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Dry Cough Syrup

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Document: leaflet MAH BRAND_PL 12063-0024 change

Dry CougTi Syrup

Dextromethorphan

PATIENT INFORMATION LEAFLET


Read all of this leaflet carefully before you take this medicine 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.

Treating cough and cold in children

ilt's normal for children to get 8 or more bolds in a year. Gradually they build up immunity and get fewer colds. Most colds yvill get better within a few days and you may not need to do more than keep your [child comfortable until they get over it. Because colds are caused by viruses, not bacteria, antibiotics don't help. Here are simple steps to help your child who has a cough or cold.

i.    If they are hot/feverish: Increase the amount of fluid your child normally drinks. Lower their temperature with a paracetamol lor ibuprofen medicine which has doses for children. (Paracetamol is not for children [under 2 months. Ibuprofen is not for children under 3 months)

ii.    For coughs: Although it is distressing to near your child cough, in fact coughing serves a purpose. It helps to clear phlegm pn the chest or mucus from the nose. Give the child plenty of warm clear fluids to drink.

iii.    To help with breathing: Plain saline nose drops, available from your pharmacy, .can help babies with blocked noses who |are having trouble feeding.

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

This medicine contains:

• dextromethorphan which is a cough suppressant.

his cough syrup helps to soothe and pontrol dry coughs.


2. Is this medicine suitable for you?

Do not take this medicine if you:

•    are allergic to dextromethorphan or any of the other ingredients

•    are in early pregnancy, unless your doctor has told you to

•    suffer from serious breathing (respiratory) problems or are at risk of developing them

•    are taking, or have taken antidepressant drugs called monoamine oxidase inhibitors (MAOI's) within the last 2 weeks (e.g. phenelzine and isocarboxazid)

•    are taking antidepressants called selective serotonin reuptake inhibitors (SSRI's) (e.g. citalopram, fluoxetine, sertraline).

Do not give to your child if they are under 6 years.

Please see your doctor or pharmacist before taking this medicine if you:

•    are pregnant or breastfeeding

•    are taking any other medicines

•    are taking alcohol

•    suffer from a very bad or persistent cough or a cough which produces lots of phlegm

•    have liver disease

•    have asthma, or are having an asthma attack

•    have an intolerance to some sugars.

If your child is susceptible to allergies, consult your doctor before giving them this cough syrup.

Information about some of the ingredients in this medicine:

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

Contains alcohol (ethanol). This medicinal product contains small amounts of ethanol (alcohol), less than 100 mg per 15 ml dose.

Please turn over


Driving and using machines

The medicine can affect your ability to drive as it may make you sleepy or dizzy.

•    Do not drive while taking this medicine until you know how it affects you

•    It may be an offence to drive when taking this medicine

•    However, you would not be committing an offence if:

o The medicine has been taken to treat a medical or dental problem and ° You have taken it according to the information provided with the medicine and

o It was not affecting your ability to drive safely

Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine. Details regarding a new driving offence concerning driving after drugs have been taken in the UK may be found here: https://www.aov.uk/drua-drivina-law.

3. How to take this medicine

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

Adults, the elderly and children over 12 years: 15 ml.

Children 6-12 years: 7.5 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.

Do not take more than 3 doses in a 24 hour period. Each dose should be taken as required but, do not repeat the dose more frequently than every 6 hours.

Do not give to children under 6 years of age.

Do not take with any other cough and cold medicine.

Do not exceed the stated dose.

If your symptoms persist or worsen, you must see a doctor or pharmacist.

If you take too much cough liquid by mistake, contact your doctor or pharmacist straight away. Very large doses can cause isickness (nausea and vomiting). _ _


^Possible side effects

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

Side effects which may occur are:

•    skin reactions such as skin rash

•    nausea (feeling sick), vomiting (being sick), diarrhoea

•    feeling drowsy, dizzy, excited or confused

•    fits

•    breathing problems.

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.aov.uk/vellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store your medicine

Keep all medicines 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: dextromethorphan hydrobromide 15 mg.

The other ingredients are: water, alcohol, menthol, sorbitol (E420), sodium cyclamate, sodium saccharin, carrageenan gum, potassium sorbate, flavourings and the colour caramel (E150).

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

7.    Who makes this medicine?

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

Text revised: April 2014.

PL 12063/0024    2747316,