Amorolfine Sandoz

Package leaflet: Information for the patient

Amorolfina Sandoz 50 mg/ml nail lacquer

Generic medicine
Please read this leaflet carefully before using this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement or if your symptoms worsen after 3 months.

Contents of this leaflet:

1. What Amorolfina Sandoz is and what it is used for
2. What you need to know before using Amorolfina Sandoz
3. How to use Amorolfina Sandoz
4. Possible side effects
5. How to store Amorolfina Sandoz
6. Contents of the pack and other information

1. What Amorolfina Sandoz is and what it is used for

Amorolfina Sandoz is used to treat fungal infections of the nails in adults.
It should only be used if the upper half or the sides of the nail are affected.
The active substance, amorolfine, prevents the growth of fungi and kills them.
Amorolfina Sandoz is effective against a wide range of fungi susceptible to amorolfine, including yeasts,
dermatophytes, and moulds. However, bacteria are not susceptible to amorolfine.
Consult your doctor if you do not notice any improvement or if symptoms worsen after 3 months.

2. What you need to know before using Amorolfina Sandoz

Do not use Amorolfina Sandoz
if you are allergic to amorolfine or to any of the other ingredients of this medicine
(listed in section 6)

Warnings and precautions
Talk to your doctor or pharmacist before using Amorolfina Sandoz if you have:
diabetes
a weakened immune system or are receiving treatment that reduces its activity
circulatory problems in the hands and feet
a severely damaged or infected nail
if you have a history of nail injury, skin conditions such as psoriasis, or any other
chronic skin condition, swelling, yellow nails associated with respiratory disorders, painful nails,
deformed/distorted nails, or any other disorder affecting the nail area.

This medicine may cause allergic reactions, some of which may be severe. In such a case, stop using this medicine immediately and remove it promptly with nail polish remover
(or with the alcohol-impregnated swabs provided in the package) and consult a doctor.

If any of the following symptoms occur, seek medical advice immediately:

• If you have difficulty breathing.
• If you notice swelling of the face, lips, tongue or throat.
• If you develop a severe skin rash.

Amorolfina Sandoz must not be applied to the skin surrounding the nail.
Avoid using artificial nails during treatment with Amorolfina Sandoz.
There is currently no experience in patients with inflammatory conditions around the nail,
diabetes, poor blood circulation, malnutrition, alcohol abuse, or in children and newborns.
Wear waterproof gloves when handling organic solvents; otherwise, the layer of Amorolfina
Sandoz on the nails will be removed.
Avoid contact of the nail lacquer with eyes, ears or mucous membranes. If Amorolfina Sandoz
comes into contact with eyes or ears, rinse immediately with water and consult your doctor or
pharmacist.

Children and adolescents
Due to lack of experience, treatment of children and adolescents is not recommended.

Other medicines and Amorolfina Sandoz
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other
medicines.
No studies on interactions between Amorolfina Sandoz and other medicines are available.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning pregnancy, or breastfeeding,
ask your doctor or pharmacist for advice before using this medicine.
Amorolfina Sandoz must not be used during pregnancy and breastfeeding.

Driving and using machines
Amorolfina Sandoz has no influence on the ability to drive or use machinery.

Amorolfina Sandoz contains ethanol
This medicine contains 0.4823 g of alcohol (ethanol) per ml of medicated nail lacquer,
equivalent to 48.23% w/w. It may cause a burning sensation on damaged skin.
Ethanol is flammable; Amorolfina Sandoz must not be used near open flames, lit cigarettes, or certain devices (e.g. hair dryers).

3. How to use Amorolfina Sandoz

Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you. If in doubt, consult your doctor or pharmacist.
For topical use. Apply to affected nails.
Apply Amorolfina Sandoz once a week to the affected fingernails or toenails.
Follow these instructions carefully during use:

Each time before applying the nail lacquer, file the infected area of the nail (particularly the nail surface) as thoroughly as possible using one of the nail files provided in the pack.
Caution: do not use the same nail file for healthy nails that was used for filing infected nails.
Then take a swab soaked in the nail polish remover provided in the package and use it to clean the surface of the diseased nail and remove any residual lacquer. One swab is sufficient to clean all affected nails. You may alternatively use a commercially available nail polish remover.

Dip the spatula provided in the pack into the nail lacquer.
Do not rub it against the edge of the bottle. Repeat this procedure for each of the affected nails.

Apply the nail lacquer over the entire surface of the nail.
Close the bottle tightly immediately after application and clean the spatula using the swab soaked in nail polish remover.

Allow the applied lacquer to dry for approximately 3–5 minutes.
After applying Amorolfina Sandoz, it is important to wash your hands.
If Amorolfina Sandoz has been applied to the nails, wait until the lacquer has dried before washing your hands.
Do not apply cosmetic nail polish until at least 10 minutes have passed after application of Amorolfina Sandoz.
Before reusing the bottle, remove any lacquer residue or layers of cosmetic nail polish from the nails and re-file the nails. Clean the nails with the swab provided and reapply Amorolfina Sandoz as directed.

Additional advice to support treatment
Towels should be washed as frequently as possible at a minimum temperature of 60 °C.
Keep shoes in a well-ventilated area to ensure they remain dry.

Duration of treatment
Fungal infections are often very persistent. Therefore, use Amorolfina Sandoz continuously without interruption until the infected nail has completely regrown healthy. This usually takes 6 months for fingernails and 9 to 12 months for toenails. However, if there is no improvement after 3 months, you must consult your doctor.

If you accidentally swallow Amorolfina Sandoz
If this occurs, contact your doctor, pharmacist, or nearest hospital immediately.

If you forget to use Amorolfina Sandoz
When you remember, resume using the product, maintaining the weekly interval as before.

If you stop using Amorolfina Sandoz
Do not stop using the nail lacquer before your doctor tells you to, or before your infected nails have completely regrown healthy. If you stop too early, the infection may return.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects may occur with the following frequencies:
Rare: may affect up to 1 in 1,000 people
damaged nails
change in nail colour
weak or brittle nails (onychorrhexis)
broken nails (onychoclasis)
Very rare: may affect up to 1 in 10,000 people
skin burning sensation
Not known: frequency cannot be estimated from the available data
systemic allergic reaction (a severe allergic reaction which may be associated with swelling of the face, lips, tongue or throat, difficulty breathing and/or a severe skin rash)
skin redness, itching
skin allergic reactions
hives or blisters

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Amorolfina Sandoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the label of the
bottle after Exp. The expiry date refers to the last day of that month.
2.5 ml and 3 ml bottle
After first opening: 6 months
5 ml bottle
After first opening: 9 months
Keep the bottle tightly closed. Keep the medicated nail lacquer away from fire or flames (the alcohol base is flammable).
Dispose of the medicine if it shows signs of deterioration, for example hardening.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Amorolfina Sandoz contains
The active substance is amorolfine (hydrochloride).
Each ml contains 55.7 mg of amorolfine hydrochloride equivalent to 50 mg of amorolfine (5 % w/v of
amorolfine).
Each 2.5 ml bottle contains 139.3 mg of amorolfine hydrochloride equivalent to 125 mg of
amorolfine.
Each 3 ml bottle contains 167.1 mg of amorolfine hydrochloride equivalent to 150 mg of amorolfine.
Each 5 ml bottle contains 278.5 mg of amorolfine hydrochloride equivalent to 250 mg of amorolfine.
The other components are: anhydrous ethanol, methacrylic acid copolymer (type A), ethyl acetate,
butyl acetate, triacetin.

Description of the appearance of Amorolfina Sandoz and contents of the pack
Amorolfina Sandoz is a medicated nail lacquer. It is a clear solution.
Amorolfina Sandoz is packaged in an amber glass bottle (type I or type III) with an HDPE cap lined with Teflon.
Pack sizes: 2.5 ml, 3 ml and 5 ml
All packs contain 30 alcohol cleansing pads (impregnated with isopropyl alcohol as nail polish remover and sealed in sachets), 10 spatulas and 30 nail files.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder
Sandoz S.p.A.
Viale Luigi Sturzo 43
20154 Milan
Italy

Manufacturer
CREAPHARM INDUSTRY
29 Rue Leon Faucher
51100 Reims
France
Farmaclair
440 Avenue du General de Gaulle
14200 Herouville Saint Clair
France
Lek Pharmaceuticals d.d.,
Verovškova ulica 57
1526 Ljubljana, Slovenia

This medicinal product is authorized in the European Economic Area Member States and in the
United Kingdom (Northern Ireland) under the following names:
Austria Exorolfin 50 mg/ml - wirkstoffhaltiger Nagellack
Bulgaria Екзодерил Макси Лак 5% лечебен лак за нокти
Czech Republic EXOROLAK
Estonia Exolorfin
Croatia EXOLAK 50 mg/ml ljekoviti lak za nokte
Hungary EXOLORFIN 50 mg/ml gyógyszeres körömlakk
Italy Amorolfina Sandoz
Lithuania Exolorfin 50 mg/ml vaistinis nagų lakas
Latvia Exolorfin 50 mg/ml vaistinis nagų lakas
Romania Exoderil 50 mg/ml, lac de unghii medicamentos
Slovenia EXOLORFIN 50 mg/ml zdravilni lak za nohte
Slovak Republic EXOROLFIN 5 %