TINTURA DE YODO REIG JOFRE 20 mg/ml CUTANEOUS SOLUTION

2. What you need to know before starting to use Iodine Tincture Reig Jofre

Do not useIodine Tincture Reig Jofre:

• If you are allergic to iodine or any of the other components of this medication (listed in section 6).
• In burned patients.
• In newborns (from 0 to 1 month).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Iodine Tincture Reig Jofre.

• Do not ingest. This medication is for exclusive external use on the skin.
• Do not use this medication for a long time or on large areas of skin without consulting your doctor, especially if:
• • you suffer from burns that affect more than 20% of the body surface
  • you have large or open wounds
  • you have kidney or liver disease
  • you suffer from any thyroid disorder
  • you are being treated with lithium.

• Protect from heat; easily flammable.
• Iodine is inactivated by the action of alkaline pH, light, and heat.
• Avoid contact with eyes, ears, and other mucous membranes.
• Do not use a dressing stuck to the treated area to avoid iodine causing burns to the occluded skin.
• This medication may stain skin and clothing. Apply water to remove the stain from the skin. For those on clothing, wash the garment with water and soap.

Children

Do not use in children under 3 years without consulting a doctor (see "Do not use Iodine Tincture Reig Jofre" in this section).

Interference with analytical tests:

If you are going to undergo any diagnostic test (including blood, urine, etc...), inform your doctor that you are using this medication, as it may alter the results.

This medication could interfere with the results of thyroid function tests and those for detecting hidden blood in feces and urine.

Other medicationsand Iodine Tincture Reig Jofre

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

In particular, you should consult your doctor if you are using this medication at the same time as lithium.

Do not apply this medication along with other products that contain mercury derivatives, as they react with iodine to form irritating compounds.

Also, do not use it along with sodium thiosulfate (used for the treatment of fungal infections), as both products are inactivated. Nor with other substances with which iodine has chemical incompatibility.

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.

Pregnant women should avoid using this medication on large areas of skin or in excess, as it may cause transient hypothyroidism in the fetus (decreased thyroid gland activity).

Breastfeeding women should avoid using this medication on large areas of skin or in excess, as the absorbed iodine may pass into breast milk, potentially causing exposure in the infant and possible thyroid dysfunction or goiter.

Driving and using machines

The influence of this medication on the ability to drive and use machines is null or insignificant.

3. How to use Iodine Tincture Reig Jofre

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

Cutaneous use.

The recommended dose is:

Apply a small amount directly to the affected area after washing and drying it. If necessary, apply 2 to 3 times a day.

To avoid irritation, do not cover the application area.

Use in children

Do not apply to babies from 0 to 1 month.

Do not apply to children under 3 years without consulting a doctor.

If its use is indispensable in children under 30 months, it will be limited to a brief and not very extensive application, followed by a rinse with sterile water.

If you use moreIodine Tincture Reig Jofrethan you should

In the event that an excessive amount of product is applied and irritation occurs, wash the affected area with plenty of water, suspend treatment, and if irritation continues, consult a doctor.

Prolonged exposure to iodine can cause alterations in thyroid gland function (a gland located in the front of the neck).

In cases of accidental ingestion of large amounts of iodine (or with prolonged use), the following may occur: abdominal pain, cough, delirium, diarrhea (sometimes with blood), fever, sensitivity in teeth and gums, metallic taste, burning in the mouth and throat, skin rashes, increased salivation, eye irritation, decreased blood pressure, and circulatory failure, inflammation of the pharynx, throat, and other nearby areas that make breathing difficult, partial loss of consciousness (stupor), nausea, vomiting, headache, alteration of kidney and thyroid functions.

In these cases, if the patient is conscious, they should ingest milk every 15 minutes to alleviate stomach irritation. Additionally, to absorb the remaining iodine, cornstarch or 15 mg of flour dissolved in half a liter of water should be administered. But, this treatment should not be administered if the person presents symptoms that make swallowing difficult (such as vomiting, convulsions, or decreased consciousness).

If the patient suffers esophageal damage, stomach lavage or vomiting should not be induced.

In general, the treatment is to support respiratory and cardiovascular function.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or go to a medical center or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you have any other doubts about the use of 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.

During the period of use of iodine tincture, the following side effects have been observed, whose frequency could not be established with precision:

Rarely, skin disorders, such as local irritation, itching, or burning. In these cases, treatment should be suspended and the affected area washed with water.

Allergic reactions may occur with symptoms such as skin and subcutaneous tissue swelling (angioedema), joint pain, bleeding into the skin, significant increase in the number of eosinophils (a type of white blood cell), fever, lymph node enlargement (lymphadenopathy), disorder that causes excessive bruising and bleeding, hives on the skin (urticaria).

Side effects may occur that can be more serious if the product is used for a long time or applied to large wounds or burns, mainly disorders of kidney and thyroid function (especially in children).

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 Medication Surveillance System for Human Use: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Iodine Tincture Reig Jofre

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

Store in the original packaging to protect it from light and moisture.

Do not store at a temperature above 25°C.

Do not use this medication after the expiration date shown on the label and packaging after CAD. The expiration date is the last day of the month indicated.

Do not use this medication if you observe turbidity in the solution.

Medications should not be thrown down the drain or into the trash. 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. Package contents and additional information

Composition ofIodine Tincture Reig Jofre

• The active principle is iodine. Each ml of solution contains 20 mg of iodine (2%).
• The other components (excipients) are potassium iodide and ethanol 50°.

Appearance of the product and package contents

The medication is a cutaneous solution (for skin use); brown in color.

It is presented in an opaque polypropylene bottle with a screw cap, containing 40 ml of solution.

Marketing authorization holder and manufacturer

Laboratorios Reig Jofré, S.A.

C/ Gran Capitán 10,

08970 Sant Joan Despí (Barcelona)

Phone: 93 480 67 00

Fax: 93 480 67 24

Date of the last revision of this leaflet:October 2023.

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