Mirtazapine 45mg orodispersible tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Mirtazapine

Available from:

Mawdsley-Brooks & Company Ltd

ATC code:

N06AX11

INN (International Name):

Mirtazapine

Dosage:

45mg

Pharmaceutical form:

Orodispersible tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04030400

Patient Information leaflet

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

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Mirtazapine 45 mg orodispersible tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 30 mg of mirtazapine.
Excipient with known effects: 18 mg of Aspartame (E951)
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Orodispersible tablet The tablets are white or almost white, 12 mm
round, biconvex,
uncoated tablets and marked M4.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of depressive illness.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The tablet should be taken out of the blister with dry hands and
should be
placed on the tongue.
The tablet will disintegrate and can be swallowed without water. The
tablet
should be swallowed without chewing.
Adults: Treatment should begin with 15 mg daily. The dosage generally
needs
to be increased to obtain an optimal clinical response. The effective
daily dose
is usually between 15 and 45 mg.
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: Since safety and efficacy of Mirtazapine has not been
established in
children, it is not recommended to treat children with Mirtazapine.
Two
randomised
placebo-controlled
trials
failed
to
demonstrate
efficacy
for
Mirtazapine in the treatment of children and adolescents with major
depressive
disorder. Safety and efficacy of Mirtazapine in paediatric depression
can not
be extrapolated from adult data.
Children and adolescents under the age of 18 years
Mirtazapine Tablets 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).
The clearance of mirtazapine may be decreased in patients with renal
or
hepatic insufficiency. This should be taken into account when
prescribing
Mirtazapine to this category of patients.
Mirt