Galenphol Paediatric 2mg/5ml linctus

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Pholcodine

Available from:

Thornton & Ross Ltd

ATC code:

R05DA08

INN (International Name):

Pholcodine

Dosage:

400microgram/1ml

Pharmaceutical form:

Oral solution

Administration route:

Oral

Class:

Schedule 5 (CD Inv)

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 03090100; GTIN: 5011309870817

Patient Information leaflet

23685112
_Data Matrix:_
VERIFIED
PCP HEADER BOX
APPROVED BY DATE
OPERATOR
ARTWORK NO
CRN
FIX
REASON F
SUF
OR
CHANGE
ISSUED BY
DATE
MHRA/IMB
SUBMISSION
REQUIRED
Yes
A
gill.kennedy
546174
11579
Addition of reporting of side effects
statement. MHRA approved.
MHRA HEADER BOX
PRODUCT TITLE
C
FONTS USED
OLOURS USED
COMPONENT
PACK SIZE
IG CODE
DIMENSIONS
PROOF NO.
DATE
Leaflet
2 Litre
23685112
210 x 148mm
2
28.11.2014
Process Black
Keyline (Does not print)
Galenphol Paediatric Linctus
Helvetica
FRONT FACE TOP
REVERSE FACE TOP
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 othe

Summary of Product characteristics

OBJECT 1
GALENPHOL PAEDIATRIC LINCTUS
Summary of Product Characteristics Updated 03-Dec-2014 | Thornton &
Ross Ltd
1. Name of the medicinal product
Galenphol Paediatric Linctus
Cofsed Paediatric Pholcodine 2mg/5ml Oral Liquid
2. Qualitative and quantitative composition
Pholcodine 2.0mg (per 5ml Dose)
For excipients, see 6.1.
3. Pharmaceutical form
Oral liquid
A viscous orange-coloured liquid.
4. Clinical particulars
4.1 Therapeutic indications
Children of 6 – 12 years of age:
Cough suppressant for relief of acute non-productive cough associated
with upper respiratory tract
infection, and when simple measures have failed to provide adequate
relief.
4.2 Posology and method of administration
6 - 12 years - 10ml three times daily
Not more than 3 doses should be given in any 24 hours
Children of 6-12 years of age: not to be used for more than 5 days
without the advice of a doctor. Parents
or carers should seek medical attention if the child's condition
deteriorates during treatment.
Galenphol Paediatric Linctus is contraindicated in children under the
age of 6 years (see section 4.3)
Do not exceed stated dose
Keep out of reach and sight of children.
4.3 Contraindications
Liver failure.
It should not be administered to patients in or at risk of developing
respiratory failure, during an attack of
asthma.
Patients receiving monoamine oxidase inhibitors or within 2 weeks of
cessation of their use.
Known hypersensitivity to any of the ingredients.
Patients with chronic bronchitis, COPD, bronchiolitis or
bronchiectasis due to sputum retention.
Not to be used in children under the age of 6 years.
4.4 Special warnings and precautions for use
Should be used with caution in patients with renal, hepatic and
respiratory disease including a history of
asthma. Galenphol Paediatric and other cough suppressants may cause
sputum retention and this may be
harmful in patients with chronic bronchitis and bronchiectasis.
Use of pholcodine with alcohol or other CNS depressants may increase
the effects on the CNS and cause
toxicity in rela