Pavacol-D

1. Name Of The Medicinal Product

Pavacol-D^®

2. Qualitative And Quantitative Composition

Dark brown liquid containing 5 mg of Pholcodine BP in each 5 ml

3. Pharmaceutical Form

Liquid for oral administration

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

Adults

One or two 5 ml spoonfuls as required. The dose may be increased to three 5 ml spoonfuls if necessary. No more than 60 ml should be taken in 24 hours.

Children

Do not give to children under 6 years of age (See Section 4.3, “Contraindications”).

From 6 to 12 years: one 5 ml spoon four to five times daily. No more than 25ml should be taken in 24 hours. Not to be used for more than 5 days.

Parents or carers should seek medical attention if the child's condition deteriorates during treatment.

Pavacol-D may be diluted with sorbitol solution BPC.

No specific information on the use of this product in the elderly is available. Clinical trials have included patients over 65 years and no adverse reactions specific to this age group have been reported.

4.3 Contraindications

Hypersensitivity to any of the ingredients, liver disease or ventilatory failure.

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.

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 Section 4.5, “Interactions with other medicinal products and other forms of interaction”).

4.4 Special Warnings And Precautions For Use

As pholcodine is a sedative, caution is needed in those patients who have airway disease e.g. asthma, as respiratory depression may occur.

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 the cough is accompanied by excessive secretions.

Caution is also needed in patients with kidney disease or a history of drug abuse.

Pholcodine should not be taken with any other cough or cold medicine (See Section 4.5, “Interactions with other medicinal products and other forms of interaction”).

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

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Alcohol or other CNS depressants may lead to greater drowsiness and sedation.

Pholcodine should not be taken with any other cough or cold medicine.

Not to be used in patients taking MAOIs or within 14 days of stopping treatment.

Interaction with neuromuscular blocking agents (anaphylaxis) has been reported.

Pholcodine may accentuate the hypotensive effects of antihypertensives. The same effect may be seen when administered with diuretics.

Pholcodine may enhance the sedative effects of central nervous system depressants including alcohol, barbiturates, hypnotics, narcotic analgesics, sedatives and tranquillisers (phenothiazines and tricyclic antidepressants).

4.6 Pregnancy And Lactation

Although Pavacol-D has been in general use for many years, there is no evidence of ill consequences during human pregnancy.

Medicines should not be used in pregnancy, especially the first trimester, unless the expected benefit is thought to outweigh any possible risk to the foetus.

4.7 Effects On Ability To Drive And Use Machines

Drowsiness occurs occasionally after taking pholcodine.

4.8 Undesirable Effects

The following side effects may be associated with the use of pholcodine:

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

Immune system disorders have been noted including hypersensitivity reactions and anaphylaxis.

4.9 Overdose

Pholcodine 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. Gastric lavage may be of use. Naloxone has been used successfully to reverse central or peripheral opioid effects in children (0.01 mg/kg body weight). Activated charcoal may also be used (1 g/kg body weight) if more than 4 mg/kg has been ingested within 1 hour, provided the airway can be protected.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pholcodine is a specific anti-tussive lacking the unwanted side-effects of opium and its derivatives. The specificity of action suggests that pholcodine acts via a distinct subset of opioid receptors.

5.2 Pharmacokinetic Properties

In a study in male volunteers receiving 15, 30, and 60 mg doses of pholcodine at 7 day intervals, pharmacokinetics were found to be independent of dose. The elimination of pholcodine is described by a two-compartment model with elimination half-life of 37± 4.2 hours. Pholcodine undergoes little conjugation and is not transformed to morphine.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Tolu balsam

Ethanol 96%

Anise Oil

Clove Oil

Peppermint Oil

Capsicum Tincture

Strong Ginger tincture

Sorbitol solution

Saccharin Sodium

Hydroxyethylcellulose

Treacle Flavour

Caramel

L-menthol

Methyl Paraben

Propyl Paraben

Purified Water

6.2 Incompatibilities

None.

6.3 Shelf Life

The shelf life expiry date for Pavacol-D is 3 years from the date of its manufacture.

When Pavacol-D is diluted an in-use shelf life of 14 days is recommended.

6.4 Special Precautions For Storage

Store below 25°C. Protect from light.

6.5 Nature And Contents Of Container

50 ml, 100 ml, 150 ml, 250 ml, 300 ml, and 1000 ml round amber glass bottle (type III glass) with a polyethylene child resistant cap.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

None stated.

7. Marketing Authorisation Holder

Alliance Pharmaceuticals Limited

Avonbridge House

Chippenham

Wiltshire

SN15 2BB

United Kingdom

8. Marketing Authorisation Number(S)

PL 16853/0100

9. Date Of First Authorisation/Renewal Of The Authorisation

14th November 2003

10. Date Of Revision Of The Text

11^th October 2010