PATIENT INFORMATION

Please read this before you start to use duofilm. If there is anything in it which you do not understand, or if you want more information or advice, ask your doctor or pharmacist.

 

 

 

 

 

What does Duofilm contain?

It contains lactic acid BP 16.7% w/w and salicylic acid BP 16.7% w/w. Duofilm also contains flexible collodion BP(contains pyroxylin, colophony, virgin castor oil, ethanol and ether).

What is Duofilm used for?

Duofilm is used to treat warts.

Before you use Duofilm

  • Duofilm contains colophony which may cause allergic contact dermatitis.
  • Duofilm may cause eye irritation. Avoid contact with eyes and other mucous membranes. In case of accidental contact with open wounds, eyes, nose or anogenital regions rinse the affected area immediately with water for 15 minutes.
  • Avoid exposure to healthy skin.
  • Duofilm may cause skin irritation. lf undue skin irritation develops treatment should be discontinued.
  • Consider alternative treatments if warts cover a large area of the body (more than 5 cm2) due to the potential risk of salicylate toxicity.
  • Duofilm is not recommended in patients with diabetes, or those suffering from poor blood circulation or poor sense of feeling(nerve damage)to the hands or feet except under the supervision of a doctor.
  • Oral salicylates taken during or immediately after a viral illness have been associated with Reye’s syndrome and hence there is a theoretical risk with topical salicylates.
    Therefore, Do not use in children or teenagers during or immediately after chickenpox, influenza, or other viral infections.
  • Do not inhale the vapour from Duofilm as it may make you feel lightheaded.
    Keep out of the sight and reach of children.

Pregnancy and Lactation:

Pregnancy: 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.

How to use Duofilm

For topical use only

  • Adults, and children aged 2 years and over: Apply daily to the affected areas only
  • Children: Treatment of infants under the age of 2 years is not recommended.
    Use in children should be under the supervision of an adult.
    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).

Duofilm is flammable. Stay away from heat,bfire or flame and do not smoke while you are applying Duofilm and just after you have applied it.

Do not use Duofilm in the following cases:

  • Salicylic acid and lactic acid solution is contraindicated in patients with a prior hypersensitivity reaction to salicylic acid, lactic acid or any other ingredient of the preparation.
  • 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.

Adverse Drug reactions:

You may experience the following in or around the area you applied Duofilm:

  • allergic reaction
  • inflammation
  • pain
  • skin irritation
  • burning sensation
  • redness
  • itching
  • skin discoloration
  • rash
  • swelling
  • scaling
  • dryness

If you accidently apply Duofilm to healthy skin you may experience:

  • blistering
  • skin flaking / exfoliation.

Overdosage:

If you accidentally swallow Duofilm, use it too often, for long periods of time or on very large areas, your body could absorb too much salicylic acid. This could lead to salicylate poisoning (salicysm). Some of the common symptoms which might occur, related to salicysm include, feeling thirsty, ringing in the ears or deafness, feeling or being sick, feeling tired, increased rate of breathing, dizziness, warm hands and feet or unusual mood or thoughts. Stop using Duofilm and see your doctor if this happens or ifyou get these symptoms or any others.

Interaction with other medicines:

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.

Storage conditions:

Duofilm should be stored in a cool place below 25°C. Do not use the solution after expiry. Duofilm is highly inflammable; keep it away from naked flame.

For reporting any Adverse event or side effects related to this product please contact us on:
contactus-me@stiefel.com

 

Duofilm is manufactured by Stiefel Laboratories (Ireland) Ltd,

Sligo, Ireland.
Date of revision: Nov 2014
Reviewed as per GDS version 2