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17,4 mm Dennis Strauss strauss@packpool.ch +41 61 201 10 23

Nauenstrasse 41 ■ 4052 Basle ■ Fon +41 61 201 10 20 Fax+41 61 201 10 21 ■ www.packpool.ch

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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 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 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 sucrose

Clarityn Allergy Syrup contains 6g of sucrose per dose; this

should be taken into account in those patients with diabetes.

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.

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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.

25% 50% 75% 100%

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5% 25% 50% 75% 100%

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How much to take:

The recommended dose is:

check

barcode

Format/measures/dieline

braille

colour separations repetition (Foil) pdf check

system

print

size first letter of brand contact person email phone

17,4 mm Dennis Strauss strauss@packpool.ch +41 61 201 10 23

Nauenstrasse 41 ■ 4052 Basle ■ Fon +41 61 201 10 20 Fax+41 61 201 10 21 ■ www.packpool.ch

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

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,

GZR-1368 Gzira Website: www.medicinesauthority.gov.mt,

e-mail: 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 Clarityn Allergy Syrup 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 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 amber glass bottles of 70 ml with a tamper-evident, childproof, polypropylene 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

RG141JA

United Kingdom

Manufacturer:

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

This leaflet was last revised in October 2015.

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