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CODEINE PHOSPHATE ORAL SOLUTION B.P.

Active substance(s): CODEINE PHOSPHATE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Codeine Phosphate Oral Solution BP

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Codeine Phosphate BP 25 mg/5 ml dose

3.

PHARMACEUTICAL FORM
Oral liquid

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
For the relief of unproductive, dry or painful cough.

4.2

Posology and Method of Administration
Adults and children over 12 years
2.5 to 5 ml to be taken four to six hourly.
The dosage may need to be reduced in the elderly.
Children under 12 years
Not recommended.

4.3

Contra-indications
Hypersensitivity to codeine, respiratory depression, obstructive airways
disease, acute alcoholism, head injuries and conditions in which the
intracranial pressure is raised. It should not be given during an attack of
bronchial asthma.

4.4

Special Warnings and Precautions for Use
Protect from light. Do not exceed the stated dose. Codeine should be
used with caution in patients with hypothyroidism, adrenocortical
insufficiency, severe kidney and liver dysfunction, prostatic
hypertrophy, myasthenia gravis, obstructive bowel disorders and in
patients with a history of drug abuse.

4.5

Interactions with other Medicaments and other forms of Interaction
Codeine may enhance the effects of CNS depressants, such as alcohol,
anaesthetics, hypnotics and sedatives, tricyclic antidepressants and
phenothiazines. Codeine may produce CNS excitation or depression in
patients treated with monoamine oxidase inhibitors or within 2 weeks of
cessation of their use.
Codeine may antagonise the gastrointestinal effects of metoclopramide
and domperidone. Codeine may be adsorbed by kaolin.

4.6

Pregnancy and Lactation
Although there is little evidence of association between malformations
and codeine in general, a possible association between respiratory
malfunctions and congenital heart malformations in the maternal use of
codeine exists. Hence its use during pregnancy should only be
considered when the appropriate practitioner considers that the benefits
outweigh the risks.
Codeine passes into breast milk in very small amounts, which are
probably insignificant and considered to be compatible with breast
feeding.

4.7

Effects on Ability to Drive and Use Machines
Codeine may cause drowsiness. If affected, do not drive or operate
machinery.

4.8

Undesirable Effects

Codeine may cause sedation, dizziness, nausea and constipation.
Repeated use of codeine may lead to tolerance and dependence.

4.9

Overdose
Symptoms
Respiratory depression, hypotension and coma.
Emergency procedures
Gastric lavage and aspiration with general supportive therapy. Naloxone
is used as an antidote.

5.

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic Properties
When administered orally at the recommended dosage level, codeine
phosphate acts as a cough suppressant.

5.2

Pharmacokinetic Properties
Codeine phosphate is absorbed in the gastrointestinal tract giving peak
plasma codeine concentrations in about one hour.
It is metabolised by o- and n-demethylation to morphine and nor-codeine
in the liver and excreted almost entirely by the kidney as conjugates with
glucuronic acid.
The plasma half-life is reported to be between 3 and 4 hours after oral
administration.

5.3

Preclinical Safety Data
No relevant data.

6.

PHARMACEUTICAL PARTICULARS

6.1

List of Excipients
Chloroform Spirit
Nipastat Sodium
Water (potable)
Syrup

6.2

Incompatibilities
No significant incompatibilities have been reported.

6.3

Shelf Life
36 months.

6.4

Special Precautions for Storage
Protect from light.

6.5

Nature and Contents of Container
Dispensing packs
2000 ml white polythene bottle with white plastic screw cap with an
aluminium faced EPE liner.
500 ml white polythene bottle with white plastic wadless screw cap.
Patient packs
100 ml and 300 ml amber glass bottles with plastic Jay cap closures.

6.6

Instruction for Use/Handling
None.

7.

MARKETING AUTHORISATION HOLDER
Wise Pharmaceuticals Ltd
Hani Wells Business Park, Unit 7,
Hardicker Street,
Manchester,
M19 2RB
United Kingdom

8.

MARKETING AUTHORISATION NUMBER
PL 18374/0037

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
12/03/2009

10

DATE OF REVISION OF THE TEXT
12/03/2009

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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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