Zispin SolTab 15 mg orodispersible tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Mirtazapine

Available from:

Merck Sharp & Dohme Ireland (Human Health) Limited

ATC code:

N06AX; N06AX11

INN (International Name):

Mirtazapine

Dosage:

15 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:

2003-02-21

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ZISPIN® 15 MG FILM-COATED TABLETS
ZISPIN® 30 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.
WHAT IS IN THIS LEAFLET
1.
What Zispin is and what it is used for
2.
What you need to know before you take Zispin
3.
How to take Zispin
4.
Possible side effects
5.
How to store Zispin
6.
Contents of the pack and other information
1.
WHAT ZISPIN IS AND WHAT IT IS USED FOR
Zispin is one of a group of medicines called
ANTIDEPRESSANTS
.
Zispin is used to treat depressive illness in adults.
Zispin 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 ZISPIN
DO NOT TAKE ZISPIN:

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 Zispin.

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 Zispin.
TELL YOUR DOCTOR BEFORE TAKING ZISPIN:
If you have ever developed a severe skin rash or skin peeling,
blistering and/or mouth sores after
taking Zispin.
CHILDREN AND ADOLESCENTS
Zispin should normally not be used for children

Summary of Product characteristics

Health Products Regulatory Authority
13 April 2021
CRN009WLH
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zispin SolTab 15 mg orodispersible tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Zispin SolTab 15 mg orodispersible tablet contains 15mg of
mirtazapine.
Excipient(s) with known effect:
Each Zispin SolTab 15 mg orodispersible tablet contains 4.65 mg
aspartame and 28 mg sucrose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Orodispersible tablet.
Round, white, standard bevelled-edge, coded with ‘TZ1’ on one
side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Zispin 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 Zispin
to this category of patients (see section 4.4).
Health Products Regulatory Authority
13 April 2021
CRN009WLH
Page 2 of 11
_Hepatic impairment_
The clearance of mirtazapine may be