Codeine 15mg tablets

Quốc gia: Vương quốc Anh

Ngôn ngữ: Tiếng Anh

Nguồn: MHRA (Medicines & Healthcare Products Regulatory Agency)

Thành phần hoạt chất:

Codeine phosphate

Sẵn có từ:

Crescent Pharma Ltd

Mã ATC:

R05DA04

INN (Tên quốc tế):

Codeine phosphate

Liều dùng:

15mg

Dạng dược phẩm:

Oral tablet

Tuyến hành chính:

Oral

Lớp học:

Schedule 5 (CD Inv)

Loại thuốc theo toa:

Valid as a prescribable product

Tóm tắt sản phẩm:

BNF: 04070200; GTIN: 5017123023132

Tờ rơi thông tin

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,

Đặc tính sản phẩm

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