Dihydrocodeine 30mg Tablets

国家: 马耳他

语言: 英文

来源: Malta Medicines Authority

有效成分:

DIHYDROCODEINE TARTRATE

可用日期:

Pinewood Laboratories Limited Ballymacarbry, Clonmel, Co. Tipperary, Ireland

ATC代码:

N02AA08

INN（国际名称）:

DIHYDROCODEINE TARTRATE 30 mg

药物剂型:

TABLET

组成:

DIHYDROCODEINE TARTRATE 30 mg

处方类型:

POM

治疗领域:

ANALGESICS

授权状态:

Withdrawn

授权日期:

2006-08-23

资料单张

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
DIHYDROCODEINE 30MG TABLETS
THIS MEDICINE CONTAINS DIHYDROCODEINE 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 USING 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, nurse 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, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Dihydrocodeine Tablets are and what they are used for
2.
What you need to know before you take Dihydrocodeine Tablets
3.
How to take Dihydrocodeine Tablets
4.
Possible side effects
5.
How to store Dihydrocodeine Tablets
6.
Contents of the pack and other information
1.
WHAT DIHYDROCODEINE TABLETS ARE AND WHAT THEY ARE USED FOR
This medicine has been prescribed for you for the relief of moderate
to severe pain.
It contains dihydrocodeine 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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DIHYDROCODEINE TABLETS

Do not take for longer than directed by your prescriber.

Taking dihydrocodeine regularly for a long time can lead to addiction,
which might make you feel
restless and irritable when you stop the tablets.

Taking a painkiller for headaches too often or for too long can make
them worse.
DO NOT TAKE DIHYDROCODEINE TABLET

产品特点

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Dihydrocodeine 30mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Dihydrocodeine tartrate 30mg
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet - Oral use
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Dihydrocodeine is used to relieve moderate to severe pain.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ _
Posology
_Adults:_
1 tablet (30mg) every four to six hours or at the discretion of the
physician.
_ _
_Elderly:_
Dosage should be reduced
_ _
_Children aged 4 to 12 years:_
0.5 to 1mg/kg bodyweight every four to six hours.
_ _
_Children under 4 years:_
Not recommended
_Chronic hepatic disease: _
_ _
The dosage should be reduced
_ _
_ _
_Moderate to severe renal impairment: _
The dosage should be reduced
_ _
_ _
For concomitant illnesses/conditions where dose reduction may be
appropriate see 4.4
Special Warnings and Precautions for Use.
Prior to starting treatment with opioids, a discussion should be held
with patients to put
in place a strategy for ending treatment with dihydrocodeine in order
to minimise the
risk of addiction and drug withdrawal syndrome (see section 4.4).
Method of administration
For oral use.
4.3
CONTRAINDICATIONS
Acute respiratory depression.
Obstructive airways disease
Known hypersensitivity to dihydrocodeine, or other opioid analgesics,
or to any of the
excipients
Acute alcoholism
Severe hepatic dysfunction
Head injury or raised intracranial pressure (in addition to the risk
of respiratory
depression and increased intracranial pressure, may affect papillary
and other responses
vital for neurological assessment).
Children under 4 years of age.
Dihydrocodeine should not be given to comatose patients.
Dihydrocodeine is also contraindicated where there is a risk of
paralytic ileus, or in
acute diarrhoeal conditions such as acute ulcerative colitis or
antibiotic associated
colitis (e.g. pseudomembranous colitis) or diarrhoea caused by
poisoning.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE