Galenphol Linctus

1. Name Of The Medicinal Product

Galenphol Linctus

Care Pholcodine 5mg/5ml Oral Solution Sugar Free

2. Qualitative And Quantitative Composition

Pholcodine 5.0mg (Per 5ml Dose)

For excipients, see 6.1.

3. Pharmaceutical Form

Oral liquid

A viscous red coloured liquid.

4. Clinical Particulars

4.1 Therapeutic Indications

Used for the relief of an unproductive dry cough.

4.2 Posology And Method Of Administration

For oral administration

Adult and children over 12 years:

Two or three 5ml spoonfuls three or four times daily.

Not more than 4 doses should be given in any 24 hours

Elderly:

Adult dose is appropriate.

Do not exceed the stated dose.

Keep out of the sight and reach of children.

4.3 Contraindications

Liver failure.

Should not be administered to patients in or at risk of developing respiratory failure or during an attack of asthma.

Patients receiving monoamine oxidase inhibitors or within 2 weeks of cessation of their use.

Patients with chronic bronchitis, COPD, bronchiolitis or bronchiectasis due to sputum retention.

Known hypersensitivity to any of the ingredients.

Children under 12 years of age.

4.4 Special Warnings And Precautions For Use

Should be used with caution in patients with renal, hepatic or respiratory disease, including a history of asthma. Galenphol and other cough suppressants may cause sputum retention and this may be harmful in patients with chronic bronchitis and bronchiectasis.

Ask a doctor before use if you suffer from a chronic or persistent cough, if you have asthma, are suffering from an acute asthma attack or where cough is accompanied by excessive secretions.

Use of pholcodine with alcohol or other CNS depressants may increase the effects on the CNS and cause toxicity in relatively smaller doses.

This medicine contains 1.2 vol% ethanol, i.e. up to 144 mg per 15 ml dose, equivalent to 4 ml beer or 2 ml wine. Harmful for those suffering from alcoholism. To be taken into account in pregnant or breastfeeding women, children and high risk groups such as patients with liver disease or epilepsy.

It also contains sodium hydroxybenzoates and amaranth dye which may cause allergic reactions (possibly delayed).

Do not exceed the stated dose.

Do not take with other cough and cold medicines.

If symptoms persist consult your doctor.

Do not give to children under 12 years.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Monoamine oxidase inhibitors: Galenphol 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 hypotensive effects 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 tranquillisers (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. If 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 respiratory depression, nausea, drowsiness, restlessness, excitement and ataxia. 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. Naloxone has been used successfully to reverse central or peripheral opioid effects in children (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

R05D A08 - Opium alkaloids and derivatives.

Galenphol 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%

Amaranth (E123)

Blanose cellulose gum (7HOF)

Saccharin sodium

Menthol

Condensed milk flavour (F12516)

Aniseed flavour (545008E)

Glycerol

Purified water

6.2 Incompatibilities

None stated.

6.3 Shelf Life

Two years from the date of manufacture.

6.4 Special Precautions For Storage

Store in a cool place.

6.5 Nature And Contents Of Container

200ml amber glass bottles with 28mm tamper evident child resistant closure with EPE/Saranex liner.

Amber HDPE 2 litre Winchester with a polypropylene cap.

6.6 Special Precautions For Disposal And Other Handling

None stated.

ADMINISTRATION DETAILS

7. Marketing Authorisation Holder

Thornton & Ross Ltd

Linthwaite

Huddersfield

HD7 5QH

United Kingdom

8. Marketing Authorisation Number(S)

PL 00240/0101

9. Date Of First Authorisation/Renewal Of The Authorisation

30 August 2002

10. Date Of Revision Of The Text

08/08/2011