Codeine 30mg tablets

দেশ: যুক্তরাজ্য

ভাষা: ইংরেজি

সূত্র: MHRA (Medicines & Healthcare Products Regulatory Agency)

সক্রিয় উপাদান:

Codeine phosphate

থেকে পাওয়া:

Bristol Laboratories Ltd

এটিসি কোড:

R05DA04

INN (আন্তর্জাতিক নাম):

Codeine phosphate

ডোজ:

30mg

ফার্মাসিউটিকাল ফর্ম:

Oral tablet

প্রশাসন রুট:

Oral

শ্রেণী:

Schedule 5 (CD Inv)

প্রেসক্রিপশন টাইপ:

Valid as a prescribable product

পণ্য সারাংশ:

BNF: 04070200; GTIN: 5060013942259 5060013941696 5060013941702

তথ্য লিফলেট

29 mm
IXXXXXX
PACKAGE LEAFLET: INFORMATION FOR THE USER
CODEINE PHOSPHATE TABLETS BP 15 MG
CODEINE PHOSPHATE TABLETS BP 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 it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
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 or pharmacist. This
includes
any possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
WHAT CODEINE PHOSPHATE IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CODEINE PHOSPHATE
3.
HOW TO TAKE CODEINE PHOSPHATE
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE CODEINE PHOSPHATE
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT CODEINE PHOSPHATE IS AND WHAT IT IS 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 Phosphate Tablets are used for the relief of:
•
mild to moderate pain.
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 pain killers such as
paracetamol
or ibuprofen alone.
•
symptoms of a dry cough or diarrhoea.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
CODEINE PHOSPHATE
DO NOT TAKE CODEINE PHOSPHATE:
•
For pain relief in children and adolescents (0-18 years of age) after
removal
of their tonsils or adenoids due to obstructive sleep apnoea syndrome.
•
If you know that you metabolise very rapidly codeine into morphine.
•
If you are breast feeding
•
If you have ever been told you are allergic to codeine phosphate,
other
similar (opioid) pain killers and/or any of the ingredients in the
tablet (see
Section 6)
•
If you have breathing

পণ্য বৈশিষ্ট্য

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Codeine Phosphate Tablets BP 30 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 30mg Codeine Phosphate Ph Eur.
Excipient with known effect: Also contains 29.40 mg of lactose.
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Tablets
A smooth, round, flat faced, bevelled edge plain white to off white
tablet.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
1.
Indicated as an analgesic for the relief of mild to moderate pain.
Codeine is indicated in children 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).
2.
For the symptomatic relief of unproductive cough and diarrhoea
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Prior to starting treatment with opioids, a discussion should be held
with patients to
put in place a strategy for ending treatment with codeine phosphate in
order to
minimise the risk of addiction and drug withdrawal syndrome (see
section 4.4).
Long term use - the risk benefit should be assessed regularly by the
prescriber.
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.
_ _
_POSOLOGY_
ANALGESIA
Adults: 30 – 60 mg every four hours to a maximum dosage of 240mg
daily.
The analgesic effect is not materially enhanced by increasing the dose
to a greater
level than that recommended above.
Elderly: Dosage should be reduced in the elderly where there is
impairment of hepatic
or renal function.
Paediatric population
Children aged 12 years to 18 years:
The recommended codeine dose for children 12 years and older should
take 30 to
60mg every 6 hou