Mirtazapine 30mg tablets

País: Regne Unit

Idioma: anglès

Font: MHRA (Medicines & Healthcare Products Regulatory Agency)

ingredients actius:

Mirtazapine

Disponible des:

Alliance Healthcare (Distribution) 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

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

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Mirtazapine 30mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Mirtazapine 30mg film-coated tablet contains 30mg of mirtazapine.
Excipient with known effect:
Each Mirtazapine 30mg film-coated tablet contains 203.6mg lactose (as
monohydrate).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet, film coated.
Brownish, scored on both sides, oval, biconvex, film-coated tablets.
Marked with “I”
on one side. The tablet can be divided 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 15mg and 45mg; the
starting dose
is 15mg or 30mg. 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).
_Elderly _
The recommended dose is the same as that for adults. In elderly
patients an
increase in dosing should be done under close supervision to elicit a
satisfactory and safe response.
_Paediatric population _
Mirtazapine tablets should not be used in children and adolescents
under the
age of 18 years (see section 4.4) 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)..
_Renal impairment _
The clearance of mirtazapine may be decreased in patients with
moderate to
severe renal impairment (creatinine clearance <40 ml/min). This should
be
taken into a