Sandoz Amorolfine 5% medicated nail polish 2.5 ml

Description Sandoz Amorolfine 5% Medicated Nail Lacquer 2.5ml

Sandoz Amorolfine 5% 2.5ml is a medicated nail polish for the treatment of nail fungus (infection due to a fungus), affecting up to 2 nails in adults.

A mycosis is generally expressed by a change in color (white, yellow or brown), and a thickening of the nail, although the aspect can vary considerably. If the infection is localized at the tip of the nail and/or on the side, follow your pharmacist's advice.

If the infection is more severe, then it is advisable to consult a doctor.

Warnings and precautions Sandoz Amorolfine 5% medicated nail polish 2.5 ml

Talk to your doctor or pharmacist before using AMOROLFINE SANDOZ 5% medicated nail polish.

Avoid contact with eyes, ears or mucous membranes.

Ask your doctor or pharmacist for advice:

if you have diabetes, if you are being treated for an immune system disease (disease that lowers the body's defenses), if you have poor circulation in your hands or feet, if your nail is severely damaged (more than two-thirds of the nail is affected) or infected.

In these cases, your doctor may add an oral treatment in addition to your medicated nail polish.

This product contains ethanol (alcohol). Too frequent use or improper application can cause irritation and dryness of the skin around the nail.

Do not apply cosmetic nail polish or false nails while using AMOROLFINE SANDOZ. If organic solvents are handled, impervious gloves must be worn, otherwise the nail polish will dissolve.

Contraindications Sandoz Amorolfine 5% Medicated Nail Lacquer 2.5 ml

Hypersensitivity to the active substance or to any of the excipients mentioned in the package insert.

Interactions Sandoz Amorolfine 5% medicated nail polish 2.5 ml

Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.

Pregnancy and breastfeeding Sandoz Amorolfine 5% medicated nail polish 2.5 ml

There are limited data on the use of amorolfine in pregnant and nursing women.

AMOROLFINE SANDOZ should not be used during pregnancy and/or lactation unless clearly needed.

If you are pregnant or breastfeeding, think you might be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking any medication.

Method of administration

To apply the varnish, carefully follow the following recommendations:

- before the first application of AMOROLFINE SANDOZ, carefully clean your nails. Remove any residual nail polish with a nail polish remover, file the nail surface (especially the affected area) as completely as possible. Be careful not to file the periungual skin,

- clean the surface of the nail and degrease it with a compress or a cloth soaked in nail polish remover,

- apply the nail polish with one of the reusable spatulas on the entire affected nail. Clean the reusable spatula between each pass from one nail to the other with a compress or a cloth soaked in nail polish remover, to avoid contamination of the nail polish. Do not wipe the spatula on the edge of the bottle,

- it is important to clean the spatula well with a compress or a cloth impregnated with nail polish remover after each application before reusing it for another nail to avoid contamination of the nail polish,

- if some nail polish has been deposited on the outside of the cap during handling, it is important to clean it with a compress or a cloth impregnated with nail polish remover in order to avoid applying this nail polish to the skin,

- close the bottle tightly.

Repeat all the above operations for each affected nail.

After each use of AMOROLFINE SANDOZ, it is important to wash your hands. However, when applying to fingernails, it is necessary to wait until the nail polish has dried completely.

The treatment must be carried out without interruption until complete regeneration of the nail and clinical and mycological healing of the affected surfaces.

The duration of treatment is generally 6 months for fingernails and 9 months for toenails (it depends essentially on the intensity, the location of the infection and the height of the nail damage).

After 3 months of use in the absence of improvement a doctor should be consulted.

Special instructions:

do not reuse nail files for healthy nails,

before each new application, remove the residual nail polish, file, if necessary, the affected nails and in any case, clean them with a compress or a cloth impregnated with solvent,

when handling organic solvents (white spirit, thinners, etc.), it is necessary to wear waterproof gloves to protect the AMOROLFINE SANDOZ coating on the nails.

Dosage Sandoz Amorolfine 5% Medicated Nail Lacquer 2.5 ml

Apply AMOROLFINE SANDOZ to affected nails once or twice a week.

Route of administration

Dermal application.

Adverse reactions Sandoz Amorolfine 5% medicated nail polish 2.5 ml

Like all medicines, this drug may cause side effects, but they do not occur systematically in everyone.

Reactions to the product are rare. Nail abnormalities (discolored nails, brittle nails, or brittle nails) have been reported after use of AMOROLFINE SANDOZ 5% medicated nail polish.

However, these abnormalities may be directly related to the nail disease.

The following adverse reactions may occur:

Rare adverse reactions (seen in less than 1 in 1000 and more than 1 in 10,000 patients)

- damaged nail,

- discolored nail,

- brittle or broken nail.

Very rare side effects (seen in less than 1 in 10,000 patients)

- burning sensation of the skin.

Undesirable effects of unknown frequency

- redness of the skin

- itching,

- contact allergies,

- urticaria (skin rash),

- blistering.

Reporting side effects

If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effect not mentioned in this leaflet. You can also report adverse reactions directly through the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Regional Pharmacovigilance Centres - Website: www.ansm.sante.fr

By reporting adverse reactions, you contribute to provide more information on the safety of the drug.

Composition

The active substance per 100 ml is: amorolfine hydrochloride 5.57g.

Amount corresponding to amorolfine base 5.00g.

The other components are : Methacrylic acid copolymer, triacetin, butyl acetate, ethyl acetate, absolute ethanol.