País: Austràlia
Idioma: anglès
Font: Department of Health (Therapeutic Goods Administration)
famciclovir, Quantity: 250 mg
Alphapharm Pty Ltd
Tablet, film coated
Excipient Ingredients: sodium stearylfumarate; silicon dioxide; copovidone; microcrystalline cellulose; crospovidone; titanium dioxide; macrogol 8000; hypromellose; polydextrose; triethyl citrate
Oral
14 tablets, 21 tablets, 20 tablets, 56 tablets, 5 tablets, 30 tablets, 3 tablets
(S4) Prescription Only Medicine
Famciclovir is indicated for the treatment of herpes zoster infection in adult patients who commence therapy within 72 hours of the onset of rash. Greatest benefit occurs if the drug is started within 48 hours.,Efficacy has not been demonstrated in patients less than 50 years of age, although the occasional younger patient with severe herpes zoster may benefit from therapy with famciclovir. Herpes zoster infection is generally a milder condition in younger patients. Famciclovir is also indicated for the treatment of recurrent episodes of genital herpes in adults and adolescents 12 years of age and older.,Famciclovir is also indicated for suppression of recurrent genital herpes.,Famciclovir is also indicated for the treatment of recurrent herpes labialis (cold sores) in immunocompetent adult patients.,Famciclovir is also indicated in immunocompromised patients for: ? treatment of uncomplicated herpes zoster ? treatment of recurrent herpes simplex ? suppression of recurrent herpes simplex
Visual Identification: White, round, coated tablets debossed with FM on one side and 250 on the other side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2020-10-13
EZOVIR – FOR COLD SORES _ _ _famciclovir_ CONSUMER MEDICINE INFORMATION 1 WHAT IS IN THIS LEAFLET This leaflet answers some common questions about EZOVIR. It does not contain all the available information. It does not take the place of talking to your pharmacist or doctor. The information in this leaflet was last updated on the date listed on the final page. Some more recent information on the medicine may be available. YOU SHOULD SPEAK TO YOUR PHARMACIST OR DOCTOR TO OBTAIN THE MOST UP TO DATE INFORMATION ON THE MEDICINE. Those updates may contain important information about the medicine and its use of which you should be aware. All medicines have risks and benefits. Your pharmacist or doctor has weighed the risks of you taking EZOVIR against the benefits it can provide. IF YOU HAVE ANY CONCERNS ABOUT THIS MEDICINE, ASK YOUR PHARMACIST OR DOCTOR. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT EZOVIR IS USED FOR EZOVIR is an antiviral medicine used to treat recurrent outbreaks of cold sores in adults 18 years of age and over who have a normal immune system (the body system which fights against harmful bacteria, viruses and fungi). Cold sores are an infection caused by a virus called herpes simplex type 1 (HSV- 1). The infection is most commonly acquired as a baby or child from contact with parents or relatives, often from kissing. Cold sores usually begin on or around the lips, mouth, and nose as small red bumps that turn into fluid- filled blisters. Cold sores can be tender and painful. Many people who get cold sores know when one is coming by a tingling, burning, itchy or painful sensation or redness in the area. This can happen very rapidly. After redness and swelling develop, blisters form. The blisters may weep or burst and this can be painful. Then a shallow ulcer and yellow crust form as the cold sore dries. The crust eventually falls off, exposing new pink- coloured skin. Generally the sores heal without scarring. After the initial infection has healed, the virus becomes dorman Llegiu el document complet
1 Version 01 AUSTRALIAN PRODUCT INFORMATION – EZOVIR (FAMCICLOVIR) TABLETS 1 NAME OF THE MEDICINE Famciclovir 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 125 mg, 250 mg or 500 mg of famciclovir as the active ingredient. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Ezovir famciclovir 125 mg Tablets are white, round, film-coated tablets, debossed with “FM” on one side and “125” on the reverse side. Ezovir famciclovir 250 mg Tablets are white, round, film-coated tablets, debossed with “FM” on one side and “250” on the reverse side. Ezovir famciclovir 500 mg Tablets are white, oval, film-coated tablets, debossed with “FM” on one side and “500” on the reverse side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ezovir is indicated for • the treatment of herpes zoster infection in adult patients who commence therapy within 72 hours of the onset of rash. Greatest benefit occurs if the drug is started within 48 hours. Efficacy has not been demonstrated in patients less than 50 years of age, although the occasional younger patient with severe herpes zoster may benefit from therapy with famciclovir. Herpes zoster infection is generally a milder condition in younger patients. • the treatment of recurrent episodes of genital herpes in adults and adolescents 12 years of age and older. • suppression of recurrent genital herpes. • treatment of recurrent herpes labialis (cold sores) in immunocompetent adult patients. Ezovir is also indicated in immunocompromised patients for: • treatment of uncomplicated herpes zoster • treatment of recurrent herpes simplex • suppression of recurrent herpes simplex _ _ 2 Version 01 4.2 DOSE AND METHOD OF ADMINISTRATION Famciclovir can be taken without regard to meals (se Section 5.2 Pharmacokinetic Properties- Effect of Food. IMMUNOCOMPETENT _Herpes zoster:_ The recommended dosage of Ezovir is 250 mg three times daily for seven days. Treatment should be initiated as soon as possible afte Llegiu el document complet