BETADINE DERMAL SOLUTION

1. What Betadine vaginal is and what it is used for

The active ingredient of this medicine, povidone iodine, is an antiseptic (which destroys germs that cause infections) that contains iodine.

Betadine is indicated as a topical vaginal antiseptic used for the antiseptic washing of the external vaginal area and for the relief of symptoms associated with vaginal infections.

2. What you need to know before starting to use Betadine vaginal

Do not use Betadine vaginal

• If you are allergic to povidone iodine or any of the other components of this medicine (listed in section 6).
• If you have hyperthyroidism or other acute thyroid diseases.
• In newborns from 0 to 1 month.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Betadine vaginal.

Vaginal route. 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 on the skin can occur due to accumulation. In that case, suspend its use. Do not heat before applying.

Patients 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 or to extensive skin areas unless strictly indicated. Even at the end of treatment, 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 young children are at higher risk of developing hypothyroidism. If used in children, it is essential to monitor the thyroid.

It is not recommended for use in newborns (from 0 to 1 month).

Using Betadine vaginal with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine.

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 affected areas may appear.

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.

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; its use should be kept to a minimum. Avoid continuous use.

Its use could produce transient hypothyroidism in fetuses and newborns. Thyroid monitoring may be necessary in children.

3. How to use Betadine vaginal

Follow the administration instructions of the medicine contained in this leaflet or as indicated by your doctor, pharmacist, or nurse. In case of doubt, ask your doctor, pharmacist, or nurse.

Vaginal route. Wash with a dilution of 2 full caps of product per liter of boiled and warm water.

Apply 1 to 2 times a day (or more often, as needed).

If you use more Betadine vaginal than you should

In case of excessive product application and skin irritation, wash the affected area with plenty of water, suspend treatment, and if irritation continues, consult a doctor.

Symptoms could be abdominal pain, anuria (suppression or decrease of urine), circulatory, respiratory, and metabolic problems. Excess iodine can produce 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 the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience 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 out of 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 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 include hypothyroidism, electrolyte imbalance, metabolic acidosis, acute renal failure, abnormal blood osmolality, exfoliative dermatitis, dry skin, and chemical burns on the skin.

If you consider that any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

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 leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines (https://www.notificaram.es). By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Betadine vaginal

Keep this medicine out of the sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines 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 medicines you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Betadine vaginal

The active ingredient is povidone iodine. Each ml of solution contains 100 mg of povidone iodine.

The other components (excipients) are: lauryl ether of macrogol 9, sodium hydroxide (E 524), and purified water.

Appearance of the product and package contents

Brown-colored solution.

It is presented in packages of 1 high-density polyethylene bottle with a black cap and reducer containing 125 ml.

Marketing authorization holder and manufacturer

Marketing authorization holder

Meda Pharma, S.L.

C/ General Aranaz, 86

28027 Madrid

Spain

Manufacturer

MEDA Manufacturing, Bordeaux (France)

Av. Pdt. J. F. Kennedy. BP 100

Medignac – Cedex

F-33700

France

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Mylan Pharmaceuticals, S.L.

C/ Plom, 2-4, 5th floor

08038 - Barcelona

Spain

Date of the last revision of this leaflet:July 2017

Detailed and updated information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/