PACKAGE LEAFLET: INFORMATION FOR THE USER • If you have a history of hypersensitivity reactions to other imidazole anti-fungal agents (e.g. econazole, clotrimazole, miconazole)
Urea Ointment PACKAGE LEAFLET: INFORMATION FOR THE USER Take special care with Canesten Fungal Nail TreatmentUreaSet: Ointment • If you have a history of hypersensitivity reactions to other imidazole anti-fungal agents (e.g. econazole, clotrimazole, miconazole) • If you have a fungal infection starting from the root of the nail (proximal subungual onychomycosis) • If you have an infection affecting more than half of one nail or more than three nails If one of the above mentioned conditions apply to you, Canesten Fungal Nail Treatment Set should not be used without medical supervision. Urea Ointment Fungal Nail Treatment Set 10 g Urea Ointment 20 g Bifonazole Cream 22 Waterproof Plasters 1 Plastic Nail Scraper Read all of this leaflet carefully before you start using this product. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. In this leaflet: 1.What Canesten® Fungal Nail Treatment Set is and what it is used for 2.Before you use Canesten Fungal Nail Treatment Set 3.How to use Canesten Fungal Nail Treatment Set 4.Possible side effects 5.How to store Canesten Fungal Nail Treatment Set 6.Further information 1.WHAT CANESTEN FUNGAL NAIL TREATMENT SET IS AND WHAT IT IS USED FOR Canesten Fungal Nail Treatment Set is a product used to treat fungal infections (onychomycosis) of the fingernail(s) and toenail(s) affecting up to 3 nails and affecting the upper half or sides of the nail. A fungal nail infection is likely to result in discoloured (white, yellow or brown), thick/rough or brittle nail, although appearance can vary considerably. Canesten Fungal Nail Treatment Set consists of a two-phase treatment (6-7 weeks): 1.In the first phase (2-3 weeks), the infected nail parts are softened by applying Canesten Urea Ointment and then removed with the help of a plastic nail scraper. 2.In the second phase (4 weeks), the fungal infection is treated by applying Canesten Bifonazole Cream on the nail bed. The Canesten Urea Ointment contains the active substance urea, which softens the infected nail. The Canesten Bifonazole Cream contains the active substance bifonazole, which belongs to a group of medicines called imidazoles. Imidazoles are anti-fungals for the treatment of fungal infections. 2.BEFORE YOU USE CANESTEN FUNGAL NAIL TREATMENT SET Do not use Canesten Fungal Nail Treatment Set: • If you are allergic (hypersensitive) to urea, bifonazole or any of the other ingredients of Canesten Fungal Nail Treatment Set (see section 6 “Further information”) Urea Ointment 1. B efore applying Canesten Urea Ointment, the affected hand or foot should be soaked in warm water for about 10 minutes. Dry thoroughly. Urea Ointment Urea Ointment Urea Ointment Urea Ointment Use in Children Fungal nail infection is a nail disease mainly affecting adults. If you think your child has a nail infection, see your doctor. Urea Ointment Using other medicines Urea Ointment taken any other Please tell your doctor Urea orOintment pharmacist if you are taking or have recently medicines, including medicines obtained without a prescription. Urea is known to increase the absorption of other medicinal products into the skin. This is especially the case for corticosteroids (used to reduce swelling, redness and itching). Ask your doctor or pharmacist if you want to use Canesten Fungal Nail Treatment Set together with other medicinal products on the same nail. Using other nail products Nail varnish or artificial nails should not be used while using Canesten Fungal Nail Treatment Set. Urea Ointment Urea Ointment 2. Apply Canesten Urea Ointment to the surface of the infected part of the nail once daily. Apply enough to cover the infected nail areas with a thin layer. Urea Ointment Urea Ointment 3. Cover the affected nail with a plaster. Gently place half the plaster over the treated nail then fold over the sides of the plaster round the toe or finger and press. If a smaller finger- or toenail is affected, the plaster should be cut in half. Take care not to touch the sticky surface of the plaster with your fingers or with the ointment, this will help it stick better. Toe bottom side 4. Fold over the other half of the plaster over the back of your toe or finger. Again, fold over the sides of the plaster round the toe or finger and press. The plaster will fit like a protective cap over the affected nail. Urea Ointment Urea Ointment Important information about some of the ingredients Canesten Urea Ointment contains Wool fat. Canesten Bifonazole cream contains cetostearyl alcohol. Both of these ingredients may cause local skin reactions (e.g. rash, itching and redness which may be signs of contact dermatitis). Pregnancy and breastfeeding You should not use this medicine without first telling your doctor or pharmacist if you are pregnant, planning to become pregnant or are breastfeeding. Your doctor or pharmacist can advise if you should use Canesten Fungal Nail Treatment Set. Urea Ointment Toe bottom side 5. The plaster should be removed every 24 hours and the affected nail should be soaked in warm water for about 10 minutes. Urea Ointment Urea Ointment 3.HOW TO USE CANESTEN FUNGAL NAIL TREATMENT SET Only use Canesten Fungal Nail Treatment Set to treat a fungal nail infection. Each tube of Canesten Urea Ointment and Canesten Bifonazole Cream is sealed – unscrew the cap and use the cap to pierce the seal. Method and route of administration 1st Phase: Removal of infected nail parts with Canesten Urea Ointment and Plastic Nail Scraper Urea Ointment Urea Ointment The first treatment phase is the softening of the infected part(s) of the nail with Canesten Urea Ointment, followed by their removal with the help of a plastic nail scraper. Canesten Urea Ointment acts only on the infected part of the nail; healthy areas remain unaffected. Always wash your hands before and after using the ointment. 6. After soaking, the softened infected nail should be removed using the plastic nail scraper. Clean the scraper thoroughly before and after each use. 7. T he treated nail(s) should be dried thoroughly. Canesten Urea Ointment and a fresh plaster should be applied daily as described in points 1 - 6 above. old the plastic nail scraper firmly by gripping the broad handle (smooth H and blunt end) only. Use the sharpened and serrated edge for scraping. Keep the plastic nail scraper until treatment has been completed. Occasionally, the skin around the nail may become irritated during treatment. If this happens to you, ask your doctor or pharmacist for advice, they may recommend a zinc paste to protect the skin or advise you to switch to a different plaster or to rubber finger stalls. Treatment with Canesten Urea Ointment should be carried out carefully every day and should be continued until no more softened infected nail can be removed (see section 1 for signs of infection). This usually takes 14 days, depending on the extent of the infection and the thickness of the nail. 2nd Phase: Anti-fungal follow-up treatment with the Canesten® Bifonazole Cream Bifonazole Cream The following side effects have been observed at unknown frequency during the treatment with Canesten Fungal Nail Treatment Set or during treatment with another similar bifonazole based medicinal product: • Contact dermatitis or allergic skin reactions (itching or redness) in the area surrounding the nail. BAYER AUSTRALIA LTD. 875 Pacific Highway, Pymble NSW 2073 Ph: 1800 023 884 This leaflet was last prepared in May 2012. • Skin infection around the nail. • Reactions of the skin like slight irritation, reddening, inflation, skin softening, peeling, localised rash, hives, blisters, burning around the nail. The second treatment phase is the anti-fungal follow-up treatment with Canesten Bifonazole cream for use on the skin (the affected nail bed). • Nail disorder, nail discolouration. Clean and dry the affected area thoroughly. If you experience an allergic reaction to the plaster, you may switch to a hypoallergenic plaster or to rubber finger stalls. Bifonazole Cream Rub Canesten Bifonazole Cream sparingly into the affected nail bed once a day preferably before bedtime. Continue treatment every day for 28 days to avoid recurrence, even if the infection seems to have cleared. What else can you do to helpBifonazole treatCream your nail infection? You can help the treatment to work if you follow this simple advice: Change towels and garments which have come in contact with the infected nails daily. This avoids transferring the infection to other parts of your body or to other people. Canesten Fungal Nail Treatment Set is for use on the finger and toes only Avoid contact with the eyes. Do not put the ointment or the cream into your mouth or swallow it. If the ointment or cream is swallowed accidentally, tell your doctor straight away or contact the Poisons Information Centre – Australia 13 11 26, New Zealand 0800 POISON (0800 764 766). These side effects are usually mild and transient. If you notice any side effects and they worry you, or if you notice anything that is making you feel unwell, please tell your doctor or pharmacist. 5.HOW TO STORE CANESTEN FUNGAL NAIL TREATMENT SET • Keep out of the reach and sight of children. • Do not use Canesten Fungal Nail Treatment Set after the expiry date (EXP) which is stated on the carton and tube of Canesten Urea Ointment and Canesten Bifonazole Cream. The expiry date refers to the last day of that month. This product should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose if no longer required. These measures will help to protect the environment. 6.FURTHER INFORMATION If you forget to use Canesten Fungal Nail Treatment Set If you forget to use a dose, use the next dose at the usual time. Do not use a double dose to make up a forgotten treatment. What Canesten Fungal Nail Treatment Set contains If you stop using Canesten Fungal Nail Treatment Set If you stop using Canesten Fungal Nail Treatment Set before completing both phases of your treatment, the fungal infection may not be fully treated and may return. – Also contains Wool fat and Beeswax-white. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4.POSSIBLE SIDE EFFECTS Canesten Fungal Nail Treatment Set can cause side effects, although not everybody gets them. Some people may be allergic to the ointment or cream. If you are allergic, a reaction will occur soon after you have used the medicine. If you experience an allergic reaction, stop using this product and consult your pharmacist or doctor for advice. Signs of an allergic reaction may include: • Rash • Swallowing or breathing problems • Swelling of your lips, face, throat or tongue • Weakness, feeling dizzy or faint • Feeling sick Urea Ointment: – The active substance is urea at a strength of 400 mg/g. Bifonazole Cream: – The active substance is bifonazole at a strength of 10 mg/g. – Also contains benzyl alcohol and cetostearyl alcohol. See section 2 ‘Important information about some of the ingredients’ for Wool fat and cetostearyl alcohol advice. What Canesten Fungal Nail Treatment Set looks like and contents of the pack Each pack consists of: 1 tube of Canesten Urea Ointment (10 g) 1 tube of Canesten Bifonazole Cream (20 g) 1 Plastic Nail Scraper 22 (2x11) Waterproof Plasters The hygiene plasters contained in the Canesten Fungal Nail Treatment Set are not available commercially. If you need more plasters, ask your pharmacist to recommend some. 11871278 BFD4184-2_05/12_BAY0029 Bifonazole Cream Manufactured by:
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