Package Leaflet: Information for the User

Cor Pik callicida colodión

Salicylic Acid/Acetic Acid

Read this leaflet carefully before you start to use this medicine because it contains important information for you.

Follow exactly the administration instructions for the medicine contained in this leaflet or those indicated 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 7 days.

It belongs to the group of medications known as anti-warts and callicidas.

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

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

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

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 skin that are infected, irritated, inflamed, or wounded.
• If you have circulation problems in your 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 exclusively for external (cutaneous) use. 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 if necessary for up to 15 minutes.
• Do not use the medication more frequently or for a longer period than recommended, or on extensive areas of skin, as this may cause adverse reactions due to absorption.
• In the case of calluses and hard skin, it is necessary to uncover the cause of their appearance and treat it accordingly (orthopedic measures, correct supports, etc.). Avoid, if possible, the causes of foot discomfort (such as tight shoes).
• If you have severe kidney or liver insufficiency, exercise caution as this may cause adverse effects.

Older adults

Older adults are more likely to have circulation problems, which should be taken into account for 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 for safety reasons or only under medical supervision.

Use of Cor Pik callicida with other medications

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

Do not use this medication with other keratolytics (calluses and warts) in the same area, as this may potentiate the effect.

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or intend 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 operating machinery

The influence of this medication on the ability to drive and operate machinery is negligible or insignificant.

Follow exactly the administration instructions of the medication contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

• Adults and children over 12 years old:

Apply a quantity of the product as indicated below on the affected area 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 on the callus, hardness or wart, 6 layers of the product, leaving the liquid to dry between applications, avoiding touching the surrounding healthy skin, preferably at bedtime and repeating at 12 hours.

The treatment may last from five to six days. Once passed, the area will be washed with hot water to which a little baking soda has been added. After 10 minutes of bath, the detachment of the treated callus or wart should begin by gently rubbing with the hand.

For calluses or hard spots, the treatment may last approximately 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 if warts spread, you should consult your doctor who will re-evaluate the treatment.

Use in children and adolescents

Do not use in children under 2 years old. In children between 2 and 12 years old, it should not be used, except under medical supervision.

If you use more Cor Pik callicida than you should

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

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

Overdose or ingestion could produce systemic toxicity symptoms by salicylates, 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use Cor Pik callicida

Do not use a double dose to compensate for the missed doses

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

Like all medications, this medication may produce adverse effects, although not all people may experience them.

In contact with healthy skin in adjacent areas, irritation of the skin, burning, redness, dermatitis, and even local ulceration could be provoked. In this case, treatment should be suspended until the irritation disappears. If the irritation improves, treatment can continue; when resuming it, special attention should be paid to ensuring the medication is in contact only with the callus or wart.

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

Allergic symptoms to the medication may appear.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is about possible adverse effects that do not appear in this prospectus.

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

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

No special conservation conditions are required.

Due to its flammability, 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 that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.

Composition of Cor Pik callicida colodión

- The active principles 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 contents of the packaging

Cor Pik callicida is presented in the form of collodion (a liquid that forms a flexible film at the application site). The liquid is colorless to yellowish-pink.

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

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder

QUIMIFAR, S.A.

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

Responsible for manufacturing

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

Last review date of this prospectus: October 2015.

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.es