STRONG PHOLCODINE LINCTUS BP - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Strong Pholcodine Linctus BP

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Name of the active substance: Pholcodine Ph Eur 0.2% w/v Excipient(s) of known effect:

Each 5ml of solution contains Sucrose 3.2g

Each 5ml of solution contains 13.6% vol% Ethanol (alcohol)

Amaranth E123, Methylhydroxy­benzoate E218, Sunset yellow E110

For a full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM

Linctus – Oral use

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

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

4.2 Posology and method of administration

Route of administration – Oral

Adults: 1 × 5 ml spoonful

The dose may be repeated 3 to 4 times daily

This medicinal product is contraindicated in children under the age of 12 years (see section 4.3).

Do not exceed the stated dose.

Keep out of sight and the reach of children.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients.

Not to be used in children under the age of 12 years.

Pholcodine should not be given to subjects in, or at risk of developing respiratory failure or during an attack of asthma.

Patients with chronic bronchitis, COPD, bronchiolitis or bronchiectasis due to sputum retention.

Patients taking monoamine oxidase inhibitors (MAOIs) or within 14 days of stopping such treatment (see also section 4.5).

Liver failure.

4.4 Special warnings and precautions for use

Should be used with caution by patients with renal, hepatic or respiratory disease, including history of asthma.

Strong Pholcodine Linctus BP 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, suffering from an acute asthma attack or where cough is accompanied by excessive secretions.

Do not take with any other cough and cold medicine.

Use of pholcodine with alcohol or other CNS depressants may increase the effects on the CNS and cause toxicity in relatively smaller doses.

Consult a doctor before use if you have a history of drug abuse.

This medicinal product contains small amounts of ethanol (alcohol)

Keep out of the sight and reach of children

Do not exceed the stated dose

Do not take with other cough medicines

If symptoms persist consult your doctor

Patients with rare hereditary problems of fructose intolerance, glucosegalactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

This medicine contains sodium hydroxybenzoates; amaranth and sunset yellow dyes which may cause allergic reactions (possibly delayed).

Do not exceed the stated dose.

Keep out of sight and the reach of children.

If symptoms persist consult your doctor.

4.5 Interaction with other medicinal products and other forms of interaction

Not to be used in patients taking MAOIs or within 14 days of stopping 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 effects of central nervous system depressants including alcohol, anxiolytics, barbiturates, hypnotics, narcotic analgesics, sedatives and tranquillisers (phenothiazines and tricyclic antidepressants).

Pholcodine is antagonistic to metoclopramide and may cause delayed absorption of antiarrhythmic drug­s.

4.6 Fertility, pregnancy and lactation

Pholcodine 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 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: (Frequencies not known: cannot be estimated from the available data)

Hypersensitivity reactions and anaphylaxis, skin reactions including rash.

Excitation, confusion.

Occasional drowsiness, dizziness.

Sputum retention, respiratory depression (in overdose).

Vomiting, gastrointestinal disturbances (nausea and constipation).

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.yellowcard.mhra.gov.uk.

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: These include nausea, drowsiness, restlessness, excitement, ataxia and respiratory depression.

Management: Treatment of overdose should be symptomatic and supportive. Respiratory distress should be treated by supportive means. Airways protected gastric lavage may be of use. 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

Pharmacotherapeutic group: Cough and cold preparations

ATC code: R05DA08

Pholcodine relieves local irritation of the respiratory tract. Its depressant effects on respiration are less than those of morphine.

5.2 Pharmacokinetic properties

Pholcodine is rapidly absorbed following oral dosage and is effective for up to 4–5 hours.

5.3 Preclinical safety data

There are no pre-clinical data of relevance to the prescriber which are additional to those already included in other sections.

6.1 List of excipients

Sucrose

Glycerol

Citric acid

Ethanol 96% w/v

Methyl hydroxybenzoate

Amaranth Solution

Quinoline Yellow (E104)

Sunset Yellow (E110)

Purified Water

6.2 Incompatibilities

None

6.3 Shelf life

Two years.

6.4 Special precautions for storage

Store below 25°C.

Protect from light.

6.5 Nature and contents of container

Bottle: Amber (Type III) glass

Closures: Child resistant closure (CRC) fitted with low density polyethylene EPE/AL/PET liner

OR

Roll on pilfer proof (ROPP) screw cap fitted with low density polyethylene EPE/AL/PET liner

Sizes: 100ml, 200 ml, 500ml, 2000ml.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

Not applicable.