Mirtazapine 15mg orodispersible tablets

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Mirtazapine

Tilgjengelig fra:

Teva UK Ltd

ATC-kode:

N06AX11

INN (International Name):

Mirtazapine

Dosering :

15mg

Legemiddelform:

Orodispersible tablet

Administreringsrute:

Oral

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 04030400; GTIN: 5017007028550

Informasjon til brukeren

Black
BLUEFISH PHARMACEUTICALS
Product name
Dimension
Artwork made to
No. of colours
Braille
Artwork code
Pantone Shades
M/MIR/UK/P01
01
MIRTAZAPINE ORODISPERSIBLE TABLETS
Strength
Packs
15/30/45 MG
NA
200 X 600 MM
100%
Country
UK
Component
LEAFLET
Manufacturer
CENTAUR
Reason of change
Revision no.
Reviewed
&
Approved by
Revision
History
PDC
QA
RA
Remarks
Folding size: 200 x 37.5 mm
FONT SIZE: HEADING - 15, 13 PTS. REST ALL 9 PTS.
Blister Layout No.:
NA
Date: 28.02.2017
02
REVISED TEXT RECEIVED ON 28.02.17
R1 - Initial Mock-up Artwork (AM-17-011), text dated (21.02.17) -
28.02.17
NA
PACKAGE LEAFLET: INFORMATION FOR THE USER
MIRTAZAPINE 15 MG ORODISPERSIBLE TABLETS
MIRTAZAPINE 30 MG ORODISPERSIBLE TABLETS
MIRTAZAPINE 45 MG ORODISPERSIBLE TABLETS
Mirtazapine
United kingdom
200 mm
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist
or nurse.
•
This medicine has been prescribed for you only. Do not pass it
on to others. It may harm them, even if their signs of illness are
the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. See section 4
WHAT IS IN THIS LEAFLET:
1.
What Mirtazapine is and what it is used for
2.
What you need to know before you take Mirtazapine
3.
How to take Mirtazapine
4.
Possible side effects
5.
Contents of the pack and other information
1. WHAT MIRTAZAPINE IS AND WHAT IT IS USED FOR
Mirtazapine is one of a group of medicines called antidepressants.
Mirtazapine is used to treat depressive illness.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
MIRTAZAPINE
DO NOT TAKE MIRTAZAPINE
-
if you are allergic (hypersensitive) to mirtazapine or any of
the other ingredients of Mirtazapine. If so, you must talk to
your doctor as soon as you can before taking Mirtazapine.
-
if you are taking or have recently taken

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Mirtazapine 15 mg orodispersible tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each orodispersible tablet contains 15 mg mirtazapine.
Excipient: aspartame 3 mg.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Orodispersible tablet.
White, round orodispersible tablets debossed with “36”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