Verufil collodion

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Verufil collodion

Salicylic Acid / Lactic Acid

Read the entire leaflet carefully before you start using this medicine, as 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 adverse effects not listed in this leaflet. See section 4.
• You should consult your doctor if your condition worsens or if there is no improvement after 7 days.

Contents of the leaflet

1. What Verufil is and what it is used for
2. What you need to know before using Verufil
3. How to use Verufil
4. Possible side effects
5. How to store Verufil
6. Contents of the pack and other information

1. What Verufil is and what it is used for

It contains as active ingredients salicylic acid and lactic acid and belongs to the group of medicines known as anti-wart and keratolytic agents. When applied to the skin, it produces softening and subsequent destruction of the stratum corneum, enabling the removal of calluses or warts.

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

Verufil collodion is indicated for use in adults and children over 12 years of age.

2. What you need to know before using Verufil

Do not use Verufil

• if you are allergic to salicylic acid, lactic acid, or any of the other ingredients of this medicine (listed in section 6)
• on areas of irritated, infected, inflamed or wounded skin
• on moles, birthmarks, or warts that have hair growing from them, red edges, or unusual coloration
• on the face, genital area, or mucous membranes (such as eyes, nose, or mouth)
• if you have circulatory problems in the peripheral 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 Verufil.

Verufil is for cutaneous use (on the skin) only.

Verufil is flammable. Keep the bottle away from flames or heat sources, and do not smoke while applying it.

Do not inhale Verufil vapors, as this may cause dizziness.

Avoid contact with eyes and other mucous membranes (nose, mouth, or genital area).

If Verufil accidentally comes into contact with open wounds or with eyes, nose, mouth, or genital area, immediately rinse the affected area thoroughly with plenty of water for 15 minutes.

Do not apply Verufil to healthy skin surrounding the wart or callus.

Do not apply Verufil over large skin areas or for prolonged periods (see section 3).

In cases of calluses and hard skin, it is necessary to identify the underlying cause and treat it accordingly (orthopedic measures, correction of pressure points, etc.). As far as possible, avoid causes of foot discomfort (such as tight footwear).

Patients with kidney or liver disease may experience adverse effects if the product is used for long periods or over extensive areas.

Elderly patients

Elderly individuals are more likely to have circulatory problems (in blood vessels), which should be taken into account due to the potential risk of adverse effects.

Children and adolescents

Verufil is contraindicated in children under 2 years of age.

In children between 2 and 12 years of age, Verufil should not be used for safety reasons.

Other medicines and Verufil

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

You must not apply other treatments for warts or calluses at the same time as Verufil, as they could enhance its effect.

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

Pregnancy, breastfeeding, and fertility

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

There is no safety information available on the use of Verufil in pregnant women.

Verufil is not recommended during pregnancy.

Verufil must not be used during breastfeeding.

Driving and operating machinery

The use of this medicinal product does not affect the ability to drive or operate machinery.

3. How to use Verufil

Follow exactly the dosage instructions provided in this leaflet or as directed by your pharmacist. If in doubt, consult your doctor or pharmacist.

Verufil is intended for topical use only (on the skin).

Recommended dose:

• Adults and children over 12 years of age:

Apply Verufil to the corn, callus, or wart once daily, preferably at bedtime.

Take special care to avoid applying the product onto the surrounding healthy skin.

If the callus or wart worsens or shows no improvement after 7 days of treatment, or if warts spread, consult your doctor or pharmacist.

If irritation occurs, consult your doctor or pharmacist.

Improvement may become evident within weeks 1–2 of treatment. However, warts may take up to 12 weeks to disappear completely.

Method of administration

1. Before application, wash the affected area with soap, rinse, and dry thoroughly with a clean towel.

2. For stubborn calluses or warts, it is advisable to soak the affected area in warm water for 5 minutes to facilitate treatment. Dry with a clean towel.

3. Gently file the surface of the wart using a nail file or coarse cloth, taking care not to cause bleeding.

4. Apply a thin layer of Verufil to the affected area using the provided brush applicator, ensuring complete coverage of the lesion while avoiding contact with the surrounding healthy skin. The adjacent healthy skin may be protected with a thin layer of petroleum jelly.

5. Allow the product to dry completely. In some cases, it may be necessary to cover the treated area with a dressing (gauze), but this should only be done under medical supervision.

Use in children and adolescents

Do not use in children under 2 years of age.

Its use is not recommended in children between 2 and 12 years of age for safety reasons.

If you use more Verufil than you should

Due to the site of application (topical use), systemic intoxication is unlikely.

Overuse or application to normal skin may cause necrosis (skin destruction), and accidental ingestion may lead to systemic salicylate toxicity.

Some common symptoms that may occur include: nausea or vomiting, confusion, diarrhea, dizziness, headache, and increased respiratory rate.

In case of overdose or accidental ingestion, consult 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 name of the medicine and the amount ingested.

If you forget to use Verufil

Do not apply a double dose to make up for the missed dose. Resume application at your next scheduled time.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

The assessment of adverse effects is based on the following frequency categories:

Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Rare: may affect up to 1 in 1,000 people

Verufil may cause the following adverse effects:

• Very common: irritation at the application site, itching, burning sensation, redness, dryness.
• Common: rash, thickening of the skin (hypertrophy).
• Rare: hypersensitivity (allergy) at the application site, including inflammation; pain, skin discoloration.
• If Verufil is accidentally applied to healthy skin, blistering, scaly skin, inflammation, and even local ulceration 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 may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es

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

5. Storage of Verufil

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

Verufil is flammable (catches fire easily), therefore it must be stored in cool places and kept away from fire or heat sources (stoves, radiators, etc.).

Store below 25°C. Keep the container tightly closed.

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

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Verufil collodion

• The active substances are Salicylic acid and Lactic acid. Each ml contains 150 mg of salicylic acid (15%) and 150 mg of lactic acid (15%).
• The other components (excipients) are: collodion (composed of pyroxilin, rosin, castor oil, ethanol, and ether).

Nature of the product and contents of the container

Verufil is presented as a collodion (a liquid that forms a flexible film at the site of application); it is a viscous, transparent, amber-yellow liquid.

It is supplied in amber-colored bottles with a screw cap and an applicator brush.

Each bottle contains 15 ml.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

Manufacturers:

Delpharm Bladel B.V.

Industrieweg 1,

BLADEL, 5531 AD,

The Netherlands

Date of the most recent revision of this leaflet: April 2020

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