Mirtazapine 15mg orodispersible tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Mirtazapine

Available from:

Almus Pharmaceuticals Ltd

ATC code:

N06AX11

INN (International Name):

Mirtazapine

Dosage:

15mg

Pharmaceutical form:

Orodispersible tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04030400; GTIN: 05060057404256

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
MIRTAZAPINE 15 MG ORODISPERSIBLE TABLETS
MIRTAZAPINE 30 MG ORODISPERSIBLE TABLETS
MIRTAZAPINE 45 MG ORODISPERSIBLE TABLETS
Mirtazapine
WHAT IS IN THIS LEAFLET:
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 in adults.
Mirtazapine Orodispersible tablets 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
ORODISPERSIBLE TABLETS DO NOT TAKE MIRTAZAPINE
−
If you are allergic to mirtazapine or any of the other ingredients of
Mirtazapine
Orodispersible tablets. If so, you must talk to your doctor as soon as
you can before taking
Mirtazapine Orodispersible tablets.
−
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
orodispersible tablets.
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 pharm

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Mirtazapine 15 mg orodispersible tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each orodispersible tablet contains 15 mg mirtazapine.
Excipient: aspartame 3 mg.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Orodispersible tablet.
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
Mirtazapine orodisperisible tables 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
30mg.
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 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 to this
category of
patients, particularly with sev