Betadine (ointment)

Description

Betadine ointment is an antiseptic, disinfectant with a wide spectrum of action. It is used for burns, cuts and lacerations, abrasions, ulcerative skin diseases

 

1. WHAT BETADINE IS AND WHAT IT IS USED FOR
Betadine ointment is an antiseptic, disinfectant product with a broad spectrum of action against bacteria, viruses, fungi and protozoa.

The preparation is used for burns, cuts and lacerations, abrasions, ulcerative skin diseases caused by poor tissue nutrition (eg bedsores, leg ulcers) and various skin diseases associated with infection.

For ulcerative skin diseases (bedsores, leg ulcer) and for skin diseases associated with infection, use the product only after consulting a doctor.

2. WHAT YOU NEED TO KNOW BEFORE YOU START USING BETADINE
Do not use Betadine
If you are allergic to povidone iodine or any other component of this preparation (listed in point 6);
in hyperthyroidism (increased activity of the thyroid gland);
if you have a thyroid adenoma or other acute thyroid diseases;
in Dühring's herpetiform dermatitis (skin inflammation similar to herpetic inflammation);
before or after radioactive iodine scintigraphy (an examination in which radioactive iodine is administered) or treatment of thyroid cancer with radioactive iodine.

Warnings and precautions
Consult your doctor before using Betadine ointment.

In case of skin irritation, contact dermatitis (rash or skin irritation caused by contact with the substance) or hypersensitivity, stop using the product.

Avoid contact of Betadine ointment with eyes.

In patients with goiter (enlargement of the thyroid gland), nodules in the thyroid gland, or other non-acute thyroid disease, there is a risk of developing increased thyroid function (hyperthyroidism) when large doses of iodine are administered. If you suffer from thyroid disease, do not use Betadine unless strictly indicated; always consult your doctor about use. Even after the end of the treatment, it is necessary to monitor the early symptoms of the possible occurrence of increased thyroid gland function and, if necessary, check the thyroid gland function.

Children and adolescents
In newborns and small children, there is an increased risk of developing reduced thyroid function when large doses of iodine are administered. The use of iodinated povidone in newborns and small children is possible only on the basis of a doctor's decision and should be limited to an absolute minimum. In children, it may be necessary to check the function of the thyroid gland.

It is necessary to completely prevent the ingestion of povidone-iodine by the child. If a child accidentally swallows the product, seek medical attention immediately.

Other medicines and Betadine
Tell your doctor or pharmacist about all the medicines you are taking, have recently taken or might take.

The simultaneous use of preparations for the treatment of wounds containing enzymatic compounds leads to a weakening of the effects of both substances. Preparations containing mercury, silver, hydrogen peroxide and taurolidine may interact with povidone iodine and should not be used simultaneously.

Iodine povidone in Betadine ointment should not be used simultaneously with reducing agents, alkaline salts and acid-reactive substances.

Long-term use of Betadine should be avoided in patients using lithium, especially on large areas.

Preparations with povidone iodine used at the same time or immediately after the application of antiseptics containing octenidine on the same or adjacent site may cause a temporary dark discoloration of the affected area.

The use of Betadine ointment can lead to false positive results of some laboratory tests (eg tests with toluidine or guaiac resin to determine blood dye or sugar in stool or urine).

The use of povidone-iodine may affect the results of some thyroid examinations (thyroid scintigraphy, determination of protein-bound iodine [PBI], radioiodine diagnostics) and may prevent the planned treatment of the thyroid gland with iodine (radioactive iodine therapy). A sufficient time interval must be left between the end of treatment with Betadine ointment and the next scintigraphy.

Pregnancy and breastfeeding
Due to the ability of iodine to pass through the placenta and be excreted in breast milk and due to the increased sensitivity of the fetus and newborn to iodine, povidone iodine should be used during pregnancy and breastfeeding only in strictly indicated cases and only on the recommendation of a doctor.

Driving vehicles and operating machines
Betadine has no or negligible influence on the ability to drive and use machines.

3. HOW TO USE BETADINE
Always use this product exactly in accordance with the package leaflet or according to the instructions of your doctor or pharmacist. If you are not sure, consult your doctor or pharmacist.

Apply a thin layer of ointment to clean, dry skin three to four times a day. Reapply the previously applied ointment each time without washing. In the case of a strongly inflamed or festering wound, the ointment can be applied more often, i.e. four to six times a day. The intervals between individual doses should be at least 4 hours. If necessary, the wound can be covered with a bandage depending on the extent and severity of the injury.

The ointment is intended for use on the skin. It must not be used near the eyes.

Treatment usually lasts several days. If the condition does not improve within 5 days or if it worsens (e.g. signs of infection appear in a non-infected wound, such as redness, pain, swelling, or pus), you must consult a doctor.

Do not use Betadine ointment for more than 7 days without consulting a doctor.

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

4. POSSIBLE ADVERSE EFFECTS
Similar to all medicines, this product can also have side effects, which may not occur in everyone.

Adverse effects are listed in the following groups according to the frequency of occurrence:

Rare side effects (affect 1 to 10 people out of 10,000):
Hypersensitivity reaction, contact dermatitis (with symptoms such as redness, small blisters and itching)

Very rare side effects (affect less than 1 person in 10,000):
Anaphylactic reaction (severe allergic reaction that causes difficulty breathing, dizziness, drop in blood pressure); hyperthyroidism (increased activity of the thyroid gland, which may cause increased appetite, weight loss, sweating, increased heart rate or restlessness) in patients with thyroid disease; angioedema (severe allergic reaction that causes swelling of the face or neck)

Not known (frequency cannot be determined from available data):
Hypothyroidism (reduced thyroid function that can cause fatigue, weight gain, slower heart rate) may occur after prolonged or extensive use of povidone-iodine;

Renal dysfunction
Electrolyte balance disorders (fluid and salt balance), metabolic acidosis (drop in blood pH), acute kidney failure, abnormal blood osmolality (may occur after absorption of large amounts of povidone iodine).

Reporting of side effects
If you experience any of the side effects, tell your doctor, pharmacist or nurse. Proceed in the same way in case of any side effects that are not listed in this package leaflet. You can also report adverse effects directly to the address: State Institute for Drug Control, Šrobárova 48, 100 41 Prague 10, website: www.sukl.cz/nahlasit-nezadouci-ucinek

By reporting side effects, you can contribute to obtaining more information about the safety of this product.

5. HOW TO STORE BETADINE
Store at a temperature of up to 25 °C in the original packaging to protect the product from light. Protect from cold or frost.

Keep out of the sight and reach of children.

Do not use this product after the expiry date stated on the box after "Use by:". The period of validity refers to the last day of the indicated month.

Do not dispose of any medicinal products in waste water or household waste. Ask your pharmacist how to dispose of preparations that you no longer use. These measures help protect the environment.

 6. PACKAGE CONTENTS AND OTHER INFORMATION

What Betadine ointment contains
The active ingredient is povidon iodinatum. One g of ointment contains 100 mg of povidonum iodinatum (iodine povidone), which corresponds to 10 mg of active iodine. Excipients are sodium bicarbonate, macrogol 400, macrogol 1000, macrogol 1500, macrogol 4000 and purified water.

What Betadine ointment looks like and what is in this package
Reddish-brown, homogeneous ointment with a weak odor of iodine, washable with water.
The package contains 1 x 20 g or 1 x 100 g of ointment.

Holder of the registration decision

EGIS PHARMACEUTICALS PLC
1106 Budapest, Keresztúri Tue 30-38.
HUNGARY

Manufacturer

EGIS Pharmaceuticals PLC
Mátyás Király u. 65.
9900 Körmend
Hungary

(under license from Mundipharma AG Basel, Switzerland)