Calcifolin

CALCIFOLIN 15 capsules
Calcium folinate
15 mg capsules for oral use
Equivalent medicine
PHARMACO-THERAPEUTIC CATEGORY
Antianaemic drugs
THERAPEUTIC INDICATIONS
Calcifolin is useful as an antidote to excessive doses of folic acid antagonists and to counteract the side effects induced by aminopterin and methotrexate. Calcifolin is also indicated in all forms of anaemia due to folate deficiency caused by increased demand, reduced utilization, or inadequate dietary intake of folates.
CONTRAINDICATIONS
Hypersensitivity to any of the components.
CALCIFOLIN must not be administered for the treatment of pernicious anaemia or other megaloblastic anaemias when vitamin B({12}) is deficient, unless used in combination with vitamin B({12}).
PRECAUTIONS FOR USE
Calcifolin, when administered in pernicious anaemia or in other megaloblastic anaemias due to vitamin B({12}) deficiency, may induce haematological remission while leaving the progression of neurological lesions unchanged (see also contraindications). In such cases, the product should be associated with appropriate vitamin B({12}) therapy, and treatment must be carried out under haematological and neurological monitoring. Anaemias during pregnancy due to increased folate requirements may be improved or normalized by administration of folinic acid.
In the treatment of overdose with folic acid antagonists, Calcifolin should be administered preferably within 1 hour, as administration beyond 4 hours is generally ineffective. The drug should be administered carefully to avoid the risk of allergic reactions or adverse effects.
INTERACTIONS WITH OTHER MEDICINES AND OTHER KINDS OF INTERACTIONS
Folinic acid antagonizes the effects of antifolates. It acts as a "rescue" agent in high-dose methotrexate therapy and as an antidote in cases of overdose.
SPECIAL WARNINGS
Keep the medicine out of the reach of children.
DOSAGE, METHOD AND DURATION OF ADMINISTRATION

• In the treatment of anaemias due to folate deficiency, the dosage is 15–25 mg/day for 10–15 days.
• In the prevention of methotrexate-induced toxic effects, the average dosage is 50 mg every 6 hours for 3 consecutive days, starting 24 hours after methotrexate infusion. This dosage may be adjusted according to the therapeutic regimen used.

OVERDOSAGE
No cases of overdose have been reported to date.
UNDESIRABLE EFFECTS
Administration of the product may, although very rarely, be followed by general hypersensitivity reactions.
If any undescribed adverse effects occur, inform your physician.
WARNING
Do not use the medicine after the expiry date stated on the packaging.
COMPOSITION
Each hard capsule contains:
Active substance:
Calcium folinate pentahydrate
(equivalent to 15 mg folinic acid) 19.10 mg
Excipients:
Lactose, precipitated silica, magnesium stearate, microcrystalline cellulose, gelatin, titanium dioxide, water.
PHARMACEUTICAL FORM
10 capsules of 15 mg
MARKETING AUTHORISATION HOLDER
LANOVA FARMACEUTICI S.R.L.
VIA CONCA D'ORO, 212, 00141 - ROMA (RM).
MANUFACTURING SITE
I.BIR.N. – Istituto Bioterapico Nazionale S.r.l.
Via Vittorio Grassi nn. 9/15 – 00155 Roma
10 August 2012