YODUK COMPLEX TABLETS

1. What Yoduk Complex is and what it is used for

It contains potassium iodide and two substances belonging to the group of B vitamins, folic acid, and cyanocobalamin (Vitamin B12); this combination may prevent the occurrence of certain birth defects caused by a deficiency of these components.

Yoduk Complex is indicated for the prevention of iodine, folic acid, and vitamin B12 deficiency disorders in women who are planning a pregnancy one month before conception and, at the doctor's discretion, during the first trimester of pregnancy, as a prevention of neural tube defects (brain and spinal cord) and neurological disorders (nervous system) in the fetus.

2. What you need to know before taking Yoduk Complex

Do not take Yoduk Complex:

• if you are allergic to potassium iodide, folic acid, cyanocobalamin, cobalt, or any of the other components of this medication (listed in section 6).
• If you have goiter (enlargement of the thyroid gland).

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Yoduk Complex.

• Because this medication contains potassium iodide and some people are particularly sensitive to iodine, treatment should be started with caution.

• You should be cautious: If you have acute bronchitis, overt or latent hyperthyroidism, Addison's disease (disorder of the glands near the kidneys), dehydration, or autoimmune thyroid disease.

• If you suffer from any of the following diseases, always inform your doctor before taking this medication: chronic urticaria or lupus erythematosus, in which vasculitis hypocomplementemia (hives with itching, usually lasting more than one day) has occurred or may occur. They are at risk of experiencing side effects as a result of iodine administration.

• Treatment with Yoduk Complex in epileptic patients should be done under strict medical supervision.

• Special caution should be exercised when starting treatment in patients with kidney disease, high potassium levels in the blood, or active tuberculosis.

• Iodized disinfectants should not be used for the disinfection of the newborn or the pregnant mother.

Interference with analytical tests: If you are going to have any diagnostic tests (including blood tests, urine tests, etc.), inform your doctor that you are taking this medication, as it may alter the results. This medication may affect thyroid function tests.

Children and Adolescents

This medication is not indicated in children under 14 years of age.

Taking Yoduk Complex with other medications

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

Some of the following medications may interact with Yoduk Complex:

• Omeprazole (for digestive ulcers).
• Chloramphenicol (antibiotic).
• Phenytoin, phenobarbital, barbiturates (medication for epilepsy).
• Methotrexate (medication for cancer or autoimmune diseases).

• Nitrofurantoin (medication used in urinary tract infections).
• Primidone (medication for epilepsy).
• Pyrimethamine (for the treatment of parasitic diseases).
• Potassium-sparing diuretics (medication for hypertension).
• Lithium salts (medication used for depression).
• Antithyroid medications (medications used for hyperthyroidism).

Taking Yoduk Complex with food, beverages, and alcohol

Do not take alcohol with this medication, as it may reduce the levels of folic acid in the blood.

Do not take green and black tea with this medication because they may reduce the levels of folic acid in the blood.

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.

Pregnancy

This medication is indicated during pregnancy, but the recommended dose should not be exceeded.

Breastfeeding

Do not take Yoduk Complex if you are breastfeeding a baby.

Driving and Using Machines

The influence of Yoduk Complex on driving or using machines is nil or insignificant.

Yoduk Complex contains sodium and potassium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; this is, essentially "sodium-free".

3. How to take Yoduk Complex

Follow the administration instructions of this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is 1 tablet per day, preferably taken before a meal.

The recommended treatment duration is 1 month before conception (or when planning a pregnancy) and, at the doctor's discretion, during the first trimester of pregnancy.

Oral route.

Swallow the tablet with enough water.

Use in Children and Adolescents

Yoduk Complex is not indicated in children under 14 years of age.

If you take more Yoduk Complex than you should

Very high doses of folic acid and vitamin B12, higher than those of Yoduk Complex, are well tolerated, so there is no risk of intoxication even with accidental massive ingestion.

In the case of iodine, administration of high doses (in the range of milligrams) or for long periods may produce a picture of iodism, characterized by metallic taste, burning in the mouth, painful sensitivity in teeth and gums, increased salivation, sneezing, and eye irritation with swelling of the eyelids. It can also cause severe headache, cough, pulmonary edema, and swelling and discomfort of the glands located below the jaw.

The pharynx, larynx, and tonsils can also become inflamed.

The signs and symptoms of iodism usually disappear spontaneously after a few days of discontinuing treatment.

In seborrheic areas, moderate eruptions may appear, rarely severe eruptions (rashes).

Gastric irritation is common when very high doses are ingested.

The use of high doses of potassium iodide or for long periods may cause hyperplasia (increase) of the thyroid gland, goiter, and severe hypothyroidism.

Excess iodine is harmful to the fetus.

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

If you forget to take Yoduk Complex

Do not take a double dose to make up for forgotten doses. Simply take the forgotten dose when you remember and take the next doses with the indicated interval between doses (24 hours).

If you stop taking Yoduk Complex

If you have any other questions 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.

Side effects are classified by organs and systems and by frequency.

Frequencies are defined as: Very common (may affect more than 1 in 10 people); common (may affect up to 1 in 10 people); uncommon (may affect up to 1 in 100 people); rare (may affect up to 1 in 1,000 people); very rare (may affect up to 1 in 10,000 people); frequency not known (cannot be estimated from available data).

In general, the adverse reactions of the active ingredients of this medication are uncommon by oral route and at the recommended dose:

Uncommon:

• Goiter. Hyperthyroidism and hypothyroidism.
• Itching, skin rashes, erythema (redness of the skin), and exacerbation of acne.
• Hypersensitivity, with symptoms such as edema (fluid accumulation) (including facial edema and glottis edema) and symptoms similar to serum sickness (fever, joint pain, lymph node inflammation, etc.), urticaria, blood disorder that causes clots in small vessels, inflammation of the arterial wall.
• Irregular heartbeat.

Frequency not known:

• Severe allergic reaction (anaphylactic reaction).

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is not listed in this package leaflet. You can also report them directly through the Spanish Medicines Monitoring System: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Yoduk Complex

Do not store above 30°C. Store in the outer packaging.

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

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

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Contents of the Package and Additional Information

Composition of Yoduk Complex

• The active ingredients are: Potassium Iodide, Folic Acid, and Cyanocobalamin (Vitamin B12).

Each tablet contains 300 micrograms of potassium iodide, equivalent to 229.35 micrograms of iodine, 400 micrograms of folic acid, and 2 micrograms of cyanocobalamin (Vitamin B12).

• The other components (excipients) are: microcrystalline cellulose (E-460), pregelatinized corn starch, amorphous silica, calcium hydrogen phosphate dihydrate, sodium croscarmellose, potato starch carboxymethylcellulose (E-463), low-substituted hydroxypropylcellulose (E-463), magnesium stearate (E-572).

Appearance of the Product and Package Contents

Yoduk Complex is presented in the form of tablets, which are round and yellowish in color with brown-pink speckles.

Each package contains 28 tablets, in PVC opaque/Aluminum blisters.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Casen Recordati, S.L.

Autovía de Logroño, km. 13,300. 50180 Utebo (Zaragoza)

Spain

Manufacturer:

Laboratorios Toll Manufacturing Services, S.L.

Aragoneses, 2

28108 Alcobendas (Madrid)

Spain

Date of the Last Revision of this Package Leaflet:October 2018.

Other Sources of Information

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