VALACICLOVIR 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:
VALACICLOVIR
Available from:
Arrow Generics Limited
Dosage:
500 Milligram
Pharmaceutical form:
Film Coated Tablet
Authorization date:
2010-11-26
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Valaciclovir 500 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains valaciclovir hydrochloride monohydrate equivalent to 500 mg valaciclovir.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated Tablet.
White, to off white, capsule shaped coated tablets with ‘VA 500’ on one side and ‘>’ on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_Varicella zoster virus (VZV) infections – herpes zoster_
Valaciclovir is indicated for the treatment of herpes zoster (shingles) and ophthalmic zoster in immunocompetent adults
(see sections 4.4).
Valaciclovir is indicated for the treatment of herpes zoster in adult patients with mild or moderate immunosuppression
(see section 4.4).
_Herpes simplex virus (HSV) infections_
Valaciclovir is indicated
•
for the treatment and suppression of HSV infections of the skin and mucous membranes including
o
treatment of first-episode of genital herpes in immunocompetent patients
o
recurrences of genital herpes in immunocompetent and immunocompromised patients
o
suppression of recurrent genital herpes in immunocompetent and immunocompromised patients
•
Treatment and suppression of recurrent ocular HSV infections (see section 4.4)
Clinical studies have not been conducted in HSV-infected patients immunocompromised for other causes than HIV-
infection (see section 5.1).
_Cytomegalovirus (CMV) infections:_
Valaciclovir is indicated for the prophylaxis of CMV infection and disease following solid organ transplantation in
adults and adolescents (see section 4.4)
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 17/04/2012_
_CRN
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