PATIENT INFORMATION LEAFLET

Verufil colodión

Salicylic Acid/Lactic Acid

Please read this leaflet carefully before you start using this medicine because it contains important information for you.

Follow exactly the administration instructions contained 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 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 you get worse or do not improve after 7 days.

1. What is Verufil 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. Storage of Verufil

6. Contents of the pack and additional information

Contains salicylic acid and lactic acid as active ingredientsand belongs to the group of medicationsanti-warts and calluses. When applied to the skinit produces softening and subsequent destruction of the stratum corneum, allowing the removal ofcalluses or warts.

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

Verufilcolodiónis indicated for adults and children over 12 years old.

Do not use Verufil

• If you are allergic to salicylic acid, lactic acid, or any other component of this medication (listed in section 6)
• On irritated, infected, inflamed, or open skin
• On moles, birthmarks, or warts with hair growth, red edges, or unusual color
• On the face, genital area, or mucous membranes (such as the eyes, nose, or mouth)
• If you have peripheral vascular problems
• 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 topical 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 the vapors of Verufil, as you may feel dizzy.

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

If Verufil accidentally comes into contact with open wounds or the 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 a prolonged period (see section 3).

In the case of calluses and hard skin, it is necessary to identify the cause of its appearance and treat it accordingly (orthopedic measures, correcting supports, etc.). Avoid, if possible, the causes of foot discomfort (such as tight shoes).

Patients with kidney or liver disease, if using the product for a long time or extensively may experience adverse effects.

Older adults

Older adults may be more likely to have circulation problems (in blood vessels), which should be taken into account for the possibility of adverse 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 medications and Verufil

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

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

Do not useVerufilwith preparations such asabrasive 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 plan to become pregnant, consult your doctor or pharmacist before using this medication.

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

It is not recommended to use Verufil during pregnancy.

Do not use Verufilduring breastfeeding.

Driving and operating machines

The use of this medication does not affectyour ability to drive or operate machines.

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

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

The recommended dose is:

- Adults and children over 12 years:

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

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

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

If irritation occurs, consult your doctor or pharmacist.

Improvement can be noticeable as early as weeks 1-2 of treatment. However, warts may take up to 12 weeks to completely disappear.

Administration Form

1. Before application, wash the affected area 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. Smooth the surface of the wart with an emery board or a coarse cloth, taking care not to cause bleeding in the area.

1. Apply a thin layer of Verufil to the affected area with the applicator brush, ensuring that the area to be treated is covered with the product, with caution to avoid contact with healthy skin surrounding the affected area. Healthy skin can be protected with a thin layer of petroleum jelly.

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

Use in children and adolescents

Do not use in children under 2 years.

Do not use in children between 2 and 12 years due to safety reasons.

If you use more Verufil than you should

Due to the area of use of this medication (topical use), poisoning is unlikely.

Overdose or use on normal skin could cause necrosis (skin destruction), or accidental ingestion could cause systemic toxicity symptoms due to salicylates.

Some common symptoms that may occur include: 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 Toxicological Information Service, Phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use Verufil

Do not apply a double dose to compensate for the missed dose. Apply the product again at your usual time.

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

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

Very frequent:may affect more than 1 in 10 people

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

Reporting 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 prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es

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

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

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

Store below25°C. Keep the bottle tightly closed.

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 packaging and medications you no longer need at the SIGRE collection point at 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 Verufil ointment

• The active principles 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: ointment base (comprising piroxilina, colophony, ricin oil, ethanol, and ether).

Appearance of the product and contents of the packaging

Verufil is presented in the form of an ointment (a liquid that forms a flexible film in the application area); it is a viscous, transparent, yellowish liquid.

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

Each bottle contains 15 ml.

Holder of the marketing authorization and responsible for manufacturing

Holder:

STADA Laboratory, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

Manufacturing responsible:

Delpharm Bladel B. V.

Industrieweg 1,

BLADEL, 5531 AD,

Netherlands

Last review date of this leaflet: April 2020

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.gob.es