Mirap DisTab 15 mg Orodispersible Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Mirtazapine

Available from:

Rowex Ltd

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:

Marketed

Authorization date:

2007-08-03

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MIRAP DISTAB 15 MG ORODISPERSIBLE TABLETS
MIRAP DISTAB 30 MG ORODISPERSIBLE TABLETS
MIRAP DISTAB 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 Mirap DisTab is and what it is used for
2.
What you need to know before you take Mirap DisTab
3.
How to take Mirap DisTab
4.
Possible side effects
5.
How to store Mirap DisTab
6.
Contents of the pack and other information
1.
WHAT MIRAP DISTAB IS AND WHAT IT IS USED FOR
Mirap DisTab is one of a group of medicines called
ANTIDEPRESSANTS
.
Mirap DisTab is used to treat depressive illness in adults.
Mirap DisTab 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 MIRAP DISTAB
DO NOT TAKE OR TELL YOUR DOCTOR BEFORE TAKING MIRAP DISTAB:

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 Mirap DisTab.

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 Mirap DisTab or other medicinal product(s

Summary of Product characteristics

Health Products Regulatory Authority
06 January 2021
CRN00C0JF
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Mirap DisTab 15 mg Orodispersible Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each orodispersible tablet contains 15 mg of mirtazapine.
Excipients with known effect
Each orodispersible tablet contains 3 mg of aspartame (E951), 15
nanograms of sulphites and 0.047 mg of benzyl alcohol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Orodispersible tablet.
White to off-white, round, flat tablets with bevelled edges and plain
on both sides.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Mirap Dis Tab 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 Mirap Dis
Tab to this category of patients (see section 4.4).
Hepatic impairment
The clearance of mirtazapine may be decreased in patients with hepatic
impairment. This shou