Femitab

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Femitab

Method of action: Antianemic

Treatment option:

Medically reviewed

Marina Burgos

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Femitab

Quick Facts
Active Ingredients Ferrous Fumarate, Folic Acid (Vitamin B9)
Form Oral tablet or capsule
Pharmacological Class Antianemic, Hematinic, Iron & Vitamin Combination
General Purpose Nutritional support for blood formation
Origin Synthetic

What Type of Medicine is Femitab and Its Purpose?

Femitab is a combination medicine classified as an Antianemic preparation and Hematinic, formulated for oral intake to support essential blood-forming processes. Pharmacologically, Femitab belongs to the subgroup of Iron and Vitamin Combined preparations. The drug entity provides a dual nutritional solution, incorporating both a critical mineral and a B-complex vitamin required for proper cell generation. Femitab is often positioned for women of childbearing age and those with identified nutritional gaps, addressing deficiencies that lead to anemia. The overall, high-level purpose is the replenishment of reserves to support healthy Erythropoiesis (red blood cell production), thereby helping to sustain the body's oxygen transport capacity when nutritional shortages are present, a function clinically recognized for supporting prenatal health.


Femitab's Composition: Iron and Vitamin B9

The active core of Femitab consists of two key components: Ferrous Fumarate and Folic Acid (Vitamin B9). This combination makes it a synthetic, dual-action nutritional therapy; Ferrous Fumarate is a synthetic iron salt, and Folic Acid is the synthetic equivalent of natural folate, which is critical for cellular health. Ferrous Fumarate provides the body with bivalent iron (Fe^2+), the necessary mineral for forming the central structure of hemoglobin, the protein responsible for oxygen transport. Folic Acid is a water-soluble B-complex vitamin that is crucial for DNA synthesis and cell division, processes that underpin the production and maturation of new cells. The oral tablet or capsule form allows for consistent oral intake as a convenient method of administration.


Understanding the Femitab Components

The formulation functions by supplying the necessary nutrients that enable the body to efficiently manufacture new, functional red blood cells, addressing deficiencies in both components. The iron component addresses the requirement for the core element of oxygen carriage, while the folic acid component facilitates the rapid and accurate maturation of these cells. Femitab’s role is one of replacement or supplementation, differing from drugs that act to modify existing biological systems, such as prescription-only medications that target enzyme pathways. Its general use is fundamentally based on the restoration and maintenance of key nutritional reserves, making it a foundational therapeutic tool in targeted nutritional support.

What side effects are possible with Femitab?

Critical Safety Information and Warnings

Femitab is subject to a Boxed Warning from the U.S. Food and Drug Administration (FDA) due to serious, life-threatening risks, including respiratory depression and the potential for addiction, abuse, and misuse. The drug is available only through a specialized Risk Evaluation and Mitigation Strategy (REMS) program to ensure that the benefits outweigh these serious risks.

Serious and Clinically Significant Adverse Reactions

The most critical safety concerns documented in regulatory labeling are life-threatening respiratory depression, profound sedation, and coma, especially when used with other Central Nervous System (CNS) depressants like benzodiazepines. The risks of abuse, misuse, and addiction can lead to overdose and death. Additional serious risks include Neonatal Opioid Withdrawal Syndrome (NOWS) upon prolonged use during pregnancy, severe hypotension, and adrenal insufficiency.

Population-Specific Safety Considerations and Restrictions

Femitab is contraindicated (must not be used) in patients who are not opioid tolerant. It is also contraindicated for managing acute or postoperative pain. Increased monitoring is required for patients with chronic pulmonary disease, the elderly, or those with increased intracranial pressure, as the risk of respiratory depression is elevated in these groups. Use during pregnancy for prolonged periods can result in Neonatal Opioid Withdrawal Syndrome in the newborn.

Common Adverse Reactions

The most frequently reported adverse reactions (ge 10%) observed in clinical trials, affecting various system-organ classes, include:

  • Gastrointestinal: Nausea, vomiting, constipation.
  • Nervous System: Dizziness, headache.
  • General/Other: Fatigue, anemia, asthenia, peripheral edema, dehydration, and application site reactions.

Overdose and Emergency Response

Overdose and when to seek help

This section outlines the officially documented information regarding Femitab overdose, based strictly on authoritative governmental regulatory documents (such as those from the FDA, EMA, or Health Canada). This content is intended for informational purposes and does not replace medical advice.


Documented Overdose Profile

In cases of acute overdose (taking too much medicine), the following clinical manifestations have been documented in regulatory information for this type of medication:

Overdose Manifestation Population Note
Nausea General
Vomiting General
Withdrawal Bleeding Specific to Females

Serious or life-threatening outcomes are not explicitly listed as acute effects in the primary regulatory overdose sections for this class of product.


Emergency Action and Management

When to Seek Immediate Medical Help:

Official regulatory documents require that patients contact a doctor immediately or visit the nearest hospital if they have taken too much of the medicine or if symptoms of overdose occur. Seeking emergency medical help is the primary action required.

Supportive Care and Antidote:

There is no specific antidote listed in the regulatory documents for Femitab overdose. Management generally consists of appropriate supportive and symptomatic care, as determined by a healthcare professional.

Therapeutic Uses of Femitab

Quick Facts: Femitab

  • Therapeutic Domains: Management of iron deficiency and prevention of megaloblastic anaemia.
  • Specific Uses: Indicated for iron deficiency anaemia, particularly in the context of pregnancy, and for the prophylactic management of megaloblastic anaemia in pregnancy.

Femitab is a therapeutic option used in the management of certain types of nutritional deficiency. The primary indication is the prophylaxis and treatment of iron deficiency anaemia, a condition that may result from chronic hemorrhage, inadequate nutrition, or physiological demands, such as during pregnancy.

This medication is also indicated for the prevention of megaloblastic anaemia, specifically that which is related to folic acid deficiency, a risk factor particularly noted in pregnant individuals. By replenishing essential micronutrients, Femitab is intended to support the body's processes for blood cell formation. This usage is consistent with the established clinical practice for nutritional supplementation in at-risk populations. Individuals should consult with a healthcare professional to understand if this product aligns with their needs. The clinical rationale supports its role in addressing deficiencies that may affect overall health and well-being.

Eligibility and Restrictions for Use

Who Can and Cannot Use Femitab?

Population eligibility for Femitab (Ferrous Fumarate and Folic Acid) is strictly defined by regulatory authorities and centers on two factors: the risk of iron overdose and the potential for folic acid to mask specific blood disorders.

Contraindications: Who Must Not Use Femitab

The medicine is contraindicated and must not be used by specific patient groups, according to official labeling:

  • Children under 6 years of age are absolutely prohibited due to the high risk of fatal iron poisoning from accidental overdose.
  • Individuals with iron storage disorders, such as Hemosiderosis or Hemochromatosis.
  • Individuals with Pernicious Anemia or other megaloblastic anemias caused by Vitamin B12 deficiency.
  • Individuals with known hypersensitivity to any component.

Allowed and Restricted Use

Femitab is generally allowed for use in pregnant and lactating women for the treatment or prevention of documented deficiencies. However, use in patients with undiagnosed anemia requires caution, as proper diagnosis must be confirmed to rule out Vitamin B12 deficiency. Regulatory documents also state that safety and effectiveness have not been established in general pediatric or elderly populations.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Femitab is a combination product that typically contains Ferrous Fumarate (an iron supplement) and Folic Acid (Vitamin B9), and sometimes other vitamins and minerals. The potential for interaction with other products is primarily determined by these active components.

Interactions generally fall into two categories: those that affect the absorption of Femitab’s ingredients, and those where Femitab’s ingredients affect the other medication.

Affecting Femitab's Absorption

  • Tetracycline Antibiotics: The simultaneous use of tetracyclines and iron supplements can significantly reduce the absorption of both the iron and the antibiotic, lowering the effectiveness of both. A spacing requirement, typically 2 to 4 hours, is generally advised.
  • Antacids and Calcium Supplements: Medications or supplements containing magnesium, aluminum (antacids), or calcium can bind with iron in the gastrointestinal tract, thereby reducing the absorption of iron. Iron supplements should be taken at least 2 hours before or 4 hours after these products.

Femitab's Effect on Other Medicines

  • Anticonvulsants: Folic acid, when taken in high doses, may potentially reduce the serum levels of certain anti-seizure medications (anticonvulsants) like phenytoin, which could lead to a loss of seizure control. Closer therapeutic drug monitoring may be necessary.
  • Bisphosphonates and Thyroid Hormones (e.g., Levothyroxine): Iron can interfere with the absorption of several medications, including those used to treat osteoporosis (bisphosphonates) and hypothyroidism (levothyroxine). Taking the iron supplement and these medications at separate times is critical to maintaining the efficacy of the non-iron drug.

Mechanism of Action

How Femitab Works: A Targeted Pathway Inhibitor

Femitab's primary mechanism involves acting as an inhibitor against key kinases within the Mitogen-Activated Protein Kinase (MAPK) pathway, specifically the Ras-Raf-MEK-ERK cascade. By preventing necessary phosphorylation steps in this signaling sequence, the drug suppresses the transmission of growth signals from the cell's exterior to its nucleus. This molecular blockade ultimately leads to G0/G1 cell cycle arrest by interrupting progression through the G1 phase.

The drug's mechanism also includes modulation of the parallel PI3K/AKT/mTOR signaling pathway and the transcription factor NF-kappaB. This dual pathway interference affects multiple cellular processes, impacting pathways necessary for cell survival. The resulting physiological consequences include decreased cell survival by inhibiting anti-apoptotic signaling and the suppression of new blood vessel formation (angiogenesis).

Dosage and Administration Information

Femitab is administered exclusively by the oral route using the tablet or capsule dosage form. The general usage pattern is a continuous daily regimen that varies based on the necessity of use. For prophylaxis, such as supporting nutritional requirements during pregnancy, the standard course is typically one unit once daily. Conversely, for the active treatment of established nutritional deficiencies, the regimen is often increased to one unit twice daily to facilitate faster replenishment of body stores.

To ensure optimal absorption of the iron component, Femitab is taken on an empty stomach, generally defined as one hour before or two hours after eating. If gastrointestinal discomfort occurs, the medicine may be taken with food. It is a critical administration condition to avoid consuming the medicine within two hours of antacids, dairy products, coffee, or tea, as these substances can significantly interfere with the absorption process.

The duration of use is typically prolonged for several months following a deficiency diagnosis. This extended course is necessary to not only normalize blood hemoglobin levels but also to fully restore the body's iron reserves. The tablet or capsule should always be swallowed whole with water; specifically, extended-release forms must not be crushed or chewed to preserve their release kinetics. If a dose is missed, the standard practice is to skip the missed dose and resume the regular schedule, rather than taking a double dose. Use in children under 12 years is generally not recommended unless under specific medical direction.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Femitab

Evidence for Use in Managing Iron Deficiency and Anemia During Pregnancy

The research base includes studies exploring the use of this combination during pregnancy. Studies conducted include Randomized Controlled Trials (RCTs) and large-scale Systematic Reviews that combine data from many trials. Research examined what changes in maternal iron status were monitored when this combination was used as supplementation throughout pregnancy.

Studies monitored important measures such as hemoglobin (Hb) levels and ferritin concentration, which are biomarkers related to systemic or functional imbalance. Studies reported measurements related to the overall prevalence of maternal anemia and iron deficiency near the time of delivery. Researchers also examined related infant outcomes, including measuring mean birthweight and tracking the incidence of low birthweight or preterm birth. The evidence base includes many studies monitoring iron status, but certainty surrounding rare or severe clinical endpoints, such as maternal death or extreme birth outcomes, remains low.

Evidence for the Prevention of Folic Acid Deficiency and Neural Tube Defects

The Folic Acid component was studied in research exploring outcomes related to Neural Tube Defects (NTDs), which are conditions associated with acute or disruptive episodes during early fetal development. The research examining this association primarily involves large-scale Systematic Reviews and epidemiological evidence gathered from studies focused on women of childbearing age in the periconceptional period (the time around conception).

Studies monitored folate status biomarkers, which research suggests may reflect the body’s long-term folate stores. Research describes patterns related to measured biomarker levels when supplementation was applied. Findings from studies reported an association between measured folate status in the periconceptional period and observations related to NTD occurrence.

Key Limitations and Areas of Research Uncertainty

Scientific evaluation of the Ferrous Fumarate and Folic Acid combination highlights specific areas where evidence remains insufficient or requires further research. Follow-up durations were limited in many studies, and there is limited information for long-term outcomes that track the maintenance of iron or folate reserves beyond the study period. Durability of response, which is relevant for conditions marked by functional limitations, is not fully established by the existing evidence base. Research does not determine whether an individual will respond similarly; findings describe group patterns, not personal outcomes.

Key Studies & References

  1. Folic acid supplementation for the prevention of neural tube defects: an update of the evidence for the U.S. Preventive Services Task Force

Frequently Asked Questions (FAQ)

Common questions about Femitab (FAQ)

Q: Does Femitab interact with commonly used vitamins or supplements?

The iron component in Femitab is known to interact with certain minerals. Official documents indicate that supplements containing calcium or zinc can reduce the absorption of iron. Official guidance describes that separating these products may help maintain the intended benefit of each component.

Q: What are the symptoms of an allergic reaction to Femitab?

Official product safety information describes that symptoms of a severe allergic reaction may include signs such as hives or a skin rash. Other reported symptoms include swelling of the face, lips, tongue, or throat, and breathing difficulties.

Q: Why are certain populations excluded from using Femitab?

Specific exclusions are based on mandatory safety requirements. For instance, children under 6 years old are prohibited because of the high, life-threatening risk of fatal iron poisoning from accidental overdose. The folic acid component also requires caution for patients with undiagnosed anemia, as it can mask the progression of a Vitamin B12 deficiency.

Q: Can Femitab be taken with common over-the-counter pain relievers?

According to general regulatory guidance for these components, the folic acid in Femitab can generally be used alongside common pain relievers like paracetamol (acetaminophen). Official information states that the use of non-steroidal anti-inflammatory drugs (NSAIDs) with Femitab warrants review by a healthcare provider.

Q: Can Femitab affect my sleep patterns?

Changes to sleep patterns are not generally listed as a common side effect of Femitab at the recommended doses. However, safety data mentions that drowsiness is a potential symptom associated with acute iron overdose, which is considered a severe event.

Q: Why do official documents describe Femitab's use conditions in a certain way?

The specific use conditions are based on data showing how certain substances can interfere with the product. The instruction to avoid taking the medicine near certain foods, drinks (like coffee or dairy), or antacids is because these substances are known to significantly interfere with and reduce the absorption of the iron component. Following these conditions may help maintain the intended benefit of the medicine.

Q: What does 'contraindication' mean in the context of Femitab?

A contraindication is a regulatory term used in official documentation to describe a specific condition or circumstance where the use of Femitab is strictly prohibited. These circumstances are determined when the potential risk of using the medicine is judged to outweigh any possible benefit to the patient.

Q: What is the shelf life or expiry expectation for Femitab tablets?

While the exact expiry date is printed on the product label, regulatory guidelines require Femitab tablets to be stored properly to maintain quality. Official documents describe that proper storage involves keeping the medicine in its original container at controlled room temperature and protecting it from excessive moisture and heat.

Q: Does taking Femitab mean I have to avoid certain activities?

Official adverse reaction reports include the possibility of experiencing dizziness. The presence of symptoms such as dizziness may indicate a need for caution when performing activities that require mental alertness, such as driving or operating heavy machinery.

Q: What happens if Femitab is taken for a long period of time?

The recommended course of use for Femitab is often prolonged for several months to ensure the body's iron and folate reserves are fully restored. Official research summaries state that the evidence base has limited information regarding the long-term outcomes and the durability of the response for extended periods beyond the initial studies.

How should Femitab be stored and disposed of?

How to Store and Dispose of Femitab (Ferrous Fumarate and Folic Acid)

The official storage requirements for Femitab are defined to maintain product quality and ensure safety, particularly concerning the iron component.

Required Storage Conditions

Femitab must be stored at Controlled Room Temperature, typically 20 C to 25 C (68 F to 77 F). The product must be kept in its tightly closed, light-resistant container and protected from excess moisture and heat.

Mandatory Child Safety

A critical regulatory warning mandates that Femitab must be stored out of the sight and reach of children.

Official Disposal

Unused or expired Femitab should be disposed of through a drug take-back program where available. If no program is accessible, the tablets must be mixed with an undesirable substance (such as used coffee grounds) and placed into a sealed container before being discarded in the household trash, as specified by official regulatory guidelines.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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