Mirtazapine 30mg orodispersible tablets

Kraj: Wielka Brytania

Język: angielski

Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)

Składnik aktywny:

Mirtazapine

Dostępny od:

Milpharm Ltd

Kod ATC:

N06AX11

INN (International Nazwa):

Mirtazapine

Dawkowanie:

30mg

Forma farmaceutyczna:

Orodispersible tablet

Droga podania:

Oral

Klasa:

No Controlled Drug Status

Typ recepty:

Valid as a prescribable product

Podsumowanie produktu:

BNF: 04030400

Ulotka dla pacjenta

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 tablets
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.
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".
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MIRTAZAPINE
DO NOT TAKE OR TELL YOUR DOCTOR BEFORE TAKING 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).
•
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).
TAKE SPECIAL CARE WITH MIRTAZAPINE:
Serious skin reactions including Stevens-Johnson syndrome (SJS), toxic
epidermal
necrolysis (TEN) and drug reaction with eosinophilia and systemic
sym

Charakterystyka produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Mirtazapine 30mg orodispersible tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each orodispersible tablet contains 30 mg mirtazapine.
Excipients with known effect: aspartame 6 mg.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Orodispersible tablet.
White, round (diameter 8.0 mm) orodispersible tablets debossed with
“37” on
one side and ‘A’ on the other side with an embossed circular edge.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Mirtazapine is indicated in adults for the treatment of episodes of
major
depression.
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).
_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.
_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 sev