Mirap 15 mg Film-Coated 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:

Film-coated tablet

Prescription type:

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

Therapeutic area:

Other antidepressants; mirtazapine

Authorization status:

Marketed

Authorization date:

2004-08-27

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MIRAP 15 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 Mirap is and what it is used for
2. What you need to know before you take Mirap
3. How to take Mirap
4. Possible side effects
5. How to store Mirap
6. Contents of the pack and other information
1. WHAT MIRAP IS AND WHAT IT IS USED FOR
Mirap is one of a group of medicines called
ANTIDEPRESSANTS
.
Mirap is used to treat depressive illness in adults.
Mirap 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
DO NOT TAKE OR TELL YOUR DOCTOR BEFORE TAKING MIRAP

if you are
ALLERGIC
to mirtazapine or any of the other ingredients of this medicine
(listed in section
6.1). If so, you must talk to your doctor as soon as you can before
taking Mirap

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 or other medicinal product(s).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Mirap.
CHILDREN AND ADOLESCENTS
Mirap should normally not be used for children and adolescents under
18

Summary of Product characteristics

HealthProductsRegulatoryAuthority
09February2022
CRN009R36
Page1of9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Mirap15mgFilm-CoatedTablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Eachfilm-coatedtabletcontains15mgofmirtazapine.
Excipient(s) with known effect
Eachfilm-coatedtabletcontains94.05mgoflactose(asmonohydrate)and0.021mgofsunsetyellowFCFlake(E110).
Forthefulllistofexcipients,seesection6.1.
3 PHARMACEUTICAL FORM
Film-coatedtablet
Yellow,film-coated,round,
biconvextabletwithaone-sidedscorenotch.
Thetabletcanbedividedintoequaldoses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Mirap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
supervisio