Active ingredients: Salicylic acid, Lactic acid
DUOFILM 16.7% + 16.7% collodion
Why is Duofilm used? What is it for?
DUOFILM contains the active ingredients salicylic acid and lactic acid. Topically applied salicylic acid acts on the superficial layer of the skin producing the loss of the top layer of the skin (peeling). Lactic acid reduces the thickening process of the skin.
DUOFILM is a medicine used for the local treatment of corns, calluses and warts.
Talk to your doctor if you do not feel better or if you feel worse after 2 weeks of treatment, in the case of corns and calluses, or after 3 months in the case of warts.
Contraindications When Duofilm should not be used
DO NOT use DUOFILM
- if you are allergic to salicylic acid, lactic acid or any of the other ingredients of this medicine
- if the wart, callus, callus, or surrounding skin is red, sore, torn / injured, or infected;
- on moles, birthmarks or warts with hair, surrounded by red or unusual colored borders;
- on warts located on the face, genitals or mucous membranes such as those of the eyes, nose and mouth.
Precautions for use What you need to know before taking Duofilm
- DUOFILM is indicated for external use only;
- avoid accidental contact with eyes, nose, mouth or vagina (mucous membranes) as it can cause irritation. In case of contact with mucous membranes or with open wounds, rinse immediately and abundantly with water, remove the film of medicine that forms and continue rinsing with water for at least a quarter of an hour;
- do not use the medicine on healthy skin around the wart, callus or callus, as this can cause irritation. In case of excessive skin irritation, stop treatment and contact your doctor or pharmacist;
- do not use DUOFILM on warts that cover an "area of the body larger than 5 cm2 (about the size of a postage stamp);
- if you have diabetes, if you have circulation problems (circulatory failure), if you have poor sensation (nerve damage) in your hands or feet, talk to your doctor or pharmacist before using DUOFILM;
- do not use DUOFILM to prevent the formation of warts;
- do not inhale DUOFILM vapors as they can cause dizziness;
- the use, especially if prolonged, of products for local use, such as DUOFILM, can give rise to sensitization phenomena (allergic reactions). In this case, stop the treatment and contact your doctor.
Children and adolescents
Do not use DUOFILM in children or adolescents who have a fever, a viral infection (such as the flu or chickenpox) or who have just recovered from these diseases.
DUOFILM can be used in children aged 2 to 12 years only if it has been prescribed by your doctor (see section 3 "How to use DUOFILM").
Interactions Which drugs or foods can modify the effect of Duofilm
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Do not use other treatments on warts, corns or calluses together with DUOFILM.
Warnings It is important to know that:
Pregnancy and breastfeeding
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 using this medicine.
Pregnancy
There is no information on the safety of DUOFILM during pregnancy.
The use of DUOFILM is not recommended in pregnancy.
Feeding time
The active substances in DUOFILM can pass into breast milk.
The use of DUOFILM is not recommended during breastfeeding.
In case of use of DUOFILM while breastfeeding, do not apply it on the breast area to prevent the baby from accidentally ingesting the product.
Driving and using machines
No effects on ability to drive and use machines are expected.
Dose, Method and Time of Administration How to use Duofilm: Posology
Always use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
How many
Warning: do not exceed the recommended doses.
Adults, including the elderly
DUOFILM must be applied once a day.
Children up to 12 years
Do not use in children under two years of age.
Talk to your doctor before using the medicine in children between the ages of 2 and 12: DUOFILM should only be used when clearly needed and under direct medical supervision. Application in children should be under adult supervision.
Like
Apply DUOFILM on the wart, callus or callus using the special brush. Apply it only on the affected part, avoiding that the liquid comes into contact with healthy skin.
Do not use DUOFILM on warts that cover an "area of the body larger than 5 cm2 (about the size of a postage stamp).
Keep away from sources of heat, flames or fire and do not smoke during and immediately after using DUOFILM, because the medicine is flammable.
Application instructions
- Immerse the area to be treated in hot water for about 5 minutes. Dry thoroughly with a clean towel and pass a nail file, abrasive stone, cardboard file or rough towel over the affected surface, taking care not to cause bleeding.
- Apply with the special DUOFILM brush on the wart, callus or callus, taking care not to apply the medicine on the healthy skin around.
- Let the solution dry completely: in the case of localized foot problems or if the wart, callus or callus covers large areas, put a plaster on the area to be treated to facilitate the absorption of the active ingredients.
When and for how long
Apply DUOFILM once a day, preferably in the evening.
Corns and calluses: do not exceed 2 weeks of treatment. If the callus or callus has not disappeared after 2 weeks of treatment, talk to your doctor or pharmacist.
Warts: do not exceed 12 weeks of treatment. If the wart has not disappeared after 12 weeks of treatment, contact your doctor or pharmacist
Also, talk to your doctor if the disorder occurs repeatedly or if you have noticed any recent changes in its characteristics
Overdose What to do if you have taken too much Duofilm
If DUOFILM is accidentally ingested, used too often, for long periods or over very large areas, the body can absorb too much salicylic acid. This can result in salicylate poisoning (salicilism). Some common symptoms related to salicilism can presenting include: feeling thirsty, ringing in the ears or deafness, nausea, tiredness, increased breathing rate, dizziness, warm hands and feet, unusual mood or thoughts.
Do not ingest DUOFILM. If you accidentally swallow the medicine or if you experience any of the symptoms listed above, stop the treatment and contact your doctor or the nearest hospital immediately.
If you forget to use DUOFILM
Continue the treatment as described in the section "How to use DUOFILM".
Do not use a double dose to make up for a forgotten dose
Side Effects What are the side effects of Duofilm
Like all medicines, this medicine can cause side effects, although not everybody gets them. The following effects may occur on or around the treated area:
- allergic reaction
- inflammation
- ache
- skin irritation
- burning sensation
- redness
- itch
- discolouration of the skin
- rash
- swelling
- loss of the top layer of the skin (peeling)
- dryness.
If DUOFILM is accidentally applied to healthy skin, flaking of the skin surface and blistering can occur. Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
Reporting of side effects
If you get 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 at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects you can help provide more information on the safety of this medicine. 5. How to store DUOF
Expiry and Retention
Keep this medicine out of the sight and reach of children.
Do not store above 25 ° C. DUOFILM is very flammable: keep away from flames and heat sources.
Do not use this medicine after the expiry date which is stated on the bottle and carton after EXP. The expiry date refers to the last day of that month. The expiry date refers to the unopened, correctly stored product.
Close the bottle tightly after use. A noticeable increase in the density of the product indicates that the bottle has not been closed properly and that the solvent contained in it has partially evaporated.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
It is important to always have the information on the medicine available, so keep both the box and the package leaflet.
What DUOFILM contains
- The active ingredients are salicylic acid and lactic acid. 100 g of product contain 16.7 g of salicylic acid and 16.7 g of lactic acid.
- The other components are elastic collodion BP (consisting of: rosin, castor oil and collodion, in turn consisting of: pyroxylin, ethyl alcohol and ether).
Description of DUOFILM appearance and contents of the pack
DUOFILM is a clear and viscous liquid, contained in a 15 ml dark glass bottle, closed by a plastic cap with brush applicator.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
DUOFILM 16.7% + 16.7% COLLODIUM
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
100 g of collodion contain:
Active ingredients: 16.7g salicylic acid;
lactic acid 16,7g.
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Collodion.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
DUOFILM is indicated for the topical treatment of warts, corns and calluses.
04.2 Posology and method of administration
For topical use only
Adults, including the elderly
DUOFILM must be applied with the special brush only on the affected part, avoiding that the liquid comes into contact with healthy skin.
DUOFILM must be applied on the wart, callus or callus once a day, preferably in the evening before going to bed, following the following instructions for use:
1. Immerse the area to be treated in hot water for about 5 minutes and dry thoroughly with a clean towel.
2. Wipe the affected surface with a nail file, an abrasive stone, a cardboard file or a rough towel, taking care not to cause bleeding.
3. Apply with the special DUOFILM brush on the wart, callus or callus, taking care not to overflow on the surrounding healthy skin.
4. Allow the solution to dry completely: in the case of localized forms of the feet or if the wart, callus or callus involves large areas, the part must be covered with a plaster to facilitate the absorption of the active ingredients.
It is recommended to continue treatment until one of the following conditions occurs:
- corns and calluses were treated for 2 weeks
- the warts were treated for 12 weeks
- or until the wart, callus or callus is completely removed and normal skin wrinkles have been restored.
For warts, clinically visible improvement should be seen in 1-2 weeks but maximum effect is expected after 4-8 weeks.
Advise the patient to consult the doctor or pharmacist if the wart persists beyond 12 weeks of treatment.
Consider alternative treatment if warts cover a large area of the body (more than 5 cm2) (see Special warnings and precautions for use).
Advise the patient to consult the doctor or pharmacist if skin irritation develops.
Due to the flammable nature of the medicinal product, patients should avoid smoking or approaching open flames during application and immediately after use.
Pediatric population
Do not administer under two years of age.
In children between 2 and 12 years of age, the product should be administered only in case of real need and under direct medical supervision.
Use in children should be under adult supervision.
Senior citizens
No dose adjustment is required as significant systemic exposure is not expected.
Hepatic insufficiency
No dose adjustment is required as significant systemic exposure is not expected.
Kidney failure
No dose adjustment is required as significant systemic exposure is not expected.
Do not exceed the recommended dose.
04.3 Contraindications
The medicinal product is contraindicated in patients with a previous hypersensitivity reaction to the active substances or to any of the excipients listed in section 6.1.
Do not use on open wounds, irritated or red skin or any infected area.
DUOFILM, should not be applied to the face, the anogenital area and large areas.
The product should not be applied to nevi, birthmarks, seborrheic warts, warts, facial or mucous warts, or warts with hair, surrounded by red or unusual colored borders.
04.4 Special warnings and appropriate precautions for use
The use, especially if prolonged, of products for topical use can give rise to sensitization phenomena. In this case it is necessary to interrupt the treatment and institute a suitable therapy.
Apply DUOFILM only on warts without overflowing on the surrounding healthy skin.
The medicine may cause eye irritation.
Avoid contact with eyes and other mucous membranes.
If the product accidentally comes into contact with mucous membranes or eyes, rinse immediately and abundantly with water, remove the collodion film that forms and continue rinsing with water for at least a quarter of an hour.
Avoid application to healthy skin (see Undesirable Effects). The medicinal product may cause skin irritation. If unexpected skin irritation develops, treatment should be discontinued.
Alternative treatment should be considered if warts cover a large area of the body (more than 5 cm2) due to the potential toxicity of salicylates.
The medicine is not recommended in diabetic patients or patients with circulatory problems or peripheral neuropathy, unless under the supervision of a doctor.
Taking oral salicylates during or immediately following viral illness has been associated with Reye's syndrome and consequently there is a theoretical risk even with topical salicylates.Therefore, the product should not be used in children or adolescents during or immediately after chickenpox, flu or other viral infections.
Salicylates have been reported to be excreted in breast milk (see Fertility, Pregnancy and Lactation).
Patients should be advised not to inhale the vapors.
Accidental ingestion of keratolytics containing salicylic acid and lactic acid in high concentrations can have serious, sometimes fatal, consequences.
The product should not be used to prevent the formation of warts.
Do not swallow.
Keep out of the sight and reach of children.
04.5 Interactions with other medicinal products and other forms of interaction
The topical solution of salicylic acid and lactic acid can increase the absorption of other topical medicines. Therefore, the concomitant use of salicylic acid and lactic acid solution and other topical medicines on the treated area should be avoided. .
Since the systemic absorption of topical solutions of salicylic acid and lactic acid is low, interaction with systemically administered medicinal products is not expected.
04.6 Pregnancy and lactation
Pregnancy
The safety of use in pregnancy of the salicylic acid-lactic acid solution is not established. Studies in animals given oral salicylic acid have shown embryo-toxicity at high doses (see Preclinical safety data).
The medicine is not recommended during pregnancy.
Feeding time
Salicylates are excreted in breast milk. The medicine is not recommended during breastfeeding.
If used or administered while breastfeeding, avoid contact with the breast area to prevent accidental ingestion by the infant.
04.7 Effects on ability to drive and use machines
No effects are expected based on the safety profile of the product.
04.8 Undesirable effects
The following convention is used to classify the frequency of an adverse reaction and is based on the CIOMS guidelines:
• very common (> 1/10),
• common (> 1/100 to
• uncommon (> 1 / 1,000 to
• rare (from> 1 / 10,000 to
• very rare (
• not known (frequency cannot be estimated from the available data).
Data from clinical studies:
Post marketing data
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "address www.agenziofarmaco.gov.it/it/responsabili
04.9 Overdose
Signs and symptoms
In case of accidental oral ingestion symptoms of salicylate toxicity may occur.
The risk of developing the symptoms of salicylate poisoning or salicylism increases if the topical solution of salicylic acid and lactic acid is used in excess or for prolonged periods of time. It is therefore very important to respect the recommended duration and frequency of treatment.
Treatment
Overdose should be treated as clinically indicated or as recommended by the poison center, where available. There is no specific treatment for accidental oral ingestion of lactic acid and salicylic acid solutions. In case of accidental ingestion, the patient should be treated according to local guidelines under appropriate observation.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: preparations for corns and warts.
ATC code: D11AF.
Mechanism of action
The locally applied salicylic acid acts as a keratolytic. The keratolytic activity produces desquamation by solubilizing the intercellular cement of the stratum corneum which leads to the flaking of the skin scales.
Lactic acid acts on the keratinization process by reducing hyperkeratosis which is characteristic of warts, corns and calluses. At high concentrations it can cause epidermolysis, with consequent destruction of the keratotic tissue, and, in the case of warts, of the virus that causes them. It also has antiseptic properties.
The flexible colloid provides a viscous vehicle that allows for accurate application of the active ingredients to the wart, callus or callus. In addition, it forms a film that helps hydrate and facilitate the destruction of hyperkeratotic tissue.
05.2 "Pharmacokinetic properties
Absorption
Salicylic acid is absorbed through the skin: where detectable, maximum plasma levels are found 6 to 12 hours after application. The systemic absorption of salicylic acid after topical administration of other preparations containing this active ingredient varies from 9% to 25%. The percentage of absorption varies in relation to the duration of contact and the vehicle used. Despite the percutaneous absorption, the exposure systemic is low due to the small doses that are administered locally on limited and localized areas of hyperkeratotic tissue.
Percutaneous absorption of lactic acid in vitro was evaluated with a continuous flow diffusion system on human abdominal skin. At pH 3, the amount of radioactivity detected in the receptor fluid, stratum corneum, epidermis and dermis was 3.6%, 6.3%, 6.6% and 13.9%, respectively.
Distribution
After percutaneous absorption, salicylic acid is distributed in the extracellular space and is approximately half bound to plasma proteins (albumin).
Metabolism
Salicylates are metabolised in the liver by microsomal enzymes to salicyluric acid and phenolic glucuronides of salicylic acid. The unmetabolized fraction is excreted in the urine as unchanged salicylic acid.
Elimination
Within 24 hours of the absorption and distribution of salicylic acid in the intracellular space, approximately 95% of the absorbed dose is found in the urine.
05.3 Preclinical safety data
The preclinical safety data on salicylic acid and lactic acid available in the literature and in the internal archives do not highlight relevant information for the indications and recommended dosages.
Carcinogenesis and mutagenesis
Carcinogenicity or genotoxicity studies have not been conducted with the solution of acetylsalicylic acid (16.7%) and lactic acid (16.7%). The data available on the individual active ingredients are shown below.
Carcinogenesis
No studies have been conducted with salicylic acid.
In a rabbit carcinogenicity study (oral doses up to 0.7 g / kg / day for 16 months) lactic acid showed no evidence of carcinogenicity.
Mutagenesis
Salicylic acid (2 mg) exhibited specific DNA damaging capabilities in vitro in the rec-assay test and for mutagenicity in the Ames test on the TA100 strain of Salmonella typhimurium with metabolic activation in vitro.
Lactic acid gave negative results in Ames tests, chromosomal aberration and unscheduled DNA synthesis for the evaluation of mutagenicity in vitro.
Reproductive toxicity
Studies on embryonic development were not conducted with the solution of acetylsalicylic acid (16.7%) and lactic acid (16.7%). The data available on the individual active ingredients are shown below.
Salicylates, including salicylic acid, pass the placental barrier in rodents, rabbits, dogs and ferrets, and are teratogenic when given orally in high doses. Salicylic acid given in high doses to pregnant female rats and mice has increased congenital malformations, mainly affecting the skeleton and nervous system.
In an embryo-fetal development study in mice, after oral administration of 570 mg / kg / day of lactic acid on gestation days 6 - 15, the only fetal effect detected was a delay in ossification of the parietal bones.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
The only excipient of DUOFILM is the elastic collodion BP, consisting of: rosin, castor oil and collodion, in turn consisting of pyroxylin, ethyl alcohol and ether.
06.2 Incompatibility
Salicylic acid is incompatible with iron salts, ethyl nitrite alcohol solution, lead acetate, iodine.
Lactic acid is incompatible with oxidizing agents, iodides, nitric acid, albumin.
06.3 Period of validity
30 months.
06.4 Special precautions for storage
Due to its high flammability, it is advisable to store the product at temperatures not exceeding 25 ° C, away from flames and heat sources.
Close the bottle tightly after use. A noticeable increase in the density of the product indicates that the bottle has not been closed properly and that the solvent contained in it has partially evaporated.
06.5 Nature of the immediate packaging and contents of the package
Duofilm is packaged in 15 ml dark glass bottles, with polyethylene cap, with brush applicator.
06.6 Instructions for use and handling
No special instructions for disposal.
Unused medicine and waste from this medicine must be disposed of in accordance with local regulations.
07.0 MARKETING AUTHORIZATION HOLDER
STIEFEL LABORATORIES (Ireland) Ltd., Finisklin Business Park, Sligo (Ireland)
08.0 MARKETING AUTHORIZATION NUMBER
Duofilm 16.7% + 16.7% Collodium. Bottle of 15 ml A.I.C. n ° 034522019
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Date of first Authorization 4 January 2000
Date of most recent renewal: 12 December 2012
10.0 DATE OF REVISION OF THE TEXT
AIFA Resolution of 12 November 2013
