Faverin 100mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Fluvoxamine maleate

Available from:

Viatris UK Healthcare Ltd

ATC code:

N06AB08

INN (International Name):

Fluvoxamine maleate

Dosage:

100mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04030300; GTIN: 5012781038603

Patient Information leaflet

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colours
Faverin, 50 mg, 100 mg, 30, 60
Leaflet (Insert)
1898304
1820846
1898304
PL46302/0034-0033
Mylan Laboratories SAS
(Chatillon sur Chalaronne - FR)
50072205
3963
400540709, 400540689
3
United Kingdom
Flat - 158X630 mm - SPE 97922
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N.A.
N.A.
10:52
22 AUG 2019
158X630mm
v3/July 2017
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Black U
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50 mg and 100 mg film-coated tablets
fluvoxamine maleate
•
Faverin treats depression and Obsessive
Compulsive
Disorder
(OCD).
Like
all
medicines it can have unwanted effects. It is
therefore important that you and your doctor
weigh up the benefits of treatment against the
possible unwanted effects, before starting
treatment.
•
Faverin should not be used to treat
depression in children and adolescents
under 18. See section 2, Use in Children and
adolescents under 18.
•
Faverin won’t work straight away. Some
people taking antidepressants feel worse
before feeling better. Your doctor should see
you regularly during your course of treatment.
Tell your doctor if you haven’t started feeling
better.
•
Some people who are depressed or anxious
think of harming or killing themselves. If you
start to feel worse, or think of harming or killing
yourself, see your doctor or go to a hospital
straight away.
•
Don’t stop taking Faverin without talking to
your doctor. If you stop taking Faverin
suddenly or miss a dose, you may get
withdrawal effects. See Section 3, How to take
Faverin.
•
If you feel restless and feel like you can’t
sit or stand still, tell your doctor. Increasing
t

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Faverin 100 mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 100 mg fluvoxamine maleate.
For a full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Film-coated tablet.
Oval, biconvex, scored, white to off-white film-coated tablets
imprinted '313'
on both sides of the score.
The tablet can be divided into equal halves.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
-
Major depressive episode
-
Obsessive Compulsive Disorder (OCD)
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Depression _
_Adults _
The recommended dose is 100 mg daily. Patients should start on 50 or
100 mg, given
as a single dose in the evening. Dosage should be reviewed and
adjusted if necessary
within 3 to 4 weeks of initiation of therapy and thereafter as judged
clinically
appropriate. Although there may be an increased potential for
undesirable effects at
higher doses, if after some weeks on the recommended dose insufficient
response is
seen some patients may benefit from having their dose increased
gradually up to a
maximum of 300 mg a day (see section 5.1). Doses up to 150 mg can be
given as a
single dose, preferably in the evening. It is advisable that a total
daily dose of more
than 150 mg is given in 2 or 3 divided doses. Dosage adjustments
should be made
carefully on an individual patient basis, to maintain the patients at
the lowest effective
dose.
Patients with depression should be treated for a sufficient period of
at least 6 months
to ensure that they are free from symptoms.
_Children/adolescents _
Faverin should not be used in children and adolescents under the age
of 18 years for
the treatment of major depressive episode. The efficacy and safety of
Faverin have
not been established in the treatment of paediatric major depressive
episode (see
section 4.4).
_Obsessive Compulsive Disorder_
_ _
_Adults _
The recommended dose is between 100-300 mg daily. Patients should
start at 50 mg
per day. Although there may be an increa