Land: Australia
Språk: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
eflornithine hydrochloride
A Menarini Australia Pty Ltd
Eflornithine hydrochloride
Registered
VANIQA ® _eflornithine_ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET? Read this leaflet carefully before using VANIQA. This leaflet answers some common questions about VANIQA. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor or pharmacist has weighed the risks of you taking VANIQA 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 IS VANIQA USED FOR? VANIQA is used to delay the regrowth of unwanted facial hair in women. VANIQA interferes with an enzyme found in the hair follicle of the skin needed for hair growth. This results in slower hair growth and shorter or fewer hairs where VANIQA is applied. VANIQA does not permanently remove hair or "cure" unwanted facial hair. It is not a depilatory. Your treatment program should include continuation of any hair removal techniques you are currently using. VANIQA will help you manage your condition. Reduction of hair growth occurs gradually. Don't be discouraged if you see no immediate improvement. Improvement may be seen as early as after 4 to 8 weeks of treatment. Improvement may take longer in some people. If no improvement is seen after 6 months of use, stop using VANIQA. Clinical studies show that in about 8 weeks after stopping treatment with VANIQA, the hair will return to the same condition as before beginning treatment. BEFORE YOU USE VANIQA _WHEN YOU MUST NOT USE IT_ DO NOT USE VANIQA IF YOU HAVE AN ALLERGY TO VANIQA OR ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. DO NOT USE VANIQA IF YOU HAVE SEVERE RENAL IMPAIRMENT, WHICH IS A SERIOUS FORM OF KIDNEY DISEASE. TALK TO YOUR DOCTOR IF YOU THINK THIS MAY APPLY TO YOU. DO NOT USE VANIQA ON A CHILD UNDER 12 YEARS, UNLESS DIRECTED BY THE CHILD’S DOCTOR. The safety and effectiveness of VANIQA in children less t Les hele dokumentet
AUSTRALIAN PRODUCT INFORMATION – VANIQA ® (EFLORNITHINE HYDROCHLORIDE) CREAM VANIQA PI vA03-0 Page 1 of 8 1 NAME OF THE MEDICINE Eflornithine hydrochloride. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION VANIQA cream contains 11.5% (115 mg/g) of eflornithine as eflornithine hydrochloride monohydrate (150 mg/g). Excipients with known effect: Contains phenoxyethanol, methyl hydroxybenzoate and propyl hydroxybenzoate. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM A smooth white to off-white cream. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS VANIQA delays the regrowth of unwanted facial hair, following depilation, in women. 4.2 DOSE AND METHOD OF ADMINISTRATION A thin layer of VANIQA should be applied to affected areas of the face and adjacent involved areas under the chin, and rubbed in thoroughly. The treated areas should not be washed for at least 4 hours. VANIQA should be used twice daily at least 8 hours apart or as directed by your doctor. The patient should continue to use hair removal techniques as needed in conjunction with VANIQA. (VANIQA should be applied at least 5 minutes after hair removal.) Cosmetics or sunscreens may be applied over treated areas after cream has dried. 4.3 CONTRAINDICATIONS VANIQA is contraindicated in patients with a history of sensitivity to any components of the preparation. VANIQA is also contraindicated in patients with severe renal impairment. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE VANIQA has only been studied on the face and adjacent involved areas under the chin of affected individuals. Usage should be limited to these areas of involvement. General FOR EXTERNAL USE ONLY. Discontinue use if hypersensitivity occurs. Transient stinging or burning may occur when applied to abraded or broken skin. Information for patients Patients using VANIQA should receive the following information and instructions: 1. This medication is not a depilatory, but rather appears to retard hair growth to improve the condition and the patient’s Les hele dokumentet