PACKAGE LEAFLET: INFORMATION FOR THE USER

Loratadine 5mg/5ml Oral Solution Loratadine

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription. However . you still need to take Loratadine 5 mg/5ml oral solution carefiilly to get the best results from it.

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

Ask your pharamacist if you need more information or advice.

You must contact a doctor if your symptoms worsen or do not improve

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet.

please tell your doctor or pharmacist.

In this leaflet:

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

2.    Before you take Loratadine 5 mg/5 ml oral solution

3.    How to take Loratadine 5 mg /5    ml    oral solution

4.    Possible side effects

5.    How to store Loratadine 5 mg/5 ml oral solution

6.    Further information

1.    WHAT LORATADINE 5MG/5ML ORAL SOLUTION IS AND WHAT IT IS USED FOR

This medicine belongs to a group of medicines called antihistamines.Throughout this leaflet, your medicine is called Loratadine oral solution.

Loratadine oral solution is used in both adults and children over 2 years of age to relieve the symptoms of hayfever such as sneezing.runny nose and buming.itchy eyes. It may also used for skin allergies such as rash.itching or urticaria(hives)

2.    BEFORE YOU TAKE    LORATADINE ORAL SOLUTION

Do not take Loratadine oral solution

if you are allergic (hypersensitive) to Loratadine or any of the other ingredients of Loratadine oral solution.

if you are pregnant.planning to become pregnant or are breast feeding.

Take special care with Loratadine oral solution

if you have had an allergic reaction to antihistamines in the past if you have severe liver disease Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is particularly important if you are taking Cimetidine (for stomach problems)

Erythromycin (an antibiotic)

Ketoconazole or fluconazole (for fungal infections)

Taking Loratadine oral solution with food and drink

This medicine may be taken with or without food.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

The safe use of loratadine during pregnancy has not been established. The use of Loratadine oral solution during pregnancy is therefore not recommended.

Loratadine. the active substance in this medicine is excreted in breast milk, therefore the use of loratadine oral solution is not recommended in breast-feeding women.

Driving and using machines

Loratadine very rarely causes drowsiness at the recommended dosage.However .individuals react differently, so if affected, do not drive or use any tools or machines .

Important information about some of the ingredients of Loratadine oral solution

This medicinal product contains maltitol and sucralose. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.

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3. HOW TO TAKE LORATADINE ORAL SOLUTION

Loratadine oral solution is for oral use only. Shake the bottle well before use. The usual dose is as shown in the table below:

If you take more Loratadine oral solution than you should

If you may have taken more Loratadine oral solution than you should .talk to a doctor or pharmacist immediately . Overdose may cause sleepiness or a faster heart beat. Immediate medical attention should be sought in the event of an overdose.

If you forget to take Loratadine oral solution

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 a forgotten dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4.    POSSIBLE SIDE EFFECTS

Like all medicines. Loratadine oral solution can cause side effects, although not everybody gets them.

If any of the following side effects happen, stop taking Loratadine oral solution and tell your doctor immediately or go to the casualty department at your nearest hospital:

severe allergic reaction which causes difficulty in breathing or dizziness

hair loss

liver problems

faster heart beats

fainting

rash

fatigue

headache

nausea (feeling sick)

gastritis (an inflammation of the lining of the stomach)

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5.    HOW TO STORE LORATADINE ORAL SOLUTION

Keep out of the reach and sight of children

Do not use Loratadine oral solution after the expiry date which is stated on the carton after EXP.The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Shelf life after first opening container is 3 months.

Do not use Loratadine oral solution if you notice any defects or signs of deterioration.

If unsure, consult your doctor or pharmacist before taking it.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6.    FURTHER INFORMATION

What Loratadine oral solution contains

The active substance is Loratadine.

The other ingredients are propylene glycol (E1520).sodium benzoate (E211). disodium edetate. maltitol (lycasin 80/55). glycerol (E422). citirc acid monohydrate, menthol, flavour peach (9/A07169) and sucralose.

What Loratadine oral solution looks like and contents of the pack

Loratadine oral solution is a clear, colourless liquid contained in either amber coloured glass bottles with a tamper proof child resistance cap or amber coloured transparent PET bottles with a tamper proof child resistance cap.

Pack size: 100ml

Marketing Authorisation Holder

Cipla (EU) Limited, Hillbrow House, Hillbrow Road, Esher, Surrey, KT10 9NW Manufacturer:

APC Pharmaceuticals & Chemicals (Europe) Ltd.,

9th floor, C.P. House, 97-107 Uxbridge Road, Ealing, London W5 5TL Distributed By:

APC Pharmaceuticals & Chemicals (Europe) Limited,

9th floor, C.P. House, 97-107 Uxbridge Road, Ealing, London W5 5TL This leaflet was last revised in November 2012.