Betaisodona vaginal gel 50 g

Betaisodona Vaginal Gel is a gel for insertion into the vagina using an applicator or for application to the outer vaginal area. Povidone-iodine has a comprehensive germicidal effect. It is effective against bacteria, fungi, spores, viruses and protozoa (single-celled organisms).
Betaisodona vaginal gel enables the natural vaginal environment to be quickly restored. Burning and itching subside quickly.
There is no need to fear that infectious pathogens will become resistant to povidone-iodine due to its mode of action.
By binding to povidone, the iodine largely loses the irritating properties of alcoholic iodine preparations and is well tolerated on skin, mucous membranes and wounds.
The iodine decolorizes during the action process, so the depth of the brown color indicates its effectiveness. If discoloration occurs, additional dosage is required.
Povidone-iodine is water-soluble and easy to wash off.

field of use

• for acute and chronic infections of the vagina and external genital organs, e.g. E.g. mixed infections, uncomplicated bacterial infections, fungal infections - even after antibiotic or cortisone therapy, trichomonas infections (infections with animal protozoa) - a simultaneous systemic treatment may be prescribed by the doctor
• Pre- and post-treatment for vaginal operations and obstetric procedures

If your symptoms worsen or there is no improvement after 2-5 days, you need to see a doctor.

Contraindications

Betaisodona vaginal gel must NOT be used

• if you are allergic to povidone-iodine or any of the other ingredients of this medicine listed in section 6,
• if you suffer from an overactive thyroid (hyperthyroidism) or other thyroid diseases,
• if you suffer from the rare chronic skin inflammation dermatitis herpetiformis Duhring,
• when using preparations containing mercury at the same time,
• before, during and after radio-iodine scintigraphy or radiation therapy of the thyroid with iodine (radio-iodine therapy) until the end of the treatment.

Interactions

Using Betaisodona Vaginal Gel together with other medicines
Tell your doctor or pharmacist if you are taking/using other medicines, have recently taken/used other medicines or plan to take/use other medicines.

DO NOT use at the same time as Betaisodona vaginal gel

• Hydrogen peroxide, enzymatic or silver- and taurolidine-containing wound treatment agents or disinfectants, as this leads to a mutual weakening of the effect,
• Betaisodona vaginal gel and preparations containing mercury, as a corrosive compound (mercury iodide) can form,
• Betaisodona vaginal gel and wound treatment products containing octenidine, as it can temporarily cause dark discoloration, taurolidine, a chemotherapy drug against bacteria and fungi, as taurolidine can be converted into an acid (formic acid) that causes intense burning.

Protein, blood or pus components can impair the effectiveness of Betaisodona Vaginal Gel.

If you are receiving lithium therapy, Betaisodona Vaginal Gel should be used with caution and only for a short time. In this case, larger amounts of iodine can be absorbed.

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Use in pregnant women and during breastfeeding may only be carried out following the express instructions of the doctor and to an extremely limited extent; Monitoring thyroid function in the mother or infant is indicated. Treatment should only last for a short time.
Iodine enters the fetus (unborn child) via the placenta and also passes into breast milk.
Effects of treatment with Betaisodona Vaginal Gel on (female) fertility are not expected.

Application

Always use this medicine exactly as described in this leaflet or exactly as your doctor or pharmacist tells you. Check with your doctor or pharmacist if you are unsure.

Dosage and method of use
For vaginal use (use in the vagina).
The recommended dose is: Insert 1 applicator filling of vaginal gel deep into the vagina daily before going to bed (see illustration “Handling the applicator”).

• Screw the applicator onto the tube thread.
• Fill the applicator by pressing on the tube. (The stick is pushed back.)
• To insert the applicator, elevate one foot or assume another relaxed position.
• Gently insert the applicator as deep into the vagina as possible, without pressing on the stick.
• Using light pressure, press the stick as far as it will go – Betaisodona Vaginal Gel has been applied.
• Remove empty applicator from vagina.
• After use, rinse the vaginal applicator with hot water and dry with a disposable towel.

To avoid stains on underwear, a sanitary pad is recommended.
In addition, Betaisodona Vaginal Gel can be applied thinly 2 - 3 times a day to the outer vaginal area and 1 - 2 cm beyond, especially in the case of vulvitis (inflammation of the outer vagina).
The treatment must be carried out daily (including during your period). In stubborn cases, Betaisodona Vaginal Gel can be used twice daily.
During the treatment, the partner should also be treated with Betaisodona vaginal gel to avoid new infections.
For vaginal disinfection before operations, as well as for the treatment of vaginal inflammation, the gel is used in the evening and left in the vagina overnight. The next morning, before the operation, the vagina can be rinsed with Betaisodona solution.

Duration of application
Betaisodona Vaginal Gel should be used as long as there are still signs of inflammation (e.g. burning or itching). If your symptoms have not improved after regular use of Betaisodona Vaginal Gel for several days (2 to 5 days), or if symptoms reoccur after treatment has been completed, please consult your doctor. Treatment should not last longer than 5 to 10 days in total, but if necessary, your doctor may prescribe longer treatment.

Note
Povidone-iodine can be easily removed from textiles and other materials with warm water and soap, or in stubborn cases with ammonia (ammonia) or fixing salt (sodium thiosulfate solution).

Use in children and adolescents
Betaisodona Vaginal Gel should not be used before the first menstrual period.

Please talk to your doctor or pharmacist if you have the impression that the effect of Betaisodona vaginal gel is too strong or too weak.

Side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The following definitions for the frequencies of adverse drug reactions were used:
Very common: may affect
up to 1 in 10 people. Common: may affect up to 1 in 10 people. Uncommon: may affect up to 1 in 100 people. Rare: may affect up to 1
in 10 people
Affects 1,000 people
Very rare: may affect up to 1 in 10,000 people
Not known: frequency cannot be estimated based on the available data

Rare side effects
Hypersensitivity, hypersensitivity reactions of the skin, which can manifest themselves in the form of itching, redness, blisters or similar

Very rare side effects
Acute general allergic reactions (anaphylactic reaction) often accompanied by a drop in blood pressure, dizziness, nausea and possibly shortness of breath, hyperthyroidism in patients who are prone to this 1), allergic, painful swelling of the skin and mucous membranes (angioedema)

Side effects with unknown frequency
Hypothyroidism2), Electrolyte imbalance3), Metabolic acidification of the blood and body 3), Acute kidney failure 3), Number of dissolved substances in the blood too high or too small 3)

1. In patients with a history of thyroid dysfunction (see Section 2 Warnings and Precautions) after ingestion of a large amount of iodine, for example in the course of large-scale use of povidone-iodine in the treatment of wounds and burns over a longer period of time
2. Hypothyroidism after long-term or excessive use of povidone-iodine
3. May occur after ingestion of a large amount of povidone-iodine (e.g. treatment of burns).

composition

The active ingredient is: Povidone-iodine
100 g Betaisodona vaginal gel contains 10 g povidone-iodine complex, total content: 1% (corresponding to 1 g) available iodine.

The other ingredients are: macrogol (4000, 1500, 1000, 400), purified water, sodium bicarbonate.

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