FOLANEMIN

FOLANEMIN 4 mg tablets
levofolinic acid calcium pentahydrate

• Pharmacotherapeutic category: Detoxifying agents for cytostatic treatments
• Therapeutic indications: All anemic conditions due to folic acid deficiency caused by increased demand, reduced utilization, or inadequate dietary intake of folates.

Essential information for correct use of the medicine

• Contraindications: Hypersensitivity to the active substance or to any of the excipients. FOLANEMIN must not be administered for the treatment of pernicious anemia or other megaloblastic anemias when vitamin B${12}$ is deficient, except in combination with vitamin B${12}$.
• Precautions for use: None.
• Interactions: Inform your doctor or pharmacist if you have recently taken any other medicines, including those without a prescription. Levofolinic acid calcium antagonizes the effects of antifolates. Concomitant use of FOLANEMIN with antiepileptic drugs such as phenobarbital, phenytoin, primidone, and succinimides may lead to an increased frequency of seizures.
• Special warnings: FOLANEMIN is an inappropriate treatment for pernicious anemia or other megaloblastic anemias due to vitamin B$_{12}$ deficiency; hematological remission may occur while neurological manifestations continue to progress. Therapy should therefore be conducted under hematological monitoring. The drug should be administered carefully to avoid the risk of allergic reactions or adverse effects. Administration of FOLANEMIN in epileptic patients treated with phenobarbital, phenytoin, primidone, and succinimides may increase seizure frequency due to decreased plasma concentration of the antiepileptic drug. Clinical monitoring is recommended, along with possible monitoring of plasma concentrations and, if necessary, adjustment of the antiepileptic drug dosage during and after FOLANEMIN administration.

Pregnancy and breastfeeding
Consult your doctor or pharmacist before taking any medicine.
Anemias during pregnancy due to increased folic acid requirements may be improved or normalized by administration of levofolinic acid.

Effects on ability to drive vehicles and use machinery
FOLANEMIN does not impair the ability to drive vehicles or operate machinery.

Instructions for correct use of the medicine

• Dosage, method and timing of administration: FOLANEMIN should be administered orally. In the treatment of anemias due to folic acid deficiency: Treatment should begin with one tablet (4 mg) daily, continuing at this dose for 10–15 days.

If a favorable response is observed, the dose may be halved and continued until hematological parameters normalize and clinical signs disappear.

• Overdose: No cases of overdose have been reported. In case of accidental ingestion/overdose of FOLANEMIN, contact a doctor immediately or go to the nearest hospital. IF YOU HAVE ANY DOUBT ABOUT THE USE OF FOLANEMIN, CONSULT YOUR DOCTOR OR PHARMACIST.
• Undesirable effects: Like all medicines, FOLANEMIN can cause side effects, although not everyone experiences them. Administration of the product may rarely be followed by general hypersensitivity reactions (fever, urticaria, hypotension, tachycardia, bronchospasm, anaphylactic shock). Following the instructions in this leaflet reduces the risk of side effects. If any of the side effects worsens, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.
• Expiry and storage: Expiry date: see the date printed on the packaging. The expiry date refers to the product stored in its original, undamaged packaging under recommended conditions. Warning: do not use the medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month. Store below 25°C. Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN.

• Composition: Each tablet contains:
  Active substance: levofolinic acid 4 mg (as levofolinic acid calcium pentahydrate)
  Excipients: Corn starch, dibasic calcium phosphate, magnesium stearate, gum arabic.
• Pharmaceutical form and contents: Tablets. Pack containing 30 tablets.
• Marketing Authorization Holder and Manufacturer

Farmitalia S.r.l.
Via Pinciana 25
00198 Rome
Manufacturer
Special Product’s Line S.p.A., via Fratta Rotonda Vado Largo, 1
03012 Anagni (FR)