FLUCONAZOLE ACTAVIS
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
22-03-2023
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Active ingredient:
FLUCONAZOLE
Available from:
Actavis Group PTC ehf
Dosage:
100 Milligram
Pharmaceutical form:
Capsules Hard
Authorization date:
2011-04-15
Summary of Product characteristics
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Summary of Product Characteristics
1 NAME OF THE MEDICINAL PRODUCT
Fluconazole Actavis 100 mg capsules, hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 100 mg fluconazole.
Excipient:
Each hard capsule contains 82 mg lactose monohydrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard.
Fluconazole Actavis 100 mg consists of light blue cap and white body, size “2” hard gelatine capsules, filled with white
powder.
4 CLINICAL PARTICULARS
4.1 Therapeutic Indications
Fluconazole Actavis is indicated for treatment of following infections caused by fungi which are known to be or are
likely to be susceptible to fluconazole:
- Acute and recurrent vaginal candidiasis when systemic therapy is considered appropriate.
- Verified fungal infections of the skin such as tinea corporis/tinea cruris/tinea pedis (caused by dermatophytes), tinea
versicolor or candidiasis when topical treatment has not succeeded or is considered inadequate. Fluconazole should
only be used to treat tinea versicolor when the infection is resistant to first line therapy or when the patient is
immunocompromised.
- Mucosal candidiasis, including oropharyngeal, oesophagal, mucocutaneous and non-invasive bronchopul
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