Patient Information Leaflet: Product Characteristics

ACFOL 5mg Tablets

Folic Acid

Read this leaflet carefully before you start taking this medicine.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others even if their symptoms are the same. It may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and additional information

Acfolbelongs to a group of medications known as antianemic preparations and is indicated for:

• Prevention and treatment of folic acid deficiency in pregnant women as a 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 neural tube defects, during four weeks before conception and the first three months of gestation.
• Treatment of folic acid deficiency that occurs in processes such as megaloblastic anemias, alcoholism, malabsorption syndromes.

Do not take Acfol

• if you are allergic (hypersensitive) to the active ingredient or any of the components of Acfol 5 mg tablets.
• in high doses if you have megaloblastic anemia (a disorder caused by a lack of vitamin B12).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Acfol:

-if you have anemia of unknown origin

Other medications and Acfol

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

Acfol may interact with folic acid antagonists (methotrexate, sulfonamides, trimethoprim, pyrimethamine, aminopterin), antiepileptics, zinc supplements, antacids, cholestyramine, colestipol, triamterene, antimalarials, oral contraceptives, sulfasalazine, antituberculars, long-term corticosteroids, and alcohol.

The simultaneous administration of folic acid or chloramphenicol in patients with folate deficiency may decrease the response to folic acid treatment.

The needs for folic acid may increase if you are taking any of those medications.

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 Acfol with food and beverages

You can take Acfol with or without food.

Pregnancy, breastfeeding, and fertility

Folic acid can be used safely during pregnancy and breastfeeding.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

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

Acfol contains lactose

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

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

Acfol is administered orally, preferably before meals. The recommended dose is:

• Treatment of deficiency states: 1 to 3 tablets daily (5-15 mg of folic acid) in 1-2 doses per day.
• For the treatment of megaloblastic anemia (folate deficiency), a dose of 5mg/day for 4 months is recommended; up to 15 mg may be necessary in cases of poor absorption.
• Prevention of neural tube defects: 1 tablet per day for four weeks before conception and the first three months of pregnancy.

If you take moreAcfolthan you should

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

However, Acfol, at usual doses, is well tolerated by the body, and there is no possibility of acute, chronic, or accidental poisoning.

If you forgot to takeAcfol

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

If you interrupt the treatment with Acfol

Your doctor will indicate the duration of treatment.

Do not discontinue treatment prematurely, as this will not provide the expected efficacy.

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

Like all medications, Acfol may have adverse effects, although not all people will experience them.

The following adverse effects have been observed, classified by organ and system and by frequencies. Frequencies are defined as rare (less than 1 in 10,000 patients)

or unknown frequency (cannot be estimated from available data):

Immune System Disorders:

Unknown:

Severe allergic reaction (anaphylactic reaction).

Skin and Subcutaneous Tissue Disorders:

Rare: Hypersensitivity reactions (allergies), such as skin erythema, pruritus, and in more severe cases, respiratory difficulty associated with bronchospasm.

Gastrointestinal Disorders:

Rare: Gastrointestinal alterations, such as diarrhea, nausea, and/or vomiting.

If you consider that any of the adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, 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 Medicines for Human Use: www.notificaRAM.es By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep out of reach and sight of children.

Store in the original packaging to protect it from light.

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 unused medicines at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Acfol

• The active principle is folic acid. Each tablet contains 5 mg of folic acid (as folic acid hydrate).
• The other components are lactose, cornstarch, magnesium stearate, polyvinylpyrrolidone, talc, and colloidal silica.

Appearance of the product and content of the packaging

Acfol is presented in the form of oral tablets in packaging of 28 and 84 tablets.

Holder of the marketing authorization

ITALFARMACO S.A.

C/ San Rafael, 3- 28108 Alcobendas (Madrid)

Tel.: 916572323

Responsible for manufacturing

ITALFARMACO S.p.A.

Viale Fulvio Testi, 330 – 20126 Milan (Italy)

Date of the last review of this leaflet: November 2020

The detailed information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).