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GALENPHOL PAEDIATRIC LINCTUS

Active substance(s): PHOLCODINE MONOHYDRATE

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CF/REG/96/2
Product Name
Cofsed Paediatric Pholcodine 2mg/5ml Oral liquid
Category/PL No. PL 00240/0102
Component
Leaflet

Pack size
100ml

IG Code:
N/A

Current V#: New V#:

Packaging Type Leaflet
Text revision no. Rev 01
Revised by:Kolsue Begum
24/01/2018
Authorised by:

CRN

Description

13643

Name change of API from ‘Pholcodine’ to Pholcodine monohydrate’

Page # 1 of 4
Date:
Date:

Text
Cofsed Paediatric Pholcodine 2mg/5ml Oral Liquid
Important information about Cofsed Paediatric Pholcodine 2mg/5ml Oral Liquid
• 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
Cofsed Paediatric Pholcodine 2mg/5ml Oral Liquid contains pholcodine monohydrate 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.

CF/REG/96
Product
Name

Cofsed Paediatric Pholcodine 2mg/5ml
Oral liquid

Category/PL PL 00240/0102
No.
Text revision Rev 01
Page # 2 of 4
no.

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.

Pregnancy or breastfeeding….
Ask your doctor or pharmacist for advice before using this medicine if you are pregnant, might be pregnant
or are breastfeeding.
Cofsed Paediatric Pholcodine 2mg/5ml Oral Liquid should not be used in pregnancy unless the doctor has
told you to do so. If you use it when breastfeeding, pholcodine monohydrate 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.
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.
Children under 6 years
Do not give to children under 6 unless your doctor tell 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.

CF/REG/96
Product
Name

Cofsed Paediatric Pholcodine 2mg/5ml
Oral liquid

Category/PL PL 00240/0102
No.
Text revision Rev 01
Page # 3 of 4
no.

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 Cofsed Paediatric Pholcodine 2mg/5ml Oral Liquid 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, or 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 or search for MHRA Yellow Card in the Google Play or Apple App Store. 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

CF/REG/96
Product
Name

Cofsed Paediatric Pholcodine 2mg/5ml
Oral liquid

Category/PL PL 00240/0102
No.
Text revision Rev 01
Page # 4 of 4
no.

What is in this medicine
The active ingredient per 5ml is: pholcodine monohydrate 2mg.
The other ingredients are: citric acid (E330), sodium methyl parahydroxybenzoate (E219), sodium ethyl
parahydroxybenzoate (E215), sodium propyl pharahydroxybenzoate, glycerol (E422), ethanol, sunset
yellow dye (E110), saccharin sodium, carmellose sodium, menthol, condensed milk flavour and purified
water.
What the medicine looks like
Cofsed Paediatric Pholcodine 2mg/5ml Oral Liquid is a thick orange liquid which smells of menthol and
aniseed. It is supplied in 100ml bottles.
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 mucous 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.
This leaflet was revised in January 2018
Cofsed is a trade mark of Thornton & Ross Ltd.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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