SERDOLECT 4 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

SERTINDOLE

Available from:

LUNDBECK ISRAEL LTD.

ATC code:

N05AE03

Pharmaceutical form:

FILM COATED TABLETS

Composition:

SERTINDOLE 4 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

H. LUNDBECK A/S, DENMARK

Therapeutic group:

SERTINDOLE

Therapeutic area:

SERTINDOLE

Therapeutic indications:

For the treatment of schizophrenia. Due to cardiovascular safety concerns serntidole should only be used for patients intolerant to at least one other anti-psychotic agent. Sertindole should not be used in emergency situations for urgent relief of symptoms in acutely disturbed patients.

Authorization date:

2022-09-30

Patient Information leaflet

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Summary of Product characteristics

קנ הז ןולע טמרופ
ב
רשואו קדבנ ונכותו תואירבה דרשמ י"ע ע
ינויב
2015
PRISCRIBING INFORMATION
1.
NAME OF THE MEDICINAL PRODUCT
SERDOLECT 4MG
SERDOLECT 16MG
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 4 mg tablet contains: sertindole 4 mg
Each 16 mg tablet contains: sertindole 16 mg
Excipients:
Each 4 mg film-coated tablet contains 60.78 mg lactose monohydrate.
Each 16 mg film-coated tablet contains 95.08 mg lactose monohydrate.
See section 4.4.
For a full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets.
Description of the tablets:
4 mg: Oval, yellow, biconvex film-coated tablets marked with “S4”
on one side.
16 mg: Oval, rose, biconvex film-coated tablets marked with “S16”
on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Sertindole is indicated for the treatment of schizophrenia.
Due to cardiovascular safety concerns, sertindole should only be used
for patients intolerant to at
least one other antipsychotic agent.
Sertindole should not be used in emergency situations for urgent
relief of symptoms in acutely
disturbed patients.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Sertindole is administered orally once daily with or without meals. In
patients where sedation is
required, a benzodiazepine may be co-administered.
Page 1 of 12
Titration
All patients should be started on sertindole 4 mg/day. The dose should
be increased by increments of
4 mg after 4-5 days on each dose until the optimal daily maintenance
dose, within the range of
12-20 mg, is reached. Due to the
α
1
-blocking activity of sertindole, symptoms of postural
hypotension may occur during the initial dose-titration period. A
starting dose of 8 mg or a rapid
increase in dose carries a significantly increased risk of postural
hypotension.
Maintenance
Dependent on individual patient response, the dose may be increased to
20mg/day. Only in
exceptional cases should the maximum dose of 24 mg be considered, as
clinical trials have not
demonstrated consisten