Mirtazapine 15mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Mirtazapine

Available from:

Phoenix Healthcare Distribution 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

Patient Information leaflet

MIRTAZAPINE 15MG AND 45MG FILM-COATED 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, 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, 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 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.
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.
•
taking or have recently taken (within the last two weeks) medicines
called monoamine oxidase
inhibitors (MAO-Is).
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR, PHARMACIST OR NURSE BEFORE TAKING MIRTAZAPINE
CHILDREN AND ADOLESCENTS
Mirtazapine should normally not be used for children and adolescents
under 18 years because efficacy has
not been demonstrated. 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 prescribe
Mirtazapine for patients under 18 because he/she decides that this is
in their best interests. If your doc

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Mirtazapine 15mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 15mg of mirtazapine
Excipient with known effects: Lactose monohydrate.
Each tablet contains 101.8mg
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
Yellow, scored on both sides, 10 x 5.2 mm oval, biconvex, film-coated
tablets.
Marked with I on one side.
The tablet can be divided into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of episodes of major depression.
Mirtazapine 15mg Tablets are indicated in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults
The effective daily dose is usually between 15 and 45mg; 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.
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 populationMirtazapine should not be used in children and
adolescents
under the age of 18 years (see section 4.4) 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 <40ml/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
patient