Label: information for the user

Yofolvit 200/400/2 microgram tablets

iodine/ folic acid/vitamin B12

Read this label carefully before starting to take this medication, as 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 only for you, 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.

Yofolvit 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 during one month before conception for the prevention of alterations in the development of the central nervous system of the fetus (neural tube defects and neurological disorders).

Do not take Yofolvit

• 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 overt 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 Yofolvit.

• Treatment with Yofolvit 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 neonate or pregnant woman disinfection.

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

• Hypocomplementemic vasculitis (inflammation of the blood vessels), goiter (increase in the size of the thyroid gland), or autoimmune thyroiditis (increase in the size of the thyroid gland), as patients with these diseases may present secondary effects as a consequence of iodine administration.
• Patients with renal diseases, hyperkalemia (elevated potassium levels in the blood), goiter, or active tuberculosis should exercise special caution when starting treatment.

Other medications and Yofolvit

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

Certain medications may interfere with Yofolvit; 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:

• Antiulcer medications (medications for acid reflux)
• Chloramphenicol (antibiotic)
• Phenytoin (medication for seizures)
• Folic acid antagonists (methotrexate)
• Fluorouracil (cancer medication)
• Potassium-sparing diuretics
• Lithium salts
• Antithyroid medications (for the treatment of hyperthyroidism)
• Other possible interactions: antiepileptic medications, 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 have to undergo a blood or urine test.

Yofolvit with food and beverages

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

Pregnancy and lactation

Yofolvit 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 daily 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.

Yofolvit contains lactose and sodium

This medication contains lactose. If your doctor has indicated that you have a certain sugar intolerance, consult with him 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 normal dose is 1 tablet per day, preferably before meals.

If you take more Yofolvit than you should

If you have taken more Yofolvit 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 or for long periods of timemay 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 (fluid accumulation in the lung)and swelling and discomfort of the parotid and submaxillary glands (glands located below the lower jaw). The pharynx, larynx, and tonsils may also become inflamed.

In fatty skin areas (seborrheic areas)moderate to severe rashes may appear.

Gastrointestinal irritationis common when high doses are ingested and may cause diarrhea, sometimeswith blood in the stool.

The 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 Yofolvit

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 (24 hours).

If you interrupt treatment with Yofolvit

Your doctor will indicate the duration of treatment. Do not stop treatment prematurely, as you will not achieve 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 all people may experience them.

The following adverse effects have been observed, classified by organs and systems and by frequencies. Adverse reactions observed after treatment with Yofolvit 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 counts).

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

Vascular 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 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 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 packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Yofolvit

The active principles are potassium iodide, folic acid, and vitamin B 12 (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 B 12 .

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

Appearance of the product and content of the packaging

Yofolvit is presented in the form of yellow-colored, circular tablets , for 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 title

Logogen Pharmaceutical Laboratories, 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

For more information about this medication, please contact the local representative of the marketing authorization holder:

Italfarmaco, S.A.

C/ San Rafael 3

28108 Alcobendas, Madrid

Spain

Last review date of this leaflet: April 2018

For detailed and updated information about this medication, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/ .