PRODUCT SUMMARY

1. NAME OF THE MEDICINAL PRODUCT

Galenphol Linctus

Care Pholcodine 5mg/5ml Oral Solution Sugar Free

2. Qualitative and Quantitative Composition

Pholcodine 5.0mg/5ml

For a full list of excipients, see section 6.1.

3    PHARMACEUTICAL FORM

Oral solution

A viscous red coloured liquid.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Cough suppressant for the relief of acute non-productive cough associated with upper respiratory tract infections.

4.2    Posology and method of administration

For oral administration Adult and children over 12 years:

One or two 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.

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 medicinal product contains small amounts of ethanol (alcohol), less than 100mg per 10 ml dose.

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

Keep out of the sight and reach of children.

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 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. 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.

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.

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.    PHARMACUETICAL PARTICULARS

6.1    List of excipients

Citric acid monohydrate (E330)

Sodium methyl parahydroxybenzoate (E219) Sodium ethyl parahydroxybenzoate (E215) Sodium propyl parahydroxybenzoate Glycerol (E422)

Ethanol

Amaranth dye (E123)

Saccharin sodium Carmellose sodium Levomenthol Condensed milk flavour Aniseed flavour Purified water

6.2    Incompatibilities

None stated.

6.3 Shelf life

Two years from the date of manufacture.

6.4    Special precautions for storage Do not store above 25°C

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 tamper evident polyethylene cap.

6.6    Instructions for use/handling

None stated.

ADMINISTRATION DETAILS

7. MARKETING AUTHORISATION HOLDER

Thornton & Ross Ltd Linthwaite Huddersfield HD7 5QH United Kingdom

8. MARKETING AUTHORISATION NUMBER

PL 00240/0101

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

30 August 2002

10 DATE OF REVISION OF THE TEXT

25/08/2015