Mirtazapine 45mg orodispersible tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Mirtazapine

Available from:

Accord-UK 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: 5012617015648

Patient Information leaflet

READ ALL OF THIS LEA
F
LET CAREFULLY BEFORE YOU START TAKING
THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
•
Keep this lea
f
let. 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 LEA
F
LET 1
WHAT MIRTAZAPINE ORODISPERSIBLE TABLETS ARE AND
WHAT THEY ARE USED FOR 2
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
MIRTAZAPINE ORODISPERSIBLE TABLETS 3
HOW TO TAKE MIRTAZAPINE ORODISPERSIBLE TABLETS 4
POSSIBLE SIDE EFFECTS 5
HOW TO STORE MIRTAZAPINE ORODISPERSIBLE TABLETS 6
CONTENTS OF THE PACK AND OTHER INFORMATION 1
WHAT MIRTAZAPINE ORODISPERSIBLE TABLETS ARE AND
WHAT THEY ARE USED FOR
Mirtazapine is one of a group of medicines called
ANTIDEPRESSANTS.
Mirtazapine is used to treat depressive illness. 2
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
MIRTAZAPINE ORODISPERSIBLE TABLETS
DO NOT TAKE MIRTAZAPINE
• 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).
DO NOT TAKE - OR - TELL YOUR DOCTOR BEFORE TAKING MIRTAZAPINE:
If you have ever developed a SEVERE SKIN RASH OR SKIN
PEELING, BLISTERING AND/OR MOUTH SORES after taking
mirtazapine or other medicinal product(s).
WARNINGS AND PRECAUTIONS
CHILDREN AND ADOLESCENTS
Mirtazapine should normally not be used for children and
adolescents under 18 years. Also, you should know that
patients under 18 have an increased risk of side-effects such
as suicide attempt, suicidal thoughts and hostility
(predominantly aggression, oppositional behaviour and
anger) when they take this class of medicines. Despite this,
your doctor may pres

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 45 mg of mirtazapine.
Excipient(s): 18 mg of Aspartame (E951)
For a 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 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.
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 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
to this category of patients, particularly with severe hepatic
impairment, as
patients with severe hepatic impairment have not been investigated
(see
section 4.4).
Paediatric population
M