Valdoxan 25mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Agomelatine

Available from:

Servier Laboratories Ltd

ATC code:

N06AX22

INN (International Name):

Agomelatine

Dosage:

25mg

Pharmaceutical form:

Tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04030400; GTIN: 5017476201102

Patient Information leaflet

1382_06.02.indd 1
05/10/2017 11:33
1382_06.02.indd 2
05/10/2017 11:33
1382_06.02.indd 3
05/10/2017 11:33
1382_06.02.indd 4
05/10/2017 11:33

Summary of Product characteristics

OBJECT 1
VALDOXAN
Summary of Product Characteristics Updated 05-Oct-2017 | Servier
Laboratories Limited
1. Name of the medicinal product
Valdoxan 25 mg film-coated tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 25 mg of agomelatine.
Excipient with known effect: each tablet contains 61.84 mg lactose (as
monohydrate)
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet [tablet].
Orange-yellow, oblong, 9.5 mm long, 5.1 mm wide film-coated tablet
with blue imprint of company logo
on one side.
4. Clinical particulars
4.1 Therapeutic indications
Treatment of major depressive episodes.
Valdoxan is indicated in adults.
4.2 Posology and method of administration
Posology
The recommended dose is 25 mg once daily taken orally at bedtime.
After two weeks of treatment, if there is no improvement of symptoms,
the dose may be increased to 50
mg once daily, i.e. two 25 mg tablets, taken together at bedtime.
Decision of dose increase has to be balanced with a higher risk of
transaminases elevation. Any dose
increase to 50 mg should be made on an individual patient benefit/risk
basis and with strict respect of
LFT monitoring.
Liver function tests should be performed in all patients before
starting treatment. Treatment should not be
initiated if transaminases exceed 3 X upper limit of normal (see
sections 4.3 and 4.4).
During treatment transaminases should be monitored periodically after
around three weeks, six weeks
(end of acute phase), twelve weeks and twenty four weeks (end of
maintenance phase) and thereafter
when clinically indicated (see also section 4.4). Treatment should be
discontinued if transaminases exceed
3 X upper limit of normal (see sections 4.3 and 4.4).
When increasing the dosage, liver function tests should again be
performed at the same frequency as
when initiating treatment.
_Treatment duration_
Patients with depression should be treated for a sufficient period of
at least 6 months to ensure that they
are free of symptoms.
_Switching t