VALHERP 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 HYDROCHLORIDE
Available from:
Helsinn Birex Therapeutics Ltd
Dosage:
500 Milligram
Pharmaceutical form:
Film Coated Tablet
Authorization date:
2009-11-06
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Valherp 500mg film coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 556.24mg of valaciclovir hydrochloride equivalent to 500 mg valaciclovir
Excipients include: Lactose Monohydrate 58.76mg per tablet.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Creamy, oblong film coated tablets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Varicella zoster virus (VZV) infections – herpes zoster
Valherp is indicated for the treatment of herpes zoster (shingles) and ophthalmic zoster in
immunocompetent adults (see sections 4.4).
Valherp 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
Valherp is indicated
o
for the treatment and suppression of HSV infections of the skin and mucous membranes including
- treatment of first-episode of genital herpes in immunocompetent patients
- recurrences of genital herpes in immunocompetent and immunocompromised patients
IRISH MEDICINES BOARD
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_Date Printed 11/01/2011_
_CRN 2093586_
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- suppression of recurrent genital herpes in immunocompetent and immunocompromised patients
o
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:_
Valherp is indicated for the prophylaxis of CMV infection and disease following solid organ transplantation
in adults and adolescents (see section 4.4)
4.2 POSOLOGY AND METHOD OF ADMINISTRATIO
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