Leaflet: information for the user

NATIFAR 200/400/2 micrograms tablets

Iodine/ folic acid/ vitamin B12

Read this 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, consult your doctor or pharmacist.
• 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 or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What isNATIFARand what it is used for

2. What you need to know before you start takingNATIFAR

3. How to takeNATIFAR

4. Possible side effects

5. Storage ofNATIFAR

6. Contents of the pack and additional information

It contains as active principles, iodine (as potassium iodide) and two substances belonging to the group of vitamins of the B complex, folic acid and cyanocobalamin (vitamin B12).

Natifar is indicated for the prevention of disorders due to iodine deficiency, folic acid deficiency, and vitamin B12 deficiency in women who are planning a pregnancy, one month before conception and, at the discretion of a doctor, during the first trimester of pregnancy,as prophylaxis for developmental deficiencies of the nervous system in the fetus (neural tube defects and neurological disorders).

Do not take NATIFAR

• if you are allergic to iodine (or potassium iodide), folic acid, vitamin B12, 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 Natifar.

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 hormonal deficiency caused by damage to the adrenal gland), dehydration, or autoimmune thyroid disease.

If you have any of the following diseases: chronic urticaria (a skin disease that produces skin eruptions in the form of hives or welts), systemic lupus erythematosus (an autoimmune disease that can affect many organs) or hypocomplementemic vasculitis (skin lesions similar to urticaria produced by inflammation of blood vessels), inform your doctor before taking this medication as it may cause significant adverse effects.

Natifar treatment in epileptic patients should be done under strict medical supervision.

Be especially cautious when starting treatment in patients with kidney disease, hyperkalemia (elevated potassium levels) or active tuberculosis.

Do not use iodine-containing disinfectants for neonate or pregnant woman disinfection.

Interference with analytical tests

If you are to undergo any diagnostic test (including blood, urine, skin tests using allergens, 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.

Taking NATIFAR with other medications

Inform your doctor or pharmacist if you are using, have used recently or may have to use any other medication.

Certain medications may interfere with Natifar. 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 such as omeprazole (medications for acid reflux)
• Chloramphenicol (antibiotic)
• Phenytoin, phenobarbital, barbiturates (medication for seizures)
• Methotrexate (medication for cancer or autoimmune diseases)
• Nitrofurantoin (medication for urinary tract infections)
• Primidone (medication for epilepsy)
• Pirimethanamine (medication for parasitic diseases)
• Potassium-sparing diuretics (medications for hypertension)
• Lithium salts (medications for psychiatric diseases)
• Antithyroid medications (medications used in hyperthyroidism)

Taking NATIFAR with food, drinks, and alcohol

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

Do not take green or black tea with this medication, as it may reduce blood levels of folic acid.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

Natifar is indicated before and during pregnancy, but the recommended dose should not be exceeded.

Since iodine crosses the placental barrier and the fetus is sensitive to pharmacologically active doses of iodine, no iodine doses should be administered at the milligram level.

Breastfeeding

Potassium iodide passes into breast milk. Natifar has no indication for use during breastfeeding.

Driving and operating machinery

The influence of Natifar on driving or operating machinery is negligible or insignificant.

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

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

Administer orally with sufficient amount of water.

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

Use in children and adolescents

Natifar is not indicated for children under 14 years old.

If you take more NATIFAR than you should

Deliberate or accidental overdose is unlikely. High-dose administration (range of milligrams) or prolonged periods of time may cause manifestations of iodism such as metallic taste, burning sensation in the mouth and throat, painful sensitivity in teeth and gums, increased salivation, nasal and eye mucosa irritation. It may also cause severe headache, productive cough, pulmonary edema (fluid accumulation in the lung) and swelling, and discomfort in salivary glands. The pharynx, larynx, and tonsils may become inflamed.

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

Gastric irritation is common whenever high doses are ingested and may cause diarrhea.

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

The use of large doses of potassium iodide or for prolonged periods of time may cause thyroid gland hyperplasia (increase), thyroid adenoma (benign tumor), goiter, or severe hypothyroidism.

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.

If you forgot to take NATIFAR

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 (24 hours).

If you interrupt the treatment with NATIFAR

Your doctor will determine the treatment duration with Natifar. Do not suspend or prolong it.

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

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

The less common adverse effects (which may affect up to 1 in 100 people) are:

• Allergic reactions, with skin eruptions accompanied by itching, redness, and symptoms such as edema (swelling), including facial and laryngeal edema, and symptoms similar to serum sickness (fever, arthralgias (joint pain), lymph node enlargement, eosinophilia (an increase in a type of white blood cell, eosinophils), urticaria (hives and itching), thrombocytopenic purpura (a blood disorder characterized by low platelet and red blood cell counts), fatal periarteritis (a vascular disease in which small and medium-sized arteries become inflamed and damaged).
• Goiter (enlargement of the thyroid gland).
• Hyperthyroidism (very high levels of thyroid hormones) and hypothyroidism (very low levels of thyroid hormones).
• Irregular heartbeats.

The adverse effects of unknown frequency are:

• Severe allergic reaction (anaphylactic reaction).

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.

No special conservation conditions are required.

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 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 NATIFAR

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

-The other components (excipients) are: mannitol (E-421), microcrystalline cellulose, sodium glycolate starch, anhydrous colloidal silica, magnesium stearate, and maltodextrin.

Appearance of the product and contents of the packaging

Yellow-colored, round tablets.

Each package contains 28 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

DESMA Pharmaceutical Laboratory SL

Paseo de la Castellana 121,Escalera Izquierda 3ºB

28046 Madrid

Spain

Responsible for manufacturing:

FINE FOODS AND PHARMACEUTICALS N.T.M., S.P.A.

Via Grignano, 43

24041 Brembate (BG)

Italy

Last review date of this leaflet: May 2024.

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/