Symvenu 4.5mg Hard Capsules

Država: Malezija

Jezik: angleščina

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktivna sestavina:

Cariprazine Hydrochloride

Dostopno od:

Mitsubishi Tanabe Pharma Malaysia Sdn. Bhd.

INN (mednarodno ime):

Cariprazine Hydrochloride

Enote v paketu:

28 Capsules

Izdeluje:

Gedeon Richter Plc

Navodilo za uporabo

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
SYMVENU
®
_ _
Cariprazine 1.5 mg hard capsules
Cariprazine 3 mg hard capsules
Cariprazine 4.5 mg hard capsules
Cariprazine 6 mg hard capsules
_ _
1
WHAT IS IN THIS LEAFLET
1.
What Symvenu is used for
2.
How Symvenu works
3.
Before you use Symvenu
4.
How to use Symvenu
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of Symvenu
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT SYMVENU IS USED FOR
Symvenu contains the active substance
cariprazine and belongs to a group of
medicines called antipsychotics. It is
used:
•
to treat adults with schizophrenia.
Schizophrenia is a disease characterised
by symptoms such as hearing, seeing or
sensing things which are not there
(hallucination), suspiciousness, mistaken
beliefs, incoherent speech and behaviour
and emotional flatness. People with this
condition may also feel depressed,
guilty, anxious, tense, or not being able
to start or keep up planned activities,
unwillingness to speak, lack of
emotional response to a situation that
would normally stimulate feelings in
others.
•
for short-term (acute) treatment of
manic or mixed episodes that happen
with bipolar I disorder.
The duration of the treatment depends
on the clinical response and tolerability,
and should be determined based on the
clinical judgement of the treating
physician.
•
to treat depressive episodes that
happen with bipolar I disorder.
Bipolar I disorder is a condition that
causes periods of severe changes in your
mood, activity levels, energy, and ability
to carry out everyday tasks. These
changes are commonly called “mood
episodes.”
HOW SYMVENU WORKS
The mechanism of action of cariprazine
is not fully known. However, the
therapeutic effect of cariprazine may be
mediated through a combination of
partial agonist activity at dopamine D
3
,
D
2
and serotonin 5-HT
1A
receptors, and
antagonist activity at serotonin 5-HT
2B
,
5-HT
2A
and histamine H
1
receptors.
BEFORE YOU

Lastnosti izdelka

1
SYMVENU
®
cariprazine hydrochloride
1.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Symvenu
®
1.5 mg hard capsules
Each hard capsule contains cariprazine hydrochloride corresponding to
1.5 mg cariprazine.
Symvenu
®
3 mg hard capsules
Each hard capsule contains cariprazine hydrochloride corresponding to
3 mg cariprazine.
Excipients with known effect
Each hard capsule contains 0.0003 mg Allura red AC (E 129).
Symvenu
®
4.5 mg hard capsules
Each hard capsule contains cariprazine hydrochloride corresponding to
4.5 mg cariprazine.
Excipients with known effect
Each hard capsule contains 0.0008 mg Allura red AC (E 129).
Symvenu
®
6 mg hard capsules
Each hard capsule contains cariprazine hydrochloride corresponding to
6 mg cariprazine.
Excipients with known effect
Each hard capsule contains 0.0096 mg Allura red AC (E 129).
For the full list of excipients, see section 5.1.
2.
PHARMACEUTICAL FORM
Hard capsule
Symvenu
®
1.5 mg hard capsules
‘Size 4’ (approximately 14.3 mm in length) hard gelatin capsule
with white opaque cap and white
opaque body imprinted with “GR 1.5” on the capsule body with black
ink. The capsules are filled with
white to yellowish white powder mixture.
Symvenu
®
3 mg hard capsules
‘Size 4’ (approximately 14.3 mm in length) hard gelatin capsule
with green opaque cap and white
opaque body imprinted with “GR 3” on the capsule body with black
ink. The capsules are filled with
white to yellowish white powder mixture.
Symvenu
®
4.5 mg hard capsules
2
‘Size 4’ (approximately 14.3 mm in length) hard gelatin capsule
with green opaque cap and green
opaque body imprinted with “GR 4.5” on the capsule body with white
ink. The capsules are filled with
white to yellowish white powder mixture.
Symvenu
®
6 mg hard capsules
‘Size 3’ (approximately 15.9 mm in length) hard gelatin capsule
with purple opaque cap and white
opaque body imprinted with “GR 6” on the capsule body with black
ink. The capsules are filled with
white to yellowish white powder mixture.
3.
CLINICAL PARTICULARS
3