Manerix 150 mg Film-coated Tablets

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

Moclobemide

Disponible desde:

Mylan IRE Healthcare Limited

Código ATC:

N06AG; N06AG02

Designación común internacional (DCI):

Moclobemide

Dosis:

150 milligram(s)

formulario farmacéutico:

Film-coated tablet

tipo de receta:

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

Área terapéutica:

Monoamine oxidase A inhibitors; moclobemide

Estado de Autorización:

Marketed

Fecha de autorización:

1991-07-04

Información para el usuario

PACKAGE LEAFLET: INFORMATION FOR THE USER
MANERIX
150 MG FILM-COATED TABLETS
moclobemide
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.
The name of your medicine is Manerix 150 mg Film-coated Tablets, which
will be called
Manerix Tablets throughout this leaflet.
WHAT IS IN THIS LEAFLET:
1.
What Manerix tablets are and what they are used for
2.
What you need to know before you take Manerix tablets
3.
How to take Manerix tablets
4.
Possible side effects
5.
How to store Manerix tablets
6.
Contents of the pack and other information
1.
WHAT MANERIX TABLETS ARE AND WHAT THEY ARE USED FOR
Manerix tablets contain the active ingredient moclobemide, which
belongs to a group of
medicines called monoamine oxidase inhibitors. Manerix tablets are
used for the treatment of
moderate or severe depression.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MANERIX TABLETS.
Do not take Manerix tablets:
-
If you are taking pethidine (a painkiller)
-
If you are taking selegiline (a treatment for Parkinson’s disease)
-
If you are taking bupropion (an antidepressant)
-
If you are taking medicines for severe headaches (triptans)
-
If you are taking tramadol
-
If you are taking dextromethorphan (cough suppressant)
-
If you are taking linezolid (an antibiotic)
-
If you are suffering from confusion
-
If you are allergic to moclobemide or any of the other ingredients of
this medicine
(listed in section 6). An allergic reaction may include rash, itching,
difficulty
breathing or swelling of the face, lips, throat or tongue.
Manerix tablets should not be taken by children.
WARNI

Ficha técnica

Health Products Regulatory Authority
05 May 2023
CRN00DDLK
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Manerix 150 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 150 mg moclobemide.
Each tablet contains 140.6 mg of lactose monohydrate.
For a full list excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Film coated tablets
Oblong pale yellow tablet with ‘150’ printed on one face, scored
on the reverse.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of moderate or severe depression.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Adults_
The initial daily dose is 300mg -usually in two or three divided
doses. The effects should usually occur within two to three
weeks. If this response is inadequate the dose may be increased to a
maximum of 600mg daily. Depending on response the
dosage may be reduced slowly to as low as 150mg daily after four
weeks. If no response occurs, treatment should be
discontinued.
The dose should not be raised until after the first week, as
bioavailability increased during this period. Treatment should
continue for at least 4-6 weeks in order to assess the efficacy of the
drug.
It is generally recommended that treatment should be continued until
the patient has been free of symptoms for four to six
months and then gradually tapered off.
_Elderly_
Older people do not require a special dose adjustment of Manerix.
_Paediatric Population_
In view of the lack of clinical data available, Manerix is not
recommended for use in the paediatric population.
Renal impairment
Patients with reduced renal function do not require a special dose
adjustment of Manerix.
Hepatic impairment
When hepatic metabolism is severely impaired by hepatic disease or a
drug that inhibits microsomal mono-oxygenase activity
(e.g. cimetidine), normal plasma levels are achieved by reducing the
daily dose of Manerix to half or one third (see section 4.5
Interaction with other medicinal products and other forms of
interaction and section