Betadine Antiseptic Topical Ointment povidone-iodine (poh-vi-dohn-ahy-uh-dahyn)

Consumer Medicine Information • if you currently have or have WHAT BETADINE ever had, a thyroid problem, WHAT IS IN THIS including swelling (nodular ANTISEPTIC TOPICAL colloid goitre, endemic LEAFLET OINTMENT IS USED goitre or Hashimoto’s This leaflet answers some FOR thyroiditis), as there may be a risk of developing common questions about Betadine Antiseptic Topical hyperthyroidism from the Betadine Antiseptic Topical Ointment contains povidone administration of large Ointment. iodine, which is used for the amounts of iodine. treatment of common skin • it should not be used for 4 It does not contain all the infections. weeks prior to treatment for available information. It does cancer of the thyroid. not take the place of talking to Betadine Antiseptic Topical • povidone iodine preparations your doctor or pharmacist. Ointment is used as an antiseptic should not be applied over a for the treatment of common This medicine is available skin infections such as infections long period and to large without prescription. However, of the skin around the nails, areas of the skin (e.g., not to you still need to use Betadine prevention of infections in minor more than 10% of the total Antiseptic Topical Ointment burns, cuts and abrasions. body surface and for not carefully to get the best results longer than 14 days) unless from it. Always read the label. strictly indicated. • on infants under 6 months of If you have any concerns Avoid excessive heat. age. about taking this medicine, • DO NOT USE IF TUBE ask your doctor or Follow the directions for use. SEAL IS BROKEN OR pharmacist. If symptoms persist, talk to AFTER EXPIRY DATE. your health professional. Keep this leaflet. You may need Keep out of reach of children. to read it again. BEFORE YOU USE You must contact a doctor if BETADINE ANTISEPTIC Pregnancy and your symptoms worsen TOPICAL OINTMENT breastfeeding or do not improve. BETADINE ANTISEPTIC If you know you are, or think TOPICAL OINTMENT IS FOR If any of the side effects become you might be pregnant, or are EXTERNAL USE ONLY. serious, or if you notice any side breastfeeding, talk to a doctor or effect not listed in this leaflet, When you must not use it pharmacist before using stop using Betadine Antiseptic Betadine Antiseptic Topical Topical Ointment immediately • avoid application to Ointment, or any other and tell a doctor or pharmacist. extensive burn areas. medicine. • known hypersensitivity to iodine or povidone. If If you are not sure whether irritation, redness or swelling any of the above apply to develops, discontinue you, speak to your doctor or treatment and consult a pharmacist before using. doctor.

betantitopoint-ccdsvx-cmiv1-30jul20 1 Tell your doctor if you have formation of a substance WHILE YOU ARE allergies to any other which can damage the skin USING BETADINE medicines, foods, preservatives or dyes. ANTISEPTIC TOPICAL HOW TO USE OINTMENT BETADINE ANTISEPTIC

TOPICAL OINTMENT • Avoid inhalation. Things you must do • Avoid contact with the Betadine Antiseptic Topical Tell your doctor if you are due eyes. Ointment is for external use to have a thyroid test, faeces only. (stool) or urine test, as Taking other medicines Betadine Antiseptic Topical Tell your doctor or pharmacist Before applying the Povidone- Ointment may affect the if you are taking any other iodine preparations ensure the results. medicines, including any that area is clean. Povidone-iodine preparations may react with you get without a prescription SIDE EFFECTS from your pharmacy, blood or pus and lead to supermarket or health food ineffectiveness of the Like all medicines, Betadine shop. In particular, you preparation. Antiseptic Topical Ointment should tell your doctor if you may cause side effects, are taking the following: Apply directly to the affected although not everybody gets area two to three times daily. them. • Lithium (for depression) can The affected area may be interact with Betadine bandaged. If you experience any of the Antiseptic Topical Ointment following side effects to affect the function of the Do not heat prior to stop using Betadine Antiseptic thyroid gland. Therefore, application. Topical Ointment and go to concurrent use should be your nearest Accident and avoided. If you do not understand the Emergency department or • Do not use other wound- instructions, ask your doctor contact your doctor treatment preparations at the or pharmacist for help. immediately: same time as a povidone- If you take too much iodine preparation as this can • allergic-type reactions, (overdose) lead to ineffectiveness of including difficulty both the preparations. The Immediately telephone your breathing or swallowing, a same thing can happen if doctor or the Poisons rash, swelling of the face, disinfectants containing Information Centre (telephone lips, throat or tongue silver, hydrogen peroxide or Australia 13 11 26 or New • itching, redness or small taurolidine are used at the Zealand 0800 POISON or blisters (rarely). same time. 0800 764766) for advice, or go • Do not use at the same time to Accident and Emergency at You may also experience the or immediately after the nearest hospital, if you following side effects: application of octenidine think that you or anyone else containing antiseptics in the may have taken too much • thyroid disorders (symptoms same or adjacent sites, as Betadine Antiseptic Topical of which include weight loss, this may lead to transient Ointment. Do this even if there increased appetite and dark discolorations in the are no signs of discomfort or sweating, or lack of energy areas involved. poisoning. and weight gain, racing pulse • The use of mercury You may need urgent medical or a feeling of unrest) can containing wound-treatment attention. occasionally occur from using products at the same time very large amounts of such with povidone-iodine products over a long period of preparations can lead to the time.

betantitopoint-ccdsvx-cmiv1-30jul20 2 • increased amounts of acid in AFTER TAKING • Sodium bicarbonate your blood (the main BETADINE ANTISEPTIC Supplier symptoms are shortness of TOPICAL OINTMENT breath, confusion and Betadine Antiseptic Topical lethargy) have been reported. Ointment is supplied in • kidney failure (symptoms Storage Australia by: include difficulty in urinating, Keep your medicine in a cool thirst and a dry mouth, and dry place where the temperature Sanofi Consumer Healthcare pain in one side of your back) stays below 25°C. 87 Yarraman Place, Virginia, has been reported. Qld 4014 Australia. • prolonged exposure to wet Do not store Betadine Antiseptic Toll-free: 1800 818 806 solution may cause redness Topical Ointment or any other and inflammation of the skin medicine in the bathroom or Betadine Antiseptic Topical or severe skin reactions near a sink. Do not leave it on a Ointment is supplied in New (rarely) or skin burns. window sill or in the car. Zealand by: Heat and dampness can destroy If your skin becomes irritated or some medicines. sanofi-aventis new zealand sensitive, discontinue use. limited Keep it where children cannot Level 8, 56 Cawley Street, Other adverse effects not listed reach it. Ellerslie, Auckland 1051, New above may also occur in some Zealand patients. Tell your doctor if you A locked cupboard at least one- notice any other effects. and-a-half metres above the Registration No AUST R 29561 ground is a good place to store Do not be alarmed by this list of medicines. This leaflet was prepared in July possible adverse effects. You 2020. may not experience any of them. Disposal

Medicines should not be betantitopoint-ccdsvx-cmiv1- Should you suffer from any of 30jul20 these side effects, or if you disposed of via wastewater notice any side effects not listed or household waste. in this leaflet, stop using Ask your pharmacist how to Betadine Antiseptic Topical dispose of medicines no Ointment immediately and tell a longer required. doctor or pharmacist. PRODUCT Reporting suspected adverse DESCRIPTION reactions after authorisation of the medicine is important. It allows continued monitoring of What it looks like the benefit/risk balance of the A brown viscous ointment in a medicine. Healthcare 25g or 65 g tube. professionals are asked to report any suspected adverse Ingredients reactions. Active ingredients: Australia: • Povidone iodine www.tga.gov.au/reporting- Inactive ingredients: problems New Zealand: • Macrogol 1000 https://nzphvc.otago.ac.nz/report • Macrogol 1500 ing • Macrogol 3350 • Macrogol 400 • Purified water

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