Codeine Phosphate Crescent Tablets 30mg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CODEINE PHOSPHATE

Available from:

Crescent Pharma International Limited 260, Triq San Albert, Gzira GZR 1150, Malta

ATC code:

R05DA04

INN (International Name):

CODEINE PHOSPHATE 30 mg

Pharmaceutical form:

TABLET

Composition:

CODEINE PHOSPHATE 30 mg

Prescription type:

POM

Therapeutic area:

COUGH AND COLD PREPARATIONS

Authorization status:

Authorised

Authorization date:

2019-08-30

Patient Information leaflet

PL-MT UK/H/7085/001/MR – Day0
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CODEINE PHOSPHATE CRESCENT TABLETS 30 MG
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
IN THIS LEAFLET
1.
What Codeine Phosphate Crescent Tablets 30 mg are and what they are
used for
2.
Before you take Codeine Phosphate Crescent Tablets 30 mg
3.
How to take Codeine Phosphate Crescent Tablets 30 mg
4.
Possible side effects
5.
How to store Codeine Phosphate Crescent Tablets 30 mg
6.
Further information
1.
WHAT CODEINE PHOSPHATE CRESCENT TABLETS 30 MG
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 adults and 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 CRESCENT TABLETS 30 MG
DO NOT TAKE THESE TABLETS IF:
•
you are allergic to codeine or any other opioid analgesic or to any of
the other ingredients (See
Section 6)
•
you suffer from any kind of lung disease, have difficulty in
breathing, or are having an asthma
attack
•
you suffer from diarrhoea due to pseudomembraneous colitis or
poisoning
•
you suffer from severe liver disease
•
you are at risk from a blocked intestine
•
you have a head injury or pressure on the brain
•
you are addicted to alcohol
•
you know that

Summary of Product characteristics

SPC-MT UK/H/7085/001/MR – Day0
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Codeine Phosphate Crescent Tablets 30 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Codeine phosphate 30 mg per tablet.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
White normal convex tablets.
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).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
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 240mg.
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:
SPC-MT UK/H/7085/001/MR – Day0
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 240mg 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).
ROUTE OF ADMINISTRATION:
Oral
4.3
CONTRAINDICATIONS
Hypersensitivity to codeine or other opioid analgesics or to any of
the excipients.
Acute respiratory depression and obstructive airways disease.
Diarrhoea due to pseudomembranous colitis or poisoning.
Severe hepatic dysfunction.
Where there is a risk of paralytic ileus.
Raised intracranial pressure or head injury.
Comatose patients
Acute alcoholism
In all paediatric patients (0-18 years of age) who undergo
tonsillectomy and/or
adenoidectomy f