Betadine 10% 125 ml vaginal solution

Betadine 10% 125 ml vaginal solution is a vaginal disinfectant based on povidone-iodine , specifically formulated for feminine intimate hygiene and protection of the vaginal mucosa . Thanks to its 10% concentration of povidone-iodine, this disinfectant solution offers an effective antiseptic action, ideal for the local treatment of vaginal infections , irritations and vaginal lesions . The product is also indicated for gynecological use in preparation for medical procedures or as a support for daily hygiene in case of need for additional protection against pathogens.

Betadine vaginal solution comes in a handy 125 ml bottle, easy to use for vaginal irrigation or direct applications, ensuring uniform distribution on the mucosa. The presence of purified water and a delicate perfume for intimate hygiene helps make the product well tolerated and suitable even for the most sensitive skin. Betadine 10% vaginal solution is particularly recommended for the prevention and treatment of vaginal infections and irritations , offering reliable protection and a lasting sensation of freshness and cleanliness.

Thanks to its broad-spectrum antiseptic action , Betadine 10% 125 ml vaginal solution is a valuable ally for intimate health, supporting the prevention of infections and promoting the well-being of the genital area. Its efficacy and safety make it one of the most used products in the gynecological field for the disinfection of the vaginal mucosa and preparation for gynecological procedures .

ACTIVE INGREDIENTS

Active ingredients contained in Betadine 10% 125 ml vaginal solution - What is the active ingredient of Betadine 10% 125 ml vaginal solution?

100 ml contain: Active ingredient: Iodopovidone (10% iodine) 10 g. For the full list of excipients, see section 6.1.

EXCIPIENTS

Composition of Betadine 10% 125 ml vaginal solution - What does Betadine 10% 125 ml vaginal solution contain?

Dodecyl glucoside, macrogol lauryl ether, intimate hygiene perfume, purified water.

DIRECTIONS

Therapeutic indications Betadine 10% 125 ml vaginal solution - Why is Betadine 10% 125 ml vaginal solution used? What is it used for?

Vaginal mucosa disinfectant.

CONTRAINDICATIONS AND SIDE EFFECTS

Contraindications Betadine 10% 125 ml vaginal solution - When should Betadine 10% 125 ml vaginal solution not be used?

• Hypersensitivity to the active substance or to any of the excipients listed in paragraph 6.1. • Hyperthyroidism

DOSAGE

Quantity and method of taking Betadine 10% 125 ml vaginal solution - How to take Betadine 10% 125 ml vaginal solution?

Irrigation: 2 tablespoons in 1/2 l of warm water, 1 or 2 times a day - Do not exceed the recommended doses. Brushing on the cervix and vagina: use the pure product. After a suitable period of time without appreciable results, consult your doctor.

CONSERVATION

Storage Betadine 10% 125 ml vaginal solution - How is Betadine 10% 125 ml vaginal solution stored?

Store away from heat.

WARNINGS

Warnings Betadine 10% 125 ml vaginal solution - About Betadine 10% 125 ml vaginal solution it is important to know that:

For external use only. Particular caution should be used in patients with pre-existing renal insufficiency who require regular applications of Betadine on damaged skin. Use of the product, especially if prolonged, may give rise to sensitization phenomena. In this case, discontinue treatment and adopt appropriate therapeutic measures. 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, povidone-iodine solution should not be used for a prolonged period of time unless strictly indicated. Even after the end of treatment, early symptoms of possible hyperthyroidism should be sought and, if necessary, thyroid function should be monitored. Do not use at least 10 days before or after a scintigraphy with radioactive iodine or in the treatment of thyroid carcinoma with radioactive iodine. 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. It may be necessary to monitor the child's thyroid function (e.g. 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. Accidental ingestion or inhalation of some disinfectants can have serious, sometimes fatal, consequences. Avoid contact with eyes.

INTERACTIONS

Interactions Betadine 10% 125 ml vaginal solution - Which medicines or foods can modify the effect of Betadine 10% 125 ml vaginal solution?

Avoid the simultaneous use of other antiseptics and detergents. 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 determines a reduction in its efficacy. The concomitant use of preparations with enzymatic components for the treatment of wounds determines 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. The use of products containing povidone-iodine in conjunction with other antiseptics containing octedine in the same or adjacent sites may cause a 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 the thyroid uptake of iodine. 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% 125 ml vaginal solution can cause side effects - What are the side effects of Betadine 10% 125 ml vaginal solution?

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 ** Skin and subcutaneous tissue disorders Rare: Contact dermatitis (with symptoms such as erythema, microvesicles and pruritus) Very rare: Angioedema Renal and urinary disorders Not known: Acute renal failure **, Abnormal blood osmolarity ** *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 (for example in the treatment of burns) ***Hypothyroidism following prolonged or extensive use of povidone-iodine 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: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sosp etta-reazione-avversa.

OVERDOSE

Overdose Betadine 10% 125ml vaginal solution - What are the risks of Betadine 10% 125ml vaginal solution in case of overdose?

In case of 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 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 disturbances, 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% 125 ml vaginal solution.

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% 125 ml vaginal solution before driving or using machines - Does Betadine 10% 125 ml vaginal solution affect driving or using machines?

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