Package leaflet: Information for the user

acerin pro, (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 the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
the doctor or pharmacist.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement or if you feel worse, consult your doctor.

Table of contents

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

1. What is acerin pro and what is it used for

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

2. Information before using Acerin pro

When not to use Acerin pro

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,
orally,
on the face and in the genital area.

Warnings and precautions

Before starting to use Acerin pro, discuss it with your doctor or pharmacist.

Discontinue treatment if excessive skin irritation occurs.
Protect eyes, respiratory tract, and mucous membranes from contact with the medicine and its vapours. If accidental contact occurs, immediately rinse thoroughly with plenty of water and consult 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, because salicylic acid can be absorbed through the skin and systemic adverse effects (affecting the whole body) may occur. If the medicine comes into contact with healthy skin surrounding the corn, immediately wash it off with water.
Do not use this medicine together with other medicines containing salicylic acid and (S)-lactic acid.
The medicine is flammable. Do not use near open flames, lit cigarettes, or certain devices (e.g. hair dryers).

Children
Acerin pro is not indicated for use in children.

Acerin pro and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently using or has recently used, as well as any medicines the patient plans to use.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Studies on the use of Acerin pro during pregnancy and breastfeeding have not been conducted.

Driving and operating machinery
Studies on the effect of Acerin pro on the ability to drive vehicles and operate machinery have not been conducted.

3. How to use acerin pro

This medicine should always be used exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Acerin pro is intended for topical use only.
Apply the medicine with the brush directly to the corn or callus on the skin. Take care not to touch healthy skin. Wait until the medicine has dried thoroughly. If necessary, the medicine may be applied for several days. Afterwards, soak the feet and gently remove the corn.
Take care to avoid dripping of the liquid from the brush or spilling the medicine.
If you feel the medicine's effect is too strong or too weak, consult your doctor or pharmacist.
Use in children
Acerin pro is not recommended for use in children.
Use of a higher than recommended dose of acerin pro
There is no data on overdose when used as directed. In case of accidental ingestion, seek medical advice immediately.
Missed application of acerin pro
Do not apply a double amount to make up for a missed application.
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Symptoms of irritation and inflammatory conditions may occur.
Applying the medicine to healthy skin may cause burning and pain.
If any disturbing symptoms occur, use of the medicine should be discontinued and you should contact your doctor immediately.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions 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 reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions enables further information on the safety of the medicine to be collected.

5. How to store acerin pro

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box and
on the label of the bottle. 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 the sewage system or in household waste. Ask your
pharmacist how to dispose of medicines no longer required. This will help protect
the environment.

6. Contents of the pack and other information

What Acerin pro contains

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

What Acerin pro looks like and contents of the pack
Acerin pro is a topical solution.
The medicinal product is packaged in a clear glass bottle with a polypropylene cap fitted with a brush applicator, placed in a cardboard box.
The pack contains 8 g of topical 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