Zofenopril Mylan 30 mg Filmdragerad tablett
Nazione: Svezia
Lingua: svedese
Fonte: Läkemedelsverket (Medical Products Agency)
Scheda tecnica
(SPC)
03-02-2011
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Principio attivo:
zofenoprilkalcium
Commercializzato da:
Mylan AB
Codice ATC:
C09AA15
INN (Nome Internazionale):
zofenopril
Dosaggio:
30 mg
Forma farmaceutica:
Filmdragerad tablett
Composizione:
zofenoprilkalcium 30 mg Aktiv substans
Classe:
Apotek
Tipo di ricetta:
Receptbelagt
Area terapeutica:
Zofenopril
Stato dell'autorizzazione:
Avregistrerad
Data dell'autorizzazione:
2011-02-11
Scheda tecnica
Produktinformationen för Zofenopril Mylan 30
mg filmdragerad tablett, MTnr 43540, 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.
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Zofenopril Mylan 30 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 30 mg of zofenopril calcium, equivalent to 28.7 mg of zofenopril.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
White, film-coated, capsule shaped, biconvex tablets of 5.5 mm x 10.0 mm with “ZP breakline
1” on one side and “M” on other side.
The tablet can be divided into equal halves.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_Hypertension_
Zofenopril Mylan is indicated for the treatment of mild to moderate essential hypertension.
_Acute Myocardial Infarction_
Zofenopril Mylan is indicated for the treatment initiated within the first 24 hours of patients
with acute myocardial infarction with or without signs and symptoms of heart failure, who are
haemodynamically stable and have not received thrombolytic therapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
NOTE! Please be aware that not all recommended dosages can be administered with this
product, since the lowest dose achievable with this product is 15 mg (half a tablet).
Zofenopril Mylan can be taken before, during or after meals. Dosage must
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