BETAISODONA

BETAISODONA Ointment

Important notes (mandatory information)

Betaisodona Ointment. Active ingredient: 100 mg/g povidone-iodine. Areas of application: is used repeatedly, for a limited period of time, for the antiseptic treatment of damaged skin (e.g. pressure sores, leg ulcers), superficial wounds, burns, infected and superinfected skin diseases.

For risks and side effects, read the package leaflet and consult your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Betaisodona Ointment
Active ingredient: 100 mg/g povidone-iodine

Read the entire package leaflet carefully before you start using this medicine, because it contains important information for you. Always use this medicine exactly as described in this package leaflet or exactly as your doctor or pharmacist has told you.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.
• If you do not feel better or if you feel worse after 2 - 5 days, contact your doctor.

What this package leaflet contains

1. WHAT IS BETAISODONA OINTMENT AND WHAT IS IT USED FOR?
2. WHAT YOU NEED TO KNOW BEFORE YOU USE BETAISODONA OINTMENT
3. HOW TO USE BETAISODONA OINTMENT
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE BETAISODONA OINTMENT
6. CONTENTS OF THE PACK AND OTHER INFORMATION

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

Betaisodona Ointment is a germicidal agent (antiseptic) for use on skin and wounds. Betaisodona Ointment is used repeatedly, for a limited period of time, for the antiseptic treatment of damaged skin (e.g. pressure sores, leg ulcers), superficial wounds, burns, infected and superinfected skin diseases.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE BETAISODONA OINTMENT

Betaisodona Ointment 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 have an overactive thyroid gland (hyperthyroidism) or another existing (manifest) thyroid disease.
• if you have the very rare chronic skin inflammation dermatitis herpetiformis Duhring.
• before, during and after the use of radioiodine as part of radiotherapy or a diagnostic examination (see section "Using Betaisodona Ointment with other medicines").
• if you are using mercury-containing preparations at the same time (see section "Using Betaisodona Ointment with other medicines").
• in newborns, infants and toddlers under one year of age.

Warnings and precautions

Please talk to your doctor or pharmacist before using Betaisodona Ointment. If you suffer from thyroid disease or have a goitre, you should only use Betaisodona Ointment 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 your doctor. Even after the end of therapy (up to 3 months), you should watch out for early symptoms of a possible overactive thyroid gland (see section 4). Your doctor will monitor your thyroid function if necessary.

Elderly people

Since elderly people are more likely to suffer from thyroid dysfunction, Betaisodona Ointment should only be used on a large scale and for a long period of time in elderly people (aged 65 and over) on the express instructions of a doctor. Your doctor may monitor your thyroid function if necessary.

Patients with impaired renal function

Long-term use in patients with impaired renal function should be avoided. Monitoring of thyroid function should be considered.

Children

After using Betaisodona Ointment, the doctor will check the thyroid function.

Using Betaisodona Ointment with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or plan to take/use any other medicines. Povidone-iodine can react with proteins and various other organic substances such as blood and pus components, which can impair its effectiveness. The effect of both medicines is weakened when used together:

• enzymatic wound treatment agents,
• hydrogen peroxide,
• taurolidine,
• silver-containing disinfectants or silver-containing wound dressings.

Do not use Betaisodona Ointment at the same time or shortly after using mercury-containing preparations, as a substance that can damage the skin may form from iodine and mercury. Do not use Betaisodona Ointment at the same time or immediately after using disinfectants containing the active ingredient octenidine on the same or adjacent areas. Otherwise, temporary dark discolouration may occur there. If you are being treated with lithium preparations, you should avoid long-term and/or large-scale use of Betaisodona Ointment, as this can promote the development of an underactive thyroid gland. For information on discolouration of materials, see section 3.

Influence on diagnostic tests or radioiodine therapy

Betaisodona Ointment can give false-positive results with various diagnostic agents (including toluidine and guaiac resin for the determination of haemoglobin or glucose in stool or urine). Betaisodona Ointment can interfere with diagnostic tests of the thyroid gland (thyroid scintigraphy, PBI determination, radioiodine diagnostics) and make planned radioiodine therapy impossible. You should wait 4 weeks after discontinuing treatment with Betaisodona Ointment before a new scintigram is taken.

Pregnancy and breast-feeding

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. Betaisodona Ointment should only be used during pregnancy and breast-feeding on the express instructions of a doctor and to a very limited extent. In this case, the thyroid function of the child must be checked. The infant must not be allowed to ingest Betaisodona Ointment orally through contact with the treated area of the body of the nursing mother.

Driving and using machines

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

3. HOW TO USE BETAISODONA OINTMENT

Always use this medicine exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure. Betaisodona Ointment is for external use only.

The recommended dose is (unless otherwise prescribed by your doctor)

Apply Betaisodona Ointment evenly to the affected area one to several times a day. If necessary, a dressing can then be applied.

The brown colour of Betaisodona Ointment is a property of the preparation and indicates its effectiveness. Increasing discolouration indicates a decrease in the effectiveness of the preparation. When completely discoloured, there is no more effectiveness. If you notice extensive discolouration of the ointment, you should reapply Betaisodona Ointment. Betaisodona Ointment should be used for as long as there are still signs of inflammation. If your symptoms do not improve after regular use for 2 to 5 days or if symptoms recur after the end of treatment, please consult your doctor.

Note

Betaisodona Ointment is fat-free and washable. It can generally be removed from textiles and other materials with warm water and soap. In stubborn cases, ammonia (sal ammoniac) or fixing salt (sodium thiosulphate) will help. Both are available in pharmacies or drugstores.

If you have used more Betaisodona Ointment than you should

Please contact your doctor, especially if you notice any of the symptoms listed in section 4. Betaisodona Ointment is for external use only. If you have accidentally swallowed a large amount of Betaisodona Ointment, please contact your doctor immediately. The following symptoms of acute iodine poisoning may occur in this case: abdominal pain and cramps, nausea, vomiting, diarrhoea, dehydration, drop in blood pressure, circulatory collapse, rapid heartbeat, bleeding tendency, lack of oxygen (bluish discolouration of the skin and mucous membranes), kidney dysfunction, urinary retention, nerve sensitivity disorders, seizures, fever, swelling of the larynx and pulmonary oedema.

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

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

Tell your doctor or healthcare professional immediately if you experience any of the following symptoms

Severe allergic reaction: Symptoms include difficulty breathing and/or swelling of the face.

Other possible side effects

Rare (may affect up to 1 in 1,000 people)

Hypersensitivity reactions; inflammation of the skin after contact (contact dermatitis, with symptoms such as redness, small blisters and itching).

Very rare (may affect up to 1 in 10,000 people)

Acute general allergic reactions, possibly with a drop in blood pressure and/or shortness of breath (anaphylactic reactions); overactive thyroid gland (iodine-induced hyperthyroidism), possibly with symptoms such as increased pulse rate or inner restlessness in patients with thyroid disease*; acute swelling of the skin or mucous membranes (angioedema).

Not known (frequency cannot be estimated from the available data)

Underactive thyroid gland*; electrolyte imbalance (also with disturbances in serum osmolarity)*, metabolic acidosis (metabolic acidosis)*; impairment of kidney function (acute renal insufficiency)*, unusual blood osmolarity*.

* After significant iodine uptake with long-term use of Betaisodona Ointment on extensive skin, wound or burn areas.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible 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. of Pharmacovigilance, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE BETAISODONA OINTMENT

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 or jar after "Use by:". The expiry date refers to the last day of the month indicated. Do not store above 25°C. Betaisodona Ointment can be used for up to 3 years after first opening. Do not use this medicine if you notice the following: If you notice extensive discolouration of the preparation, the medicine must be disposed of. Never dispose of medicines via wastewater (e.g. not via the toilet or sink). Ask your pharmacist how to dispose of the medicine when you no longer use it. In this way, you help to protect the environment. Further information can be found at www.bfarm.de/arzneimittelentsorgung.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Betaisodona Ointment contains
The active ingredient is povidone-iodine. 1 g Betaisodona Ointment contains 100 mg povidone-iodine with a content of 10% available iodine. The average molecular weight of povidone is approximately 40,000. The other ingredients are: Macrogols 400, 1000, 1500, 4000, sodium hydrogen carbonate, purified water.

What Betaisodona Ointment looks like and contents of the pack

Betaisodona is a reddish-brown ointment.

Pack sizes

Tubes with 25 g, 100 g or as a bundle pack 3 x 100 g or a jar with 300 g. Not all pack sizes may be marketed.

Pharmaceutical entrepreneur and manufacturer

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 leaflet was last revised in August 2021.

Source: Information from the package leaflet
Status: 09/2024
Active ingredient: 100 mg/g povidone-iodine. Areas of application: is used repeatedly, for a limited period of time, for the antiseptic treatment of damaged skin (e.g. pressure sores, leg ulcers), superficial wounds, burns, infected and superinfected skin diseases.