Prospecto:Information for the User

Iodine Reig Jofre 20 mg/ml Topical Solution

Iodine

Read this entire prospect carefully before starting to use this medication, because it contains important information for you.

Follow exactly the medication administration instructions contained in this prospect or those indicated by your doctor, pharmacist, or nurse.

• Keep this prospect, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.

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

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

1.What is Iodine Reig Jofre and what is it used for

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

3.How to use Iodine Reig Jofre

4.Possible adverse effects

5Storage of Iodine Reig Jofre

6.Contents of the package and additional information

Iodine, the active principle of the iodine tincture, presents an antiseptic action against a wide variety of microorganisms, including fungi. It acts by destroying them.

It is a general skin antiseptic for use in small superficial wounds and for skin disinfection before venous puncture (blood extraction from a vein) or before a surgical intervention.

Do not useTintura de yodo 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 (0 to 1 month).

Warnings and precautions

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

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

• Protect from heat; highly flammable.
• Iodine is inactivated by alkaline pH, light, and heat.
• Avoid contact with the eyes, ears, and other mucous membranes.
• Do not use adhesive bandages on the treated area, to avoid the iodine causing burns on the occluded skin.
• This medication may stain the skin and clothing. Apply water to remove the stain from the skin. For 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 Tintura de yodo Reig Jofre", in this section).

Interference with analytical tests:

If you are 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 may interfere with thyroid function tests and tests for occult blood in stool and urine.

Other medications and Tintura de yodo Reig Jofre

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

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

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

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

Pregnancy,lactation,and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

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

Women breastfeeding should avoid using this medication on extensive skin areas 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 operating machinery

The influence of this medication on the ability to drive and operate machinery is negligible or insignificant.

Follow exactly the medication administration instructions contained in this leaflet or those 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 in children under 30 months is unavoidable, it will be limited to a brief and limited application, followed by a rinse with sterile water.

If you use moreTintura de yodo Reig Jofrethan you should

In the event of excessive application of the product and irritation occurs, wash the affected area with plenty of water, discontinue treatment and, if irritation continues, consult a doctor.

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

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

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, they should be given cornstarch or 15 mg of flour dissolved in half a liter of water. However,, DO NOT administer this treatment if the person presents symptoms that make swallowing difficult (such as vomiting, convulsions or decreased consciousness).

If the patient suffers esophageal damage, the stomach lavage or induced vomiting cannot be performed.

Generally, 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you have any other doubts about the use of thismedication, ask your doctor,pharmacistor nurse.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

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

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

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

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is possible adverse effects that do not appear in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use: www.notificaram.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keepthis medicationout 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 25º C.

Do not usethis medicationafter the expiration date that appears onthe label and on the packagingafter CAD. The expiration date is the last day of the month indicated.

Do not usethis medicationif you observe turbidity in the solution.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGREcollection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofTintura de yodo Reig Jofre

• The active ingredient 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 product and contents of the packaging

The medicine is a topical solution (for use on the skin); brown in color.

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

Holder of the marketing authorization and responsible for manufacturing

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 last review of this leaflet:October 2023.

The detailed information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.