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Package Leaflet: Information for the User Verrucutan 5 Mg/G + 100 Mg/G Cutaneous Solution Fluorouracil, Salicylic Acid Read

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Package Leaflet: Information for the User Verrucutan 5 Mg/G + 100 Mg/G Cutaneous Solution Fluorouracil, Salicylic Acid Read Dermapharm AG DE/H/4624/001/IB/008 Package leaflet, page 1 of 5 Package leaflet: Information for the user Verrucutan 5 mg/g + 100 mg/g cutaneous solution Fluorouracil, salicylic acid Read all of this leaflet carefully before you start using this medicine because it contains important information for you. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet: 1. What Verrucutan is and what it is used for 2. What you need to know before you use Verrucutan 3. How to use Verrucutan 4. Possible side effects 5. How to store Verrucutan 6. Contents of the pack and other information 1. What Verrucutan is and what it is used for Verrucutan is a therapeutic agent for warts. Verrucutan is used for common warts, verrucas on the sole of the feet (plantar warts) and flat warts (plane, juvenile warts) of the arms and legs. 2. What you need to know before you use Verrucutan Do not use Verrucutan if you are allergic to fluorouracil, salicylic acid or any of the other ingredients of this medicine (listed in section 6) if you are breastfeeding if you are pregnant or if you cannot definitely rule out the possibility of pregnancy in infants if you are aware of impaired kidney function if you use certain antiviral medicines to treat chickenpox or shingles (herpes zoster therapy). You must not use Verrucutan if you are currently on treatment with brivudine, sorivudine and/or similar substance groups as part of treatment for herpes zoster, or have been so within the past 4 weeks. The active substance fluorouracil, in combination with brivudine, sorivudine and their derivatives, may significantly increase the side effects of Verrucutan. You may not start treatment with fluorouracil for at least 4 weeks after completion of herpes zoster treatment with brivudine or sorivudine. If you are being or have been recently treated for a herpes zoster infection, please tell your doctor about the medicines taken. Verrucutan is not intended for use on large areas of skin (more than 25 cm2) and must not come into contact with the eyes and mucous membranes. Warnings and precautions 2020-07-24 Dermapharm AG DE/H/4624/001/IB/008 Package leaflet, page 2 of 5 Talk to your doctor or pharmacist before using Verrucutan, if you know that you do not have any activity of the enzyme dihydropyrimidine dehydrogenase (DPD) (complete DPD deficiency). Be careful when using Verrucutan if you are taking phenytoin for epileptic seizures. If you are taking phenytoin, combined use of Verrucutan may lead to increased blood levels of phenytoin. For this reason, you should be checked regularly for increased phenytoin blood levels. If skin areas with a thin upper layer are affected by warts, you should apply Verrucutan less frequently and have the treated area medically checked more often, as this can lead to scarring. Please note that regular medical check-ups are required if your ability to feel touch, pain and temperature is limited (sensory disorders e.g. due to diabetes). Verrucutan must not come into contact with textiles or acrylics (e.g. acrylic bathtubs) during use. The solution may cause irreversible stains. Please note, that Verrucutan is flammable before the film of the lacquer has been formed. Keep away from open fire and flames. Verrucutan should not be used on bleeding lesions. Children Verrucutan should not be used in infants. As the risk of overdose is higher in children than in adults, the recommended treatment area and frequency of treatment must - especially in small children - not be exceeded. Other medicines and Verrucutan Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines. This is particularly important because, when several medicines are taken at the same time, the effect of the individual medicines may become stronger or weaker. You must not use Verrucutan if you are taking or have taken certain medicines to treat viral diseases like chickenpox or shingles (brivudine, sorivudine or their derivatives) in the past 4 weeks. You need to be particularly careful if you are taking medicines for seizures (phenytoin). It is known from the systemic use of fluorouracil in cancer therapy that the co-administration of phenytoin can lead to increased phenytoin levels. Due to the possible absorption of salicylic acid, interactions with methotrexate (medicine used to treat certain rheumatic diseases, cancer or severe psoriasis) and sulphonylureas (contained in some hypoglycemic medicines (antidiabetics)) are possible. 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 using this medicine. Verrucutan must not be used during breast-feeding, pregnancy and if the possibility of pregnancy cannot be definitely ruled out. Driving and using machines No special precautions are required. Verrucutan contains dimethyl sulfoxide Dimethyl sulfoxide may be irritant to the skin. 2020-07-24 Dermapharm AG DE/H/4624/001/IB/008 Package leaflet, page 3 of 5 3. How to use Verrucutan Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Dosage Unless otherwise prescribed, Verrucutan is applied two to three times a day on each wart. Method of administration For cutaneous use. Verrucutan must only come into contact with the wart and not the healthy skin surrounding the wart; where appropriate, the surrounding skin should be covered with a paste or ointment. If necessary, your doctor or pharmacist can recommend you a suitable product. It is advisable to wipe the spatula on the neck of the bottle before dabbing. For very small warts, you should use a toothpick or something similar instead of the spatula for more precise application. Before each new application of Verrucutan, you should remove the existing film-coating by peeling it off. For warts around or under the nail, you must make sure that the nail is intact and Verrucutan cannot get into the nail bed. Verrucutan is not intended for use on large areas of skin. The total treatment area combined should be no more than 25 cm2. It is recommended that you regularly consult your doctor during treatment. Experience shows that, in many cases (e.g. with severely protruding warts or verrucas), it is beneficial to have your doctor remove the dead tissue during treatment with Verrucutan. Duration of treatment The average duration of treatment is 6 weeks. After successful treatment, treatment should be continued for about another week. Please talk to your doctor or pharmacist if you have the impression that the effect of Verrucutan is too strong or too weak. If you use more Verrucutan than you should In this case, please contact your doctor. If you forget to use Verrucutan Do not use a double dose to make up for a forgotten dose. Continue to apply as prescribed by your doctor or described in this package leaflet. If you stop using Verrucutan In this case, please contact your doctor. 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. Very common (may affect more than 1 in 10 people): there may be skin redness, inflammation, irritation, burning, pain and itching at the application site. Common (may affect up to 1 in 10 people): there may be bleeding, crusting and weeping of the skin at the application site. Skin may scale and erosive skin reactions (loss of upper skin tissue) may occur. Headache may occur. 2020-07-24 Dermapharm AG DE/H/4624/001/IB/008 Package leaflet, page 4 of 5 Uncommon (may affect up to 1 in 100 people): skin inflammation, oedema and ulcers may occur at the application site. In the eyes, increased tear production, itching and dry eyes may occur. - Rare (may affect up to 1 in 1,000 people): a severe burning sensation may occur, so that you will have to stop treatment. Verrucutan contains salicylic acid. This component may lead to mild signs of irritation such as skin inflammation (dermatitis) and hypersensitivity reactions (contact allergic reactions). These signs of irritation can also appear as itching, redness and blisters beyond the application site. In the area surrounding the wart, there may be whitish discolouration and peeling of the skin. 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 listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine. 5. How to store Verrucutan Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the bottle label and carton after “EXP”. The expiry date refers to the last day of that month. Do not store above 30 °C. Do not refrigerate or freeze. Once opened, the product is stable for 6 months. The bottle must be closed tightly after use.
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