Betatul 250 mg medicated dressing
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Betatul 250 mg impregnated dressing
Povidone iodine
Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.
Follow exactly the instructions for use of this medicine provided in this leaflet or those given by your doctor, pharmacist, or nurse.
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Keep this leaflet, as you may need to read it again.
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If you need advice or more information, consult your pharmacist.
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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.
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You should consult a doctor if you get worse or do not improve.
Contents of this leaflet
- What Betatul is and what it is used for
- What you need to know before using Betatul
- How to use Betatul
- Possible adverse effects
- How to store Betatul
- Contents of the pack and other information
1. What Betatul is and what it is used for
Povidone iodine, the active substance in this medicine, is an antiseptic (which destroys germs that cause infections) containing iodine.
Betatul is indicated as a general antiseptic for skin use, in minor wounds and superficial cuts, mild burns, and abrasions.
2. What you need to know before using Betatul
Do not use Betatul
- If you are allergic to povidone iodine or to any of the other components 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 products containing mercury due to the formation of a substance that may damage the skin.
- In children under 1 year of age.
Warnings and precautions
Consult your doctor, pharmacist, or nurse before starting to use Betatul.
For external use only. Do not ingest. Avoid contact with eyes, ears, and other mucous membranes. Consult your doctor if symptoms persist or worsen.
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, Betatul should not be applied for prolonged periods or over large skin areas unless strictly indicated. Even after treatment has ended, 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 radioactive iodine treatment for thyroid carcinoma.
Thyroid function tests should be performed if prolonged use is required.
Children
Newborns and young children are at higher risk of developing hypothyroidism. When used in children, thyroid monitoring is important.
Use in children under 1 year of age is not recommended.
Use of Betatul 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 mercury-containing compounds, silver, hydrogen peroxide, or taurolidine (antiseptics).
Prolonged use should be avoided in patients receiving concomitant lithium therapy (used in psychiatry).
When used simultaneously or after antiseptics containing octenidine, transient dark discoloration of the affected areas may occur.
Interaction with diagnostic tests: the use of povidone iodine may lead to errors in toluidine or guaiacol tests for detecting 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 need to undergo any diagnostic testing.
Inform your doctor if:
- Symptoms do not improve or worsen.
- You have received treatments 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, breastfeeding, think you might 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 Betatul
Follow exactly the instructions for use provided in this leaflet or those indicated by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse.
Cutaneous use. After washing and drying, apply directly to the affected area. Cover with gauze or cotton. Secure with a bandage.
Change daily or every 2 days.
If you use more Betatul than you should
If an excessive amount of the product is applied and skin irritation occurs, wash the affected area thoroughly with 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 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, ask your doctor, pharmacist, or nurse.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.
In rare cases where skin irritation or allergy occurs, discontinue treatment and wash the affected area with water.
Rare adverse effects (may affect between 1 and 10 out of 10,000 people) are hypersensitivity and contact dermatitis, which manifests 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 with 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.
If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.
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 through the Spanish Pharmacovigilance System for Human Medicines (https://www.notificaram.es). By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Betatul
Keep this medicine out of the sight and reach of children.
Store below 30°C in the original packaging to protect it from light and moisture.
Do not use this medicine after the expiry date stated on the container after CAD or EXP. The expiry date is the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.
6. Contents of the pack and other information
Composition of Betatul
The active substance is povidone-iodine. Each 10 x 10 cm gel-impregnated dressing contains 250 mg of povidone-iodine. The other components (excipients) are: polyethylene glycol 400, polyethylene glycol 4000, polyethylene glycol 6000, purified water and absorbent gauze.
Appearance of the product and contents of the pack
Pack containing 10 polypropylene sachets, each containing 1 gel-impregnated dressing.
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. Pdt. 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: August 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.gob.es/