Codeine 30mg tablets

Страна: Великобритания

Език: английски

Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активна съставка:

Codeine phosphate

Предлага се от:

Sandoz Ltd

АТС код:

R05DA04

INN (Международно Name):

Codeine phosphate

дозиране:

30mg

Лекарствена форма:

Oral tablet

Начин на приложение:

Oral

Клас:

Schedule 5 (CD Inv)

Вид предписание :

Valid as a prescribable product

Каталог на резюме:

BNF: 04070200

Листовка

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
CODEINE PHOSPHATE TABLETS 15 MG, 30 MG AND 60 MG
READ ALL OF THE LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE

Keep this leaflet. You may need to read it again.

If you have any further questions, 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 gets 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 Tablets are and what they are used for
2.
Before you take Codeine Phosphate Tablets
3.
How to take Codeine Phosphate Tablets
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
The name of your medicine is Codeine Phosphate Tablets 15 mg, 30 mg or
60 mg.
The active ingredient, codeine phosphate, is an analgesic or
painkilling medicine. It also has
cough-suppressant properties and can be useful for stopping chronic
diarrhoea.
Codeine Phosphate Tablets are used in adults for:
•
the relief of mild to moderate pain
•
to relieve coughing
•
to treat the symptoms of chronic diarrhoea by making the stools more
solid and less
frequent.
Codeine can be used for the short-term relief of moderate pain that is
not relieved by other
painkillers such as paracetamol or ibuprofen alone.
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.
2.
BEFORE YOU TAKE CODEINE PHOSPHATE TABLETS
DO NOT TAKE THIS MEDICINE BEFORE TELLING YOUR DOCTOR:
•
if you are allergic or have previously been allergic to codeine,
codeine phosphate, or any
of the other ingredients in Codeine Phosphate Tablets
2
•
if you are, or might be pregnant, or are breast-feeding
•
if you have hav

Данни за продукта

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
4.1
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 patient