Mirtazapine 45mg orodispersible tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Mirtazapine

Available from:

Viatris UK Healthcare Ltd

ATC code:

N06AX11

INN (International Name):

Mirtazapine

Dosage:

45mg

Pharmaceutical form:

Orodispersible tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04030400; GTIN: 5016695001999

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
MIRTAZAPINE 15 MG ORODISPERSIBLE TABLETS
MIRTAZAPINE 30 MG ORODISPERSIBLE TABLETS
MIRTAZAPINE 45 MG ORODISPERSIBLE 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.
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
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.
2.
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 you are taking or have recently taken (within the last two
weeks) medicines called
monoamine oxidase inhibitors (MAO-inhibitors).
WARNING AND PRECAUTIONS
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 medicines. Serious skin reactions including
Stevens-Johnson syndrome (SJS),
toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia
and systemic symptoms (DRESS)
have been reported with the use of Mirtazapine. Stop using and seek
medical attention immediately if
you notice any of the symptoms described in section 4 in relation to
these serious skin re

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
MIRTAZAPINE 15 MG ORODISPERSIBLE TABLETS
MIRTAZAPINE 30 MG ORODISPERSIBLE TABLETS
MIRTAZAPINE 45 MG ORODISPERSIBLE TABLETS
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each orodispersible tablet contains 45 mg of mirtazapine.
Excipient with known effects:
Each orodispersible tablet contains 9 mg aspartame
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Orodispersible tablet.
Round and white, marked with the code ‘38’ on one side and ‘A’
on the other side.
4.1
THERAPEUTIC INDICATIONS
Treatment of episodes of major depression 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).
_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 sever