Codeine Phosphate 30mg Tablets

Land: Malta

Språk: engelska

Källa: Medicines Authority

Aktiva substanser:

CODEINE PHOSPHATE

Tillgänglig från:

Wockhardt UK Limited

ATC-kod:

N02AA59

INN (International namn):

CODEINE PHOSPHATE

Läkemedelsform:

TABLET

Sammansättning:

CODEINE PHOSPHATE 30 mg

Receptbelagda typ:

POM

Terapiområde:

ANALGESICS

Bemyndigande status:

Authorised

Tillstånd datum:

2006-08-18

Bipacksedel

MEASURE BAR SHOULD BE 150MM AT 100% SCALE 
Customer
Description
Item Code
Profile
Size
Min. Point Size
Market
Language
Proof By
Proof No.
Date
Artwork No.
Pharma
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)
Text Limit 
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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

Produktens egenskaper

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 

CLINICAL PARTICULARS

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 

FOR MILD TO MODERATE PAIN  

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 

D