FOLIC ACID ASPOL 10mg HARD CAPSULES

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Folic Acid ASPOL 10 mg capsules

Contents of the pack and other information:

1. What Folic Acid ASPOL 10 mg hard capsules are and what they are used for.
2. What you need to know before you take Folic Acid ASPOL 10 mg hard capsules.
3. How to take Folic Acid ASPOL 10 mg hard capsules.
4. Possible side effects.
5. Storage of Folic Acid ASPOL 10 mg capsules.
6. Contents of the pack and other information.

1. What Folic Acid ASPOL 10 mg capsules are and what they are used for

Folic Acid ASPOL is presented in capsules for oral use and belongs to a group of medicines called antianemic preparations and is indicated in:

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

• Prevention and treatment of folic acid deficiencyin pregnant women: as prevention of neural tube defects (spina bifida, anencephaly, encephalocele) and other congenital defects, especially in women with a history of a child or fetus with these deficiencies in the neural tube. Prevention and treatment should be started four weeks before conception and continued during the first three months of gestation.

2. What you need to know before you take Folic Acid ASPOL 10 mg capsules

Do not take Folic Acid ASPOL 10 mg capsules:

• If you are allergic to folic acid or any of the other ingredients of this medicine (listed in section 6).
• If you have a vitamin B12 deficiency anemia, since folic acid increases the requirements of this vitamin, worsening neurological symptoms.
• Patient with Addisonian pernicious anemia may produce combined subacute degeneration of the spinal cord.

Warnings and precautions

Be particularly careful if you have an anemia of unknown origin.

Taking Folic Acid ASPOL 10 mg capsules with other medicines:

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

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

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

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

The need for folic acid may increase in patients who are administered any of these medicines. Therefore, before starting treatment with Folic Acid 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 Folic Acid ASPOL 10 mg capsules with food and drinks

Food and drinks do not affect the effect of Folic Acid ASPOL 10 mg capsules.

Pregnancy, breastfeeding, and fertility

Folic acid can be used safely during pregnancy and breastfeeding.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

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

Folic Acid ASPOL 10 mg capsules contain lactose

Patients with hereditary galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

Folic Acid ASPOL 10 mg capsules do not contain gluten.

3. How to take Folic Acid ASPOL 10 mg capsules

Capsules for oral use.

The usual therapeutic dose is 10 mg per day.

The capsules should be taken whole with enough water.

Folic acid is administered orally in a single daily dose, and its intestinal absorption is not affected by the presence of food.

Follow exactly the administration instructions of this medicine indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

• Treatment of disorders that involve a deficiency of folic acid: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 deficiencyin pregnant women,especially in women with a history of a child or fetus with these deficiencies in the neural tube (spina bifida, anencephaly, encephalocele) may reduce the risk for subsequent pregnancies by receiving a folic acid supplement in their diet: 10 mg four weeks before conception and continuing with 10 mg during the first three months of gestation.

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

Prophylactic treatment should always be carried out under supervision.

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

Use in children and adolescents

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

If you take more Folic Acid ASPOL 10 mg capsules than you should

No cases of overdose are known.

Usual doses of Folic Acid 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 Toxicology Information Service, phone: 91.562.04.20.

If you forget to take Folic Acid ASPOL 10 mg capsules

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

If you stop taking Folic Acid ASPOL 10 mg capsules

Your doctor will indicate the duration of treatment with Folic Acid ASPOL 10 mg capsules. Do not stop treatment before, even if you feel better, as it will not have the expected efficacy.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Side 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, exanthematic eruptions, general malaise, and bronchospasm.

Frequency not known: Severe allergic reaction (anaphylactic reaction).

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

• Psychiatric disorders:neuropsychiatric alterations such as sleep disturbances, excitement, cognitive alterations, aggressiveness, mental depression, and confusion.

If you experience any side effect, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines. Website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Folic Acid ASPOL 10 mg capsules

No special storage conditions are required.

Keep in the original package to protect from light.

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

Expiry date:

Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Disposal of the medicine:

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Folic Acid ASPOL 10 mg capsules

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

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

• Does not contain gluten.

Appearance of the product and contents of the pack

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 pack contains 5 blisters (50 capsules)

Marketing authorization holder and manufacturer

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 revision of this leaflet

April 2018

Other sources of information

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