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

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

PAROXETINEHYDROCHLORIDE 0,5-WATER 2,3 mg/ml SAMENSTELLING overeenkomend met ; PAROXETINE 2 mg/ml

Beschikbaar vanaf:

GlaxoSmithKline B.V. Van Asch van Wijckstraat 55H 3811 LP AMERSFOORT

ATC-code:

N06AB05

INN (Algemene Internationale Benaming):

PAROXETINEHYDROCHLORIDE 0,5-WATER 2,3 mg/ml SAMENSTELLING overeenkomend met ; PAROXETINE 2 mg/ml

farmaceutische vorm:

Suspensie voor oraal gebruik

Samenstelling:

CARMELLOSE NATRIUM (E 466) ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CITROENSMAAKSTOF ; CITROENZUUR 0-WATER (E 330) ; GLYCEROL (E 422) ; MALTITOL (E 965) ; MANNITOL (D-) (E 421) ; METHYLPARAHYDROXYBENZOAAT (E 218) ; POLACRILINE KALIUM ; PROPYLEENGLYCOL (E 1520) 50 mg/ml ; PROPYLPARAHYDROXYBENZOAAT ; SACCHAROIDE NATRIUM X-WATER (E 954) ; SIMETICON EMULSIE ; SINAASAPPELSMAAKSTOF ; SORBITOL, VLOEIBAAR, NIET-KRISTALLISEERBAAR (E 420) ; TRINATRIUMCITRAAT 2-WATER (E 331) ; WATER, GEZUIVERD ; ZONNEGEEL FCF (E 110), CARMELLOSE NATRIUM (E 466) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CITROENSMAAKSTOF ; CITROENZUUR 0-WATER (E 330) ; GLYCEROL (E 422) ; MALTITOL (E 965) ; MANNITOL (D-) (E 421) ; METHYLPARAHYDROXYBENZOAAT (E 218) ; POLACRILINE KALIUM ; PROPYLEENGLYCOL (E 1520) 50 mg/ml ; PROPYLPARAHYDROXYBENZOAAT ; SACCHAROIDE NATRIUM X-WATER (E 954) ; SIMETICON EMULSIE ; SINAASAPPELSMAAKSTOF ; SORBITOL, VLOEIBAAR, NIET-KRISTALLISEERBAAR (E 420) ; TRINATRIUMCITRAAT 2-WATER (E 331) ; WATER, GEZUIVERD ; ZONNEGEEL FCF (E 110), CARMELLOSE NATRIUM (E 466) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CITROENSMAAKSTOF ; CITROENZUUR 0-WATER (E 330) ; GLYCEROL (E 422) ; MALTITOL (E 965) ; MANNITOL (D-) (E 421) ; METHYLPARAHYDROXYBENZOAAT (E 218) ; POLACRILINE KALIUM ; PROPYLEENGLYCOL (E 1520) 50 mg/ml ; PROPYLPARAHYDROXYBENZOAAT (E 216) ; SACCHAROIDE NATRIUM X-WATER (E 954) ; SIMETICON EMULSIE ; SINAASAPPELSMAAKSTOF ; SORBITOL, VLOEIBAAR, NIET-KRISTALLISEERBAAR (E 420) ; TRINATRIUMCITRAAT 2-WATER (E 331) ; WATER, GEZUIVERD ; ZONNEGEEL FCF (E 110), 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 X-WATER (E 954) ; SIMETICON EMULSIE ; SINAASAPPELSMAAKSTOF ; SORBITOL, VLOEIBAAR, KRISTALLISEERBAAR (E 420) ; TRINATRIUMCITRAAT 2-WATER (E 331) ; WATER, GEZUIVERD ; ZONNEGEEL FCF (E 110)

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Paroxetine

Autorisatie datum:

1900-01-01

Bijsluiter

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).
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 NEED TO KNOW BEFORE YOU TAKE PAROXETINE GSK
DO NOT TAKE PAROXETINE GSK
…
-
IF YOU ARE TAKING MEDICINES CALLED MONOAMINE OXIDASE INHIBITO

Productkenmerken

1/16
1.
NAME OF MEDICINAL PRODUCT
Paroxetine GSK 2 mg/ml, oral suspension
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
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 (E218)
-
6 mg propyl parahydroxybenzoate (E216)
-
0.9 mg sunset yellow FCF (E110)
-
(maximum) 2.7 g sorbitol (E420)
-
(typically) 283 mg maltitol (E965)
-
500 mg propylene glycol (E1520)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral suspension.
A bright orange fairly viscous suspension having an odour of oranges,
free from foreign matter.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of
-
Major Depressive Episode
-
Obsessive Compulsive Disorder
-
Panic Disorder with and without agoraphobia
-
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 of therapy.
As with all antidepressant medicinal products, dosage should be
reviewed and adjusted if necessary
within 3 to 4 weeks of initiation of therapy and thereafter as judged
clinically appropriate. In some
patients, with insufficient response to 20 mg, the dose may be
increased gradually up to a maximum of
50 mg a day in 10 mg steps according to the patient’s response.
_ _
_ _
Patients with depression should be treated for a sufficient period of
at least 6 months to ensure that
they are free from symptoms.
IAin833
_Obsessive compulsive disorder (OCD) _
The recommended dose is 40 mg daily. Patients should start on 20
mg/day and the dose may be
increased gradually in 10 mg increments to the recommended dose. If
after some weeks on the
recommended dose insufficient response is seen some patients may
benefit from having their dose
incr