Galenphol Paediatric Linctus

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 in pregnancy or lactation.

Galenphol should be avoided during pregnancy unless considered necessary by the physician and should be avoided during the first trimester. Opioid administration near term in the third trimester may cause respiratory depression in the newborn, withdrawal effects in neonates of dependent mothers, gastric stasis and risk of inhalation pneumonia in the mother during labour.

Pholcodine has been detected in human milk but in amounts usually too small to be harmful; however mothers may vary considerably in their capacity to metabolise pholcodine with a risk of morphine overdose in the 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.

4.9 Overdose

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. Pharmaceutical Particulars

6.1 List Of Excipients

Citric acid monohydrate

Nipasept sodium [containing: Sodium Methyl Parahydroxybenzoate (E219), Sodium Ethyl Parahydroxybenzoate (E215) & Sodium Propyl Parahydroxybenzoate (E217)]

Alcohol 96%

Sunset yellow FCF (E110)

Blanose cellulose gum 71HOF

Saccharin sodium

Menthol

Condensed milk flavour F12516

Aniseed flavour 545008E

Glycerol

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 And Other Handling

Not applicable.

ADMINISTRATION DETAILS

7. Marketing Authorisation Holder

Thornton & Ross limited

Linthwaite

Huddersifeld

West Yorkshire

HD7 5QH, United Kingdom

8. Marketing Authorisation Number(S)

PL 00240/0102

9. Date Of First Authorisation/Renewal Of The Authorisation

22 Ju1y 2002

10. Date Of Revision Of The Text

08/08/2011