Codeine Phosphate 30mg Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CODEINE PHOSPHATE

Available from:

Pinewood Laboratories Limited Ballymacarbry, Clonmel, Co. Tipperary, Ireland

ATC code:

N02AA

INN (International Name):

CODEINE PHOSPHATE 30 mg

Pharmaceutical form:

TABLET

Composition:

CODEINE PHOSPHATE 30 mg

Prescription type:

POM

Therapeutic area:

ANALGESICS

Authorization status:

Withdrawn

Authorization date:

2006-08-18

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
CODEINE PHOSPHATE TABLETS
THIS MEDICINE CONTAINS CODEINE WHICH IS AN OPIOID, WHICH CAN CAUSE
ADDICTION. YOU CAN
GET WITHDRAWAL SYMPTOMS IF YOU STOP TAKING IT SUDDENLY.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 medicine has been prescribed for you to relieve pain, suppress
coughs or treat diarrhoea.
It contains codeine which belongs to a class of medicines called
opioids, which are ‘pain
relievers’. This medicine has been prescribed to you and should not
be given to anyone else.
Opioids can cause addiction and you may get withdrawal symptoms if you
stop taking it
suddenly. Your prescriber should have explained how long you will be
taking it for and when
it is appropriate to stop, how to do this safely.
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 painkillers such as paracetamol or
ibuprofen alone.
2. BEFORE YOU TAKE CODEINE PHOSPHATE TABLETS
Talk to your prescriber before taking this medicine if you:

are or have ever been addicted to opioids, alcohol, prescription
medicines, or illegal drugs.

have previously suffered from withdrawal symptoms such as agitation,
anxiety, shaking or
sweating,

Summary of Product characteristics

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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.
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
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
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:
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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:
D