Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
The name of your medicine is Duofilm. It contains
two medicines called salicylic acid and lactic acid.
It works by softening the skin of a wart, causing it
to peel off.
Duofilm is used to treat warts.
e Awart is an infection in the top layers of the skin. It is caused by a virus.
e Warts can be spread when the virus touches damaged skin.
e Itis more likely to spread in places which are warm and moist. This is why one of the most common places to catch warts is swimming pools.
e |tcan take from a few weeks to several months for the wart to appear.
PaPens
2. Before you use Duofilm
Do not use Duofilm if:
e you are allergic to the salicylic acid, lactic acid or any of the other ingredients of Duofilm (listed in Section 6).
e you have warts on your face, around your back passage or genitals, moles, birthmarks, warts with hair growing from them or other sensitive areas.
e the area of skin is irritated, reddened or infected. Do not use on open wounds.
e the child being treated is under 2 years of age.
Do not use Duofilm if the above applies to you. If
you are not sure, talk to your doctor or
pharmacist before you start using Duofilm.
Take special care with Duofilm
e Do not inhale the vapour.
e Do not use with other medicines on the affected area.
e Duofilm is not recommended for patients who suffer from diabetes, poor blood circulation or nerve damage to the hands and feet.
e Duofilm contains colophony, which may cause allergic skin reactions (contact dermatitis).
e This medicine contains 10%v/v ethanol in each application. It may cause burning sensation on damaged skin.
e Avoid contact with eyes, other sensitive areas and healthy skin. In case of accidental contact with the eyes or other sensitive areas, rinse well with water.
If you apply Duofilm to healthy skin, you may experience blistering. Stop use and talk to your doctor or pharmacist.
e Duofilm is not recommended to be used during or immediately after a viral illness. Do not use in children or teenagers during or after chicken pox, influenza or other viral infections.
e Duofilm is not recommended to be used during pregnancy or breast-feeding.
e If used during breast-feeding, take care to wash off all traces to avoid accidental swallowing by the child.
Approved by: Date:
STAD
( a _
A
ee
Product Title: Duofilm Cutaneous Solution
Pack Size: 15ml
Mat.No:92977352102_15ML_PI
L
Dimensions: 135 x 200
Keyline Ref:
Barcode:
Pharmacode: 513
Verified
Datamatrix:
Reason for Change: Excipient guidelines
1. Colour: ma Black
2. Colour: ma Keyline (Non-Pri
nting)
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Proof Number: 2
Date: 07.04.2021
Operator: EVA Artwork Number: 1207075
CRN: 18142
Suffix: A
Local Authority submission required: Yes
If this medicine is from your doctor or pharmacist, do exactly as they have told you. Otherwise, follow the instructions below. If you do not understand the instructions, or you are not sure, ask your doctor or pharmacist.
Using Duofilm
e Use Duofilm once a day, before bedtime, using the brush in the pack.
e It may take 4 to 8 weeks for visible improvement.
e Keep using Duofilm either until the wart has been treated for 12 weeks or until you can see the lines of your skin again (called 'ridge lines').
e Speak to a pharmacist or doctor if warts last longer than 12 weeks or if skin irritation develops.
e Avoid smoking or being near an open flame whilst using Duofilm, or immediately after use.
How to use Duofilm
1. Remove any plasters.
2. Soak the warts in hot water for five minutes.
3. Dry the area with your own towel.
4. Rub the top of the warts carefully with a pumice stone, nail file, coarse washcloth or emery board.
5. Then put on enough Duofilm to cover the warts. Try not to get it on the normal skin around the warts.
6. Let the Duofilm dry thoroughly.
7. Cover the wart with a plaster if possible to help the ingredients get to work.
To stop warts spreading to others
Remember that warts can spread to others.
e Only use your own towel.
e If your warts are on the bottom of your feet, do not walk around bare foot.
Children
Duofilm is not recommended for use in children under 2 years of age. Children under 12 years should only use the medicine with help from an adult.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them. Duofilm may cause allergic skin reactions (allergic dermatitis), rash, dryness, scaling, irritation, itching, swelling, burning sensation, redness, excessive skin growth, discolouration of the skin, blistering, pain and hypersensitivity at the site of application.
lf you accidentally apply Duofilm to healthy skin you may experience blistering and skin exfoliation.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
e Keep out of the sight and reach of children.
e Do not use Duofilm after the expiry date stated on the bottle and carton.
e Do not store above 25°C.
e Duofilm is highly flammable, keep it away from naked flames.
e Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Further information
What Duofilm contains
e The active substances are lactic acid 15.0% w/w and salicylic acid 16.7% w/w.
e The other ingredient is flexible collodion (contains pyroxylin, colophony, virgin castor oil, ethanol and ether).
What Duofilm looks like and the contents of the pack
Duofilm is supplied in bottles of 15m. Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Thornton & Ross Ltd., Linthwaite, Huddersfield, HD7 5QH, UK.
Manufacturer:
Delpharm Bladel B.V. Industrieweg 1,
5531 AD BLADEL, The Netherlands
PL 00240/0551
Date of preparation April 2021
9297735 2102 GB 31023300.06
Approved by:
Date:
Duofilm Topical Solution comes as solution. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Duofilm Topical Solution is salicylic acid.
Medicines with the same active substance include: Bazuka Extra Strength Gel, Bazuka Extra Strength Treatment Gel, Boots Corn Removal Plasters, Occlusal, Salicylic Acid Ointment BP. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Duofilm Topical Solution, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Duofilm is indicated for the treatment of warts.
Adults, the elderly and children aged 2 years and over.
Apply daily to the affected areas only.
Children:
Children under the age of 12 years should be treated under supervision.
Treatment of infants under the age of 2 years is not recommended.
Duofilm should be applied to the wart once daily preferably at bedtime.
Procedure for application:
1. The wart should be soaked in warm water for 5 minutes and dried thoroughly with a clean towel.
2. The surface of the wart should be rubbed with a nail file, pumice stone, emery board or coarse washcloth, with care taken not to cause bleeding.
3. A thin layer of Duofilm should be applied directly to the wart. Care should be taken to avoid the healthy surrounding skin.
4. The solution should be allowed to dry thoroughly. The wart should be covered with a plaster (dressing) if it is large or if it is on the foot to help penetration of ingredients.
It is recommended that treatment continues until whichever of the following occurs first:
• Warts have been treated for 12 weeks
• The wart is completely cleared and the normal ridgelines of the skin have been restored.
For warts, clinically visible improvement should occur in 1-2 weeks, but the maximum effect may be expected after 4-8 weeks.
If warts persist beyond 12 weeks of treatment, the patient should be advised to consult their pharmacist or doctor.
Consider alternative treatments if warts cover a large area of the body (more than 5 cm2) (see Warnings and Precautions).
Patients should be advised to consult a pharmacist or doctor if skin irritation develops.
Due to the flammable nature of Duofilm, patients should avoid smoking or being near an open flame during application and immediately after use.
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Do not use on open wounds, irritated or reddened skin, or any area that is infected.
Duofilm should not be used on the face, anogenital regions, moles, birthmarks, mucous membranes, warts with hair growing from them, red edges or an unusual colour. Avoid applying to normal skin.
Topical Duofilm may increase the absorption of other topically applied medicines. Therefore, concomitant use of Duofilm and other topical medicines on the treated area should be avoided. As systemic exposure of topically applied Duofilm is low, interaction with systemically administered medicines is not anticipated.
Pregnancy
The safety of Duofilm during human pregnancy has not been established. Studies in animals given salicylic acid orally demonstrated embryo toxicity at high doses (see Non-Clinical Information).
Duofilm is not recommended during pregnancy.
Lactation
Salicylates are excreted in human milk. Duofilm is not recommended during lactation.
If used or administered during lactation, care should be taken to avoid contact with the breast area in order to avoid accidental ingestion by the infant.
None
Symptoms and Signs
In the event of accidental oral ingestion symptoms of salicylate toxicity may occur.
The risk of developing symptoms of salicylate poisoning or salicylism is increased if Duofilm is used excessively or if it is used for prolonged periods of time. Therefore, duration of use and recommended frequency compliance is very important.
Treatment
Management should be as clinically indicated.
Ask anything about Duofilm Topical Solution. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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