FAMCICLOVIR Film Coated Tablet 500 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
25-04-2024
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Active ingredient:
FAMCICLOVIR
Available from:
Fannin UK Ltd
Dosage:
500 Milligram
Pharmaceutical form:
Film Coated Tablet
Authorization date:
2011-10-14
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Famciclovir 500 mg Film-Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500 mg famciclovir.
Each tablet contains 44 mg lactose.
For a full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Famciclovir 500 mg tablets are white to off-white coloured, capsule shaped, biconvex film-coated tablets
plain on both sides.
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 immunocompromisedadults
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 zoster in immunocompetent adults
500 mg three times daily for seven days.
Treatment should be initiated as soon as possible after a diagnosis of herpes zoster.
Herpes zoster in immunocompromised adults
500 mg three times daily for ten days.
Treatment should be initiated as soon as possible after a diagnosis of herpes zoster.
Genital herpes in immunocompetent adults
First episode of genital herpes: 250 mg three times daily for five days. Initiation of treatment is recommended as soon
as possible after a diagnosis
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