Risperoc 4 mg Munsönderfallande tablett
Country: Sweden
Language: Swedish
Source: Läkemedelsverket (Medical Products Agency)
Summary of Product characteristics
(SPC)
03-06-2010
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Active ingredient:
risperidon
Available from:
Hexal AG
ATC code:
N05AX08
INN (International Name):
risperidone
Dosage:
4 mg
Pharmaceutical form:
Munsönderfallande tablett
Composition:
aspartam Hjälpämne; mannitol Hjälpämne; risperidon 4 mg Aktiv substans
Class:
Apotek
Prescription type:
Receptbelagt
Therapeutic area:
Risperidon
Authorization status:
Avregistrerad
Authorization date:
2010-06-11
Summary of Product characteristics
Produktinformationen för Risperoc 3, 4
mg munsönderfallande tablett, MTnr 42090, 42091,
gäller vid det tillfälle då läkemedlet godkändes. Informationen kommer inte att uppdateras
eftersom läkemedlet inte marknadsförs i Sverige. Av
samma anledning finns inte någon
svensk produktinformation.
Den engelska produktinformationen kommer dock att uppdateras för
de produkter där Sverige
är referensland.
Om läkemedelsnamnet i följande produktinformation inte stämmer med namnet på
dokumentet, beror det på att läkemedlet i Sverige är
godkänt under ett annat namn.
1.
NAME OF THE MEDICINAL PRODUCT
Risperoc 3 mg orodispersible tablets
Risperoc 4 mg orodispersible tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each orodispersible tablet contains 3 mg risperidone.
Each orodispersible tablet contains 4 mg risperidone.
Excipients:
Each orodispersible tablet contains 2.40 mg aspartame and 0.021 mg sorbitol.
Each orodispersible tablet contains 3.20 mg aspartame and 0.028 mg sorbitol.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Orodispersible tablet.
Round, slightly convex, pink marbled orodispersible tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Risperoc is indicated for the treatment of schizophrenia.
Risperoc is indicated for the treatment of moderate to severe manic episodes associated with bipolar
disorders.
Risperoc is indicated for the short-term treatment (up to 6 weeks) of persistent aggression in patients
with moderate to severe Alzheimer’s dementia unresponsive to non-pharmacological approaches and
when there is a risk of harm to self or others.
Risperoc is indicated for the short-term symptomatic treatment (up to 6 weeks) of persistent
aggression in conduct disorder in children from the age of 5 years and adolescents with subaverage
in
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