BETADINE * COLLUT FL 200ML 1%

BETADINE * COLLUT FL 200ML 1%

Therapeutic indications

Betadine 10% Cutaneous solution, alcoholic:Disinfection and cleaning of injured skin (superficial small wounds, pressure sores with limited involvement to the epidermis). The medicine can be used for skin disinfection before surgery.Betadine 1% Mouthwash:Disinfection of the oral mucosa.Betadine 10% Gel:Disinfection of injured skin (superficial small wounds, pressure sores with limited involvement to the epidermis).Betadine 10% Impregnated gauzes:Disinfection of injured skin (superficial small wounds, pressure sores with limited involvement to the epidermis).

Dosage and method of use

Betadine 10% Cutaneous solution, alcoholic:Apply the undiluted Betadine alcohol solution once or twice over the entire area of the skin to be disinfected. Distribute the product with a sterile gauze. Let it dry completely.Betadine 1% Mouthwash:Dilute to your taste, only when necessary, bearing in mind that the effectiveness is maintained at the dilution of 1 part of Betadine for 2 parts of water, and gargle 2-3 times a day. DO NOT EXCEED THE RECOMMENDED DOSE.Betadine 10% Gel:Apply a light layer of gel directly to the affected area (small in size) twice a day as needed. DO NOT EXCEED THE RECOMMENDED DOSE.Betadine 10% Impregnated gauzes:Apply 1 gauze, 1-3 times a day. DO NOT EXCEED THE RECOMMENDED DOSE.

Contraindications

• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. • Hyperthyroidism • Do not use in children under 6 months of age. • The mouthwash should not be used in children under 6 years of age.

Side effects

Undesirable effects are classified according to their frequency: Very common (≥ 1/10) Common (> 1/100 a Immune system disorders Rare Hypersensitivity Very rare Anaphylactic reactionEndocrine pathologiesVery rare Hyperthyroidism * (sometimes with symptoms such as tachycardia or agitation) Not known Hypothyroidism ***Metabolism and nutrition disordersNot known Electrolyte imbalance **, Metabolic acidosis **Respiratory, thoracic and mediastinal disordersNot known Pneumonia ***** (only when using Betadine 1% mouthwash)Skin and subcutaneous tissue disordersRare Contact dermatitis (with symptoms such as erythema, microvesicles and pruritus) Very rare Angioedema Not known Exfoliative dermatitis, Dry skin ^^ (only when using Betadine 10% cutaneous solution, alcoholic)Renal and urinary disordersNot known Acute renal failure **, Abnormal blood osmolarity **Injury, poisoning and procedural complicationsNot known Chemical skin burn ****, Thermal burn ^ (only when using Betadine 10% cutaneous solution, alcoholic) * In patients with a history of thyroid disease (see section Warnings and special precautions for use) following high iodine uptake, e.g. after long-term use of povidone-iodine solution for the treatment of wounds and burns on large skin areas. ** May occur as a result of uptake of high amounts of povidone iodone (e.g. in the treatment of burns) *** Hypothyroidism following prolonged or extensive use of povidone iodone **** As a result of "build-up" behind the patient during preoperative preparation ***** Complications due to inhalation - see section 4.4 ^ Due to high flammability, Povidone-iodine alcohol solution must dry completely before devices (especially HF surgical devices) can be used ^^ May occur after repeated applications due to the high alcohol content in the solution; the risk is greater for the genital area (e.g. scrotum)Reporting of suspected adverse reactionsReporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at: www.aifa.gov.it/content/segnalazioni-reazioni-avverse

Special warnings

For external use only. The product should not be applied to severely damaged skin and large surfaces. Do not use for prolonged treatments: especially if prolonged use can give rise to sensitization phenomena. In this case, the treatment should be stopped and a clinical evaluation should be performed. Particular caution should be used in patients with pre-existing renal insufficiency who require regular applications of Betadine on damaged skin (see section 5.2). Patients with goiter, thyroid nodules or other acute and non-acute thyroid disorders are at risk of developing thyroid hyperfunction (hyperthyroidism) following the administration of large amounts of iodine. In this patient population, povidone iodine solution should not be used for an extended period of time and on large body surfaces. Even after the end of the treatment it is necessary to look for the early symptoms of possible hyperthyroidism and to monitor the thyroid function. Do not use at least 10 days before performing a scintigraphy or after radioactive iodine scintigraphy or in the treatment with radioactive iodine of thyroid cancer. The pediatric population has an increased risk of developing hypothyroidism following applications of high doses of iodine. Due to the permeability of the skin and their high sensitivity to iodine, the use of povidone iodine should be minimized in children. The child's thyroid function may need to be checked (for example, T4 and TSH levels). Any oral ingestion of povidone iodine by the child should be avoided. In pediatric age use only under strict supervision and in cases of real need. The accidental ingestion or inhalation of some disinfectants can have serious, sometimes fatal consequences. Avoid contact with eyes.Betadine 10% cutaneous solution, alcoholic:The alcohol solution is highly flammable: it must dry completely before any devices (especially high frequency surgical devices) are applied. In pre-operative preparation, avoid accumulation under the patient, as chemical skin burns can occur. Prolonged exposure to moisture conditions related to the solution may cause irritation or, rarely, severe skin reactions. In case of skin irritation, contact dermatitis or hypersensitivity, discontinue use. Do not heat before application.Betadine 1% mouthwash:Care should be taken in case of oropharyngeal use to avoid inhalation of Betadine 1% mouthwash through the respiratory tract as it can cause complications such as pneumonia. This can particularly occur in intubated patients. Long-term use of povidone-iodine for gargling should be avoided in pregnant women, nursing mothers and people with a high risk of developing thyroid dysfunction due to excessive iodine intake (see sections 4.6 and 5.2).Important information about some of the ingredientsBetadine 1% Mouthwash contains less than 1 mmol (23 mg) of sodium per 20 ml of mouthwash, i.e. essentially 'sodium-free'. Betadine 1% Mouthwash contains 681.88 mg of alcohol (ethanol) in 20ml of mouthwash. The amount in 20ml of this medicine is equivalent to less than 18ml of beer or 8ml of wine.The small amount of alcohol in this medicine will have no noticeable effect.

Pregnancy and breastfeeding

During pregnancy and lactation, povidone iodine solution should only be used if strictly necessary and at the lowest possible dose, due to the ability of iodine to cross the placenta and to be secreted into breast milk and the high sensitivity of the fetus. and of the newborn to iodine. In addition, iodine is more concentrated in breast milk than serum, therefore it can cause transient hypothyroidism with increased TSH (thyroid stimulating hormone) in the fetus or newborn.

Expiry and retention

Betadine 1% Mouthwash: store at a temperature not exceeding 25 ° C.Betadine 10% Cutaneous solution, alcoholic: store at a temperature not exceeding 25 ° CBetadine 10% Gel and Betadine 10% Impregnated gauze: store at a temperature not exceeding 30 ° C

Interactions with other drugs

Avoid simultaneous use of other antiseptics and detergents. The polyvinylpyrrolidone-iodine complex is effective and stable at pH values between 2.0 and 7.0. It is possible that the complex reacts with proteins or other unsaturated organic compounds, resulting in a reduction in its effectiveness. The concomitant use of preparations with enzymatic components for the treatment of wounds leads to a weakening of the effects of both substances. Povidone iodine should not be used simultaneously with products containing mercury salts or benzonium compounds, carbonates, tannic acid, alkali, hydrogen peroxide, taurolidine and silver. The use of povidone-containing products concomitantly with other octedin-containing antiseptics in the same or adjacent sites may cause a momentary darkening of the affected areas. The oxidative effect of povidone-iodine preparations may cause false positive results of some diagnostic laboratory tests (e.g. toluidine or guaiac gum tests for the determination of hemoglobin or glucose in faeces or urine). Avoid routine use in patients concomitantly treated with lithium Absorption of iodine from povidone-iodine solution may reduce thyroid iodine uptake. This can interfere with various tests (thyroid scintigraphy, determination of iodine-binding proteins, radioactive iodine diagnostics) and can make a planned treatment of the thyroid with iodine (radioactive iodine therapy) impossible. After the end of the treatment, an adequate period of time must elapse before performing a new scintigraphy.

Overdose

In case of intentional or accidental overdose (highly unlikely for pharmaceutical forms such as gauze), hypothyroidism or hyperthyroidism may occur. Systemic absorption of iodine after repeated applications of the product on extensive wounds or severe burns can produce a range of symptoms such as: metallic taste, increased salivation, burning or stinging in the mouth and throat, irritation or swelling of the eyes, fever, rash skin, diarrhea and gastrointestinal disorders, hypotension, tachycardia, metabolic acidosis, hypernatremia, renal insufficiency, pulmonary edema and shock.In case of accidental ingestion of large quantities of product, institute symptomatic and supportive treatment with particular attention to the electrolyte balance and to renal and thyroid function.

Active principles

Betadine 10% Cutaneous solution, alcoholic:100 ml contain: Active ingredient: Iodopovidone (10% iodine) g 10.Betadine 1% Mouthwash: 100 ml contain: Active ingredient: Iodopovidone (10% iodine) g 1.0. Excipient with known effect: ethanolBetadine 10% Gel:100 g of gel or gel contain: Active ingredient: Iodopovidone (10% iodine) g 10.Betadine 10% Impregnated gauze1 gauze tablet of 1 dm² of 3 g contains: Active ingredient: Iodopovidone (10% iodine) g 0.25. For the full list of excipients, see section 6.1.

Excipients

Betadine 10% Cutaneous solution, alcoholic:Isopropyl alcohol, Citric acid, Dibasic sodium phosphate, Purified water.Betadine 10% Gel:Polyethylene glycol 400, Polyethylene glycol 4000, Polyethylene glycol 6000, Purified water.Betadine 1% Mouthwash:Ethanol, Glycerol, Eucalyptol, Menthol, Sodium saccharin, Citric acid monohydrate, Dibasic sodium phosphate dihydrate, Potassium iodate Purified water.Betadine 10% Impregnated gauzes:Polyethylene glycol 400, Polyethylene glycol 4000, Polyethylene glycol 6000, Purified water.