Serdolect 20mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Sertindole

Available from:

Imported (Denmark)

ATC code:

N05AE03

INN (International Name):

Sertindole

Dosage:

20mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04020100; GTIN: 5702157188208

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SERDOLECT 4 MG, 12 MG, 16 MG AND 20 MG FILM-COATED TABLETS
Sertindole
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE, BECAUSE
IT CONTAINS IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It
may harm them, even if their signs of illness are the same as yours.
•
If you get any side effects talk to your doctor or pharmacist. This
includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
WHAT SERDOLECT IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE SERDOLECT
3.
HOW TO TAKE SERDOLECT
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE SERDOLECT
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT SERDOLECT IS AND WHAT IT IS USED FOR
Serdolect contains the active substance sertindole and belongs to a
group of
medicines known as antipsychotics. It acts on nerve pathways in
specific brain areas
and helps there to correct chemical imbalances that cause your
symptoms.
Serdolect is used to treat SCHIZOPHRENIA in cases where another
medicine was not
effective.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE SERDOLECT
DO NOT TAKE SERDOLECT
if you are/have:
•
allergic to sertindole or any of the other ingredients of this
medicine (listed in
section 6).
•
untreated low potassium or magnesium in the blood
•
a significant heart and blood circulation disease
•
a severe heart disease such as
-
heart failure with tissue swelling caused by excess fluid
-
enlargement of the heart
-
irregular or slow heartbeat
•
born with or have had an episode of prolonged heart ventricle
activity, measured
in an ECG, or someone in your family has this abnormal heart rhythm
•
severely reduced liver function
•
taking medicines that prolong the time of the heart ventricle activity
or affect the
liver function. See the first two bull

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Serdolect 20 mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 20 mg tablet contains: sertindole 20 mg
Excipients:
Each 20 mg film-coated tablet contains 112. 90 mg lactose.
See section 4.4.
For a full list of excipients see section 6.1
3
PHARMACEUTICAL FORM
Film-coated tablet
Description of tablets:
Oval, pink, biconvex, film coated tablets marked with “S20” 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.
NOTE: ECG monitoring is required before and during treatment with
sertindole; see section 4.4.
Clinical studies have shown that sertindole prolongs the QT interval
to a greater extent than some
other antipsychotics. Sertindole should therefore only be used for
patients intolerant to at least one
other antipsychotic agent.
Prescribing physicians should comply fully with the required safety
measures: see sections 4.3 and
4.4.
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
20 mg/day. Only in
exceptional cases sh