This information is intended for use by health professionals

1. Name of the medicinal product

Galenphol Paediatric Linctus

Cofsed Paediatric Pholcodine 2mg/5ml Oral Liquid

2. Qualitative and quantitative composition

Pholcodine monohydrate 2.0mg per 5ml (Recommended dose is 10ml)

Excipients with known effect

This medicine contains, per 10ml dose:

96mg Ethanol

11.25mg Sodium Methyl Parahydroxybenzoate

1.5mg Sodium Propyl Parahydroxybenzoate

2.25mg Sodium Ethyl Parahydroxybenzoate

0.25mg Sunset Yellow Dye

For the full list of excipients, see section 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 the 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.

Caution is needed in patients with a history of drug abuse. Pholcodine is an opioid and addiction is observed with opioids as a class.

Use of pholcodine monohydrate 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 your child suffers from a chronic or persistent cough, or where cough is accompanied by excessive secretions.

If symptoms persist consult your doctor.

Warning: Do not take more medicine than the label tells you to.

Do not take with other cough and cold medicines.

Do not give to children under 6 years

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

Concomitant use of this medicine 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).

Severe cutaneous adverse reactions (SCARs) including acute generalized exanthematous pustulosis (AGEP), which can be life-threatening or fatal, have been reported in patients treated with this medicine, most likely in the first week. Patients should be advised of the signs and symptoms and monitored closely for skin reactions. If signs and symptoms suggestive of these reactions appear, this medicine should be withdrawn immediately.

Ingredients with specified warnings

This medicine contains less than 1mmol sodium (23mg) per 10ml dose, that is to say essentially 'sodium-free'.

This medicine contains 96mg of alcohol (ethanol) in each 10ml dose. The amount in 10ml of this medicine is equivalent to less than 3ml of beer or 1ml of wine. The small amount of alcohol in this medicine will not have any noticeable effects,

This medicine contains sodium parahydroxybenzoates and Sunset Yellow Dye which may cause allergic reactions (possibly delayed).

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 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 tranquilisers (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 Paediatric in pregnancy or lactation. Galenphol Paediatric 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. 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 monohydrate:

Occasional drowsiness, dizziness, excitation, confusion, sputum retention, vomiting, gastrointestinal disturbances (nausea and constipation) and skin reactions including rash.

Skin and subcutaneous tissue Disorders: Frequency unknown: Acute generalised exanthematous pustulosis (see section 4.4).

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 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 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 (E330)

Sodium methyl parahydroxybenzoate (E219)

Sodium ethyl parahydroxybenzoate (E215)

Sodium propyl parahydroxybenzoate

Ethanol

Sunset yellow dye (E110)

Saccharin sodium

Carmellose sodium

Menthol

Condensed milk flavour

Orange flavour

Glycerol (E422)

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.

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

14/07/2005

10. Date of revision of the text

30/11/2021