Sycrest

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

asenapine (as maleate) 

Saatavilla:

N.V. Organon

ATC-koodi:

N05AH05

INN (Kansainvälinen yleisnimi):

asenapine

Terapeuttinen ryhmä:

Psycholeptics

Terapeuttinen alue:

Bipolar Disorder

Käyttöaiheet:

Sycrest is indicated for the treatment of moderate to severe manic episodes associated with bipolar I disorder in adults.

Tuoteyhteenveto:

Revision: 21

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2010-09-01

Pakkausseloste

38
B. PACKAGE LEAFLET
39
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SYCREST 5 MG SUBLINGUAL TABLETS
SYCREST 10 MG SUBLINGUAL TABLETS
asenapine
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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Sycrest is and what it is used for
2.
What you need to know before you take Sycrest
3.
How to take Sycrest
4.
Possible side effects
5.
How to store Sycrest
6.
Contents of the pack and other information
1.
WHAT SYCREST IS AND WHAT IT IS USED FOR
Sycrest contains the active substance asenapine. This medicine belongs
to a group of medicines called
antipsychotics. Sycrest is used to treat moderate to severe manic
episodes associated with bipolar I
disorder in adults. Antipsychotic medicines affect the chemicals that
allow communication between
nerve cells (neurotransmitters). Illnesses that affect the brain, such
as bipolar I disorder, may be due to
certain chemicals in the brain, such as dopamine and serotonin, being
out of balance and these
imbalances may cause some of the symptoms you may be experiencing.
Exactly how this medicine
works is unknown, however, it is believed to adjust the balance of
these chemicals.
Manic episodes associated with bipolar I disorder is a condition with
symptoms such as feeling “high”,
having excessive amounts of energy, needing much less sleep than
usual, talking very quickly with
racing ideas and sometimes severe irritability.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE SYCREST
DO NOT TAKE SYCREST
If you are allergic to asenapine or any of the other ingredients

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Sycrest 5 mg sublingual tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sublingual tablet contains 5 mg asenapine (as maleate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Sublingual tablet
Round, white to off-white, sublingual tablets debossed with “5” on
one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Sycrest is indicated for the treatment of moderate to severe manic
episodes associated with bipolar I
disorder in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended starting dose of Sycrest as monotherapy is 5 mg twice
daily. One dose should be
taken in the morning and one dose should be taken in the evening. The
dose can be increased to 10 mg
twice daily based on individual clinical response and tolerability.
See section 5.1. For combination
therapy a starting dose of 5 mg twice daily is recommended. Depending
on the clinical response and
tolerability in the individual patient, the dose can be increased to
10 mg twice daily.
Special populations
_Elderly _
Sycrest should be used with care in the elderly. Limited data on
efficacy in patients 65 years of age
and older are available. Available pharmacokinetic data are described
in section 5.2.
_Renal impairment _
No dose adjustment is required for patients with renal impairment.
There is no experience with
asenapine in patients with severe renal impairment who have a
creatinine clearance less than
15 mL/min.
_Hepatic impairment _
No dose adjustment is required for patients with mild hepatic
impairment. The possibility of elevated
asenapine plasma levels cannot be excluded in some patients with
moderate hepatic impairment
(Child-Pugh B) and caution is advised. In subjects with severe hepatic
impairment (Child-Pugh C), a
7-fold increase in asenapine exposure was observed. Thus, Sycrest is
not recommended in patients
with severe hepatic impairment.
_Paediatric population _
A pharmacokinetic study and a short term