Package leaflet: Information for the user

Acerin, (195 mg + 98 mg)/g, cutaneous solution
Acidum salicylicum + Acidum (S)-lacticum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, consult your pharmacist.
If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement or if you feel worse, you should contact your doctor.

Contents of the leaflet

What Acerin is and what it is used for
Important information before using Acerin
How to use Acerin
Possible side effects
How to store Acerin
Contents of the pack and other information

1. What Acerin is and what it is used for

Acerin is a solution for topical application to the skin. It contains two active substances – salicylic acid and (S)-lactic acid.
Salicylic acid has a keratolytic effect; it softens and loosens thickened horny layer of the skin, facilitating its desquamation.
(S)-lactic acid is a caustic agent which destroys the keratinized layer of the skin.
Indications
Removal of calluses and thickened skin.

2. Important information before using Acerin

When not to use Acerin

if the patient is allergic to salicylic acid, (S)-lactic acid, or any of the other ingredients of this medicine (listed in section 6),
if the patient has diabetes,
if the patient has circulatory disorders,
if the skin around the corn is damaged or diseased,
in children under 2 years of age,
orally,
on the face or in the genital area.

Warnings and precautions
Before starting treatment with Acerin, discuss it with your doctor or pharmacist.

If excessive skin irritation occurs, discontinue treatment.
Protect the eyes, respiratory tract, and mucous membranes from contact with the medicine and its fumes. If accidental contact occurs with eyes or mucous membranes, immediately rinse thoroughly with plenty of water and contact a doctor.
Protect the skin surrounding the corn from contact with the medicine, as it may cause burns. The medicine should be applied exclusively to the corn or calloused skin.
Do not apply the medicine to unchanged, healthy skin or damaged skin, as salicylic acid may be absorbed through the skin, leading to systemic adverse reactions (affecting the whole body). If healthy skin surrounding the corn is accidentally covered with the medicine, wash it immediately with water.
Do not use this medicine together with other medicines containing salicylic acid and (S)-lactic acid.
This medicine is flammable. Do not use near open flames, lit cigarettes, or certain devices (e.g. hair dryers).

Children
Acerin must not be used in children under 2 years of age.
Acerin and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
No studies have been conducted on the use of Acerin during pregnancy and breastfeeding.
Driving and operating machinery
No studies have been conducted on the effect of Acerin on the ability to drive or operate machinery.

3. How to use Acerin

This medicine should always be used exactly as described in this patient information leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Acerin is intended for external use only.
After application, hands should be thoroughly washed (unless the affected area is on the hands).

Recommended dose
Adults and adolescents over 12 years of age
Apply Acerin once or twice daily, using the provided brush to spread a thin layer only onto the corn or callus.
Take care not to apply the medicine to the surrounding healthy skin. After application, wait until the medicine has completely dried and formed a protective film. If necessary, the treatment may be continued for several days, up to a maximum of 2 weeks. Afterwards, soak the feet and gently remove the corn.
Once a week, before reapplying the medicine, it is recommended to gently remove softened, dead layers of skin (e.g. using a file or pumice stone).
Care should be taken to avoid dripping of the liquid from the brush or spilling the medicine.
If you feel the effect of the medicine is too strong or too weak, consult your doctor or pharmacist.

Use in children
Acerin may be used in children aged 2 to 12 years, following consultation with and under supervision of a doctor.
Acerin must not be used in children under 2 years of age.

Overdose of Acerin
There is no available data on overdose when used according to the recommended dosage and instructions.
In case of accidental ingestion, contact a doctor immediately.

Missed dose of Acerin
Do not use a double dose to make up for a missed dose.
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.
Symptoms of irritation and inflammatory reactions may occur.
Application of the medicine to healthy skin may cause burning and pain. If any disturbing symptoms occur,
use of the medicine should be discontinued and a doctor should be contacted immediately.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49-21-301
Fax: + 48 22 49-21-309
Website: https://smz.ezdrowie.gov.pl

Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Acerin

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box and
the bottle label. The expiry date refers to the last day of the stated month.
Store below 25°C in a dry place.
Keep the container tightly closed. Store in the original packaging.
This medicine is flammable. Keep away from fire.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such measures will help
protect the environment.

6. Contents of the package and other information

What Acerin contains

The active substances in the medicine are salicylic acid and (S)-lactic acid. 1 g of topical solution contains 195 mg of salicylic acid and 98 mg of (S)-lactic acid.
The other ingredients are: cellulose acetate phthalate, rosin, acetone, n-butyl acetate.

What Acerin looks like and contents of the pack
Acerin is a topical solution.
The medicine comes in a bottle made of colorless glass with a polypropylene cap fitted with a brush applicator, placed in a cardboard box.
The pack contains 8 g of solution.

Marketing Authorisation Holder and Manufacturer
Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
Tel. + 48 42 22-53-100