VALACICLOVIR GENERICHEALTH valaciclovir hydrochloride 1000mg tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

valaciclovir hydrochloride monohydrate, Quantity: 1223.4 mg

Available from:

Generic Health Pty Ltd

INN (International Name):

Valaciclovir hydrochloride monohydrate

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: povidone; magnesium stearate; microcrystalline cellulose; titanium dioxide; hypromellose; hyprolose; macrogol 400

Administration route:

Oral

Units in package:

4 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

For the treatment of herpes zoster (shingles) in adult patients who commence therapy within 72 hours of the onset of rash. For the treatment of opthalmic zoster. For the treatment of recurrent herpes labialis (cold sores). For the treatment of clinical episodes of genital herpes simplex infections. For the prevention of recurrent genital herpes. Reduction of transmission of genital herpes in patients suffering from recurrent genital herpes. In addition to therapy with Altic, it is recommended that patients use safer sex practices (See Precautions). Prophylaxis of cytomegalovirus (CMV) infection and disease following solid organ transplantation in patients at risk of CMV disease.

Product summary:

Visual Identification: Oval, white, biconvex, 11.0 x 22.0 mm with VC3 on one side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2011-05-18

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – VALACICLOVIR GENERICHEALTH
(VALACICLOVIR HYDROCHLORIDE MONOHYDRATE) FILM-COATED TABLET
1
NAME OF THE MEDICINE
Valaciclovir hydrochloride monohydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Valaciclovir generichealth tablets come in three strengths and contain
either 250 mg, 500 mg or 1000 mg
of valaciclovir (as hydrochloride monohydrate).
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Valaciclovir generichealth 250 mg: Oval, white, biconvex, film-coated
tablets, 13.8 x 6.9 mm with VC1
on one side.
Valaciclovir generichealth 500 mg: Oval, white, biconvex, film-coated
tablets, 17.6 x 8.8 mm with VC2
on one side.
Valaciclovir generichealth 1000 mg: Oval, white, biconvex, film-coated
tablets, 22.0 x 11.0 mm with VC3
on one side.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of herpes zoster (shingles) in adult patients who
commence therapy within 72 hours
of the onset of rash.
For the treatment of ophthalmic zoster.
For the treatment of recurrent herpes labialis (cold sores).
For the treatment of clinical episodes of genital herpes simplex
infections.
For the prevention of recurrent genital herpes.
Reduction of transmission of genital herpes in patients suffering from
recurrent genital herpes. In
addition to therapy with Valaciclovir generichealth, it is recommended
that patients use safer sex
practices (see SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE).
Prophylaxis of cytomegalovirus (CMV) infection and disease following
solid organ transplantation in
patients at risk of CMV disease.
Valaciclovir generichealth v5
Page 2 of 26
(valaciclovir hydrochloride monohydrate) film-coated tablet
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSAGE IN ADULTS
For the treatment of herpes zoster
For treatment of herpes zoster, 1000 mg of valaciclovir three times a
day for 7 days.
For the treatment of herpes labialis (cold sores)
The recommended dosage of valaciclovir for the treatment of cold sores
is 2000 mg twice daily for 1