Consumer medicine information

What is in this leaflet

This leaflet answers some common questions about Telfast Decongestant.

It does not contain all the available information.

It does not take the place of talking to your pharmacist or doctor.

All medicines have risks and benefits. Your pharmacist or doctor has weighed the risks of you taking this medicine against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your pharmacist or doctor.

Keep this leaflet with the medicine. You may need to read it again.

What Telfast Decongestant is used for

Telfast Decongestant is used to relieve the symptoms of seasonal and perennial allergic rhinitis (including hayfever) with sinus/nasal congestion. Symptoms include:

• nasal and sinus congestion
• sneezing
• itchy, runny nose
• watery, itchy eyes
• itchy throat.

TELFAST Decongestant tablets contain a combination of two active ingredients, "fexofenadine" (an antihistamine) and "pseudoephedrine" (a decongestant).

Antihistamines help reduce allergic symptoms caused by a substance called histamine. Examples of these include: watery, itchy eyes, sneezing and runny nose.

Decongestants, like pseudoephedrine, work by reducing congestion in the upper respiratory tract, including the nose, nasal passages and sinuses, making it easier to breathe.

Your pharmacist or doctor may have given this medicine to you for another reason.

Ask your doctor or pharmacist if you have any questions about why this medicine has been recommended for you. Telfast Decongestant is only available from your pharmacist.

Before you take Telfast Decongestant

When you must not take it

Do not take this medicine if you are allergic to fexofenadine, pseudoephedrine, terfenadine or any of the other ingredients in Telfast Decongestant. These are listed at the end of this leaflet.

Some of the symptoms of an allergic reaction to Telfast Decongestant may include:

• shortness of breath
• wheezing or difficulty breathing
• swelling of the face, lips, tongue or other parts of the body
• rash, itching or hives on the skin.

Do not take Telfast Decongestant if you have:

• very high blood pressure
• severe coronary artery disease (heart disease caused by poor blood flow or narrowing of the blood vessels of the heart)
• narrow angle glaucoma
• urinary retention
• a sensitivity to adrenergic events (symptoms include insomnia, dizziness, weakness, tremor or irregular heart beat)
• or if you have taken monoamine oxidase inhibitors (medicines used to treat depression) in the last 14 days.

Do not take this medicine if you are pregnant or plan to become pregnant. This medicine is not recommended to be used during pregnancy. Your pharmacist or doctor will discuss the benefits and possible risks of taking the medicine during pregnancy.

Do not give this medicine to a child under the age of 12 years, unless your doctor has told you to do so.

If you are not sure whether you should start taking this medicine, talk to your pharmacist or doctor.

Do not use it after the expiry date (EXP) printed on the pack. If you take this medicine after the expiry date has passed, it may not work as well.

Do not use it if the packaging is damaged or shows signs of tampering.

Before you start to take it

Tell your pharmacist or doctor if you are allergic to any of the ingredients listed at the end of this leaflet.

Tell your pharmacist or doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your pharmacist or doctor if you are pregnant or intend to become pregnant. This medicine is not recommended to be used during pregnancy. Your pharmacist or doctor will discuss the risks and benefits of taking it if you are pregnant.

Tell your pharmacist or doctor if you are breastfeeding or planning to breastfeed. Small amounts of the drug pass into the breast milk. Your pharmacist or doctor will discuss the risks and benefits of taking it if you are breastfeeding or planning to breastfeed.

Tell your pharmacist or doctor if you have or have had any of the following medical conditions:

• high blood pressure
• hyperthyroidism (overactive thyroid gland)
• diabetes including diabetes mellitus
• heart disease and poor blood flow in the blood vessels of the heart
• glaucoma (high pressure in the eyes)
• prostate problems (including prostatic hypertrophy)
• liver or kidney disease
• hyperreactivity or sensitivity to ephedrine.

Tell your pharmacist or doctor if you plan to have surgery.

If you have not told your pharmacist or doctor about any of the above, tell them before you take this medicine.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food store.

Some medicines and Telfast Decongestant may interfere with each other. These include medicines used to treat:

• depression
• high blood pressure
• heart conditions
• urinary tract infections and bladder problems
• behavioural disorders
• congestion (phenylephrine)
  and
• appetite suppressants.

These medicines may be affected by Telfast Decongestant, or may affect how well it works. You may need to use different amounts of your medicine or you may need to take different medicines. Your pharmacist or doctor will advise you.

Your pharmacist or doctor has more information on medicines to be careful with or to avoid while taking this medicine.

How to take Telfast Decongestant

How much to take

Your pharmacist or doctor will tell you how much Telfast Decongestant you should take.

The recommended dose for adults and children over the age of 12 years, is one tablet 12 hourly.

Do not take more than the dose your pharmacist or doctor has directed.

Talk to your doctor or pharmacist if you are unsure what dose to take. The dosage directed by your pharmacist or doctor may be different to the recommended dose.

How to take it

Telfast Decongestant should be swallowed whole with a full glass of water, and be taken before a meal.

When to take it

Take the dose before a meal and ensure that you take the dose at about the same time each day.

If you forget to take it

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Otherwise, take it as soon as you remember, and then go back to taking it as you would normally.

Do not take a double dose to make up for the dose that you missed. This may increase the chance of you getting an unwanted side effect.

If you are not sure what to do, ask your pharmacist or doctor. If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.

If you take too much (overdose)

Immediately telephone your doctor, or the Poisons Information Centre (telephone Australia 13 11 26), or go to Accident and Emergency at your nearest hospital, if you think you or anyone else may have taken too much Telfast Decongestant. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

While you are taking Telfast Decongestant

Things you must do

Talk to your pharmacist or doctor if your symptoms do not improve. Your pharmacist or doctor will assess your condition and decide if you should continue to take the medicine.

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

If you are about to be started on any new medicine, tell your pharmacist or doctor that you are taking Telfast Decongestant.

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

If you become pregnant while you are taking this medicine, stop taking it and tell your pharmacist or doctor immediately.

Things you must 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 take Telfast Decongestant to treat any other complaints unless your pharmacist or doctor tells you to.

Things to be careful of

Be careful driving or operating machinery until you know how this medicine affects you. This medicine may cause dizziness or light-headedness in some people, if this happens, do not drive or operate machinery. Make sure you know how you react to it before you drive a car, operate machinery, or do anything else that could be dangerous if you are dizzy.

Be careful if you are elderly, unwell or taking other medicines. Some people may experience side effects such as drowsiness, confusion, dizziness and unsteadiness, which may increase the risk of a fall.

Things to be careful of

After the active ingredient is absorbed into your body, you may see the empty tablet shell in your faeces (bowel motions). This is normal and does not affect the way Telfast Decongestant works.

Side Effects

Tell your pharmacist or doctor as soon as possible if you do not feel well while you are taking Telfast Decongestant. This medicine helps most people with allergic rhinitis (hayfever) and sinus/nasal congestion, but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Ask your pharmacist or doctor to answer any questions you may have.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

Tell your pharmacist or doctor if you notice any of the following and they worry you:

• headache
• nausea
• fatigue
• dry mouth
• anorexia
• drowsiness
• difficulty sleeping
• nervousness
• excitability
• restlessness
• dizziness
• fear or anxiety
• rapid heart beat
• tremor
• hallucinations.

The above list includes the more common side effects of your medicine. They are usually mild and short-lived.

Children and people over 65 years of age may have an increased chance of getting side effects.

Tell your pharmacist or doctor immediately, or go to Accident and Emergency at your nearest hospital if you notice any of the following:

• urine retention
• shortness of breath
• wheezing or difficulty breathing
• swelling of the face, lips, tongue or other parts of the body
• rash, itching or hives on the skin.

The above list includes very serious side effects. If you have them, you may have had a serious allergic reaction to Telfast Decongestant. You may need urgent medical attention or hospitalisation. These side effects are very rare.

Other side effects not listed above may also occur in some patients. Tell your pharmacist or doctor if you notice anything else that is making you feel unwell.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

After taking Telfast Decongestant

Storage

Keep your tablets in the original pack until it is time to take them. If you take the tablets out of the box or blister pack they may not keep well.

Keep it in a cool, dry place where the temperature stays below 25 degrees C.

Do not store Telfast Decongestant or any other medicine in the bathroom or near a sink.

Do not leave it in the car or on window sills. Heat and dampness can destroy some medicines.

Keep it 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 taking Telfast Decongestant, or it has passed its expiry date, ask your pharmacist what to do with any that are left over.

Product Description

What it looks like

Telfast Decongestant tablets have two layers, are capsule shaped, film coated tablets. One half of the tablet is off white and the other half is tan in colour. The off white half of the tablet is marked with "06/012D".

Telfast Decongestant tablets are available in packs of 6 tablets.

Ingredients

Active Ingredient
Telfast Decongestant contains 60mg of fexofenadine hydrochloride and 120mg of pseudoephedrine hydrochloride as the active ingredients per tablet.

Inactive Ingredients
The tablets also contain:

• cellulose
• maize starch
• croscarmellose sodium
• magnesium stearate
• carnauba wax
• stearic acid
• silica
• opadry film coat.

Distributor

Telfast Decongestant is supplied in Australia by:
Aventis Pharma Pty Limited
27 Sirius Road
LANE COVE NSW 2066

Telfast Decongestant tablets:
AUST R 72552

This leaflet was prepared in November 2014.

® Registered Trademark

telfast-d-ccdsv6-cmiv3-03nov14

Published by MIMS May 2015

1 Name of Medicine

Fexofenadine hydrochloride and pseudoephedrine hydrochloride.

2 Qualitative and Quantitative Composition

Each Telfast Decongestant tablet contains 60 mg of fexofenadine hydrochloride in an immediate release formulation and 120 mg of pseudoephedrine hydrochloride in a wax matrix for sustained release.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Telfast Decongestant tablets are bilayer, capsule shaped, film coated tablets with one half (lengthwise) white to off-white and the other half tan. The white half of the tablet is debossed with "06/012D".

4 Clinical Particulars

4.1 Therapeutic Indications

For the relief of the symptoms of allergic rhinitis with nasal congestion when both the antiallergic properties of fexofenadine hydrochloride and the decongestant activity of pseudoephedrine hydrochloride are required.

4.2 Dose and Method of Administration

For adults and children over the age of 12 years, the recommended dosage of Telfast Decongestant is one tablet 12 hourly. The tablet should be swallowed whole and administration with or after a high fat meal should be avoided.
The safety and efficacy of Telfast Decongestant in patients under the age of 12 years has not been established.
Dosage adjustment is not required in the elderly or in patients with hepatic impairment. However, for renally impaired patients, a dose of one tablet once daily is recommended as a starting dose (see Section 4.4 Special Warnings and Precautions for Use).
The maximum tolerated dose of Telfast Decongestant has not been established.

4.3 Contraindications

Telfast Decongestant is contraindicated in patients with a known hypersensitivity to fexofenadine, pseudoephedrine, terfenadine or any excipient.
Pseudoephedrine and thus Telfast Decongestant is contraindicated in the following patients:
Patients with severe hypertension or severe coronary artery disease, narrow angle glaucoma, urinary retention or those who have shown sensitivity to adrenergic events (manifestations include insomnia, dizziness, weakness, tremor or arrhythmia).
Patients with urinary retention related to urethroprostatic disorders.
Patients receiving monoamine oxidase (MAO) inhibitors or patients who have received MAO inhibitors in the previous 14 days (see Section 4.4 Special Warnings and Precautions for Use).
Patients with a history of seizures.
Patients using other vasoconstrictor agents used as nasal decongestants, whether administered orally or nasally (see Section 4.4 Special Warnings and Precautions for Use).

4.4 Special Warnings and Precautions for Use

Sympathomimetics, such as pseudoephedrine, should be used with caution in patients with diabetes mellitus, hypertension, heart disease, increased intraocular pressure, hyperthyroidism, prostatic hypertrophy, renal disease and hyperreactivity to ephedrine, stroke and psychosis.
Like some sympathomimetics amines, pseudoephedrine may produce CNS stimulation with convulsions or cardiovascular collapse. Patients should be informed that the inactive ingredients of Telfast Decongestant may be eliminated in the faeces in a form that may resemble the original tablet.
Treatment should be discontinued if patients develop:
Hypertension;
Tachycardia, palpitations, cardiac arrhythmias;
Any neurological symptoms such as onset or worsening of headache.
Neurological and psychiatric symptoms and irregular heartbeat have been reported after systemic administration of vasoconstrictors, especially with overdose (see Section 4.9 Overdose).

Use in renal impairment.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

Related to pseudoephedrine component.

Interference with serological testing.

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.
Co-administration 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 co-administration 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.
A clinical drug-drug interaction study showed that co-administration of apalutamide (a weak inducer of P-glycoprotein) and a single oral dose of 30 mg fexofenadine resulted in a 30% decrease in AUC of fexofenadine.
Concomitant use of pseudoephedrine with antihypertensive drugs which interfere with sympathetic activity, such as methyldopa or reserpine, may reduce their antihypertensive effects.
Concomitant use of pseudoephedrine with sympathomimetic or vasoconstrictor agents may have an additive cardiovascular effect (see Section 4.4 Special Warnings and Precautions for Use).
The use of pseudoephedrine within 14 days of use or after discontinuation of use of a monoamine oxidase (MAO) inhibitor is contraindicated. Concomitant use of pseudoephedrine with monoamine oxidase inhibitors (MAOI) may lead to paroxysmal hypertension and hyperthermia, which can be fatal. (See Section 4.4 Special Warnings and Precautions for Use.)
Concomitant use of pseudoephedrine with tricyclic antidepressants may diminish or enhance the effect of pseudoephedrine.
Concomitant use of pseudoephedrine with digitalis, quinidine or tricyclic antidepressants may increase risk of arrhythmia.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

No data available.

4.8 Adverse Effects (Undesirable Effects)

Clinical trials.

Post-marketing.

Psychiatric disorders.

Nervous system disorders.

Cardiac disorders.

Vascular disorders.

Gastrointestinal disorders.

Immune system disorders.

Respiratory, thoracic and mediastinal disorders.

Skin and subcutaneous tissue disorders.

Renal and urinary disorders.

General disorders and administration site.

Reporting suspected adverse effects.

4.9 Overdose

In the case of an overdose, standard measures to remove any unabsorbed drug should be considered. Haemodialysis is not an effective means of removing fexofenadine from blood. Excretion of pseudoephedrine is increased by lowering the pH of the urine. Symptomatic and supportive treatment is recommended. If sympathomimetic amines are necessary, caution should be used in the presence of pseudoephedrine.

Fexofenadine.

Pseudoephedrine.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

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%. Co-administration 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 radio-labelled 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 serum half-life of pseudoephedrine is approximately 4 to 8 hours. The elimination half-life may be decreased at urine pH < 6 and may be increased at urine pH > 8. About 43% to 96% of an administered dose is excreted unchanged in the urine, the remainder is apparently metabolised by the liver.
The pharmacokinetics of fexofenadine hydrochloride and pseudoephedrine hydrochloride are not altered when they are administered together.
Fexofenadine hydrochloride was rapidly absorbed with T_max occurring at 2.1 hours and 1.7 hours post dose after multiple and single doses of Telfast Decongestant, respectively, in healthy volunteers. In the same studies, the T_max after multiple and single dosing of pseudoephedrine hydrochloride was determined to be 4.8 hours and 5.5 hours respectively.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Telfast Decongestant tablets also contain microcrystalline cellulose, pregelatinised maize starch, croscarmellose sodium, magnesium stearate, carnauba wax, stearic acid, colloidal anhydrous silica and Opadry-YS-1-7006 Clear.

6.2 Incompatibilities

No data available.

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

Store below 25°C.

6.5 Nature and Contents of Container

Telfast Decongestant tablets are available in PVC/PE/PVDC aluminium blister packs of 2, 6 and 10.

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 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 Decongestant. The chemical name is benzeneacetic acid, 4-[1-hydroxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]butyl]-α,α-dimethyl-, hydrochloride.
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.
Pseudoephedrine hydrochloride is a white or off-white crystal or powder and is an orally active sympathomimetic amine which exerts a decongestant action on the nasal mucosa.

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

Pharmacist Only Medicine (Schedule 3).

Summary Table of Changes