Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
aciclovir, Quantity: 800 mg
Arrotex Pharmaceuticals Pty Ltd
Aciclovir
Tablet, uncoated
Excipient Ingredients: microcrystalline cellulose; sodium starch glycollate; pregelatinised maize starch; magnesium stearate; colloidal anhydrous silica
Oral
35 tablets
(S4) Prescription Only Medicine
ARX-ACICLOVIR tablets are indicated for use in adult patients for: (1) the treatment of first episode (primary or non-primary) genital herpes and the management of recurrent episodes of genital herpes in certain patients. (2) the treatment of acute attacks of herpes zoster (shingles) when the duration of rash is less than 72 hours. (3) the management of patients with advaned symptomatic HIV disease CD4 + counts < 150 x 10(6)/L). In accordance with details specified in the "Indications" and the "Dosage and Administration" sections of the approved product information provided as Attachment 1.
Visual Identification: White to off-white, capsule shaped, biconvex tablets, with 'ACV' debossed on one side and '800' on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2011-08-09
ACICLOVIR APOTEX _Aciclovir_ CONSUMER MEDICINE INFORMATION _FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about this medicine. It does not contain all the available information. It does not take the place of talking to your doctor. All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT THIS MEDICINE IS USED FOR Aciclovir belongs to a group of medicines called anti-virals. The 200 mg strength is used to: • treat genital herpes. It makes an outbreak of genital herpes shorter and less severe • prevent or reduce the number of outbreaks and/or severity of genital herpes in people who experience them often. The 800 mg strength is used: • to treat shingles, also known as herpes zoster. Shingles is caused by the same virus which causes chicken pox. It usually involves nerve pain and a blistery rash, limited to one area of the body. If taken within 72 hours of first getting the rash, aciclovir makes an outbreak of shingles shorter and less severe • as part of the management program for certain infections in people who have the human immunodeficiency virus (HIV). HIV is the virus that causes acquired immune deficiency syndrome (AIDS). Aciclovir does not cure AIDS or get rid of the HIV virus from your body, but it may prevent further damage to the immune system by stopping production of the herpes viruses. _HOW IT WORKS_ Aciclovir works by stopping the production of the virus that causes herpes and shingles. It does not get rid of the virus from your body. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is not addictive. This medicine is available only with a doctor's prescr Read the complete document
1 AUSTRALIAN PRODUCT INFORMATION – ACICLOVIR APOTEX (ACICLOVIR) 1 NAME OF THE MEDICINE Aciclovir 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 200 mg or 800 mg aciclovir For the full list of excipients, see Section 6.1 List of Excipients. 3 PHARMACEUTICAL FORM _200 mg_: capsule shaped, biconvex, white to off-white tablets embossed “200” on one side and “ACV” on the other side. _800 mg:_ capsule shaped, biconvex, white to off-white tablets embossed “800” on one side and “ACV” on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ADULTS Treatment of first episode (primary or nonprimary) genital herpes and the management of recurrent episodes of genital herpes in certain patients. Treatment of acute attacks of herpes zoster (shingles) when the duration of rash is less than 72 hours. The management of patients with advanced symptomatic human immunodeficiency virus (HIV) disease (CD4+ counts < 150 × 10 6 /L). Genital herpes _Initial episodes _ The duration of viral shedding is reduced very significantly; the duration of pain and time to healing are also reduced. The promptness of initiation of therapy and/or the patient’s prior exposure to herpes simplex virus (HSV) may influence the degree of benefit from therapy. Intravenous aciclovir should be considered in patients in whom prostration, CNS involvement or inability to take oral medication requires hospitalisation and initiation of more aggressive management. Aciclovir does not prevent the establishment of latency in initial episodes. _Recurrent episodes _ _Suppression. _In patients with frequent recurrences, suppressive therapy prevents or reduces the frequency and/or severity of recurrences in a high proportion of patients. Abortive episodes (prodromal symptoms without vesicle formation) and occasional breakthrough episodes may, however, continue to occur during suppressive therapy. 2 Suppressive therapy is not considered appropriate for patients in whom attacks are mild, last for short periods and/or occur in Read the complete document