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MEDA PHARMA SpA

BETADINE*SOLUZ CUT 125ML 10%

BETADINE*SOLUZ CUT 125ML 10%

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PRODUCT NET WEIGHT

125ml

EAN

023907076

MINSAN

023907076

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Disinfection and cleaning of damaged skin (wounds, sores, etc.).


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Therapeutic indications

Disinfection and cleaning of damaged skin (wounds, sores, etc.).

Dosage and method of use

Betadine 10% cutaneous solution : It is applied 2 times a day directly on small wounds and skin infections. A quantity of 5 ml of solution (containing 50 mg of iodine) is sufficient to treat an area of ​​about 15 cm on each side. For skin antisepsis: apply a protective layer of the brown solution until a medium intensity color is obtained: a non-staining surface film is formed. Betadine 5% cutaneous spray solution : Hold the spray 10 cm from the skin and press the valve with the bottle in an upright position by spraying a medium intensity brown protective layer 2 times a day and leave to dry: a protective film is formed at prolonged antimicrobial activity. A bandage can be used after the treatment. A quantity of 5 ml of solution (containing 50 mg of iodine) is sufficient to treat an area of ​​about 15 cm on each side. Warning, do not spray with the bottle tilted, avoid inhaling or breathing the sprayed liquid.

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Hyperthyroidism. Do not use in children less than six months of age.

Side effects

The undesirable effects are ranked 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 a < 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 ** Skin and subcutaneous tissue disorders Rare: Contact dermatitis (with symptoms such as erythema, microvesicles and pruritus ) Very rare: Angioedema Not known: Exfoliative dermatitis Renal and urinary disorders Not known: Acute renal failure ** Blood osmolarity abnormal ** *In patients with a history of thyroid disease (see section Warnings and special precautions for use) as a result of 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 following uptake of large amounts of povidone-iodine (e.g. in treatment of burns) ***Hypothyroidism following prolonged or extensive use of povidone-iodine Reporting of suspected adverse reactions Reporting suspected adverse reactions occurring after Authorization of the medicinal product is important, as it allows continuous 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: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.

Special warnings

Do not use for prolonged treatments. Particular caution should be used in patients with pre-existing renal insufficiency who require regular applications of Betadine on damaged skin. For external use only. Especially if prolonged use can give rise to sensitization phenomena. In this case, interrupt the treatment and adopt suitable therapeutic measures. Patients with goiter, thyroid nodules, or other acute and non-acute thyroid disease 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 a prolonged period of time and on large body surfaces unless strictly indicated. Even after the end of treatment, early symptoms of possible hyperthyroidism should be looked for and, if necessary, thyroid function should be monitored. Do not use at least 10 days before or after radioactive iodine scanning or in radioactive iodine treatment of thyroid cancer. The pediatric population has a higher 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. A check of your child's thyroid function (e.g. T4 and TSH levels) may be necessary. Any oral ingestion of povidone-iodine by the child should be avoided. In children, 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.

Pregnancy and breastfeeding

During pregnancy and lactation, the 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 be secreted in breast milk and due to the high sensitivity of the fetus and of the newborn to iodine. Furthermore, iodine is concentrated more in breast milk than in serum, therefore it can cause transient hypothyroidism with an increase in TSH (thyroid stimulating hormone) in the fetus or newborn

Expiration and conservation

Betadine 5% solution cutaneous spray : keep away from heat, tightly closed. Betadine 10% cutaneous solution : store at a temperature not exceeding 25°C

Interactions with other drugs

Avoid the simultaneous use of other antiseptics and cleansers. The polyvinylpyrrolidone-iodine complex is effective at pH values ​​between 2.0 and 7.0. It is possible that the complex reacts with proteins or other unsaturated organic compounds, and that this leads to a reduction in its effectiveness. 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 benzoin compounds, carbonates, tannic acid, alkalis, hydrogen peroxide, taurolidine and silver. Concomitant use of povidone-iodine products with other octedin-containing antiseptics in the same or adjacent sites may cause temporary darkening of the affected areas. The oxidative effect of povidone-iodine preparations can lead to false positive results of some laboratory diagnostic tests (eg tests with toluidine or guaiac gum for the determination of hemoglobin or glucose in faeces or urine). Avoid habitual use in patients receiving simultaneous treatment with lithium. Iodine absorption from povidone-iodine solution may reduce thyroid iodine uptake. This can interfere with various examinations (thyroid scan, determination of iodine-binding proteins, radioactive iodine diagnostics) and can make a planned treatment of the thyroid gland 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 the event of an intentional or accidental overdose, hypothyroidism or hyperthyroidism may occur. Systemic absorption of iodine after repeated applications of the product on large wounds or severe burns can produce a series of symptoms such as: metallic taste, increased salivation, burning or stinging in the mouth and throat, eye irritation or swelling, fever, rash skin, diarrhea and gastrointestinal disturbances, hypotension, tachycardia, metabolic acidosis, hypernatraemia, renal failure, pulmonary edema and shock. In the event of accidental ingestion of large quantities of the product, institute symptomatic and supportive treatment with particular attention to the electrolyte balance and renal and thyroid function.

Active principles

Betadine 10% cutaneous solution 100 ml contain: Active ingredient : Povidone-iodine (10% iodine) g 10 Betadine 5% cutaneous spray solution 100 ml contain: Active ingredient : Povidone-iodine (10% iodine) g 5 For the complete list of excipients, see section 6.1.

Excipients

Betadine 10% cutaneous solution: Glycerol, Macrogol lauryl ether, Dibasic sodium phosphate dihydrate, Citric acid monohydrate, Sodium hydroxide, Purified water. Betadine 5% cutaneous spray solution: Glycerin, Nonoxinol 9, Disodium phosphate dihydrate, Citric acid anhydrous, Purified water, Propellant: Nitrogen.

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