FOLIFILL

Package leaflet: Information for the user

Folifill 5 mg tablets

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, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Folifill is and what it is used for

Folifill contains the active substance folic acid. This substance belongs to the vitamin B group (or folates).
Folifill is used to treat conditions of folate deficiency in the body, which occur when:

• the need for folates is increased;
• absorption of dietary folates is inadequate;
• the body has a reduced ability to utilize folates;
• dietary intake of folates is insufficient.

2. What you need to know before taking Folifill

Do not take Folifill

• if you are allergic to folic acid or to any of the other ingredients of this medicine (listed in section 6);
• if you have a tumour.
• if you suffer from pernicious anaemia (a severe form of anaemia caused by vitamin B12 deficiency) (see “Warnings and precautions”)

Warnings and precautions
Talk to your doctor or pharmacist before taking Folifill.
Your doctor will prescribe regular blood tests during treatment with this medicine.
Be especially careful with this medicine:

• if you suffer from megaloblastic anaemia of unknown origin, as folic acid may make it more difficult to diagnose pernicious anaemia, leading to progression of its neurological complications. This may cause severe neurological damage before the correct diagnosis is made.

Do not take Folifill if you suffer from a specific type of anaemia (pernicious anaemia due to vitamin B12 deficiency), as this medicine may mask the worsening of symptoms of your disease by improving blood test results without actually treating it.

Other medicines and Folifill
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular, inform your doctor if you are taking:

• Antiepileptic medicines (phenytoin, primidone, sodium valproate, carbamazepine, barbiturates including phenobarbital), as this medicine may reduce their effectiveness;
• methotrexate (used for the treatment of rheumatoid arthritis, psoriasis and certain tumours) and sulfasalazine (used in the treatment of inflammatory bowel diseases and rheumatoid arthritis), as they may reduce the activity of this medicine;
• chloramphenicol (an antibiotic), as it may reduce the activity of this medicine;
• acetylsalicylic acid (used as an anti-inflammatory, painkiller and to reduce fever, e.g. Aspirin), as it may reduce the effectiveness of this medicine.

Inform your doctor if you are scheduled for a surgical procedure requiring anaesthesia, as nitrous oxide (a gas used to induce anaesthesia) may cause a sudden decrease in folic acid levels in your body.

Folifill and alcohol
Do not take this medicine with alcohol. Alcohol may reduce the effectiveness of this medicine.

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.

Pregnancy
Folifill 5 mg tablets can be used during pregnancy.
Folic acid deficiency or abnormal folate metabolism is associated with the occurrence of birth defects and certain neural tube defects. Deficiency of this vitamin or its metabolites may also be responsible for some cases of spontaneous abortion and intrauterine growth retardation.
However, there are no safety data available for doses exceeding 4–5 mg per day; therefore, in such cases the daily dose should not exceed 5 mg.

Breastfeeding
This medicine may be used during breastfeeding.
Folic acid passes into breast milk, but this does not cause any adverse effects in breastfed infants.

Driving and using machines
FOLIFILL does not affect or has negligible effect on the ability to drive vehicles or operate machinery.

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

3. How to take Folifill

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

Adults
The recommended dose is: 1–2 tablets per day, according to the doctor's instructions.

Use in children
1–2 tablets per day, as for adults, or modified according to the doctor's instructions.

Use during pregnancy
The daily dose must not exceed 5 mg: 1 tablet per day.

If you take more Folifill than you should
In case of accidental overdose, contact your doctor immediately or go to the nearest hospital.

If you forget to take Folifill
Do not take a double dose to make up for the missed dose.

If you stop taking Folifill
Do not stop treatment with Folifill without first consulting your doctor.

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 in patients taking this medicine:

• Skin irritation (erythema), rash, itching, appearance of swollen areas on the skin causing itching (urticaria), difficulty breathing (dyspnoea), and anaphylactic shock (a severe allergic reaction causing breathing difficulties, swelling of the face, lips, tongue and other body parts): in this last case, contact your doctor immediately.
• Sleep disorders, nightmares.
• Loss of appetite (anorexia), nausea, bloated stomach (abdominal distension), and flatulence.
• Malaise, irritability.

Following the instructions contained in this leaflet reduces the risk of side effects.
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 Folifill

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.". The expiry date refers to the last day of that month. The expiry date applies to the product stored in its original intact packaging and kept under proper storage conditions.
Store below 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Folifill contains

• The active substance is folic acid. Each tablet contains 5 mg of folic acid.
• The other ingredients are: lactose monohydrate, corn starch, povidone, anhydrous colloidal silica, magnesium stearate, talc.

Description of the appearance of Folifill and package contents
Folifill is available as tablets.
Pack containing 28 tablets of 5 mg.
Pack containing 120 tablets of 5 mg.
Marketing Authorization Holder and Manufacturer
Italfarmaco S.p.A.
Viale F. Testi, 330
20126 Milan