Meptid 200 mg film-coated Tablets

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

Meptazinol

Disponibil de la:

Almirall, S.A.

Codul ATC:

N02AX; N02AX05

INN (nume internaţional):

Meptazinol

Dozare:

200  milligram(s)

Forma farmaceutică:

Film-coated tablet

Tip de prescriptie medicala:

Product subject to prescription which may not be renewed (A)

Zonă Terapeutică:

Other opioids; meptazinol

Statutul autorizaţiei:

Marketed

Data de autorizare:

1988-05-24

Prospect

ARTWORK INFORMATION PANEL
DESCRIPTION:
PRINTING COLOURS
NON PRINTING COLOURS
COLOUR REFERENCE IN PMS BRIDGE
EQUATE WITH CMYK
PROOF:
REGULATORY TEXT:
ITEM NUMBER:
MATERIAL SIZE:
DESIGNER:
FONTS:
FONT SIZE:
DATE:
MANUFACTURER’S TECHNICAL CHECK:
Manufacturer confirms the printability and
technical compliance of this packaging material
for correct use during packaging process.
Date and Signature
INLINE CONTROL CODE
PIL Meptid 200mg tab GB_IE Mock up
uk-pl-meptidtabs-Nov2018-tracked (1/2)
Graphik Regular, GRAPHIK SEMIBOLD
Mock up
170 x 220 mm
21.06.2019
8pt
1
Die cut
P Black
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 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.
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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
1. WHAT MEPTID TABLETS ARE AND WHAT THEY ARE USED FOR
The name of this medicine is Meptid 200 mg
Film-Coated Tablets but will be referred to as Meptid
Tablets throughout the remainder of the leaflet.
Meptid Tablets belong to a group of medicines known
as opioid analgesics, which are used to relieve pain.
They contain meptazinol as the active ingredient.
Meptid Tablets are used for the short-term treatment of
moderate pain from a variety of causes.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MEPTID TABLETS
DO NOT TAKE MEPTID TABLETS IF YOU
-
are allergic to meptazinol or

Caracteristicilor produsului

Health Products Regulatory Authority
28 January 2022
CRN00CS57
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Meptid 200 mg film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200 mg of meptazinol (as hydrochloride).
Excipients: Sunset yellow (E110) 1.47 mg.
For a 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
200 mg 3 to 6 hourly as required. Usually 1 tablet 4 hourly.
ELDERLY
The adult dosage schedule may 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, affects 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)
Health Products Regulatory Authority
28 January 2022
CRN00CS57
Page 2 of 6
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Meptazinol has a favourable respiratory profile but caution should be
exercised in patients whose respiratory system is already
compromised.
Patients with moderate to severe renal impairment should be given a
reduced dose as the effect in these patients may be
prolonged and