Mirtazapine 15mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Mirtazapine

Available from:

Noumed Life Sciences Ltd

ATC code:

N06AX11

INN (International Name):

Mirtazapine

Dosage:

15mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04030400; GTIN: 05060453460238

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MIRTAZAPINE 15 MG ORODISPERSIBLE TABLETS
MIRTAZAPINE 30 MG ORODISPERSIBLE TABLETS
MIRTAZAPINE 45 MG ORODISPERSIBLE TABLETS
(MIRTAZAPINE)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 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 Mirtazapine is and what it is used for
2.
What you need to know before you take Mirtazapine
3.
How to take Mirtazapine
4.
Possible side effects
5.
How to store Mirtazapine
6.
Contents of pack and other information
1.
WHAT MIRTAZAPINE IS AND WHAT IT IS USED FOR
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 (MAO-Is).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Mirtazapine.
CHILDREN AND ADOLESCENTS
Mirtazapine should normally not be used for children and adolescents
under 18 years
because effi

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Mirtazapine 15 mg Tablets.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
15mg: Each tablet contains 15 mg mirtazapine.
Excipient with known effects:
Lactose monohydrate: 99.0 mg
Sunset Yellow FCF (E110): 0.021 mg
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Film-coated tablet.
Mirtazapine 15 mg Tablets are yellow, oblong and biconvex tablets with
a score line
on one side.
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.
Children and adolescents under the age of 18 years
Mirtazapine Tablets 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 Tablets to this
category of
patients (see section 4.4).
Hepatic impairment
The clearance of mirtazapine may be decreased in patients with hepatic
impairment. This should be taken into account when prescribing
Mirtazapine
Tablets
to
this
category
of
patients,
particularly
with
severe
hepatic
impairment,
as
patie