FULL CMI

Telfast^® (tell-fast)

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 am I using Telfast?
2. What should I know before I use Telfast?
3. What if I am taking other medicines?
4. How do I use Telfast?
5. What should I know while using Telfast?
6. Are there any side effects?
7. Product details

1. Why am I using Telfast?

Telfast contains the active ingredient fexofenadine hydrochloride. Telfast 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 not to cause drowsiness.

Telfast 60 mg tablets are used to relieve the symptoms of seasonal and perennial allergic rhinitis (including hayfever) in adults and children aged 12 years or older.

Telfast 120 mg tablets are used to relieve the symptoms of hayfever (seasonal allergic rhinitis (including hayfever) such as sneezing, itchy, watery or red eyes and itchy, blocked or runny nose in adults and children aged 12 years or older.

Telfast 180 mg tablets are used to relieve the symptoms of hayfever (seasonal allergic rhinitis) such as sneezing, itchy, watery or red eyes and itchy, blocked or runny nose as well as the symptoms of urticaria otherwise known as hives or itchy rash in adults and children aged 12 years or older.

2. What should I know before I use Telfast?

Warnings

Do not use Telfast if:

• you are pregnant, intend to become pregnant, or if you are breastfeeding, unless advised to do so by a Doctor or Pharmacist.
• you are allergic to ingredient fexofenadine hydrochloride, or any of the ingredients listed at the end of this leaflet.
• Always check the ingredients to make sure you can use this medicine.
• you are under 12 years of age
• the expiry date (EXP) printed on the pack has passed or if the packaging is damaged or shows signs of tampering.

If you take it after the expiry date has passed, it may not work as well.

Check with your doctor if you have the following:

• have any other medical conditions
• take any medicines for any other condition

During treatment, you 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?

Pregnancy and breastfeeding

Do not take Telfast if you are pregnant, intend to become pregnant, or if you are breastfeeding, unless advised to do so by a Doctor or Pharmacist.

3. What if I am taking other medicines?

If you are taking medicines to treat heartburn and indigestion that contain aluminium or magnesium hydroxide, wait 2 hours before taking Telfast.

Tell your doctor or pharmacist if you are taking 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 may interfere with Telfast and affect how it works.

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

4. How do I use Telfast?

How much to take

• For the relief of the symptoms of seasonal and perennial allergic rhinitis (including hayfever), the usual dosage for adults and children over 12 years old is one Telfast 60mg tablet twice daily, when required.
• For the relief of the symptoms of hayfever, the usual dosage for adults and children over 12 years of age is one Telfast 120 mg tablet daily when required, or one Telfast 180 mg tablet daily, when required.
• For relief of symptoms of hives or itchy rash, the usual dosage for adults and children over 12 years of age is one Telfast 180 mg tablet daily when required.
• Follow the instructions written on the back of the box.
• If you take the wrong dose, Telfast may not work as well and your symptoms may not improve.

When to take Telfast

• The duration of treatment depends on the type and duration of your complaint.
• Talk to your pharmacist or doctor about how long to take Telfast.
• If Telfast does not relieve your symptoms, do not take extra tablets. Tell your doctor or pharmacist.

How to take Telfast

• Take Telfast with a glass of water to make it easier to swallow.
• Telfast may be taken with or without food.

If you forget to use Telfast

Do not try to make up for missed doses by taking more than one dose at a time.

This may increase the chance of getting an unwanted side effect.

If it is almost time for your next dose, skip the dose you missed and take the next dose when you are meant to. But if there is still a long time to go before your next dose, take it as soon as you remember, and then go back to taking it as you would normally.

If you use too much Telfast

If you think that you have used too much Telfast, you may need urgent medical attention.

You should immediately:

• phone the Poisons Information Centre (by calling 13 11 26 in Australia or 0800 764 766 in New Zealand), or
• contact your doctor or pharmacist, or
• go to the Emergency Department at your nearest hospital.

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

You may need urgent medical attention.

If you take too much Telfast, you may feel dizzy, drowsy or have a dry mouth.

5. What should I know while using Telfast?

Things you should do

Tell all the doctors, dentists and pharmacists who are treating you that you are taking Telfast.

If you are about to be started on any new medicine, tell your Doctor or Pharmacist that you are taking Telfast.

If you are to have surgery that needs a general anaesthetic, tell the doctor or dentist that you are taking this medicine.

If you become pregnant while taking Telfast, consult your Doctor or Pharmacist.

Things you should not do

• Do not take 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 condition as you.
• Do not use this medicine to treat any other complaints unless your pharmacist tells you to.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Telfast affects you.

Looking after your medicine

• Keep the medicine in a cool, dry place where the temperature stays below 30°C.
• Keep your tablets in the blister pack until it is time to take them.

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

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

• in the bathroom or near a sink, or
• in the car or on window sills.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

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

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience 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 about side effects.

Less serious side effects

Tell your doctor or pharmacist if you notice anything else that may be making you 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 you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available without a doctor's prescription.

What Telfast contains

Do not take this medicine if you are allergic to any of these ingredients.

What Telfast looks like

Telfast 60 mg tablets are peach coloured, oval and double convex in shape, and are available in packs of 20 tablets. (AUST R 70949)

Telfast 120 mg tablets are peach coloured with a modified capsule shape, debossed with '012' (underlined) on one side and a scripted "e" on the other and are available in packs of 10 or 30 tablets. (AUST R 63339)

Telfast 180 mg tablets are peach coloured with a modified capsule shape, debossed with '018' (underlined) on one side and a scripted "e" on the other and are available in packs of 10, 30, 50, 60, 70, 80, 90 and 100 tablets. (AUST R 63338)*

*only available in Australia. Note not all pack sizes are marketed.

Who distributes Telfast

Distributed in Australia by:

Sanofi Consumer Healthcare,
87 Yarraman Place, Virginia,
Qld 4014 Australia.
Toll-free: 1800 818 806
Email: [email protected]

Distributed in New Zealand by:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
PO Box 62027
Sylvia Park Auckland 1644
Freecall: 0800 283 684
Email: [email protected]

This leaflet was prepared in October 2022.

tel-s2-ccdsv5-cmiv5-19oct22

Published by MIMS December 2022

1 Name of Medicine

Fexofenadine (as hydrochloride).

2 Qualitative and Quantitative Composition

Telfast 6-11 years tablets*.

Telfast 60 mg tablets.

Telfast 120 mg tablets.

Telfast 180 mg tablets.

Telfast Oral Liquid (reformulation).

3 Pharmaceutical Form

Telfast 6-11 years tablets*.

Telfast 60 mg tablets.

Telfast 120 mg tablets.

Telfast 180 mg tablets.

Telfast Oral Liquid (reformulation).

4 Clinical Particulars

4.1 Therapeutic Indications

Oral liquid.

6-11 years tablets*.

60 mg tablets.

120 mg tablets.

180 mg tablets.

4.2 Dose and Method of Administration

Paediatrics.

Children aged 2 to 11 years.

Children aged 6 to 23 months.

Children aged 2 to 11 years.

Adults and children aged 12 years or older.

Allergic rhinitis.

Seasonal allergic rhinitis.

Urticaria.

4.3 Contraindications

Telfast is contraindicated in patients with a known hypersensitivity to fexofenadine, terfenadine or any of its excipients.

4.4 Special Warnings and Precautions for Use

Use in renal impairment.

Use in hepatic impairment.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

As fexofenadine undergoes negligible hepatic biotransformation, it is unlikely to interact with other drugs through hepatic metabolism.
The pharmacokinetics of fexofenadine HCl and pseudoephedrine are not altered when both drugs are co-administered.
Coadministration of fexofenadine with erythromycin or ketoconazole has been found to result in a 2 - 3 times increase in the level of fexofenadine in plasma. The changes were not accompanied by any effects on the QT interval and were not associated with any increase in adverse events compared to the drugs given singly. Fexofenadine had no effect on the pharmacokinetics of erythromycin or ketoconazole.
Animal studies have shown that the increase in plasma levels of fexofenadine observed after coadministration of erythromycin or ketoconazole appears to be due to an increase in gastrointestinal absorption and either a decrease in biliary excretion or gastrointestinal secretion, respectively.
No interaction between fexofenadine and omeprazole has been observed. However, the administration of an antacid containing aluminium and magnesium hydroxide gel 15 minutes prior to fexofenadine HCl causes a reduction in bioavailability, most likely due to binding in the gastrointestinal tract. It is advisable to leave 2 hours between administration of fexofenadine HCl and aluminium and magnesium hydroxide containing antacids.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

Telfast is generally well tolerated. In placebo controlled trials involving seasonal allergic rhinitis and chronic idiopathic urticaria patients, adverse events were comparable in fexofenadine and placebo treated patients. The most common adverse events reported in controlled clinical trials were headache, fatigue, dizziness or drowsiness, and nausea. No apparent dose trends were revealed in adverse events.
Events that have been reported during controlled trials involving seasonal allergic rhinitis and chronic idiopathic urticaria patients with incidences less than 1% and similar to placebo and have been reported rarely during postmarketing surveillance include: fatigue, insomnia, nervousness, and sleep disorders or paroniria. In rare cases, rash, urticaria, pruritus and hypersensitivity reactions with manifestations such as angioedema, chest tightness, dyspnoea, flushing and systemic anaphylaxis have been reported.
Adverse events reported in placebo controlled chronic idiopathic urticaria studies were similar to those reported in placebo controlled seasonal allergic rhinitis studies. In placebo controlled trials involving paediatric seasonal allergic rhinitis patients (6-11 years of age), adverse events were similar to those observed in trials involving seasonal allergic rhinitis patients 12 years and older.
In controlled clinical trials involving paediatric patients 6 months to 5 years of age, there were no unexpected adverse events in patients treated with fexofenadine hydrochloride.
As with adults, the incidence of adverse events with fexofenadine in paediatric patients was similar to placebo.

Reporting suspected adverse effects.

4.9 Overdose

There is no clinical experience with a fexofenadine overdose. The maximum single dose tested in clinical trials is 800 mg in six healthy subjects. In a multiple dose study, doses of 690 mg every 12 hours for 28.5 days were given to three healthy subjects and, in another study with forty subjects, a dose of 400 mg every 12 hours was given for 6.5 days. No clinically significant adverse events were reported in these studies.
In the case of an overdose, standard measures to remove any unabsorbed drug should be employed. Symptomatic and supportive treatment is recommended. Haemodialysis is not an effective means of removing fexofenadine from plasma.
For general advice on management of overdose, contact the Poisons Information Centre, telephone number 13 11 26 (Australia) or the National Poisons Centre, 0800 POISON or 0800 764 766 (New Zealand).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Antihistamine for systemic use, ATC code: R06A X26.

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

Fexofenadine HCl is rapidly absorbed into the body following oral administration, with t_max occurring approximately 1 - 3 hours post-dose. Following administration of a single 60 mg oral dose to healthy volunteers, fexofenadine HCl was rapidly absorbed, with a mean C_max of 209 nanogram/mL. Following the administration of single oral doses of 120 mg and 180 mg fexofenadine HCl, the mean C_max values were approximately 427 nanogram/mL and 494 nanogram/mL, respectively.
The absolute bioavailability following fexofenadine HCl administration was estimated to be 33%. Coadministration with food has no clinically significant effect on the absorption of fexofenadine HCl.
The single and multiple dose pharmacokinetics of fexofenadine are linear for oral doses up to 120 mg bd. A dose of 240 mg bd produced a slightly greater than proportional increase (8.8%) in steady state area under the curve, indicating that fexofenadine pharmacokinetics are practically linear at daily doses between 40 mg and 240 mg. Fexofenadine is 60% to 70% bound to plasma proteins.
Fexofenadine undergoes negligible metabolism. Following a single radiolabelled 60 mg oral dose, approximately 80% and 11% of the total [14C]-fexofenadine dose was excreted in faeces and urine, respectively.
The plasma concentration vs. time profiles of fexofenadine follow a bi-exponential decline with a mean terminal elimination half-life ranging from 14 to 15 hours following multiple dosing.
The pharmacokinetics of fexofenadine in seasonal allergic rhinitis patients are similar to those in healthy subjects.
Studies indicated that females may be exposed to higher plasma levels than males, however, there was no indication of any difference in efficacy or in the frequency of adverse events reported. Elderly patients, patients with hepatic impairment and patients with cardiac disease exposed to fexofenadine by administration of terfenadine showed no statistically significant differences in pharmacokinetic parameters for fexofenadine, compared to healthy individuals. Although peak plasma level and half-life were increased 68% and 15%, respectively, in elderly patients and 54% and 19%, respectively, in patients with renal disease, regardless of disease severity, these levels are within the range of plasma levels shown to be tolerated in short term dose ranging trials.
The pharmacokinetics of fexofenadine in children and adults are similar, including t_max, clearance (corrected for body surface area), t_1/2 and volume of distribution, because fexofenadine undergoes negligible metabolism, with 80% of the dose being eliminated unchanged in the faeces. In contrast, other H₁-receptor antagonists, which are extensively metabolised in the hepatic cytochrome P450 system, usually have shorter half-life values in children than adults.
In children, studies indicate that 30 or 60 mg fexofenadine suppresses the histamine induced wheal and flare within 1 to 2 hours, with both doses producing similar mean maximal suppression.
A dose of 5 mL of Telfast Oral Liquid containing 30 mg of fexofenadine HCl is bioequivalent to a 30 mg dose of Telfast tablets. Following oral administration of a 30 mg dose of Telfast Oral Liquid to healthy adult subjects, the mean C_max was 118.0 nanogram/mL and occurred at approximately 1.0 hour.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Telfast tablets contain the following excipients: croscarmellose sodium, pregelatinised maize starch, microcrystalline cellulose, magnesium stearate, hypromellose, povidone, titanium dioxide, colloidal anhydrous silica, macrogol 400, Pigment Blend Pink PB1254 (ARTG PI No.3225) and Pigment Blend Yellow PB1255 (ARTG PI No.3226).
Telfast Oral Liquid (reformulation) contains 6 mg/mL of fexofenadine HCl. Telfast Oral Liquid (reformulation) also contains the following excipients: propylene glycol, edetate disodium, xanthan gum, poloxamer 407, titanium dioxide, sodium phosphate monobasic monohydrate, sodium phosphate dibasic heptahydrate, potassium sorbate, artificial raspberry cream flavour (ARTG PI No. 12546), sucrose, xylitol and purified water.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Telfast 6-11 years tablets*.

Telfast 60 mg tablets.

Telfast 120 mg tablets.

Telfast 180 mg tablets.

Telfast Oral Liquid (reformulation).

6.5 Nature and Contents of Container

Telfast 6-11 years tablets*.

Telfast 60 mg tablets.

Telfast 120 mg tablets.

Telfast 180 mg tablets.

Telfast Oral Liquid (reformulation).

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Fexofenadine occurs as a fine white to off-white powder. It is freely soluble in methanol, soluble in ethanol, slightly soluble in water (3.6 mg/mL) and only very slightly soluble in chloroform and hexane.
Fexofenadine is the carboxylic acid metabolite of terfenadine. It is an orally-active non sedating histamine H1-receptor antagonist that is administered as the hydrochloride salt in Telfast. The chemical name is benzeneacetic acid, 4-[1-hydroxy-4-[4- (hydroxydiphenylmethyl)-1-piperidinyl]butyl]- α,α-dimethyl-, hydrochloride.

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

Pharmacy Medicine (Schedule 2).

Summary Table of Changes