Risperidon Sandoz 1, filmomhulde tabletten 1 mg

Country: Նիդերլանդեր

language: հոլանդերեն

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

active_ingredient:

RISPERIDON

MAH:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

ATC_code:

N05AX08

INN:

RISPERIDONE

pharmaceutical_form:

Filmomhulde tablet

composition:

CELLULOSE, MICROKRISTALLIJN (E 460) ; HYPROMELLOSE (E 464) ; LACTOSE 1-WATER ; MACROGOL 4000 ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171),

administration_route:

Oraal gebruik

therapeutic_area:

Risperidone

leaflet_short:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); HYPROMELLOSE (E 464); LACTOSE 1-WATER; MACROGOL 4000; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL, GEPREGELATINEERD; SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171);

authorization_date:

2004-08-31

PIL

Sandoz B.V.
Page 1 of 13
Risperidon Sandoz
®
1/2/3/4, filmomhulde tabletten 1/2/3/4 mg
RVG 28914-7
1313-V16
1.3.1.3. Bijsluiter
November 2019
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
RISPERIDON SANDOZ® 1, FILMOMHULDE TABLETTEN 1 MG
RISPERIDON SANDOZ® 2, FILMOMHULDE TABLETTEN 2 MG
RISPERIDON SANDOZ® 3, FILMOMHULDE TABLETTEN 3 MG
RISPERIDON SANDOZ® 4, FILMOMHULDE TABLETTEN 4 MG
risperidone
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 [nationally completed name ] is and what it is used for
2.
What you need to know before you take [nationally completed name]
3.
How to take [nationally completed name]
4.
Possible side effects
5.
How to store [nationally completed name]
6.
Contents of the pack and other information
1.
WHAT [INVENTED NAME] IS AND WHAT IT IS USED FOR
[invented name] contains the active substance risperidone. It belongs
to a group of medicines called
‘ANTI-PSYCHOTICS’.
[invented name] is used to treat the following:

Schizophrenia, where you may see, hear or feel things that are not
there, believe things that are
not true or feel unusually suspicious, or confused

Mania, where you may feel very excited, elated, agitated, enthusiastic
or hyperactive Mania
occurs in an illness called “bipolar disorder”

Short-term treatment (up to 6 weeks) of long-term aggression in people
with Alzheimer’s
dementia, who harm themselves or others. Alternative (non-drug)
treatments should have been
used previously

Short-term treatment (up to 6 weeks) of long-term, a

SPC

Sandoz B.V.
Page 1 of 24
Risperidon Sandoz
®
1/2/3/4, filmomhulde tabletten 1/2/3/4 mg
RVG 28914-5-6-7
1311-V14
1.3.1 Summary of Product Characteristics
November 2019
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Risperidon Sandoz 1, filmomhulde tabletten 1 mg
Risperidon Sandoz 2, filmomhulde tabletten 2 mg
Risperidon Sandoz 3, filmomhulde tabletten 3 mg
Risperidon Sandoz 4, filmomhulde tabletten 4 mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 1 mg risperidone.
Excipients with known effect:
Each film-coated tablet contains 51.25 mg lactose (as lactose
monohydrate).
Each film-coated tablet contains 2 mg risperidone.
Excipients with known effect:
Each film-coated tablet contains 101.45 mg lactose (as lactose
monohydrate).
Each film-coated tablet contains 3 mg risperidone.
Excipients with known effect:
Each film-coated tablet contains 151.94 mg lactose (as lactose
monohydrate).
Each film-coated tablet contains 4 mg risperidone.
Excipients with known effect:
Each film-coated tablet contains 202.49 mg lactose (as lactose
monohydrate).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet.
white, oval film-coated tablet with breaking notch, one sided
debossment “1”
apricot, oval film-coated tablet with breaking notch, one sided
debossment “2”
yellow, oval film-coated tablet with breaking notch, one sided
debossment “3”
green, oval film-coated tablets with breaking notch, one sided
debossment “4”
Sandoz B.V.
Page 2 of 24
Risperidon Sandoz
®
1/2/3/4, filmomhulde tabletten 1/2/3/4 mg
RVG 28914-5-6-7
1311-V14
1.3.1 Summary of Product Characteristics
November 2019
The tablet can be divided into equal doses.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Risperidone is indicated for the treatment of schizophrenia.
Risperidone is indicated for the treatment of moderate to severe manic
episodes associated with
bipolar disorders.
Risperidone is indicated for the short-term treatment (up to 6 weeks)
of persistent