SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT

Pavacol-D

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

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

Excipients with known effect:

Each 5 ml of the product contains:

44mg of Ethanol 96%,

1.138g of Sorbitol (E420),

2.500mg of Methyl hydroxybenzoate (E218) and 0.500mg of Propyl hydroxybenzoate (E216).

For the full list of excipients, see section 6.1.

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

Pavacol D is not to be used for more than 5 days without the advice of a doctor. The patient should seek medical attention if their condition deteriorates during treatment.

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.

Elderly

No specific information on the use of this product in the elderly is available.

Method of administration:

Oral

Pavacol-D may be diluted with sorbitol solution

4.3    Contraindications

•    Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

•    Patients with liver disease.

•    Patients with ventilatory failure.

•    Patients in or at risk of developing respiratory failure.

•    Not to be used in children under the age of 6 years.

•    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 interactions).

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.

Use with caution in patients suffering from a chronic or persistent cough, asthma, or in patients 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 (See section 4.5, “Interactions with other medicinal products and other forms of interaction”)

Patients with rare hereditary problems of fructose intolerance should not take this medicine. May have a mild laxative effect. Calorific value 2.6 kcal/g sorbitol (E420).

This medicinal product contains small amounts of ethanol (alcohol), less than 100mg per 5ml dose.

Also contains propyl hydroxybenzoate (E216) and methyl hydroxybenzoate (E218); both of which may cause allergic reactions (possibly delayed).

4.5 Interaction with other medicinal products and other forms of interaction

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 (see section 4.3 contraindications).

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); see section 4.4 special warnings and precautions for use.

Pholcodine can interfere with opiate immunoassays giving a positive result for up to 7 weeks.

4.6 Fertility, pregnancy and lactation

Pregnancy

No data is available.

Breast-feeding

It is unknown whether pholcodine is excreted in human milk.

A risk to the newborn/infant cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Pavacol D therapy taking

into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

Fertility

No data is available.

4.7 Effects on ability to drive and use machines

Drowsiness occurs occasionally after taking pholcodine.

This medicine can impair cognitive function and can affect a patient’s ability to drive safely. This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act 1988. When prescribing this medicine, patients should be told:

•    The medicine is likely to affect your ability to drive

•    Do not drive until you know how the medicine affects you

•    It is an offence to drive while under the influence of this medicine

•    However, you would not be committing an offence (called ‘statutory defence’) if:

o The medicine has been prescribed to treat a medical or dental problem and

o You have taken it according to the instructions given by the prescriber and in the information provided with the medicine and o It was not affecting your ability to drive safely

4.8 Undesirable effects

Undesirable effects are listed by MedDRA System Organ Classes.

Assessment of undesirable effects is based on the following frequency groupings:

Very common: >1/10

Common: >1/100 to <1/10

Uncommon: >1/1,000 to <1/100

Rare: >1/10,000 to <1/1,000

Very rare: <1/10,000

Not known: cannot be estimated from the available data

System Organ Class	Undesirable Effect and Frequency
Immune system	Not known:
disorders	Immune system disorders including hypersensitivity reactions and anaphylaxis
Psychiatric disorders	Not known: Excitation Confusion
Nervous system	Not known:
disorders	Drowsiness Dizziness

Respiratory, thoracic and mediastinal disorders	Not known: Sputum retention
Gastrointestinal disorders	Not known: Vomiting Gastrointestinal disturbances (nausea and constipation)
Skin and subcutaneous tissue disorders	Not known: Skin reaction including rash

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.

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, respiratory depression, CNS depression and respiratory failure. Rarely convulsions and hyperpyrexia may occur.

Management: Treatment of overdose should be symptomatic and supportive.. Naloxone has been used successfully to reverse central or peripheral opioid effects in children and adults. Activated charcoal may also be used 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

Pharmacotherapeutic group: Cough and cold preparations, Opium alkaloids and derivatives

ATC code: R05DA 08

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 an 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%

Star Anise Oil Clove Oil Peppermint Oil Capsicum Tincture Strong Ginger tincture Sorbitol solution (E420) Saccharin Sodium Hydroxyethylcellulose Treacle Flavour Caramel Levomenthol

Methyl hydroxybenzoate (E218) Propyl hydroxybenzoate (E216) 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

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

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

22/02/2009

DATE OF REVISION OF THE TEXT

01/05/2015