Folic acid Aspol 10 mg hard capsules

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Folic Acid ASPOL 10 mg capsules

Package leaflet:

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

1. What is Folic Acid ASPOL 10 mg capsules and what is it used for

Folic Acid ASPOL is presented in capsules for oral use and belongs to a group of medicines known as antianaemic preparations. It is indicated for:

• Treatment of conditions associated with folic acid deficiency: Megaloblastic anaemias, chronic alcoholism, hepatic cirrhosis, intestinal malabsorption syndromes (congenital, coeliac disease, ethanol-induced, intestinal mucosa disorders, tropical and non-tropical sprue, Crohn's disease, surgical resection), and congenital disorders of folate metabolism.

• Prevention and treatment of folic acid deficiency in pregnant women: for the prevention of neural tube defects (spina bifida, anencephaly, encephalocele) and other congenital abnormalities, particularly in women with a history of a child or fetus affected by such neural tube defects. Prevention and treatment should begin four weeks before conception and continue throughout the first three months of pregnancy.

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

Do not take Folic Acid ASPOL 10 mg capsules:

• If you are allergic to folic acid or to any of the other ingredients of this medicine (listed in section 6).
• If you have anemia due to vitamin B12 deficiency, as folic acid increases the requirements for this vitamin, thereby worsening neurological symptoms.
• In patients with Addisonian pernicious anemia, combined subacute degeneration of the spinal cord may occur.

Warnings and precautions

Exercise particular caution if you have anemia of unknown origin.

Taking Folic Acid ASPOL 10 mg capsules with other medicines:

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

Folic acid may reduce plasma concentrations of phenobarbital, phenytoin, primidone, and succinimides by increasing their metabolism, which may lead to an increased frequency of convulsive seizures. Therefore, concomitant use with these medicines is not recommended. If necessary, your doctor should closely monitor you and appropriately adjust the dose of your anticonvulsant medication.

Concomitant 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 causing folate deficiency, include: 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, and antituberculosis agents.

The requirements for folic acid may increase in patients taking any of these medicines. Therefore, before starting treatment with Folic Acid ASPOL, the patient's clinical condition should be evaluated, as a dose adjustment may be necessary.

Interference with diagnostic tests:

Administration of high and continuous doses of folic acid may reduce blood vitamin B12 concentrations.

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 become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

No effects on the ability to drive or operate machinery have been reported.

Folic Acid ASPOL 10 mg capsules contains lactose

Patients with hereditary galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine. If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

Folic Acid ASPOL 10 mg capsules does 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 swallowed whole with sufficient water.

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

Follow exactly the administration instructions for this medicine as indicated by your doctor. If in 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) daily 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) daily until pharmacological response and hematological normalization are achieved.

• Prevention and treatment of folic acid deficiency in pregnant women: Women with a history of a child or fetus affected by neural tube defects (spina bifida, anencephaly, encephalocele) can reduce the risk in subsequent pregnancies by receiving a dietary supplement of folic acid: 10 mg four weeks before conception and continuing with 10 mg during the first three months of pregnancy.

It is recommended to plan pregnancy following medical advice, so that, unless contraindicated, 10 mg of folic acid daily orally is prescribed starting four weeks before conception and continuing during the first three months of gestation.

Prophylactic treatment should always be carried out under medical supervision.

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

Use in children and adolescents

Children aged 12 to 18 years: 10 mg once daily. The maintenance dose is 10 mg once weekly 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 risk of acute, chronic, or accidental intoxication. When high doses are administered, folic acid is excreted in the urine.

No cases of overdose have been reported.

In case of accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 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 missed doses.

If you stop taking Folic Acid ASPOL 10 mg capsules

Your doctor will advise you on the duration of treatment with Folic Acid ASPOL 10 mg capsules. Do not discontinue treatment prematurely, even if you feel better, as the expected efficacy may not be achieved.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

The adverse effects that may occur do so rarely (affecting between 1 and 10 out of every 10,000 patients):

• Immune system disorders: Allergic and individual hypersensitivity reactions such as erythema, pruritus, exanthematous rashes, general malaise, and bronchospasm.

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

• Gastrointestinal disorders: Anorexia, nausea, abdominal distension, flatulence, diarrhoea, and taste disturbances (bitter taste).

• Psychiatric disorders: Neuropsychiatric disturbances such as sleep disorders, excitement, cognitive disturbances, aggressiveness, 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products. Website: www.notificaRAM.es. By reporting adverse 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 container to protect it from light.

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

Expiry:

Do not use this medicine after the expiry date stated on the container after EXP. The expiry date refers to the last day of the month indicated.

Disposal of the medicine:

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of ÁCIDO Ácido Fólico ASPOL 10 mg capsules

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

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

• Does not contain gluten.

Appearance of the product and contents of the container

Ácido Fólico ASPOL 10 mg capsules are presented as hard gelatin capsules, with a white body and a green cap, containing inside a yellowish fine powder.

The capsules are supplied 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 most recent revision of this leaflet

April 2018

Other sources of information

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.es