Tintura de Yodo Reig Jofre 20 mg/ml cutaneous solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Tintura de yodo Reig Jofre 20 mg/ml cutaneous solution

Iodine

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

Follow exactly the instructions for use provided in this leaflet or those given by your doctor, pharmacist, or nurse.

• Keep this leaflet, as you may need to read it again.

• If you need advice or more information, consult your pharmacist.

• If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

• You should consult a doctor if your condition worsens or if you do not improve after 7 days.

Contents of the leaflet

1. What Tintura de yodo Reig Jofre is and what it is used for
2. What you need to know before using Tintura de yodo Reig Jofre
3. How to use Tintura de yodo Reig Jofre
4. Possible adverse effects
5. How to store Tintura de yodo Reig Jofre
6. Contents of the pack and other information

1. What Tintura de yodo Reig Jofre is and what it is used for

Iodine, the active ingredient in iodine tincture, has an antiseptic action against a wide variety of germs, including fungi. It works by destroying them.

It is a general antiseptic for use on the skin in minor or superficial wounds, and for disinfecting the skin prior to venous puncture (blood extraction from a vein) or before a surgical procedure.

2. What you need to know before using Tintura de yodo Reig Jofre

Do not use Tintura de yodo Reig Jofre:

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Tintura de yodo Reig Jofre.

• Do not ingest. This medicine is for external use only, on the skin.

• Do not use this medicine for long periods or on large areas of skin without consulting your doctor, especially if:

  • you have burns affecting more than 20% of the body surface
  • you have large or open wounds
  • you suffer from kidney or liver disease
  • you have any disorder of the thyroid gland
  • you are being treated with lithium-containing medication.

• Protect from heat; highly flammable.

• Iodine is inactivated by alkaline pH, light, and heat.

• Avoid contact with eyes, ears, and other mucous membranes.

• Do not use adhesive bandages on the treated area, to prevent iodine from causing skin burns due to occlusion.

• This medicine may stain skin and clothing. Rinse skin with water to remove stains. For clothing stains, wash the garment with water and soap.

Children

Do not use in children under 3 years of age without consulting a doctor (see "Do not use Tintura de yodo Reig Jofre", in this section).

Interference with diagnostic tests:

If you are scheduled to undergo any diagnostic tests (including blood and urine analyses, etc.), inform your doctor that you are using this medicine, as it may alter test results.

This medicine may interfere with thyroid function tests and with tests for detecting occult blood in feces and urine.

Other medicines and Tintura de yodo Reig Jofre

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

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

Do not apply this medicine together with other products containing mercury derivatives, as they react with iodine to form irritating compounds.

Also do not use it together with sodium thiosulfate (used for the treatment of fungal infections), as both products inactivate each other. Do not use it together with other substances with which iodine is chemically incompatible.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

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

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

Driving and using machines

The effect of this medicine on the ability to drive and operate machinery is none or negligible.

3. How to use Reig Jofre Iodine Tincture

Follow exactly the instructions for use provided in this leaflet or those given by your doctor, pharmacist, or nurse. If you are unsure, ask your doctor, pharmacist, or nurse.

For cutaneous use.

Recommended dose:

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

To avoid irritation, do not cover the treated area.

Use in children

Do not apply to infants aged 0 to 1 month.

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

If use in children under 30 months is essential, limit it to brief and limited applications, followed by rinsing with sterile water.

If you use more Reig Jofre Iodine Tincture than you should

If an excessive amount of product is applied and irritation occurs, wash the affected area thoroughly with abundant water, discontinue treatment, and if irritation persists, consult a doctor.

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

In cases of accidental ingestion of large amounts of iodine (or prolonged use), the following may occur: abdominal pain, cough, delirium, diarrhea (sometimes with blood), fever, tenderness of teeth and gums, metallic taste, burning sensation in mouth and throat, skin rashes, increased salivation, eye irritation, low blood pressure and circulatory failure, inflammation of the pharynx, throat and surrounding tissues causing breathing difficulties, partial loss of consciousness (stupor), nausea, vomiting, headache, and disturbances in kidney and thyroid function.

In such cases, if the patient is conscious, milk should be administered every 15 minutes to relieve gastric irritation. In addition, to absorb residual iodine, administer cornstarch or 15 mg of flour dissolved in half a liter of water. However, this treatment must NOT be given if the person shows symptoms that make swallowing difficult (such as vomiting, convulsions, or decreased level of consciousness).

If esophageal damage has occurred, gastric lavage or induction of vomiting must not be performed.

In general, treatment consists of supporting respiratory and cardiovascular function.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, go to a medical center, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the name of the medicine 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 produce adverse effects, although not everyone will experience them.

During the period of use of iodine tincture, the following adverse effects have been observed, although their frequency cannot be precisely determined:

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

Allergic reactions may occur, with symptoms such as swelling of the skin and underlying tissues (angioedema), joint pain, bleeding into the skin, significant increase in eosinophils (a type of white blood cells), fever, enlargement of lymph nodes (lymphadenopathy), a disorder causing excessive bruising and bleeding, and hives on the skin (urticaria).

Adverse effects may occur that could become more serious if the product is used for a prolonged period or applied to large wounds or burns, mainly disorders affecting kidney and thyroid function (particularly in children).

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 via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Reig Jofre Iodine Tincture

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

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

Do not store above 25°C.

Do not use this medicine after the expiry date stated on the label and on the packaging, following EXP. The expiry date refers to the last day of the month indicated.

Do not use this medicine if cloudiness of the solution is observed.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This way, you will help protect the environment.

6. Package contents and other information

Composition of Reig Jofre Iodine Tincture

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

Appearance of the medicinal product and contents of the container

The medicine is a cutaneous solution (for use on the skin) with a brown colour.

It is supplied 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)

Tel.: 93 480 67 00

Fax: 93 480 67 24

Date of the most recent review of this leaflet: October 2023.

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