Pajjiż: Awstralja
Lingwa: Ingliż
Sors: Department of Health (Therapeutic Goods Administration)
valaciclovir hydrochloride monohydrate, Quantity: 305.85 mg
Generic Health Pty Ltd
Valaciclovir hydrochloride monohydrate
Tablet, film coated
Excipient Ingredients: magnesium stearate; povidone; microcrystalline cellulose; titanium dioxide; hypromellose; hyprolose; macrogol 400
Oral
30 tablets, 20 tablets, 10 tablets, 100 tablets, 60 tablets, 40 tablets, 90 tablets, 50 tablets
(S4) Prescription Only Medicine
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.
Visual Identification: Oval, white, biconvex, 13.8 x 6.9 mm with VC1 on one side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2011-05-18
CONSUMER MEDICINE INFORMATION VALACICLOVIR GENERICHEALTH TREATMENT OF ZOSTER AND HERPES LABIALIS (VALACICLOVIR HYDROCHLORIDE MONOHYDRATE) FILM-COATED TABLET WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Valaciclovir generichealth. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of you taking Valaciclovir generichealth against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR DOCTOR OR PHARMACIST. Keep this leaflet with your medicine. You may need to read it again. WHAT VALACICLOVIR GENERICHEALTH IS USED FOR Valaciclovir generichealth is used to treat shingles (herpes zoster), ophthalmic zoster (shingles affecting the eye region) and cold sores (herpes labialis). Valaciclovir generichealth belongs to a group of medicines called antivirals. It works by stopping the multiplication of the virus which causes the shingles and cold sores. Valaciclovir generichealth reduces the length and severity of an outbreak and the duration of pain associated with the shingles and cold sores. It is important to start treatment within three days of the shingles attack. For treatment of cold sores the tablets should be taken at the earliest symptom of a cold sore (eg. tingling, itching, or burning). Valaciclovir generichealth tablets are more effective in patients 50 years and over. Your doctor may have prescribed Valaciclovir generichealth for another reason. Ask your doctor if you have any questions about why Valaciclovir generichealth has been prescribed for you. VALACICLOVIR GENERICHEALTH IS NOT RECOMMENDED FOR USE IN CHILDREN, AS THERE HAVE BEEN NO STUDIES OF ITS EFFECTS IN CHILDREN. Valaciclovir generichealth is available only with a doctor’s prescription. There is no evidence that Valaciclovir generichealth is addictive. BEFORE YOU TAKE VALACICLOVIR GENERICHEALTH _WHEN YOU MUST NOT TAKE IT _ D Aqra d-dokument sħiħ
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 Aqra d-dokument sħiħ