ACFOL 5 mg TABLETS

Introduction

Patient Information Leaflet

ACFOL 5mg tablets

Folic acid

Read the entire leaflet carefully before starting to take the medicine.

• Keep this leaflet as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed to you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What is Acfol and what is it used for
2. What you need to know before taking Acfol
3. How to take Acfol
4. Possible side effects
5. Storage of Acfol

Package contents and additional information

1. What is Acfol and what is it used for

Acfol belongs to a group of medicines called antianemic preparations and is indicated for:

• Prevention and treatment of folic acid deficiency in pregnant women to prevent neural tube defects (spina bifida, anencephaly, encephalocele) and other congenital defects, especially in women with a history of a child or fetus with these defects, for four weeks before conception and the first three months of pregnancy.
• Treatment of folic acid deficiency that occurs in processes such as megaloblastic anemia, alcoholism, and malabsorption syndromes.

2. What you need to know before taking Acfol

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 medicines and Acfol

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those obtained 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, corticosteroids (prolonged use), and alcohol.

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

The need for folic acid may increase if you are taking any of these medicines.

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 drinks

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 medicine.

Driving and using machines

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

Acfol contains lactose

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

3. How to take Acfol

Follow exactly the administration instructions of this medicine 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 5 mg/day is recommended for 4 months; 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 more Acfol than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology 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 intoxication.

If you forget to take Acfol

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

If you stop taking Acfol

Your doctor will indicate the duration of treatment.

Do not stop treatment before, as it will not have the expected efficacy.

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

4. Possible side effects

Like all medicines, Acfol can have side effects, although not everyone will experience them.

The following side effects have been observed, which are classified by organs and systems and by frequency. The frequencies are defined as rare (less than 1 in 10,000 patients) or unknown frequency (cannot be estimated from the available data):

Immune system disorders:

Unknown:

Severe allergic reaction (anaphylactic reaction).

Skin and subcutaneous tissue disorders:

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

Gastrointestinal disorders:

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

If you consider that any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaRAM.es By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Acfol

Keep out of the reach and sight of children.

Store in the original packaging to protect it from light.

Do not use this medicine after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medicines in the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package contents and additional information

Composition of Acfol

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

Appearance of the product and package contents

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

Marketing authorization holder

ITALFARMACO S.A.

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

Phone: 916572323

Manufacturer

ITALFARMACO S.p.A.

Viale Fulvio Testi, 330 – 20126 Milan (Italy)

Date of the last revision of this leaflet: November 2020

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