Cor Pik Callicida collodion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Cor Pik callicida collodion

Salicylic acid/Acetic acid

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or if there is no improvement after 7 days.

Contents of the leaflet

1. What Cor Pik callicida is and what it is used for
2. What you need to know before using Cor Pik callicida
3. How to use Cor Pik callicida
4. Possible adverse effects
5. Storage of Cor Pik callicida
6. Contents of the pack and other information

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

It belongs to the group of medicines known as anti-warts and keratolytic agents.

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

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

Cor Pik callicida is indicated for use in adults and children over 12 years of age.

2. What you need to know before using 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 medicine (listed in section 6).
• On moles or on areas of skin that are infected, irritated, inflamed, or wounded.
• If you have circulatory problems in the blood vessels.
• If you are diabetic.
• In children under 2 years of age.

Warnings and precautions

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

• This medicine 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, and mucous membranes (e.g., mouth, nose, etc.). In case of accidental application to eyes or mucous membranes, rinse thoroughly with abundant water if necessary for up to 15 minutes.
• Do not use the medicine more frequently or for longer than recommended, or on extensive areas of skin, as adverse reactions due to absorption may occur.
• In the case of calluses and hard skin, it is necessary to identify the cause of their appearance and treat it accordingly (orthopedic measures, correcting pressure points, etc.). Avoid, as far as possible, factors causing foot discomfort (such as tight footwear).
• If you have severe kidney or liver impairment, use with caution, as adverse effects may occur.

Elderly patients

Older individuals are more likely to have blood vessel problems, which should be taken into account due to the potential risk of adverse effects.

Children

Do not use in children under 2 years of age. It should not be used in children between 2 and 12 years of age for safety reasons, or only under medical supervision.

Use of Cor Pik callicida with other medicines

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

Do not use this medicine simultaneously with other keratolytic agents (callifuges or anti-wart products) on the same area, as this could enhance the effect.

Do not use this medicine with preparations such as abrasive soaps or products containing exfoliating agents (benzoyl peroxide, resorcinol, sulfur, tretinoin), or those containing alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

As a precautionary measure, it is preferable to avoid the use of Cor Pik callicida during pregnancy and breastfeeding.

Driving and use of machines

The effect of this medicine on the ability to drive and operate machinery is negligible or none.

3. How to use Cor Pik callicida

Follow exactly the instructions for medication administration provided in this leaflet or those given by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

• Adults and children over 12 years:

Apply an amount of the product as indicated below to the affected area 1 or 2 times daily for six days.

For topical use only.

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

Using the brush provided, apply 6 layers of the product onto the corn, callus, or wart, allowing the liquid to dry between applications, taking care to avoid contact with the surrounding healthy skin. It is preferable to apply the product at bedtime and repeat after 12 hours.

Treatment may last five to six days. After this period, wash the area with hot water to which a small amount of bicarbonate has been added. After ten minutes of soaking, gently rub the treated area with your hand to initiate removal of the corn or wart.

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

If the corn worsens after 7 days of treatment or deteriorates following treatment, or if warts spread, consult your doctor, who will reconsider the treatment approach.

Use in children and adolescents

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

If you use more Cor Pik callicida than you should

Because this medicine is for external use only and applied to a very specific area, systemic intoxication is unlikely.

In case of accidental contact with eyes or mucous membranes, rinse thoroughly with plenty of water.

Overdose or accidental ingestion could lead to symptoms of systemic salicylate toxicity, including ear-related, gastrointestinal, or other symptoms.

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

If you forget to use Cor Pik callicida

Do not use a double dose to make up for a missed dose.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may produce adverse effects, although not everyone will experience them.

Contact with healthy skin in surrounding areas may cause skin irritation, burning, redness, dermatitis, and even local ulceration. In such cases, treatment must be discontinued until the irritation resolves. If the irritation improves, treatment may be continued; when resuming, special care must be taken to ensure that the medicine comes into contact only with the callus or wart.

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

Symptoms of allergy to the medicine may occur.

Reporting of adverse effects

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

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

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Cor Pik callicida

No special storage conditions are required.

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

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Cor Pik callicida collodion

• The active substances 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).

Product presentation and pack contents

Cor Pik callicida is presented as a collodion (a liquid that forms a flexible film at the site of application). The liquid ranges from colourless to yellowish-pink.

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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 most recent revision of this summary: October 2015.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es