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    LIVOGEN CAPTABS

    Ferrous Fumarate & Folic Acid Tablets BP

    Composition:

    Each film coated captab contains:

    Ferrous Fumarate IP ............................ 152 mg

    Equivalent to 50 mg elemental iron

    Folic Acid IP ....................................... 1500 mcg

    (Appropriate overages added)

    Colours : Ponceau 4R and Titanium Dioxide IP

    WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.

    Indications: Indicated in therapeutic management of: (1) all types of anemias due to nutritional deficiencies, in pregnancy and lactation (2) Iron deficiency anemia associated with other nutritional deficiencies.

    Clinical Pharmacology:

    Iron:

    Iron is an important component of haemoglobin (Hb), which carries oxygen to the different tissues for their metabolism. Iron is also an essential component of myoglobin, heme enzymes such as the cytochromes, catalase and peroxidise; and the mitochondrial enzyme a-glycerophophate oxidase.

    Iron exists in the environment largely as ferric oxide or hydroxide. In this state, its biological availability is limited, unless solubilised by acid or chelating agents. However, iron absorption has been found to be better in the ferrous form, as compared to the ferric form. In addition, it has been found that compared to the other salts available, viz: sulphate, gluconate, citrate etc. fumarate has the highest iron content i.e. 33% and highest rate of utilization i.e. 15%. Hence, the ferrous fumarate form is best suited for a hematinic.

    Folic acid:

    Folic acid is required for nucleoprotein synthesis, and maintenance of normal erythropoiesis. It stimulates production of red and white blood cells and platelets and certain nucleic acids, where it is involved as a cofactor for transformation reactions in the biosynthesis of purines and thymidylates of nucleic acids. Impairment of thymidylate synthesis, in patients with folic acid deficiency, is thought to account for the defective deoxyribonucleic acid (DNA) synthesis, that leads to megaloblast formation, and megaloblastic and macrocytic anemias. Livogen captab contains Iron in Ferrous Fumarate form, ensuring efficient Iron absorption and utilization. Livogen captab contains optimum content of Ferrous Fumarate in order to decrease the gastrointestinal effects experienced during therapeutic Iron supplementation in anemic patients. Each captab of Livogen yields 50 mg of elemental iron. Thus, Livogen captab, containing ferrous fumarate and folic acid, becomes necessary to treat mixed nutritional anemia for pregnant and lactating women, when there is increased demand for these nutrients.

    Contraindications:

    This product is contraindicated for:

    • • Hypersensitivity to the active substances (folic acid or iron) or to any of the excipients.

    • • Patients with iron storage disease, including haemosiderosis (including patients who require repeated blood transfusions) and haemochromatosis (iron overload).

    • • Patients with inflammatory bowel disease, including regional enteritis and ulcerative colitis.

    • • Patients with active peptic ulcer, intestinal strictures, and diverticulae.

    • • Patients with anaemia other than those due to iron deficiency (ie. Haemolytic anaemia).

    • • Patients with co-existing deficiency of Vitamin B12 or Folic acid

    • • Patients with porphyrias (ie. erythropoietic protoporphyria, porphyria cutanea tarda).

    • • Oral and parenteral iron preparations should not be used concomitantly.

    • • Elderly patients may be at increased risk of serious adverse reactions

    Special warnings and precautions for use

    Vitamin B9 (folic acid):

    • • Caution should be exercised when administering folic acid to patients who may have folate dependent tumours and for concomitant use with chemotherapy drugs/folate antagonists (e.g. Methotrexate, Raltitrexed,Tegafur, Fluorouracil, Capecitabine). Folate supplementation may enhance growth and proliferation of neoplastic cells. The promotion of carcinogenesis or cancer growth has, however, not unequivocally been demonstrated in epidemiological studies and may depend on additional other factors.

    • • Folic acid is removed by hemodialysis.

    • • Folic acid at doses above 1.0 mg/day may obscure vitamin B12 deficiency anemia or pernicious anemia, resulting in potential nerve damage if left uncorrected. Please ensure differential diagnosis of anemia (Iron deficiency anemia or B12 deficiency anemia) is conducted before prescribing this medicine. Anaemia due to combined iron and Vitamin B12 or folate deficiencies may be microcytic in type, patients with microcytic anaemia resistant to treatment with iron alone should be screened for Vitamin B12 or folate deficiency.

    • • Folic acid should not be routinely used in patients who have coronary stents.

    Ferrous salts:

    • • Iron preparations colour the faeces black, which may interfere with tests used for detection of occult blood in the stools.

    • • Patients suffering from iron overload are particularly susceptible to infection. Treatment of iron overload should be with caution.

    • • Some post gastrectomy (total or partial or gastric bypass) patients show poor absorption of iron.

    • • Due to the risk of mouth ulcerations and tooth discolouration, tablets should not be sucked, chewed or kept in the mouth, but swallowed whole with water.

    Fertility, pregnancy and lactation

    Pregnancy and Breastfeeding

    Folic acid is indicated during pregnancy and lactation, as demands for folic acid are increased in pregnant and lactating women.

    Iron is indicated during pregnancy and lactation as demands for iron are increased in pregnant and lactating women. Pregnant women may be more susceptible to gastrointestinal side effects.

    Effects on ability to drive and use machines

    There are no known effects of this preparation on the ability to drive or use machines.

    Interaction with other medicinal products and other forms of interaction:

    Vitamin B9 (folic acid):

    • • Fluorouracil toxicity may occur in patients taking folic acid and this combination should be avoided.

    Drugs that may reduce the absorption of vitamin B9 (folic acid):

    • • Antacids, sulfasalazine, ion exchange resins, edible clay, H2 receptor antagonists and proton pump inhibitors may reduce folic acid absorption. Patients should be advised to take antacids at least two hours after administration of folic acid.

    • • Triamterene may contribute to megaloblastic anemia in cases where folic acid stores have been depleted.

    Vitamin B9 may reduce the efficacy of the following treatments:

    • • Folic acid has been observed to reduce plasma levels of anticonvulsants, particularly phenytoin, phenobarbital and primidone and therefore patients should be carefully monitored by the physician and the anticonvulsant drug dose adjusted as necessary.

    Drugs that may reduce the efficacy of vitamin B9 (folic acid):

    • • Antibiotics such as trimethoprim or sulfonamides, alone or in combination as co-trimoxazole, may reduce the effect of folic acid and this may be serious in patients with megaloblastic anemia.

    Laboratory test interactions

    • • Antibiotics may interfere with the microbiological assay for serum and erythrocyte folic acid concentrations and may cause falsely low results.

    Ferrous salts:

    Drugs that may reduce the absorption of ferrous salts:

    • • Absorption of iron may be reduced in the presence of antacids and proton pump inhibitors which reduce stomach acid.

    • • Iron absorption may also be reduced in the presence of food (e.g. tea, coffee, wholegrain cereals, eggs and milk), oral neomycin, calcium, oral magnesium salts and other mineral supplements, zinc supplements, and trientine and ion exchange resins.

    • • Bicarbonates, carbonates, oxalates, or phosphates, may impair the absorption of iron by the formation of insoluble complexes although only limited data are available regarding this effect.

    • • Iron absorption may be increased by ascorbic or citric acid. A gap of 2-3 hours is to be kept before taking any other medicines, and 4 hours between taking eltrombopag and this medicine.

    Ferrous salts may reduce the efficacy of the following treatments:

    • • The response to iron may be delayed in patients receiving systemic chloramphenicol.

    • • The hypotensive effect of methyldopa is reduced by iron.

    • • Iron reduces the absorption of fluoroquinolones, tetracyclines, levodopa, carbidopa, entacapone, bisphosphonates, penicillamine, thyroid hormones such as levothyroxine.

    Adverse reactions:

    Generally, Livogen is well tolerated, however, occasional gastrointestinal disturbances such as nausea, anorexia, vomiting, constipation, diarrhoea, etc. may be observed.

    Other adverse reactions (unknown frequency) include hypersensitivity reactions with erythema, urticaria and pruritus. Vitamin B12 deficiency and darkening of stools may also occur. Haemosiderosis may occur as a result of excessive or mistaken therapy.

    Overdose

    The patient should be monitored for a minimum period of 24 hours from the asymptomatic state. Late effects of intoxication may in some cases be observed between 24 and 48 hours after ingestion and consist of shock or severe gastrointestinal bleeding. Intestinal obstruction may occur several weeks after the event.

    Vitamin B9:

    No defined toxic effects due to excessive doses of folic acid are known.

    Ferrous salts:

    Iron overdosage is an acute emergency requiring urgent medical attention and is particularly dangerous in young children. An acute intake of > 40 mg/kg of elemental iron is considered extremely dangerous in young children. Iron overdose above 40 mg/kg bodyweight may be life-threatening resulting in corrosive damages to the gastrointestinal mucosa and lethargy.

    Symptom:

    Initial symptoms of iron overdosage include nausea, vomiting, diarrhoea, abdominal pain, hematemesis, rectal bleeding, lethargy and circulatory collapse. Hyperglycaemia and metabolic acidosis may occur. However, if overdosage is suspected, treatment should be implemented immediately. In severe cases, after a latent phase, relapse may occur after 24-48 hours manifested by hypotension, coma, hypothermia, hepatocellular necrosis, renal failure, pulmonary oedema, diffuse vascular congestion, coagulopathy and/or convulsions. In many cases, full recovery may be complicated by long-term effects such as hepatic necrosis, toxic encephalitis, CNS damage and pyloric stenosis.

    Treatment:

    Treatment usually consists of using an emetic, gastric lavage, and IV infusion of desferrioxamine, and other measures as clinically indicated.

    Reporting of suspected adverse reactions:

    Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via email ID and contact number provided on pack.

    Dosage and type of Administration:

    For therapeutic use:

    Adults:

    1 captab once daily

    Storage:

    Store at or below 25°C. Protect from light and moisture. Keep out of reach of children.

    Shelf life:

    Please refer to bottle label or blister/carton

    Presentation:

    30 (bottles) or 10 x 3 x 15 (blister packs) captabs

    Date of Information:

    10th November, 2022.

    Manufactured by-

    Procter & Gamble Health Limited Registered Office: Ground Floor and First Floor, P&G Plaza, Cardinal Gracious Road, Chakala, Andheri (East), Mumbai – 400099

    For manufacturing site : Refer pack