Betaisodona Vaginal - Gel

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Betaisodona Vaginal Gel is a gel for insertion into the vagina (vagina) using an applicator or for application to the external vaginal area.

How is it used?

What is Betaisodona Vaginal Gel and what is it used for?

Betaisodona Vaginal Gel is a gel for insertion into the vagina (vagina) using an applicator or for application to the external 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 a rapid restoration of the natural vaginal environment. Burning and itching subside quickly.
Resistance of infectious agents (resistance) to povidone-iodine is not to be feared due to the mode of action.
Due to the binding to povidone, iodine largely loses the irritating properties of alcoholic iodine preparations and is well tolerated on skin, mucous membranes and wounds.
During the action process, the iodine discolours, so the depth of the brown colour indicates its effectiveness. If discoloured, a follow-up dose is required.
Povidone-iodine is water-soluble and easily washable.

Areas of application

• in acute and chronic infections of the vagina and external genitalia, e.g. mixed infections, uncomplicated bacterial infections, fungal infections - also after antibiotic or cortisone therapy, trichomonal infections (infections with animal protozoa) - a simultaneous systemic treatment is prescribed by the doctor if necessary
• Pre- and post-treatment for vaginal operations and obstetric procedures

If your symptoms worsen or do not improve after 2-5 days, you must see a doctor.

What should you consider before taking it?

What should you consider before using Betaisodona Vaginal Gel?

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 hyperthyroidism (overactive thyroid gland) or other thyroid diseases,
• if you suffer from the rare chronic skin inflammation Dermatitis herpetiformis Duhring,
• with simultaneous use of mercury-containing preparations,
• before, during and after radio-iodine scintigraphy or radiotherapy of the thyroid gland with iodine (radio-iodine therapy) until the end of treatment.

Warnings and precautions

Please talk to your doctor or pharmacist before using Betaisodona Vaginal Gel.

• In thyroid diseases (especially in elderly patients) or in the case of a goitre, povidone-iodine should only be used for a longer period of time after a strict benefit-risk assessment by the doctor, as subsequent hyperthyroidism cannot be completely ruled out. Even after discontinuation of therapy (up to 3 months), these patients should be monitored for early symptoms of hyperthyroidism and, if necessary, thyroid function should be monitored.
• There is a possibility that the tear resistance and safety of condoms or
  diaphragms are impaired during treatment with Betaisodona Vaginal Gel.
• Influence on diagnostic tests:
• Under the use of povidone-iodine, the iodine uptake of the thyroid gland can be reduced, this can lead to disturbances in various examinations of the thyroid gland and make planned treatment (radio-iodine therapy) impossible. An interval of 1 - 2 weeks after discontinuation of treatment with povidone-iodine should be observed.
• Due to the oxidising effect of povidone-iodine, various laboratory tests can give false-positive results (including toluidine and guaiac resin for the determination of haemoglobin or glucose in stool or urine).
• Due to the oxidative property of povidone-iodine, metals can become rusty, plastics are generally povidone-iodine-resistant. In individual cases, a mostly transient discolouration may occur.
• Due to the oxidative property of povidone-iodine, metals can become rusty, plastics are generally povidone-iodine-resistant. In individual cases, a mostly transient discolouration may occur.

Children and adolescents

• Use before the first menstrual period is not recommended. In children and adolescents before the first menstrual period, careful consideration of the benefits and risks of therapy with Betaisodona Vaginal Gel is required by the doctor, as there is not yet sufficient experience for a general recommendation of this dosage form for this age group.
• In newborns and infants up to the age of 6 months, povidone-iodine should only be used after a strict benefit/risk assessment by the doctor and only to a very limited extent. If necessary, thyroid function should be monitored.

Use of Betaisodona Vaginal Gel together with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any 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 mutual weakening of the effect,
• Betaisodona Vaginal Gel and mercury-containing preparations, as a corrosive compound (mercury iodide) can form,
• Betaisodona Vaginal Gel and octenidine-containing wound treatment agents, as temporary dark discolouration may occur,Taurolidine, a chemotherapeutic agent against bacteria and fungi, as taurolidine can be converted into an acid (formic acid) which 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 period of time. In this case, larger amounts of iodine can be absorbed.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, or if you suspect 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 breast-feeding may only be carried out on the express instructions of the doctor and to a very limited extent; monitoring of thyroid function in the mother or infant is indicated. Treatment should only be short-term.
Iodine passes through the placenta (placenta) into the foetus (unborn child) and also passes into breast milk.
Effects of treatment with Betaisodona Vaginal Gel on (female) fertility are not to be expected.

Driving and using machines

Betaisodona Vaginal Gel has no influence on the ability to drive and use machines.

How should the medicine be taken?

How to use Betaisodona Vaginal Gel?

Always use this medicine exactly as described in this leaflet or exactly as directed by your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.

Dosage and method of administration

For vaginal use (application in the vagina).
The recommended dose is: 1 applicator full of vaginal gel inserted deep into the vagina daily before bedtime (see figure "Handling the applicator").










1. Screw the applicator onto the tube thread.

2. Fill the applicator by pressing on the tube. (The
rod is pushed back.)
3. To insert the applicator, put one foot
up or take another relaxed position.
4. Gently insert the applicator as deep as possible into the vagina, do not press on the rod.
5. Press the rod gently until it stops - Betaisodona Vaginal Gel is applied.
6. Pull the empty applicator out of the vagina.
7. After use, rinse the vaginal applicator with hot
water and dry with a disposable tissue.



Figure Handling the applicator

To avoid stains on underwear, a pad is recommended.

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

Duration of use

The use of Betaisodona Vaginal Gel should be continued as long as there are still signs of inflammation (e.g. burning or itching). If your symptoms have not improved after several days (2 to 5 days) of regular use of Betaisodona Vaginal Gel, or if symptoms recur after the end of treatment, please consult your doctor. Treatment should not last longer than 5 to 10 days in total, but if necessary, your doctor may prescribe a longer course of treatment.

Note

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

If you have used more Betaisodona Vaginal Gel than you should,

please read section 4. What side effects are possible?

After accidental ingestion of very large amounts of povidone-iodine (oral intoxication, ingestion of more than 10 g povidone-iodine), the following symptoms may occur: abdominal pain and cramps, nausea, vomiting, diarrhoea, dehydration, drop in blood pressure, bleeding tendency, kidney damage, urinary retention, oxygen deficiency, circulatory collapse, nerve sensitivity disorder, laryngeal swelling, pulmonary oedema and fever.

For the doctor:
Information on the treatment of an overdose can be found at the end of the package leaflet.

If you forget to use Betaisodona Vaginal Gel

Do not use double the amount if you have forgotten the previous application.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

What side effects are possible?

How should Betaisodona Vaginal Gel be stored?

Do not store above 25 °C.

Keep this medicine out of the reach of children.

Do not use this medicine after the expiry date which is stated on the tube and carton after "use by:". The expiry date refers to the last day of the month indicated.

The medicine can be used until the stated expiry date even after the tube has been opened for the first time.

Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In this way, you help to protect the environment.

Special notes on the content

Contents of the pack and further information

What Betaisodona Vaginal Gel contains:

- The active substance is: Povidone-iodine
100 g Betaisodona Vaginal Gel contains 10 g povidone-iodine complex,
Total content: 1 % (equivalent to 1 g) available iodine.
- The other ingredients are: Macrogol (4000, 1500, 1000, 400), purified water, sodium hydrogen carbonate.

What Betaisodona Vaginal Gel looks like and contents of the pack

Red-brown, homogeneous vaginal gel, free of undissolved particles, tube of 50 g with applicator
The applicator is a tested medical device CE of Schägner GmbH, Industriestraße 3, D-76479 Steinmauern.