Codeine 60mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Codeine phosphate

Available from:

Teva UK Ltd

ATC code:

R05DA04

INN (International Name):

Codeine phosphate

Dosage:

60mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

Schedule 5 (CD Inv)

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04070200; GTIN: 5017007050933

Patient Information leaflet

CODEINE PHOSPHATE CONTAINS LACTOSE
•
Patients who are intolerant to lactose should note that
Codeine Phosphate tablets contain a small amount of
lactose. If your doctor has told you that you have
intolerance to some sugars, contact your doctor before
taking this medicine.
HOW TO TAKE CODEINE PHOSPHATE
Always take this medicine exactly as your doctor or pharmacist
has told you. Check with your doctor if you are not sure.
Your prescriber should have discussed with you, how long the
course of tablets will last. They will arrange a plan for stopping
treatment. This will outline how to gradually reduce the dose
and stop taking the medicine.
DO NOT TAKE A HIGHER DOSE OR MORE OFTEN THAN THE DOCTOR HAS
TOLD YOU.
The recommended dose is:
ADULTS
PAIN RELIEF
30 – 60 mg every four hours when necessary, up to a
maximum of 240 mg in 24 hours.
TREATMENT OF DIARRHOEA
30 mg three to four times daily.
TREATMENT OF COUGH
15 - 30 mg three to four times daily.
USE IN CHILDREN AND ADOLESCENTS
CHILDREN AGED 12 YEARS TO 18 YEARS
The recommended codeine dose for children 12 years and
older should be up to a maximum dose of codeine of 240 mg
daily.
ANALGESIC USE
30 - 60 mg every 6 hours as needed. The dose is based on the
body weight (0.5 - 1 mg/kg)
FOR COUGH
The dose is based on bodyweight 1 - 2 mg/kg daily in 4 to 6
divided doses.
The use of cough suppressants containing codeine is not
generally recommended in children.
ANTI-DIARRHOEAL USE
Not recommended.
CHILDREN AGED UNDER 12 YEARS:
Codeine Phosphate is not suitable for use in children under
12 years of age, due to the risk of severe breathing problems.
THE ELDERLY, OR PATIENTS WITH LIVER OR KIDNEY PROBLEMS:
•
A reduced adult dosage, as prescribed by your doctor.
The tablets should be swallowed preferably with a drink of
water.
The medicine should not be taken for more than 3 days and if
no effective pain relief is achieved the patients/carers should
be advised to seek the views of a physician.
IF YOU TAKE MORE CODEINE PHOSPHATE THAN YOU SHOULD
If you (or someone else) swallow

Summary of Product characteristics

PRODUCT SUMMARY
1.
NAME OF THE MEDICINAL PRODUCT
Codeine Phosphate 60 mg Tablets BP
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 60mg Codeine Phosphate.
For the full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White to off-white, biconvex tablets, marked ‘APS’ on one side and
‘60/0509’ on the
reverse; or marked ‘APS’ over ‘0509’ on one side and plain on
the reverse.
4
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Codeine Phosphate Tablets are indicated in patients older than 12
years of age for the
treatment of mild to moderate acute pain which is not relieved by
other analgesics
such as paracetamol or ibuprofen (alone), diarrhoea and troublesome
cough.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Prior to starting treatment with opioids, a discussion should be held
with patients to
put in place a strategy for ending treatment with codeine in order to
minimise the risk
of addiction and drug withdrawal syndrome (see section 4.4).
Posology
Codeine should be used at the lowest effective dose for the shortest
period of time.
The duration of treatment should be limited to 3 days and if no
effective pain relief is
achieved the patients/carers should be advised to seek the views of a
physician.
_Adults_
Analgesic use
30-60 mg every four hours when necessary, up to a maximum of 240 mg
daily.
Anti-diarrhoeal use
30 mg three to four times daily.
Antitussive use
15-30 mg three to four times daily._ _
_ _
_Paediatric population_
Children under 12 years
Not suitable.
Codeine Phosphate is contraindicated in children below the age of 12
years for
symptomatic treatment of cough (see sections 4.3). Codeine should not
be used in
children below the age of 12 years because of the risk of opioid
toxicity due to the
variable and unpredictable metabolism of codeine to morphine (see
sections 4.3 and
4.4).
Children aged 12 years to 18 years:
Analgesic use
The recommended dose for children 12 years or older should be 30-60 mg
every 6
hours when necessary up to a maximum dose of co