VERUFIL COLLODION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Verufil collodion

Salicylic Acid/Lactic Acid

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

Follow the administration instructions of the medicine 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 side effects not listed in this package leaflet. See section 4.
• You should consult your doctor if it worsens or does not improve after 7 days.

Contents of the package leaflet

1. What is Verufil and what is it used for
2. What you need to know before starting to use Verufil
3. How to use Verufil
4. Possible side effects
5. Storage of Verufil
6. Package contents and additional information

1. What is Verufil and what is it used for

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

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

Verufil collodion is indicated for adults and children over 12 years old.

2. What you need to know before starting to use Verufil

Do not use Verufil

• if you are allergic to salicylic acid, lactic acid, or any of the other components of this medicine (listed in section 6)
• on irritated, infected, inflamed, or wounded skin areas
• on moles, birthmarks, or warts with hair growth, red edges, or unusual color
• on the face, genital area, or mucous membranes (such as eyes, nose, or mouth)
• if you have circulation problems in the peripheral vessels
• if you are diabetic
• in children under 2 years old.

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 and do not smoke while applying it.

Do not inhale Verufil vapors, as you may feel dizzy.

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

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

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

Do not apply Verufil to large areas or for an extended period (see section 3).

In the case of calluses and hardness, it is necessary to discover 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 footwear).

Patients with kidney or liver disease, if they use the product for a long time or extensively, may experience side effects.

Elderly people

Elderly people may be more likely to have circulation problems (in blood vessels), which should be taken into account due to the possibility of side effects.

Children and adolescents

Verufil is contraindicated in children under 2 years old.

In children between 2 and 12 years old, it should not be used for safety reasons.

Other medicines and Verufil

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

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

Do not use Verufil with preparations such as abrasive soaps or products containing exfoliants (benzoyl peroxide, resorcinol, sulfur, tretinoin) or those containing 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 medicine.

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

Verufil is not recommended during pregnancy.

Do not use Verufil during breastfeeding.

Driving and using machines

The use of this medicine does not affect the ability to drive or operate machines.

3. How to use Verufil

Follow the administration instructions of the medicine contained in this package leaflet or as indicated by your pharmacist. In case of doubt, ask your doctor or pharmacist.

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

The recommended dose is:

• Adults and children over 12 years old:

Apply Verufil to the callus, hardness, or wart once a day, preferably at bedtime.

Be especially careful not to apply the product to the healthy skin surrounding the affected area.

If the callus or wart worsens or remains the same after 7 days of treatment, or the warts spread, consult your doctor or pharmacist.

If irritation occurs, consult your doctor or pharmacist.

Within 1-2 weeks of treatment, a noticeable improvement can already be seen. But warts may take up to 12 weeks to disappear completely.

Method of administration

1. Before application, wash the area to be treated with soap, rinse, and dry with a clean towel.

1. In case of stubborn callus or wart, it is recommended to soak the affected area in warm water for 5 minutes to facilitate treatment. Dry with a clean towel.

1. The surface of the wart should be filed with a nail file or coarse cloth, taking care not to cause bleeding in the area.

1. Apply a thin layer of Verufil to the affected area with the help of the applicator brush, making sure the area to be treated is covered with the product, taking care to avoid contact with the surrounding healthy skin. You can protect the surrounding healthy skin with a thin layer of petroleum jelly.

1. Let the product dry completely. In some cases, it may be necessary to cover the affected area with a dressing (gauze), but this should be under medical supervision.

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 for safety reasons.

If you use more Verufil than you should

Due to the area of use of this medicine (cutaneous use), intoxication is unlikely.

Overdose or use on normal skin could produce necrosis (skin destruction), or accidental ingestion could produce symptoms of systemic salicylate toxicity.

Some of the frequent symptoms that may occur are: discomfort or vomiting, confusion, diarrhea, dizziness, headache, increased respiratory rate.

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 medicine and the amount ingested.

If you forget to use Verufil

Do not apply a double dose to make up for the forgotten dose. Apply the product again at your usual time.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone may experience them.

The assessment of side effects is based on the following frequencies:

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 side effects:

• Very common: irritation at the application site, itching, burning sensation, redness, dryness.
• Common: rash, skin thickening (hypertrophy).
• Rare: hypersensitivity (allergy) at the application site, including inflammation; pain, skin discoloration.
• If you accidentally apply Verufil to healthy skin, the following may appear: blisters, scaly skin, inflammation, and even local ulceration.

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 Medicines and Health Products Agency (AEMPS) website: www.notificaRAM.es

By reporting side 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 (easily ignites), so it should be kept in a cool place, away from fire or heat sources (stoves, radiators...).

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

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

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package contents and additional information

Composition of Verufil collodion

• The active ingredients 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 pyroxylin, colophony, castor oil, ethanol, and ether).

Appearance of the product and package contents

Verufil is presented as a collodion (liquid that forms a flexible film on the application area); it is a viscous, transparent, amber-colored liquid.

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

Each bottle contains 15 ml.

Marketing authorization holder and manufacturer

Holder:

Laboratory STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

Manufacturers:

Delpharm Bladel B. V.

Industrieweg 1,

BLADEL, 5531 AD,

Netherlands

Date of the last revision of this package leaflet: April 2020

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