Mirtazapine Bluefish 15 mg orodispersible tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Mirtazapine

Available from:

Bluefish Pharmaceuticals AB

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:

2008-04-25

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
MIRTAZAPINE BLUEFISH 15 MG ORODISPERSIBLE TABLETS
MIRTAZAPINE BLUEFISH 30 MG ORODISPERSIBLE TABLETS
MIRTAZAPINE BLUEFISH 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 or
nurse.
•
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 or
nurse.This includes any possible
side effects not listed in this leaflet. See section 4
WHAT IS IN THIS LEAFLET:
1.
What Mirtazapine Bluefish is and what it is used for
2. What you need to know before you take Mirtazapine Bluefish
3. How to take Mirtazapine Bluefish
4. Possible side effects
5. How to store Mirtazapine Bluefish
6. Contents of the pack and other information
1.
WHAT MIRTAZAPINE BLUEFISH IS AND WHAT IT IS USED FOR
Mirtazapine Bluefish
is one of a group of medicines called antidepressants
.
Mirtazapine Bluefish is
used to treat depressive illness in adults. Mirtazapine Bluefish 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 BLUEFISH
DO NOT TAKE MIRTAZAPINE BLUEFISH
- 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-Is).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist or nurse before taking Mirtazapine
Bluefish.
DO NOT TAKE - OR - TELL YOUR DOCTOR BEFORE TAKING

Summary of Product characteristics

Health Products Regulatory Authority
13 April 2023
CRN00D7ML
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Mirtazapine Bluefish 15 mg orodispersible tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each orodispersible tablet contains 15 mg mirtazapine.
Excipientwith known effect: aspartame 3 mg.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Orodispersible tablet.
Mirtazapine Bluefish 15 mg orodispersible tablets:
White, round orodispersible tablets debossed with “36” on one side
and ‘A’ on the other side with an embossed circular edge.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
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.
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 years as efficacy was not demonstrated in two
short-term clinical trials (see section 5.1) and because of safety
concerns (see sections 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 be taken into account when prescribing
Mirtazapine Bluefish to this category of patients (see also section
4.4).
Hepatic impairment:
The clearance of mirtazapine may be decreased in patients with hepatic
impairment. This should be taken into account w