Mirtazapine 45mg orodispersible tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Mirtazapine

Available from:

Sigma Pharmaceuticals Plc

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

Myriad Pro
9 pt
9 pt
Mirtazapine_45mg_15mg_30mg_all
Leaflet
1941517
1936886
1941517
N/A
Aurobindo Pharma Ltd
(Unit-III : Hyderabad - IN)
P1521870
21870
N/A
102854961/0020
3
United Kingdom
Leaflet KLD 280 x 480 mm (60 x 35 mm)
N/A
1
280 x 480 mm
BLACK
1 / 2
N/A
v3/Jul 2017
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23:00
18 Sep 19
PACKAGE LEAFLET: INFORMATION FOR THE USER
MIRTAZAPINE 15 MG ORODISPERSIBLE TABLETS
MIRTAZAPINE 30 MG ORODISPERSIBLE TABLETS
MIRTAZAPINE 45 MG ORODISPERSIBLE TABLETS
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.
•
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. 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 in adults.
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 you are taking or have recen

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