Onilaq 5% medicated nail polish 2.5ml with applicator cap and accessories

Onilaq 5% medicated nail polish is an antifungal treatment based on amorolfine , indicated for the treatment of fungal nail infections (onychomycosis) . Its formula penetrates deep into the nail, gradually eliminating the fungus and promoting healthy regrowth. The practical applicator cap and the accessories included allow for precise and hygienic application, ensuring an effective and simple treatment to perform at home.

ACTIVE INGREDIENTS

Active ingredients contained in Onilaq 5% medicated nail polish 2.5ml with applicator cap and accessories - What is the active ingredient in Onilaq 5% medicated nail polish 2.5ml with applicator cap and accessories?

ONILAQ 5% medicated nail polish contains 5% w/v (50 mg/ml) amorolfine as amorolfine hydrochloride. This medicinal product contains 0.552 g of alcohol (ethanol) in every 1 g, which is equivalent to 55.2% w/w. For the full list of excipients, see section 6.1.

EXCIPIENTS

Composition of Onilaq 5% medicated nail polish 2.5ml with applicator cap and accessories - What does Onilaq 5% medicated nail polish 2.5ml with applicator cap and accessories contain?

Methacrylic acid copolymer type A (EUDRAGIT RL100), Triacetin, Butyl acetate, Ethyl acetate, Absolute ethyl alcohol.

DIRECTIONS

Therapeutic indications Onilaq 5% medicated nail polish 2.5ml with applicator cap and accessories - Why is Onilaq 5% medicated nail polish 2.5ml with applicator cap and accessories used? What is it for?

Treatment of mild distal and lateral subungual onychomycosis caused by dermatophytes, yeasts and moulds involving no more than two nails in adults.

CONTRAINDICATIONS SIDE EFFECTS

Contraindications Onilaq 5% medicated nail polish 2.5ml with applicator cap and accessories - When should Onilaq 5% medicated nail polish 2.5ml with applicator cap and accessories not be used?

Hypersensitivity to the active substance or to any of the excipients listed in paragraph 6.1.

DOSAGE

Quantity and method of taking Onilaq 5% medicated nail polish 2.5ml with applicator cap and accessories - How do you take Onilaq 5% medicated nail polish 2.5ml with applicator cap and accessories?

Dosage Apply ONILAQ to the affected nails once a week. Method of administration Apply the nail polish carefully following the following recommendations: A. Before starting the first treatment with ONILAQ, clean the nails thoroughly. Remove any layers of previously applied nail polish with a nail polish remover; then, using a nail file, file the surface of the nail (in particular the surface of the affected nail) as carefully as possible. Be careful not to file the peri-ungual skin area. B. The surface of the nail must be clean and degreased using one of the cleansing pads (supplied). C. Using one of the applicators supplied (reusable), apply the nail polish to the entire surface of the nail. Between one application on the nail and the next, clean the applicator with the cleansing pad supplied, so as to avoid contaminating the medicated nail polish. Do not rub the applicator on the edge of the bottle itself. D. To avoid contaminating the nail polish, the applicator must be thoroughly cleaned with one of the cleaning pads provided after each application before treating another nail. E. If the nail polish comes into contact with the outside of the cap, clean with a cleaning pad provided to avoid contact with the skin. F. Keep the bottle tightly closed. Repeat the procedure for each affected nail. It is important to wash your hands after each application of ONILAQ. If applying to fingernails, wait until the nail polish is completely dry before washing. Treatment must be continued without interruption until the nail has regenerated and the affected areas have finally healed. In general, the duration of treatment is 6 months for fingernails and 9 months for toenails (the duration depends essentially on the intensity, location, growth rate of the nail and extent of the infection). After 3 months of treatment without results, consult your doctor. Special instructions: • Files used for diseased nails should not be used for healthy nails. • Before each new application, remove any remaining polish, file the affected nails if necessary, and then always clean them with a cleansing pad.

CONSERVATION

Storage Onilaq 5% medicated nail polish 2.5ml with applicator cap and accessories - How do you store Onilaq 5% medicated nail polish 2.5ml with applicator cap and accessories?

Keep the bottle away from heat sources. Close the bottle by screwing it tightly after use.

WARNINGS

Warnings Onilaq 5% medicated nail polish 2.5ml with applicator cap and accessories - About Onilaq 5% medicated nail polish 2.5ml with applicator cap and accessories it is important to know that:

Special warnings : Onilaq should not be applied to the skin around the nail. Avoid any contact of ONILAQ with eyes, ears or mucous membranes. Due to the lack of clinical experience to date, children should not be treated with Onilaq. Treatment should be established by the doctor in the case of patients suffering from peripheral vascular diseases, diabetes, diseases of the immune system, as well as in patients with nail dystrophy or severely damaged nails (with lesions greater than two thirds of the nail plate). In these cases, systemic therapy should be planned. Patients with a previous history of lesions, skin conditions such as psoriasis or other chronic skin conditions, edema, respiratory disorders (Yellow Nail Syndrome), painful nails, distorted/deformed nails or other symptoms should consult their doctor before starting treatment. During treatment with amorolfine, cosmetic nail polish or artificial nails should not be used. If organic solvents are used, it is advisable to wear waterproof gloves so as not to remove the layer of amorolfine medicated nail polish. After using this product, a systemic or local allergic reaction may occur. In this case, immediately stop using the product and consult a doctor. Carefully remove the product using nail polish remover. The product should not be reapplied. This medicine contains ethanol, which may cause a burning sensation on damaged skin. This medicine contains ethanol, which is a flammable substance, therefore it should not be used near open flames, lit cigarettes or certain devices (e.g. hair dryers). Precautions for use: In the absence of clinical data, the use of ONILAQ is not recommended in patients under 18 years of age.

INTERACTIONS

Interactions Onilaq 5% medicated nail polish 2.5ml with applicator cap and accessories - Which medicines or foods can modify the effect of Onilaq 5% medicated nail polish 2.5ml with applicator cap and accessories?

Currently available data do not highlight the existence of clinically relevant interactions.

SIDE EFFECTS

Like all medicines, Onilaq 5% medicated nail polish 2.5ml with applicator cap and accessories can cause side effects - What are the side effects of Onilaq 5% medicated nail polish 2.5ml with applicator cap and accessories?

*Post-marketing experience. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at: http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

OVERDOSE

Overdose Onilaq 5% medicated nail polish 2.5ml with applicator cap and accessories - What are the risks of Onilaq 5% medicated nail polish 2.5ml with applicator cap and accessories in case of overdose?

Systemic overdose reactions are not expected following topical administration of ONILAQ. In case of accidental ingestion, appropriate measures should be taken to treat symptoms.

PREGNANCY AND BREASTFEEDING

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Onilaq 5% medicated nail polish 2.5ml with applicator cap and accessories

Clinical experience with the use of amorolfine during pregnancy and/or lactation is limited. Only a few cases of exposure to topical amorolfine in pregnant women have been reported during the post-authorisation period, therefore the potential risk is unknown. Studies in animals have shown reproductive toxicity at high oral doses (see section 5.3); it is not known whether amorolfine is excreted in human milk. Amorolfine should not be used during pregnancy and/or lactation unless clearly necessary.

DRIVING AND USE OF MACHINERY

Taking Onilaq 5% medicated nail polish 2.5ml with applicator cap and accessories before driving or using machines - Does Onilaq 5% medicated nail polish 2.5ml with applicator cap and accessories affect driving or using machines?

Not relevant.