Mirtazapine 45mg orodispersible tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Mirtazapine

Available from:

Consilient Health Ltd

ATC code:

N06AX11

INN (International Name):

Mirtazapine

Dosage:

45mg

Pharmaceutical form:

Orodispersible tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04030400; GTIN: 3838989546472

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 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 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 the 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:
-
If you have ever developed a severe skin rash or skin peeling,
blistering and/or mouth sores
after taking mirtazapine or o

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Mirtazapine 45 mg orodispersible tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 30 mg of mirtazapine.
Excipient with known effects: 18 mg of Aspartame (E951)
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Orodispersible tablet The tablets are white or almost white, 12 mm
round, biconvex,
uncoated tablets and marked M4.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of depressive illness.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The tablet should be taken out of the blister with dry hands and
should be
placed on the tongue.
The tablet will disintegrate and can be swallowed without water. The
tablet
should be swallowed without chewing.
Adults: Treatment should begin with 15 mg daily. The dosage generally
needs
to be increased to obtain an optimal clinical response. The effective
daily dose
is usually between 15 and 45 mg.
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: Since safety and efficacy of Mirtazapine has not been
established in
children, it is not recommended to treat children with Mirtazapine.
Two
randomised
placebo-controlled
trials
failed
to
demonstrate
efficacy
for
Mirtazapine in the treatment of children and adolescents with major
depressive
disorder. Safety and efficacy of Mirtazapine in paediatric depression
can not
be extrapolated from adult data.
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).
The clearance of mirtazapine may be decreased in patients with renal
or
hepatic insufficiency. This should be taken into account when
prescribing
Mirtazapine to this category of patients.
Mirt