Codeine 60mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Codeine phosphate

Available from:

Ranbaxy (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

Patient Information leaflet

MEASURE BAR SHOULD BE 150MM AT 100% SCALE
Customer
Description
Item Code
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Wockhardt UK Limited
Codeine Phosphate Weifa leaflet
107021/3
n-a
206 x 336mm
matt.pirie-scott
1
21/04/2015
569101
404
Process Black
Keylines (Does not print)
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UK
English
9.3pt (main body) / 9.3pt (variables)
PACKAGE LEAFLET: INFORMATION FOR THE USER
CODEINE PHOSPHATE TABLETS
Read all of this leaflet carefully before you start using this
medicine.
– Keep this leaflet. You may need to read it again.
–
If you have further questions, please ask your doctor, nurse or
pharmacist.
–
This medicine has been prescribed for you personally and you should
not pass it on to others. It may harm them, even if their symptoms are
the same as yours.
–
If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor, nurse or pharmacist.
In this leaflet:
1.
What Codeine Phosphate Tablets are and what
they are used for
2.
Before you take Codeine Phosphate Tablets
3. How Codeine Phosphate Tablets should be taken
4. Possible side effects
5. How to store Codeine Phosphate Tablets
6. Further information
1.
WHAT CODEINE PHOSPHATE TABLETS ARE AND WHAT THEY ARE
USED FOR
This product contains codeine. Codeine belongs to a group of medicines
called opioid analgesics which act to relieve pain. It can be used on
its
own or in combination with other pain killers such as paracetamol.
Codeine can be used in children over 12 years of age for the
short-term
relief of moderate pain that is not relieved by other p

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Codeine Phosphate 60mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Codeine Phosphate BP 60 mg
3.
PHARMACEUTICAL FORM
Tablets
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).
As an anti-tussive.
For the symptomatic treatment of chronic diarrhoea.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
_Dosage: _
IN ACUTE MODERATE PAIN:
ADULTS:
The recommended dosage range is 30 to 60 mg.
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.
PAEDIATRIC POPULATION:
Children aged 12 years to 18 years:
The recommended codeine dose for children 12 years and older should be
30
to 60 mg_ _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).
AS AN ANTI-TUSSIVE:
ADULTS:
15-30mg three or four times daily.
CHILDREN:
Not suitable for children.
FOR THE SYMPTOMATIC TREATMENT OF CHRONIC DIARRHOEA:
ADULTS:
15-60 mg three to four times daily.
CHILDREN:
Not suitable for children.
There is no evidence that the dose differs in the elderly.
_ _
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._ _
_Method of Administration: _
To be taken by mouth.
4.3.
CONTRAINDICATIONS
Hypersensitivity to codeine or any of the tablet excipients.
Acute respiratory depression and acute alcoholism where there is a
risk of