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GALENPHOL PAEDIATRIC LINCTUS

Active substance: PHOLCODINE

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Cofsed Paediatric

2. Before you use this medicine

Pholcodine 2mg/5ml Oral Liquid

Do not use the medicine if your
child has….

FRONT FACE TOP

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

• 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.

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.

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

• Give two 5ml spoonfuls (10ml) three times a day.
No more than 3 doses should be given in any
24 hours.

Turn over
M744

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.







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.

5. Storing this medicine
REVERSE FACE TOP

If you give too much

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.

• Keep it out of the reach and sight 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.

4. Possible side effects

6. Further information

Like all medicines Cofsed Paediatric Pholcodine
2mg/5ml Oral Liquid can have side effects,
although these don’t affect everyone.

What is in this medicine

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

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.

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.

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,

What the medicine looks like

This leaflet was revised in February 2011

Cofsed Paediatric Pholcodine 2mg/5ml Oral
Liquid is a thick orange liquid which smells of
menthol and aniseed. It is supplied in 100ml
bottles.

Cofsed is a trade mark of
Thornton & Ross Ltd.
M744

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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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