Galenphol Paediatric Linctus
SUMMARY OF PRODUCT CHARACTERISTICS
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 relatively small doses.
Ask a doctor before use if you suffer from a chronic or persistent cough, or where cough is accompanied by excessive secretions.
If symptoms persist consult your doctor.
Do not exceed the stated dose
Do not take with other cough and cold medicines
Do not give to children under 6 years
4.5 Interaction with other medicinal products and other forms of interaction
Monoamine oxidase inhibitors: This product should not be used within 14 days of treatment.
Interaction with neuromuscular blocking agents (anaphylaxis) has been reported.
The reduction of blood pressure caused by antihypertensives may accentuate the hypotensiveeffects of pholcodine. Diuretics may have the same effect.
Pholcodine may enhance the sedative effect of central nervous system depressants including alcohol, barbiturates, hypnotics, narcotic analgesics, sedatives and tranquilisers (phenothiazines and tricyclic antidepressants).
4.6 Pregnancy and lactation
No data available on the use of Galenphol Paediatric in pregnancy or lactation. Galenphol Paediatric should only be used in pregnancy if considered necessary by the physician and should be avoided during the first trimester.
Pholcodine has been detected in human milk but in amounts unlikely to affect the suckling infant.
4.7 Effects on ability to drive and use machines
Using the dose recommended, it is not considered to be a hazard, however, the use of pholcodine may cause sedation, dizziness and nausea. lf affected, driving or operation of machinery would not be advised.
4.8 Undesirable effects
The following side effects may be associated with the use of Pholcodine: Occasional drowsiness, dizziness, excitation, confusion, sputum retention, vomiting, gastrointestinal disturbances (nausea and constipation) and skin reactions including rash.
Immune system disorders have been noted including hypersensitivity reactions and anaphylaxis.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
Overdose
4.9
It is thought to be of low toxicity, but the effects in overdosage will be potentiated by simultaneous ingestion of alcohol and psychotropic drugs.
Symptoms of overdose include restlessness, excitement, ataxia, respiratory depression, nausea and drowsiness. Treatment should be symptomatic to maintain vital functions. Respiratory distress should be treated by supportive means. Airways protective gastric lavage may be used. In severe cases a narcotic antagonist such as naloxone may be considered (0.01mg/kg body weight). Other treatment option is activated charcoal (1g/kg body weight) if more than 4mg/kg has been ingested within 1 hour, provided the airway can be protected.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
RO5D A08 - Opium alkaloids and derivatives
This medicinal product contains Pholcodine which is a centrally acting cough suppressant. It has none of the other properties of opiate agents.
5.2 Pharmacokinetic properties
None stated.
5.3 Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
6. PHARMACUETICAL PARTICULARS
6.1 List of excipients
Citric acid (E330)
Sodium methyl parahydroxybenzoate (E219) Sodium ethyl parahydroxybenzoate (E215) Sodium propyl parahydroxybenzoate Ethanol
Sunset yellow dye (E110)
Saccharin sodium Carmellose sodium Menthol
Condensed milk flavour Orange flavour Glycerol (E422)
Purified water 6.2 Incompatibilities
None stated.
6.3 Shelf life
24 months from the date of manufacture.
6.4 Special precautions for storage
Protect from light.
6.5 Nature and contents of container
Amber HDPE 2 litre Winchester with a polypropylene cap.
100ml (fill volume 90ml or 100ml) amber glass bottle with a 28mm tamper evident child resistant closure with a low density polyethylene plug; cartonned and a 2.5ml/5ml double ended spoon included.
Not all packs sizes may be marketed
6.6 Special precautions for disposal
Not applicable.
MARKETING AUTHORISATION HOLDER
7
Thornton & Ross limited
Linthwaite
Huddersifeld
West Yorkshire
HD75QH
United Kingdom
8. MARKETING AUTHORISATION NUMBER
PL 00240/0102
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
14/07/2005