Mirtazapine 30mg orodispersible tablets

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)

Δραστική ουσία:

Mirtazapine

Διαθέσιμο από:

Bluefish Pharmaceuticals AB

Φαρμακολογική κατηγορία (ATC):

N06AX11

INN (Διεθνής Όνομα):

Mirtazapine

Δοσολογία:

30mg

Φαρμακοτεχνική μορφή:

Orodispersible tablet

Οδός χορήγησης:

Oral

Kατηγορία:

No Controlled Drug Status

Τρόπος διάθεσης:

Valid as a prescribable product

Περίληψη προϊόντος:

BNF: 04030400; GTIN: 7311921339302

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.

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Mirtazapine 30 mg orodispersible tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each orodispersible tablet contains 30 mg mirtazapine.
Excipient: aspartame 6 mg.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Orodispersible tablet.
White, round orodispersible tablets debossed with “37”on one side
and ‘A’ on the
other side with an embossed circular edge.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Mirtazapine orodisperisible tables is indicated in adults for the
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
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.
_ _
_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 tablets 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 sev