Dihydrocodeine 30mg tablets

国: イギリス

言語: 英語

ソース: MHRA (Medicines & Healthcare Products Regulatory Agency)

有効成分:

Dihydrocodeine tartrate

から入手可能:

Teva UK Ltd

ATCコード:

N02AA08

INN（国際名）:

Dihydrocodeine tartrate

投薬量:

30mg

医薬品形態:

Oral tablet

投与経路:

Oral

クラス:

Schedule 5 (CD Inv)

処方タイプ:

Valid as a prescribable product

製品概要:

BNF: 04070200; GTIN: 5017007054238 5017007054252

情報リーフレット

PACKAGE LEAFLET: INFORMATION FOR THE USER
DIHYDROCODEINE 30 MG TABLETS
THIS MEDICINE CONTAINS DIHYDROCODEINE TARTRATE 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 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 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. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Dihydrocodeine is and what it is used for
2.
What you need to know before you take Dihydrocodeine
3.
How to take Dihydrocodeine
4.
Possible side effects
5.
How to store Dihydrocodeine
6.
Contents of the pack and other information
1.
WHAT DIHYDROCODEINE IS AND WHAT IT IS USED FOR
This medicine has been prescribed for you for the relief of moderate
to severe pain. It contains
dihydrocodeine tartrate 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, and how to do this safely.
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

suffer from problems with your breathing

suffer from alcoholism

have suffered a significant head injury

are at risk of paralytic ileus (an inactive bowel) which may cause a
blockage of the gut

are having an asthma attack
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製品の特徴

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Dihydrocodeine 30 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 30 mg of Dihydrocodeine Tartrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White, flat, bevel edged tablets, engraved 5B4 with a breakline.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Dihydrocodeine tablets are indicated for the relief of moderate to
severe pain.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
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).
Dihydrocodeine tablets are best administered after food.
_Adults _
1 tablet (30 mg) every 4 to 6 hours or at the discretion of the
physician.
_ _
_Children 4 to 12 years of age _
0.5 to 1 mg/kg body weight, every 4 to 6 hours.
_Children under 4 years of age _
Dihydrocodeine is not recommended.
Method of administration
For oral administration
4.3
CONTRAINDICATIONS
Hypersensitivity to dihydrocodeine or any of the tablet constituents;
respiratory
depression; obstructive airways disease; where there is a risk of
paralytic ileus; acute
alcoholism. Dihydrocodeine should also be avoided in patients with
raised
intracranial pressure or with significant head injury (in addition to
interfering with
respiration, it affects papillary response vital for neurological
assessment).
Dihydrocodeine may cause the release of histamine, it should not be
given during an
asthma attack and should be given with caution to asthmatics.
Patients with rare hereditary problems of galactose intolerance, the
Lapp lactase
deficiency or glucose galactose malabsorption should not take this
medicine.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Dihydrocodeine should not be given during an attack of asthma, and
should be
administered with due care to persons liable to such attacks.
Dihydrocodeine