REMERON 15 mg TABLET

Pajjiż: Afrika t’Isfel

Lingwa: Ingliż

Sors: South African Health Products Regulatory Authority (SAHPRA)

Disponibbli minn:

Organon South Africa (Pty) Ltd

Dożaġġ:

See ingredients

Għamla farmaċewtika:

TABLET

Kompożizzjoni:

EACH TABLET CONTAINS MIRTAZAPINE 15,0 mg

L-istatus ta 'awtorizzazzjoni:

Registered

Data ta 'l-awtorizzazzjoni:

2000-06-07

Fuljett ta 'informazzjoni

Page 1 of 14
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
PROPRIETARY NAME AND DOSAGE FORM
REMERON
®
15 mg Tablet
REMERON
®
30 mg Tablet
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN REMERON

Keep this leaflet. You may need to read it again.

If you have further questions, please ask your doctor or your
pharmacist.

REMERON has been prescribed for you personally and you should not
share your
medicine with other people. It may harm them, even if their symptoms
are the same as
yours.
1.
WHAT REMERON CONTAINS
Each REMERON 15 mg tablet contains as active ingredient 15 mg
mirtazapine and each 30
mg tablet contains as active ingredient 30 mg mirtazapine.
The inactive ingredients are maize starch, hydroxypropyl cellulose,
magnesium stearate,
colloidal silicon dioxide, lactose monohydrate, hydroxypropyl
methylcellulose, polyethylene
glycol, titanium dioxide and red and yellow iron oxide colouring
agents.
2.
WHAT REMERON IS USED FOR
This medicine belongs to a group of medicines known as
antidepressants.
REMERON is used to treat depression in adults.
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Page 2 of 14
It may take up to 4 weeks before you experience an improvement.
3.
BEFORE TAKING REMERON
DO NOT TAKE REMERON:

If you are allergic (hypersensitive) to mirtazapine or any of the
other ingredients of
REMERON. If so, you must talk to your doctor as soon as you can before
taking
REMERON.

If you are taking or have recently taken (within the last 2 weeks)
medicines called
monoamine oxidase inhibitors (MAO-Is).
TAKE SPECIAL CARE WITH REMERON
USE IN CHILDREN AND ADOLESCENTS UNDER 18 YEARS OF AGE
REMERON should not be used for children and adolescents under 18
years, as 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 have
taken this class of medicines.
THOUGHTS OF SUICIDE AND WORSENING OF YOUR DEPRESSION
If you are depressed you may have thoughts of harming or killing
yourself. These thoughts
may be increas

Karatteristiċi tal-prodott

Page 1 of 19
SCHEDULING STATUS
PROPRIETARY NAME AND DOSAGE FORM
REMERON
®
15 mg Tablet
REMERON
®
30 mg Tablet
COMPOSITION
Each REMERON 15 mg film-coated tablet contains 15 mg of mirtazapine.
Contains sugar: lactose monohydrate 114 mg.
Excipients: colloidal anhydrous silica, hydroxypropyl cellulose,
magnesium stearate and maize
starch.
Coating layer: hydroxypropyl methylcellulose, polyethylene glycol,
titanium dioxide and iron
oxide yellow.
Each REMERON 30 mg film-coated tablet contains 30 mg of mirtazapine.
Contains sugar: lactose monohydrate 227 mg.
Excipients: colloidal anhydrous silica, hydroxypropyl cellulose,
magnesium stearate and maize
starch.
Coating layer: hydroxypropyl methylcellulose, polyethylene glycol,
titanium dioxide, iron oxide
yellow, iron oxide red.
PHARMACOLOGICAL CLASSIFICATION
A.1.2 Psychoanaleptics (antidepressants)
PHARMACOLOGICAL ACTION
PHARMACODYNAMIC PROPERTIES
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Page 2 of 19
Mirtazapine is a tetracyclic antidepressant, belonging to the
piperazino-azepine group of
compounds. Mirtazapine is an antagonist of central α
2
-auto and hetero-adrenoceptors which
causes an increase in both noradrenaline and serotonin release.
The effect of released serotonin is exerted specifically via 5-HT
1
type receptors, because 5-
HT
2
and 5-HT
3
type receptors are specifically blocked by mirtazapine. Both
enantiomers of
mirtazapine are presumed to contribute to the antidepressant activity,
the S(+) enantiomer
by blocking α
2
-auto and hetero-adrenoceptors and 5-HT
2
receptors and the R(-) enantiomer
by blocking α
2
hetero-adrenoceptors and 5-HT
3
receptors.
In one study there was no efficacy difference indicated between the
two enantiomers,
despite their different receptor affinities.
The potent histamine H
1
-antagonistic activity of mirtazapine is responsible for its sedative
properties. Mirtazapine has modest antagonism on cholinergic activity.
Mirtazapine has
modest peripheral α
1
-adrenergic antagonist activities and has been associated with acute
postural hypotension (see SIDE EFFECTS).
PHARMA