EGIS

BETADINE OINTMENT 10% X 20G

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Composition. The active substance is povidone-iodine. One gram of ointment contains 10 mg active iodine in the form of 100 mg povidone-iodine. The other components are: sodium hydrogen carbonate, macrogol 400, macrogol 1000, macrogol 1500, macrogol 4000, purified water.

Therapeutic indications. Betadine contains free iodine as its active substance. This is an antiseptic that destroys bacteria, fungi, and some protozoa.

Betadine is a broad-spectrum antiseptic used for local treatment or for preventing infections of minor wounds, small-surface burns, and minor surgical procedures. It is recommended for the treatment of fungal and bacterial skin infections, as well as stasis and decubitus ulcers.

Dosage and administration.

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are not sure.

It is intended for local administration.

For the treatment of infections: apply the ointment 1-2 times a day. The maximum duration of treatment is 14 days.

For infection prevention: apply the ointment 1-2 times a week for as long as necessary. The affected skin should be clean and dry. Apply Betadine to the affected area, which you can then cover with a dressing or bandage.

Precautions.

Before using Betadine, consult your doctor or pharmacist. Discontinue treatment if skin irritations, contact dermatitis, or hypersensitivity reactions occur.

Do not heat the medicine before use. Keep out of reach of children.

When administering large quantities of iodine, patients with goiter, thyroid nodules, or other non-acute thyroid conditions are at risk of developing hyperthyroidism (overactivity of the thyroid function). In the absence of strict indications, povidone-iodine should not be applied to this category of patients for a long period of time or over a large skin surface. Even after the treatment ends, a possible appearance of hyperthyroidism symptoms should be monitored, and if necessary, thyroid function should be checked. The treatment should not be used before or after radioactive iodine scintigraphy or radioactive iodine treatment for thyroid carcinoma.

Special warnings.

Pregnancy and breastfeeding

During pregnancy and breastfeeding, povidone-iodine should only be used if strictly indicated and for a minimum period of time. Because iodine crosses the placenta and is excreted in breast milk, and due to the increased sensitivity of the fetus or newborn to iodine, povidone-iodine should be used in the smallest possible quantities during pregnancy and breastfeeding. Furthermore, the iodine concentration is higher in breast milk compared to the serum concentration. The use of povidone-iodine can induce transient hypothyroidism (reduced thyroid gland activity) with high TSH (thyroid-stimulating hormone) values in the fetus or newborn. Monitoring of the child's thyroid gland function may be necessary. Possible oral ingestion of the solution by the infant must be strictly avoided.

Driving and using machines

Betadine does not affect the ability to drive vehicles or use machines.

Packaging. It is packaged in boxes with an Al tube containing 20 g of ointment.

Page updated on: 08.06.2021