Acfol 5 mg tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
ACFOL 5mg tablets
folic acid
Read the entire 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 and should not be given to other people, even if they have the same symptoms, as it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
Leaflet contents
- What ACFOL is and what it is used for
- What you need to know before taking ACFOL
- How to take ACFOL
- Possible side effects
- How to store ACFOL
Pack contents and additional information
1. What Acfol is and what it is used for
Acfol belongs to a group of medicines called antianaemic preparations and is indicated for:
- Prevention and treatment of folic acid deficiency in pregnant women, as prevention of neural tube defects (spina bifida, anencephaly, encephalocele) and other congenital abnormalities, 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 pregnancy.
- Treatment of folic acid deficiency occurring in conditions such as megaloblastic anaemias, alcoholism, and malabsorption syndromes.
2. What you need to know before starting to take Acfol
Do not take Acfol
- if you are allergic (hypersensitive) to the active substance or to any of the components of Acfol 5 mg tablets.
- in high doses if you have megaloblastic anaemia (a disorder caused by vitamin B12 deficiency).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before starting to take Acfol:
- if you have anaemia of unknown origin.
Other medicines and Acfol
Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.
Acfol may interact with folic acid antagonists (methotrexate, sulfonamides, trimethoprim, pyrimethamine, aminopterine), antiepileptics, zinc supplements, antacids, cholestyramine, colestipol, triamterene, antimalarials, oral contraceptives, sulfasalazine, antituberculosis agents, corticosteroids (long-term use), and alcohol.
Concomitant administration of folic acid or chloramphenicol in patients with folate deficiency may reduce the response to folic acid treatment.
The requirement for folic acid may increase if you are taking any of these medicines.
Interference with diagnostic tests:
Administration of large and continuous doses of folic acid may reduce the blood concentration of vitamin B12.
Taking Acfol with food and drink
You may take Acfol with or without food.
Pregnancy, breastfeeding, and fertility
Folic acid may be safely used 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 or operate machinery have been reported.
Acfol contains lactose
This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.
3. How to take Acfol
Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in 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.
- Treatment of megaloblastic anemia (folate deficiency): a dose of 5 mg/day for 4 months is recommended; up to 15 mg may be required in cases of impaired absorption.
- Prevention of neural tube defects: 1 tablet daily for four weeks before conception and during the first three months of pregnancy.
If you take more Acfol than you should
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91.562.04.20.
However, Acfol is well tolerated by the body at usual doses, and there is no risk 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 advise you on the duration of treatment.
Do not discontinue treatment prematurely, as it will not have the expected efficacy.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Acfol may have adverse effects, although not everyone experiences them.
The following adverse effects have been observed, classified by system organ class and frequency. Frequencies are defined as rare (less than 1 in 10,000 patients) or frequency not known (cannot be estimated from available data):
Immune system disorders:
Not known:
Severe allergic reaction (anaphylactic reaction).
Skin and subcutaneous tissue disorders:
Rare: Hypersensitivity reactions (allergy), such as skin erythema, pruritus, and in more severe cases, respiratory difficulty associated with bronchospasm.
Gastrointestinal disorders:
Rare: Gastrointestinal disturbances, such as diarrhea, nausea and/or vomiting.
If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not mentioned in this leaflet, inform your doctor or pharmacist.
Reporting of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es By reporting adverse effects, you can help provide 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 from light.
Do not use this medicine after the expiry date stated on the container after EXP. The expiry date is the last day of the month indicated.
Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point 
at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.
6. Contents of the pack and other information
Composition of Acfol
- The active substance is folic acid. Each tablet contains 5 mg of folic acid (as folic acid monohydrate).
- The other components are lactose, corn starch, magnesium stearate, polyvinylpyrrolidone, talc and colloidal silicon dioxide.
Appearance of the product and pack sizes
Acfol is available as tablets for oral administration in packs of 28 and 84 tablets.
Marketing Authorization Holder
ITALFARMACO S.A.
C/ San Rafael, 3- 28108 Alcobendas (Madrid)
Tel.: 916572323
Manufacturer
ITALFARMACO S.p.A.
Viale Fulvio Testi, 330 – 20126 Milan (Italy)
Date of the most recent review of this leaflet: November 2020
Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).