Expectorant Cough Syrup

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Document: leaflet MAH BRAND_PL 12063-0023 change

Pack Copy Specification	Junior Expectorant Cough Syrup -Leaflet
Marketing Authorisation number	PL 12063/0023

Guaifenesin

PATIENT INFORMATION LEAFLET

Read all of this leaflet carefully before you give this medicine to your child, because it contains important information you need to know.

This medicine is available without prescription, however, you still need to use this product carefully to get the best results from it. Keep this leaflet as you may need to read it again. Ask your pharmacist if you need more information or advice.

1. What is this medicine and what is it used for?

This medicine contains:

• guaifenesin which is an expectorant to help loosen phlegm This cough syrup helps to relieve chesty coughs.

2. Is this medicine suitable for your child?

Do not give this medicine to your child if they:

• are allergic to guaifenesin or any of the other ingredients

• suffer from porphyria, which is a type of blood disorder that causes skin or nervous system problems

• are under 6 years of age.

Please see your doctor or pharmacist before you give this medicine to your child if they:

• have a long-term cough or asthma, or are having an asthma attack

• suffer from a very bad cough or if your child’s cough lasts for more than 5 days, or comes back, or if they also have a fever, rash or persistent headache

• have an intolerance to some sugars

• are taking cough suppressants (e.g. dextromethorphan, pholcodine).

Information about some of the ingredients in this medicine:

Contains sorbitol (E420). If you have been told by your doctor that your child has an intolerance to some sugars, contact your doctor before giving this medicinal product to your child.

3. How to give this medicine to your child

Shake the bottle well before use. Measure the syrup using the dosing cup provided.

Pack Copy Specification	Junior Expectorant Cough Syrup -Leaflet
Marketing Authorisation number	PL 12063/0023

Children 6 - 12 years: 15 ml. If the child’s symptoms get worse while taking this syrup see your doctor. Not to be used for more than 5 days without the advice of a doctor.

Each dose should be given as required but, do not repeat the dose more frequently than every 6 hours.

Not more than 3 doses should be given in any 24 hours. Do not exceed the stated dose.

Do not give to children under 6 years of age.

Do not give with any other cough and cold medicine.

If your child takes too much cough liquid by mistake, contact your doctor or pharmacist straight away. Very large doses can cause sickness (nausea and vomiting).

4. Possible side effects

Most people do not have any side effects while taking this medicine. However, if your child experiences any side effects, or anything else unusual happens, stop giving them the medicine immediately, and see your doctor or pharmacist.

Side effects which may occur are:

• stomach ache and discomfort, nausea (feeling sick), vomiting (being sick)

• allergic reactions such as skin rash.

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 your medicine

Keep out of the sight and reach of children.

Do not store above 25°C.

Do not use this medicine after the expiry date printed on the pack.

6. What is in this medicine?

Each 15 ml dose of liquid contains the active ingredient: guaifenesin 100 mg.

The other ingredients are: water, glycerin, sorbitol (E420), potassium sorbate, sodium saccharin, sodium cyclamate, carrageenan gum, flavourings (balsam, cherry and jackfruit) and colour: anthocyanin red (E163).

This product is available in a pack size of 150 ml.

Pack Copy Specification	Junior Expectorant Cough Syrup -Leaflet
Marketing Authorisation number	PL 12063/0023

7. Who makes this medicine?

The Marketing Authorisation holder and manufacturer is Wrafton Laboratories Limited, Braunton, Devon, EX33 2DL, UK.

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PL 12063/0023