfast 6 – 11 Years Tablets – AUST R 75139
® Registered Trademark
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