Ferrous Sulfate CONTRAINDICATIONS

Hypersensitivity to Ferrous sulfate, patients receiving repeated

Feroneo blood transfusions, concomitant parenteral iron, hemochromatosis
and other iron overload syndromes.
325 mg / 5 ml Syrup
Iron Supplement Therapy PRECAUTIONS AND WARNINGS
Consult your doctor if you have iron overload disorder, abuse of
alcohol, liver problems, stomach or intestinal problems, and
vitamin B12 deficiency.
PRODUCT DESCRIPTION
Orange colored liquid with distinct orange scent and flavor. PREGNANCY AND LACTATION
Ferrous Sulfate is found in breast milk. If you are
breastfeedingwhile taking Ferrous Sulfate syrup, discuss ny
possible risks to your baby with your physician.

INTERACTIONS
Concurrent administration with tetracyclines may impair
absorption of both agents. The absorption of ciprofloxacin,
norfloxacin and ofloxacin is reduced by oral iron. Cholestyramine
may bind iron to the gastrointestinal tract, thus preventing its
Iron(2+);sulfate absorption. The absorption of iron salts is also decreased in the
presence of antacids, preparations containing zinc, calcium,
FORMULATION phosphorus, trientine, or when taken with tea, coffee, milk, eggs
Each 5 mL (1 teaspoonful) contains and whole grains. Iron supplements should not be taken within
Ferrous Sulfate 325 mg one hour before or two hours after ingestion of these products.
As elemental iron 65.47 mg
ADVERSE DRUG REACTIONS
PHARMACODYNAMICS Constipation, diarrhea, stomach cramps, or upset stomach may
Ferrous Sulfate (Feroneo) is used in the treatment of iron occur. Iron may cause your stools to turn black. Gastrointestinal
deficiency anemia. Iron preparations have no intrinsic therapeutic discomfort, nausea, and vomiting have occasionally been reported
activity except as a nutrient source: their use without evidence of with particularly large doses.
iron deficiency, or reasonable expectation of its occurrence, is to
be deprecated. Iron, in excess, is toxic and hemochromatosis may OVERDOSAGE AND TREATMENT
result from chronic injection of iron preparations used as tonics, Symptoms of overdose may include stomach pain, nausea,
especially in individuals with undiagnosed blood disorders. vomiting, diarrhea. If someone has overdosed and has serious
Patients with chronic anemia are particularly at risk from iron symptoms such as passing out or trouble breathing, call medical
storage disease. attention immediately.
PHARMACOKINETICS STORAGE CONDITION
Ferrous Sulfate (Feroneo) is irregularly and incompletely Store at room temperature between 59-86 degrees F (15-30
absorbed from the gastrointestinal tract. Absorption is aided by degrees C) away from light and moisture. Do not freeze liquid
the acid secretion of the stomach or by dietary acids and is more forms of this medication.
readily effected when the iron is in the ferrous state or is part of
the hem complex. Absorption is also increased in conditions of INSTRUCTIONS AND SPECIAL PRECAUTIONS
iron deficiency or in the fasting state but is decreased if the body Accidental overdose of iron-containing products is a leading
stores are overloaded. Only about 5-15% of the iron ingested in cause of fatal poisoning in children younger than 6 years. Keep
food is normally absorbed. this product out of reach of children. If overdose does occur, seek
immediate medical attention or call a poison control center.
INDICATION
Ferrous Sulfate (Feroneo) is an iron supplement used to treat or ADR REPORTING STATEMENT
prevent low blood levels of iron. It is also for the prevention and For suspected adverse drug reaction, report to the FDA:
treatment of iron-deficiency anemia. www.fda.gov.ph.
DOSAGE AND ROUTE OF ADMINISTRATION Galeneo Laboratories
National Road, Barangay Haling, Calamba
Age Group Dosing (Oral) City, Laguna, Philippines
Children 2.5-5 mL (1/2-1
teaspoon) daily
Adults 5-10 mL (1-2 teaspoons) REG NUMBER
daily FPH-007
DATE OF REVISION OF PACKAGE INSERT
02/2017
DATE OF FIRST AUTHORIZATION
02/2017