Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about taking this medicine,
speak to your pharmacist or doctor.
This medicine is new or being used differently. Please report side effects. See the
full CMI for further details.
1. Why am I taking ALLERTINE?
ALLERTINE contains the active ingredient bilastine. ALLERTINE is used to relieve the
symptoms of hayfever and other forms of allergic rhinitis. It may also be used to
treat itchy skin rashes.
2. What should I know before I take ALLERTINE?
Do not use if you have ever had an allergic reaction to bilastine or any of the ingredients
listed at the end of the CMI.
Talk to your pharmacist or doctor if you are pregnant, likely to become pregnant or
are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with ALLERTINE and affect how it works.
4. How do I take ALLERTINE?
Adults and adolescents 12 years & over: Take one tablet daily, as required to manage your symptoms.
Swallow the tablet with a glass of water, on an empty stomach (at least 1 hour before or 2 hours after meals or fruit juices).
5. What should I know while taking ALLERTINE?
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Things you should do
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Discuss any side effects that concern you with your pharmacist or doctor.
If you are started on a new medicine, remind your doctor or pharmacist that you are
taking ALLERTINE.
If symptoms persist or appear to worsen, check with your pharmacist or doctor for
advice.
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Driving or using machines
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ALLERTINE has been shown not to affect adult driving performance. However, as medicine
responses for each person can vary, check how this medicine affects you before driving
or operating machinery.
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Looking after your medicine
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Keep your medicine in a cool dry place where the temperature stays below 30°C.
Keep your medicine in the original pack until it is time to take.
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6. Are there any side effects?
The most common side effects of ALLERTINE are headache, sleepiness and stomach pain.
Serious side effects may include difficulty breathing, swelling of face, lips or tongue,
sudden or rapidly developing rash or itching of skin or collapsing or losing consciousness.
This medicine is subject to additional monitoring. This will allow quick identification
of new safety information. You can help by reporting any side effects you may get.
You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems .
Active ingredient:
bilastine
Full Consumer Medicine Information (CMI)
This leaflet provides important information about taking ALLERTINE. You should also speak to your pharmacist or doctor if you would like further information
or if you have any concerns or questions about taking ALLERTINE.
Where to find information in this leaflet:
1. Why am I taking ALLERTINE?
ALLERTINE contains the active ingredient bilastine. ALLERTINE is one of a group of medicines called non-drowsy antihistamines.
ALLERTINE is used to relieve the symptoms of hayfever (sneezing, itchy, runny, blocked nose, red watery and itchy eyes) and other forms of allergic rhinitis. It may also be used to treat itchy skin rashes
(hives or urticaria).
2. What should I know before I take ALLERTINE?
Warnings
Do not use ALLERTINE if:
you are allergic to bilastine, or any of the ingredients listed at the end of this
leaflet.
Always check the ingredients to make sure you can use this medicine.
Check with your pharmacist or doctor if you:
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
Check with your pharmacist or doctor if you are pregnant or likely to become pregnant.
Talk to your pharmacist or doctor if you are breastfeeding or intend to breastfeed.
Do not take ALLERTINE if you are pregnant or breastfeeding unless your doctor has
advised you to.
Use in Children
Do not give ALLERTINE to a child under the age of 12 years.
The safety of ALLERTINE and how well it works has not been studied in children younger
than 12 years of age.
3. What if I am taking other medicines?
Tell your pharmacist or doctor 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 ALLERTINE may interfere with each other and affect how well each
works. These include:
Diltiazem, a medicine for the treatment of high blood pressure and angina.
Cyclosporine, a medicine used to reduce the activity of the immune system.
Ketoconazole, a medicine used to treat fungal infections.
Erythromycin, a medicine used to treat a wide variety of bacterial infections.
Check with your pharmacist or doctor if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect ALLERTINE.
4. How do I take ALLERTINE?
How much to take
Adults and adolescents 12 years & over: Take one tablet daily, as required to manage
your symptoms.
Swallow the tablet with a glass of water.
If you have difficulty swallowing, the tablet may be halved along the score line.
When to take ALLERTINE
Take ALLERTINE on an empty stomach, at least 1 hour before or 2 hours after food or fruit juice (particularly
grapefruit juice).
Food and fruit juice can interfere with the absorption of ALLERTINE by the body.
How long to take ALLERTINE
ALLERTINE helps control your condition, but it does not cure it. You can stop taking
ALLERTINE when you know you are no longer exposed to your hayfever/ allergy triggers,
or you know you have obtained sufficient relief from your symptoms. ALLERTINE can
be restarted if your symptoms recur or are expected to recur.
If you take too much ALLERTINE
If you think that you have taken too much ALLERTINE, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26 in Australia), 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 taking ALLERTINE?
Things you should do
Discuss any side effects that concern you with your pharmacist or doctor.
If you are started on a new medicine, remind your doctor or pharmacist that you are
taking ALLERTINE.
If your symptoms persist or appear to worsen, do not take extra tablets. Check with
your pharmacist or doctor for advice.
Tell your pharmacist or doctor immediately if you become pregnant while you are taking
this medicine.
Driving or using machines
It has been demonstrated that bilastine does not affect adult driving performance.
However, the response from each patient to the medicine may be different. Therefore,
as for any new medicine, you should check how this medicine affects you, before driving
or operating machinery.
Looking after your medicine
Keep your medicine where the temperature stays below 30°C.
Keep your medicine in the original pack until it is time to take.
Follow the instructions on 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 pharmacist or doctor if you
have any further questions.
Do not be alarmed by the following list of side effects. You may not experience any
of them. Similar side effects were seen in patients taking ‘dummy’ or placebo tablets
during the clinical studies.
Less serious side effects
Serious side effects
Tell your pharmacist or doctor 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.
7. Product details
This medicine is available over-the-counter without a doctor's prescription.
What ALLERTINE contains
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Active ingredient
(main ingredient)
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Each tablet contains 20 mg of bilastine
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Other ingredients
(inactive ingredients)
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microcrystalline cellulose
sodium starch glycollate type A
colloidal anhydrous silica
magnesium stearate
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Do not take this medicine if you are allergic to any of these ingredients.
ALLERTINE does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.
What ALLERTINE looks like
ALLERTINE is a white, oval, biconvex and scored tablet (AUST R 387574).
Available in blister packs of 4, 10, 20, 30, 40, 50, 60, 70, 80, 90 or 100 tablets.
Not all pack sizes may be supplied.
Who distributes ALLERTINE
A. Menarini Australia Pty. Ltd.,
Level 8, 67 Albert Avenue,
Chatswood, NSW 2067
Phone 1800 644 542
® Trademark
[CMI vA03-0]
This leaflet was prepared in September 2023.