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CLARITYN ALLERGY 1MG/ML SYRUP

Active substance(s): LORATADINE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Clarityn Allergy 1mg/ml Syrup
Loratadine
Read all of this leaflet carefully before you start taking this medicine because it contains important
information for you.
Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist, or nurse has told
you.
Keep this leaflet. You may need to read it again.
Ask your pharmacist if you need more information or advice.
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
You must talk to a doctor if you do not feel better, if you feel worse or if your symptoms change. See
section 4.
What is in this leaflet:
1.
What Clarityn Allergy Syrup is and what it is used for
2.
What you need to know before you take Clarityn Allergy Syrup
3.
How to take Clarityn Allergy Syrup
4.
Possible side effects
5.
How to store Clarityn Allergy Syrup
6.
Contents of the pack and other information

1.

What Clarityn Allergy Syrup is and what it is used for

The full name of your medicine is Clarityn Allergy Syrup.
What Clarityn Allergy Syrup is
Clarityn Allergy Syrup contains the active substance loratadine which belongs to a class of medicines called
“antihistamines”.
How Clarityn Allergy Syrup works
Clarityn Allergy Syrup helps to reduce your allergy symptoms by stopping the effects of a substance called
“histamine”, which is produced in the body when you are allergic to something.
When Clarityn Allergy Syrup should be taken
Clarityn Allergy Syrup relieves symptoms associated with allergic rhinitis (for example, hayfever), such as
sneezing, runny or itchy nose and burning or itchy eyes in adults and children over the age of 2 years.
The syrup may also be used to help relieve symptoms of urticaria (itching and redness), which is often
known as hives or nettle rash.
The effect of Clarityn Syrup will last a whole day and should help you to continue your normal daily
activities and sleep.
You must talk to a doctor if you do not feel better or if you feel worse.
2.

What you need to know before you take Clarityn Allergy Syrup

Do not take Clarityn Allergy Syrup
 if you are allergic (hypersensitive) to loratadine or any of the other ingredients of this medicine (listed in
section 6)
 if you are pregnant or breastfeeding

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Clarityn Allergy Syrup:
 if you have liver disease
 if you are scheduled to have any skin tests for allergies. Do not take Clarityn Allergy Syrup for two days
before having these tests. This is because it may affect test results.
If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking
Clarityn Allergy Syrup.
Children
Do not give Clarityn Allergy Syrup to children younger than 2 years old.
Other medicines and Clarityn Allergy Syrup
The side effects of Clarityn Allergy Syrup may increase when used together with medicines that alter the
performance of some enzymes responsible for drug-metabolism in the liver. However, in clinical studies, no
increase in side effects of loratadine was seen with products that altered the performance of these enzymes.
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other
medicines. This includes medicines obtained without a prescription.
Clarityn Allergy Syrup with alcohol
Clarityn Allergy Syrup has not been shown to add to the effects of an alcoholic drink.
Pregnancy and breast-feeding
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist
for advice before taking this medicine.
As a precautionary measure, it is preferable to avoid the use of Clarityn Allergy Syrup during pregnancy.
Do not take Clarityn Allergy Syrup if you are breast-feeding. Loratadine is excreted in breast milk.
Driving and using machines
In clinical trials that assessed driving ability, no impairment was observed in patients receiving loratadine.
At the recommended dose, Clarityn Allergy Syrup is not expected to cause you to be drowsy or less alert.
However, very rarely some people experience drowsiness, which may affect their ability to drive or use
machines.
Clarityn Allergy Syrup contains:
Maltitol liquid: This medicine contains 3 g maltitol liquid in each spoonful (5 ml) which is equivalent to
600.69 mg/ml. If you have been told by your doctor that you have an intolerance to some sugars, contact
your doctor before taking this medicine.
Sorbitol: This medicine contains 700 mg sorbitol in each spoonful (5 ml) which is equivalent to 140 mg/ml.
Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to
some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic
disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or
receive this medicine.
Propylene glycol: This medicine contains 250 mg propylene glycol in each spoonful (5 ml) which is
equivalent to 50 mg/ml.
Sodium benzoate: This medicine contains 2.5 mg sodium benzoate in each spoonful (5 mL) which is
equivalent to 0.5 mg/ml.
Sodium: This medicine contains less than 1 mmol sodium (23 mg) per spoonful (5 ml), that is
to say essentially ‘sodium-free’.

3.

How to take Clarityn Allergy Syrup

Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told
you. Check with your doctor, pharmacist or nurse if you are not sure.
Taking this medicine
 Water or other liquid is not needed to swallow the syrup.



The syrup may be taken with or without food.

Giving this medicine to children:
It is important to know how much your child weighs to make sure that you give the correct amount of
medicine. For example, a 9 year old child weighs about 30kg (4st 7lb). If in doubt weigh your child and then
follow the instructions in the table.
Do not give to children under 2 years.
How much to take:
The recommended dose is:
Age

How much to take

How often to take

Once daily
Children of 2 to 12 years who weigh 30kg (4st 7lb) or 1 x 5 ml spoonful
less
Once daily
Children of 2 to 12 years who weigh more than 30kg 2 x 5 ml spoonfuls
(4st 7lb)
Adults and children over 12 years
2 x 5 ml spoonfuls
Once daily
If you have severe liver problems your doctor or pharmacist may advise you to take the recommended
amount every other day. If this applies to you follow their instructions.

If you take more syrup than you should
If you take more Clarityn Allergy Syrup than you should, talk to your doctor or pharmacist straight away. No
serious problems are expected, however you may get a headache, have a rapid heartbeat or feel sleepy.
If you forget to take your syrup
If you forget to take your dose, take it as soon as you remember, then continue to take it as usual.
 Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most commonly reported side effects in adults and children over 12 years of age are:
 drowsiness
 headache
 increased appetite
 difficulty sleeping
The most commonly reported side effects in children aged 2 through 12 years are:
 headache
 nervousness
 tiredness
The following very rare side effects (may affect up to 1 in 10,000 people) have also been seen during the
marketing of loratadine:
 severe allergic reaction (including swelling)
 dizziness
 convulsion
 fast or irregular heartbeat
 nausea (feeling sick)
 dry mouth
 upset stomach






liver problems
hair loss
rash
tiredness

The frequency of the following side effect is not known:
 weight gain
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly (see details below). By reporting side
effects you can help provide more information on the safety of this medicine.
United Kingdom: Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard
Malta: ADR Reporting, The Medicines Authority, Post-Licensing Directorate, 203 Level 3, Rue D'Argens,
GŻR-1368 Gżira Website: www.medicinesauthority.gov.mt, e-mail:
postlicensing.medicinesauthority@gov.mt
5.







6.

How to store Clarityn Allergy Syrup
Keep this medicine out of the sight and reach of children.
Do not freeze. Keep the bottle in the outer carton in order to protect from light.
Do not use this medicine after the expiry date which is stated on the bottle after ‘Exp’. The expiry date
relates to the last day of that month.
Clarityn Allergy Syrup is to be used within 1 month after opening.
Do not use this medicine if you notice any changes in the appearance of the syrup.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help to protect the environment.
Contents of the pack and other information

What Clarityn Allergy Syrup contains
 The active substance is loratadine. Each 10ml of the syrup contains 10 mg loratadine.
 The other ingredients are disodium edetate (E386), sodium dihydrogen phosphate dihydrate (E339),
maltitol liquid (E965), propylene glycol (E1520), glycerol (E422), phosphoric acid (E338),, sodium
benzoate (E211), sorbitol liquid (E420), sucralose (E955), artificial mixed berries flavour and purified
water.
What Clarityn Allergy Syrup looks like and contents of the pack
Clarityn Allergy Syrup is a clear, colourless to light yellow syrup.
Clarityn Allergy Syrup is available in white opaque plastic bottles of 60 ml with a tamper-evident,
childproof plastic cap. A 5ml plastic spoon is included.
Not all bottle sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Bayer plc, Consumer Care Division
Bayer House, Strawberry Hill
Newbury
Berkshire
RG14 1JA
United Kingdom
Manufacturer:

Berlimed S.A.
Poligono Industrial Santa Rosa
Calle Francisco Alonso No.7
28806 Alcalá de Henares (Madrid)
Spain

This leaflet was last revised in November 2017.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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