MYCONAIL

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE

PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986

The medicine is dispensed without a doctor’s prescription.

MYCONAIL

Lacquer for treatment of nails

Each 1 gram contains: 80 mg ciclopirox

Inactive and allergenic ingredients in the medicine - see section

6 in the leaflet.

Read this leaflet carefully in its entirety before using the

medicine. This leaflet contains concise information about the

medicine. If you have further questions, refer to the doctor or

pharmacist.

The medicine is not intended for children below the age of 12.

Use the medicine in the correct manner.

Consult a pharmacist if you need further information.

Keep this leaflet; you may need to read it again.

1. WHAT IS THE MEDICINE INTENDED FOR?

The medicine is intended to treat fungal infections of the nails.

Therapeutic group: Antimycotic (antifungal) medicine from the

hydroxypyridone group.

2. BEFORE USING THE MEDICINE

Do not use this medicine:

∙ if you are sensitive (allergic) to the active ingredient ciclopirox

or to any of the other ingredients contained in the medicine

(see section 6 in the leaflet).

∙ if you are pregnant or breastfeeding.

∙ in children below the age of 12.

Special warnings regarding use of the medicine

∙ Before treatment with Myconail, tell the doctor if:

∘ you are sensitive to any food or medicine.

∘ you have diabetes and you are being treated with insulin.

∘ you have diabetic neuropathy or you have numbness problems

in the fingers or toes.

∘ you are suffering, or have suffered in the past, from

immune system suppression (e.g., if you underwent a

transplantation).

∘ you are taking medicines for epilepsy.

∘ you are using topical corticosteroids regularly (on a monthly

basis).

∘ you are using inhalers containing steroids on a regular basis.

This medicine is intended for application on the nails and the

surrounding skin only. The medicine is not intended for use in

the eyes or mouth, for intravaginal use or for application on the

skin (aside from the skin around the affected nail).

∙ Caution! Inflammable substance; keep away from fire. Do

not light a cigarette or be exposed to an open flame until

the medicine has completely dried.

Avoid contact between the medicine and the eyes and mucous

membranes. In case of contact with the eyes, wash thoroughly

with water for a long time. Do not apply lacquer or other cosmetic

products on the affected nail while using this medicine.

Avoid contact between the medicine and the skin, aside from

the skin close to the nail.

If you have diabetes or are suffering from diabetic neuropathy,

inform the medical staff in order to decide how to remove and/or

cut the affected nail.

Drug interactions

If you are taking, or have recently taken other medicines,

including non-prescription medicines and nutritional

supplements, tell the doctor or pharmacist. Do not apply

lacquer or other cosmetic products on the affected nail during

the course of treatment with the medicine.

∙ Concomitant use of Myconail and systemic antifungal medicines

is not recommended.

Pregnancy and breastfeeding

Do not use this medicine if you are pregnant or breastfeeding.

3. HOW SHOULD YOU USE THE MEDICINE?

Check with the doctor or pharmacist if you are uncertain.

The usual dosage is:

Apply an even coat with the applicator brush once a day,

preferably in the evening.

Do not exceed the recommended dose.

Do not swallow; for external use only.

Avoid contact with the eyes and mucous membranes. In case of

contact with the eyes, wash thoroughly with water for a long time.

Do not apply lacquer or other cosmetic products on the affected

nail during the course of treatment with the medicine.

Avoid contact between the medicine and the skin, aside from

the skin close to the nail.

Instructions for use:

Before commencing treatment with the medicine, cut the affected

nail with scissors as much as possible, and file with a disposable

nail file.

Apply an even coat on the surface of the nail and on the skin

close to the nail (5 mm).

If possible, apply on the skin under the nail and under the surface

of the nail. Contact with the surrounding skin may cause mild

irritation and/or redness.

To achieve maximal benefit from the treatment, the affected

parts of the nail must be removed once a month by a healthcare

professional.

Throughout the treatment period, apply on the previous coat, and

remove the coats of lacquer once a week, using a cosmetic nail

polish remover, such as acetone, to allow the active ingredient

to penetrate, and file the nail with a disposable nail file. Do

not remove the lacquer on a daily basis. Do not use cosmetic

lacquer.

∙ The duration of treatment with the medicine depends on the

severity of the infection and on the affected area.

∙ For fingernails, it is preferable to use for 3 months. For toenails,

it is preferable to use for 6 months. Do not continue treatment

beyond 6 months.

If you accidentally used a higher dosage or if a child or anyone

else has accidentally swallowed the medicine, immediately

refer to a doctor or proceed to a hospital emergency room and

bring the package of the medicine with you.

How can you contribute to the success of the treatment?

Moisture enhances fungal growth; therefore, keep the affected

area dry.

Wash the affected area before each application of the medicine.

An antifungal powder can be used to dry the area between

treatments with the lacquer.

If the treatment is for the toenails – be sure to thoroughly wash and

dry, especially between the toes. It is preferable to wear cotton

socks; avoid wearing socks made of wool or synthetic materials.

It is preferable to change them a few times a day (depending on

the amount of sweat).

It is recommended to wear sandals without socks in the

appropriate seasons.

∙ Do not take medicines in the dark! Check the label and the

dose each time you take a medicine. Wear glasses if you need

them.

If you have further questions regarding use of this medicine,

consult a doctor or pharmacist.

4. SIDE EFFECTS

As with any medicine, use of Myconail may cause side effects

in some users. Do not be alarmed by the list of side effects. You

may not suffer from any of them.

Discontinue use and refer to a doctor as soon as possible if

sensitivity or a chemical irritation to the medicine develops or if

you are suffering from a severe reaction of the skin in the treated

area, such as: redness, burning sensation, tingling, blistering,

swelling, rash or peeling (rare) (effects that occur in more than 1

in 10,000 patients and in less than 1 in 1,000 patients).

Refer to a doctor in cases of: itching or oozing in the treated

area.

An additional rare side effect: allergic reaction manifested by skin

inflammation in the treated area.

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

redness and peeling of the skin around the nails, if the medicine

comes into contact with the skin around the nail.

Additional side effects: rash, manifested by moderate, temporary

redness around the nail or redness in the skin fold around the

nail. In addition, nail disorders including: change in the color and

shape of the nail and ingrown nail may occur.

If a side effect occurs, if one of the side effects worsens, or if

you suffer from a side effect not mentioned in this leaflet, consult

with the doctor.

Reporting side effects:

Side effects can be reported to the Ministry of Health by clicking

on the link “Report Side Effects of Drug Treatment” found on

the Ministry of Health homepage (www.health.gov.il) that directs

you to the online form for reporting side effects, or by entering

the link:

https://sideeffects.health.gov.il

In addition, you can report to Perrigo via the following address:

www.perrigo-pharma.co.il

5. HOW SHOULD THE MEDICINE BE STORED?

∙ Avoid poisoning! This medicine, and any other medicine, should

be kept in a safe place out of the sight and reach of children

and/or infants in order to avoid poisoning. Do not induce

vomiting without explicit instruction from the doctor.

∙ Do not use the medicine after the expiry date (exp. date) that

appears on the package and bottle label. The expiry date refers

to the last day of that month.

∙ Store in the original package, in a cool and dark place, below

25°C.

∙ Can be used for 6 months after first opening, but not later than

the expiry date.

∙ Close tightly to avoid penetration of air and moisture.

6. FURTHER INFORMATION

∙ In addition to the active ingredient, the medicine also

contains:

Isopropyl alcohol, Ethylacetate, Gantrez ES-435

∙ What the medicine looks like and the contents of the package:

a bottle with 6.6 mL fluid and an applicator brush.

∙ Registration holder and address: Perrigo Israel Agencies Ltd.,

1 Rakefet St., Shoham.

∙ Manufacturer: Perrigo Company, Allegan, Michigan, USA.

∙ This leaflet was checked and approved by the Ministry of Health

in: February 2016.

∙ Registration number of the medicine in the National Drug

Registry of the Ministry of Health: 14171.31856