Betadine 10% 100g gel

Betadine 10% 100 g gel is an antibacterial gel based on povidone-iodine , specifically formulated for skin disinfection and treatment of superficial wounds , small bedsores and other skin lesions involving only the epidermis. Thanks to its broad-spectrum antiseptic action, Betadine 10% gel is effective in preventing infections and reducing the bacterial load on damaged skin, offering reliable protection against the main pathogens responsible for skin infections.

The dermatological gel formulation allows for easy application directly to the affected area, promoting uniform distribution and prolonged action. Betadine 10% gel is indicated for topical use and is an ideal solution for the daily management of small wounds , abrasions, cuts, grazes and for the treatment of sores in the initial phase. The presence of povidone-iodine guarantees rapid and persistent action, helping to keep the skin protected and promote an environment favorable to healing.

Betadine 10% 100 g gel is a reference disinfectant in pharmacies, chosen by professionals and families for its proven effectiveness in disinfecting damaged skin and preventing skin infections . Its composition is designed to offer maximum safety and tolerability, making it suitable for repeated treatments on sensitive skin areas or those at risk of infection.

ACTIVE INGREDIENTS

Active ingredients contained in Betadine 10 % 100 g gel - What is the active ingredient in Betadine 10 % 100 g gel?

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

EXCIPIENTS

Composition of Betadine 10 % 100 g gel - What does Betadine 10 % 100 g gel contain?

Betadine 10% Cutaneous solution, alcoholic: Isopropyl alcohol, Citric acid, Disodium 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, Disodium phosphate dihydrate, Potassium iodate, Purified water. Betadine 10% Impregnated gauze: Polyethylene glycol 400, Polyethylene glycol 4000, Polyethylene glycol 6000, Purified water.

DIRECTIONS

Therapeutic indications Betadine 10 % 100 g gel - Why is Betadine 10 % 100 g gel used? What is it used for?

Betadine 10% Alcoholic cutaneous solution: Disinfection and cleansing of damaged skin (small superficial wounds, bedsores limited to the epidermis). The medicine can be used to disinfect the skin before surgery. Betadine 1% Mouthwash: Disinfection of the oral mucosa. Betadine 10% Gel: Disinfection of damaged skin (small superficial wounds, bedsores limited to the epidermis). Betadine 10% Impregnated gauze: Disinfection of damaged skin (small superficial wounds, bedsores limited to the epidermis).

CONTRAINDICATIONS AND SIDE EFFECTS

Contraindications Betadine 10 % 100 g gel - When should Betadine 10 % 100 g gel not be used?

• Hypersensitivity to the active substance or to any of the excipients listed in paragraph 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.

DOSAGE

Quantity and method of taking Betadine 10% 100 g gel - How to take Betadine 10% 100 g gel?

Betadine 10% Alcoholic Skin Solution: Apply undiluted Betadine alcohol solution once or twice over the entire area of ​​skin to be disinfected. Spread the product with sterile gauze. Allow to dry completely. Betadine 1% Mouthwash: Dilute to taste, only when necessary, keeping in mind that effectiveness is maintained at a dilution of 1 part Betadine to 2 parts water, and gargle, 2-3 times a day. DO NOT EXCEED THE RECOMMENDED DOSES. Betadine 10% Gel: Apply a light layer of gel 2 times a day as needed directly to the affected area (small). DO NOT EXCEED THE RECOMMENDED DOSES. Betadine 10% Impregnated Gauze: Apply 1 gauze, 1-3 times a day. DO NOT EXCEED THE RECOMMENDED DOSES.

CONSERVATION

Storage Betadine 10% 100g gel - How to store Betadine 10% 100g gel?

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

WARNINGS

Warnings Betadine 10 % 100 g gel - About Betadine 10 % 100 g gel it is important to know that:

For external use only. The product should not be applied to severely damaged skin or to large surfaces. Do not use for prolonged treatments: use, especially if prolonged, may give rise to sensitization phenomena. In this case, 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 diseases are at risk of developing thyroid hyperfunction (hyperthyroidism) following the administration of large amounts of iodine. In this patient population, the povidone-iodine solution should not be used for a prolonged period of time or on large body surfaces. Even after the end of treatment, early symptoms of possible hyperthyroidism should be sought and thyroid function should be monitored. Do not use at least 10 days before or after a radioiodine scintigraphy or in the treatment of thyroid carcinoma with radioiodine. The pediatric population is at greater risk of developing hypothyroidism, following the application 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 reduced to the minimum necessary in children. Monitoring of the child's thyroid function (for example, T4 and TSH levels) may be necessary. 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. Accidental ingestion or inhalation of some disinfectants can have serious, sometimes fatal, consequences. Avoid contact with eyes. Betadine 10% cutaneous solution, alcoholic: The alcoholic solution is highly flammable: it must dry completely before any device is applied (in particular high-frequency surgical devices). In pre-operative preparation, avoid accumulation under the patient as chemical burns to the skin may occur. Prolonged exposure to moist conditions related to the solution may cause irritation or, rarely, severe skin reactions. If skin irritation, contact dermatitis or hypersensitivity occurs, discontinue use. Do not heat prior to application. Betadine 1% mouthwash: Care should be taken in oropharyngeal use to avoid inhalation of Betadine 1% mouthwash through the respiratory tract as this may cause complications such as pneumonia. This may occur particularly in intubated patients. Long-term use of povidone-iodine gargles should be avoided in pregnant women, breast-feeding mothers and in persons 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 ingredients Betadine 1% Mouthwash contains less than 1 mmol sodium (23 mg) per 20 ml of mouthwash, that is to say essentially 'sodium-free'. Betadine 1% Mouthwash contains 681.88 mg of alcohol (ethanol) in 20 ml of mouthwash. The amount in 20 ml of this medicine is equivalent to less than 18 ml of beer or 8 ml of wine. The small amount of alcohol in this medicine will not produce any noticeable effects.

INTERACTIONS

Interactions Betadine 10 % 100 g gel - Which medicines or foods can modify the effect of Betadine 10 % 100 g gel?

Avoid the 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, which may reduce its effectiveness. The concomitant use of preparations with enzymatic components for the treatment of wounds weakens the effects of both substances. Povidone-iodine should not be used simultaneously with products containing mercury salts or benzonium compounds, carbonates, tannic acid, alkalis, hydrogen peroxide, taurolidine and silver. The use of products containing povidone-iodine in conjunction with other antiseptics containing octedine in the same or adjacent sites may cause temporary darkening of the affected areas. The oxidative effect of povidone-iodine preparations may cause false positive results in some laboratory diagnostic tests (e.g. toluidine or guaiac gum tests for haemoglobin or glucose in stool or urine). Avoid routine use in patients receiving concomitant lithium treatment. The absorption of iodine from povidone-iodine solution may reduce thyroid iodine uptake. This may interfere with various tests (thyroid scintigraphy, determination of iodine-binding proteins, radioiodine diagnostics) and may make planned iodine treatment of the thyroid impossible (radioiodine therapy). After the end of treatment, an adequate period of time must elapse before a new scintigraphy is performed.

SIDE EFFECTS

Like all medicines, Betadine 10 % 100 g gel can cause side effects - What are the side effects of Betadine 10 % 100 g gel?

Undesirable effects are classified according to their frequency: Very common (≥ 1/10) Common (> 1/100 to < 1/10) Uncommon (≥ 1/1,000 to < 1/100) Rare (≥ 1/10,000 to < 1/1,000) Very rare (< 1/10,000) Not known (frequency cannot be estimated from the available data) Immune system disorders Rare Hypersensitivity Very rare Anaphylactic reaction Endocrine disorders Very rare Hyperthyroidism * (sometimes with symptoms such as tachycardia or agitation) Not known Hypothyroidism *** Metabolism and nutrition disorders Not known Electrolyte imbalance **, Metabolic acidosis ** Respiratory, thoracic and mediastinal disorders Not known Pneumonia ***** (only in case of use of Betadine 1% mouthwash) Skin and subcutaneous tissue disorders Rare Contact dermatitis (with symptoms such as erythema, microvesicles and itching) Very rare Angioedema Not known Exfoliative dermatitis, Dry skin ^^ (only in case of use of Betadine 10% cutaneous solution, alcoholic) Renal and urinary disorders Not known Acute renal failure **, Abnormal blood osmolarity ** Injury, poisoning and procedural complications Not known Chemical skin burn ****, Thermal burn ^ (only in case of use of 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, for example after long-term use of povidone-iodine solution for the treatment of wounds and burns on large areas of skin. **May occur following uptake of high amounts of povidone-iodine (e.g. in the treatment of burns) ***Hypothyroidism following prolonged or extensive use of povidone-iodine **** Following “accumulation” behind the patient during pre-operative preparation *****Complications due to inhalation - see section 4.4 ^Due to the high flammability, the alcoholic povidone-iodine solution must dry completely before devices (particularly high frequency 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. the scrotum) Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at: www.aifa.gov.it/content/segnalazioni-reazioni-avverse

OVERDOSE

Overdose Betadine 10 % 100 g gel - What are the risks of Betadine 10 % 100 g gel in case of overdose?

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

PREGNANCY AND BREASTFEEDING

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Betadine 10% 100 g gel.

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

DRIVING AND USE OF MACHINERY

Taking Betadine 10% 100g gel before driving or using machines - Does Betadine 10% 100g gel affect driving or using machines?

Betadine does not alter the ability to drive vehicles or use machines.