FOLICOM

Package leaflet: Information for the patient

Folicom 5 mg tablets

Anhydrous folic acid
Please read all of 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 their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Folicom is and what it is used for

Folic acid belongs to a group of medicines called vitamin B.
Folicom may be used for:
Treatment of:

• anaemias, including those caused by poor diet, malabsorption of food as in the case of coeliac disease, vitamin B deficiency, 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 should know before taking Folicom

Do not take Folicom:

• 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 vitamin B__ deficiency or anaemia due to unknown causes.

Warnings and precautions
Talk to your doctor or pharmacist before taking Folicom:

• if you have a malignant disease or a tumour.

Other medicines and Folicom
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 may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Folicom contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take Folicom

Take this medicine exactly as instructed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
The recommended dose is:
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 pregnancy and for
whom risk is known:
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
Children under 6 years of age
Folicom must not be used in children under 6 years of age, as the tablets are not a suitable dosage form for this age group.
To treat anaemia caused by folic acid deficiency:
Children and adolescents from 6 to 18 years of age: 5 mg daily for 4 months; maintenance therapy: 5 mg daily every 1-7 days.
To treat anaemia or malabsorption disorders:
Children from 6 to 12 years of age: 5 mg once daily.
Children and adolescents from 12 to 18 years of age: 5–10 mg once daily.
Method of administration
For oral use.

• Swallow the tablets whole with some water at the same time every day.
• Take this medicine for the entire duration prescribed by your doctor.

If you take more Folicom than you should
If you (or someone else) swallow many tablets at once, or if you think a child has ingested
any tablets, contact immediately the nearest hospital emergency department or your doctor.
If you forget to take Folicom
If you forget to take a tablet, take it as soon as you remember, unless it is almost time for the next dose. Do not take a double dose to make up for the missed tablet. Take the remaining doses at the correct time.
If you stop taking Folicom
If you have any doubts about using 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 and may require urgent medical attention or hospitalisation. If this occurs, stop taking Folicom immediately and contact your doctor or go to the nearest hospital emergency department.
Stomach problems: nausea, loss of appetite, feeling of fullness and flatulence.

Reporting of side effects
If you experience any side effect, 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/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Folicom

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after EXP. 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. Contents of the pack and other information

What Folicom contains

• The active substance is folic acid (anhydrous). Each tablet contains folic acid equivalent to 5 mg of anhydrous folic acid.
• The other ingredients are: maize starch, lactose monohydrate, microcrystalline cellulose, anhydrous colloidal silicon dioxide, magnesium stearate.

Description of the appearance of Folicom and pack sizes
Yellow, uncoated, circular, biconvex tablets, 5.5 mm in diameter, marked with the letters “FO” on one side.
Pack sizes:
Blister packs: 20 and 60 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Medic Italia s.r.l.
Via Germano Sommeiller n. 12
00185 Rome, Italy

Manufacturer responsible for batch release
Actavis UK Limited
Whiddon Valley
Barnstaple
North Devon
EX32 8NS, UK
Balkanpharma – Dupnitsa AD
3, Samokovsko Shosse Str.
2600 Dupnitsa
Bulgaria

This medicinal product is authorised in the European Economic Area countries under the following names:
Iceland Acifol
Italy Folicom