BETADINE SOAPY 40 mg/ml CUTANEOUS SOLUTION
Ask a doctor about a prescription for BETADINE SOAPY 40 mg/ml CUTANEOUS SOLUTION
How to use BETADINE SOAPY 40 mg/ml CUTANEOUS SOLUTION
Introduction
Package Leaflet: Information for the User
Betadinesoap 40 mg/ml cutaneous solution
Povidone iodine
Read the entire package leaflet carefully before starting to use this medication, as it contains important information for you.
Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor, pharmacist, or nurse.
- Keep this package leaflet, as you may need to read it again.
- If you need advice or more information, consult your pharmacist.
- If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this package leaflet. See section 4.
- You should consult a doctor if it worsens or does not improve.
Contents of the Package Leaflet
- What Betadine soap is and what it is used for.
- What you need to know before starting to use Betadine soap.
- How to use Betadine soap.
- Possible side effects.
- Storage of Betadine soap.
- Contents of the package and additional information.
1. What Betadine soap is and what it is used for
Povidone iodine, the active ingredient of this medication, is an antiseptic (which destroys germs that cause infections) that contains iodine.
Betadine is indicated as an antiseptic soap used for the antiseptic washing of skin and hands with small wounds, superficial cuts, or abrasions.
2. What you need to know before starting to use Betadine soap
Do not use Betadine soap
- If you are allergic to povidone iodine or any of the other components of this medication (listed in section 6).
- If you have hyperthyroidism or other acute thyroid diseases.
- Before, during, and after the administration of radioactive iodine
- With products that contain mercury due to the formation of a substance that can 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.
External use. 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 an operation, avoid accumulation under the patient. It can cause irritation and rarely severe skin reactions. Chemical burns can occur on the skin due to accumulation. In that case, suspend its use. Do not heat before applying.
Patient with goiter, thyroid nodules, or other non-acute thyroid diseases are at risk of developing hyperthyroidism with the administration of high amounts of iodine. In these patients, it should not be applied for prolonged periods of time and in extensive areas of skin unless strictly indicated. Even at the end of treatment, you should be alert to early symptoms of possible hyperthyroidism and, if necessary, control thyroid function.
It should not be used before or after a radioactive iodine scan or treatment of thyroid carcinoma with radioactive iodine.
Thyroid function tests should be performed in case of prolonged use.
Children
Newborns and small children are at greater risk of developing hypothyroidism. If used in children, it is essential to monitor the thyroid.
The use of Betadine soap is not recommended in children under one year of age.
Using Betadine soap with other medications
Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.
Do not use with mercurial derivatives, silver, hydrogen peroxide, or taurolidine (antiseptics).
Continuous use should be avoided in patients undergoing simultaneous therapy with lithium (used in psychiatry).
When used at the same time or after antiseptics with octenidine, a transient dark discoloration of the involved areas may appear.
This medication contains 52.5 mg of benzoic acid in every 100 ml. Benzoic acid may cause local irritation.
Interaction with diagnostic tests: the use of povidone iodine may lead to errors in tests with toluidine or guaiacol to determine hemoglobin or glucose in feces or urine. It may also interfere with thyroid tests and treatments with radioactive iodine.
Inform your doctor when you need to undergo any diagnostic test.
Inform your doctor if:
- Symptoms do not improve or worsen
- You have received radioactive iodine treatments in the last 4 weeks
- You have an allergy or skin irritation such as redness, small blisters, itching, or rash that 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 medication.
Use only if strictly indicated; its use should be kept to a minimum. Avoid continuous use.
Its use could cause transient hypothyroidism in fetuses and newborns. Thyroid control may be necessary in children.
You should consult your doctor about using it in children between 1 and 2 years old.
Driving and using machines
Betadine does not affect the ability to drive or use machinery.
3. How to use Betadine soap
Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor, pharmacist, or nurse. In case of doubt, ask your doctor, pharmacist, or nurse.
Cutaneous use. Use 2 to 3 times a day (or more often if needed), a small amount of product, rubbing for 2-5 minutes until foam is obtained. Rinse with plenty of water or with a sterile gauze soaked in water.
If you use more Betadine soap than you should
In case you apply an excessive amount of product and skin irritation occurs, wash the affected area with plenty of water, suspend treatment, and if irritation continues, consult your doctor.
Symptoms could be abdominal pain, anuria (suppression or decrease of urine), circulatory, respiratory, and metabolic problems. Excess iodine can cause goiter, hypothyroidism, and hyperthyroidism.
In case of accidental ingestion, go to a medical center or call the Toxicology Information Service, phone: 91 562 04 20, indicating the product and the amount ingested.
If you have any other doubts about using this medication, ask your doctor, pharmacist, or nurse.
4. Possible side effects
Like all medications, this medication can cause side effects, although not everyone experiences them.
In rare cases where skin irritation or allergy occurs, suspend treatment and wash the affected area with water.
Rare side effects (may affect between 1 and 10 in every 10,000 people) are hypersensitivity and contact dermatitis, which manifests with red skin, small blisters, and itching.
Very rare side effects (may affect less than 1 in every 10,000 people) include anaphylactic reactions (severe allergic reaction), hyperthyroidism with tachycardia and agitation, and angioedema (swelling caused by allergy).
Other side effects of unknown frequency have been hypothyroidism, electrolyte imbalance, metabolic acidosis, acute renal failure, abnormal blood osmolarity, exfoliative dermatitis, dry skin, skin discoloration, and chemical burns on the skin.
Reporting side effects:
If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.
5. Storage of Betadine soap
Keep this medication out of sight and reach of children.
Store below 30°C.
Do not use this medication after the expiration date shown on the packaging after CAD or EXP. The expiration date is the last day of the month indicated.
Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.
6. Contents of the package and additional information
Composition of Betadine soap
The active ingredient is povidone iodine. Each ml of solution contains 40 mg of povidone iodine.
The other components (excipients) are: solution of ethoxylated ammonium lauryl sulfate (contains benzoic acid), polyethylene glycol 400, sodium hydroxide, potassium iodate, and purified water.
Appearance of the product and contents of the package
Brown-colored solution.
It comes in packages of 1 high-density polyethylene bottle with a black cap and reducer containing 125 ml or 500 ml of solution.
Marketing authorization holder and manufacturer
Marketing authorization holder
Cooper Consumer Health B.V.
Verrijn Stuartweg 60,
1112 AX Diemen,
Netherlands
Manufacturer
MEDA Manufacturing, Bordeaux
Av. Pdt. J. F. Kennedy. BP 100
Mérignac – Cedex
F-33700
France
You can request more information about this medication by contacting the local representative of the marketing authorization holder:
Vemedia Pharma Hispania, S.A.
C/ Aragón, 182, 5th floor
08011 Barcelona
Spain
Date of the last revision of this package leaflet:July 2022
Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) https://www.aemps.gob.es/
- Country of registration
- Active substance
- Prescription requiredNo
- Manufacturer
- CompositionHIDROXIDO DE SODIO (E 524) (pH ≤5,3 c.s.p - mg), IODATO POTASICO (0,03 g mg)
- This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
- Alternatives to BETADINE SOAPY 40 mg/ml CUTANEOUS SOLUTIONDosage form: TOPICAL SOLUTION, 100 mg/mlActive substance: povidone-iodineManufacturer: Cooper Consumer Health B.V.Prescription not requiredDosage form: GEL, 10% povidone iodineActive substance: povidone-iodineManufacturer: Cooper Consumer Health B.V.Prescription not requiredDosage form: TOPICAL SOLUTION, 7.5% povidone iodineActive substance: povidone-iodineManufacturer: Cooper Consumer Health B.V.Prescription not required
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