Mirtazapine 15mg tablets

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktívna zložka:

Mirtazapine

Dostupné z:

Teva 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: 5017007028574

Príbalový leták

MIRTAZAPINE 15 MG
FILM-COATED 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 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.
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. Content of the pack and other
information
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.
Mirtazapine will take 1 to 2 weeks before
it starts working. After 2 to 4 weeks you
may start feeling better. You must talk to
your doctor if you do not feel better or if
you feel worse after 2 to 4 weeks. More
information is in section 3 heading
"When can you expect to start feeling
better".
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.
• If you are taking or have recently
taken (within the last two weeks)
medicines called monoamine oxidase
inhibitors (MAO-Is).
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR OR PHARMACIST BEFORE
TAKING MIRTAZAPINE
DO NOT TAKE - OR - TELL YOUR
DOCTOR BEFORE TAKING Mirtazapine:
IF YOU HAVE EVER DEVELOPED A SEVERE SKIN
RASH OR SKIN PEELING, BLISTERING AND/OR
MOUTH SORES after taking Mirtazapine or
other medicinal product(s).
CHILDREN AND ADOLESCENTS
Mirtazapine should normally not be
used

Súhrn charakteristických

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Mirtazapine 15 mg Film-coated Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 15 mg of mirtazapine
Excipients with known effect:
15 mg: Each tablet contains 107.7 mg lactose
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
Yellow, round tablets. One side of the tablet has a scoreline with the
marking ”9” on
one side of the scoreline and the number ”3” on the other. The
other side of the tablet
is marked with the number ”7206”. The score line is not intended
for breaking the
tablet.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of episodes of major depression
Mirtazapine is indicated in adults.
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.
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).
Older people
The recommended dose is the same as that for adults. In older people
an increase in
dosing should be done under close supervision to elicit a satisfactory
and safe response.
Paediatric population
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
re