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PAGE 1: FRONT FACE (INSIDE OF REEL)

LORATADINE 5 mg/5 ml SYRUP

PATIENT INFORMATION LEAFLET

Please read this leaflet carefully before you start to take this medicine.

This medicine is available without prescription, for you to treat a mild illness without a doctor's help. Nevertheless, you still need to use Loratadine 5 mg/5 ml Syrup carefully to get the best results from it.

•    Keep this leaflet. You may need to read it again.

•    Ask your pharmacist if you need more information or advice.

•    You must see a doctor if your symptoms worsen or do not improve.

IN THIS LEAFLET:

1. What Loratadine 5 mg/5 ml Syrup is and what it is used for

2.    Before you take/use Loratadine 5 mg/5 ml Syrup

3.    How to take/use Loratadine 5 mg/5 ml Syrup

4.    Possible side effects

5.    Storing Loratadine 5 mg/5 ml Syrup.

The name of your medicine is Loratadine 5 mg/5 ml Syrup. It is a colour free peach flavoured syrup.

•    The active substance is: Loratadine

•    Other ingredients: propylene glycol, glycerol (E422), sodium benzoate (E211), citric acid monohydrate, sucrose, peach flavour and purified water.

Marketing Authorisation Holder and Manufacturer:

Pinewood Laboratories Ltd., Ballymacarbry, Clonmel, Co.Tipperary, Ireland.

Product Licence Number: PL 04917/0067

OWHAT LORATADINE 5 mg/5 ml

SYRUP IS AND WHAT IT IS USED FOR

• This medicine belongs to a group of medicines called antihistamines • This product is presented in pack sizes of 60 ml, 100 ml and 150 ml; not all pack sizes may be marketed.

Loratadine 5 mg/5 ml Syrup is used in both adults and children over 2 years of age to relieve the symptoms of hayfever such as sneezing, runny nose and burning, itchy eyes. It may also be used for skin allergies such as rash, itching or urticaria (hives).

BEFORE YOU TAKE/USE LORATADINE 5 mg/5 ml SYRUP

Do not take/use Loratadine 5 mg/5 ml Syrup

•    If you or your child are hypersensitive (have a bad reaction to) to any of the ingredients in this medicine.

•    If you are pregnant, planning to become pregnant or are breast-feeding.

Consult your doctor if you:

•    Have had an allergic reaction to antihistamines in the past.

•    If you have severe liver impediment.

Driving and using machines:

Loratadine very rarely causes drowsiness at the recommended dosage. However, individuals react differently so if affected, do not drive or operate machinery.

Important information about some of the ingredients of Loratadine 5 mg/5 ml

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Taking/using other medicines

Please consult your doctor of pharmacist if you are taking, or have recently taken, any other medicine - even those not prescribed, especially:-

•    cimetidine (for stomach problems)

•    erythromycin (an antibiotic)

•    ketoconazole or fluconazole (for fungal infections)

•    quinidine (for heart problems)

•    fluoxetine (for depression).

Antihistamines may prevent response to allergens in skin allergy testing, therefore this medicine should be stopped four days prior to such testing.

HOWTOTAKE/USE LORATADINE 5 mg/5 ml SYRUP

For oral use only. Shake the bottle well before use. Use measuring device provided. Each spoon is a 5 ml dose.

Adults & children over 12 years of age:	10 ml (10 mg) of the syrup once daily
Children 2 to 12 years of age with: Body weight more than 30 kg Body weight 30 kg or less	10 ml (10 mg) of the syrup once daily 5 ml (5 mg) of the syrup once daily

Do not exceed the stated dose.

If you have the impression that Loratadine 5 mg/5 ml Syrup is too strong or too weak, talk to your doctor or pharmacist.

If you take/use more Loratadine 5 mg/5 ml Syrup than you should

If you may have taken/used more Loratadine 5 mg/5 ml Syrup than you should, talk to a doctor or pharmacist immediately. Overdose may cause mild drowsiness.

If you forget to take Loratadine 5 mg/5 ml Syrup

If you forget to take a dose, take it as soon as you remember, unless it is nearly time for the next dose. Do not take a double dose to make up for the forgotten individual doses.

Q POSSIBLE SIDE EFFECTS

Like all medicines, Loratadine 5 mg/5 ml Syrup can have side effects.

If any of the following happen, stop taking Loratadine 5 mg/5 ml Syrup and tell your doctor immediately or go to the casualty department at your nearest hospital:

• severe allergic reaction (swelling of the face, mouth, lips or throat).

•    disturbances in heart rhythm

•    fainting

•    fatigue

•    headache

•    nausea.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

STORING LORATADINE 5 mg/5 ml SYRUP

There are no special storage instructions. Keep this medicine out of the reach and sight of children. Shelf life after opening -6 months.

Use by date: Do not use this medicine after the expiry date shown on the label.

Do not use Loratadine 5 mg/5 ml Syrup if you notice any defects or signs of deterioration. If unsure consult your pharmacist before taking. Return all unused medicines to your pharmacist for safe disposal.

This leaflet was approved:

This leaflet was updated: October 2007