Label: information for the user

Callicida Kendu 500 mg/g ointment

Salicylic acid

Read this label carefully before starting to use this medication, as it contains important information for you.

Follow exactly the medication administration instructions contained in this label or those indicated by your doctor or pharmacist.

• Keep this label, as you may need to refer to 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 not listed in this label.
• You should consult a doctor if your condition worsens or does not improve after 4-6 days.

It is a medication that contains high concentrations of salicylic acid, which has keratolytic properties, meaning it causes softening and subsequent destruction of the stratum corneum of the skin.

Callicida Kendu is indicated for the removal of calluses, hard spots, or corns, in adults and children over 14 years old.

No use Callicida Kendu

• If you are allergic to salicylic acid, salicylates, or any of the other components of this medication (listed in section 6).
• If you have peripheral circulation problems.
• If you are diabetic.
• On the face or over the eyes, mucous membranes (such as genitals), or other skin lesions other than those listed in section 1.
• On red, inflamed, or irritated areas.
• In children under 2 years old.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Callicida Kendu.

• This medication is for external use only (cutaneous use).
• Avoid contact with healthy skin.
• Although a careful application is made, the complete or partial detachment of the callus may cause some inflammatory reaction.

Consult your doctor or pharmacist if the discomfort increases during treatment or persists. It is necessary to discover the cause of the disorder and treat it accordingly (orthopedic measures, correct supports, modify footwear).

• You should avoid prolonged use and/or large doses, as otherwise, salicylate toxicity may occur.
• Patients with severe renal insufficiency may experience a reduction in blood glucose levels (hypoglycemia).

Children

This medication is contraindicated in children under 2 years old. Use in children aged 2 to 14 years will only be made under medical supervision.

Use of Callicida Kendu 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 concurrently with other products in the same area, such as: other keratolytic products, abrasive soaps, benzoyl peroxide, resorcinol, sulfur, tretinoin, or preparations 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.

You should not use Callicida Kendu during pregnancy, except for short-term treatment of a small area of skin.

Oral forms (e.g., tablets) of this class of medications may cause adverse effects on the fetus. It is unknown if the same risks apply to Callicida Kendu when used on the skin.

Driving and operating machinery

No effects have been described that may affect driving or operating machinery.

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

Cutaneous use.

Adults and children over 14 years:Apply a small amount of Callicida Kendu, sufficient to cover the callus or hardness or wart that you wish to eliminate, once a day, at bedtime. After approximately 6 days, the callus will begin to detach on its own or with the help of a wash or a hot water bath.

If necessary, you can repeat the treatment leaving a period of rest between both of at least 5 days.

If the treatment is not effective after 4-6 days or if symptoms worsen or persist, you must consult your doctor who will reconsider if other measures are necessary.

Do not use Callicida Kendu for more than 7 consecutive days.

Administration guidelines:

Cutaneous use.

After application, the area may be covered with a gauze or bandage.

Use in children

Do not use in children from 2 to 14 years without consulting a doctor.

If you use more Callicida Kendu than you should

Due to the administration route of this medication (cutaneous use), poisoning is unlikely.

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

Overdose or ingestion may cause systemic toxicity symptoms by salicylates.

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

If you forgot to use Callicida Kendu

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, Callicida Kendu may produce adverse effects, although not all people will experience them.

When applying the product, the following may appear: irritation, burning, and itching, even local dermatitis (skin inflammation) and ulceration. In these cases, it is recommended to temporarily suspend treatment until the irritation disappears. Upon resuming treatment, special attention should be paid to ensure the ointment is only in contact with the callus.

If the ointment is applied to open wounds, excessive erythema (redness) and skin peeling may occur; other possible adverse effects include: scarring due to treatment.

Allergic reactions may occur.

If you experience adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospectus.

No special conservation conditions are required.

Keep this medication out of the 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.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging 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 packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Callicida Kendu 500 mg/g ointment

• The active ingredient is Salicylic Acid. Each gram of ointment contains 500 mg of salicylic acid (50%).
• The other components (excipients) are: white petrolatum and paraffin oil.

Appearance of the product and content of the packaging

Callicida Kendu is a homogeneous white ointment, smooth to the touch without lumps or additives.

It is presented in aluminum tubes with 10 g of ointment.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Urgo S.L. - C/Florida, 29

20120 HERNANI (Guipúzcoa)

Spain

Last review date of this leaflet: October 2024.

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