Folic acid SF

Package leaflet: Information for the patient

Folic Acid SF 5 mg tablets

Anhydrous folic acid
Read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Acido Folico SF is and what it is used for

Folic acid belongs to a group of medicines called vitamin B.
Acido Folico SF can be used for:

Treatment of:

• anaemias, including those caused by poor diet, malabsorption such as in coeliac disease, folic acid deficiency, during infancy or pregnancy.

Prevention of:

• folic acid deficiency in patients taking medicines used to treat epilepsy.
• neural tube defects in the fetus (such as spina bifida), in women who are planning a pregnancy and who are at risk of having a baby affected by this defect.

2. What you need to know before taking Acido Folico SF

Do not take Acido Folico SF

• if you are allergic to folic acid or to any of the other ingredients of this medicine (listed in section 6). An allergic reaction may include skin rash, itching, difficulty breathing, or swelling of the face, lips, throat, or tongue;
• if you have been diagnosed with anaemia of unknown cause.

Warnings and precautions
Talk to your doctor or pharmacist before taking Acido Folico SF

• if you have a malignant disease or a tumour;
• if you suffer from vitamin B₁₂ deficiency. Patients with vitamin B₁₂ deficiency should not be treated with folic acid unless adequate amounts of hydroxocobalamin are also administered.

Children
Acido Folico SF should not be used in children under 6 years of age, as the tablets are not a suitable dosage form for children younger than 6 years. For children older than 6 years, please read section 3 How to take Acido Folico SF.

Other medicines and Acido Folico SF
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
This particularly concerns the following medicines:

• medicines used to treat epileptic seizures such as phenytoin, phenobarbital, and primidone;
• chloramphenicol and cotrimoxazole used to treat infections;
• sulfasalazine used to treat ulcerative colitis, Crohn’s disease, or rheumatoid arthritis.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
This medicine is not intended for use in healthy pregnant women for whom lower doses are recommended, but for pregnant women with folic acid deficiency or women at risk of recurrence of neural tube defects.

Driving and using machines
Acido Folico SF has no effect or negligible effect on the ability to drive vehicles and operate machinery.

Acido Folico SF contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Folic Acid SF

Take this medicine exactly as instructed by your doctor or
pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Oral use:

• Swallow the tablet whole with water, at the same time each day.
• Take this medicine for as long as your doctor has prescribed.

Recommended dose:
Adults (including elderly patients)
To treat anaemia caused by folic acid deficiency and to prevent folic acid deficiency caused by certain medicines: 5 mg daily for 4 months; the dose may be increased up to 15 mg daily.
To prevent neural tube defects in the fetus of women who are planning a pregnancy and who are known to be at risk: 5 mg daily, starting at least 3 months before conception and continuing throughout the first trimester of
pregnancy.
To treat confirmed folic acid deficiency during pregnancy: 5 mg daily until delivery.

Use in children and adolescents
Folic Acid SF must not be used in children under 6 years of age, as the tablets are not an appropriate dosage form for children under 6 years.
To treat anaemia caused by folic acid deficiency:
Children and adolescents aged 6 to 18 years: 5 mg daily for 4 months; maintenance therapy: 5 mg once daily every 1–7 days.
To treat anaemia or malabsorption disorders:
Children aged 6 to 12 years: 5 mg once daily.
Children and adolescents aged 12 to 18 years: 5–10 mg once daily.

If you take more Folic Acid SF than you should
If you (or someone else) swallow a large number of tablets at once, or if you suspect that a child has ingested
any tablets, contact immediately the nearest hospital emergency department or your doctor.

If you forget to take Folic Acid SF
If you forget to take a tablet, take it as soon as you remember, unless it is almost time for your next dose. Do not take a double dose to make up for a forgotten tablet. Take the remaining doses at the correct time.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

The following rare side effects (may affect up to 1 in 1,000 people) have been reported:

• An allergic reaction: skin rash, swelling of the face, lips, tongue or throat, or difficulty breathing or swallowing. This is a very serious side effect. It may require urgent medical attention or hospitalization. If this occurs, stop taking Folic Acid SF immediately and contact your doctor or the nearest hospital emergency department without delay.
• Stomach problems: nausea, loss of appetite, feeling of fullness, and flatulence.

The following side effects have been reported with unknown frequency:

• Severe allergic reaction (anaphylactic reaction)

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website:
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Folic Acid SF

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and label.
The expiry date refers to the last day of that month.
Do not store above 25°C.
Keep in the original packaging to protect the medicine from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Pack contents and other information

What Acido Folico SF contains

• The active substance is anhydrous folic acid 5 mg.
• The other components are: maize starch, monohydrate lactose, microcrystalline cellulose, anhydrous colloidal silicon dioxide, magnesium stearate.

Description of the appearance of Acido Folico SF and pack contents
Tablet.
Yellow, circular, biconvex, uncoated tablets, 5.5 mm in diameter,
marked with the letters "FO" on one side.
Pack sizes:
Blister packs: 20, 28, 60 and 120 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
SF Group S.r.l.
Via Tiburtina 1143 – 00156
Rome
Italy

Manufacturer
Lachifarma S.r.l.
Laboratorio Chimico Salentino
s.s. 16, zona industriale
73010 Zollino (LE)
Italy

This medicinal product is authorized in the European Economic Area countries
under the following
names:
Iceland: Benfol
Italy: Acido Folico SF