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Galenphol Paediatric Linctus

(pholcodine)

Important information about Galenphol Paediatric Linctus

•    This medicine relieves the symptoms of dry coughs in children between the ages of 6 and 12 years.

•    It should be used when simple measures have failed to relieve symptoms. See section 7.

Do not give....

•    If your child has breathing problems including bronchitis. See section 2.

•    To children under 6 years.

•    With other cough and cold medicines.

•    For longer than 5 days without seeing your doctor.

Talk to your doctor....

•    If your child's cough gets worse while taking this medicine.

Now read the rest of the leaflet before you use this medicine. It includes other information which might be especially important for you.

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

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

•    If you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

1. What the medicine is for

Galenphol Paediatric Linctus contains pholcodine which reduces the desire to cough.

It is used to relieve dry coughs (which are without phlegm) associated with chest infections.

2. Before you use this medicine

□ Do not use the medicine if your child has....

• An allergy to any of the ingredients listed in section 6.

• Liver disease.

• Shallow breath or other breathing problems including bronchitis.

• An asthma attack.

• Taken MAOIs (monoamine oxidase inhibitors)

for depression within the last two weeks.

• Taken other cough and cold medicines.

• Or is under 6 years old.

Talk to your doctor if your child has..

•    Kidney or liver problems.

•    A history of asthma.

•    A cough for a long time or a cough which produces lots of phlegm.

A Talk to your doctor or pharmacist if your child is taking..

• Medicine for high blood pressure, e.g. ACE inhibitors, beta blockers.

• Diuretics, which help remove fluid from the body, e.g. furosemide hydrochlorothiazide.

• Medicines used to treat sleeplessness, anxiety and schizophrenia.

• Alcohol or tranquillisers.

• Pain killers, e.g. morphine.

• Or is having surgery, as muscle relaxants used may react with this medicine.

Pregnant or breastfeeding..

Ask your doctor or pharmacist for advice before using this medicine if you are pregnant, might be pregnant or are breastfeeding. Galenphol

Paediatric Linctus should not be used in pregnancy unless the doctor has told you to do so. If you use it when breastfeeding, pholcodine in this medicine will be present in small amounts in your milk.

Driving and using machines..

This medicine may cause drowsiness. If you are affected do not drive or operate machinery.

Can adults take this medicine?

This medicine is for children. Adults will not get full benefit by using it as it is not designed for them. Ask your doctor or pharmacist for advice on more suitable medicines for adults.

A Important information about some of the ingredients

• This medicine contains small amounts of ethanol (alcohol), less than 100mg per 10ml dose.

• It also contains sodium hydroxybenzoates and sunset yellow dye which may cause allergic reactions (possibly delayed).

3. How to use this medicine

Give this medicine by mouth.

The normal dose is given below but your doctor may prescribe a different amount for you. Always follow the instructions given by the doctor or pharmacist.

Children aged 6 - 12 years

• Give two 5ml spoonfuls (10ml) three times a day.

No more than 3 doses should be given in any 24 hours.

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Children under 6 years

Do not give to children under 6 unless your doctor tells you to.

DO NOT EXCEED THE STATED DOSE.

If your child's symptoms persist for more than 5 days or get worse, you should ask your doctor for advice.

A If you give too much

If you accidentally give too much, see a doctor straight away. Take the pack with you to show which medicine your child has swallowed.

If you forget a dose

Give the next dose as soon as you remember.

Do not give a double dose. You can then carry on with the normal dose at the correct time.

4. Possible side effects

Like all medicines Galenphol Paediatric Linctus can have side effects, although these don't affect everyone.

Important side effects:

If you think your child has any of the following side effects or symptoms, stop using this medicine immediately and see a doctor as soon as possible.

•    Allergic reactions which cause difficulty in breathing, fever, swelling of the mouth, lips or skin, severe rashes and itching.

Other possible side effects:

•    Feeling sick • Constipation • Dizziness

•    Drowsiness • Getting excited • Confusion

•    Being sick • Rash • Failure to cough up phlegm.

If you notice these or any other side effect not included above, stop use and tell your doctor or pharmacist. They will tell you what to do.

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.    Storing this medicine

•    Keep it out of the sight and reach of children.

•    Keep protected from light.

•    Do not use after the expiry date shown on the carton or pharmacist's label.

•    Medicine should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of any unused medicine. These measures will help to protect the environment.

6.    Further information

What is in this medicine

The active ingredient per 5ml is:

pholcodine 2mg.

The other ingredients are:

citric acid (E330),

sodium methyl parahydroxybenzoate (E219), sodium ethyl parahydroxybenzoate (E215), sodium propyl parahydroxybenzoate, glycerol (E422), ethanol, sunset yellow dye (E110), saccharin sodium, carmellose sodium, menthol, condensed milk flavour, aniseed flavour and purified water.

What the medicine looks like

Galenphol Paediatric Linctus is a thick orange liquid which smells of menthol and aniseed. It is supplied in 90ml or 100ml bottles of which not all packs may be marketed or alternatively dispensed for your child by the pharmacist.

7. Treating coughs and colds in children

It is normal for children to get 8 or more colds in a year. Gradually they build up immunity and get fewer colds. Most colds will 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. The following steps can help your child.

If they are hot or feverish

Increase the amount of fluid your child normally drinks. Lower their temperature with a paracetamol or ibuprofen medicine which has doses for children. (Paracetamol is not for children under 2 months. Ibuprofen is not for children under 3 months.)

For Coughs

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

To help with breathing

Plain salt water nose drops, available from your pharmacy, can help babies with blocked noses who are having trouble feeding.

Marketing authorisation holder and manufacturer

Thornton and Ross Ltd., Huddersfield,

HD7 5QH, UK.

This leaflet was last revised in October 2014

Galenphol is a trade mark of Thornton & Ross Ltd.

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