GALENPHOL STRONG LINCTUS - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Galenphol Strong Linctus

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Active Ingredients:

Pholcodine monohydrate BP 10.0mg (Per 5ml Dose)

Excipients of known effect

This medicine contains, per 5ml dose:

77mg Ethanol

5.625 mg Sodium Methyl Parahydroxybenzoate

1.125 mg Sodium Ethyl Parahydroxybenzoate

0.75mg Sodium Propyl Parahydroxybenzoate

0.1mg Amaranth Dye

0.5mg Sunset Yellow Dye

For the full list of excipients, see section 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.

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

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.

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 sodium parahydroxyben­zoates, amaranth and sunset yellow dyes which may cause allergic reactions (possibly delayed).

It also contains 77mg of alcohol (ethanol) in each 5ml dose. The amount in 5ml of this medicine is equivalent to less than 2ml of beer or 1ml of wine. The small amount of alcohol in this medicine will not have any noticeable effects.

It also contains less than 1mmol sodium (23mg) per 5ml dose, that is to say essentially ‘sodium-free’.

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

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).

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 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.

5.1 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.

6.1

Citric acid monohydrate (E330)

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

Aniseed flavour (545008E)

Glycerin (E422)

Purified water

6.2 Incompatibilities

None stated.

6.3

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

None stated.