Document: spc-doc_PL 03105-0059 change

• spc-doc_PL 00014-5718R
• spc-doc_PL 03105-0059
• spc-doc_PL 03105-0060
• spc-doc_PL 04917-0002
• spc-doc_PL 04917-0005

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SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Pholcodine Linctus Bell’s Healthcare 5mg per 5ml Oral Solution Manordine Cough Linctus Superdrug Pholcodine Linctus BP Morrisons Pholcodine Linctus Oral Solution

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Pholcodine 5 mg per 5 ml

Excipient(s) of known effect:

Each 10ml of solution contains Sucrose 8g

Each 10ml of solution contains 6.6% vol% Ethanol (alcohol)

Amaranth E123, Sodium methylhydroxybenzoate E219, Sunset yellow E110

For a full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM

Oral Solution

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

Oral

Adults and Elderly:    1 - 2 teaspoonful (5-10 ml)

Children: 6 - 12 years    C2 - 1 teaspoonful (2.5-5 ml)

These doses may be repeated 3 - 4 times a day

This medicinal product is contraindicated in children under the age of 6 years (see section 4.3).

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.

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 6 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).

•    Pholcodine should not be given to subjects with 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.

•    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.

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, barbiturates, hypnotics, narcotic analgesics, sedatives and tranquillisers (phenothiazines and tricyclic antidepressants).

Pholcodine may be antagonistic to cisapride, domperidone and metoclopramide.

Pholcodine may cause delayed absorption of mexiletine.

4.6 Fertility, pregnancy and lactation

Use with caution only where benefit exceeds risk. Opioids may depress neonatal respiration, cause withdrawal effects in neonates of depended mothers, and be associated with gastric stasis and risk of inhalation pneumonia in mother during labour.

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)

Immune system disorders:

Hypersensitivity reactions and anaphylaxis, skin reactions including rash.

Psychiatric disorders:

Excitation, confusion.

Nervous system disorders:

Occasional drowsiness, dizziness.

Respiratory, thoracic and mediastinal disorders:

Sputum retention, respiratory depression (in overdose).

Gastrointestinal disorders:

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 that already included in other sections.

6.1 List of excipients

Sucrose

Ethanol 96% w/v Glycerol Citric acid

Amaranth solution

Sodium methyl hydroxybenzoate Quinoline Yellow (E104)

Sunset Yellow (E110)

Purified Water

6.2    Incompatibilities

Not known

6.3    Shelflife

Three years.

6.4 Special precautions for storage

Do not store above 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.

30 ml CE marked polypropylene measuring cup with 2.5 ml, 3.3 ml, 4 ml, 5 ml,

7.5 ml, 10 ml, 15 ml, 20 ml and 25 ml graduations.

(May not be included in all marketed products)

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

None.

7    MARKETING AUTHORISATION HOLDER

Bell, Sons and Co (Druggists) Ltd [Trading Style - Bell’s Healthcare] Gifford House,

Slaidburn Crescent