Dihydrocodeine 30mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Dihydrocodeine tartrate

Available from:

Arrow Generics 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

Patient Information leaflet

1
PATIENT INFORMATION LEAFLET
DYHYDROCODEINE 30 MG TABLETS
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 or pharmacist.
•
This medicines has been prescribed for you. Do not pass it on to
others, it may harm them, even if
their symptoms 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.
1. WHAT DIHYDROCODIENE IS USED FOR
Dihydrocodeine tablets are used to relieve moderate to severe pain.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DIHYDROCODEINE
DO NOT TAKE DIHYDROCODEINE IF:
•
you are allergic (hypersensitive) to dihydrocodeine or any of the
other ingredients of this medicine
(listed in section 6)
•
you have a medical condition where you find it difficult to breathe
•
you are having an asthma attack
•
you have a head injury or increased pressure in your head e.g. due to
brain disease
•
you have a condition where the small bowel (part of your gut) does not
work properly (paralytic
ileus)
•
you are addicted to alcohol
WARNINGS AND PRECAUTIONS
•
Do not take for longer than directed by your doctor or pharmacist.
•
Avoid drinking alcohol while you are taking these tablets.
•
Taking dihydrocodeine regularly for a long time can lead to addition,
which might cause you to
feel restless and irritable when you stop the tablet.
•
Taking a painkiller for headaches too often or for too long can make
them worse.
TALK TO YOUR DOCTOR OR PHARMACIST BEFORE YOU START THIS MEDICINE IF
YOU
:
•
have kidney or liver problems
•
have an under-active thyroid
•
have asthma or allergic disorders
•
are debilitated (in a weakened state)
•
have low blood pressure or you are suffering from shock
•
have an obstruction of inflammation of the gut or narrowing of the
urethra 9tube which passes
urine from the bladder

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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