COR PIK CALLICIDA COLODION

Introduction

Package Leaflet: Information for the User

Cor Pik Callicida Collodion

Salicylic Acid/Acetic Acid

Read the entire package leaflet carefully before starting to use this medication, as it contains important information for you.

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 7 days.

Contents of the Package Leaflet

1. What Cor Pik Callicida is and what it is used for.
2. What you need to know before starting to use Cor Pik Callicida
3. How to use Cor Pik Callicida
4. Possible side effects.
5. Storage of Cor Pik Callicida
6. Package Contents and Additional Information

1. What Cor Pik Callicida is and what it is used for

It belongs to the group of medications called anti-warts and callicides.

It contains salicylic acid and acetic acid as active ingredients, which, when applied to the skin, produce softening and subsequent destruction of calluses, hard skin, or warts.

It is indicated for local treatment of calluses, hard skin, and warts.

Cor Pik Callicida is indicated for adults and children over 12 years old.

2. What you need to know before starting to use Cor Pik Callicida

Do not use Cor Pik Callicida:

• If you are allergic to salicylic acid, acetic acid, or any of the other components of this medication (listed in section 6).
• On moles or areas of the skin that are infected, irritated, inflamed, or wounded.
• If you have circulation problems in the blood vessels.
• If you are diabetic.
• In children under 2 years old.

Warnings and Precautions

Consult your doctor or pharmacist before starting to use Cor Pik Callicida.

• This medication is for external use only (cutaneous). Do not ingest.
• Cor Pik Callicida is flammable. Keep the bottle away from flames or heat and do not smoke while applying it.
• Avoid contact with healthy skin surrounding the callus or wart, eyes, face, mucous membranes (e.g., mouth, nose...). In case of accidental application to the eyes or mucous membranes, rinse with plenty of water for up to 15 minutes if necessary.
• Do not use the medication more frequently or for a longer period than recommended, nor on extensive areas of skin, as adverse reactions may occur due to absorption.
• In the case of calluses and hard skin, it is necessary to discover the cause of their appearance and treat it accordingly (orthopedic measures, correcting supports, etc.). Avoid, if possible, the causes of foot discomfort (such as tight shoes).
• If you have severe kidney or liver failure, you should be cautious because adverse effects may occur.

Elderly People

Elderly people are more likely to have blood vessel problems, which should be taken into account due to the possibility of adverse effects.

Children

Do not use in children under 2 years old. Do not use in children between 2 and 12 years old except under medical supervision.

Using Cor Pik Callicida with Other Medications

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

Do not use this medication along with other keratolytics (callicides and anti-warts) in the same area, as the effect may be enhanced.

Do not use this medication with preparations such as abrasive soaps or products containing exfoliants (benzoyl peroxide, resorcinol, sulfur, tretinoin) or alcohol.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

As a precaution, it is preferable to avoid using Cor Pik Callicida during pregnancy and breastfeeding.

Driving and Using Machines

The influence of this medication on the ability to drive and use machines is nil or insignificant.

3. How to Use Cor Pik Callicida

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

• Adults and children over 12 years old:

Apply an amount of the product as indicated below to the area to be treated 1 or 2 times a day, for six days.

Cutaneous use.

Before each application, wash the affected area with warm soapy water and dry.

Apply with the help of the brush to the callus, hard skin, or wart, 6 layers of the product, allowing the liquid to dry between applications, avoiding contact with the surrounding healthy skin, preferably at bedtime and repeating after 12 hours.

Treatment may last from five to six days. After this time, wash the area with warm water to which a little bicarbonate has been added. After 10 minutes of bathing, the treated callus or wart should start to come off by gently rubbing with the hand.

For calluses or hard skin, treatment can last up to 7 days; warts may take longer to disappear completely (even several weeks).

If the callus worsens after 7 days of treatment or worsens after treatment, or the warts spread, you should consult a doctor who will reassess the treatment.

Use in Children and Adolescents

Do not use in children under 2 years old. In children between 2 and 12 years old, do not use except under medical supervision.

If You Use More Cor Pik Callicida Than You Should

Due to its external use and application to a very specific area, it is unlikely that episodes of intoxication will occur.

In case of accidental application to the eyes or mucous membranes, rinse with plenty of water.

Overdose or ingestion could produce symptoms of systemic salicylate toxicity, with symptoms in the ears, digestive system, or others.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or go to a medical center, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If You Forget to Use Cor Pik Callicida

Do not use a double dose to make up for forgotten doses.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

In contact with healthy skin in adjacent areas, skin irritation, burning, redness, dermatitis, and even local ulcers may occur. In this case, treatment should be suspended until the irritation disappears. If the irritation improves, treatment can be continued; when resuming, special attention should be paid to ensuring the medication only comes into contact with the callus or wart.

If this irritation becomes more severe, treatment should be interrupted and the doctor informed.

Allergic reactions to the medication may occur.

Reporting Side Effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this package leaflet.

You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: www.notificaRAM.es

By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Cor Pik Callicida

No special storage conditions are required.

As it is flammable, keep the bottle tightly closed and away from flames or heat.

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Cor Pik Callicida Collodion

• The active ingredients are: Salicylic Acid and Acetic Acid. Each gram contains 100 mg of salicylic acid (10%) and 21.2 mg of acetic acid (2.12%).

• The other components (excipients) are: Lactic Acid, Castor Oil, and Collodion (elastic).

Appearance of the Product and Package Contents

Cor Pik Callicida is presented in the form of a collodion (liquid that forms a flexible film on the application area). The liquid is colorless to yellow-rosy.

It is presented in a topaz glass bottle with a cap provided with an applicator brush, containing 10 g or 20 g of collodion.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Holder

QUIMIFAR, S.A.

Comadran, 37 (Barbera del Valles (Barcelona)) - 08210 – Spain

Manufacturer

INDUSTRIAS FARMACEUTICAS PUERTO GALIANO, S.A.

Parque Europolis, Calle S, nº 4 (Las Rozas (Madrid)) - 28230 – Spain

or

QUIMIFAR, S.A.

Comadran, 37 (Barbera del Valles (Barcelona)) - 08210 – Spain

Date of the Last Revision of this Package Leaflet: October 2015.

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es