Composition:

Each vaginal ovule contains:

Povidone Iodine 250 mg

Properties:

Povidone iodine is antiseptic with broad spectrum bactericidal and fungicidal.

Indications:

Local treatment of vaginal infections with sensitive germs, including (Candidate vaginitis, trichomonas vaginitis, non-specific and mixed infection, pre-operative treatment of obstetrics and gynecology, local cleaning).

Contraindications:

Povidone Iodine should not be used in the following situations:

• History of allergy to any of the constituents, especially povidone iodine.
• During the 2nd and 3rd trimester of pregnancy, with prolonged use.
• During breastfeeding with prolonged use.
• Povidone Iodine is generally not recommended in combination with spermicidal products as well as mercury-derived antiseptics.

Warnings:

• Avoid prolonged or repeated use. Due to transmucosal resorption of iodine, prolonged use of Povidone Iodine may expose to systemic effects.
• Do not use a first aid antiseptic longer than one week.
• Do not use over large areas of the body.
• In the event of a genital infection, your partner may be contaminated even though he does not show any symptoms. If not treated together, recontamination is possible.

Side effects:

With repeated and prolonged administrations, iodine overload may occur that can lead to thyroid dysfunction. In addition, there may be irritation of the mucous membranes. Exceptionally hypersensitivity reactions, including: urticaria, angioedema, anaphylactic shock.

Drug Interactions:

• Spermicides: Any local vaginal treatment may inactivate local spermicidal contraception.
• Mercurial antiseptics: The concomitant use of iodinated and mercurial antiseptics lead to the occurrence of: erythema, phlyctens, even mucocutaneous necrosis.

Pregnancy & Lactation:

• Animal studies have not shown a teratogenic effect. In the clinic, there are currently no sufficiently relevant data to assess a possible malformities effect of povidone iodine when administered in the first trimester of pregnancy.
• Iodine overload, very likely with prolongeduse of Povidone Iodine, can lead to fetal, biological or even clinical hypothyroidism (goiter). Accordingly, prolonged use of Povidone Iodine is contraindicated from the 2nd trimester.
• Iodine passes into milk at higher concentrations than maternal plasma. Due to the risk of hypothyroidism in infants, breastfeeding is contraindicated with prolongedtreatment with Povidone Iodine.

Dosage & Administration:

Adult Women: One ovule in the vaginal depth every night for 8 to 16 days.

Overdose:

In case of overdose thyroid dysfunction can be observed. Treatment will be symptomatic.

Storage Store at temperature below 25^°c.

How supplied: 6 vaginal ovules packed in a carton package.

8 vaginal ovules packed in a carton package.