Telfast® Oral Liquid and 6-11 Years Tablets

Active ingredient(s): Fexofenadine hydrochloride


Consumer Medicine Information (CMI)

This leaflet provides important information about using Telfast. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Telfast.

Where to find information in this leaflet:

1. Why is my child using Telfast?
2. What should I know before my child uses Telfast?
3. What if my child is taking other medicines?
4. How do I give Telfast to my child?
5. What should I know while my child is taking Telfast?
6. Are there any side effects?
7. Product details

1. Why is my child using Telfast?

Telfast contains the active ingredient fexofenadine hydrochloride. Fexofenadine hydrochloride 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:

Your pharmacist or doctor may have recommended this medicine for another reason.

2. What should I know before my child uses Telfast?

Warnings

Do not give Telfast to your child if:

Always check the ingredients to make sure your child can use this medicine.

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.

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.

Check with your doctor or pharmacist if your child:

Your pharmacist or doctor will consider these points when recommending Telfast.

During treatment, your child may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

3. What if my child is taking other medicines?

Tell your doctor or pharmacist if your child is being given any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and Telfast may interfere with each other.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements your child is taking and if these affect Telfast.

4. How do I give Telfast to my child?

How much to give your child

For Hayfever/Allergic Rhinitis:

5 mL (equivalent to 30 mg) of Telfast Oral Liquid, twice daily, when required.

5 mL (equivalent to 30 mg) of Telfast Oral Liquid or one 6 - 11 Years tablet#, twice daily, when required.

For Hives/Nettle Rash:

2.5 mL (equivalent to 15 mg) of Telfast Oral Liquid twice daily, when required.

5 mL (equivalent to 30 mg) of Telfast Oral Liquid twice daily, when required.

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.

Follow the instructions provided with the medicine.

Do not exceed the recommended dosage.

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 Telfast to your child

How long should it be given for

The duration of treatment depends on the type and duration of your complaint.

Talk to your pharmacist or 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 your child takes too much Telfast

If you think that your child has taken too much Telfast, your child may need urgent medical attention.

You should immediately:

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while my child is taking Telfast?

Things you should do

Remind any doctor, dentist or pharmacist who is 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 should 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.

Looking after your child's medicine

If you take the tablets out of the box or blister pack they may not keep well.

Follow the instructions in the carton on how to take care of your child's medicine properly.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

Heat and dampness can destroy some medicines.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If your child no longer needs to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not give this medicine to your child after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If your child experiences any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions.

Less serious side effects

Less serious side effects

What to do

Gastrointestinal related

  • nausea

Head and neurology related

  • headache
  • tiredness
  • dizziness
  • drowsiness

Speak to your doctor or pharmacist if you have any of these less serious side effects and they worry you.

Tell your doctor or pharmacist if you notice anything else that may be making your child feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects your child experiences, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems or Medsafe in New Zealand https://www.medsafe.govt.nz/safety/report-a-problem.asp#Medicine.. By reporting side effects, you can help provide more information on the safety of this medicine.

7. Product details

This medicine is available over-the-counter without a doctor's prescription.

What Telfast contains

Active ingredient

(main ingredient)

Telfast Oral Liquid - each 5 mL of oral liquid contains 30 mg of fexofenadine.

Telfast 6 - 11 Years tablets# - each tablet contains 30 mg of fexofenadine hydrochloride.

Other ingredients

(inactive ingredients)

Telfast Oral Liquid:

  • butyl hydroxybenzoate
  • edetate disodium
  • poloxamer 407
  • propylene glycol
  • propyl hydroxybenzoate
  • purified water
  • raspberry cream flavour
  • sodium phosphate dibasic heptahydrate
  • sodium phosphate monobasic monohydrate
  • sucrose
  • titanium dioxide
  • xanthan gum
  • xylitol

Telfast 6-11 Years tablets#

  • colloidal anhydrous silica
  • croscarmellose sodium
  • hypromellose
  • iron oxide
  • macrogol 400
  • magnesium stearate
  • microcrystalline cellulose
  • povidone
  • pregelatinised maize starch
  • titanium dioxide

Do not take give this medicine to your child if your child is allergic to any of these ingredients.

Telfast 6 - 11 Years tablets# do not contain any gluten, lactose or preservatives.

What Telfast looks like

Telfast Oral Liquid is a white liquid and is available in 60ml and 150 mL bottles (AUST R 156262)

Telfast 6 - 11 Years tablets# are round, peach coloured tablets with 03 embossed on one side and 'e' on the other (AUST R 75139)

They are available in blister packs of 20 tablets.

#Not marketed

Who distributes Telfast

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

56 Cawley Street

Ellersie, Auckland

New Zealand

This leaflet was prepared in May 2021.

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