Infections

1 film-coated tablet contains:
valaciclovir hydrochloride - 556.2 mg (equivalent to valaciclovir 500.0 mg).

Film-coated tablets, 500 mg.
10 capsules in a blister of PVC film and aluminum printed glazed foil.
1, 2, 3, 4, 5, or 6 blisters with patient leaflets are placed in a carton pack.

Adults and adolescents aged between 12 and 18
    treatment of skin and mucosa infections caused by HSV including newly diagnosed recurrent genital herpes (Herpes genitalis) and labial herpes (Herpes labialis);
    prophylaxis (suppression) of skin and mucosa infections caused by HSV including genital herpes including immunocompromised patients;
    prophylaxis of infections caused by cytomegalovirus (CMV) and diseases after transplantation of parenchymal organs.
Adults
    treatment of herpes zoster (shingles) and ophthalmic herpes zoster.

Oral, regardless of the meal with water.
Treatment of skin and mucosa infections caused by HSV including newly diagnosed recurrent genital herpes (Herpes genitalis) and labial herpes (Herpes labialis)/

Immunocompetent Adults and Adolescents Aged between 12 and 18
The recommended dose is 500 mg twice daily.
In case of relapse, treatment should last 3 or 5 days. In initial herpes that may proceed in a more severe form the treatment should be started as early as possible and its duration should be extended from 5 to
10 days. In recurrent HSV the most efficient is to administer valaciclovir at the prodromal stage or immediately at the earliest symptom of the disease. Valaciclovir can prevent lesion development when taken at the first signs and symptoms of an HSV recurrence.
Labial herpes can be alternatively effectively treated with valaciclovir dose of 2000 mg twice daily for 1 day. The second dose should be taken in approximately 12 h (but not less than in 6 h) after the first dose. In this dosage regimen the duration of treatment should not be longer that 1 day because longer treatment period does not lead to any additional clinical benefit.
Therapy should be initiated at the earliest symptom of a labial herpes (e.g., tingling, itching, or burning).
Prophylaxis (suppression) of skin and mucosa infections caused by HSV including genital herpes including immunocompromised patients/

Immunocompetent Adults and Adolescents Aged between 12 and 18
In immunocompetent patients the recommended dose is 500 mg once daily.
In 6-12 months of treatment the efficiency of therapy should be assessed.

Immunocompromised Adult Patients
In immunocompromised adult patients the recommended dose is 500 mg twice daily.
In 6-12 months of treatment the efficiency of therapy should be assessed.
Prophylaxis of infections caused by CMV and diseases after transplantation of parenchymal organs

Adults and adolescents aged between 12 and 18
The recommended dose is 2000 mg 4 times daily administered earliest possible after transplantation. The dose should be decreased depending on creatinine clearance.
The duration of treatment is generally 90 days but in patients at high risk the course of treatment can be prolonged.
Treatment of herpes zoster (shingles) and ophthalmic herpes zoster

Adults
The recommended dose is 1000 mg three times daily for 7 days.

Special Populations

Patients with Renal Impairment
Dose reduction is recommended for patients with evident renal impairment (see dosage regiment in Table 2). Adequate hydro-electrolytic balance should be maintained for such patients.
Valaciclovir should be administered after hemodialysis in patients receiving hemodialysis periodically.
Creatinine clearance should be frequently monitored especially when renal function changes are fast, for example, immediately after transplantation or after engraftment, while the dose of valaciclovir is adjusted based on creatinine clearance values.
Experience is not available for the use of valaciclovir in pediatric patients with a creatinine clearance less than
50 ml/min/1.73 m2.
Table 2. Valaciclovir Dosage Adjustments for Adults and Adolescents Aged between 12 and 18 years old with Renal Impairment

Patients with Hepatic Impairment
According to existing data on usage of 1000 mg single dose of valaciclovir, dose modification is not required in adult patients with mild or moderate cirrhosis (hepatic synthetic function maintained). Pharmacokinetic data in patients with advanced hepatic dysfunction (decompensated cirrhosis), impaired hepatic synthetic function and evidence of portal-systemic shunting do not indicate the need for dosage adjustment either. However, clinical data for these pathologies is limited.

Pediatric patients aged below 12
There is no data on the use of valaciclovir in children under 12 years of age.

Elderly Patients
The possibility of renal impairment in geriatric patients must be considered and the dosage of Valaciclovir should be adjusted accordingly (see Table 2). Adequate hydro-electrolytic balance should be maintained.