AMOROLFINA 50 мг/мл Лак для ногтей медицинский

Содержание инструкции

1. Amorolfina Sandoz 50 mg/ml medicated nail lacquer
   1. What is Amorolfina Sandoz and what is it 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. Package contents and other information

Amorolfina Sandoz 50 mg/ml medicated nail lacquer

Generic medicine

Read this leaflet carefully before using this medicine as it contains important
information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or
pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms get worse 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 is Amorolfina Sandoz and what is it used for

Amorolfina Sandoz is used for the treatment of 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 acts against a wide variety of fungi susceptible to amorolfine, such as yeasts,
skin fungi and moulds. However, bacteria are not susceptible to amorolfine.
Contact your doctor if you do not notice any improvement or if your 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 suffer from:
diabetes
a weakened immune system or are undergoing treatment to reduce its activity
problems with blood circulation 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 other
chronic skin condition, swelling, yellow nails associated with respiratory disorders, painful nails,
distorted/deformed nails or any other disorder in the nail area.
This medicine may cause allergic reactions, some of which may be severe. In this
case, stop using this medicine and remove it immediately with a nail polish remover
(or with the alcohol-soaked pads provided in the package) and consult a doctor.
If any of the following symptoms occur, seek immediate medical attention:

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

Amorolfina Sandoz should not be applied to the skin around the nail.
Avoid the use of artificial nails during treatment with Amorolfina Sandoz.
There is no experience yet in patients with inflammatory changes surrounding the nail,
diabetes, poor blood circulation, malnutrition, alcohol abuse or in children and infants.
Wear waterproof gloves while using organic solvents, otherwise the layer of Amorolfina
Sandoz on the nails will be removed.
Avoid getting the nail polish in contact with eyes, ears or mucous membranes. If Amorolfina Sandoz
comes into contact with eyes and ears, wash 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
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
No studies are available on the interaction of Amorolfina Sandoz with other medicines.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before using this medicine.
Amorolfina Sandoz should not be used during pregnancy and breastfeeding.

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

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

3. How to use Amorolfina Sandoz

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you have any doubts, ask your doctor or pharmacist.
For topical use. To be applied to the affected nails.
Apply Amorolfina Sandoz once a week to the affected nails of the foot or hand.
Follow these instructions during use:

Each time before applying the nail polish, file the
infected area of the nail (in particular the
surface of the nail) as thoroughly as possible with one of the
nail files provided.

Caution:do not use the same
file for healthy nails that you used to file infected nails.

Then take a swab soaked in nail polish remover
provided in the package. Use it to clean the
surface of the diseased nail and remove any remaining
nail polish residue. One swab is sufficient to clean all
diseased nails. You can also use a nail polish remover
that you find on the market.

Dip the spatula, provided, into the nail polish.
Do not rub it on the edge of the bottle. Repeat this
operation for each of the diseased nails.

Apply the nail polish to the entire surface of the nail.

Close the bottle tightly immediately after
applying the nail polish and clean the spatula using the
swab soaked in nail polish remover.

Let the applied nail polish dry for about 3-5 minutes.
After applying Amorolfina Sandoz, it is important to wash your hands.
If Amorolfina Sandoz is applied to the nails, you must wait for them to dry before
washing your hands.

Do not use cosmetic nail polish before an interval of 10 minutes
has elapsed from the application of Amorolfina Sandoz.
Before reusing the bottle, remove any nail polish residue or layers of cosmetic nail polish
on the nails and file the nails again. Clean the nails with the swab provided and
reapply Amorolfina Sandoz as directed.

Further advice to support treatment
Towels should be washed as often as possible at a minimum temperature of 60 °C.
Keep shoes in a well-ventilated position to keep them dry.

Duration of treatment
Fungal infections are very often persistent. Therefore, use Amorolfina Sandoz without
interruption, until the diseased nail has completely regrown healthy. This usually
takes 6 months for fingernails and from 9 to 12 months for toenails. However, if there is
no improvement after 3 months, you should consult your doctor.
If you accidentally ingest Amorolfina Sandoz
If this should happen, contact your doctor, pharmacist or the nearest hospital immediately.

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

If you stop using Amorolfina Sandoz
Do not stop using the nail polish before your doctor tells you to or before your diseased nails
have completely regrown healthy. If you stop too soon, the infection may return.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects can occur with the following frequencies:

Rare,may affect up to 1 in 1,000 people
damaged nails
alteration of nail color
weak or brittle nails (onychorrhexis)
broken nails (onychoschizia)

Very rare,may affect up to 1 in 10,000 people
skin burning

Not known,the frequency cannot be estimated from the available data
systemic allergic reaction (a severe allergic reaction that may be associated with swelling of the
face, lips, tongue or throat, difficulty breathing and/or a severe skin rash)
skin redness, itching
allergic skin reactions
hives or blisters

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your doctor or
pharmacist. You can also report side effects directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects you can help to 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 which is stated on the package and on the label of the
bottle after Exp. The expiry date refers to the last day of that month.
Bottle of 2.5 ml and 3 ml
After first opening: 6 months
Bottle of 5 ml
After first opening: 9 months
Keep the bottle tightly closed. Keep the medicated nail polish away from heat or flames (the
alcoholic base is flammable).
Discard the medicine if it shows signs of deterioration, for example, hardened.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Amorolfina Sandoz contains
The active ingredient 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 ingredients are: anhydrous ethanol, ammonium methacrylate 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 with a Teflon coating.
Pack size: 2.5 ml, 3ml and 5ml
All packs contain 30 alcohol cleansing pads (impregnated with isopropyl alcohol as a
solvent for nail polish and sealed in sachets), 10 spatulas and 30 nail files
Not all pack sizes may be marketed.

Marketing Authorisation 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 authorised in the Member States of the European Economic Area and in the
United Kingdom (Northern Ireland) under the following denominations:
Austria Exorolfin 50 mg/ml - wirkstoffhaltiger Nagellack
Bulgaria Exoderil Maxi Lac 5% medicinal nail lacquer
Czech Republic EXOROLAK
Estonia Exolorfin
Croatia EXOLAK 50 mg/ml medicinal nail lacquer
Hungary EXOLORFIN 50 mg/ml medicinal nail polish
Italy Amorolfina Sandoz
Lithuania Exolorfin 50 mg/ml medicinal nail polish
Latvia Exolorfin 50 mg/ml medicinal nail polish
Romania Exoderil 50 mg/ml, medicinal nail lacquer
Slovenia EXOLORFIN 50 mg/ml medicinal nail lacquer
Slovak Republic EXOROLFIN 5 %