INTERACTIONS WITH OTHER MEDICAMENTS
FERROUS SULFATE
FERLACASOL®
325 mg Capsule
Anti-Anemia
(Oral Iron Supplement)
FORMULATION/COMPOSITION:
Each capsule contains:
Dried Ferrous Sulfate ………………………………………………………………………….325 mg
(Equivalent to 65 mg of Elemental Iron)
PRODUCT DESCRIPTION:
Ferrous Sulfate 325 mg loose capsule (FERLACASOL) are hard shelled gelatin capsules with a
standard red opaque cap and orange opaque body filled with yellowish to brown pellets.
PHARMACODYNAMICS:
Ferrous sulfate replenishes iron, an essential component in the formation of hemoglobin,
myoglobin, and various enzymes. It replaces the iron that is usually found in hemoglobin and
myoglobin. Iron participates in oxygen transport and storage, electron transport and energy
metabolism, antioxidant and beneficial pro-oxidant functions, oxygen sensing, tissue
proliferation and growth, as well as DNA replication and repair
PHARMACOKINETICS:
Ferrous Sulfate absorption takes place mainly in the entire length of the GI tract, but primary
absorption sites are the duodenum and proximal jejunum. Up to 10% of iron is absorbed by
healthy individuals; patients with iron-deficiency anemia may absorb up to 60%. Enteric
coating and some extended-release formulas have decreased absorption because they’re
designed to release iron past the points of highest absorption; food may decrease absorption
by 33% to 50%. As for distribution, it is transported through GI mucosal cells directly into the
blood, where it’s immediately bound to a carrier protein, transferrin, and transported to the
bone marrow for incorporation into hemoglobin. Iron is highly protein-bound. Then, liberated
by the destruction of hemoglobin but is conserved and reused by the body. Healthy people
lose very little iron each day. Men and postmenopausal women lose about 1 mg/day, and
premenopausal women about 1.5 mg/day. The loss usually occurs in nails, hair, feces, and
urine; trace amounts are lost in bile and sweat.
INDICATION
Ferrous sulfate is an iron supplement used for the prevention and treatment of iron deficiency
anemia in adults and children. Treatment of iron-deficiency anemia and in people on
hemodialysis who are receiving erythropoietin. Iron is an important mineral that the body
needs to produce red blood cells and keep you in good health.
DOSAGE AND MODE OF ADMINISTRATION
For Adults: 100 to 200 mg elemental iron P.O. t.i.d. For extended-release capsules, 150 to
250 mg P.O. once or twice daily. For extended-release tablets, 160 to 525 mg once or
twice daily.
For Elderly patients: May need higher doses because reduced gastric secretions and
achlorhydria may lower capacity for iron absorption.
CONTRAINDICATIONS
Contraindicated in patients receiving repeated blood transfusions and in those with
hemosiderosis, primary hemochromatosis, hemolytic anemia unless iron deficiency anemia is
also present, peptic ulceration, ulcerative colitis, or regional enteritis. Use cautiously on long-
term basis.
Overdose and Treatment:
The lethal dose of iron is 200 to 250 mg/kg; fatalities have occurred with lower doses. Signs
and symptoms may follow ingestion of 20 to 60 mg/kg. Between 30 minutes and 8 hours after
ingestion, patient may experience lethargy, nausea, vomiting, green and then tarry stools,
weak and rapid pulse, hypotension, dehydration, acidosis, and coma. If death doesn’t
immediately ensue, symptoms may clear for about 24 hours. At 12 to 48 hours, symptoms may
return, accompanied by diffuse vascular congestion, pulmonary edema, shock, seizures,
anuria, and hyperthermia. Death may follow.
Treatment requires immediate support of airway, breathing, and circulation. In conscious
patient with intact gag reflex, induce emesis with ipecac; otherwise, empty stomach by gastric
lavage. Follow emesis with lavage, using a 1% sodium bicarbonate solution, to convert iron to
less irritating, poorly absorbed form (phosphate solutions have been used, but carry hazard of
other adverse effects). Take abdominal X-ray to determine continued presence of excess iron;
if serum iron levels exceed 350 mg/dl, deferoxamine may be used for systemic chelation.
Survivors are likely to sustain organ damage, including pyloric or antral stenosis, hepatic
cirrhosis, CNS damage, and intestinal obstruction.
Special considerations:
• Drug may be taken with meals to minimize GI effects; maximum absorption will occur if
drug is taken between meals.
• Ferrous sulfate blackens feces and may interfere with tests for occult blood in the stool; the
guaiac test and orthotoluidine test may yield false-positive results, but the benzidine test is
usually not affected.
• Iron overload may decrease uptake of technetium 99m and thus interfere with skeletal
imaging.
• Drug may cause dark-colored stools.
• Drug may stain teeth.
For Geriatric patients
• Iron-induced constipation is common in elderly patients; stress proper diet.
For Breast-feeding patients
• Iron supplements are commonly recommended for breast-feeding women; no adverse
effects have been documented.
For Pediatric patients
• Extended-release iron capsules or tablets usually aren’t recommended for children.
Overdose may be fatal; treat immediately.
• Drug-drug. (Antacids, aluminum-containing phosphate binders, cholestyramine,
cimetidine, vitamin C and E)
- Separate doses by 1- to 2-hour intervals
- Increases response to iron therapy
- Monitor patient carefully.
- May interfere with ferrous fumarate absorption even when doses are
separated. Avoid use together.
- May decrease L-thyroxine absorption.
- Monitor thyroid function.
- May decrease absorption of these drugs
- Decreases ferrous fumarate and penicillamine absorption.
- May decrease quinolone absorption.
- Inhibits absorption of both drugs
- Give tetracycline 3 hours after or 2 hours before iron supplement.
- Increases iron absorption, may be used as a beneficial drug interaction.
• Drug-herb. (Black cohosh, chamomile, feverfew, gossypol, hawthorn, nettle, plantain,
St. John’s wort)
- Decreases iron absorption. Discourage use together.
• Drug-food. (Cereals, cheese, coffee, eggs, milk, tea, whole-grain breads, yogurt)
- May impair oral iron absorption. Discourage use together.
WARNINGS AND PRECAUTIONSs
Do not exceed recommended dosage. The treatment of any anemic condition should be
under the advice and supervision of a physician. Since oral iron products interfere with
absorption of certain antibiotics, these products should not be taken within two hours of
each other. Occasional gastrointestinal discomfort (such as nausea) may be minimized by
taking with meals. Iron-containing products may occasionally cause constipation or diarrhea.
Due to the risk of mouth ulceration and tooth discoloration, tablets should not be sucked,
chewed or kept in the mouth but swallowed whole with water. If you cannot follow this
instruction or have difficulty swallowing, please contact your doctor. Taking Ferrous Sulfate
tablets with food and drink
Do not take this medicine with tea, milk or eggs as they reduce the absorption of it in the
stomach.
Pregnancy and breast-feeding
During the first 12 weeks of pregnancy only take this medicine if your doctor has specifically
recommended it. For the remainder of the pregnancy Ferrous Sulfate Tablets can be taken to
prevent iron deficiency. If are pregnant or nursing a baby, seek the advice of a health
professional before using this product.
Driving and using machinery
This medicine does not affect your ability to drive a car or operate machinery.
Important information about some of the ingredients in Ferrous Sulfate Tablets
- This medicine contains sucrose and glucose. If you have been told by your doctor that you
have an intolerance to some sugars, contact your doctor before taking this medicinal
product.
ADVERSE EFFECTS / UNDESIRABLE EFFECTS
Adverse effects of ferrous sulfate occur in Gastrointestinal are nausea, epigastric pain,
vomiting, constipation, black stools, diarrhea, anorexia
ADR REPORTING STATEMENT
“For suspected adverse drug reaction, report to the FDA: www.fda.gov.ph
Seek medical attention immediately at the first sign of any adverse drug reaction”
STORAGE CONDITIONS
Store at room temperature (25°C). Store in the original container to protect from moisture.
AVAILABILITY:
Ferrous Sulfate 325 mg capsule, Bottle of 100’s
DISPOSAL AND HANDLING
Ferrous Sulfate Capsules should not be taken after the expiry date on the label; the expiry
date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will help
protect the environment.
MANUFACTURED AND DISTRIBUTED BY:
LA CASA DE MEDICA
Blk 4 Lot 29 Metropolis North Subdivision, Bagumbong Caloocan City”
DATE OF FIRST AUTHORIZATION – February 2019
DATE OF REVISION OF PACKAGE INSERT – September 26, 2020
DR-SPH3A202002
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DOSAGE FORM AND
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3180%20Ferrous%20Sulfate.pdf?fbclid=IwAR3B_N71s7_yZ2B-
5F5dRq9pdRN3_TnNbgRuXrjCqRdgohWMZrsQNBiJDrU
INDICATIONS
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FORMULATION/COMPOSITION https://ww2.fda.gov.ph/index.php/consumers-corner/registered-drugs-2/337435-DRP-5322
PHARMACODYNAMICS AND https://www.glowm.com/resources/glowm/cd/pages/drugs/f011.html
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OF ADMINISTRATION https://www.medicines.org.uk/emc/files/pil.3130.pdf

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AND DESCRIPTION https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9f3b7188-9e27-45d1-a7f7-
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EXPIRATION DATE https://www.medicines.org.uk/emc/product/5930/smpc#gref