Mirtazapine 30mg tablets

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)

Δραστική ουσία:

Mirtazapine

Διαθέσιμο από:

Phoenix Healthcare Distribution Ltd

Φαρμακολογική κατηγορία (ATC):

N06AX11

INN (Διεθνής Όνομα):

Mirtazapine

Δοσολογία:

30mg

Φαρμακοτεχνική μορφή:

Oral tablet

Οδός χορήγησης:

Oral

Kατηγορία:

No Controlled Drug Status

Τρόπος διάθεσης:

Valid as a prescribable product

Περίληψη προϊόντος:

BNF: 04030400

Φύλλο οδηγιών χρήσης

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

Αρχείο Π.Χ.Π.

1.
NAME OF THE MEDICINAL PRODUCT
Mirtazapine 30mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 30 mg of mirtazapine.
Excipient with known effects:
Lactose monohydrate: 203.60 mg
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Brownish, scored on both sides, 12.7 x 6.5 mm oval, biconvex,
film-coated tablets. Marked
with I on one side.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Major depressive episode.
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
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.
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.
Children and adolescents under the age of 18 years
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).
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 account
when prescribing mirtazapine to this category of patients (see section
4.4).
Hepatic impairment
The clearance of mirtazapine may be decreased in patients with hepatic
impairment. This should be taken into account when prescribing
mirtazapine to
this category of patients, particularly with severe hepatic
impairment, as patients
with severe hepatic impairment have not been investigated (see section
4.4).
Mirtazapin