Therapeutic Indications: ONYTEC 80mg nail varnish is an anti-fungal treatment for finger and toe nails and for the skin around them. It is indicated for the treatment of light to moderate nail fungus (onychomycosis) due to filamentous fungi and / or other fungi that can be cured by ciclopirox. The active ingredient is ciclopirox which stops the growth of fungus and kills them. It improves nail health. Contraindications: Do not use ONYTEC 80mg/g nail varnish: · If you are allergic (very sensitive) to the ciclopirox or one of its components contained in Onytec. · on children younger than 18 years due to the lack of data. Cautions: In case of sensitisation, stop treatment and consult your doctor. As with any topical treatment of onychomycosis, in the case of more than one infected nail (more than 5), if more than two-thirds of the nail plate is reached and in the case of predisposing factors such as diabetes and the immune disorders, consult your doctor who could possibly add an oral treatment in addition to your medicated varnish. If you are diabetic, be careful when cutting your nails. Avoid contact with eyes and mucous membranes. This should only be used for local use. Do not apply normal nail varnish or other cosmetic products on the treated nails. Interaction with other drugs: Talk to your doctor or pharmacist if you take or have recently taken any other drug, including any non-prescription drugs. Pregnancy and breast feeding: Pregnancy: Consult your doctor or pharmacist before taking any drugs. This nail varnish should only be used if absolute need after your doctor has evaluated the benefits and consequences of the nail varnish. Breast feeding: No data concerning the passing of ciclopirox into human milk. This nail varnish should only be used if absolute need after your doctor has evaluated the benefits and consequences of the nail varnish. Dosage: You must use ONYTEC nail varnish exactly as indicated in this notice. IF IN DOUBT CONSULT YOUR DOCTOR OR PHARMACIST. How to use: The ONYTEC 80mg/g nail varnish must be applied in a thin layer once per day or on the infected nails. The nails need to be clean and dry. The nail varnish must be applied on the whole surface of the nail and the skin 5mm adjacent. Where possible, ONYTEC 80 mg/g, nail polish should be applied under the free edge of the nail. Leave the nail varnish to dry for about 30 seconds. Frequency of dose: The nails must not be cleaned for at least 6 hours so it is recommended to apply the varnish in the evening before going to bed. After this 6 hours, you can wash as normal. It is not necessary to take off the varnish with a varnish remover but with water instead. Sometimes due to insufficiency cleaning of nails, a white layer might appear on the surface of the nail a few days after treatment. Use a neutral soap with a brush or sponge to get rid of the white marks. Length of treatment: Treatment should continue until symptoms have disappeared, until all signs of the infection have disappeared and/or nails have grown. Complete healing of the nails is normally within 6 months, and 9-12 months for toe nails. If the nail is severely affected by a single finger or toe or by several nails, an additional oral treatment may be considered. Seek advice from your doctor or pharmacist if this is the case. If the nail varnish does not seen effective or it is too strong, speak to your doctor. Symptoms and instructions in case of overdose: No case of an overdose has been reported. Side effects: Like all medication, this drug can cause side effects, but will not arise for everyone. Very rare side effects (affects less than 1 in 10,000): Redness, peeling, burning and itching. Unknown frequency side effects: Rash, eczema. Discolouration of the nail (this can also be linked to nail mycosis). The reported side effects have been short-term effects. Composition: Active Ingredient: ciclopirox. 1 g of nail varnish contains 80mg of ciclopirox. Other ingredients: Ethyl acetate, 96% ethanol, cetostearylic alcohol, hydroxypropyl-chitosane, purified water.
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