Dihydrocodeine 30mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Dihydrocodeine tartrate

Available from:

Sigma Pharmaceuticals Plc

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

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
DIHYDROCODEINE 30MG TABLETS
(DIHYDROCODEINE TARTRATE BP)
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 to read it again.
- If you have any further questions, ask your doctor, pharmacist or
nurse.
- 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 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
Dihydrocodeine Tablets are used as a strong pain killer (known as an
opioid) for the relief of
moderate to severe pain.
2.
WHAT YOU NEED TO KNOW
BEFORE YOU TAKE DIHYDROCODEINE TABLETS
DO NOT TAKE DIHYDROCODEINE TABLETS IF:
• You know that you are allergic to dihydrocodeine tartrate, or any
of the other ingredients
(listed
in section 6 )
• You suffer from breathing problems, for example chronic bronchitis
or if you are having an
asthma attack (both are conditions of shortness of breath, wheezing
and chest tightness)
•You suffer from paralytic ileus (paralysis of the gut which stops
the movement of food
through the intestine)
• You have a head injury or suffer from increased pressure on the
brain.
Children
Dihydrocodeine Tablets are not recommended for children under 12
years.
WARNINGS AND PRECAUTIONS
• Do not take for longer than directed by your prescriber
• Taking dihydrocodeine (DHC) regularly for a long time can lead to
addiction, which might
cause you to feel restless and irritable when you stop

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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