Codeine 15mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Codeine phosphate

Available from:

Wockhardt UK Ltd

ATC code:

R05DA04

INN (International Name):

Codeine phosphate

Dosage:

15mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

Schedule 5 (CD Inv)

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04070200; GTIN: 5012727903095 5012727905495

Patient Information leaflet

CHANGE CONTROL : Version changes due to change in:
Size/Layout Regulatory Non-Regulatory
Changes in detail:
• Regulatory text amends • New single wing Wockhardt logo
• Pharmcode placed on 8mm from the cutting edge
• Added arrow to indicate pharmacode reading
• Removed pre-printed India neutral code
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 painkillers such as paracetamol or
ibuprofen alone.
These tablets are used to relieve pain, suppress coughs and treat
diarrhoea.
2. BEFORE YOU TAKE CODEINE PHOSPHATE TABLETS
• do not take for longer than directed by your prescriber
• taking codeine regularly for a long time can lead to addiction,
which might
make you feel restless and irritable when you stop the tablets
• taking a painkiller for headaches too often or for too long can
make them worse
Codeine Phosphate

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Codeine Phosphate 15mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Codeine Phosphate 15mg
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 patients
4.3
CONTRAINDICATIONS