Zismirt orotab 45 mg Orodispersible Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Mirtazapine

Available from:

McDermott Laboratories Ltd., T/A Gerard Laboratories

ATC code:

N06AX; N06AX11

INN (International Name):

Mirtazapine

Dosage:

45 milligram(s)

Pharmaceutical form:

Orodispersible tablet

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Other antidepressants; mirtazapine

Authorization status:

Not marketed

Authorization date:

2008-01-25

Patient Information leaflet

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ZISMIRT OROTAB 15 MG ORODISPERSIBLE TABLETS
ZISMIRT OROTAB 30 MG ORODISPERSIBLE TABLETS
ZISMIRT OROTAB 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 Zismirt orotab is and what it is used for
2.
What you need to know before you take Zismirt orotab
3.
How to take Zismirt orotab
4.
Possible side effects
5.
How to store Zismirt orotab
6.
Contents of the pack and other information
1.
WHAT ZISMIRT OROTAB IS AND WHAT IT IS USED FOR
Zismirt orotab is one of a group of medicines called
ANTIDEPRESSANTS
.
Zismirt orotab is used to treat depressive illness in adults.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZISMIRT OROTAB
DO NOT TAKE ZISMIRT OROTAB:
-
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).
WARNINGS AND PRECAUTIONS
DO NOT TAKE OR TELL YOUR DOCTOR BEFORE TAKING ZISMIRT OROTAB:
If you have ever developed a severe skin rash or skin peeling,
blistering and/or mouth sores after taking
Zismirt orotab 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 Zismirt orotab. Stop using and seek
medical attention immediately if
you notice any of the symptoms

Summary of Product characteristics

Health Products Regulatory Authority
18 November 2022
CRN00CK5G
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zismirt orotab 45 mg Orodispersible Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each orodispersible tablet contains 45 mg mirtazapine.
Excipient with known effects:
Each orodispersible tablet contains 9 mg aspartame.
For the full list of the 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 CLINICAL PARTICULARS
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. Zismirt orotab 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,