Yoduk Complex tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Yoduk Complex tablets

Potassium iodide / Folic acid / Cyanocobalamin (Vitamin B12)

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Package leaflet contents

1. What Yoduk Complex is and what it is used for
2. What you need to know before taking Yoduk Complex
3. How to take Yoduk Complex
4. Possible side effects
5. Storage of Yoduk Complex

6. Contents of the container and additional information

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

It contains as active ingredients potassium iodide and two substances belonging to the vitamin B complex group, folic acid and cyanocobalamin (Vitamin B12); this combination may help prevent the occurrence of certain birth disorders caused by deficiency of these components.

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

2. What you need to know before starting to take 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 medicine (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.

• Since this medicine contains potassium iodide and some people are especially sensitive to iodine, treatment should be started with caution.

• Exercise caution if you have acute bronchitis, manifest or latent hyperthyroidism, Addison's disease (a disorder of glands near the kidneys), dehydration, or autoimmune thyroid disease.

• If you suffer from any of the following conditions, always inform your doctor before taking this medicine: chronic urticaria or systemic lupus erythematosus, in which hypocomplementemic vasculitis (itchy rash, usually lasting more than one day) has occurred or may occur. These conditions carry a risk of adverse effects following iodine administration.

• Treatment with Yoduk Complex in patients with epilepsy should be carried out under strict medical supervision.

• Special caution is required when initiating treatment in patients with renal disease, elevated blood potassium levels, or active tuberculosis.

• Iodinated disinfectants must not be used for disinfection of newborns or pregnant mothers.

Interference with diagnostic tests: If you are due to have any diagnostic tests (including blood or urine analyses, etc.), inform your doctor that you are taking this medicine, as it may alter test results. This medicine may affect tests of thyroid function.

Children and adolescents

This medicine is not indicated for children under 14 years of age.

Taking Yoduk Complex with other medicines

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

The following medicines may interact with Yoduk Complex:

• Omeprazole (for peptic ulcers).
• Chloramphenicol (antibiotic).
• Phenytoin, phenobarbital, barbiturates (medicines for epilepsy).
• Methotrexate (medicine for cancer or autoimmune diseases).
• Nitrofurantoin (medicine used for urinary tract infections).
• Primidone (medicine for epilepsy).
• Pyrimethamine (for treatment of parasitic diseases).
• Potassium-sparing diuretics (medicines for hypertension).
• Lithium salts (medicine used for depression).
• Antithyroid drugs (medicines used in hyperthyroidism).

Taking Yoduk Complex with food, beverages, and alcohol

Do not consume alcohol with this medicine, as it may reduce blood levels of folic acid.

Do not drink green or black tea with this medicine, as they may reduce blood levels of folic acid.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

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

Lactation

Do not take Yoduk Complex if you are breastfeeding.

Driving and use of machines

The influence of Yoduk Complex on driving or use of machines is negligible or none.

Yoduk Complex contains sodium and potassium

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

3. How to take Yoduk Complex

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

The recommended duration of treatment is 1 month, starting before conception (or when pregnancy is planned) and, at your doctor's discretion, continuing throughout the first trimester of pregnancy.

For oral use.

Swallow the tablet with sufficient water.

Use in children and adolescents

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

If you take more Yoduk Complex than you should

Very high doses of folic acid and vitamin B12 than those contained in Yoduk Complex are well tolerated, so poisoning is unlikely even after accidental massive ingestion.

Regarding iodine, administration of high doses (milligram range) or over long periods of time may cause a condition known as iodism, characterized by a metallic taste, mouth burning, painful sensitivity of teeth and gums, increased salivation, sneezing, and eye irritation with eyelid swelling. Severe headache, cough, pulmonary edema, and swelling and discomfort of glands located below the lower jaw may also occur. The pharynx, larynx, and tonsils may become inflamed as well.

Signs and symptoms of iodism usually resolve spontaneously within a few days after discontinuation of treatment.

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

Gastric irritation is common whenever very high doses are ingested.

The use of large doses of potassium iodide or prolonged administration may lead to hyperplasia (enlargement) of the thyroid gland, goiter, and severe hypothyroidism.

Excess iodine is harmful to the fetus.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, stating the name of the medicine 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 missed doses. Simply take the missed dose as soon as you remember, and take the following doses at the recommended intervals (24 hours apart).

If you stop taking Yoduk Complex

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 can cause adverse effects, although not everyone will experience them.

Adverse effects are classified by organs and systems and by frequencies.

Frequencies are defined as follows: 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 the available data).

In general, the adverse reactions of the active substances in this medicine are uncommon with oral administration and at the recommended dose:

Uncommon:

• Goiter. Hyper and hypothyroidism.
• Itching, skin rashes, erythema (redness of the skin), and worsening of acne.
• Hypersensitivity, with symptoms such as edema (fluid accumulation) (including facial edema and glottis edema) and serum sickness-like symptoms (fever, joint pain, lymph node swelling, etc.), urticaria, blood disorder causing clots in small vessels, inflammation of the arterial wall.
• Irregular heartbeats.

Frequency not known:

• Severe allergic reaction (anaphylactic reaction).

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor, pharmacist, or nurse, even if it is an adverse reaction not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Yoduk Complex

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

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

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

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Yoduk Complex

• The active substances 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).

• Other components (excipients): microcrystalline cellulose (E-460), pregelatinized corn starch, amorphous silica, dicalcium hydrogen phosphate dihydrate, sodium croscarmellose, sodium carboxymethyl starch (potato), low-substituted hydroxypropylcellulose (E-463), magnesium stearate (E-572).

Appearance of the product and contents of the pack

Yoduk Complex is presented as yellowish tablets with pinkish-brown speckles, round in shape.

Each pack contains 28 tablets in opaque PVC/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 most recent review of this leaflet: October 2018.

Other sources of information

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