Leaflet: information for the user

Yoduk Complex tablets

Potassium iodide/ Folic acid/ Cyanocobalamin (Vitamin B12)

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

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

Contents of the leaflet

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

6.Contents of the pack and additional information

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

Yoduk Complex is indicated for the prevention of disorders caused by deficiency of iodine, folic acid, and vitamin B12in women who are planning a pregnancy one month before conception and, at medical discretion, during the first trimester of pregnancy, as a prevention of neural tube defects (of the brain and spinal cord) and neurological disorders (of the nervous system) in the fetus.

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 especially sensitive to iodine, treatment should be initiated with caution.

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

• If you suffer from any of the following diseases, remember to inform your doctor before taking this medication: chronic urticaria or lupus erythematosus, in which vasculitis hypocomplementemia (itchy rash lasting more than a day) has occurred or may occur. They present a risk of experiencing adverse effects as a result of the administration of iodine.

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

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

• Do not use iodine-containing disinfectants for the disinfection of newborns or pregnant women.

Interference with diagnostic tests: If you are going to have any diagnostic test (including blood, urine, 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 old.

Yoduk Complex with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, 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 for urinary tract infections).

• Primidone (medication for epilepsy).
• Pyrimethamine (for treatment of parasitic diseases).
• Diuretics that spare potassium (medication for hypertension).
• Lithium salts (medication used for depression).
• Antithyroid medications (medications used for hyperthyroidism).

Yoduk Complex with food, drinks, 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, as it may reduce the levels of folic acid in the blood.

Pregnancy, breastfeeding, and fertility

If you are pregnant, 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 operating machines

The influence of Yoduk Complex on driving or operating machines is negligible or insignificant.

Yoduk Complex contains sodium and potassium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially “sodium-free”.

Followexactly the administration instructions for this medication as indicated byyour doctor or pharmacist. In case of 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 your doctor's discretion, during the first trimester of pregnancy.

Oral route.

Swallow the tablet with a sufficient amount of water.

Use in children and adolescents

Yoduk Complexis not indicated for children under 14 years old.

If you take more Yoduk Complex than you should

Very high doses of folic acid and vitamin B12compared to Yoduk Complex are well tolerated, so there is no risk of poisoning even in accidental massive ingestion.

In the case of iodine, the administration of high doses (in the range of milligrams) or for long periods of time can produce a condition of iodism, characterized by a metallic taste, burning sensation 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 lower jaw. The pharynx, larynx and tonsils may 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 (eczema) may occur.

Gastric irritation is common whenever very high doses are ingested.

The use of large doses of potassium iodide or for long periods of time can produce hyperplasia (increase) of the thyroid gland, goiter and severe hypothyroidism.

Excessive iodine is harmful to the fetus.

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

If you forgot to take Yoduk Complex

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

If you interrupt the treatment with Yoduk Complex

If you have any other doubts about the use of this medication, ask your doctor, pharmacist or nurse.

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

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

Frequencies are defined as: Very frequent (may affect more than 1 in 10 people); frequent (may affect up to 1 in 10 people); infrequent (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); unknown frequency (cannot be estimated from available data).

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

Infrequent:

• Goiter. Hyper and hypothyroidism.
• Itching, skin eruptions, erythema (skin redness), and acne flare-ups.
• Hypersensitivity, with symptoms such as edema (fluid accumulation) (including facial and laryngeal edema) and symptoms similar to serum sickness (fever, joint pains, lymph node inflammation, etc.), urticaria, blood disorder causing small vessel thrombosis, arterial wall inflammation.
• Irregular heartbeats.

Unknown frequency:

• Severe allergic reaction (anaphylactic reaction).

Reporting Adverse Effects

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

Do not store at a temperature above30°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 that appears on the packaging after CAD.The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection pointof the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Yoduk Complex

• The active principles are:Potassium iodide, Folic acid and Cyanocobalamin (Vitamin B12).

Each tablet contains300 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), Pre-gelatinized cornstarch, Amorphous silica, Dihydrated calcium phosphate, Sodium croscarmellose, Sodium carboxymethyl starch, Low-substitution hydroxypropyl cellulose (E-463), Magnesium stearate (E-572).

Appearance of the product and contents of the packaging

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

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Casen Recordati, S.L.

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

Spain

Responsible for manufacturing:

Laboratorios Toll Manufacturing Services, S.L.

Aragoneses, 2

28108 Alcobendas (Madrid)

Spain

Last review date of this leaflet:October 2018.

Other sources of information

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