Mirtazapine 30mg tablets

দেশ: যুক্তরাজ্য

ভাষা: ইংরেজি

সূত্র: MHRA (Medicines & Healthcare Products Regulatory Agency)

সক্রিয় উপাদান:

Mirtazapine

থেকে পাওয়া:

Mawdsley-Brooks & Company Ltd

এটিসি কোড:

N06AX11

INN (আন্তর্জাতিক নাম):

Mirtazapine

ডোজ:

30mg

ফার্মাসিউটিকাল ফর্ম:

Oral tablet

প্রশাসন রুট:

Oral

শ্রেণী:

No Controlled Drug Status

প্রেসক্রিপশন টাইপ:

Valid as a prescribable product

পণ্য সারাংশ:

BNF: 04030400

তথ্য লিফলেট

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

পণ্য বৈশিষ্ট্য

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Mirtazapine 30mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Mirtazapine 30mg film-coated tablet contains 30mg of mirtazapine.
Excipient with known effect:
Each Mirtazapine 30mg film-coated tablet contains 203.6mg lactose (as
monohydrate).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet, film coated.
Brownish, scored on both sides, 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.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
The effective daily dose is usually between 15mg and 45mg; the
starting dose
is 15mg 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.
_Paediatric population _
Mirtazapine tablets 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 <40 ml/min). This should
be
taken into a