Betaisodona Vaginal - Suppositories

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Betaisodona Vaginal Suppositories are suppositories for insertion into the vagina.

How is it used?

What are Betaisodona Vaginal Suppositories and what are they used for?

Betaisodona Vaginal Suppositories are suppositories for insertion into the vagina. They dissolve slowly after insertion and release the active ingredient. Povidone-iodine has a broad spectrum of germicidal effects. It is effective against bacteria, fungi, spores, viruses and protozoa (single-celled organisms).

Betaisodona Vaginal Suppositories enable a rapid restoration of the natural vaginal environment. Burning and itching subside quickly.
Resistance (resistance of infectious agents) to povidone-iodine is not to be feared due to its 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, 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, for example mixed infections, uncomplicated bacterial infections, fungal infections - also after antibiotic or cortisone therapy, trichomonad infections (infections with animal protozoa) - if necessary, a simultaneous systemic treatment will be prescribed by the doctor
- 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 Suppositories?

Betaisodona Vaginal Suppositories 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 preparations containing mercury,
• 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 Suppositories.

• 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 Suppositories.
• Influence on diagnostic examinations:
  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 oxidizing 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 by the doctor is necessary before therapy with Betaisodona Vaginal Suppositories, 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 Suppositories 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 Suppositories

• 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 Suppositories and preparations containing mercury, as a corrosive compound (mercury iodide) can form,
• Betaisodona Vaginal Suppositories 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 Suppositories.

If you are receiving lithium therapy, Betaisodona Vaginal Suppositories 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 Suppositories on (female) fertility are not to be expected.

Driving and using machines

Betaisodona Vaginal Suppositories have no influence on the ability to drive and use machines.

How should the medicine be taken?

How to use Betaisodona Vaginal Suppositories?

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)
Remove Betaisodona Vaginal Suppository from the wrapper, moisten well and insert deep into the vagina. It is recommended to wear a pad during treatment.
The recommended dose is: Insert 1 Betaisodona Vaginal Suppository deep into the vagina in the evening before going to bed.
Treatment should be carried out daily (also during menstruation).
In stubborn cases, Betaisodona Vaginal Suppositories can also be used twice a day.
To support this therapy, Betaisodona Vaginal Gel can be applied to the external genital area, especially in the case of inflammation of the external vagina (vulvitis).
During treatment, the partner should also be treated with Betaisodona Vaginal Gel to avoid new infections.
Do not use Betaisodona Vaginal Suppositories together with other agents in the vagina. Duration of use

The use of Betaisodona Vaginal Suppositories 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 Suppositories, or if symptoms recur after the end of treatment, please consult your doctor. Treatment should not last longer than 5 to 10 days, 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 Suppositories 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 Suppositories is too strong or too weak.

If you have used more Betaisodona Vaginal Suppositories 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 oedema, 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 Suppositories

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 to store Betaisodona Vaginal Suppositories?

Keep this medicine out of the reach of children.
Do not store above 25 °C.
Store in the original package to protect the contents from light.

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

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 Suppositories contain:

- The active substance is: Povidone-iodine

1 Betaisodona Vaginal Suppository contains 200 mg povidone-iodine complex,
Total content: 20 mg available iodine.

- The other ingredient is: Macrogol (1500 and 4000).

What Betaisodona Vaginal Suppositories look like and contents of the pack

Red-brown heart-shaped vaginal suppositories in packs of 7 and 14