Mirtazapine 15mg tablets

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktívna zložka:

Mirtazapine

Dostupné z:

Accord-UK Ltd

ATC kód:

N06AX11

INN (Medzinárodný Name):

Mirtazapine

Dávkovanie:

15mg

Forma lieku:

Oral tablet

Spôsob podávania:

Oral

Trieda:

No Controlled Drug Status

Typ predpisu:

Valid as a prescribable product

Prehľad produktov:

BNF: 04030400; GTIN: 5012617017604

Príbalový leták

Actavis BST - Packing Technical
[e-mail]
Dimensions:
Component:
Date Sent:
Technologist: TECHNICALLY APPROVED
Pharmacode:
JDE No.:
Mirtazapine 15 & 45mg x 28’s (UK)
296x210 (Reel Fed)
50847015
Leaflet for Blisters
8229
R.Wrey
19/02/15
296x210 Leaflet Reel Fed Bi Fold Profile (BST)
Mirtazapine 15mg & 45mg tablet leaflet - UK
item no:
print proof no:
origination date:
originated by:
revision date:
revised by:
dimensions:
pharmacode:
colours/plates:
approved for print/date
Non Printing Colours
1. Black
2.
3.
4.
5.
6.
1. profile
2.
3.
date sent:
supplier:
technically app. date:
min pt size:
TECHNICAL APPROVAL
AAAH6970
6
20.02.15
jh
15.06.15
jh
UK
296 x 210
7, 8, 9
N/A
N/A
page 4
page 1
50847015
AAAH6970
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, 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,
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
HOW TO STORE MIRTAZAPINE
6
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 to mirtazapine or any of the other ingredients
of this medicine (listed in section 6). If so, you must
talk to your doctor as soon as you can before taking
Mirtazapine.
·
taking or have recently taken (within the last two
weeks) medicines called m

Súhrn charakteristických

OBJECT 1
MIRTAZAPINE 15MG TABLETS
Summary of Product Characteristics Updated 03-Aug-2015 | Accord-UK Ltd
1. Name of the medicinal product
Mirtazapine 15mg Tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 15mg of mirtazapine
Excipient with known effects: Lactose monohydrate.
Each tablet contains 101.8mg
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
Yellow, scored on both sides, 10 x 5.2 mm 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.
Mirtazapine 15mg Tablets are indicated in adults.
4.2 Posology and method of administration
Posology
Adults
The effective daily dose is usually between 15 and 45mg; 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.
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 populationMirtazapine 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 <40ml/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 t