Folix 5 mg Tablet, 1 strip

Folix 5 mg Tablet, 1 strip

Composition

Each tablet contains Calcium Folinate BP equivalent to Folinic Acid 5 mg.

Pharmacology

Calcium Folinate is a Calcium Salt of Folinic Acid (citrovorum factor), which is an active metabolite of Folic Acid and an essential co-enzyme for nucleic and synthesis used in

Cytotoxic therapy.

Indications

Folix is indicated –

• To diminish the toxicity and counteract the effects of over dosage of Folic Acid antagonists.

• To treat the Megaloblastic anemia due to folate deficiency, nutritional deficiency.

• To treat the Megaloblastic anemia of pregnancy and infancy due to folate deficiency.

Dosage and Administration

Route of administration: Oral.

1. Reduction of harmful effects of folic acid antagonists : One 5-15 mg tablet every 6 hours for 2 to 3 days.

2. Megaloblastic anemia : One 5-15 mg tablet daily.

Or as directed by the physician.

Contraindications

Folinic Acid is contraindicated for the following:

• Known hypersensitivity to Folinic Acid or to any components of the product formulation.

• Pernicious anemia or other Megaloblastic anemia where Vitamin B12 is deficient.

Warning & Precautions

• Folinic Acid treatment may mask pernicious anemia and other Megaloblastic anemia resulting from Vitamin B12 deficiency.

• Folinic Acid should only be used with 5-fluorouracil or Methotrexate under the direct supervision of a clinician experienced in the use of cancer chemotherapeutic agents.

Side-Effects

Common: Allergic reaction – Like sudden itchy rash (hives) & swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing),

Fits and fainting.

Rare: Not Known

Use in pregnancy & Lactation

There are no adequate and well-controlled clinical studies conducted in pregnant or breastfeeding women. It is not known whether this drug is excreted in human milk. As many drugs are excreted in human milk, caution should be exercised when Folinic Acid is administered to a nursing mother.

Use in Children & Adolescents

There are no data available in children.

Drug Interactions

With Medicine:

• Many Cytotoxic medicinal products direct or indirect DNA synthesis inhibitor – lead to macrocytosis (Hydroxycarbamide, Cytarabine, Mercaptopurine, Thioguanine). Such macrocytosis should not be treated with Folinic Acid.

• In epileptic patients (treated with Phenobarbital, Phenytoin, Primidone, and Succinimides), there is a risk to increase the frequency of seizures due to a decrease of plasma

concentrations of anti-epileptic drug.

With food & others: Interaction of Folinic acid with any kind of food is not known.

Overdose

There have been no reported sequelae in patients who have received significantly more Folinic Acid than the recommended dosage. However, excessive amounts of Calcium Folinate may nullify the chemotherapeutic effect of Folic Acid antagonists.

Storage

Store below 30°C temperature & dry place, protected from light. Keep out of the reach of children.

Packing

Each box contains 3 x 10 tablets in Alu-Alu blisters.