BETAISODONA

BETAISODONA solution

Important notes (mandatory information)

Betaisodona solution. Active ingredient: Povidone-iodine. Areas of application: for disinfecting intact external skin or antisepsis of mucous membranes, e.g. before operations, biopsies, injections, punctures, blood draws and bladder catheterizations.

For risks and side effects, read the package insert and consult your doctor or pharmacist!


INSTRUCTIONS FOR USE: INFORMATION FOR THE USER

Betaisodona solution
Active ingredient: Povidone-iodine

Read the entire package insert carefully, as 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 insert. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If your symptoms worsen or do not improve after 2–5 days, you must consult a doctor.
• If any of the listed side effects affect you significantly or if you notice side effects that are not listed in this package insert, please inform your doctor or pharmacist.

This package insert 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. FURTHER INFORMATION.

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

Betaisodona solution is a germicide (antiseptic) for use on skin, mucous membranes and wounds. Betaisodona solution is used once for disinfecting intact external skin or antisepsis of mucous membranes, e.g. before operations, biopsies, injections, punctures, blood draws and bladder catheterizations. Betaisodona solution is used repeatedly, for a limited time, for antiseptic wound treatment (e.g. pressure sores, leg ulcers) for burns, infected and superinfected skin conditions and for surgical hand disinfection.

2. WHAT SHOULD YOU CONSIDER BEFORE USING BETAISODONA SOLUTION?

Betaisodona solution must not be used:

• in the case of an overactive thyroid (hyperthyroidism) or another existing (manifest) thyroid condition,
• in the very rare chronic skin condition dermatitis herpetiformis Duhring,
• during and until the completion of radiation therapy with iodine (radio-iodine therapy) or if such treatment is planned for you,
• if you are hypersensitive (allergic) to the active ingredient or any of the other ingredients of Betaisodona solution.

Special care should be taken when using Betaisodona solution

If you suffer from thyroid conditions or have a goiter, you should only use Betaisodona solution for a long period of time and over a large area (e.g. over 10% of the body surface and for more than 14 days) on the express instructions of a doctor. Thyroid function should also be monitored after the end of treatment (for up to 3 months). When using Betaisodona solution for skin disinfection before operations, avoid "pooling" 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, avoid swallowing, as this can otherwise lead to breathing difficulties or even pneumonia.

Elderly people

Since elderly people (> 65 years) more frequently suffer from thyroid dysfunction, Betaisodona solution should only be used over a large area and for a long period of time in elderly people on the express instructions of a doctor. Thyroid function may need to be monitored.

Newborns and infants

Betaisodona solution should only be used in newborns and infants up to the age of 6 months on the express instructions of a doctor and extremely sparingly. Thyroid function must be monitored. Betaisodona solution must not be ingested by the infant when breastfeeding.

When using Betaisodona solution with other medicines

Please inform your doctor or pharmacist if you are taking/using or have recently taken/used other medicines, even if they are non-prescription medicines. Povidone-iodine can react with protein and various other organic substances such as blood and pus components, which can impair its effectiveness. When Betaisodona solution is used at the same time as enzymatic wound treatment agents, the enzyme component is oxidized by the iodine and the effect of both medicines is thus weakened. A mutual weakening of the effect also occurs when Betaisodona solution is used at the same time as hydrogen peroxide, taurolidine and silver-containing disinfectants or silver-containing wound dressings (formation of silver iodide). Betaisodona solution must not be used at the same time or shortly after using mercury-containing disinfectants, as a substance that damages the skin can form under certain circumstances from iodine and mercury. Do not use Betaisodona solution at the same time or immediately after using disinfectants with the active ingredient octenidine on the same or adjacent areas, as this can otherwise lead to temporary dark discoloration. If you are being treated with lithium preparations, you should avoid using Betaisodona solution for a long period of time and/or over a large area, as ingested iodine can promote the development of hypothyroidism caused by lithium. For information on discoloration of materials, see section 3. How should Betaisodona solution be used?, penultimate paragraph.

Influence on diagnostic tests or radio-iodine therapy

Due to the oxidizing effect of the active ingredient povidone-iodine, various diagnostics can 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 influence the iodine uptake of the thyroid; this can lead to disruptions of diagnostic tests of the thyroid (thyroid scintigraphy, PBI determination, radio-iodine diagnostics) during treatment with Betaisodona solution and make planned radio-iodine therapy impossible. An interval of at least 1–2 weeks should be maintained between discontinuing treatment with Betaisodona solution and taking a new scintigram.

When using Betaisodona solution together with food and drink

Not applicable.

Pregnancy and breastfeeding

Ask your doctor or pharmacist for advice before using any medicine. Betaisodona solution should only be used during pregnancy and breastfeeding on the express instructions of a doctor and extremely sparingly. In this case, thyroid function must be monitored in the child. Betaisodona solution must not be ingested by the infant via the mouth through contact with the treated area of the body of the breastfeeding mother.

Driving and operating machinery

Betaisodona solution has no influence on the ability to drive and operate machinery.

3. HOW SHOULD BETAISODONA SOLUTION BE USED?

Always use Betaisodona solution exactly as described in this package insert. Please ask your doctor or pharmacist if you are not completely sure.

Dosage

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

• For skin disinfection or mucous membrane antisepsis, e.g. before surgical procedures, biopsies, injections, punctures, blood draws, bladder catheterizations, Betaisodona solution should be used undiluted.
• When disinfecting sebaceous glands-poor skin, the contact time before e.g. injections, punctures and blood draws is at least 1 minute, before surgical procedures at least 3 minutes. When disinfecting sebaceous glands-rich skin, the contact time is at least 10 minutes. The skin must be kept moist with the undiluted preparation during the entire contact time.
• For surgical hand disinfection, Betaisodona solution is rubbed into the hands undiluted, the contact time is 5 minutes. The hands must be kept moist with the undiluted preparation during the entire contact time.
• For antiseptic wound treatment, Betaisodona solution is applied undiluted to the areas to be treated.
• In antiseptic surface therapy of burn wounds, Betaisodona solution is usually applied undiluted to the areas to be treated.
• For antiseptic rinses, washes and baths, Betaisodona solution can be diluted. The following dilutions are recommended as guidelines:
  • rinses in the context of wound treatment (e.g. pressure sores, 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.

Examples of quantities for creating the corresponding dilutions

Dilution	Betaisodona solution quantity in ml	Water/saline or Ringer's solution quantity in ml
01:02	5	10
01:20	5	100
01:25	4	100
0,11111111	10	1000 (= 1 liter)

Type of application

Betaisodona solution is intended for external use, undiluted and in dilutions. Normal tap water is suitable for dilution. If approximate isotonicity is desired, physiological saline solution or Ringer's solution can be used. The dilutions should always be freshly prepared and used immediately. Betaisodona solution should be applied to the area to be treated until it is completely wet. The antiseptic film that forms when it dries can be easily washed off with water. The brown coloration of Betaisodona solution is a property of the preparation and indicates its effectiveness. Increasing discoloration indicates a decrease in the effectiveness of the preparation. If the solution becomes completely discolored, it is no longer effective. If you notice extensive discoloration of the solution, you should reapply Betaisodona solution. To prepare antiseptic full baths, water should first be added to the tub and then the required amount of Betaisodona solution, to avoid discoloration of the tub due to the development of iodine-containing vapors. Since iodine can be found as a yellow precipitate in the surroundings, immediate cleaning of the tub is recommended. When disinfecting the skin before operations, "pooling" under the patient should be avoided due to possible skin irritation.

Duration of use

Betaisodona solution can be used once or several times a day. When used repeatedly, the frequency and duration of use depend on the area of application. The application should be continued as long as there are still signs of inflammation. If your symptoms have not improved after several days (2 to 5 days) of regular use, or if symptoms recur after the end of 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 (sal ammoniac) or fixing salt (sodium thiosulfate) can help. Both are available in pharmacies or drugstores.

If you have used a larger amount of Betaisodona solution than you should

Please read section 4. What side effects are possible?

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Betaisodona solution can have side effects, although not everybody gets them.

The following frequency information is used to evaluate side effects:
Very common:	more than 1 in 10 treated persons
Common:	1 to 10 in 100 treated persons
Uncommon:	1 to 10 in 1,000 treated persons
Rare:	1 to 10 in 10,000 treated persons
Very rare:	less than 1 in 10,000 treated persons
Not known:	frequency cannot be estimated from the available data.

Possible side effects

Immune system disorders/skin disorders

Rare: Hypersensitivity reactions of the skin, e.g. contact allergic reactions of the late type, which can manifest as itching, redness, blisters, burning or similar. Skin irritation after skin disinfection before operations in cases where "pooling" has occurred under the patient.
Very rare: acute allergic general 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 uptake can occur with long-term use of Betaisodona solution on large areas of skin, wounds or burns.
Very rare: overactive thyroid (iodine-induced hyperthyroidism), possibly with symptoms such as increased pulse or restlessness in patients with thyroid conditions (see also section 2. What should you consider before using Betaisodona solution?).

Metabolic and nutritional disorders/kidney and urinary tract disorders

Rare: After using large amounts of povidone-iodine-containing medicines (e.g. in burn treatment): electrolyte and serum osmolarity disorders, impairment of kidney function, acidification of the blood (metabolic acidosis).

Reporting of side effects

If you notice side effects, contact your doctor or pharmacist. This also applies to side effects that are not listed in this package insert. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Department of Pharmacovigilance, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help to provide more information about the safety of this medicine.

5. HOW SHOULD BETAISODONA SOLUTION BE STORED?

Keep medicine out of the reach of children. Do not use the medicine after the expiry date stated on the bottle label and folding box after "Use by". The expiry date refers to the last day of the month. Storage conditions: Do not store above 25°C. Note on shelf life after opening or preparation: You can use Betaisodona solution for up to 3 years after first opening. You must not use Betaisodona solution if you notice extensive discoloration of the preparation.

6. FURTHER INFORMATION

What Betaisodona solution contains

The active ingredient is: Povidone-iodine. 100 ml Betaisodona solution contains 10 g povidone-iodine with a content of 11% available iodine. 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, purified water.

What Betaisodona solution looks like and contents of the pack

The reddish-brown Betaisodona solution is available in bottles of 30 ml, 100 ml, 500 ml and 1000 ml (Euro bottle).

Pharmaceutical entrepreneur

Mundipharma GmbH
De-Saint-Exupery-Straße 10
60549 Frankfurt am Main
Telephone: (0 69) 506029-000
Telefax: (0 69) 506029-201

Manufacturer

Fidelio Healthcare Limburg GmbH
Mundipharmastraße 2
65549 Limburg

This package insert was last revised in September 2018.

Source: Information from the package insert
Status: 10/2019
Active ingredient: Povidone-iodine Areas of application: for disinfecting intact external skin or antisepsis of mucous membranes, e.g. before operations, biopsies, injections, punctures, blood draws and bladder catheterizations.