PROSPECTO : INFORMATION FOR THE USER

Folic Acid ASPOL 10 mg capsules

Folic Acid ASPOL is presented in oral capsules and belongs to a group of medications known as antianemic preparations and is indicated for:

• Treatment of disorders that involve a deficiency of folic acid: Megaloblastic anemias, chronic alcoholism, liver cirrhosis, intestinal malabsorption syndromes (congenital, celiac disease, ethanol-induced, intestinal mucosa alterations, tropical and non-tropical sprue, Crohn's disease, surgical resection), and congenital disorders of folate metabolism.

• Prevention and treatment of folic acid deficiencyinpregnant women: As a prevention of neural tube defects (spina bifida, anencephaly, encephalocele) and other congenital defects, especially in women with a history of children or fetuses with these neural tube defects. Prevention and treatment should be initiated four weeks before conception and continued during the first three months of gestation.

Do not take Ácido Fólico ASPOL 10 mg capsules:

• If you are allergic to folic acid or any of the other components of this medication (listed in section 6).
• If you have a vitamin B12 deficiency anemia, as folic acid increases the requirements for this vitamin, exacerbating neurological symptoms.
• Patients with pernicious anemia Addisonian may experience subcutaneous degeneration of the spinal cord.

Warnings and precautions

Be especially careful if you have anemia of unknown origin.

Taking Ácido Fólico ASPOL 10 mg capsules with other medications:

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

Folic acid may decrease plasma concentrations of phenobarbital, phenytoin, primidone, and succinimides by increasing their metabolism and the frequency of seizures. Therefore, concomitant use is not recommended. If necessary, the doctor should closely monitor the patient and adjust the anticonvulsant dose appropriately.

The simultaneous administration of folic acid and chloramphenicol in patients with folate deficiency may antagonize the hematopoietic response to folic acid.

Other medications that may adversely affect the absorption or metabolism of folic acid, potentially producing states of folate deficiency are: zinc supplements, antacids, cholestyramine, colestipol, triamterene, antimalarials, sulfasalazine, corticosteroids (long-term use), oral contraceptives, antiepileptics (carbamazepine or valproic acid), folic acid antagonists (methotrexate, sulfonamides, trimethoprim, pyrimethamine, aminopterin, cotrimoxazole, triamterene), alcohol, or antituberculars.

The needs for folic acid may increase in patients receiving any of these medications. Therefore, before starting treatment with Ácido Fólico ASPOL, the patient's clinical condition should be evaluated, as it may be necessary to adjust the dose.

Interference with diagnostic tests:

The administration of large and continuous doses of folic acid may reduce the concentration of vitamin B12 in the blood.

Taking Ácido Fólico ASPOL 10 mg capsules with food and beverages

Foods and beverages do not affect the effect of Ácido Fólico ASPOL 10 mg capsules.

Pregnancy, lactation, and fertility

Folic acid can be used safely during pregnancy and lactation.

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.

Driving and operating machinery

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

Ácido Fólico ASPOL 10 mg capsules contain lactose

Patients with hereditary intolerance to galactose, Lapp lactase deficiency, or problems with glucose or galactose absorption should not take this medication. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Ácido Fólico ASPOL 10 mg capsules do not contain gluten.

Oral capsules.

The usual therapeutic dose is 10 mg per day.

The capsules should be taken whole with sufficient amounts of water.

Folic acid is administered orally once a day, and its intestinal absorption is not affected by the presence of food.

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:

• Treatment of disorders associated with folic acid deficiency:Initially 10 to 20 mg (1-2 capsules) per day until pharmacological response and hematological normalization are achieved. The daily maintenance dose is 10 mg.

• Treatment of megaloblastic anemia due to folic acid deficiency:10 to 20 mg (1-2

• capsules) per day until pharmacological response and hematological normalization are achieved.

• Prevention and treatment of folic acid deficiencyinpregnant women,especially in women with a history of children or fetuses with these deficiencies in the neural tube (spina bifida, anencephaly, encephalocele) may reduce the risk for the following pregnancies by receiving a folic acid supplement: 10 mg four weeks before conception and continue with 10 mg during the first three months of gestation.

It is recommended to plan the pregnancy, after consulting a doctor, so that, unless contraindicated, 10 mg of folic acid per day is prescribed orally four weeks before conception and during the first three months of gestation.

Prophylactic treatment should always be performed under medical supervision

In established folate deficiency by hematological values in pregnant women: 10 mg per day, continuing throughout pregnancy or until normalization of these values.

Use in children and adolescents

Children 12 to 18 years old: 10 mg once a day. The maintenance dose is 10 mg every 7 days until hematological normalization is achieved.

If you take more Ácido Fólico ASPOL 10 mg capsules than you should

No cases of overdose have been reported.

The usual doses of Ácido Fólico ASPOL 10 mg capsules are well tolerated by the body, and there is no possibility of acute, chronic, or accidental intoxication. When high doses are administered, folic acid is eliminated in the urine.

No cases of overdose have been reported.

In case of accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91.562.04.20.

If you forgot to take Ácido Fólico ASPOL 10 mg capsules

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

If you interrupt treatment with Ácido Fólico ASPOL 10 mg capsules

Your doctor will indicate the duration of treatment with Ácido Fólico ASPOL 10 mg capsules. Do not discontinue treatment even if you feel better, as you will not achieve the expected efficacy.

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 will experience them.

The adverse effects that may appear do so with rare frequency (affect between 1 and 10 of every 10,000 patients):

• Immune System Disorders: Allergic and hypersensitivity reactions such as erythema, pruritus, exanthematous eruptions, general malaise, and bronchial spasm.

Unknown Frequency: Severe Allergic Reaction (Anaphylactic Reaction).

• Gastrointestinal Disorders:Anorexia, nausea, abdominal distension, flatulence, diarrhea, and taste alterations (bitter taste).

• Psychiatric Disorders:Neuro-psychiatric alterations such as sleep disturbances, excitement, cognitive alterations, aggression, mental depression, and confusion.

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 Medication Human Use Pharmacovigilance System. Website: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

No requires special storage conditions.

Store in the original packaging to protect it from light.

Keep this medication out of the sight and reach of children.

Expiration Date:

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.

Disposal of the Medication:

Medications should not be thrown away through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Composition of ACID FOLIC ASPOL 10 mg capsules

• The active ingredient is folic acid. Each capsule contains 10 mg of folic acid.

• The other components are lactose monohydrate, talc, anhydrous colloidal silica, magnesium stearate, gelatin, indigo carmine (E132), quinoline yellow (E104), and titanium dioxide (E171).

• It does not contain gluten.

Appearance of the product and content of the packaging

Folic Acid ASPOL 10 mg capsulesare presented in the form of hard gelatin capsules, with a white body and a green head, containing a fine yellowish powder inside.

The capsules are presented in PVC/PVDC/Aluminum blisters containing 10 capsules.

Each package contains 5 blisters (50 capsules)

Holder of the marketing authorization and responsible for manufacturing

INTERPHARMA, S.A.

C/ Santa Rosa, 6

08921 Santa Coloma de Gramenet (Barcelona)

or

INDUSTRIA QUIMICA Y

FARMACEUTICA VIR, S.A.

Date of the last review of this leaflet

April 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.es