Codeine 30mg 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:

30mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

Schedule 5 (CD Inv)

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04070200; GTIN: 5017007050841 5017007050902

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

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Codeine Phosphate 30mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Codeine phosphate 30mg
For excipients see 6.1
3
PHARMACEUTICAL FORM
Oral - tablet
4.1
THERAPEUTIC INDICATIONS
Codeine is indicated in patients older than 12 years of age for the
treatment of
acute moderate pain which is not considered to be relieved by other
analgesics
such as paracetamol or ibuprofen (alone).
Dry or painful cough
Diarrhoea
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Oral route
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).
FOR MILD TO MODERATE PAIN
ADULTS:
Codeine should be used at the lowest effective dose for the shortest
period of
time. This dose may be taken, up to 4 times a day at intervals of not
less than 6
hours. Maximum daily dose of codeine should not exceed 240 mg.
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.
PAEDIATRIC POPULATION:
CHILDREN_ _AGED 12 YEARS TO 18 YEARS:_ _
The recommended codeine dose for children 12 years and older should be
30-
60mg every 6 hours when necessary up to a maximum dose of codeine of
240
mg daily. The dose is based on the body weight (0.5-1mg/kg).
CHILDREN AGED LESS THAN 12 YEARS:
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).
ELDERLY:
Dosage should be reduced in elderly patients.
FOR DRY OR PAINFUL COUGH
ADULTS:
15-30mg, 3-4 times daily
CHILDREN:
Not recommended
ELDERLY:
Dosage should be reduced in elderly patients
DIARRHOEA
ADULTS:
30mg three to four times daily (range 15-60mg)
CHILDREN:
Not recommended
ELDERLY:
Dosage should be reduced in elderly patient