Label: informationfor the user

Yodocefol 200/400/2 microgram tablets

iodine/ folic acid/vitamin B12

Read this label carefully before starting to take this medication because

it contains important information for you.

• Keep this label, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you alone, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

Yodocefol is indicated for the prevention of iodine deficiency disorders (IDD), folate and vitamin B12 deficiency in pregnant women during the first trimester of pregnancy and for one month before conception as a prevention of alterations in the central nervous system development of the fetus (neural tube defects and neurological disorders).

Do not take Yodocefol

• If you are allergic to potassium iodide, folic acid, vitamin B12, or any of the other components of this medication (listed in section 6).

Especially related to potassium iodide:

• If you have acute bronchitis.
• If you have manifest hyperthyroidism (increased thyroid function with symptoms).
• If you have latent hyperthyroidism (increased thyroid function without symptoms), do not take a dose of iodine greater than 150 micrograms per day.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Yodocefol.

-Treatment with Yodocefol in epileptic patients should be done under strict medical supervision.

• This medication contains potassium iodide. Some people are especially sensitive to iodine, so treatment should be initiated with caution.

-This medication, containing potassium iodide, may affect the thyroid gland. Its administration may interfere with thyroid function tests.

-Do not use disinfectants containing iodine for the disinfection of the newborn or pregnant woman.

If you suffer from any of the following diseases, remember to inform your doctor before taking this medication:

• Henoch-Schönlein purpura (inflammation of the blood vessels), goiter (enlargement of the thyroid gland), or autoimmune thyroiditis (enlargement of the thyroid gland), as patients with these diseases may present side effects as a consequence of iodine administration.
• Patients with kidney disease, hyperkalemia (elevated potassium levels in the blood), goiter, or active tuberculosis should exercise special caution when starting treatment.

Other medications and Yodocefol

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

Certain medications may interact with Yodocefol; in these cases, it may be necessary to change the dose, interrupt treatment with one of them, or wait at least 3 hours between administration of both.

It is essential to inform your doctor if you are taking or have taken recently any of the following medications:

• Antacids (medications for acid reflux)
• Chloramphenicol (antibiotic)
• Phenytoin (medication for seizures)
• Antifolic antagonists (methotrexate)
• Fluorouracil (cancer medication)
• Potassium-sparing diuretics
• Lithium salts
• Antithyroid medications (for the treatment of hyperthyroidism)
• Other possible interactions: antiepileptics, estrogens, prolonged use of corticosteroids, trimethoprim/sulfamethoxazole combination (treatment for certain infections), and alcohol abuse.

Interference with diagnostic tests

This medication, containing potassium iodide, may affect the thyroid gland. Its administration may interfere with thyroid function tests.

Inform your doctor that you are taking this medication if you need to undergo a blood or urine test.

Yodocefol with food and beverages

No interactions of Yodocefol with any food or beverage are known.

Pregnancy and lactation

Yodocefol is indicated for the prevention of iodine, folic acid, and vitamin B12 deficiencies before and during pregnancy, as it contains these three active principles in the recommended doses for pregnancy. Administration of potassium iodide, folic acid, and vitamin B12 in doses higher than the recommended daily doses should be done under medical control and evaluating the benefit-risk ratio. If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

No effects on the ability to drive and operate machinery have been observed.

Yodocefol contains lactose and sodium

This medication contains lactose. If your doctor has indicated that you have a certain sugar intolerance, consult with them before taking this medication.

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

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. The usual dose is 1 tablet per day, preferably before meals.

If you take more Yodocefol than you should

If you have taken more Yodocefol than you should or in case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20.

Deliberate or accidental poisoning with this medication is unlikely.

Taking very high doses of this medication as indicated in this leaflet or for long periods of time may cause a metallic taste, burning sensation in the mouth and throat, painful sensitivity in teeth and gums, increased salivation, nasal mucosa irritation, sneezing, and eye irritation with eyelid swelling (symptoms known as "iodism").

It may also cause severe headache, cough, pulmonary edema (accumulation of fluid in the lung), swelling and discomfort of the parotid and submaxillary glands (glands located below the lower jaw), and inflammation of the pharynx, larynx, and tonsils.

In areas of the skin with more fat (seborrheic areas), moderate to severe rashes may appear.

Gastrointestinal irritation is common when high doses are ingested and may cause diarrhea, sometimes with blood in the stool.

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

The use of large doses of potassium iodide or for long periods of time may cause thyroid gland hyperplasia (enlargement), goiter, and severe hypothyroidism (decreased thyroid function).

If you forgot to take Yodocefol

Do not take a double dose to compensate for the missed dose. 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 Yodocefol

Your doctor will indicate the duration of treatment. Do not stop treatment before, as you will not have the expected effectiveness.

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

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

The following adverse effects have been observed, classified by organs and systems and by frequencies. Adverse reactions observed after treatment with Yodocefol are considered rare (may affect up to 1 in 100 people); frequency unknown (cannot be estimated from available data).

Blood and Lymphatic System Disorders

Thrombotic Thrombocytopenic Purpura (blood disorder characterized by low platelet and red blood cell count).

Endocrine System Disorders

Goiter.

Hyper- and Hypothyroidism (abnormal thyroid function).

Gastrointestinal System Disorders

Transient diarrhea, nausea, vomiting, abdominal distension/pain, flatulence (gas), metallic taste, and increased salivation.

Skin and Subcutaneous Tissue Disorders

Itching, skin rash, erythema (inflammatory redness of the skin), urticaria (hives and itching) and angioedema (development of large hives, especially around the eyes, lips, and throat).

Vascular System Disorders

Vasculitis (hypersensitivity reaction to the medication that involves inflammation and damage to skin blood vessels).

Fatal Periarteritis (vascular disease in which small and medium-sized arteries are inflamed and damaged).

Immune System Disorders

Edema (swelling), including facial and laryngeal edema.

Unknown: severe allergic reaction (anaphylactic reaction).

General Disorders and Administration Site Conditions

Hypersensitivity reactions (allergies) and general discomfort.

Reporting of Adverse Effects

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

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.

This medication does not require special conditions for conservation.

Medications 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 point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Yodocefol

The active principles are potassium iodide, folic acid, and vitamin B12(cianocobalamina). Each tablet contains 262 micrograms of potassium iodide (equivalent to 200 micrograms of iodine), 400 micrograms of folic acid (as folic acid hydrate) and 2 micrograms of vitamin B12.

The other components (excipients) are: Lactose monohydrate, microcrystalline cellulose, carboxymethylcellulose sodium (type A) (from potato), calcium stearate, trisodium citrate, citric acid, and maltodextrin.

Appearance of the product and contents of the packaging

Yodocefol is presented in the form of round, yellow-colored tabletsfor oral administration in packs of 28 tablets.

The tablets are arranged following a calendar with the days of the week to facilitate correct administration.

Holder of the marketing authorization

Italfarmaco, S.A.

C/ San Rafael, 3

28108 Alcobendas, Madrid

Spain

Tel.: 91 657 23 23

Responsible for manufacturing

ITALFARMACO S.p.A.

Viale Fulvio Testi, 330

20126 Milan

Italy

Revision date of this leaflet:April 2018

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/.