This information is intended for use by health professionals

1. Name of the medicinal product

Galenphol Strong Linctus

2. Qualitative and quantitative composition

Active Ingredients:

Pholcodine monohydrate 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 monohydrate 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.

Risk from concomitant use of sedative medicines such as benzodiazepines or related drugs:

Concomitant use of pholcodine and sedative medicines such as benzodiazepines or related drugs may result in sedation, respiratory depression, coma and death. Because of these risks, concomitant prescribing with these sedative medicines should be reserved for patients for whom alternative treatment options are not possible. If a decision is made to prescribe this medicine concomitantly with sedative medicines, the lowest effective dose should be used, and the duration of treatment should be as short as possible.

The patients should be followed closely for signs and symptoms of respiratory depression and sedation. In this respect, it is strongly recommended to inform patients and their caregivers to be aware of these symptoms (see section 4.5).

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 monohydrate. Diuretics may have the same effect.

Pholcodine monohydrate may enhance the sedative effect of central nervous system depressants including alcohol, barbiturates, hypnotics, narcotic analgesics, sedatives and tranquillisers (phenothiazines and tricyclic antidepressants).

Sedative medicines such as benzodiazepines or related drugs:

The concomitant use of opioids with sedative medicines such as benzodiazepines or related drugs increases the risk of sedation, respiratory depression, coma and death because of additive CNS depressant effect. The dose and duration of concomitant use should be limited (see section 4.4).

4.6 Fertility, 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 monohydrate 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 monohydrate 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 monohydrate:

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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

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 monohydrate 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

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.

Do not store above 25°C.

6.5 Nature and contents of container

Amber HDPE 2 litre Winchester with a tamper evident polyethylene cap.

6.6 Special precautions for disposal and other handling

None stated.

7. Marketing authorisation holder

Thornton & Ross Ltd

Linthwaite

Huddersfield

HD7 5QH

United Kingdom

8. Marketing authorisation number(s)

PL 00240/0103

9. Date of first authorisation/renewal of the authorisation

14/07/2005

10. Date of revision of the text

19/03/2019