POVIDONE-IODINE (BETADINE®) 1% oral solution ANTISEPTIC
For symptomatic relief of sore throat
NAME OF PRODUCT
Povidone-lodine (BETADINE®) 1% Oral Antiseptic Solution
Read this leaflet carefully before you start using this product.
• 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 THE PRODUCT
Povidone-lodine (BETADINE®) 1% Oral Antiseptic Solution contains povidone-iodine which is an antiseptic that kills a wide range of germs including bacteria, viruses and fungi. Povidone-lodine (BETADINE®) has not been associated with bacterial, viral or fungal resistance. It has a pleasant tasting menthol flavour.
1. WHAT IS POVIDONE IODINE (BETADINE®) ORAL ANTISEPTIC SOLUTION?
Povidone-lodine (BETADINE®) 1% Oral Antiseptic Solution is a broad spectrum germicidal gargle in a USP Type II Amber Bottle with Plastic Screw Cap. Its golden brown color indicates a potent iodine germ-killing power. It is mint-flavored, well tolerated and does not stain the teeth. It is available in 60 mL, 120 mL, 240 mL and 500 mL.
2. STRENGTH OF POVIDONE IODINE (BETADINE®) ORAL ANTISEPTIC SOLUTION
Each ml contains Povidone-lodine (BETADINE®) 10 mg equivalent to 1mg of available iodine.
3. WHAT IS POVIDONE IODINE (BETADINE®) ORAL ANTISEPTIC SOLUTION USED FOR?
Povidone-lodine (BETADINE®) 1% Oral Antiseptic Solution is indicated for the symptomatic treatment of conditions that cause inflammation or infection (viral, bacterial or fungal) of the mouth or throat such as sore throat (pharyngitis), tonsillitis, oral thrush, gum diseases such as gingivitis and periodontitis, oral ulcers, common colds and flu as well as stomatitis, which is a condition where there is ulceration and inflammation of the mouth.
For oral mucositis, which is an ulceration of the mouth caused by cancer therapies such as chemotherapy and/or radiotherapy.
Povidone-lodine (BETADINE®) 1% Oral Antiseptic Solution can be used as a protective measure to aid in infection control. It has been shown to kill viruses, bacteria and fungi that are associated with:
• Respiratory infections such as common cold, MERS, flu, pneumonia
• Hospital acquired infections, infections caused by antibiotic-resistant bacteria
• Pre-mouth rinse prior to dental procedure to minimize risk of viral infectious disease outbreaks
Povidone-lodine (BETADINE®) 1% Oral Antiseptic Solution can also be used for oral hygiene, before or after oral and dental surgery such as tonsillectomy and dental procedures. It can also be used to remove plaque causing bacteria that can result in oral infections and bad breath.
Povidone-lodine (BETADINE®) 1% Oral Antiseptic Solution is an ideal degerming soak for dentures and toothbrushes.
4. HOW MUCH AND HOW OFTEN SHOULD YOU USE POVIDONE-IODINE (BETADINE®) ORAL ANTISEPTIC SOLUTION?
Povidone-lodine (BETADINE®) is not recommended for children below 2 years of age.
For Povidone-lodine (BETADINE®) 1% Oral Antiseptic Solution, use undiluted or dilute with one part water.
Adults and children aged 6 years and above
Rinse and gargle with 10 ml up to four times a day for:
• 30 seconds for sore throat, oral hygiene, during outbreaks, before surgery and dental procedures
• 2 to 3 minutes each for ulcers, oral mucositis
Spit out after use. Do not swallow. Rinsing after use is not necessary.
For Oral Use Only.
5. WHEN SHOULD YOU NOT USE POVIDONE-IODINE (BETADINE®) ORAL ANTISEPTIC SOLUTION?
Povidone-lodine (BETADINE®) oral antiseptic solution should not be used:
• If you have hypersensitivity to the active substance or to any of the excipients
• If you are to receive or are currently receiving radioactive iodine treatments
• If you are using products containing mercury such as thiomersal
• If you have a thyroid problem
• In children under 1 year of age
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.
Povidone-lodine (BETADINE®) does not affect your ability to drive or use machinery. Povidone-lodine (BETADINE®) can cause side effects such as skin irritation, redness, swelling, small blisters, itching,
or dry skin, tiredness, weakness, confusion, rapid shallow breathing, passing little or no urine, fluid retention and swelling of legs, ankle and feet.
For more information about any other possible risks associated with Povidone-lodine (BETADINE®) solution, please consult your doctor or pharmacist.
7. WHAT OTHER MEDICINE OR FOOD SHOULD BE AVOIDED WHILE USING POVIDONE IODINE (BETADINE®)ORAL ANTISEPTIC SOLUTION?
Other antiseptics or medications can affect how POVIDONE IODINE (BETADINE®) works.
Avoid preparations containing hydrogen peroxide, silver, taurolidine or octenidine.
Tell your doctor if you are using Povidone-lodine (BETADINE®) before any diagnostic test.
8. WHAT SHOULD YOU DO IF YOU MISS A DOSE?
Follow the usage instructions mentioned in section 4. If you miss a treatment and it is almost time for the next dose, skip the missed dose, and apply your next dose when you are meant to.
9. HOW SHOULD YOU KEEP POVIDONE IODINE (BETADINE®) ORAL ANTISEPTIC SOLUTION?
Use within 6 months after first opening. Do not use Povidone-lodine (BETADINE®) oral antiseptic solution after the expiry date indicated on the bottle.
Store at temperatures not exceeding 30°C.
Keep Out of Reach of Children.
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 blood, excessive sweating, difficulty in breathing, metabolic acidosis, anxiety and pale skin, abdominal symptoms, anuria, circulatory collapse, pulmonary edema and metabolic abnormalities, 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 POVIDONE-IODINE (BETADINE®) ORAL ANTISEPTIC SOLUTION
Povidone-lodine (BETADINE®) oral antiseptic solution should only be used if agreed with a healthcare professional:
• If you are pregnant or breastfeeding
• You have received radioactive iodine treatments within the last 4 weeks
• Children between 1 to 6 years of age
Povidone-lodine (BETADINE®) does not stain. However, if product accidentally comes in contact with your clothes, wash immediately with water.
Avoid contact with jewelry, especially silver containing articles.
Do not heat prior to application.
13. WHEN SHOULD YOU CONSULT YOUR DOCTOR?
Consult your doctor or pharmacist immediately if you have any of the following signs or symptoms:
• Allergic reactions that occur quickly and include an itchy raised skin rash (hives), a body rash, sudden breathing problems, feeling faint, swelling of the mouth, face, lips, tongue or throat-seek medical help straight away
• Symptoms of a thyroid problem may include feeling nervous, moody, difficulty sleeping, hand tremors, fast or irregular heartbeat, trouble breathing, feeling very hot or sweaty, weight loss, weight gain and tiredness.
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.
If accidentally swallowed, contact your healthcare professional or hospital immediately.
For suspected adverse drug reaction/s with the use of this product, immediately seek medical attention and report to the FDA at www.fda.gov.ph and iNova Pharma Philippines, Inc. at drugsafety@inovapharma.com
Registration Number: DRHR-328
Date of First Authorization: 22 February 1977
Manufactured by:
INTERPHIL LABORATORIES, INC.
Canlubang Industrial Estate, Bo. Pittland, Cabuyao, Laguna
For:
iNova Pharmaceuticals (Singapore) Pte. Limited
Marketing Authorization Holder:
iNova Pharma Philippines, Inc.
Unit 1201 & 1208, The Finance Centre 9th Avenue corner 26th Street, Bonifacio Global City, Fort Bonifacio, Taguig City, Metro Manila
Date of revision: 09 October 2024
®:BETADINE is a registered trademark of iNova Pharma SG Pte Ltd.
