Betadine Jabonoso 75 mg/ml cutaneous solution
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Betadine Soap 75 mg/ml Cutaneous Solution
Povidone iodine
Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.
Follow exactly the instructions for use provided in this leaflet or those given by your doctor, pharmacist, or nurse.
- Keep this leaflet, as you may need to read it again.
- If you need advice or further information, consult your pharmacist.
- If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are effects not listed in this leaflet. See section 4.
- You should consult a doctor if your condition worsens or does not improve.
Leaflet contents
- What Betadine Soap is and what it is used for.
- What you need to know before using Betadine Soap.
- How to use Betadine Soap.
- Possible adverse effects.
- How to store Betadine Soap.
- Contents of the pack and other information.
1. What Betadine soap is and what it is used for
Povidone iodine, the active substance of this medicine, is an antiseptic (which destroys germs that cause infections) containing iodine.
Betadine is indicated as an antiseptic soap used for antiseptic washing of the hands and skin.
2. What you need to know before using Betadine soap
Do not use Betadine soap
- If you are allergic to povidone-iodine or to any of the other ingredients of this medicine (listed in section 6).
- If you have hyperthyroidism or other acute thyroid diseases.
- Before, during, and after administration of radioactive iodine.
- With mercury-containing products due to the formation of a substance that may damage the skin.
- In children under one year of age.
Warnings and precautions
Consult your doctor, pharmacist, or nurse before starting to use Betadine soap.
For external use only. Do not ingest. Avoid contact with eyes, ears, and other mucous membranes. Consult your doctor if symptoms persist or worsen.
If used in preparation before surgery, avoid accumulation under the patient. This may cause irritation and, rarely, severe skin reactions. Chemical burns of the skin may occur due to pooling. In such cases, discontinue use. Do not heat before application.
Patients with goiter, thyroid nodules, or other non-acute thyroid diseases are at risk of developing hyperthyroidism when exposed to high amounts of iodine. In these patients, prolonged application over large skin areas should be avoided unless strictly indicated. Even after treatment ends, early signs of possible hyperthyroidism should be monitored, and thyroid function should be checked if necessary.
Do not use before or after radioactive iodine scintigraphy or treatment of thyroid carcinoma with radioactive iodine.
Thyroid function tests should be performed if prolonged use is required.
This medicine contains 110 mg of benzoic acid per 100 ml. Benzoic acid may cause local irritation.
Children
Newborns and young children are at higher risk of developing hypothyroidism. If used in children, thyroid monitoring is important.
The use of Betadine soap is not recommended in children under one year of age.
Use of Betadine soap with other medicines
Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.
Do not use with mercurial compounds, silver, hydrogen peroxide, or taurolidine (antiseptics).
Prolonged use should be avoided in patients receiving concomitant lithium therapy (used in psychiatry).
Transient dark discoloration of the involved areas may occur when used simultaneously or after antiseptics containing octenidine.
Interaction with diagnostic tests: the use of povidone-iodine may lead to errors in tests using toluidine or guaiacol to detect hemoglobin or glucose in feces or urine. It may also interfere with thyroid function tests and treatments with radioactive iodine.
Inform your doctor if you are scheduled for any diagnostic test.
Inform your doctor if:
- Symptoms do not improve or worsen.
- You have received treatment with radioactive iodine within the last 4 weeks.
- You have an allergy or skin irritation such as redness, small blisters, itching, or rash, which may appear immediately.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
Use only if strictly indicated, and keep usage to the absolute minimum. Avoid prolonged use.
Its use could cause transient hypothyroidism in fetuses and newborns. Thyroid monitoring in infants may be necessary.
Consult your doctor regarding use in children between 1 and 2 years of age.
Driving and using machines
Betadine does not affect the ability to drive or operate machinery.
3. How to use Betadine soap
Follow exactly the instructions for use of the medicine contained in this leaflet or as directed by your doctor, pharmacist, or nurse. In case of doubt, consult your doctor, pharmacist, or nurse.
For topical use. Use a small amount of the product, rubbing gently for about 2–5 minutes until foam forms. Rinse thoroughly with plenty of water or with a sterile gauze soaked in water. Apply 2–3 times a day (or more frequently, as needed).
If you use more Betadine soap than you should
If an excessive amount of the product is applied and skin irritation occurs, wash the affected area thoroughly with abundant water, discontinue treatment, and if irritation persists, consult a doctor.
Symptoms may include abdominal pain, anuria (suppression or reduction of urine), circulatory, respiratory, and metabolic problems. Excess iodine may cause goiter, hypothyroidism, and hyperthyroidism.
In case of accidental ingestion, go immediately to a medical center or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the product and the amount ingested.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
In rare cases of skin irritation or allergy, discontinue treatment and wash the affected area with water.
Rare adverse effects (may affect between 1 and 10 in every 10,000 people) include hypersensitivity and contact dermatitis, manifesting as red skin, small blisters, and itching.
Very rarely (may affect fewer than 1 in 10,000 people), anaphylactic reactions (severe allergic reaction), hyperthyroidism with tachycardia and agitation, and angioedema (swelling caused by allergy) have been observed.
Other adverse effects of unknown frequency include hypothyroidism, electrolyte imbalance, metabolic acidosis, acute renal failure, abnormal blood osmolarity, exfoliative dermatitis, dry skin, skin discoloration, and chemical burn on the skin.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products (https://www.notificaram.es). By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Betadine soap solution
Keep this medicine out of the sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date stated on the packaging following CAD or EXP. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Betadine Soap Solution
The active substance is povidone-iodine. Each ml of solution contains 75 mg of povidone-iodine.
The other components (excipients) are: ammonium lauryl sulfate ethoxylated solution (containing benzoic acid), polyethylene glycol 400, sodium hydroxide, potassium iodate, and purified water.
Appearance of the product and contents of the container
Brown-colored soap solution.
Presented in a pack containing 1 high-density polyethylene bottle with a black cap and reducer, containing 500 ml of solution.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Cooper Consumer Health B.V.
Verrijn Stuartweg 60,
1112 AX Diemen,
The Netherlands
Manufacturer
MEDA Manufacturing, Bordeaux
Av. Président J. F. Kennedy. BP 100
Merignac – Cedex
F-33700
France
For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:
Vemedia Pharma Hispania, S.A.
C/ Aragón, 182, 5th floor
08011 Barcelona
Spain
Date of the most recent review of this leaflet: 2022
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) https://www.aemps.es/