Olanzapin HEXAL 7,5 mg Filmdragerad tablett
Country: Sweden
Language: Swedish
Source: Läkemedelsverket (Medical Products Agency)
Summary of Product characteristics
(SPC)
12-06-2008
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Active ingredient:
olanzapin
Available from:
Hexal AG
ATC code:
N05AH03
INN (International Name):
olanzapine
Dosage:
7,5 mg
Pharmaceutical form:
Filmdragerad tablett
Composition:
olanzapin 7,5 mg Aktiv substans; laktosmonohydrat Hjälpämne
Class:
Apotek
Prescription type:
Receptbelagt
Therapeutic area:
Olanzapin
Authorization status:
Avregistrerad
Authorization date:
2008-06-19
Summary of Product characteristics
Produktinformationen för Olanzafloc 2,5 mg, 5 mg, 7,5 mg, 10 mg, 15 mg, 20 mg, MTnr 24653, 24654,
24655, 24656, 24657, 24658, 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.
Om läkemedelsnamnet i följande produktinformation inte stämmer med namnet på dokumentet, beror
det på att läkemedlet i Sverige är godkänt under ett annat namn.
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Olanzafloc 2.5 mg film-coated tablets
Olanzafloc 5 mg film-coated tablets
Olanzafloc 7.5 mg film-coated tablets
Olanzafloc 10 mg film-coated tablets
Olanzafloc 15 mg film-coated tablets
Olanzafloc 20 mg film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
2.5 mg:
Each film-coated tablet contains 2.5 mg olanzapine.
Excipient: 74.11 mg lactose/film-coated tablet
5 mg:
Each film-coated tablet contains 5 mg olanzapine.
Excipient: 148.22 mg lactose/film-coated tablet
7.5 mg:
Each film-coated tablet contains 7.5 mg olanzapine.
Excipient: 222.33 mg lactose/film-coated tablet
10 mg:
Each film-coated tablet contains 10mg olanzapine.
Excipient: 296.44 mg lactose/film-coated tablet
15 mg:
Each film-coated tablet contains 15 mg olanzapine.
Excipient: 169.31 mg lactose/film-coated tablet
20 mg:
Each film-coated tablet contains 20 mg olanzapine.
Excipient: 225.75 mg lactose/film-coated tablet
For a full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Film-coated tablet
2.5 mg:
white, round (6.5 mm diameter).
5 mg:
white, round (8 mm diameter), with a breaking notch on one side.
The tablet can be divided into equal halves.
7.5 mg:
white, round (9 mm diameter).
10 mg:
white, round (10 mm diameter), with a breaking
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