Land: Australien
Sprog: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
mometasone furoate, Quantity: 1 mg/g
Ego Pharmaceuticals Pty Ltd
mometasone furoate
Lotion
Excipient Ingredients: industrial methylated spirit; citric acid; propylene glycol; hypromellose; purified water
Topical
1 x 30 mL
(S4) Prescription Only Medicine
For the short term (up to four continuous weeks) relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses such as psoriasis and atopic dermatitis.,ZATAMIL lotion is suitable for use in scalp psoriaris and application to other areas of the body.
Visual Identification: Clear, colourless to straw coloured, slightly thickened solution; Container Type: Bottle; Container Material: HDPE; Container Life Time: 30 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2012-05-10
ZATAMIL _Mometasone furoate 0.1% w/w_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Zatamil. It does not contain all the available information. It does not take the place of talking to your pharmacist or doctor. All medicines have risks and benefits. Your doctor has weighed the risks of you using Zatamil against the benefits he expects it will have for you. If you have any concerns about this medicine, ask your doctor or pharmacist. Keep this leaflet with your medicine. You may need to read it again. WHAT IS ZATAMIL USED FOR? The name of this medicine is Zatamil. It contains the active ingredient called mometasone furoate. Zatamil is a type of cortisone and belongs to the group of medicines called corticosteroids. There are three dosage forms of Zatamil: gel, ointment and lotion. Zatamil lotion is formulated for easier application to the scalp and other hairy parts of the body. ZATAMIL IS USED ON THE SKIN TO RELIEVE THE REDNESS, SWELLING, ITCHING AND DISCOMFORT OF MANY SKIN PROBLEMS SUCH AS: • PSORIASIS (a stubborn skin disorder with raised, rough, reddened areas covered with dry, fine silvery scales) • ECZEMA (an often itchy skin condition with redness, swelling, oozing of fluid, crusting which may lead to scaling) • OTHER TYPES OF DERMATITIS Your doctor, however, may have prescribed Zatamil for another purpose. Ask your doctor if you have any questions about why Zatamil has been prescribed for you. Zatamil is available only with a doctor's prescription. Zatamil is not addictive. BEFORE YOU USE ZATAMIL _WHEN YOU MUST NOT USE_ _ZATAMIL_ 1. DO NOT USE ZATAMIL IF YOU HAVE HAD AN ALLERGIC REACTION TO : • mometasone furoate • any other corticosteroids • any of the ingredients in Zatamil listed at the end of this leaflet 2. DO NOT USE ZATAMIL: • IF YOU HAVE A VIRAL SKIN INFECTION (SUCH AS COLD SORES, SHINGLES OR CHICKEN POX) • IF YOU HAVE A FUNGAL SKIN INFECTION (SUCH AS THRUSH, TINEA OR RINGWORM) • ON ACNE • FOR INFLAMMATION AROUND THE MOUTH Læs hele dokumentet
1 AUSTRALIAN PRODUCT INFORMATION – ZATAMIL (MOMETASONE FUROATE) GEL, LOTION, OINTMENT 1 NAME OF THE MEDICINE Mometasone furoate. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Mometasone furoate 0.1% (1mg/g). Mometasone furoate is a white to off-white powder which is practically insoluble in water, soluble in acetone and in methylene chloride, slightly soluble in ethanol (96 per cent). For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Zatamil Hydrogel is a clear, colourless to straw-coloured gel. Zatamil Ointment is an opaque white to off-white ointment. Zatamil Lotion is a clear, colourless to straw-coloured lotion. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Short term (up to four continuous weeks) relief of inflammation and pruritic manifestations of corticosteroid-responsive dermatoses, such as psoriasis and atopic dermatitis. Zatamil Lotion is suitable for use in scalp psoriasis and applications to other areas of the body. 4.2 D OSE AND METHOD OF ADMINISTRATION Apply a thin film of the ointment or gel to the affected skin once daily. For Zatamil Lotion few drops should be applied to the affected skin areas including scalp sites once daily; massage gently and thoroughly until the medication disappears. 4.3 C ONTRAINDICATIONS Hypersensitivity to mometasone furoate or to other corticosteroids. As with other corticosteroids, Zatamil is contraindicated in most viral infections of the skin, tuberculosis, acne rosacea, perioral dermatitis, fungal skin infections and ulcerative conditions. 4.4 S PECIAL WARNINGS AND PRECAUTIONS FOR USE For external use only. Avoid contact with eyes. 2 If irritation or sensitisation develops, treatment should be discontinued and appropriate therapy instituted. In the presence of an infection, an antibacterial or antifungal agent, as appropriate should be added to the treatment regimen. If the infection does not resolve promptly, corticosteroid therapy should be discontinued until the infection is controlled. As with all topical corticoste Læs hele dokumentet