Folic acid Eg

Package leaflet: Information for the patient

Acido Folico EG 5 mg tablets

Anhydrous folic acid
Please 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 others, even if their symptoms are the same as yours, 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 Acido Folico EG is and what it is used for
2. What you need to know before taking Acido Folico EG
3. How to take Acido Folico EG
4. Possible side effects
5. How to store Acido Folico EG
6. Contents of the pack and other information

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

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

Treatment of:

• anaemia, including anaemias caused by poor diet, malabsorption of food 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 foetus (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 EG

Do not take Acido Folico EG

• 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 EG

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

Children
Acido Folico EG must 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 EG.

Other medicines and Acido Folico EG
Inform 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 may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
This medicine is not intended for use in healthy pregnant women who require lower doses, but for pregnant women with folic acid deficiency or women at risk of recurrence of neural tube defects.

Driving and using machines
Acido Folico EG has no effect or has a negligible effect on the ability to drive and use machines.

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

3. How to take Acido Folico EG

Take this medicine exactly as directed 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 the duration prescribed by your doctor.

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 foetus of women who are planning pregnancy and who are known to be at risk: 5 mg daily, starting at least 3 months before conception and continuing during the first trimester of pregnancy.
To treat confirmed folic acid deficiency during pregnancy: 5 mg daily until delivery.

Use in children and adolescents
Acido Folico EG must not be used in children under 6 years of age, as the tablets are not a suitable dosage form for children below 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 every 1 to 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 Acido Folico EG than you should
If you (or someone else) swallow several tablets at once, or if you think a child has swallowed any tablets, contact immediately the nearest hospital emergency department or your doctor.

If you forget to take Acido Folico EG
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 the forgotten tablet. Take the remaining doses at the usual scheduled times.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences 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 which may require urgent medical attention or hospitalisation. If this occurs, stop taking Folic Acid EG immediately and contact your doctor or go to the nearest hospital emergency department straight away.
• 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, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at
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 EG

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
on the 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. Package contents and other information

What Acido Folico EG contains

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

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

Marketing Authorisation Holder
EG S.p.A. Via Pavia, 6 – 20136 Milano
Manufacturer
Lachifarma S.r.l.
Laboratorio Chimico
Salentino
s.s. 16 zona industriale
73010 Zollino (LE)
Italy

This medicinal product is authorised in the European Economic Area countries
under the following names:
Iceland: Folium
Italy: Acido Folico EG