Galenphol Strong Linctus
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Galenphol Strong Linctus
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredients:
Pholcodine BP 10.0mg (Per 5ml Dose)
For excipients, see 6.1.
3. PHARMACEUTICAL FORM
Oral liquid
A viscous deep orange-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.
Adults and Children over 12 years:
One 5ml spoonful every four to six hours.
Children under 12:
Not recommended.
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.
It 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.
Not for use in children under 12 years of age.
4.4 Special warnings and precautions for use
Use with caution in patients with renal, hepatic or respiratory disease, including a history of asthma. Galenphol Strong 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 sodium hydroxybenzoates, amaranth and sunset yellow dyes 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 Strong 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 Strong in pregnancy or lactation. It 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, restlessness, excitement, ataxia, 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. 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 Strong 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.
6.1 List of excipients
Citric acid monohydrate Sodium Methyl Parahydroxybenzoate (E219) Sodium Ethyl Parahydroxybenzoate (E215) Sodium Propyl Parahydroxybenzoate (E217) Alcohol 96%
Sunset yellow FCF (E110)
Amaranth (E123)
Carmellose sodium Soluble saccharin Levomenthol
Condensed milk flavour (F12516)
Aniseed flavour (545008E)
Glycerin Purified water
6.2 Incompatibilities
None stated.
6.3 Shelf life
Two years 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 tamper evident polyethylene cap.
6.6 Special precautions for disposal
None stated.
7 MARKETING AUTHORISATION HOLDER
Thornton & Ross Ltd Linthwaite Huddersfield HD75QH United Kingdom
8. MARKETING AUTHORISATION NUMBER(S)
PL 00240/0103
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
14/07/2005
10
DATE OF REVISION OF THE TEXT
25/08/2015