PAVACOL-D

Active substance: PHOLCODINE

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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 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.
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”).
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.
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
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

Saccharin Sodium
Hydroxyethylcellulose
Treacle Flavour
Caramel
Levomenthol
Methyl hydroxybenzoate
Propyl hydroxybenzoate
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

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
22/02/2009

10

DATE OF REVISION OF THE TEXT
23/11/2012

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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