ATOVIT FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Atovit Film-Coated Tablets

(Folic Acid, Vitamin B12, Potassium Iodide, Iron)

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, 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 side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What Atovit film-coated tablets are and what they are used for
2. What you need to know before taking Atovit film-coated tablets
3. How to take Atovit film-coated tablets
4. Possible side effects
5. Storage of Atovit film-coated tablets
6. Package contents and additional information

1. What Atovit film-coated tablets are and what they are used for

Atovit film-coated tablets belong to a group of medications that contain vitamins and minerals.

Atovit film-coated tablets are used to prevent disorders caused by iodine deficiency (IDD), folic acid, and vitamin B12 in pregnant women during the first trimester as prophylaxis for neural tube defects and prevention of neurological disorders in the fetus, in women diagnosed with iron deficiency anemia and/or iron deficiency states.

2. What you need to know before taking Atovit film-coated tablets

Do not take Atovit film-coated tablets

• If you are allergic to folic acid, vitamin B12, potassium iodide, iron, or any of the other components of this medication (listed in section 6).
• If you have a peptic ulcer.
• If you have inflammatory bowel disease, including regional enteritis and ulcerative colitis, intestinal stenosis, and diverticula.
• If you have chronic pancreatitis or liver cirrhosis, iron should not be administered.
• If you have diseases related to iron accumulation, such as hemosiderosis, hemochromatosis, and hemoglobinopathies, as well as certain types of anemia related to iron deficiency, such as aplastic anemia, hemolytic anemia, or sideroblastic anemia.
• If you are receiving iron treatment through a vein or if you are receiving blood transfusions.
• If you are receiving treatment with antihypertensive medication (methyldopa) or with antibiotics (chloramphenicol).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Atovit film-coated tablets.

• Because this medication contains potassium iodide and some people are particularly sensitive to iodine, treatment should be started with caution.
• Iodides can affect the thyroid gland, so administration of these preparations may interfere with thyroid function tests.

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

• Diseases affecting your thyroid gland: goiter, hyperthyroidism, autoimmune thyroiditis.
• Diseases related to your immune system: hypocomplementemic vasculitis, chronic urticaria, systemic lupus erythematosus.
• Diseases affecting your kidneys: Addison's disease and dehydration, hyperkalemia.

• If you have some infectious diseases, such as active tuberculosis.
• Due to the iron content, discuss with your doctor if you have:

• If you suffer from anemia, gastroduodenal ulcer, intestinal inflammation, or liver failure.
• If you have a disease related to the hemoglobin of your red blood cells (erythropoietic porphyria).

Medications containing iron can color the stool black and may interfere with tests used to detect blood in the stool.

• Consult your doctor if you are taking medications for epilepsy (phenytoin, phenobarbital, and primidone) or if you are taking medications for Parkinson's disease (levodopa, carbidopa, and entacapone).

Taking Atovit film-coated tablets with other medications

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

Certain medications may interact with Atovit film-coated tablets. 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.

• Vitamin C (ascorbic acid),
• Antibiotic medications used to treat certain infections (tetracycline, minocycline, doxycycline, ciprofloxacin, levofloxacin),
• Medications used to treat HIV infection (dolutegravir),
• Medications used to treat thyroid disorders (thyroxine),
• Medications used to treat Wilson's disease (penicillamine),
• Medications containing aluminum, magnesium, or calcium,
• Medications used to treat high cholesterol levels (cholestyramine),
• Medications used to treat osteoporosis (bisphosphonates),

• Immunosuppressive medications (mycophenolate),
• Medications used to treat thrombocytopenic purpura (eltrombopag),
• Medications that modify urine pH to favor the elimination of kidney stones (acetohydroxamic acid),

It is essential to inform your doctor if you are taking or have recently taken any of the following medications, as their effects or those of Atovit may be modified, or your doctor may need more exhaustive control:

• Anti-ulcer medications and antacids used to treat gastric acidity and gastroduodenal ulcers.
• Medications used to treat epilepsy (phenytoin, phenobarbital, and primidone),
• Medications used to promote urine formation (potassium-sparing diuretics).
• Medications used to treat certain mental disorders (lithium),
• Medications used to treat gout (colchicine),
• Medications used to treat certain intestinal disorders, such as Crohn's disease or ulcerative colitis (aminosalicylic acid, sulfasalazine),
• Folic acid antagonist medications (methotrexate),
• Certain antibiotic medications (nitrofurantoin, cefdinir)

Taking Atovit film-coated tablets with food and beverages

Avoid consuming green and black tea. This medication may be absorbed in smaller amounts when taken with coffee, milk, cereals, calcium supplements, soy, and medications containing bicarbonate, carbonates, oxalates, or phosphates.

Pregnancy and breastfeeding

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

Pregnancy

Atovit film-coated tablets contain folic acid, vitamin B12, iodine, and iron in the recommended doses for pregnancy. Administration to pregnant women of these four active ingredients in doses higher than the recommended daily doses should be done under the decision of your doctor.

Breastfeeding

This medication is not indicated during breastfeeding.

Driving and using machines

The influence of this medication on the ability to drive and use machines is nil or insignificant.

Atovit contains Cochineal Red A

This medication may cause allergic reactions because it contains Cochineal Red A (E-124).

It can cause asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Atovit film-coated tablets

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

The recommended daily dose is 1 tablet per day, taken before meals. Your doctor will determine the duration of treatment with Atovit film-coated tablets. Do not suspend or prolong it.

If you take more Atovit film-coated tablets than you should

High doses of folic acid and vitamin B12, much higher than those of Atovit film-coated tablets, are well tolerated, so intoxication is very unlikely even in case of accidental massive ingestion.

In case of poisoning by the components of Atovit, the symptoms that may occur are alterations in sleep patterns, difficulty concentrating, irritability, hyperactivity, and confusion, due to excess folic acid.

Excess vitamin B12 can cause mild and transient diarrhea, transient exanthema, itching, sensation of generalized swelling, formation of thrombi in small veins, anaphylaxis, pulmonary edema, and heart failure.

In the case of iodine, administration of high doses or for long periods can produce a picture of iodism, characterized by metallic taste, burning in the mouth and throat, painful sensitivity in teeth and gums, increased salivation, inflammation of the nasal mucosa, sneezing, and eye irritation with swelling of the eyelids. It can also cause severe headache, cough, pulmonary edema, and swelling and discomfort of the parotid and submaxillary glands (glands located below the lower jaw). The pharynx, larynx, and tonsils can also become inflamed. In seborrheic areas, moderate eruptions (rashes) may appear, although rarely severe. Gastric irritation is common when very high doses are ingested and can cause diarrhea, sometimes with blood. The use of high doses of potassium iodide or for long periods can cause an increase in the size of the thyroid gland, goiter, and severe hypothyroidism.

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

Regarding excess iron, the initial symptoms are related to the irritating contact of iron with the intestinal mucosa: nausea, vomiting, diarrhea, epigastric pain, hematemesis, and rectorrhagia. This situation can evolve, and subsequent complications are hypotension, coma, liver necrosis, and kidney failure.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service, Telephone 915 620 420, indicating the medication and the amount used.

If you forget to take Atovit film-coated tablets

Do not take a double dose to make up for forgotten doses.

Take the forgotten dose when you remember and take the next doses with the indicated interval between doses (24 hours)

If you interrupt treatment with Atovit film-coated tablets

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

4. Possible side effects

Like all medications, Atovit film-coated tablets can cause side effects, although not everyone experiences them.

Frequencies are established according to the following classification:

Very common(≥ 1/10)

Common(≥ 1/100 to <1>

Uncommon(≥ 1/1,000 to <1>

Rare(≥ 1/10,000 to <1>

Very rare(<1>

Frequency not known(cannot be estimated from available data)

The following side effects have been observed:

Blood and lymphatic system disorders

Uncommon. Thrombotic thrombocytopenic purpura (blood disorder characterized by low platelet count and red blood cells)

Immune system disorders

Uncommon: Edema (including facial and glottal edema)

Rare: Allergic reactions, specifically bronchospasm, erythema, skin rash, and pruritus

Frequency not known: Severe allergic reaction (anaphylactic reaction)

Endocrine disorders

Uncommon: Goiter, hypo- and hyperthyroidism

Vascular disorders

Uncommon: Vasculitis (hypersensitivity to the medication that leads to inflammation and damage to blood vessels in the skin).

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

Gastrointestinal disorders

Uncommon: Transient diarrhea, nausea, vomiting, abdominal swelling/pain, and flatulence.

Acidity, constipation, or diarrhea, and dark-colored stools.

Metallic taste and increased salivation.

Hepatobiliary disorders

Very rare: Elevated liver enzymes

Skin and subcutaneous tissue disorders

Uncommon: Itching, skin eruptions, erythema (inflammatory redness of the skin), urticaria (rash in the form of hives and itching)

General disorders and administration site conditions

Uncommon: Hypersensitivity and general malaise. Signs and symptoms similar to serum sickness: fever, joint pain (arthralgias), lymph node enlargement, and increased number of a type of white blood cell in the blood (eosinophilia).

Reporting of side effects

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

5. Storage of Atovit film-coated tablets

No special storage conditions are required.

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the packaging after "EXP". The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Atovit film-coated tablets

The active ingredients are folic acid, vitamin B12, potassium iodide, and iron. Each film-coated tablet contains 400 micrograms of folic acid, 2 micrograms of vitamin B12, 300 micrograms of potassium iodide, and 30 mg of iron.

The other components are: microcrystalline cellulose, anhydrous colloidal silica, sodium croscarmellose, low-substitution hydroxypropylcellulose, magnesium stearate, Opadry II (partially hydrolyzed polyvinyl alcohol, macrogol 3350, titanium dioxide (E-171), talc, red iron oxide (E-172), yellow iron oxide (E-172), and Cochineal Red A (E-124)), and purified water.

Appearance of the product and package contents

The Atovit film-coated tablets are circular and biconvex.

They are presented in packages of 28 tablets, packaged in opaque PVC/Aluminum blisters.

Marketing authorization holder and manufacturer

Marketing authorization holder

Farmalider SA

C/ La Granja 1

28108 Alcobendas - Madrid

Spain

Manufacturer

Toll Manufacturing Services S.L.

C/ Aragoneses, 2

28108 Alcobendas, Madrid

Spain

or

Farmalider S.A.

C/ Aragoneses 2,

28108 Alcobendas, Madrid

Spain

Date of the last revision of this package leaflet: June 2021

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) https://www.aemps.gob.es/