Hemarate FA

Hemarate FA

Manufacturer:

BIOFEMME, Inc

Distributor:

UNILAB, Inc
Full Prescribing Info
Contents
Iron, vitamin B-complex, folic acid.
Description
Each tablet contains: Elemental Iron (as Ferrous Sulfate, 187 mg) 60 mg, Folic Acid 600 mcg, Pyridoxine Hydrochloride (Vitamin B6) 20 mg, Cyanocobalamin (Vitamin B12) 25 mcg.
Hemarate FA tablet contains iron, folic acid, vitamins B6 and B12. These nutrients are essential for healthy blood, synthesis of hemoglobin (an oxygen containing protein which gives blood its red color) and to prevent and treat iron deficiency anemia (IDA).
Folic acid, vitamins B6 and B12 are also required in the metabolism of homocysteine to prevent its accumulation in the blood. Elevated blood homocysteine or hyperhomocysteinemia may be a risk factor in the development of cardiovascular disease. The effects of homocysteine in pregnancy include preeclampsia and adverse pregnancy outcomes. Hyperhomocysteinemia has also been reported to result in neural tube defects (NTDs).
Iron, folic acid, vitamins B6 and B12 have the following functions: See table.

Click on icon to see table/diagram/image
Indications/Uses
For the prevention and treatment of iron deficiency anemia, folate deficiency and for the lowering of plasma homocysteine.
Dosage/Direction for Use
Orally, one tablet daily as soon as pregnancy is detected.
Or, as directed by a doctor.
Missed Dose: If the patient misses a dose, just take the next dose and the subsequent doses at the usual recommended schedule, i.e., once a day.
Do not double the dose unless recommended by a doctor.
Overdosage
Iron: Acute iron overdosage (e.g., intake of ≥1,500 mg elemental iron for a 50 kg adult) can be divided into four stages: Stage I: Occurs up to six hours after ingestion, the principal symptoms are vomiting and diarrhea. Other symptoms include hypotension, tachycardia (rapid heartbeat) and central nervous system depression ranging from lethargy (sleepiness) to coma (state of unconsciousness).
Stage II: May occur 6 to 24 hours after ingestion and is characterized by a temporary remission or signs of overdosage are decreased.
Stage III: GI symptoms recur accompanied by shock, metabolic acidosis (increased acid in the blood), coma, hepatic necrosis (death of liver tissue), jaundice (yellowish color of the skin, eyes and other tissues), hypoglycemia (low blood sugar), kidney failure, and pulmonary edema (fluid in the lungs).
Stage IV: Occurs several weeks after ingestion and is characterized by GI obstruction (blockage) and liver damage.
Vitamin B6: Long term administration (i.e., 2 months or longer) of large (megadose) dosages (e.g., 2 g or more daily) of pyridoxine can cause sensory neuropathy or neuronopathy syndromes.
Other side effects reported with megadoses of pyridoxine include peripheral neuropathy, unsteady gait (manner of walking), loss of limb reflexes/numbness and tingling in feet and hands, hyperesthesia (increased physical sensitivity), muscle weakness, impaired or absent tendon reflexes; bone pain, headache, dizziness, sleepiness, nausea, upset stomach, breast tenderness, photosensitivity on sun exposure, and exacerbation of acne.
If the patient has taken more than the recommended dosage, consult a doctor or contact a poison control center immediately.
Contraindications
If the patient is allergic to any ingredient in the product.
Iron supplement should be avoided in conditions associated with iron overload (e.g., hemochromatosis, hemosiderosis, thalassemia).
Special Precautions
Iron supplement should be used with extreme caution in those with chronic liver failure, alcoholic cirrhosis, chronic alcoholism, and pancreatic insufficiency.
Iron should be used cautiously in those with a history of gastritis, peptic ulcer, and GI bleeding.
Individuals with an active or suspected infection should generally avoid iron supplements.
A moderate increase in iron stores has been associated with an increased risk of ischemic heart disease and cancer.
Do not take more than the recommended dose. If the patient is taking other supplements, read the label, since those supplements may contain the same ingredients as this product.
Consult a doctor: If any undesirable effect occurs.
Adverse Reactions
The amount of nutrients in this product is relatively nontoxic and is usually well tolerated. However, undesirable effects may occur, particularly when the nutrients are used at high doses (e.g., concomitant use of other multivitamin-mineral supplements), see also Overdosage.
Iron: The most common undesirable effects of iron are gastrointestinal (GI) problems, including nausea, vomiting, bloating, abdominal discomfort/epigastric pain, black stools, diarrhea, constipation and anorexia.
Nervous system disorders: Metallic taste.
Gastrointestinal disorders: flatulence, gastrointestinal irritation, heartburn, stomach discomfort.
Injury, poisoning and procedural complications: Long-term administration of large amounts of iron may cause hemosiderosis clinically resembling hemochromatosis, which is a genetic condition characterized by excessive iron absorption, excess tissue iron stores, and potential tissue injury.
Vitamin B6: Although vitamin B6 is generally considered to be relatively nontoxic, adverse neurologic effects have been reported following chronic administration of large pyridoxine dosages, e.g., more than 200 mg daily.
Psychiatric disorders: Sleepiness.
Nervous system disorders: Headache, paresthesia (tingling, prickling, or burning sensation).
Gastrointestinal disorders: Nausea.
Investigations: Decreased serum folic acid concentrations, increased serum aspartate aminotransferase (AST, a liver enzyme).
Drug Interactions
Iron: Cefdinir; bisphosphonates; carbidopa/levodopa; entacapone; fluoroquinolones; levodopa; levothyroxine; methyldopa; mycophenolate mofetil; penicillamine; and tetracyclines: Iron may reduce the absorption of these drugs.
Tell the doctor about other medicines the patient is taking including supplements and herbal products.
Storage
Store at temperatures not exceeding 30°C.
Protect from light.
ATC Classification
B03AE02 - iron, multivitamins and folic acid ; Belongs to the class of iron in other combinations. Used in the treatment of anemia.
Presentation/Packing
Tab (round, pink, biconvex bisected on one side and plain on the other side) 100's.
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