POVIDONE-IODINE BETADINE

Transcription

1 POVIDONE-IODINE BETADINE NAME OF PRODUCT BETADINE 10% OINTMENT Read this leaflet carefully before you start using BETADINE ointment. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. DESCRIPTION OF PRODUCT POVIDONE-IODINE (BETADINE ) ointment is a reddish brown, smooth, homogenous ointment. It is available in 5 & 15 g aluminum tube. 1. WHAT IS BETADINE OINTMENT? POVIDONE-IODINE (BETADINE ) ointment is a topical agent active against organisms commonly encountered in skin and wound infections. It contains 10% povidone-iodine equivalent to 1% available iodine. The active ingredient povidone-iodine substantially retains the broad spectrum germicidal activity of iodine against the commonly encountered organisms in skin and wound infections, without the undesirable features or disadvantages of iodine. POVIDONE-IODINE (BETADINE ) ointment is decisively microbicidal against all 4 major classes of pathogens: bacteria (both Gram-positive and Gram-negative, as well as antibiotic-resistant strains) fungi, viruses and protozoa. The foremost documented broad spectrum topical microbicidal power of POVIDONE-IODINE (BETADINE ) ointment is active even in the presence of blood, pus and serum and the germicidal activity is more prolonged than that of iodine tincture. POVIDONE-IODINE (BETADINE ) ointment is in a water-soluble base and is not greasy or sticky. It permits bandaging of treated area, is virtually non-irritating to skin and mucosa and does not block air from reaching site of application. It easily washes off from skin and natural fabrics. POVIDONE-IODINE (BETADINE ) ointment does not interfere with granulation or skin grafting in burns. 2. STRENGTH OF BETADINE OINTMENT Each g contains 100 mg POVIDONE-IODINE (BETADINE ) equivalent to 10 mg available iodine 3. WHAT IS BETADINE OINTMENT USED FOR? POVIDONE-IODINE (BETADINE ) ointment is an ideal topical agent for the treatment of common skin infections; prevention of infection in minor burns, lacerations, cuts and abrasions; and for infection control during insertion and care of urinary catheters, circumcision, suture removal and dressing changes.

2 POVIDONE-IODINE (BETADINE ) ointment may be used for degerming care of stasis ulcers, decubitus ulcers and the umbilical area. It can be used also for degerming during use of intravenous devices in blood transfusions, hyperalimentation, cutdowns, CVP catheterization and in other procedures where degerming is needed. 4. HOW MUCH AND HOW OFTEN SHOULD YOU USE BETADINE OINTMENT? Use POVIDONE-IODINE (BETADINE ) Ointment as prescribed by your doctor. Clean and dry the affected skin. Apply POVIDONE-IODINE (BETADINE ) ointment liberally and cover with a dressing or bandage. POVIDONE-IODINE (BETADINE ) ointment may be used as often as required. If you have any further questions on the use of POVIDONE-IODINE (BETADINE ) ointment, ask your doctor or pharmacist. 5. WHEN SHOULD YOU NOT USE BETADINE OINTMENT? POVIDONE-IODINE (BETADINE ) ointment should not be used: If you are allergic to iodine or povidone If you have an overactive thyroid gland (hyperthyroidism) or any thyroid diseases If you are on lithium therapy Before and after a specific medical treatment involving the use of radioactive iodine If you feel you have experienced an allergic reaction, stop using POVIDONE-IODINE (BETADINE ) ointment and inform your doctor or pharmacist immediately. 6. SIDE EFFECTS All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects. The side effects listed below may not include all of the side effects reported. For more information about any other possible risks associated with POVIDONE-IODINE (BETADINE ) ointment, please consult your doctor or pharmacist. Please note that the side effects related to the use of POVIDONE-IODINE (BETADINE ) ointment occur rarely. Rarely, hypersensitive/allergic skin reaction may occur, which can appear in the form of: itchiness redness small blisters Very rarely, acute generalized allergic reactions have been reported with drop in blood pressure difficulty in breathing swelling of the skin and mucosa

3 If you notice any side effects, please consult your doctor or pharmacist. The long term use of the product, not in accordance with the usage instructions mentioned under section 4, may lead to possible absorption of iodine into the body. This may lead to overactive thyroid gland function if you have a history of thyroid problems, rapid heartbeat (tachycardia) and restlessness imbalance of electrolytes abnormal blood concentration (osmolarity) abnormal kidney function (renal impairment) 7. WHAT OTHER MEDICINE OR FOOD SHOULD BE AVOIDED WHILE USING BETADINE OINTMENT? Do not apply other medications to the same affected areas you treat with POVIDONE- IODINE (BETADINE ) ointment, unless your doctor has told you so. It is not likely that other drugs you take orally or inject will have an effect on externally applied POVIDONE-IODINE (BETADINE ) ointment. The concomitant use of other externally applied wound healing medicines /preparations may alter the effect of POVIDONE-IODINE (BETADINE ) ointment or both. Products containing enzymatic component, alkali, mercury, silver, hydrogen peroxide, tannic acid and taurolidine may interact with povidone-iodine and should not be used concomitantly. Povidone-iodine products when used concomitantly or immediately after application of octenidine containing antiseptics in the same or adjacent sites may lead to transient dark discolorations in the areas involved. Due to the oxidative effect of povidone-iodine preparations various diagnostic agents can show false-positive lab results (e.g., tests with toluidine or gum guaiac for the determination of hemoglobin or glucose in the stool or the urine). Absorption of iodine from povidone-iodine may interfere with thyroid function tests. Do not start a new treatment medication without telling your doctor. For more information about any other possible risks associated with POVIDONE-IODINE (BETADINE ) ointment, please consult your doctor or pharmacist. 8. WHAT SHOULD YOU DO IF YOU MISS A DOSE? Follow the usage instructions mentioned in section 4. If you miss a treatment use it as soon as you remember. For more information please consult your doctor or pharmacist. 9. HOW SHOULD YOU KEEP BETADINE OINTMENT? Do not use POVIDONE-IODINE (BETADINE ) ointment after the expiry date indicated on the tube and carton. Store at temperatures not exceeding 30 C. 10. SIGNS & SYMPTOMS OF OVERDOSE In the unlikely event you experience any of the following symptoms: stomach pain, unable to pass urine, loss of appetite, weakness, nausea and vomiting, coughing up

4 blood, excessive sweating, difficulty in breathing, metabolic acidosis, anxiety and pale skin, immediately consult your doctor. Treatment is symptomatic and supportive. 11. WHAT TO DO WHEN YOU HAVE USED MORE THAN THE RECOMMENDED DOSAGE? Please consult your doctor or pharmacist. 12. CARE THAT SHOULD BE TAKEN WHEN USING BETADINE OINTMENT In pre-operative preparation, avoid pooling beneath the patient. Prolonged exposure to wet solution may cause irritation or rarely, severe skin reactions. Chemical burns of skin due to pooling may occur. In instances of skin irritation, contact dermatitis or hypersensitivity, discontinue use. Do not heat POVIDONE-IODINE (BETADINE ) ointment prior to use. Avoid getting POVIDONE-IODINE (BETADINE ) ointment in your eyes. Avoid solutions containing a detergent if treating open wounds with povidone-iodine. POVIDONE-IODINE (BETADINE ) ointment is intended FOR EXTERNAL USE ONLY. Not for use on extensive body areas and should not be used over a long period of time unless strictly indicated. Patients with goiter, thyroid nodules or other non-acute thyroid diseases are at risk of developing thyroid hyperfunction (hyperthyroidism) from the administration of large amounts of iodine. In this patient population, povidone-iodine should not be applied for an extended period of time and to large areas of the skin unless strictly indicated. Even after the end of the treatment one should look for the early symptoms of possible hyperthyroidism and if necessary the thyroid function should be monitored. It should not be used prior to or after radioiodine scintigraphy or radioiodine treatment of thyroid carcinoma. Newborns and small infants are at increased risk of developing hypothyroidism from the administration of large amounts of iodine. Because of the permeable nature of the skin and their increased sensitivity to iodine, the use of povidone-iodine should be kept to the absolute minimum in newborns and small infants. A check of their thyroid function (e.g. T 4 levels and TSH levels) may be necessary. Avoid use in patients with renal impairment. If symptoms persist, consult your doctor. Pregnancy and Lactation During pregnancy and lactation, POVIDONE-IODINE (BETADINE ) ointment should only be used if strictly prescribed by the doctor and its use should be kept to the absolute minimum. Seek medical advice from your doctor or pharmacist. 13. WHEN SHOULD YOU CONSULT YOUR DOCTOR? In case of allergic symptoms, stop treatment and consult your doctor.

5 Call your doctor if your symptoms do not improve or if they get worse. Also call your doctor if your symptoms had cleared up but reappeared again. Manufactured for: By: Mundipharma Distribution GmbH Interphil Laboratories, Inc. (Philippine Branch) Canlubang Industrial Estate, 29/F Robinsons Equitable Tower, Bo. Pittland, Cabuyao, Laguna #4 ADB Ave. cor. Poveda St., Ortigas Center, Pasig City, Philippines 1605 Under license by: Mundipharma B.V. / The Netherlands : BETADINE is a Registered Trademark. This leaflet was last revised on December 10, 2015 (CCDS v.4 16 November 2015). PH-BET-0566-V3-1215