Ducray Kerafilm Solution

Kerafilm is recommended for the local treatment of corns, calluses, corns, and warts.

Composition of Kerafilm Cornicide and Warticide by Ducray Pierre Fabre

The keratolytic therapeutic activity of Kerafilm solution is due to its composition, per 100g of solution, of two active ingredients:

salicylic acid at a dose of 16.7g,
lactic acid at a dose of 16.7g.

It also contains collodion.

Using Kerafilm for corns, calluses, and hand and plantar warts

Kerafilm is used topically.

Kerafilm should be applied at bedtime to a clean and dry area.

When applying Kerafilm, care should be taken not to spill onto healthy skin to avoid irritation.

To do this, apply neutral nail polish around the area to be treated to protect healthy skin. Then, after replacing the cap with the spatula-equipped cap, apply the Kerafilm solution using the spatula.

Kerafilm Dosage

The recommended dose is one application morning and one evening.

Kerafilm Treatment Duration

If treatment fails on warts after one month, contact your doctor.

Precautions for Use with Kerafilm for Warts

Use of Kerafilm by Age

Use in adolescents and children should be carried out under adult supervision. For children under 6 years of age, KERAFILM should only be used after consulting a doctor.

Using Kerafilm for Corns, Calluses, and Corns

In the case of corns, calluses, or corns, it is recommended to investigate their cause. Consult your doctor or a podiatrist.

Using Kerafilm in Cases of Diabetes or Other Conditions

If you suffer from the following conditions:

diabetes,
arteritis
neuropathy

then a medical consultation is necessary before using Kerafilm.

Using Kerafilm during pregnancy or breastfeeding

If you are pregnant or breastfeeding, consult your doctor before using Kerafilm, as the active ingredients can penetrate the body. Therefore, only use KERAFILM during pregnancy after medical advice for the single, short-term treatment of a small area of ??skin, callus, wart, corn, or corn.

Contraindications for Kerafilm Pierre Fabre

Do not use Kerafilm in the following cases:

If you are allergic to one of its components or active substances,
On mucous membranes,
On infected corns,
On large areas.

Side effects of Kerafilm

Kerafilm may cause side effects such as:

A burning sensation or local irritation,
An allergic reaction.

If symptoms such as pain, irritation, damaged skin (ulceration), or bleeding occur after using Kerafilm, discontinue treatment with Kerafilm.

Keep out of the reach and sight of children.

Capacity: 10 ml

At Pierre Fabre Laboratory, consider Cyteal foaming disinfectant.





SUMMARY OF PRODUCT CHARACTERISTICS

ANSM - Updated on: 10/10/2024

1. NAME OF THE MEDICINAL PRODUCT

KERAFILM, solution for topical application

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Salicylic acid.................................................................................................................... 16.7 g

Lactic acid.............................................................................................................................. 16.7 g

Per 100 g of solution for topical application

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Clear, colorless to slightly yellow liquid.

Solution for topical application.

4. CLINICAL PARTICULARS

4.1. Therapeutic indications

Adjunctive local treatment of corns, calluses, corns, and warts.

KERAFILM is indicated for adults, adolescents, and children over 6 years of age.

4.2. Dosage and Administration

Dosage

One application morning and evening.

Pediatric Population

In children and adolescents, treatment with this medication requires increased monitoring.

Use in children and adolescents should be carried out under adult supervision.

In children under 6 years of age, KERAFILM should only be used after medical advice.

Safety and efficacy in children under 6 years of age have not been established.

Administration

External use.

Cutaneous application.

Apply the solution with a spatula to the area to be treated, avoiding spillage onto healthy skin. It is possible to protect healthy skin beforehand by applying a neutral nail polish.

4.3. Contraindications

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.

Infected corns.

4.4. Special warnings and precautions for use

Special warnings

The use of cornicides should be exercised with great caution in patients with arterial disease, diabetes, and neuropathy.

Precautions for use

In case of pain, irritation, ulceration, or bleeding, treatment should be discontinued.

Treatment of warts: If treatment fails after one month of effective treatment, the appropriate course of action should be reassessed.

Treatment of corns, calluses, and corns: It may be useful to identify the cause and treat it accordingly.

Do not use on mucous membranes.

Do not use on healthy skin.

4.5. Interactions with other medicinal products and other forms of interaction

The data available to date do not suggest the existence of clinically significant interactions.

4.6. Fertility, pregnancy, and lactation

Pregnancy

There are no or limited data on the use of KERAFILM during pregnancy.

KERAFILM should not be used during pregnancy, except for the single, short-term treatment of a small skin area/callus/wart/corn/corn.

It is unknown whether systemic exposure of KERAFILM achieved after topical administration can be harmful to an embryo/fetus.

During the third trimester of pregnancy, systemic use of prostaglandin synthetase inhibitors may induce cardiopulmonary and renal toxicity in the fetus. At the end of pregnancy, prolonged bleeding times may occur in both mother and child, and labor may be delayed.

Breastfeeding

Salicylates are excreted in breast milk. A risk to the breastfed child cannot be excluded.

KERAFILM should not be used during breastfeeding.

Fertility

Animal studies have not shown an effect on fertility. There are no data on human fertility.

4.7. Effects on ability to drive and use machines

Not applicable.

4.8. Adverse Reactions

Table of Adverse Reactions

Adverse reactions are listed below by System Organ Class and frequency. Frequencies are defined according to the following categories: very common (? 1/10); common (? 1/100 to < 1/10); Uncommon (? 1/1,000 to < 1/100); Rare (? 1/10,000 to < 1/1,000); Very rare (< 1/10,000); Not known (cannot be estimated from the available data).

System Organ Class

MedDRA Preferred Term

Frequency not known

Skin and subcutaneous tissue disorders

Application site reactions:

- Irritation

- Burning sensation

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals should report any suspected adverse reactions via the national reporting system: French National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: https://signalement.social-sante.gouv.fr/.

4.9. Overdose

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Warticides and coricides, ATC code: D11AF.

5.2. Pharmacokinetic properties

Absorption

The absorption of salicylic acid and lactic acid is highly dependent on the composition of the vehicle, pH, skin structure, and application conditions (single dose, repeated doses, occlusion). Topical salicylic acid is readily absorbed when applied to the skin. Sixty percent of the administered salicylic acid dose is absorbed through the skin.

The percutaneous absorption of lactic acid was evaluated in vitro using human abdominal skin with a continuous-flow diffusion system. At a pH of 3, the percentage of radioactivity detected in the receptor fluid, stratum corneum, epidermis, and dermis was 3.6/6.3/6.6 and 13.9%, respectively.

Distribution

Following percutaneous absorption, salicylic acid is distributed throughout the tissues and extracellular space. Approximately 50–80% of salicylate in the blood is bound to plasma proteins. The apparent volume of distribution is 0.1–0.2 L/kg.

Biotransformation

Salicylates are metabolized in the liver. The main metabolites are salicyluric acid, phenolic glucuronide, and acyl glucuronide. Unmetabolized salicylic acid is excreted in the urine as unchanged salicylic acid.

Elimination

Salicylates are primarily excreted by the kidneys in the form of free salicylate, salicyluric acid, salicylic glucuronides, and gentisic acid.

5.3. Preclinical Safety Data

No conventional studies have been conducted with KERAFILM.

A literature review shows that salicylic acid and lactic acid, after cutaneous application, reveal no particular hazard for humans, based on repeated-dose toxicity, genotoxicity, and carcinogenic potential studies.

Salicylates are embryotoxic and teratogenic after oral administration at high doses in animal studies. Lactic acid and salicylic acid are considered skin irritants. In ex vivo studies, lactic acid has been shown to cause serious eye damage.

6. PHARMACEUTICAL INFORMATION

6.1. List of excipients

Collodion.

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

2 years.

6.4. Special precautions for storage

Store below 25°C.

Flammable product, keep away from all sources of heat.

6.5. Nature and contents of container

10 ml or 15 ml type III brown glass bottle, closed with a polypropylene stopper with a low-density polyethylene seal and insert.

This cap should be replaced after first use with a polypropylene cap with a low-density polyethylene insert and a high-density polyethylene spatula.

6.6. Special precautions for disposal and handling

Close the bottle tightly after use.

Any unused medicinal product or waste material must be disposed of in accordance with local regulations.

7. MARKETING AUTHORIZATION HOLDER

PIERRE FABRE MEDICAMENT

LES CAUQUILLOUS

81500 LAVAUR

8. MARKETING AUTHORIZATION NUMBER(S)

· 34009 325 952 0 4: 10 ml bottle (brown glass) + applicator cap (PE)

· 34009 340 140 3 1: 15 ml bottle (brown glass) + applicator cap (PE)

9. DATE OF FIRST AUTHORIZATION/RENEWAL OF THE AUTHORIZATION

[To be completed later by the holder]

10. DATE OF TEXT UPDATE

[To be completed later by the holder]

11. DOSIMETRY

Not applicable.

12. INSTRUCTIONS FOR PREPARING RADIOPHARMACEUTICALS

Not applicable.

CONDITIONS OF PRESCRIPTION AND DISPENSING

Medication not subject to prescription.


LEAFLET
ANSM - Updated on: 10/10/2024
Name of the medicinal product
KERAFILM, solution for topical application
Salicylic acid, Lactic acid
Box
Please read all of this leaflet carefully before using this medicine because it contains important information for you.
You must always use this medicine exactly as provided in this leaflet or by your doctor or pharmacist.
Keep this leaflet. You may need to read it again.
Ask your pharmacist for advice or information.
If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
You must talk to your doctor if you do not feel better or if you feel worse.
What is in this leaflet? 1. What is KERAFILM, solution for topical application and what is it used for?
2. What you need to know before using KERAFILM, solution for topical application?
3. How to use KERAFILM, solution for topical application?
4. Possible side effects?
5. How to store KERAFILM, solution for topical application?
6. Contents of the pack and other information.
1. WHAT IS KERAFILM, solution for topical application AND WHAT IS IT USED FOR?
Pharmacotherapeutic group: Verrucides and coricides, ATC code: D11AF.
This medication is recommended for the adjunctive local treatment of corns, calluses, corns, and warts.
KERAFILM is indicated for adults, adolescents, and children over 6 years of age. 2. WHAT YOU NEED TO KNOW BEFORE USING KERAFILM, solution for topical application?
Never use KERAFILM, solution for topical application:
· if you are allergic to the active ingredients or any of the other ingredients of this medicine (listed in section 6),
· on infected corns.
Warnings and precautions
Talk to your doctor or pharmacist before using KERAFILM, solution for topical application.
Take special care with KERAFILM, solution for topical application:
Special warnings
If you have a blood vessel disease with narrowing of your arteries (arteritis), loss of feeling in the hands and feet (neuropathy), or diabetes, consult your doctor before using this medicine.
Due to the risk of the active ingredients entering the bloodstream, this product should not be applied to large areas. Precautions for Use
· In case of pain, irritation, damaged skin (ulceration), or bleeding, treatment should be discontinued.
· Treatment of warts: If after one month of application, following the instructions for use, the treatment is ineffective, you should contact your doctor or pharmacist.
· Treatment of corns, calluses, and corns: It may be useful to investigate the cause and treat it accordingly.
· Do not use on mucous membranes.
· When applying, do not apply to healthy (unaffected) skin.
Children and Adolescents
In children and adolescents, treatment with this medication requires closer monitoring.
Use in children and adolescents should be carried out under adult supervision.
In children under 6 years of age, KERAFILM should only be used after consulting a doctor. Safety and effectiveness in children under 6 years of age have not been established.
Other medicines and KERAFILM topical solution
Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.
KERAFILM topical solution with food, drink, and alcohol
Not applicable.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
You should not use KERAFILM during pregnancy, except for the single, short-term treatment of a small skin area/callus/wart/corn/corn.
Oral forms (e.g., tablets) in this class of products may cause side effects in the unborn child. It is not known if the same risks apply to KERAFILM when used on the skin/callus/wart/corn/corn. KERAFILM should not be used while breastfeeding.
Driving and using machines
Not applicable.
KERAFILM, solution for topical application contains
Not applicable.
3. HOW TO USE KERAFILM, solution for topical application?
Always use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if you are unsure.
After the first use, replace the cap with the insert and spatula. The original cap should no longer be used.
The recommended dose is one application morning and evening.
For cutaneous use.
External use.
Apply the solution with the spatula to the area to be treated, without spilling onto healthy (unaffected) skin. It is possible to protect healthy skin beforehand by applying a neutral nail polish.
If you use more KERAFILM, solution for topical application than you should
Not applicable.
If you forget to use KERAFILM, solution for topical application
Not applicable.
If you stop using KERAFILM, solution for topical application
Not applicable.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur at the site of KERAFILM application with an unknown frequency (frequency cannot be estimated from the available data):
· Local irritation.
· Burning sensation.
Reporting of side effects
If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system: French National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: https://signalement.social-sante.gouv.fr/.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. HOW TO STORE KERAFILM, solution for topical application?
Keep this medicine out of the sight and reach of children.
Storage conditions
Store below 25°C.
Keep the bottle tightly closed after use.
Flammable product, keep away from all heat sources.
Do not use this medicine after the expiry date shown on the packaging after EXP. The expiry date refers to the last day of that month.
Do not dispose of any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION
What KERAFILM, solution for topical application contains
· The active ingredients are:
Salicylic acid.............................................................................................................................. 16.7 g
Lactic acid.............................................................................................................................. 16.7 g
Per 100 g of solution for topical application.

· The other ingredient is: Collodion
What KERAFILM, solution for topical application looks like and contents of the outer packaging
This medicine is a clear, colorless to slightly yellow liquid.
Solution for topical application. 10 ml or 15 ml bottle closed with a stopper. This stopper must be replaced after first use with the stopper and a spatula.
Marketing Authorization Holder
PIERRE FABRE MEDICAMENT
LES CAUQUILLOUS
81500 LAVAUR
Marketing Authorization Holder
PIERRE FABRE MEDICAMENT
Parc Industriel de la Chartreuse
81100 CASTRES
Manufacturer
FARMACLAIR – HEROUVILLE SAINT CLAIR
440 avenue du Général de Gaulle
14200 HEROUVILLE SAINT CLAIR
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
This leaflet was last revised:
[to be completed later by the holder]
Other
Detailed information on this medicinal product is available on the ANSM website (France). Health Education Tip:
What are corns, calluses, and corns?
These are diffuse thickenings of the skin of the foot, usually on both feet, which tend to crack.
Corns are layers of dead skin that form in a small area of ??friction. Beneath the exposed area, an inverted cone of hard skin penetrates the deeper tissues of the skin. The typical location of corns is the tops of the toe joints or on the side of the little toe.
Corns (or soft corns) have the same origin but form between the toes: two raised bumps face each other, usually between the fourth and fifth toes. These particular corns are whitish, spongy with a red border and, sometimes, a black dot in the center.
Calluses tend to appear on the soles of the feet over a large area. People with these abnormalities experience pain in these areas, particularly when wearing tight shoes. They are generally benign. However, in patients with diabetes, they can develop into sores that are difficult to heal.
What causes corns and calluses?
Friction from walking is the main cause of corns, corns, and calluses. As skin becomes thinner and drier with age, these problems occur more frequently in older people. They are particularly common in women, athletes, those with thin skin on their feet, and those with large toes. Corns are caused by repeated pressure on the skin caused by shoes that are too tight. Circulatory disorders or toe deformities (e.g., bunions or hallux valgus) can promote their appearance.
How can corns and calluses be prevented?
· Moisturize the skin on your feet with a special cream every day after washing.
· Wear suitable shoes. Choose very comfortable shoes made of soft materials (canvas, soft leather, etc.). If you change your shoes often, choose wide shoes that don't squeeze your feet.
· Opt for seamless shoes, as these can cause annoying rubbing. Make sure there's room on the side and above your toes.
· Avoid shoes with high heels and pointed toes. Choose shoes with low heels (4 to 5 cm).
· Use bandages to create a protective zone in areas where corns and calluses usually form.
What is a wart?
Wart located on the sole of the foot (plantar):
A single wart is deep and well-defined by a ring of calluses (thickened skin). It is painful when walking due to the pressure exerted by body weight. Its center is speckled with blackish dots. These are small blood vessels, which explains why this wart can sometimes bleed.
"Common" wart (on the hands):
Most often, the wart is round and rough, dome-shaped. Single or multiple, it measures a few millimeters in diameter and is located mainly on the fingers and the back of the hands. It can also be located under the nails or around their edges. In the latter case, the wart is sometimes very painful and can cause deformation or detachment of the nails.
How do you "catch" warts?
Warts are caused by skin contamination by a virus from the papillomavirus family. Remember that the papillomavirus is a virus present on the skin surface of more than 50% of individuals. Warts are benign. They appear after several months of incubation. Most of them disappear spontaneously within a few months, but some can persist for years. It should also be noted that recurrences are common.
Warts are contagious in several ways:
· Either through self-contamination, where the carrier contaminates another part of their body through their hand;
· Or through direct contact with a person with warts. However, the risk of human-to-human contamination is low. Thus, there is no risk of "catching" warts by shaking hands with someone with warts. There is no need to separate dishes or laundry from a person with warts;
· Or through indirect contact with a contaminated surface when the skin is damaged. The only prevention is to avoid contact with the virus. Indeed, contamination often occurs in a gym, a communal shower, or a swimming pool. Plantar warts occur more easily after swimming in heated water, which softens the callous layer of the feet. Rough surfaces around pools and on swimming pool diving boards promote skin lesions and viral infection.
How can warts be prevented?
Some simple hygiene measures can help prevent warts:
· Avoid walking barefoot in public places (poolside, changing rooms, gyms, public showers, etc.): wear sandals or flip-flops;
· Dry your feet thoroughly; the virus penetrates more easily through damp skin;
· Do not use a file or pumice stone that has been used to scrub a wart;
· Do not scratch or rub another person's warts;
· Do not take the towel or washcloth of a person with a wart;
· Do not share socks or shoes with a person who has plantar warts.