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Clarityn Allergy 1mg/Ml Syrup

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Clarityn

Allergy 1mg/ml Syrup Loratadine


Read all of this leaflet carefully before you start taking this medicine because It contains Important Information Inr 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.

•    You must talk to a doctor if you do not feel better, if you feel worse or if your symptoms change.

•    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.

What is in this leaflet:

1.    What Clirityn Allergy Syrup is and what it is used for

2.    What you need to know before you take Clarityn Allergy Syrup

3.    Howto take Clarityn Allergy Syrup

4.    Possible side effects

5.    Howto 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 Claritvn Allergy Svrunis

Clarityn Allergy Syrup contains the active substance

loratadine which belongs to a class of medicines called

“antihistamines.”

How Claritvn Allergy 5™ 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 CMvflA/femvSimc should betaken 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 AllergySyrup.

Children

Do not give Clarityn AllergySyrup to children youngerthan 2 years old.

Other medicines and Clarityn Allergy Syrup 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

Do not take Clarityn Allergy Syrup if you are pregnant.

Do not take Clarityn AllergySyrup if you are breast-feeding. Loratadine is excreted in breast milk.

Driving and using machines At the recommended dose, Clarityn Allergy Syrupis 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 sucrose Clarityn Allergy Syrup contains sucrose; thus if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

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.


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How much to take:

The recommended dose is:

Age

How much to take

How often to take

Children of 2 to 12 years who weigh 30kg (4st 7lb) or less

1 x5ml spoonful

Once daily

Children of 2 to 12 years who weigh moie than 30kg (4st 7lb)

2 x5ml spoonfuls

Once daily

Adults and children over 12 years

2 x5ml 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 SyrupM 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

•    dizziness

•    fast or irregular heartbeat

•    nausea (feeling sick)

•    dry mouth

•    upset stomach

•    liver problems

•    hair loss

•    rash

•    tiredness

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:

wm.mhra.gov.uk/yellowcard

Malta: ADR Reporting, The Medicines Authority,

Post-Licensing Directorate, 203 Level 3, Rue D'Argens,

GZR-1368 Gzira Website: wm.medlcinesauthority.gov.mt,

emil:postlicensing.medicinesauthority§gov.mt

5.    How to store Clarityn Allergy Syrup

•    Keep this medicine out of the sight and reach of children.

•    This medicinal product does not require any special storage conditions. 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.

6.    Contents of the pack and other information What MynAffery/Syrep contains

•    The active substance is loratadine. Each 10ml of the syrup contains 10 mg loratadine.

•    The other ingredients are propylene glycol E1520, glycerol (E422), sucrose, citric acid anyhdrous, sodium benzoate (E211), artificial peach flavouring and purified water.

What Clarilyu 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 amber glass bottles of 70 ml with a tamper-evident, childproof, polypropylene cap. A5ml plastic spoon is included.

Not all bottle sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Aulhurisalion Holder

Merck Sharp & Dohme Limited Hertford Road Hoddesdon

Hertfordshire, EN119BU UK

Manufacturer:

Schering-Plough LaboNV Industriepark, 30 B-2220 Heist-op-den Berg Belgium

This leaflet was last revised in May 2014

PIL.CIaritynSyrupGSL.14.UK.4077-IA-032


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