Package leaflet

NAME OF THE MEDICINAL PRODUCT
BALFOLIC 400 micrograms tablets
Folic acid
Equivalent medicinal product

PHARMACOTHERAPEUTIC CATEGORY
Folic acid

THERAPEUTIC INDICATIONS
Primary prevention of neural tube defects in the unborn child in women of childbearing age who are planning pregnancy.

CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients.
Patients with tumours.

PRECAUTIONS FOR USE
The following categories of patients should undergo a more thorough evaluation before starting treatment with BALFOLIC, as their clinical condition may require administration of folic acid at higher doses than those provided by BALFOLIC:

women who have previously experienced, in one or more pregnancies (completed or not), neural tube development defects;
women with a family history of neural tube development defects;
women being treated with antiepileptic drugs: carbamazepine or valproic acid;
women being treated with folic acid antagonists (methotrexate, sulfasalazine) (see “Interactions”);
women with megaloblastic anaemia due to folic acid deficiency.

BALFOLIC is not effective in preventing the occurrence of neural tube development defects if treatment is initiated after the fourth week of pregnancy.

Folic acid must not be administered alone to patients with pernicious anaemia or other vitamin B12 deficiency states, or to patients with megaloblastic anaemia of unknown origin. Indeed, folic acid may mask the diagnosis of pernicious anaemia by reducing its haematological manifestations, but it is unable to counteract the progression of its neurological complications. This may result in severe neurological damage before the correct diagnosis is made.

It should be considered that in women taking folic acid antagonists, administration of folinic acid is more appropriate than higher doses of folic acid.

Concomitant use of BALFOLIC with phenobarbital, phenytoin or primidone is not recommended (see “Interactions”).

INTERACTIONS
Inform your doctor or pharmacist if you have recently taken any other medicinal products, including those without a prescription.

BALFOLIC may reduce plasma concentrations of phenobarbital, phenytoin and primidone by increasing their metabolism. Consequently, concomitant use of BALFOLIC with phenobarbital, phenytoin or primidone is not recommended (see “Precautions for use”). If combined treatment is necessary, careful monitoring of plasma concentrations of these antiepileptic drugs should be performed.

Methotrexate and sulfasalazine may reduce the activity of folic acid due to their antagonistic action.

Tea, including green tea, reduces the absorption of folic acid; therefore, taking the medicinal product together with tea should be avoided.

SPECIAL WARNINGS

Pregnancy and breastfeeding
Seek advice from your doctor or pharmacist before taking any medicinal product.

BALFOLIC is indicated for the prevention of neural tube development defects before and during pregnancy.

Folic acid is excreted in breast milk.

Driving and use of machines
There are no data available on the effects of the product on the ability to drive. However, such an effect is unlikely.

Important information about certain excipients
BALFOLIC contains lactose; therefore, patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.

DOSAGE, METHOD AND DURATION OF ADMINISTRATION
1 tablet daily, from 1 month before to 3 months after conception.

The daily dosage may be doubled in cases of inadequate folate intake. The product is administered orally, before meals.

This dosage is not adequate if the woman has previously had pregnancies with NTD (Neural Tube Defects) (see “Precautions for use”).

OVERDOSE
The risk of folic acid toxicity is very low because folic acid is a water-soluble vitamin and excess is excreted in urine. Only at high doses (15 mg/day) have adverse effects been reported, including sleep disturbances, irritability, overstimulation, and confusion.

The doses of folic acid contained in BALFOLIC are very low; therefore, the risk of toxicity from overdose is remote.

In case of accidental ingestion/overdose of BALFOLIC, contact your doctor immediately or go to the nearest hospital.

If you have any doubts about the use of BALFOLIC, consult your doctor or pharmacist.

UNDESIRABLE EFFECTS
Like all medicinal products, BALFOLIC can cause undesirable effects, although not everybody experiences them.

Allergic reactions (erythema, pruritus, urticaria) have been reported rarely.

Gastrointestinal disorders (nausea, abdominal discomfort, flatulence), irritability and insomnia have generally been reported in association with higher doses of folic acid than those contained in BALFOLIC.

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

Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, consult your doctor or pharmacist. Adverse effects can also be reported directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. Reporting adverse effects contributes to providing more information on the safety of this medicinal product.

EXPIRY DATE AND STORAGE INSTRUCTIONS
Expiry date: see the date printed on the packaging.
The expiry date refers to the product kept unopened and stored correctly.
Warning: do not use the medicinal product after the expiry date stated on the packaging.

Store at a temperature not exceeding 30°C.

Medicinal products must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicinal products no longer in use. This will help protect the environment.

Keep BALFOLIC out of the sight and reach of children.

COMPOSITION
Each tablet contains:
Folic acid 400 mcg
Excipients: Monohydrate lactose, microcrystalline cellulose, sodium carboxymethylstarch A, magnesium stearate

PHARMACEUTICAL FORM AND CONTENT
400 micrograms tablets – 120 tablets for oral use

MARKETING AUTHORISATION HOLDER
Laboratori Baldacci SpA - Via San Michele degli Scalzi 73 – 56124 PISA

MANUFACTURER
Laboratori Baldacci SpA - Via San Michele degli Scalzi 73 – 56124 PISA

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