Paroxetine GSK suspensie 2 mg/ml, suspensie voor oraal gebruik

Země: Nizozemsko

Jazyk: nizozemština

Zdroj: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Aktivní složka:

PAROXETINE HYDROCHLORIDE 0,5-WATER SAMENSTELLING overeenkomend met; PAROXETINE;

Dostupné s:

GlaxoSmithKline B.V.

ATC kód:

N06AB05

INN (Mezinárodní Name):

PAROXETINE HYDROCHLORIDE 0,5-WATER COMPOSITION corresponding to; PAROXETINE;

Léková forma:

Suspensie voor oraal gebruik

Podání:

Oraal gebruik

Terapeutické oblasti:

Paroxetine

Přehled produktů:

Hulpstoffen: CARMELLOSE NATRIUM (E 466); CELLULOSE, MICROKRISTALLIJN (E 460); CITROENSMAAKSTOF; CITROENZUUR 0-WATER (E 330); GLYCEROL (E 422); METHYLPARAHYDROXYBENZOAAT (E 218); POLACRILINE KALIUM; PROPYLEENGLYCOL (E 1520) 50 mg/ml; PROPYLPARAHYDROXYBENZOAAT (E 216); SACCHAROIDE NATRIUM 0-WATER (E 954); SIMETICON EMULSIE; SINAASAPPELSMAAKSTOF; SORBITOL, VLOEIBAAR, KRISTALLISEERBAAR (E 420); TRINATRIUMCITRAAT 2-WATER (E 331); WATER, GEZUIVERD; ZONNEGEEL FCF (E 110);

Informace pro uživatele

1/10
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PAROXETINE GSK SUSPENSIE 2 MG/ML
suspensie voor oraal gebruik
Paroxetine (as the hydrochloride hemihydrate)
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 Paroxetine GSK is and what it is used for
2.
What you need to know before you take Paroxetine GSK
3.
How to take Paroxetine GSK
4.
Possible side effects
5.
How to store Paroxetine GSK
6.
Contents of the pack and other information
1.
WHAT PAROXETINE GSK IS AND WHAT IT IS USED FOR
PAROXETINE GSK IS A TREATMENT FOR ADULTS WITH DEPRESSION AND/OR
ANXIETY DISORDERS. The anxiety
disorders that Paroxetine GSK is used to treat are: obsessive
compulsive disorder (repetitive, obsessive
thoughts with uncontrollable behaviour), panic disorder (panic
attacks, including those caused by
agoraphobia, which is a fear of open spaces), social anxiety disorder
(fear or avoidance of social
situations), post traumatic stress disorder (anxiety caused by a
traumatic event) and generalised
anxiety disorder (generally feeling very anxious or nervous).
Paroxetine GSK is one of a group of medicines called SSRIs (selective
serotonin reuptake inhibitors).
Everyone has a substance called serotonin in their brain. People who
are depressed or anxious have
lower levels of serotonin than others. It is not fully understood how
Paroxetine GSK and other SSRIs
work but they may help by increasing the level of serotonin in the
brain. Treating depression or
anxiety disorders properly is important to help you get better.
2.
WHAT YOU N

Charakteristika produktu

1/18
1.
NAME OF MEDICINAL PRODUCT
Paroxetine GSK 10 mg tablet, film coated tablets
Paroxetine GSK 20 mg, film coated tablets
Paroxetine GSK 30 mg, film coated tablets
Paroxetine GSK suspensie 2 mg/ml, oral suspension
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg/20 mg/30 mg paroxetine (as
paroxetine hydrochloride
hemihydrate).
_ _
Each 10 ml of oral suspension contains 20 mg paroxetine (as paroxetine
hydrochloride hemihydrate).
Excipients with known effect – each 10 ml of oral suspension
contains:
-
20 mg methyl parahydroxybenzoate
-
6 mg propyl parahydroxybenzoate
-
0.9 mg sunset yellow FCF (E110)
-
4 g sorbitol (E420).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Oral suspension.
<10 mg tablet>_ _

<20 mg tablet>

<30 mg tablet>

4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of
-
Major Depressive Episode
-
Obsessive Compulsive Disorder
-
Panic Disorder with and without agoraphobia
2/18
-
Social Anxiety Disorders/Social phobia
-
Generalised Anxiety Disorder
-
Post-Traumatic Stress Disorder_ _
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
MAJOR DEPRESSIVE EPISODE _ _
The recommended dose is 20 mg daily. In general, improvement in
patients starts after one week but
may only become evident from the second week