Mirtazapine 30mg tablets

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)

Δραστική ουσία:

Mirtazapine

Διαθέσιμο από:

DE Pharmaceuticals

Φαρμακολογική κατηγορία (ATC):

N06AX11

INN (Διεθνής Όνομα):

Mirtazapine

Δοσολογία:

30mg

Φαρμακοτεχνική μορφή:

Oral tablet

Οδός χορήγησης:

Oral

Kατηγορία:

No Controlled Drug Status

Τρόπος διάθεσης:

Valid as a prescribable product

Περίληψη προϊόντος:

BNF: 04030400

Φύλλο οδηγιών χρήσης

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

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Mirtazapine 30mg Tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 30mg of mirtazapine.
Excipient(s) with known effect
Each film-coated tablet contains 203.6 mg Lactose
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet
Brownish, scored on both sides, 12.7 x 6.5mm oval, biconvex,
film-coated
tablets. Marked with I on one side.
4.1 THERAPEUTIC INDICATIONS
Mirtazapine is indicated in adults for the treatment of major
depressive episode.
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 30 mg.
The antidepressive effect of mirtazapine usually becomes evident after
1 to 2 weeks
use. Treatment with an adequate dose should result in a positive
response within 2 to
4 weeks. With an insufficient response, the dose can be increased up
to the maximum
dose. After having obtained an optimal clinical effect and the patient
is free of
symptoms, the treatment should be continued for 4 to 6 months, until a
gradual
discontinuation can be considered. If no clinical response is observed
within 2 to 4
weeks of treatment with the maximum dose, the treatment should be
gradually
discontinued. Gradually tapering down the dosage is necessary to avoid
withdrawal
symptoms (see section 4.4).
_Elderly patients:_ The recommended dose is the same as that for
adults. In elderly
patients, changes especially increments of dosage must be made
cautiously and under
close supervision to elicit a satisfactory and safe response.
_Paediatric population_
Mirtazapine should not be used in children and adolescents (under 18
years of age), as
efficacy was not demonstrated in two short-term clinical trial (see
section 5.1) and
because of safety concern (see section 4.4, 4.8 and 5.1), the use is
not recommended.
_Renal impairment_
The clearance of mirtazapine may be decreased in patients with
moderate to severe
renal impairmen