Codeine 60mg tablets

Ülke: Birleşik Krallık

Dil: İngilizce

Kaynak: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktif bileşen:

Codeine phosphate

Mevcut itibaren:

Arrow Generics Ltd

ATC kodu:

R05DA04

INN (International Adı):

Codeine phosphate

Doz:

60mg

Farmasötik formu:

Oral tablet

Uygulama yolu:

Oral

Sınıf:

Schedule 5 (CD Inv)

Reçete türü:

Valid as a prescribable product

Ürün özeti:

BNF: 04070200

Bilgilendirme broşürü

MEASURE BAR SHOULD BE 150MM AT 100% SCALE
Customer
Description
Item Code
Profile
Size
Min. Point Size
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Proof By
Proof No.
Date
Artwork No.
Pharma
Code
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Wockhardt UK Limited
Codeine Phosphate Weifa leaflet
107021/3
n-a
206 x 336mm
matt.pirie-scott
1
21/04/2015
569101
404
Process Black
Keylines (Does not print)
Text Limit
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UK
English
9.3pt (main body) / 9.3pt (variables)
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 p

Ürün özellikleri

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Codeine Phosphate 60mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Codeine Phosphate 60mg
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
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
Acute
respiratory
depression,
hypersensitivity
to
codeine
or
other
opioid
analgesics or to any of the excipients, obstructive airways disease,
liver disease,
severe hepatic dysfunction, acute alcoholism.
Use should be avoided in patients