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Simple Linctus Paediatric

Document: leaflet MAH BRAND_PL 04917-0007 change

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SIMPLE LINCTUS PAEDIATRIC SUGAR FREE Citric Acid Monohydrate 31.25mg/5ml

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

This medicine is available without prescription, however, you still need to give Simple Linctus Paediatric Sugar Free to your child 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 contact a doctor if your symptoms worsen or do not improve after a few days.

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 Simple Linctus Paediatric Sugar Free is and what it is used for

2.    Before you give Simple Linctus Paediatric Sugar Free

3.    Flow to give Simple Linctus Paediatric Sugar Free

4.    Possible side effects

5.    Flow to store Simple Linctus    Paediatric Sugar    Free

6.    Further information

1.    WHAT SIMPLE LINCTUS PAEDIATRIC    SUGAR FREE IS AND WHAT IT IS USED FOR

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Simple Linctus Paediatric Sugar Free is a medicine which helps to stop a mild non-specific cough in children.

2.    BEFORE YOU GIVE SIMPLE LINCTUS PAEDIATRIC SUGAR FREE

DO NOT give Simple Linctus Paediatric Sugar Free if:

•    the child is allergic to citric acid or any of the other ingredients in this medicine (see Section 6 and end of Section 2).

Taking other medicines

Please tell your doctor or pharmacist if your child is taking or has recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

This medicine is intended for use in children. However, ask your doctor or pharmacist for advice before taking Simple Linctus Paediatric Sugar Free during pregnancy, or if you are breast-feeding.

Driving and using machines

This medicine is intended for use in children. However, Simple Linctus Paediatric Sugar Free has no known effect on ability to drive or use machines.

Important information about some of the other ingredients of Simple Linctus Paediatric Sugar Free

Simple Linctus Paediatric Sugar Free contains

•    maltitol liquid (E965). If you have been told that your child has an intolerance to some sugars, contact your doctor before taking this medicinal product.

•    small amounts of ethanol (alcohol), less than 100mg per 5ml dose.

3.    HOW TO GIVE SIMPLE LINCTUS PAEDIATRIC SUGAR FREE

Always give the product to the child exactly as advised. You should check with your doctor or pharmacist if you are not sure.

Only to be taken by mouth.

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The usual dose is:

Children:    One or two 5ml spoonfuls taken 3-4 times daily.

Adults:    Simple Linctus Paediatric Sugar Free is not recommended. A different formulation of

Simple Linctus Sugar Free is available for adults; please see your pharmacist.

If your child takes more Simple Linctus Paediatric Sugar Free than they should:

If your child takes too much Simple Linctus Paediatric Sugar Free over a long period of time it may cause erosion of the teeth and local irritation.

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

4.    POSSIBLE SIDE EFFECTS

Like all medicines, Simple Linctus Paediatric Sugar Free can cause side effects, although not everybody gets them. 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 via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5.    HOW TO STORE SIMPLE LINCTUS PAEDIATRIC SUGAR FREE

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Keep out of the sight and reach of children. Store below 25°C.

Do not use Simple Linctus Paediatric Sugar Free after the expiry date which is stated on the label or carton. The expiry date refers to the last day of that month.

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 Simple Linctus Paediatric Sugar Free contains:

•    The active substance is Citric Acid Monohydrate 31,25mg/5ml equivalent to 28.57mg/5ml Anhydrous Citric Acid.

•    The other ingredients are glycerol (E422), sodium carboxymethylcellulose, sodium benzoate (E211), saccharin sodium (E954), maltitol liquid (E965), ethanol, star anise oil, and purified water.

What Simple Linctus Paediatric Sugar Free looks like and contents of the pack

Simple Linctus Paediatric Sugar Free is a clear sugar free syrup, available in 2000ml plastic (HDPE) bottles, or in 100ml, 125ml and 200ml amber glass bottles. This medicinal product is a sugar free and colour free product.

Marketing Authorisation Holder and Manufacturer

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

PL 04917/0007

This leaflet was last updated in 08/2015.

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