Moclobemide 300mg tablets

البلد: المملكة المتحدة

اللغة: الإنجليزية

المصدر: MHRA (Medicines & Healthcare Products Regulatory Agency)

العنصر النشط:

Moclobemide

متاح من:

Tillomed Laboratories Ltd

ATC رمز:

N06AG02

INN (الاسم الدولي):

Moclobemide

جرعة:

300mg

الشكل الصيدلاني:

Oral tablet

طريقة التعاطي:

Oral

الفئة:

No Controlled Drug Status

نوع الوصفة الطبية :

Valid as a prescribable product

ملخص المنتج:

BNF: 04030200; GTIN: 5024655001668

نشرة المعلومات

PPaattiieenntt IInnffoorrmmaattiioonn LLeeaafflleett
IInn tthhiiss lleeaafflleett::
1. What is in
Moclobemide Tablets
?
2. What is your medicine used for?
3. Before you take
Moclobemide Tablets
4. How to take
Moclobemide Tablets
5. Possible side effects
6. Storing your
Moclobemide Tablets
MOCLOBEMIDE 150 MG TABLETS
MOCLOBEMIDE 300 MG TABLETS
11.. WWhhaatt iiss iinn
MMoocclloobbeemmiiddee TTaabblleettss
??
Your doctor has prescribed either
Moclobemide 150 mg Tablets
or
Moclobemide
300 mg Tablets
. Each tablet contains either 150mg or 300mg of the active ingredient
moclobemide.
Both strengths are film-coated and contain the following inactive
ingredients: lactose,
maize starch, sodium starch glycollate, povidone and magnesium
stearate. The 150
mg tablets also contain: lactose monohydrate, hypromellose, titanium
dioxide (E171),
glyceryl triacetate and ferric oxide yellow (E172). The coating for
the 300 mg tablets
contains: hyprolose, titanium dioxide, hypromellose and macrogol 400.
The 150 mg tablets are yellow, oval tablets, scored on one side and
marked 'P 150' on
the other; while the 300 mg tablets are white, oval tablets, scored on
one side and
marked 'P 300' on the other. The tablets are scored so they can easily
be broken in half.
Your tablets are available in blister packs containing 30 tablets.
MMaarrkkeettiinngg AAuutthhoorriissaattiioonn HHoollddeerr::
ratiopharm GmbH, Graf-Arco-Strasse 3, D-89079 Ulm, Germany
MMaannuuffaaccttuurreerr::
Nordmark Arzneimittel GmbH & Co. KG, Pinnauallee 4, D-25436 Uetersen,
Germany
22.. WWhhaatt iiss yyoouurr mmeeddiicciinnee uusseedd ffoorr
Moclobemide belongs to a group of medicines called selective monoamine
oxidase
inhibitors (MAOIs) or antidepressants.
Your doctor has prescribed for you this medicine in order to relieve
the symptoms of
depression.
33.. BBeeffoorree yyoouu ttaakkee
MMoocclloobbeemmi
iddee TTaabblleettss
D
Doo nnoott ttaakkee tthhiiss mmeeddiicciinnee iiff::
•
You
are
allergic
to
moclobemide
or
to
the
ingredients
listed
above. Allergic
reactions may inc

خصائص المنتج

PRODUCT SUMMARY
1.
TRADE NAME OF THE MEDICINAL PRODUCT
Moclobemide 300mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 300mg moclobemide.
For excipients, see 6.1
3.
PHARMACEUTICAL FORM
Film-coated tablet
White, coated, oval, biconvex shaped tablets with a white core, scored
on one
side and imprinted ”P” logo ”300” on the other side.
The tablets are breakable.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Moclobemide is indicated for the treatment of major depressive
episodes.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Adults: Initial usual dose 300mg, administered in divided doses after
meals.
The tablets should be taken with fluid.
If necessary, the daily dose can be increased to 600mg per day.
However, the
dose should not be increased during the 1
st
week of treatment, because the
bioavailability increases during this time and a clinical effect may
not be seen
for 1-3 weeks. In individual cases, the therapeutic dose can be
gradually
reduced to 150 mg per day, depending on effect.
Duration of treatment:
Treatment with moclobemide should be continued for at least 4-6 weeks
to be
able to judge the efficacy of moclobemide.
Treatment with moclobemide should preferably be continued for a
symptom
free period of 4-6 months. Then treatment can be gradually tapered
off.
Antidepressants, particularly MAOIs, should be withdrawn gradually to
reduce the risk of withdrawal symptoms.
Elderly:
No special dose adjustment is required.
Children:
In view of the lack of clinical data available, moclobemide is not
recommended for use in children.
Renal/hepatic impairment:
Patients with reduced renal function do not require a special dose
adjustment.
In patients with impaired hepatic function, the daily dose of
Moclobemide
should be reduced to a half or one third.
4.3.
CONTRA-INDICATIONS
•
Hypersensitivity to moclobemide or to any of the excipients.
•
Acute confusion.
•
Patients with phaeochromocytoma.
•
Children under the age of 18.
•
Concomitant treatment with selegiline, and 5-HT re-