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Ferlatum Fol

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Ferlatum Fol

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Method of action: Antianemic, Hematopoietic

Treatment option:

Medically reviewed

Laura Arias

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.

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Overview of Ferlatum Fol

Property Description
Active ingredients Ferrous protein succinylate and Ferric L-5-methyltetrahydrofolate
Form Oral solution (in single-dose vials)
Pharmacological class Hematinic and Antianemic preparation
Common use Addressing deficiencies of iron and folate
Origin Derived chemical compound (chelated iron and synthetic vitamin)

What Type of Medicine is Ferlatum Fol?

Ferlatum Fol is formally classified as an antianemic preparation belonging to the hematinic class of medicines, functioning as a combined nutritional supplement. Its core purpose is to supply elements necessary to support the body's processes for maintaining healthy blood cell formation, or hematopoiesis. It is specifically structured as a combination product, providing both the essential iron mineral source and the necessary folate compound. Iron supplements are used to manage anemia by correcting deficiencies in this vital mineral. This medicine offers a dual approach, often utilized in scenarios such as managing nutritional deficits during pregnancy to supporting blood health.

Composition and Form: Ferrous Protein Succinylate Oral Solution

Ferlatum Fol is defined by its two active therapeutic entities: Ferrous protein succinylate and Ferric L-5-methyltetrahydrofolate. The Ferrous protein succinylate is a unique, chelated iron compound where the divalent iron (Fe^2+) is protected by a protein carrier. Ferlatum Fol is presented as a drinkable oral solution, contrasting with solid dosage forms, and is typically dispensed in single-dose vials for oral administration. This liquid presentation differentiates it, making it suitable for patient groups, such as children or those with swallowing difficulties, who require a non-tablet form.

How Does the Composition Provide a General Benefit?

The unique composition provides a general benefit by simultaneously supporting two critical processes: iron replacement therapy and efficient folate metabolism support. The Ferrous protein succinylate component is designed to enhance gastrointestinal tolerance compared to traditional ferrous salts, as its protected structure aims to reduce the premature release of iron in the stomach. Chelated or protein-bound iron forms are associated with improved tolerability profiles and are generally well-tolerated by patients receiving treatment. Furthermore, the inclusion of Ferric L-5-methyltetrahydrofolate supplies folate in its already active form, which is immediately available for cellular use, efficiently supporting the processes necessary for healthy erythropoiesis.

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What side effects are possible with Ferlatum Fol?

Possible Side Effects and Safety Information

This section outlines the adverse reactions and safety restrictions for Ferlatum Fol (Iron Polymaltose and Folic Acid), as documented in official government regulatory sources.

Adverse Reactions by Frequency

The most commonly reported adverse effects are classified as Rare, meaning they affect between 1 in 10,000 and 1 in 1,000 users. These effects primarily involve the gastrointestinal system:

  • Nausea
  • Diarrhoea
  • Constipation

Serious Safety Considerations

The most critical safety risk involves the potential for overdosage of the iron component. Symptoms of iron overdosage can be severe and may include abdominal pain, vomiting of blood, and circulatory collapse. In acute, severe cases, overdosage can potentially lead to encephalopathy, acute liver cell death, and acute kidney failure after a time delay.

Restrictions and Limitations

Regulatory documents specify certain conditions where this medicine is contraindicated (must not be used) or requires special caution.

Classification Condition
Contraindications Known hypersensitivity to any component (iron or folic acid).
Anaemia of an undiagnosed cause.
Caution Required Patients with iron overload (haemochromatosis).
Patients with haemolytic anaemias.
Patients with folate-dependent tumours.

Folic acid should not be used as the sole treatment for pernicious anaemia, as it will not prevent the associated neurological complications.

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Overdose and Emergency Response

The official regulatory documents state that the overdose profile for this medicine is dominated by the severe, multi-systemic toxicity of its iron component. Ingestion may initially present as severe gastrointestinal distress, including vomiting, abdominal pain, and bloody stools. This often precedes a potentially deceptive temporary improvement period before the onset of severe systemic toxicity. Manifestations include circulatory collapse, shock, metabolic acidosis, and CNS depression. Overdose can progress to life-threatening complications, notably acute hepatic necrosis and acute renal failure, over multiple stages.

Immediate medical attention must be sought for any suspected overdose. Emergency services must be contacted immediately if the affected individual is collapsed, having seizures, or is unresponsive. A critical regulatory warning emphasizes that accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6 years.

Management procedures documented in official labeling include aggressive supportive and symptomatic care, and the use of the specific chelating antidote, Deferoxamine. Continuous clinical monitoring of vital signs and serum iron levels is required during treatment to manage this staged toxicity and guide procedural measures like whole bowel irrigation.

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Therapeutic Uses of Ferlatum Fol

What Ferlatum Fol Treats: Main Uses and Benefits

Ferlatum Fol is therapeutically aligned with addressing clinical states arising from the deficiency of two essential blood components: iron and folate. The primary benefit centers on providing symptomatic relief for conditions marked by systemic imbalance. Iron and folic acid supplementation is commonly used in symptomatic management across conditions marked by deficiency.

This medication is commonly used to treat conditions such as established iron deficiency anemia, the precursor state known as latent iron deficiency, and any coexisting folate insufficiency. It is considered relevant in scenarios of heightened physiological demand, particularly for pregnant individuals and women of reproductive age who experience predictable, increased requirements. The therapeutic purpose is to address the systemic imbalance that causes chronic fatigue, generalized weakness (asthenia), and a general lack of energy.

The medicine supports the patient during difficult episodes by easing distress and may assist with maintaining functional stability.

“The goal is to provide supportive relief when symptoms interfere with routine activities.”


Quick Fact: Supportive Management for Anemia-Related Symptoms

Addressing Fatigue and Symptoms that Interfere with Daily Functioning

Ferlatum Fol helps manage symptom clusters related to systemic imbalance. This support helps maintain a sense of stability when symptoms are more noticeable, contributing to improved day-to-day comfort during symptomatic periods.

Regulatory References

  1. NIH National Center for Biotechnology Information guidance
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Eligibility and Restrictions for Use

Official Population Eligibility Rules

The eligibility for Ferlatum Fol is strictly governed by regulatory documentation, which defines precise constraints on who can and who must not use the medicine.

Absolute Contraindications

The use of this medicine is absolutely forbidden for individuals with a confirmed hypersensitivity to any of its active substances or excipients. Furthermore, the medicine is contraindicated in any patient with conditions that cause systemic iron overload, including Haemochromatosis and Haemosiderosis, as well as other related conditions such as Chronic Hemolysis.

Diagnostic and Conditional Restrictions

Ferlatum Fol must not be used to treat anaemia until the specific aetiology (cause) has been definitively diagnosed. This critical restriction is documented to prevent the folate component from masking a coexisting, more serious Vitamin B12 deficiency. Use is also restricted and requires caution in patients diagnosed with haemolytic anaemias.

Age and Life Stage Eligibility

The medicine is permitted for use in adults and is often specifically indicated for pregnant individuals and those who are lactating. However, for certain combination forms, the medicine is generally not recommended for routine use in either the paediatric population or older adults, according to regulatory labeling.

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What should I know about interactions with other medicines?

The official interaction profile for Ferlatum Fol is governed by two key regulatory constraints. The Ferrous protein succinylate component causes chelation-mediated absorption interference, a pharmacokinetic effect that requires mandatory time separation of administration from many co-administered oral medications. This action prevents the reduced systemic exposure of agents such as Quinolone and Tetracycline antibiotics, Bisphosphonates, and Levothyroxine. Regulatory documents strictly classify the combination with the metal chelator Dimercaprol as restricted and to be avoided.

The Ferric L-5-methyltetrahydrofolate component is subject to pharmacodynamic antagonism and level-altering effects. This interaction pattern includes a documented risk of reduced therapeutic efficacy when combined with Folate Antagonists (e.g., Methotrexate). Furthermore, the folate component may lead to a decreased serum concentration of specific Anticonvulsants (e.g., Phenytoin).

Antacids and Calcium supplements are officially noted as substances that reduce the absorption of the iron component. Additionally, chronic alcohol consumption is documented to potentially increase folate elimination. A final procedural note in official labeling states that Antibiotics may interfere with microbiological assays for serum folate, which can result in falsely low test results.

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Mechanism of Action

Ferlatum Fol contains two active components: Ferric Protein Succinylate and a source of folinic acid (a reduced folate). The mechanistic action is twofold.

Iron Component

Ferric Protein Succinylate is a complex where trivalent ferric iron ( Fe^3+) is bound to succinylated milk proteins. Due to the complex's pH-dependent solubility, the compound precipitates in the acidic gastric environment, preventing premature release of Fe^3+. Upon transit to the less acidic, more alkaline environment of the duodenum, the complex resolubilizes. Pancreatic proteases then hydrolyze the protein component, releasing free Fe^3+ ions into the intestinal lumen.

Before entering the absorptive enterocytes, Fe^3+ is reduced to bivalent ferrous iron ( Fe^2+) by the duodenal cytochrome b ( DCYTB). Fe^2+ is then transported into the cell via the Divalent Metal Transporter 1 ( DMT1). Inside the enterocyte, the iron is either stored bound to ferritin or exported into the systemic circulation by ferroportin. Plasma Fe^2+ is re-oxidized to Fe^3+ by hephaestin and binds to transferrin for systemic distribution to tissues, including the bone marrow, where it is incorporated into heme for hemoglobin synthesis.

Folinic Acid Component

Folinic acid, a form of N^5-formyl tetrahydrofolate ( THF), acts as a biologically active form of the B9 coenzyme. It bypasses the need for reduction by dihydrofolate reductase required for folic acid activation. Folinic acid provides the necessary one-carbon units for the intracellular pathway of purine and pyrimidine synthesis, which are essential precursors for deoxyribonucleic acid ( DNA) and ribonucleic acid ( RNA) formation, and for the synthesis of certain amino acids like methionine and glycine. This coenzymatic action supports cellular proliferation and the metabolic cascades within high-turnover tissues, such as those responsible for hematopoiesis.

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Dosage and Administration Information

How to Use Ferlatum Fol

Ferlatum Fol is administered exclusively via the oral route as a liquid solution, which is typically dispensed in single-dose vials. The liquid form facilitates use for individuals, including pediatric patients, who may experience difficulty swallowing tablets.

Official Dosing and Administration Timing

Usage Pattern General Administration Principles
Route & Form Oral solution, to be swallowed.
Treatment Dose Regimens generally follow the principle of 100 mg to 200 mg of elemental iron per day.
Frequency Once daily (OD) or divided into multiple daily doses (e.g., BID).

For optimal absorption of the iron component, the dose should preferentially be taken on an empty stomach (e.g., 1 hour before a meal). If gastrointestinal tolerance is an issue, the medicine may be taken after meals. The solution may be mixed with a small amount of water or non-dairy fruit juice before swallowing to assist ingestion.

Duration and Procedural Rules

Treatment with the combined iron and folate preparation is generally continued for 3 to 6 months. Therapy must be maintained for an additional 2 to 3 months after blood levels (e.g., hemoglobin) return to normal, with the goal of fully replenishing body iron stores (ferritin).

The combined formulation is specifically indicated for use in pregnant and lactating individuals. If a dose is missed, standard instructions specify that the patient should skip the missed dose and resume the regular schedule without taking a double dose.

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Recent Clinical Evidence

Recent Clinical Evidence: Iron Protein Succinylate and Folate

Research on Ferlatum Fol, a combination of iron protein succinylate and calcium folinate (folic acid), has focused primarily on its use in addressing co-existing iron and folate deficiencies, particularly during periods of increased demand such as pregnancy. The iron component is a trivalent ferric iron ( Fe^3+) complex designed to optimize absorption.


Efficacy and Comparative Studies

Studies frequently compare the efficacy of iron protein succinylate to traditional oral iron salts, such as ferrous sulfate. A systematic review of research conducted over several decades found that iron protein succinylate was associated with significant changes in hemoglobin and ferritin levels across various patient populations with iron deficiency anemia. The magnitude of these changes was reported as similar or greater than those observed with comparator iron treatments.


Tolerability and Combination Therapy

Oral iron supplements are often associated with gastrointestinal adverse events. Iron protein succinylate is formulated to precipitate in the acidic environment of the stomach, releasing the iron primarily in the duodenum. This pH-dependent release mechanism is intended to support better gastrointestinal tolerability, which is a key factor in patient adherence to therapy. Clinical data suggest a favorable tolerability profile compared to some ferrous iron salts.

The addition of folic acid (calcium folinate) to the iron component in Ferlatum Fol addresses the dual nutritional needs often present in anemia and during pregnancy, where adequate folate is critical for red blood cell synthesis and fetal development. The combination is evaluated for its comprehensive support in managing both micronutrient deficiencies.

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Frequently Asked Questions (FAQ)

Common questions about Ferlatum Fol (FAQ)


Q: Is Ferlatum Fol the same as just taking iron tablets?

A: Ferlatum Fol is administered as an oral solution in single-dose vials, which is a key difference from solid dosage forms like tablets. The liquid form is intended to facilitate use for individuals, including children, who may have difficulty swallowing. Official information confirms the medicine provides both iron and a form of folate.

Q: How quickly should I expect to see an effect from Ferlatum Fol?

A: While treatment for complete iron store replenishment is generally prescribed for several months, initial signs of improvement in blood levels, such as hemoglobin, may be observed within the first few weeks of consistent use, according to general guidance on iron therapy. Treatment is officially advised to be continued after blood levels return to normal to fully replenish the body’s iron stores.

Q: Are there certain foods or drinks that should be avoided while using Ferlatum Fol?

A: Regulatory information indicates that substances which reduce iron absorption, such as antacids and calcium supplements, may lessen the medicine’s effectiveness. To minimize the risk of reduced absorption, time separation of administration from known inhibitors, including beverages like coffee and tea, is a common procedural note in iron supplementation.

Q: Do older adults use Ferlatum Fol for specific conditions?

A: Official guidance specifies that this medicine is generally not recommended for routine use in the older adult population. Use in this population is determined by an individual assessment of a diagnosed deficiency, as routine use is generally not recommended.

Q: Can Ferlatum Fol affect the absorption of other non-drug supplements?

A: Official regulatory documents specifically state that the absorption of the iron component can be reduced by certain non-drug substances, namely antacids and calcium supplements. Procedural notes advise time separation of administration from these substances.

Q: Is the liquid form of Ferlatum Fol generally preferred over other dosage forms?

A: The medicine is structured as a drinkable oral solution, which is an advantage for patient groups who have difficulty swallowing tablets, such as children. This liquid presentation is intended to support patient adherence and suitability for these groups.

Q: What are the general expectations for blood test improvements after starting Ferlatum Fol?

A: Initial improvements in blood test values are often observed within a few weeks of starting the treatment, but individual patient response may vary. Therapy is maintained until blood levels, like hemoglobin, return to normal and for a period afterward to ensure that body iron stores (ferritin) are fully replenished, as described in regulatory guidelines.

Q: Can Ferlatum Fol be used by vegetarians or vegans?

A: The official active ingredient description states that the iron component is bound to succinylated milk proteins. The presence of this binding agent means that individuals should check this ingredient against their personal dietary requirements, such as vegetarian or vegan diets.

Q: What does the term 'lactoferrin' mean in relation to Ferlatum Fol?

A: The official name of the iron complex used in this medicine is Ferric Protein Succinylate. It is structured so the iron is bound to succinylated milk proteins, which is the term used in regulatory documents for the protein carrier.

Q: Does Ferlatum Fol contain any common allergens like gluten or lactose?

A: The iron component is bound to succinylated milk proteins. Regulatory labels typically specify the presence or absence of excipients like lactose (milk sugar) or gluten; this information is found in the specific patient information leaflet.

Q: What are the symptoms of low iron that Ferlatum Fol is intended to address?

A: The primary purpose of the medicine is to correct the deficiencies that cause symptoms commonly associated with iron deficiency anemia. These symptoms often include generalized weakness and fatigue.

Q: What are the most important things to know before starting Ferlatum Fol?

A: Official documentation highlights the importance of being aware of the absolute contraindications, such as existing iron overload or undiagnosed anemia. Key procedural rules include the requirement for time separation from interacting drugs and the instruction to skip a dose rather than taking a double dose if a regular dose is missed.

Q: Can Ferlatum Fol cause dark stools or changes in stool color?

A: It is a common and expected effect of taking oral iron supplements that they will cause the stool to appear darkened or black. This is a known, expected effect of the iron component. Individuals should discuss any concerns with a healthcare professional.

Q: Are there any documented long-term side effects associated with Ferlatum Fol?

A: The medicine is typically prescribed for a defined period to correct a deficiency. A specific caution related to the folate component is documented: Folate can mask an existing Vitamin B12 deficiency, and if that deficiency is left untreated, it may potentially lead to serious neurological complications over time.

Q: Do any official drug documents warn against using Ferlatum Fol with dairy products?

A: Official guidance warns that calcium and calcium supplements reduce the absorption of iron. Because dairy products are a significant source of calcium, consuming them close to the time of administration may interfere with the iron component’s absorption.

Q: Is it normal for urine color to change while taking Ferlatum Fol?

A: The medicine contains folinic acid (a form of Vitamin B9). Since this is a water-soluble vitamin, any excess that the body does not use is excreted. This may cause the urine to turn a brighter yellow or orange color. Individuals should consult their healthcare provider if they have concerns about changes in urine color.

Q: Are there restrictions on donating blood while taking Ferlatum Fol?

A: According to guidelines from major blood donation authorities, individuals who are taking prescribed medication to treat a nutritional deficiency (which is the purpose of this drug) are typically restricted from donating blood. This is to ensure the donor’s underlying condition is fully resolved.

Q: How does Ferlatum Fol relate to treating iron deficiency without anemia?

A: Clinical authorities recognize that iron deficiency can exist even when anemia is not yet present. Treatment guidelines for this condition, known as Iron Deficiency Without Anemia (IDWA), often specify that oral iron supplementation is the primary therapeutic approach.

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How should Ferlatum Fol be stored and disposed of?

Storage Requirements

Ferlatum Fol (Ferrous protein succinylate and Ferric L-5-methyltetrahydrofolate oral solution) must be stored strictly according to its official regulatory labeling. The medicine must be kept at a temperature not above 25 C (77 F) to preserve its integrity and labeled two-year shelf-life. The liquid product must also be stored in a dry place and protected from light.

Child Safety and Disposal

The medicine must be securely kept out of the sight and reach of children due to its iron content. Disposal of any unused or expired Ferlatum Fol must be conducted safely and in compliance with applicable local regulations for medicinal waste.

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

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