FAMLOV Film Coated Tablet 250 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
20-03-2023
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Active ingredient:
FAMCICLOVIR
Available from:
Arrow Generics Limited
Dosage:
250 Milligram
Pharmaceutical form:
Film Coated Tablet
Authorization date:
2008-10-17
Summary of Product characteristics
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Summary of Product Characteristics
1 NAME OF THE MEDICINAL PRODUCT
Famlov 250mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 250mg of famciclovir.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated Tablet.
White, round, coated tablet with ‘FC’ over “250” on one side and ‘>’ on the other side.
4 CLINICAL PARTICULARS
4.1 Therapeutic Indications
Varicella zoster virus (VZV) infections – herpes zoster
- Famciclovir is indicated for
- the treatment of herpes zoster and ophthalmic zoster in immunocompetent adults (see section 4.4)
- the treatment of herpes zoster in immunocompromised adults (see section 4.4)
Herpes simplex virus (HSV) infections – genital herpes
Famciclovir is indicated for
- the treatment of first and recurrent episodes of genital herpes in immunocompetent adults
- the treatment of recurrent episodes of genital herpes in immunocompromised adults
- the suppression of recurrent genital herpes in immunocompetent and immunocompromised adults
Clinical studies have not been conducted in HSV-infected patients immunocompromised for other causes than HIV-
infection (see section 5.1).
4.2 Posology and method of administration
Herpes zoste
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