Mirtazapine 30mg orodispersible 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:

Orodispersible tablet

Οδός χορήγησης:

Oral

Kατηγορία:

No Controlled Drug Status

Τρόπος διάθεσης:

Valid as a prescribable product

Περίληψη προϊόντος:

BNF: 04030400

Φύλλο οδηγιών χρήσης

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 or
nurse.
•
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 or
nurse.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.
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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MIRTAZAPINE
DO NOT TAKE MIRTAZAPINE
-
if you are allergic (hypersensitive) to mirtazapine or any of the
other ingredients of
Mirtazapine. 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).
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).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist or nurse before taking Mirtazapine.
CHILDREN AND ADOLESCENTS
Mirtazapine should normally not be used for children and
adolescents under 18 years. Also, you should know that patients under
18 have an increased
risk of side-effects such as suicide attempt, suicidal thoughts and
hostility (predominantly
aggression, oppositional behaviour and anger) when they take this
class of medicines. Despite
this, your doctor may prescribe Mirt

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Mirtazapine 30 mg orodispersible tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each orodispersible tablet contains 30 mg mirtazapine.
Excipient: aspartame 6 mg.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Orodispersible tablet.
White, round 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 orodisperisible tables 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
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.
_ _
_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 tablets 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