Mirtazapine 45 mg Film-Coated Tablets

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

Mirtazapine

Tilgængelig fra:

Accord Healthcare Ireland Ltd.

ATC-kode:

N06AX; N06AX11

INN (International Name):

Mirtazapine

Dosering:

45 milligram(s)

Lægemiddelform:

Film-coated tablet

Recept type:

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

Terapeutisk område:

Other antidepressants; mirtazapine

Autorisation status:

Marketed

Autorisation dato:

2006-02-17

Indlægsseddel

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MIRTAZAPINE 15 MG, 30 MG & 45 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.
1 What Mirtazapine is and what it is used for
2.
2 What you need to know before you take Mirtazapine
3.
3 How to take Mirtazapine
4.
4 Possible side effects
5.
5 How to store Mirtazapine
6.
6 Contents of the pack and other information
1.
WHAT MIRTAZAPINE IS AND WHAT IT IS USED FOR
Mirtazapine contains the active ingredient mirtazapine.
Mirtazapine is one of a group of medicines called
ANTIDEPRESSANTS
.
Mirtazapine is used to treat depressive illness in adults.
Mirtazapine 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 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 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 (MAOIs).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Mirtazapine.
TELL YOUR DOCTOR BEFORE TAKING MIRTAZAPINE:
If you have ever developed a severe skin rash or skin peeling,
blisteri

Produktets egenskaber

Health Products Regulatory Authority
25 January 2022
CRN00CPZK
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Mirtazapine 45 mg Film-Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Mirtazapine 45 mg film-coated tablet contains 45 mg of
mirtazapine.
Excipients with known effect:
Each Mirtazapine 45 mg film-coated tablet contains 305.4 mg lactose
(as monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
White, 14.5 x 7.5 mm oval, biconvex film-coated tablets, marked I.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Mirtazapine 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.
_Paediatric population_
Mirtazapine should not be used in children and adolescents under the
age of 18 as efficacy was not demonstrated in two
short-term clinical trials (see section 5.1) and because of safety
concerns (see section 4.4, 4.8 and 5.1).
_Renal impairment _
The clearance of mirtazapine may be decreased in patients with
moderate to severe renal impairment (creatinine clearance <
40 ml/min). This should