BETADINE SOLUZ VAG 125ML 10%

BETADINE 10% VAGINAL DEAL

active ingredients

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

Excellent

Dodecilglucoside, macrogol lauriletere, perfume for intimate hygiene, purified water.

Therapeutic indications

Vaginal mucosa disinfectant.

Contraindications

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

Population

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

Conservation

Keep away from heat.

Warnings

Only for external use. Particular caution should be used in patients with pre-existing renal failure that need regular Betadine applications on loose skin. The use of the product, especially if prolonged, can give rise to awareness phenomena. In this case, stop the treatment and take appropriate therapeutic measures. Patients with goiter, thyroid nodules or other acute and non-acute thyroid pathologies are at risk of developing thyroid hyperfunction (hyperthyroidism) as a result of administration of large amounts of iodine. In this population of patients, the solution of iodopovidone should not be used for a prolonged period of time if not strictly indicated. Even after the end of the treatment, we need to look for the early symptoms of possible hyperthyroidism and, if necessary, we need to monitor the thyroid function. Do not use at least 10 days before making a scintigraphy or after scintigraphy with radioactive iodine or in treatment with radioactive iodine of thyroid carcinoma. The pediatric population is more likely to develop hypothyroidism as a result of high doses of iodine. Due to the permeability of the skin and their high sensitivity to iodine, the use of ioodopovidone must be reduced to the minimum indispensable in children. A control of the thyroid function of the child may be necessary (e.g. levels of T4 and TSH). Any oral ingestion of hypopovidone by the child must be avoided. In pediatric age use only under strict control and in cases of actual need. Ingestion or accidental inhalation of some disinfectants may have serious, sometimes fatal consequences. Avoid contact with eyes.

Interactions

Avoid the contemporary use of other antiseptics and detergents. The polyvinylpyrrolidone-idine 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 of its effectiveness. The concomitant use of preparations with enzyme components for the treatment of wounds causes a weakening of the effects of both substances. Hyodopovidone should not be used at the same time as mercury salts or benzoin compounds, carbonates, tannic acid, alkali, hydrogen peroxide, taurolidine and silver. The use of products containing iodopovidone in conjunction with other antiseptics containing octedine in the same locations or in adjacent locations can cause a momentary dark coloring of the affected areas. The oxidative effect of the preparations based on hypopovidone can cause false positive results of some laboratory diagnostic tests (e.g. tests with toluidine or gum of sheath for the determination of hemoglobin or glucose in feces or urine). Avoid regular use in patients in contemporary treatment with lithium. The absorption of iodine from the solution of iodopovidone can reduce thyroid captation of iodine. This can interfere with different examinations (thyroid science, iodine binding protein determination, diagnostic with radioactive iodine) and can make a planned treatment of thyroid with iodine impossible (radioactive iodine therapy). After the end of the treatment, before performing a new scintigraphy it is necessary to spend an appropriate period of time.

Effects

Undesirable effects are classified according to their frequency: Very common (≥ 1/10) Common (> 1/100 a Rare immune system disorders: Very rare hypersensitivity: Anaphylactic reaction Endocrine diseases Very rare: Hyperthyroidism* (sometimes with symptoms such as tachycardia or agitation) Notable: Hypothyroidism [Bleep] Disorders of metabolism and nutrition Notable: Electrolytic imbalance **, metabolic acidosis ** Pathologies of skin and subcutaneous tissue Raro: Contact dermatitis (with symptoms such as erythema, microvescicles and itching) Very rare: Angioedema Kidney and urinary pathologies Notable: Acute renal insufficiency **, Abnormal blood Osmolarity ** ** In patients with history of thyroid pathologies (see paragraph Warnings and special precautions of use) following high iodine caption, for example after long-term use of hypopovidone solution for the treatment of wounds and burns on extended skin areas. **It may occur as a result of the high amount of iodopovidone (e.g. in the treatment of burns) ***Ipothyroidism as a result of prolonged or extended use of hypopovidone Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sosp ect-reaction-adversa.

Overdosing

In case of overdose, intentional or accidental, hypothyroidism or hyperthyroidism can be manifested. Systemic absorption of iodine after repeated applications of the product on extended wounds or severe burns can produce a number of symptoms such as: metallic flavor, increased salivation, burning or pungent pain in the mouth and throat, irritation or swelling in the eyes, fever, skin rash, diarrhea and gastrointestinal disorders, hypotension, tachycardia, metabolic acidosis, hypernatriemia, kidney function failure, pulmonary edema and shock. In case of accidental ingestion of high quantities of product establish a symptomatic and support treatment with particular attention to the electrolytic balance and renal and thyroid function.

During pregnancy and breastfeeding, the solution of iodopovidone should only be used if strictly necessary and at the minimum possible dose, due to the ability of iodine to cross the placenta and to be secreted in breast milk and for the high sensitivity of the fetus and the newborn to iodine. Iodine also concentrates more in breast milk than whey, therefore it can cause transient hypothyroidism with increase of TSH (the thyroid stimulating hormone) in the fetus or in the newborn.

Source: Farmadati