Meptid 200mg tablets

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Meptazinol hydrochloride

Tilgjengelig fra:

Almirall Ltd

ATC-kode:

N02AX05

INN (International Name):

Meptazinol hydrochloride

Dosering :

200mg

Legemiddelform:

Oral tablet

Administreringsrute:

Oral

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 04070200; GTIN: 5021840002202

Informasjon til brukeren

ARTWORK INFORMATION PANEL
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MANUFACTURER’S TECHNICAL CHECK:
Manufacturer confirms the printability and
technical compliance of this packaging material
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Date and Signature
LAETUS CODE
PIL Meptid 200 mg 112 tab GB/IE 8083181-01 (1/2)
ie-uk-pl-meptidtabs-Jul2020approved.doc
8083181-01
173 x 455 mm - P074
02.11.2020
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VISUAL MARKS:
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PACKAGE LEAFLET: INFORMATION FOR THE USER
MEPTID
200 MG
FILM-COATED TABLETS
Meptazinol
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPOR-
TANT 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 Meptid Tablets are and what they are
used for
2. What you need to know before you take
Meptid Tablets
3. How to take Meptid Tablets
4. Possible side effects
5. How to store Meptid Tablets
6. Contents of the pack and other information
THIS MEDICINE CONTAINS MEPTAZINOL WHICH IS AN
OPIOID, WHICH CAN CAUSE ADDICTION. YOU CAN GET
WITHDRAWAL SYMPTOMS IF YOU STOP TAKING IT
SUDDENLY.
1. WHAT MEPTID TABLETS ARE AND WHAT THEY
ARE USED FOR
This medicine has been prescribed for you for the
short term treatment of moderatepain. It contains
meptazinol which belongs to a class of medicines
called opioids, which are ‘pain relievers’. This
medicine has been prescribed to you and should
not

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Meptid 200mg Film-Coated Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200mg of meptazinol (as hydrochloride).
Excipient with known effect
Each tablet contains 2.15 mg of sunset yellow FCF (E 110).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Oval, biconvex, orange, film coated tablets. The tablets are engraved
“MPL 023” on one side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Meptid Tablets are indicated for the short term treatment of moderate
pain.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Prior to starting treatment with opioids, a discussion should be held
with patients to put in place a
strategy for ending treatment with meptazinol in order to minimise the
risk of addiction and drug
withdrawal syndrome (see section 4.4).
Posology
ADULTS
Intramuscular dosage: 75-100mg Meptid. The injection may be repeated
2-4 hourly as required.
For obstetric pain a dose of 100-150mg should be used according to
weight. This dose should
approximate 2mg/kg.
Intravenous dosage: 50-100mg Meptid by slow intravenous injection. The
injection may be
repeated 2-4 hourly as required. If vomiting occurs, a suitable
antiemetic should be given.
Epidural/intrathecal use: This formulation is not suitable for these
routes.
ELDERLY
The adult dosage schedule can be used in the elderly.
PAEDIATRIC POPULATION
No data are available.
4.3
CONTRAINDICATIONS
•
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
•
Patients with the following conditions:
- acute alcoholism and where there is a risk of paralytic ileus
- raised intracranial pressure or head injury (in addition to
interfering with respiration, affect
pupillary responses vital for neurological assessment).
- acute respiratory depression
- during an asthma attack
- patients on monoamine-oxidase inhibitors (MAOIs) and for 14 days
after discontinuing an
MAOI (see section 4.5)
4.4
SPECIAL WARNINGS AN