Mirtazapine 30mg tablets

País: Regne Unit

Idioma: anglès

Font: MHRA (Medicines & Healthcare Products Regulatory Agency)

ingredients actius:

Mirtazapine

Disponible des:

Viatris UK Healthcare Ltd

Codi ATC:

N06AX11

Designació comuna internacional (DCI):

Mirtazapine

Dosis:

30mg

formulario farmacéutico:

Oral tablet

Vía de administración:

Oral

clase:

No Controlled Drug Status

tipo de receta:

Valid as a prescribable product

Resumen del producto:

BNF: 04030400; GTIN: 5016695000671

Informació per a l'usuari

1.3.1 SPC, LABELLING AND PACKAGE LEAFLET
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
CARTON
1.
NAME OF THE MEDICINAL PRODUCT
Mirtazapine 15 mg orodispersible tablets
Mirtazapine
Mirtazapine 30 mg orodispersible tablets
Mirtazapine
Mirtazapine 45 mg orodispersible tablets
Mirtazapine
2.
STATEMENT OF ACTIVE SUBSTANCE(S)
Each orodispersible tablet contains 15 mg mirtazapine.
Each orodispersible tablet contains 30 mg mirtazapine.
Each orodispersible tablet contains 45 mg mirtazapine.
3.
LIST OF EXCIPIENTS
Contains aspartame (E951), see leaflet for further information.
4.
PHARMACEUTICAL FORM AND CONTENTS
Orodispersible tablet
_6 orodispersible tablets _
_18 orodispersible tablets _
_30 orodispersible tablets _
_48 orodispersible tablets _
_90 orodispersible tablets _
_96 orodispersible tablets _
5.
METHOD AND ROUTE(S) OF ADMINISTRATION
_ _
Oral use.
Read the package leaflet before use.
6.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE
STORED OUT OF THE SIGHT AND REACH OF CHILDREN
Keep out of the sight and reach of children.
1.3.1 SPC, LABELLING AND PACKAGE LEAFLET
7.
OTHER SPECIAL WARNING(S), IF NECESSARY
-------
8.
EXPIRY DATE
EXP
_ _
9.
SPECIAL STORAGE CONDITIONS
-------
10.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL
PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL
PRODUCTS, IF APPROPRIATE
-------
11.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION
HOLDER
Bluefish Pharmceuticals AB, Stockholm, Sweden.
12.
MARKETING AUTHORISATION NUMBER(S)
Mirtazapine 15 mg Orodispersible Tablets: PL 31774/0013
Mirtazapine 30 mg Orodispersible Tablets: PL 31774/0014
Mirtazapine 45 mg Orodispersible Tablets: PL 31774/0015
13.
BATCH NUMBER
Lot
14.
GENERAL CLASSIFICATION FOR SUPPLY
15.
INSTRUCTIONS ON USE
-------
16.
INFORMATION IN BRAILLE
Mirtazapine 15 mg
Mirtazapine 30 mg
Mirtazapine 45 mg
POM
1.3.1 SPC, LABELLING AND PACKAGE LEAFLET
17.
UNIQUE IDENTIFIER – 2D BARCODE_ _
<2D barcode carrying the unique identifier included.>
18.
UNIQUE IDENTIFIER - HUMAN READABLE DATA_ _
PC: {number}
SN: {number}
NN: {number}
1

Fitxa tècnica

OBJECT 1
MIRTAZAPINE 30 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 19-Dec-2017 | Generics UK
T/A Mylan
1. Name of the medicinal product
Mirtazapine 30 mg Film-coated Tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 30 mg of mirtazapine.
Excipients with known effect:
Each tablet contains 226.5 mg lactose anhydrous and 1.8 mg lactose
monohydrate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet
A normal convex, circular buff film coated tablet debossed “MR
scoreline 30” on one side and “G” on the
other.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4. Clinical particulars
4.1 Therapeutic indications
Treatment of episodes of major depression
4.2 Posology and method of administration
Posology
_Adults_
The effective daily dose is usually between 15 and 45 mg; the starting
dose is 15 or 30 mg. Mirtazapine
begins to exert its effect in general after 1-2 weeks of treatment.
Treatment with an adequate dose should
result in a positive response within 2-4 weeks. With an insufficient
response, the dose can be increased up
to the maximum dose. If there is no response within a further 2-4
weeks, then treatment should be
stopped.
Patients with depression should be treated for a sufficient period of
at least 6 months to ensure that they
are free from symptoms.
It is recommended to discontinue treatment with mirtazapine gradually
to avoid withdrawal symptoms
(see section 4.4).
_Older people_
The recommended dose is the same as that for adults. In older people,
an increase in dosing should be
done under close supervision to elicit a satisfactory and safe
response.
_Paediatric population_
Mirtazapine should not be used in children and adolescents under the
age of 18 years as efficacy was not
demonstrated in two short-term clinical trials (see section 5.1) and
because of safety concerns (see
sections 4.4, 4.8 and 5.1)
_Patients with renal impairment_
The clearance of