Dihydrocodeine 30mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Dihydrocodeine tartrate

Available from:

Wockhardt UK Ltd

ATC code:

N02AA08

INN (International Name):

Dihydrocodeine tartrate

Dosage:

30mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

Schedule 5 (CD Inv)

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04070200; GTIN: 5012727903149 5012727903101 5012727905556

Patient Information leaflet

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 TABLETS

Summary of Product characteristics

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
4.1.
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
Dihydrocodeine should be given in reduced doses or with caution to
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