Sonafine Topical Emulsion- 45g (Generic PruTect)

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Sonafine Topical Emulsion

USES: For the treatment of any dermal wound, consult a physician. Use Sonafine only as directed. • Sonafine is non-toxic, it is for topical use only and should not be ingested or taken internally. • Sonafine does not contain a sunscreen and should not be used prior to extended exposure to the sun. • The use of Sonafine on skin rashes due to allergies has not been studied sufficiently and therefore is not recommended. • Following the application of Sonafine a temporary tingling sensation may occur (10 to 15 minutes). • If clinical signs of infection are present, appropriate treatment should be initiated. If clinically indicated, use of Sonafine may be continued during the anti-infective therapy. • If condition does not improve within 10-14 days, consult a physician. • Sonafine may dissolve fuchsin when this dye is used to dene the margins of the radiation elds to be treated.

OTHER USES: Sonafine is indicated for use in: • Full Thickness Wounds, Pressure Sores, Dermal Ulcers including Lower Leg Ulcers • Superficial Wounds • 1st and 2nd Degree Burns, including Sunburns • Dermal Donor and Graft Site Management • Radiation Dermatitis • Minor Abrasions

HOW TO USE: Sonafine is for topical use only as directed by a healthcare professional. Wounds, Abrasions, Full Thickness Wounds, Dermal Graft Site Management and Donor Site Management • Wash the affected area(s) with saline, clean water, or a suitable wound cleanser. • Apply Sonafine on and around the affected area(s) in thick layers 1/4 to 1/2 inch thick. • If applying gauze dressing, moisten the dressing lightly before application. • Reapply Sonafine as described above every 24 to 48 hours or as directed until the wound or lesion has healed fully. • For donor site management, apply Sonafine after skin removal and cover with a moist dressing. Reapply as directed. • For dermal graft site management, apply Sonafine to the graft site only after the graft has taken successfully. Sonafine can be washed away with a saline solution or clean water without causing damage to the newly formed tissues. 1st and 2nd Degree Burns, Including Sunburns • Before application of Sonafine to burns, take precaution in removing any clothing in the affected area(s). • Apply Sonafine as soon as possible on and around the affected area(s), in a thick 1/4 to 1/2 inch layer until the skin no longer absorbs the product. A white waxy residue may remain. If pain from the burn persists, apply thinner layers of Sonafine until the pain has ceased. • Continue to apply Sonafine until the affected areas(s) has healed completely. • Application of Sonafine to the affected area(s) should continue during any subsequent physical therapy treatments. Radiation Dermatitis • Apply a generous amount of Sonafine three times per day, seven days a week to the treated area(s), gently massaging the area(s) until Sonafine is completely absorbed. • Sonafine may be applied as indicated by the treating physician (see WARNINGS). • Continue to apply Sonafine as described above until the skin has fully recovered. • Do not interrupt applications during the course of radiation therapy, even for one day. • Do not apply Sonafine 4 hours prior to a radiation session.

SIDE EFFECTS: Dizziness, lightheadedness, weakness, nausea, flushing, constipation, and headache may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. To lower the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: fainting, new or worsening symptoms of heart failure (such as shortness of breath, swelling ankles/feet, unusual tiredness, unusual/sudden weight gain), slow/irregular/pounding/fast heartbeat, mental/mood changes (such as depression, agitation), unusual dreams, severe stomach/abdominal pain, dark urine, persistent nausea/vomiting, yellowing eyes/skin. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: For the treatment of any dermal wound, consult a physician. Use Sonafine only as directed. • Sonafine is non-toxic, it is for topical use only and should not be ingested or taken internally. • Sonafine does not contain a sunscreen and should not be used prior to extended exposure to the sun. • The use of Sonafine on skin rashes due to allergies has not been studied sufficiently and therefore is not recommended. • Following the application of Sonafine a temporary tingling sensation may occur (10 to 15 minutes). • If clinical signs of infection are present, appropriate treatment should be initiated. If clinically indicated, use of Sonafine may be continued during the anti-infective therapy. • If condition does not improve within 10-14 days, consult a physician. • Sonafine may dissolve fuchsin when this dye is used to dene the margins of the radiation elds to be treated.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor\'s approval. Some products that may interact with this drug include: digoxin, fingolimod. Other medications can affect the removal of diltiazem from your body, which may affect how this medication works. Examples include cimetidine, St. John\'s wort, azole antifungals such as ketoconazole, macrolide antibiotics such as erythromycin, rifamycins including rifabutin and rifampin. This medication can slow down the removal of other medications from your body, which may affect how they work. Examples of affected drugs include aprepitant/fosaprepitant, asunaprevir, buspirone, colchicine, ivabradine, certain benzodiazepines (triazolam, midazolam), among others. Some products have ingredients that could raise your heart rate or blood pressure. Tell your pharmacist what products you are using, and ask how to use them safely (especially cough-and-cold products, diet aids, or NSAIDs such as ibuprofen/naproxen).

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others. Talk with your doctor about making changes to your lifestyle that may help this medication work better (such as stress reduction programs, exercise, and dietary changes). Laboratory and/or medical tests (such as kidney/ liver function tests, pulse, blood pressure, EKG) may be performed from time to time to monitor your progress or check for side effects. Consult your doctor for more details. There are different brands and types of this medication available. Many do not have the same effects. Do not change brands or types without consulting your doctor or pharmacist. Have your blood pressure and pulse (heart rate) checked regularly while taking this medication. Learn how to check your own blood pressure and pulse at home, and share the results with your doctor.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

Information last revised December 2017. Copyright(c) 2017 First Databan