Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I using Telfast Decongestant?
Telfast Decongestant contains the active ingredient fexofenadine hydrochloride and
pseudoephedrine hydrochloride. Telfast Decongestant is used to relieve the symptoms
of seasonal and perennial allergic rhinitis (including hayfever) with sinus/nasal
congestion. For more information, see Section
1. Why am I using Telfast Decongestant? in the full CMI.
2. What should I know before I use Telfast Decongestant?
Do not use if you have ever had an allergic reaction to Telfast Decongestant or any
of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section
2. What should I know before I use Telfast Decongestant? in the full CMI.
3. What if I am taking other medicines?
4. How do I use Telfast Decongestant?
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.
Telfast Decongestant should be swallowed whole with a full glass of water, before
a meal.
Do not take more than the dose your pharmacist or doctor has directed.
5. What should I know while using Telfast Decongestant?
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Things you should do
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Tell any doctor, dentist or pharmacist you visit that you are using Telfast Decongestant.
Tell your doctor or pharmacist if you plan to become pregnant, are pregnant, or breastfeeding.
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Things you should not do
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Do not taken more than the recommended dose unless your pharmacist or doctor tells
you to.
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Driving or using machines
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Telfast Decongestant may cause dizziness or light-headedness in some people. If this
happens, do not drive or operate machinery.
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Drinking alcohol
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Tell your doctor if you drink alcohol.
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Looking after your medicine
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Keep Telfast Decongestant in a cool dry place where the temperature is below 25°C.
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6. Are there any side effects?
Common side effects include headache, dizziness, hallucinations, difficulty sleeping,
fatigue, drowsiness, rapid heartbeat, dry mouth, nausea, loss of appetite, nervousness,
restlessness, excitability, fear of anxiety and tremor. Serious side effects include
symptoms of allergic reaction, including shortness or breath, difficulty breathing,
swelling of any part of the face and body, rash, itching or hives on the skin, or
urinary retention.
For more information, including what to do if you have any side effects, see Section
6. Are there any side effects? in the full CMI
Active ingredient(s): Fexofenadine hydrochloride/ pseudoephedrine hydrochloride
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Telfast Decongestant. 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 Decongestant.
Where to find information in this leaflet:
1. Why am I using Telfast Decongestant?
Telfast Decongestant contains two active ingredients - fexofenadine hydrochloride
and pseudoephedrine hydrochloride.
Fexofenadine hydrochloride is an antihistamine which is used to help reduce allergic
symptoms caused by a substance called histamine. Examples of these include: watery,
itchy eyes, sneezing and runny nose.
Pseudoephedrine hydrochloride is a decongestant that works by reducing the amount
of fluids in your upper respiratory tract, such as your nose, nasal passages and sinus,
which can make it hard to breathe.
Telfast Decongestant is used to relive the symptoms of seasonal and perennial allergic
rhinitis (including hay fever) with sinus/nasal congestion. Symptoms of this can include:
nasal and sinus congestion, sneezing, itchy and runny nose, watery eyes and an itchy
throat.
2. What should I know before I use Telfast Decongestant?
Warnings
Do not use Telfast Decongestant if you have:
you are allergic to fexofenadine hydrochloride, pseudoephedrine hydrochloride or terfenadine
or any of the ingredients listed at the end of this leaflet.
Always check the ingredients to make sure you can use this medicine.
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
urinary retention related to urethroprostatic (bladder and prostate) disorders
a sensitivity to adrenergic events (symptoms include insomnia, dizziness, weakness,
tremor or irregular heartbeat)
taken or stopped taking monoamine oxidase inhibitors (medicines used to treat depression)
in the last 14 days.
history of seizures
Do not give this medicine to a child under the age of 12 years, unless your doctor
has told you to.
If you are unsure whether you should start taking this medicine, talk to your pharmacist
or doctor.
Check with your doctor if you have any of the following 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
psychosis
onset or worsening of headache
Tell your dentist, pharmacist or doctor if you plan to have surgery. If you have not
told your dentist, pharmacist or doctor about any of the above, tell them before you
take this medicine.
Your pharmacist or doctor has more information on medicines to be careful with or
to avoid while taking this medicine.
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
Pseudoephedrine is excreted in breast milk.
Do not take this medicine if you are pregnant or plan to become pregnant. If you become
pregnant while talking this medicine, stop taking it and tell your pharmacist or doctor
immediately.
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.
Tell your pharmacist or doctor if you are breastfeeding or planning to breastfeed.
Your pharmacist or doctor will discuss the risks and benefits of taking it if you
are breastfeeding or planning to breastfeed.
3. What if I am taking other medicines?
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 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)
appetite suppressors
narrowing blood vessels (medicines administered through the mouth or nose)
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.
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 Decongestant.
4. How do I use 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.
Follow the instructions provided and use Telfast Decongestant until your doctor tells
you to stop.
Talk to your pharmacist or doctor if you are unsure what dose to take.
When to take Telfast Decongestant
Telfast Decongestant should be taken before a meal.
You should take the dose at about the same time each day.
You should avoid taking Telfast Decongestant with or after a high fat meal.
How to take Telfast Decongestant
Telfast Decongestant should be swallowed whole with a full glass of water.
If you forget to take Telfast Decongestant
Telfast Decongestant should be used regularly at the same time each day.
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 you missed.
This may increase the change of getting an unwanted side effect.
If you are unsure 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 use too much Telfast Decongestant
If you think that you have used too much Telfast Decongestant, you may need urgent
medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while using Telfast Decongestant?
Things you should do:
Talk to your pharmacist or doctor if your symptoms don't improve.
Tell all the doctors, dentists and pharmacists who are treating you that you are taking
Telfast Decongestant. This is important if you are about to be started on any new
medicine or if you are having any type of surgery.
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.
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.
Pseudoephedrine can lead to positive results in sport doping tests.
Call your doctor straight away if you:
Do not feel well while you are taking Telfast Decongestant
Things you should not do:
Do not taken 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
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Telfast
Decongestant affects you.
Telfast Decongestant 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.
Drinking alcohol
Tell your doctor if you drink alcohol.
Looking after your medicine
Follow the instructions in the carton on how to take care of your medicine properly.
Keep your tablets in the original pack until it is time to take them.
Store it in a cool dry place away from moisture, heat or sunlight where the temperature
is below 25 degrees C; 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?
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 some people.
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.
Children and people over 65 years of age may have an increased chance of getting side
effects.
Less serious side effects
Other side effects (frequency unknown)
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Other side effects (frequency unknown)
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What to do
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Psychiatric related:
anxiety
hallucination
inability to sleep
nervousness symptoms such as irritable mood, increased activity or restlessness
low self-esteem
racing thoughts, talking fast and distractibility
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Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these side effects.
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Nervous system related:
seizures
stroke
headache
dizziness
shaking known as tremors
sleepiness
Heart related:
fast or irregular heart beats known as palpitations
high blood pressure
abnormal fast heart beat (fast or irregular)
Stomach related:
feeling unwell
vomiting
dry mouth
decreased appetite
inflammation of the colon symptoms include diarrhoea, stomach pain
Breathing related:
shortness of breath
Skin and tissue related:
rash
hives symptoms include itchy swellings on the skin
itching
excessive sweating
Kidney related:
difficulty passing urine
pain when passing urine
Immune system related:
allergic reaction
Administration site and other:
tiredness
thirst
unusual weakness
chest pain
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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 with a doctor's prescription.
What Telfast Decongestant contains
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Active ingredient
(main ingredient)
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Fexofenadine hydrochloride
Pseudoephedrine hydrochloride
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Other ingredients
(inactive ingredients)
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microcrystalline cellulose
pregelatinised maize starch
croscarmellose sodium
magnesium stearate
carnauba wax
stearic acid
colloidal anhydrous silica
OpadryYS-1-7006 Clear
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Do not take this medicine if you are allergic to any of these ingredients.
What Telfast Decongestant looks like
Telfast Decongestant tablets have two layers, are capsule shaped, film coated tablets.
One half (lengthwise) 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 2, 6 and 10 tablets.
Aust R 72552
Who distributes Telfast Decongestant
Sanofi Consumer Healthcare
87 Yarraman Place
Virginia
Qld 4014 Australia
This leaflet was prepared in October 2021.
® Registered Trademark
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