Mirtazapine 30mg tablets

البلد: المملكة المتحدة

اللغة: الإنجليزية

المصدر: MHRA (Medicines & Healthcare Products Regulatory Agency)

العنصر النشط:

Mirtazapine

متاح من:

Crescent Pharma Ltd

ATC رمز:

N06AX11

INN (الاسم الدولي):

Mirtazapine

جرعة:

30mg

الشكل الصيدلاني:

Oral tablet

طريقة التعاطي:

Oral

الفئة:

No Controlled Drug Status

نوع الوصفة الطبية :

Valid as a prescribable product

ملخص المنتج:

BNF: 04030400; GTIN: 5017123712135

نشرة المعلومات

PATIENT INFORMATION LEAFLET
MIRTAZAPINE 30mg
TABLETS
Mirtazapine
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 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.
In
THIS LEAFLET
1.
What Mirtazapine Tablets is and what it is used for
2.
What you need
to
know before you take Mirtazapine Tablets
3.
How
to take Mirtazapine Tablets
4.
Possible side effects
5.
How to store Mirtazapine Tablets
6.
Contents
of
the pack and other information
1.
WHAT MIRTAZAPINE TABLETS IS AND WHAT IT IS USED
FOR
Mirtazapine 30mg Tablets contain the active substance, mirtazapine.
Mirtazapine is one
of
a group of medicines called antidepressants.
Depression is linked to a shortage
of
substances which carry messages in
the
brain (including serotonin
and
noradrenaline). Mirtazapine helps to
relieve the shortage
of
these 'brain messages'. Common signs
of
depression
include feelings
of
worthlessness
or
deep sadness; difficulty with everyday
tasks; sleeping
too
much
or
not being able to sleep; feeling anxious; and
changes in appetite.
It may take 2 to 4 weeks before you start to feel better and sleep
better. It
is
important to take your medicine every
day
and not to stop taking it unless
your doctor tells you to. If you do, your symptoms may
come
back
.
2. WHATYOU NEED TO KNOW BEFORE YOU TAKE
MIRTAZAPINE TABLETS
DO
NOT
TAKE MIRTAZAPLNE
30MG
TABLETS:
•
if
you are allergic
to
mirtazapine or any of the other ingredients of
Mirtazapine 30mg Tablets
•
if
you are taking
or
have recently taken (within the last
two
weeks)
medicines called monoamine oxidase inhibitors (MAOls)
WARNINGS AND PRECAUTIONS
CHILDREN

خصائص المنتج

1.
NAME OF THE MEDICINAL PRODUCT
Mirtazapine 30mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 30 mg of mirtazapine.
Excipient with known effects:
Lactose monohydrate: 203.60 mg
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Brownish, scored on both sides, 12.7 x 6.5 mm oval, biconvex,
film-coated tablets. Marked
with I on one side.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Major depressive episode.
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
Adults
The effective daily dose is usually between 15 and 45 mg; the starting
dose is 15
or 30 mg.
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.
Children and adolescents under the age of 18 years
Mirtazapine 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).
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 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 severe hepatic
impairment, as patients
with severe hepatic impairment have not been investigated (see section
4.4).
Mirtazapin