Dihydrocodeine 30mg tablets

Valsts: Lielbritānija

Valoda: angļu

Klimata pārmaiņas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktīvā sastāvdaļa:

Dihydrocodeine tartrate

Pieejams no:

Accord-UK Ltd

ATĶ kods:

N02AA08

SNN (starptautisko nepatentēto nosaukumu):

Dihydrocodeine tartrate

Deva:

30mg

Zāļu forma:

Oral tablet

Ievadīšanas:

Oral

Klase:

Schedule 5 (CD Inv)

Receptes veids:

Valid as a prescribable product

Produktu pārskats:

BNF: 04070200; GTIN: 5012617015341 5012617021236 05012617010155

Lietošanas instrukcija

148x210 Leaflet Reel Fed Profile (BST)
Dimensions:
Component:
Date Sent:
Technologist: TECHNICALLY APPROVED
Pharmacode:
JDE No.:
Dihydrocodeine Tablets
30mg x 28, 30, 100 (UK)
148x210 (Reel Fed)
50999094
Leaflet for Blisters
4553
T. Hull
08/03/21
approved for print/date
PROOF ROUND
Technical
Approval
DATE SENT:
DATE RECEIVED:
Item number:
ORIGINATOR:
ORIGINATION DATE:
REVISION DATE:
REVISED BY:
DIMENSIONS:
MIN BODY TEXT SIZE:
SUPPLIER:
NON PRINTING COLOURS
COLOURS
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2.
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6.
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[e-mail]
T. Hull
16.03.2021
23/03/2021
C.Grant
148x210
7pt
Accord Barnstaple
n/a
DIHYDROCODEINE 30MG TABLETS PIL - UK
Black
Profile
BBBB0939
03
* Please note that ONLY Artwork Studio is permitted to make changes to
the above artwork.
No changes are permitted by any 3rd party other than added notes and
mark ups for required changes.
Version 7
12.02.2020
Cartons and label leaflets only
(labels only when specified)
German GTIN 14
(incorporating PZN):
THIS MEDICINE 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 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 fo

Produkta apraksts

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Dihydrocodeine Tablets BP 30mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 30mg Dihydrocodeine Tartrate.
Excipients with known effect:
Each 30mg tablet contains 143.00 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
White uncoated tablets.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
As an analgesic for the relief of moderate to severe pain.
Dihydrocodeine
Tablets 30mg are indicated in all painful conditions where an alert
patient is
desired, _eg_ sciatica, osteo-arthritis, chronic rheumatoid arthritis,
arthritis of the
spine, peripheral vascular disease, post-herpetic neuralgia, Paget's
disease,
malignant disease, post-operative pain.
Because dihydrocodeine, in the recommended doses, causes little or no
respiratory depression, its use in the treatment of post-operative
pain may
reduce the risk of chest complications.
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
Tablets 30mg in order to minimise the risk of addiction and drug
withdrawal
syndrome (see section 4.4).
The analgesic effect is not materially enhanced by increasing the dose
above
that recommended below; in severe cases the interval between doses
should be
reduced to obtain the requisite analgesic cover.
_Adults and children over 12 years:_ One tablet (30mg) every 4 to 6
hours when
necessary after food. Maximum dose in 24 hours 180mg (6 tablets).
_ _
_Paediatric population:_
Not recommended for children under 12 years old.
_ _
_Elderly:_ Dosage should be reduced in the elderly. See also
sub-section 4.4
Special warnings and special precautions for use.
Method of administration
For oral use.
4.3
CONTRAINDICATIONS
•
Hypersensitivity to the active substance or to any of the excipients
listed in
section 6.1.
•
Respiratory depression
•
Obstructive airways di