Braunol mucous membrane antiseptic
7.5% solution for use on the skin Povidone-iodine

Areas of Povidone iodine, BRAUNOL mucous membrane antiseptic application:

Braunol® is an antiseptic (germicidal agent) for use on skin, mucous membranes and wounds.

For single use Povidone iodine, BRAUNOL mucous membrane antiseptic:

Disinfection of the intact external skin or antiseptic of the mucous membrane such as: B. before operations, biopsies, injections, punctures, blood samples and bladder catheterizations.

For repeated, time-limited use:
Antiseptic wound treatment (e.g. pressure ulcers, leg ulcers), burns, infected and superinfected skin diseases.
Hygienic and surgical hand disinfection.

Povidone iodine, BRAUNOL mucous membrane antiseptic

Active ingredients

75 mg povidone iodine

ingredients

2 mg sodium iodate
Sodium hydroxide for pH adjustment
Water, purified
Sodium dihydrogen phosphate-2-water
Macrogol-9-lauryl ether

Indication :

The medicine is an antiseptic (germicidal agent) for use on skin, mucous membranes and wounds.
For one-time use:
- Disinfection of the intact external skin or antiseptic of the mucous membrane such as: B. before operations, biopsies, injections, punctures, blood samples and bladder catheterizations.
For repeated, time-limited use:
- Antiseptic wound treatment (e.g. pressure ulcers, leg ulcers), burns, infected and superinfected skin diseases.
Hygienic and surgical hand disinfection.

Dosage :

Always use the product exactly as directed. Please ask your doctor or pharmacist if you are not sure.
For skin disinfection or antiseptic of the mucous membrane, e.g. B. before surgical procedures, biopsies, injections, punctures, blood samples, bladder catheterizations, the preparation should be used undiluted.
For skin disinfection of skin with few sebum glands, the exposure time is at least 15 seconds, for skin rich in sebaceous glands it is at least 10 minutes. The skin should be kept moist with the undiluted preparation throughout the entire exposure time.
During preoperative skin disinfection, “puddle formation” under the patient must be avoided due to possible skin irritation.
The medicine should be used undiluted for hand disinfection.
For hygienic hand disinfection, 3 ml is rubbed into the hands. Wash hands after exposure for 1 minute.
For surgical hand disinfection, 2 x 5 ml are rubbed into the hands for an exposure time of 5 minutes. Hands must be kept moist with the undiluted preparation throughout the entire exposure time.
For the antiseptic treatment of superficial wounds, the medicine is applied undiluted to the areas to be treated.
The solution can be diluted for antiseptic rinses, washes and baths.
- The following dilutions are recommended as guidelines:
  - Rinsing as part of wound treatment (e.g. decubitus, leg ulcer, gangrene) and perioperative infection prophylaxis 1:2 to 1:20
  - Antiseptic washes 1:2 to 1:25
  - Antiseptic partial baths approx. 1:25
  - Antiseptic full baths approx. 1:100

Frequency and duration of use
- If used repeatedly, the frequency and duration of use depends on the indication.
- The medicine can be used once or several times a day.
- Wound treatment should be continued as long as there are still signs of infection or a clear risk of infection in the wound conditions. If your symptoms have not improved after regular use for several days (2 to 5 days), or if symptoms recur after treatment has been completed, please consult your doctor.

If you have any further questions about using the medicine, ask your doctor or pharmacist.

Way :

The medicine is intended for external use undiluted and in dilutions.
The medicine should be applied to the area to be treated until it is completely wetted. The antiseptic film that forms when it dries can be easily washed off with water.
Normal tap water is suitable for dilution. If approximate isotonicity is desired, physiological saline or Ringer's solution can be used. The dilutions should always be made fresh and used as soon as possible.
To prepare antiseptic baths, water should first be poured into the tub and then the required amount of medication to avoid discoloration of the tub due to the development of fumes containing iodine.
The brown color of the drug is a property of the preparation and indicates its effectiveness. Extensive discoloration indicates that the effectiveness of the preparation has been exhausted.

Side effects :

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Significant side effects or signs to look out for and actions to take if affected:
Very rarely (in less than 1 in 10,000 people treated) the following occur:
- Skin hypersensitivity reactions, e.g. B. contact allergic reactions of the late type, which can manifest themselves in the form of itching, redness, blisters, etc.
- Acute reactions of the immune system (anaphylactic reactions) involving other organs (e.g. skin, respiratory tract, circulatory system).
If you experience any of these side effects, stop using the product and contact your doctor as soon as possible.
Other possible side effects
- Uncommon (affects less than 1 in 100 people): Local burning sensation at the start of treatment
- Significant iodine absorption can occur with long-term use of Braunol on extensive wound and burn areas. Very rarely, patients with a history of thyroid disease may have an overactive thyroid (iodine-induced hyperthyroidism), sometimes with symptoms such as: B. pulse acceleration or inner restlessness, develop (see under contraindications).
- After the use of large amounts of medicines containing povidone-iodine (e.g. in the treatment of burns), the occurrence of (additional) electrolyte and serum osmolarity disorders, impairment of kidney function and hyperacidification of the blood (metabolic acidosis) has been described .
- In very rare cases, patients with severe corneal defects developed clouding of the cornea due to the formation of calcium phosphates during treatment with eye drops containing phosphates.
Please inform your doctor or pharmacist if any of the side effects listed seriously affects you or if you notice side effects that are not listed.

Interactions :

Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even if they are non-prescription medicines.
Povidone-iodine, the active ingredient of the drug, is expected to interact with protein and various other organic substances, such as: B. blood and pus components, reacts, which can impair its effectiveness.
When the drug and enzymatic wound treatment agents are used at the same time, the enzyme component is oxidized by the iodine, thereby weakening the effect of both drugs.
A mutual weakening of the effect also occurs when the drug is used simultaneously with silver-containing disinfectants, hydrogen peroxide or taurolidine.
The medicine must not be used simultaneously or shortly afterwards with wound treatment or disinfectants containing mercury, as iodine and mercury may form a substance that damages the skin.
Patients who are being treated with lithium preparations should avoid regular use of the drug, especially over large areas, as ingested iodine can promote the triggering of hypothyroidism, which may be caused by lithium.

Contraindications :

The medicine must not be used
- if you are sensitive (allergic) to povidone-iodine or any of the other ingredients.
- if you suffer from an overactive thyroid (hyperthyroidism) or another existing (manifest) thyroid disease,
- if you suffer from the very rare chronic skin inflammation dermatitis herpetiformis Duhring,
- if you have had radiotherapy of the thyroid gland with iodine (radioiodine therapy) planned or carried out (until treatment is completed).
- for very small premature babies (birth weight less than 1500 g)

Pregnancy and breastfeeding :

pregnancy
- During pregnancy and breastfeeding, the medicine should only be used on the express instructions of the doctor and in an extremely limited manner. In this case, a check of the child's thyroid function is necessary.
lactation
- Accidental ingestion of the drug by the infant with its mouth on the breast of the nursing mother must be avoided at all costs.

Patient information :

Particular caution when using the drug is required:
- After thyroid disease or in the case of goiter, you should only use it over a longer period of time and over large areas (e.g. over 10% of the body surface and longer than 14 days) if the doctor has expressly instructed you. Even after therapy has ended (up to 3 months), attention should be paid to early symptoms of possible hyperthyroidism and thyroid function should be monitored if necessary.
- If lithium therapy is used at the same time, regular use of the drug should be avoided
- Because of the oxidizing effect of the active ingredient povidone-iodine, various diagnostic tests can produce false positive results during treatment with the drug (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 in diagnostic examinations of the thyroid (thyroid scintigraphy, PBI determination, radioiodine diagnostics) during treatment with the drug and make planned radioiodine therapy impossible. Before a new scintigram is taken, an interval of at least 1 - 2 weeks should be maintained after discontinuation of treatment with the drug
- Children:
  - Avoid repeated use in newborns. After using the preparation, a check of thyroid function is necessary.
  - Accidental ingestion by the infant through the mouth must be avoided at all costs.
- Older people:
  - The risk of hyperthyroidism caused by iodine is increased in older people. You should therefore only use the medicine after consulting your doctor. In older patients with goiter or a particular predisposition to thyroid dysfunction, large-scale and long-term use of the drug should only be carried out on the express instructions of the doctor. If necessary, thyroid function should be monitored.

Povidone iodine, BRAUNOL mucous membrane antiseptic