Codeine 15mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Codeine phosphate

Available from:

Waymade Healthcare Plc

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

Patient Information leaflet

Patient Information Leaflet
SOVEREIGN
MEDICAL
CODEINE PHOSPHATE 15 mg, 30 mg and 60 mg Tablets
READ ALL OF THIS LEAFLET BEFORE YOU START TAKING THIS MEDICINE

Please keep this leaflet. You may need to read it again.

If you have any further questions, please ask your doctor or
pharmacist.

This medicine has been prescribed for you. Do 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 becomes serious, or if you notice any side
effects not listed in this
leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What Codeine Phosphate 15 mg, 30 mg and 60 mg Tablets are and what
they are used for
2. Before you take Codeine Phosphate 15 mg, 30 mg and 60 mg Tablets
3. How to take Codeine Phosphate 15 mg, 30 mg and 60 mg Tablets
4. Possible side effects
5. How to store Codeine Phosphate 15 mg, 30 mg and 60 mg Tablets
6. Further information
1. WHAT CODEINE PHOSPHATE TABLETS 15 MG, 30 MG, AND 60 MG TABLETS ARE
AND
WHAT THEY ARE USED FOR
The name of your medicine is Codeine Phosphate 15mg, 30mg or 60mg
Tablets. The active
ingredient is codeine phosphate.
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 painkillers 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.
It can also be used to prevent coughs and to treat the symptoms of
chronic diarrhoea.
2. BEFORE YOU TAKE CODEINE PHOSPHATE 15 MG, 30 MG AND 60 MG TABLETS
DO NOT TAKE THIS MEDICATION:

if you have ever had an allergic reaction to any of the ingredients of
Codeine Phosphate 15
mg, 30 mg and 60 mg tablets or any other medicines that you may have
taken to relieve pain.
(allergic reactions include mild symptoms such as itching and/or rash.
More severe
symptoms include swelling of the face, lips, tongue an

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 BP 15 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