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POTTERS DRY COUGH PASTILLES

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Potter's Pholcodine Cough Pastilles
Potter s Dry Cough Pastilles

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Pholcodine BP

3.

0.12 % w/w (2.2 mg per pastille)

PHARMACEUTICAL FORM
Lozenge (Pastille)

4.

CLINICAL PARTICULARS

4.1

Therapeutic indications
For the relief of stubborn coughs.

4.2

Posology and method of administration
Oral
Adults, the elderly and children of 12 years and above: Up to 2 pastilles every 4
hours. Not suitable for children under 12 years.

4.3 Contraindications
Hypersensitivity to any of the ingredients
Hepatic or renal failure
4.4 Special warnings and precautions for use
Cough suppressants may depress respiration and cause retention of sputum. They should
therefore be used with caution in patients with chronic obstructive airways disease, chronic
bronchitis and bronchiectasis.

Keep out of reach and sight of children.
If symptoms persist consult your doctor.
Do not exceed the stated dose.
Do not take with any other cough and cold medicines.
Contains a total of 1g of sucrose and liquid glucose. Patients with rare hereditary problems
of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency
should not take this medicine.
4.5. Interactions with other Medicaments and other forms of Interaction
Pholcodine should not be taken with any other cough or cold medicine.
Monoamine oxidase inhibitors
Pholcodine should not be used in patients taking MAOIs or within 14 days of
stopping treatment.
Neuromuscular blocking agents
Previous use of pholcodine may increase the risk of hypersensitivity reactions and
anaphylaxis with use of neuromuscular blocking agents.
Antihypertensive agents
The reduction of blood pressure caused by antihypertensive agents including diuretics
may accentuate the hypotensive effects of pholcodine.
CNS depressants
Pholcodine may enhance the sedative effect of central nervous system depressants
including alcohol, barbiturates, hypnotics, narcotic analgesics, sedatives and
tranquillisers (phenothiazines, tricyclic antidepressants).

4.6.

Fertility, Pregnancy and Lactation
Pregnancy
There is no or inadequate evidence of the safety of the active ingredients in this medicine in
human pregnancy. The potential risk for humans is unknown.
In the absence of sufficient data, the use during pregnancy is not recommended.
Lactation
It is not known whether the active ingredients of this product are excreted in human breast
milk.
In the absence of sufficient data, the use during lactation is not recommended.
Fertility
Studies on the effects on fertility have not been investigated.

4.7 Effects on ability to drive and use machines
Patients who experience drowsiness should not drive or operate machinery.
4.8 Undesirable effects
Immune system disorders: hypersensitivity reactions, anaphylaxis
Nervous system disorders: Drowsiness
Gastrointestinal disorders: Constipation
Skin & subcutaneous tissue disorders: Rash, urticaria, angioedema
4.9 Overdose
Symptoms
Symptoms of overdose may include nausea, drowsiness, restlessness, excitement, ataxia and
respiratory depression.
Management
Management should include general symptomatic and supportive measures including a clear
airway and monitoring of vital signs until stable. Consider use of activated charcoal if the
overdose has been taken in the previous hour. In cases of severe poisoning, the specific
narcotic antagonist naloxone may be used. Due to the long elimination half-life of
pholcodine (see section 5.2) repeated doses may be required.
5.
PHARMACOLOGICAL PROPERTIES
5.1

Pharmacodynamic properties
Pholcodine is a cough suppresant with a mild sedative action.

5.2 Pharmacokinetic Properties
Pholcodine acts both systemically after buccal absorption and locally in the oropharnx.
Maximum plasma concentrations are attained 4 to 8 hours after an oral dose. A study in six
healthy volunteers following a single oral dose of 60 mg pholcodine indicated an elimination
half-life of 37 4.2 hours and volume of distribution of 43.3 4.6 L/kg.
Pholcodine is protein bound to the extent of 23.5%.
Pholcodine is metabolised in the liver but undergoes little conjugation.
There is little or no metabolism of pholcodine to morphine and this may account for the lack
of analgesic activity, morphine-like side effects and addictive potential.
5.3
Preclinical safety data
None available specific to the product.

6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Granulated sugar
Modified starch
Liquid glucose BPC 1963
Vegetable fat
Quinoline yellow E104
Green S E142
Menthol BP
Aniseed oil BP
Peppermint oil BP
Eucalyptus oil BP
Water

6.2

Incompatibilities
None known.

6.3

Shelf life
36 months

6.4

Special precautions for storage
None.

6.5

Nature and contents of container
Heat sealed polythene/aluminium foil/paper sachet or metallised
polypropylene/polyethylene foil sachet integral with a carton. Contents 45g.

6.6

Special precautions for disposal

None.
7.

MARKETING AUTHORISATION HOLDER
Ernest Jackson & Co Ltd
High Street
Crediton
Devon
EX17 3AP
UK.

8.

MARKETING AUTHORISATION NUMBER
PL 00094/5020R

9.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
18th January 1973 / Last renewal 4th June 1994

10

DATE OF REVISION OF THE TEXT
11/07/2013

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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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