Dihydrocodeine Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

DIHYDROCODEINE TARTRATE

Available from:

Wockhardt UK Limited

ATC code:

N02AA08

INN (International Name):

DIHYDROCODEINE TARTRATE

Pharmaceutical form:

TABLET

Composition:

DIHYDROCODEINE TARTRATE 30 mg

Prescription type:

POM

Therapeutic area:

ANALGESICS

Authorization status:

Authorised

Authorization date:

2006-08-23

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
DIHYDROCODEINE 30MG 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 Dihydrocodeine Tablets are and what they are used for
2.
Before you take Dihydrocodeine Tablets
3.
How Dihydrocodeine Tablets should be taken
4.
Possible side effects
5.
How to store Dihydrocodeine Tablets
6.
Further information
1.
WHAT DIHYDROCODEINE TABLETS ARE AND WHAT THEY ARE USED FOR
Dihydrocodeine belongs to a group of medicines known as opioid
analgesics, which are used to relieve
pain, Dihydrocodeine tablets are used for the relief of moderate to
severe pain.
2.
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.
DIHYDROCODEINE TABLETS SHOULD NOT BE GIVEN IF YOU:

have ever had a reaction to or been told that you are allergic to
dihydrocodeine, any other opioid
analgesic or any of the other ingredients in the tablets (see section
6)

have been told that you have a tumour of the adrenal gland near your
kidney called
phaeochromocytoma

have severe problems with breathing

are pregnant or breast-feeding.

have increased pressure on the brain, have just had a head injury or
if you are unconscious

are suffering from acute alcoholism

are at risk from a blocked intestine

have severe stomach cramps c

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 excipients, see 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
_ _
_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
_ _
Page 2 of 8
_ _
For concomitant illnesses/conditions where dose reduction may be
appropriate see 4.4
Special Warnings and Precautions for 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
patients with
asthma and decreased respiratory reserve. Avoid use during an acute
asthma attack
(see 4.3 Contraindication). Dihydrocodeine should be given in reduced
doses or with
caution to elderly or debilitated patients (see 4.2 Posology)