Betadine Antiseptic

Povidone-iodine.

Cream: BETADINE Cream is a yellow-brown cream.
The active substance is povidone iodine 5.0% w/w.
Ointment: BETADINE Antiseptic Ointment is a red-brown ointment.
The active substance is Povidone-iodine Ph Eur 10% w/w.
Dry Powder Spray: The active substance is Povidone-Iodine Ph Eur 2.5% w/w.
Surgical Scrub: BETADINE Surgical Scrub is a reddish-brown viscous scrub.
The active substance is Povidone-Iodine 7.5% w/v.
Solution: Contains an active ingredient povidone-iodine 10% w/v.
Excipients/Inactive Ingredients: Cream: The other excipients are Cetostearyl Alcohol, White Soft Paraffin, Sodium Hydroxide, Liquid Paraffin, Glycerol, Sorbitan Stearate, Polysorbate 60, Macrogol Stearate, Potassium Iodate, Purified Water.
Ointment: The other excipients are Macrogol 400 and 4000, Sodium Bicarbonate, Purified water.
Dry Powder Spray: The other excipients are Isopropyl Myristate, Propane, Butane, Isobutane, n-Pentane.
Surgical Scrub: The other excipients are Coco glucoside 52%, Sodium Laureth Sulfate 70%, Glycerol 98%, Hydroxyethyl Cellulose, Sodium Hydroxide, Citric Acid Monohydrate, Disodium Phosphate Anhydrous, Potassium Iodate, Water Purified.

Cream: BETADINE Cream is an antiseptic cream which contains the active ingredient povidone-iodine which belongs to the pharmaceutical group of antiseptics.
It is indicated in major and minor burns, cuts and abrasions.
Ointment: BETADINE Antiseptic Ointment is a topical antiseptic and for protection from infection for burns, scalds, blister, cuts, scratches and grazes.
Dry Powder Spray: BETADINE Dry Powder Spray is a wide spectrum antiseptic recommended for the treatment and prevention of infection in wounds, including ulcers, burns, cuts and other minor injuries.
Non-selective microbiocidal action: BETADINE Dry Powder Spray has clinically proven broad microbicidal spectrum of available antiseptic solutions. It is rapidly effective in killing most organisms, including bacteria, viruses and fungi.
Surgical Scrub: BETADINE Surgical Scrub is a topical antiseptic. As an antiseptic surgical scrub, apply sufficient amount to skin at least once for pre-operative scrubbing by surgical teams or as directed by the physician for antiseptic use.
Solution: Unlike other antiseptics, BETADINE antiseptic solution contains an effective antiseptic ingredient PVP-I which is effective against bacteria, fungi and viruses.

Always use this medicine exactly as described in original leafllet or as prescribed. Patients must be advised to check with the doctor or pharmacist if they are not sure.
If the patient forgets to use BETADINE: If the patient forgets to use the medication, advise the patient to use it as soon as he/she remembers unless it's time for the next application. Then, the original instructions for use should be followed. A double dose should not be taken to make up for a forgotten dose.
If the patient stops using BETADINE: The duration of treatment is decided according to the indications of the problem. Patients must be advised for any further questions on the use of this medicine.
Cream: Use in Adults, Elderly and Children: Topical use.
The skin should be cleaned and dried before application. Apply the cream to the affected area 1-2 times daily or more if required.
If desired cover the affected area with a dressing or bandage.
If there is no improvement after 2-5 days of regular use, advise the patient to consult the doctor.
Ointment: Use in adults, elderly and children: Topical use.
Spread BETADINE Antiseptic Ointment evenly over the area of damaged skin, 1-2 times a day. If necessary, a dressing can be applied.
If there is no improvement after several days (2-5 days) of regular application of BETADINE Antiseptic Ointment, advise the patient to consult the doctor.
Dry Powder Spray: For external, topical use.
Adults, Elderly and Children over 2 years of age: Shake well before use. Spray from a distance of 6-10 inches onto the parts to be treated. A thin layer of dust is formed. If necessary, cover with a dressing. The dry powder can be applied several times a day (every 3-4 hours).
Surgical Scrub: Adults, Elderly and Children: Topical use.
Moisten the hands and/or the areas of the skin to be treated.
Apply BETADINE Surgical Scrub, use about 5 ml for hands, otherwise 2 ml/100 cm² of body surface and rub in well for 1 minute. To obtain a better lather a few drops of water can be added. Then rinse off or wash off with clean water.
Solution: As an antiseptic for cleansing of wounds, lacerations cut, burns of various degrees. Apply sufficient amount of antiseptic solution to the affected area at least once or as directed by physician.

If BETADINE is used more than the patient should: In such case or in the event of accidental or deliberate ingestion of large quantities of BETADINE, patients must be advised to immediately contact the doctor or nearest hospital.
Symptoms: Excess iodine can produce goitre and hypothyroidism or hyperthyroidism. Systemic absorption of iodine after repeated application of povidone iodine to large areas of wounds or burns may lead to a number of adverse effects (Ointment).
Overdose can cause symptoms like metallic taste in the mouth, increased salivation, burning or pain in the throat or mouth, irritation and swelling in the eyes, breathing difficulties due to pulmonary oedema, skin reactions, gastrointestinal upset and diarrhoea, metabolic acidosis, hypernatraemia, renal impairment, up to anuria and circulatory collapse.
Systemic toxicity may result in renal impairment (including anuria), tachycardia, hypotension, circulatory failure, oedema of glottis resulting in asphyxia, or pulmonary oedema, seizures, fever and metabolic acidosis. Hyperthyroidism or hypothyroidism may also develop.
Therapy: In the case of deliberate or accidental ingestion of large quantities of BETADINE, symptomatic and supportive treatment should be provided, with special attention to electrolyte balance and renal and thyroid function.
For severe hypotension, intravenous fluid should be administered; vasopressors should be added if necessary.
Endotracheal intubation may be required if caustic injury to the upper airway results in significant swelling and oedema.
Vomiting should not be induced. Patient should be maintained in a position to keep the airways open and prevent aspiration (in case of vomiting).
If the patient is not vomiting and can tolerate oral feeding, then ingestion of starchy food (e.g. potato, flour, starch, bread) may help convert iodine to less toxic iodide. If no signs of bowel perforation are present, irrigation of the stomach with starch solution via nasogastric tube may be utilized (gastric effluent will turn dark blue-purple and the colour can be used as a guide in determining when lavage can be terminated).
Haemodialysis effectively clears iodine and should be employed in severe cases of iodine poisoning particularly if renal failure is present. Continuous venovenous haemodiafiltration is less effective than haemodialysis.
In case of thyroid dysfunction, treatment with povidone-iodine should be discontinued.

Do not use BETADINE: If the patient is allergic to povidone-iodine/iodine or any of the other ingredients of this medicine (listed in Description); If the patient is hypersensitive to iodine/active substance(s) or any other of the ingredients/excipients listed in Description; If the patient suffers with hyperthyroidism or other thyroid disorders (in particular nodular colloid goitre, endemic goitre and Hashimoto's thyroiditis); If the patient is taking lithium; Before, during and after radio-iodine administration or radioiodine scintigraphy or radioiodine treatment of thyroid carcinoma; In patients using products containing mercury.
Cream and Surgical Scrub: Do not use in children under 1 year of age.
Ointment and Dry Powder Spray: Do not use in children under two years of age
Dry Powder Spray: Do not use in serous cavities.

Patients must be advised before using BETADINE.
Special caution is needed when regular applications to broken skin are made to patients with pre-existing renal insufficiency.
Avoid solutions containing a detergent if treating open wounds with povidone-iodine.
Cream, Ointment and Surgical Scrub: Povidone-Iodine should not cover for a long period large area of the skin (e.g. not more than 10% of the total body surface and not for longer than 14 days) unless strictly indicated. Even after the end of the treatment (up to 3 months) one should look for the early symptoms of possible hyperthyroidism and if necessary the thyroid function should be monitored.
Ointment, Dry Powder Spray and Surgical Scrub: Thyroid function tests may be affected using products containing iodine.
Contamination with povidone-iodine of several tests for detecting occult blood in faeces or blood in urine may produce false-positive results.
Cream: Patients with goitre, thyroid nodules, or other non-acute thyroid diseases are at risk of developing hyperthyroidism from the administration of large amounts of iodine.
BETADINE should not be used prior to or after radioiodine scintigraphy or radioiodine treatment of thyroid carcinoma.
Do not heat prior to application.
For external use only.
Ointment: Thyroid function tests should be performed during prolonged use.
Dry Powder Spray: Avoid inhalation and eye contact.
Driving and using machines: There are no effects on the ability to drive and use machines.
Use in Children: Cream: Do not use in children under 1 year of age. BETADINE Cream should only be used in children above 1 year, if strictly indicated under medical supervision and its use should be kept to the absolute minimum.
Ointment and Dry Powder Spray: Do not use in children under two years of age.
Surgical Scrub: Do not use in children under 1 year of age. Should only be used under medical supervision in children between the age of 1 and 2 years.

If the patient is pregnant or breast-feeding, thinks she may be pregnant or is planning to have a baby, advise the patient to ask the doctor or pharmacist for advice before taking this medicine. Povidone Iodine passes into the placenta and is secreted in breast milk. Povidone Iodine use should be avoided unless the potential benefit to the mother justifies the potential risk to the foetus and neonate or if a safer alternative is unavailable. BETADINE should only be used if strictly indicated and its use should be kept to the absolute minimum.
During pregnancy and lactation, BETADINE Ointment, Dry Powder Spray and Surgical Scrub should only be used under medical supervision.
Fertility: There are limited human fertility data for Povidone iodine. No data are available on fertility outcomes.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Cream: Common side effects (affecting >1% of people using BETADINE Cream): None stated.
Uncommon side effects (affecting <1% of people using BETADINE Cream): Immune system disorders: Hypersensitivity, Anaphylactic reaction.
Endocrine disorders: Hyperthyroidism (sometimes with symptoms such as tachycardia or restlessness).
Skin and subcutaneous disorders: Contact dermatitis (with symptoms such as erythema, small blisters and pruritus), Angioedema.
Frequency not known but may also occur: Endocrine disorders: Hypothyroidism.
Metabolism and nutrition disorders: Electrolyte imbalance, Metabolic acidosis.
Renal and urinary disorders: Acute renal failure, Blood osmolarity abnormal.
Injury, poisoning and procedural complications: Chemical burn of skin.
Skin and subcutaneous disorders: Skin discolouration.
Ointment: Povidone-iodine use could lead to transient skin discolouration at the application site. Povidone-Iodine may produce local skin reactions although it is less irritant than iodine. The application of Povidone-Iodine to large wounds or severe burns may produce systemic adverse effects such as metabolic acidosis, hypernatraemia and impairment of renal function. In single cases acute generalised allergic reactions with drop in blood pressure and/or shortness of breath (anaphylactic reactions) have been reported. The long term use of Povidone-Iodine for the treatment of wounds and burns over extensive areas of the skin can lead to a notable uptake of iodine. In isolated cases patients with a history of thyroid disease can develop hyperfunction of the thyroid (iodine induced hyperthyroidism) sometimes with symptoms such as racing pulse or a feeling of unrest (see Precautions). Should the patient experienced any of the previously mentioned side effects or any other unusual effects, the patient must be advised to stop using the medicine and to consult the doctor or pharmacist at once.
Dry Powder Spray: Povidone-Iodine may produce local skin reactions although it is less irritant than iodine. The application of povidone-Iodine to large wounds or severe burns may produce systemic adverse effects such as metabolic acidosis, hypernatriaemia and impairment of renal function. Should the patient experience any of the previously mentioned side effects or any other unusual effects, the patient must be advised to stop using the medicine and to consult the doctor or pharmacists at once.
Surgical Scrub: Povidone-iodine use could lead to transient skin discolouration at the application site.
Povidone-Iodine may produce local skin reactions although it is less irritant than iodine. The application of Povidone-Iodine to large wounds or severe burns may produce systemic adverse effects such as metabolic acidosis, hypernatraemia and impairment of renal function.
In single cases acute generalised allergic reactions with drop in blood pressure and/or shortness of breath (anaphylactic reactions) have been reported.
Should the patient experienced any of the previously mentioned side effects or any other unusual effects, the patient must be advised to stop using the medicine and to consult the doctor or pharmacist at once.

Patients must be advised to inform the doctor or pharmacist if they are using, have recently used or might use any other medicines.
The concomitant use of wound-treatment preparations containing enzymatic component, hydrogen peroxide, silver and taurolidine leads to a weakening of the effects of both substances. Products containing mercury, silver, hydrogen peroxide, and taurolidine may interact with povidone-iodine and should not be used concomitantly. Simultaneous use with mercury products may lead to the formation of a substance, which can damage the skin.
Absorption of iodine from povidone-iodine or using this treatment may interfere with tests of thyroid function or radioiodine therapy and can make a planned treatment of the thyroid with iodine impossible. After the end of the treatment, 4 weeks (for Cream, Ointment and Surgical Scrub) and an interval of at least 1-2 weeks (for Dry Powder Spray) should be allowed before a new scintigram is carried out.
Several types of tests for detecting occult (not visible) blood in faeces or blood in urine may be affected (i.e. produce false-positive results), due to the oxidative effect of povidone-iodine preparations.
Transient dark discolorations may occur after the concomitant use with povidone-iodine products or before or after application use of octenidine containing antiseptics in the same or adjacent sites.
Povidone-iodine use could lead to transient skin discolouration at the application site caused by the drug product's own colour.
Cream: The PVP-iodine complex is effective at pH values of between 2.0 and 7.0. It has to be expected that the complex will react with protein and other unsaturated organic compounds, leading to impairment of its effectiveness.

Do not throw away any medicines via wastewater or household waste. Ask the pharmacist how to throw away medicines no longer use. These measures will help protect the environment.
Dry Powder Spray: Do not pierce or burn, even when empty. Do not spray on a naked flame or any incandescent material.

Store this product at or below 25°C, in the packaging that it comes in.
Dry Powder Spray: Protect the pressure container from sunlight. Do not expose it to temperatures exceeding 50°C.

Surgical Dressings & Wound Care

D08AG02 - povidone-iodine ; Belongs to the class of iodine product antiseptics. Used in the treatment of dermatological diseases.

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