PHOLCODINE 5 MG PER 5ML ORAL SOLUTION, PHOLCODINE LINCTUS 5 MG PER 5ML ORAL SOLUTION, PHOLCODINE LINCTUS BELLS HEALTHCARE 5 MG PER 5ML ORAL SOLUTION - summary of medicine characteristics

Pholcodine Linctus Bell’s Healthcare 5mg per 5ml Oral Solution

Pholcodine Linctus 5mg per 5ml Oral Solution

Pholcodine 5mg per 5ml Oral Solution

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Pholcodine 5 mg per 5ml

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               ^ – 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.

Children under 12 years of age.

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

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 disease

4.4 Special warnings and precautions for use

Should be used with caution in patients with renal, hepatic or respiratory disease including a history of asthma. Pholcodine Linctus 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.

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

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

It also contains sodium hydroxybenzoates and amaranth dye which may cause allergic reactions (possibly delayed).

This medicinal product contains small amounts of ethanol (alcohol), less than 100mg per 10ml dose. This medicine contains 6.6 vol% ethanol (alcohol), i.e. up to 526 mg per 10 ml, equivalent to 13.3 ml of beer or 5.5 ml of wine per 10 ml. Harmful for those suffering from alcoholism.

Keep out of sight and the reach of children.

Do not exceed the stated dose.

If symptoms persist consult your doctor.

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

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

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).

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).

Pholcodine may be antagonistic to cisapride, domperidone and metoclopramide.

Pholcodine may cause delayed absorption of mexiletine.

4.6 Fertility, pregnancy and lactation

No data available on the use of Pholcodine Linctus, Strong Pholcodine Linctus in pregnancy or lactation.

Pholcodine linctus 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 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.

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Cough and cold preparations             AT­C code:

R05DA08 Opium alkaloids and derivatives.

Pholcodine Linctus contains pholcodine monohydrate which is a centrally acting cough suppressant. It has none of the other properties of opiate agents.

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 Shelf life

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.