Povidone iodine, BETAISODONA solution

Betaisodona solution. Active ingredient: povidone-iodine. Indications: For disinfection of intact external skin or antiseptic of mucous membranes, e.g., before operations, biopsies, injections, punctures, blood draws, and bladder catheterizations.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist!


PACKAGE LEAFLET: INFORMATION FOR THE USER

Betaisodona solution
Active ingredient: povidone-iodine

Read the entire package leaflet carefully because it contains important information for you. This medicine is also available without a prescription. However, to achieve the best possible treatment results, Betaisodona solution must be used as directed.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need further information or advice.
• If your symptoms worsen or do not improve after 2-5 days, you must definitely consult a doctor.
• If any of the side effects listed affect you seriously or if you notice side effects not listed in this leaflet, please inform your doctor or pharmacist.

This package leaflet contains:

1. WHAT IS BETAISODONA SOLUTION AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING BETAISODONA SOLUTION?
3. HOW SHOULD BETAISODONA SOLUTION BE USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD BETAISODONA SOLUTION BE STORED?
6. MORE INFORMATION.

Povidone iodine, BETAISODONA solution

1. WHAT IS BETAISODONA SOLUTION AND WHAT IS IT USED FOR?

Betaisodona Solution is a germicidal agent (antiseptic) for use on skin, mucous membranes, and wounds. Betaisodona Solution is used once for disinfecting intact external skin or antisepticizing mucous membranes, for example, before operations, biopsies, injections, punctures, blood draws, and bladder catheterizations. Betaisodona Solution is used repeatedly and for a limited period for antiseptic wound treatment (e.g., pressure ulcers, leg ulcers), in burns, infected and superinfected skin diseases, and for surgical hand disinfection.

2. WHAT SHOULD YOU CONSIDER BEFORE USING BETAISODONA SOLUTION?

Betaisodona Solution must not be used:

• in the case of hyperthyroidism or another existing (manifest) thyroid disease,
• in the very rare chronic skin inflammation Dermatitis herpetiformis Duhring,
• during and until completion of radiotherapy with iodine (radioiodine therapy) or if you are scheduled to undergo such treatment,
• if you are hypersensitive (allergic) to the active ingredient or any of the other ingredients of Betaisodona solution.

Special care is required when using Betaisodona solution:
If you suffer from thyroid disease or goiter, you should only use Betaisodona solution for a long time and over a large area (e.g. over 10% of the body surface and for longer than 14 days) on the express instructions of your doctor. Even after treatment has ended (up to 3 months), early symptoms of possible hyperthyroidism should be observed (see section 4. What side effects are possible?) and thyroid function should be monitored if necessary. When using Betaisodona solution for skin disinfection before surgery, avoid puddles under the patient, as prolonged skin contact with the undried solution can, in rare cases, trigger severe burn-like skin reactions. When using Betaisodona solution in the throat area, swallowing should be avoided, as otherwise breathing difficulties and even pneumonia may occur.

Elderly:
Since elderly people are more likely to suffer from thyroid dysfunction, the extended and extensive application of Betaisodona solution to elderly people (> 65 years) should only be carried out on the express instructions of a physician. Thyroid function should be monitored if necessary.

Newborns and infants:
In newborns and infants up to the age of 6 months, Betaisodona solution should only be used on the express instructions of a physician and only to a very limited extent. Monitoring of thyroid function is necessary. Ingestion of Betaisodona solution by the infant during breastfeeding must be avoided.

When using Betaisodona solution with other medications:
Please inform your doctor or pharmacist if you are taking/using or have recently taken/used any other medicines, including medicines obtained without a prescription. Povidone-iodine can react with protein and various other organic substances such as blood and pus components, which may impair its effectiveness. If Betaisodona solution is used at the same time as enzymatic wound treatment agents, the enzyme component is oxidized by the iodine, thereby weakening the effect of both medicines. A mutual weakening of the effects also occurs when Betaisodona solution is used at the same time as hydrogen peroxide, taurolidine, silver-containing disinfectants or silver-containing wound dressings (formation of silver iodide). Betaisodona solution must not be used at the same time as or shortly after mercury-containing disinfectants, as under certain circumstances the combination of iodine and mercury can form a substance that is harmful to the skin. Do not use Betaisodona solution at the same time as or immediately after applying disinfectants containing the active ingredient octenidine to the same or adjacent areas, as this may otherwise cause temporary dark discoloration. If you are being treated with lithium preparations, you should avoid prolonged and/or large-area application of Betaisodona solution, as absorbed iodine can promote the possible triggering of hypothyroidism caused by lithium. For information on the discoloration of materials, see section 3. How should Betaisodona solution be used?, penultimate paragraph.

Influence on diagnostic tests or radioiodine therapy:
Due to the oxidizing effect of the active ingredient povidone-iodine, various diagnostic tests may produce false-positive results during treatment with Betaisodona solution (including toluidine and guaiac resin for determining hemoglobin or glucose in stool or urine). Povidone-iodine can interfere with the thyroid's iodine uptake. This can lead to interference with diagnostic thyroid examinations (thyroid scintigraphy, PBI determination, radioiodine diagnostics) during treatment with Betaisodona solution and make planned radioiodine therapy impossible. A new scintigram should be performed at least 1-2 weeks after discontinuing treatment with Betaisodona solution.

When using Betaisodona solution with food and beverages:
Not applicable.

Pregnancy and breastfeeding:
Consult your doctor or pharmacist before using any medication. During pregnancy and breastfeeding, Betaisodona solution should only be used on the express instructions of a doctor and only to a very limited extent. In this case, monitoring of the child's thyroid function is necessary. Oral ingestion of Betaisodona solution by the infant through contact with the treated area of the nursing mother's body must be avoided.

Driving and operating machinery:
Betaisodona solution does not affect the ability to drive or operate machinery.

3. HOW SHOULD BETAISODONA SOLUTION BE USED?

Always use Betaisodona solution exactly as directed in this package leaflet. Please consult your doctor or pharmacist if you are unsure.

Dosage:
Unless otherwise prescribed by your doctor, Betaisodona solution is usually used in the following dilutions and with the following exposure times:

• For skin disinfection or mucous membrane antiseptics, e.g. before surgical procedures, biopsies, injections, punctures, blood sampling, bladder catheterizations, Betaisodona solution should be used undiluted.
• When disinfecting skin with few sebaceous glands, the contact time is at least 1 minute before injections, punctures, and blood draws, and at least 3 minutes before surgical procedures. When disinfecting skin with many sebaceous glands, the contact time is at least 10 minutes. The skin must be kept moist with the undiluted product throughout the contact time.
• For surgical hand disinfection, Betaisodona solution is rubbed undiluted into the hands, leaving them on for 5 minutes. The hands must be kept moist with the undiluted product throughout the entire application time.
• For antiseptic wound treatment, Betaisodona solution is applied undiluted to the areas to be treated.
• In the antiseptic surface therapy of burn wounds, Betaisodona solution is usually applied undiluted to the areas to be treated.
• Betaisodona solution can be diluted for antiseptic rinses, washes, and baths. The following dilutions are recommended as guidelines:
  • Irrigation as part of wound treatment (e.g. pressure ulcers, lower leg ulcers, burns) and prevention of inflammation before, during and after operations 1:2 to 1:20,
  • antiseptic washes 1:2 to 1:25,
  • Antiseptic partial baths approx. 1:25, antiseptic full baths approx. 1:100.

Quantities examples for creating the corresponding dilutions:

Method of application:
Betaisodona solution is intended for external use undiluted and in diluted form. Normal tap water is suitable for dilution. If approximate isotonicity is desired, physiological saline solution or Ringer's solution can be used. The dilutions must always be prepared fresh and used promptly. Betaisodona solution should be applied to the treated area until completely wetted. The antiseptic film that forms upon drying can be easily washed off with water. The brown color of Betaisodona solution is a property of the product and indicates its effectiveness. Increasing discoloration indicates a decrease in the product's effectiveness. Complete discoloration indicates that the product is no longer effective. If you notice significant discoloration of the solution, you should reapply Betaisodona solution. To prepare antiseptic full baths, first add water and then the required amount of Betaisodona solution to avoid discoloration of the bath due to the development of iodine-containing vapors. Since iodine can form as a yellow precipitate in the surrounding area, immediate cleaning of the bath is recommended. When disinfecting the skin before operations, avoid the formation of puddles under the patient due to possible skin irritation.

Duration of use:
Betaisodona solution can be applied once or several times a day. For repeated use, the frequency and duration of use depends on the specific application. Use should be continued as long as signs of inflammation persist. If your symptoms have not improved after several days of regular use (2 to 5 days), or if symptoms recur after treatment, please consult your doctor.

Note:
Betaisodona solution can generally be washed out of textiles and other materials with warm water and soap. In stubborn cases, ammonia (ammonia spirit) or fixing salt (sodium thiosulfate) can help. Both are available from pharmacies or drugstores.

If you have used more Betaisodona Solution than you should:
Please read section 4. Possible side effects.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Betaisodona Solution can cause side effects, although not everybody gets them.

Possible side effects:
Diseases of the immune system/skin diseases:
Rare: Hypersensitivity reactions of the skin, e.g. delayed-type contact allergic reactions, which can manifest themselves in the form of itching, redness, blisters, burning, etc. Skin irritation after skin disinfection before operations in cases where puddles have formed under the patient.
Very rare: Acute general allergic reactions, possibly with a drop in blood pressure and/or shortness of breath (anaphylactic reactions)%%% Acute swelling of the skin or mucous membranes (angioedema or Quincke's edema).

Endocrine disorders:
Significant iodine absorption can occur with long-term use of Betaisodona solution on extensive skin, wound, or burn areas.
Very rare: Overactive thyroid (iodine-induced hyperthyroidism), possibly with symptoms such as. B. Increased heart rate or inner restlessness in patients with thyroid disorders (see also section 2. What should you consider before using Betaisodona solution?).

Metabolism and nutritional disorders/disorders of the kidney and urinary tract:
Rare: After using large quantities of povidone-iodine-containing medicines (e.g. in the treatment of burns): electrolyte and serum osmolarity disorders, impaired kidney function, hyperacidity of the blood (metabolic acidosis).

Reporting of side effects:
If you notice any side effects, contact your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. Pharmacovigilance, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW SHOULD BETAISODONA SOLUTION BE STORED?

Keep out of the reach and sight of children. Do not use this medicine after the expiry date stated on the bottle label and carton after ###Use by###. The expiry date refers to the last day of that month. Storage conditions: Do not store above 25°C. Shelf life after opening or preparation: Once opened, you can use Betaisodona solution for up to 3 years. Do not use Betaisodona solution if you notice significant discoloration of the product.

6. FURTHER INFORMATION

What Betaisodona solution contains:
The active ingredient is povidone-iodine. 100 ml of Betaisodona solution contains 10 g of povidone-iodine with an available iodine content of 11%. The average molecular weight of povidone is approximately 40,000. The other ingredients are: glycerol, nonoxynol 9, disodium hydrogen phosphate, anhydrous citric acid (Ph. Eur.), sodium hydroxide, potassium iodate, and purified water.

What Betaisodona solution looks like and what it contains:
The reddish-brown Betaisodona solution is available in 30 ml, 100 ml, 500 ml, and 1000 ml (Euro bottle) bottles.

Pharmaceutical Entrepreneur:
Mundipharma GmbH
De-Saint-Exupery-Straße 10
60549 Frankfurt am Main


Manufacturer:
Fidelio Healthcare Limburg GmbH
Mundipharmastraße 2
65549 Limburg

This package leaflet was last revised in September 2024.

Source: Information from the package leaflet
as of: 10/2024

Active ingredient: Povidone-Iodine

Areas of application: for disinfection of intact outer skin or antiseptic of the mucous membrane, e.g. before operations, biopsies, injections, punctures, blood sampling and bladder catheterization.

Povidone iodine, BETAISODONA solution