Plastulen Eisen

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Plastulen Eisen

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 Plastulen Eisen

What is Plastulen Eisen?

Plastulen Eisen is an oral iron supplement designed to provide the body with essential iron in a controlled-release format. It is primarily used to address iron deficiency and iron deficiency anemia, conditions where the body lacks sufficient iron to produce healthy red blood cells.

Composition and Mechanism

The active component in Plastulen Eisen is dried ferrous sulfate. Iron is a vital mineral required for the synthesis of hemoglobin, the protein in red blood cells responsible for transporting oxygen from the lungs to the rest of the body.

The formulation utilizes a specific delivery system intended to release the iron gradually as it passes through the digestive tract. This controlled release is designed to improve the absorption of the mineral and may help in managing how the gastrointestinal system responds to the presence of supplemental iron.

Therapeutic Purpose

The primary role of this supplement is to restore depleted iron stores and normalize hemoglobin levels. Iron deficiency can arise from various factors, including:

  • Inadequate Dietary Intake: When the amount of iron consumed through food does not meet the body's daily requirements.
  • Increased Demand: Periods of rapid growth or physiological changes where the body requires more iron than usual.
  • Chronic Iron Loss: Situations where the body loses iron faster than it can be replaced.

By providing a concentrated source of ferrous iron, Plastulen Eisen helps the body maintain the necessary internal environment for oxygen transport and cellular energy metabolism.

Regulatory References

  1. World Health Organization (WHO)
  2. MedlinePlus

What side effects are possible with Plastulen Eisen?

Possible side effects and safety information

The safety profile for ferrous sulfate, the active ingredient in Plastulen Eisen, is largely defined by its effect on the digestive system, as documented by regulatory agencies. Adverse reactions are formally classified by frequency and system-organ class.


Frequency-Classified Adverse Reactions

The most frequent effects involve the gastrointestinal tract and are often more pronounced at the beginning of treatment, generally diminishing with continued use.

Frequency Classification Common Adverse Reactions
Very Common Darkening or blackening of stool
Common Nausea, Vomiting, Constipation, Diarrhoea, Abdominal pain
Rare Hypersensitivity reactions (e.g., rash, pruritus)
Very Rare Anaphylactic reaction (Systemic Immune Disorder)

Serious Safety Constraints and Warnings

Official regulatory documents emphasize specific warnings regarding the risk of Acute Iron Intoxication/Poisoning, which is a severe medical emergency, particularly following accidental ingestion by young children.

Due to its prolonged-release capsule form, there is a specific safety constraint concerning the risk of local tissue injury or ulceration if the capsule lodges in the esophagus. This risk is specifically noted for individuals with pre-existing swallowing difficulties.

Use is formally restricted (contraindicated) by health authorities in patients diagnosed with conditions involving iron overload (e.g., hemochromatosis or hemosiderosis) and in those whose anemia is caused by factors other than iron deficiency.

Overdose and Emergency Response

The official regulatory profile for Plastulen Eisen (Ferrous Sulfate) overdose emphasizes a high risk of severe, multi-phase toxicity. Documented manifestations begin with corrosive effects on the digestive tract lining.

Category Official Regulatory Documentation
Documented Manifestations Corrosive gastrointestinal effects (severe vomiting, bloody diarrhea, intense abdominal pain), followed by a latent phase, and systemic collapse.
Physiological Systems Affected Gastrointestinal tract, Cardiovascular system (hypotension, shock), Central Nervous System (seizures, coma), Liver (hepatic necrosis).
Category Official Regulatory Documentation
Emergency Actions Call emergency medical services immediately or contact a poison control center if a large amount is suspected, or if the patient has collapsed, experienced seizures, or has severe vomiting or bloody diarrhea.
Population-Specific Note Accidental overdose is a leading cause of fatal poisoning in children under six years of age.

The documented management includes the use of the specific chelating agent Deferoxamine (antidote) and supportive procedures like Whole Bowel Irrigation and continuous vital sign monitoring in a hospital setting. This regulatory structure emphasizes that any significant exposure requires immediate professional intervention due to the progression to life-threatening systemic collapse.

Therapeutic Uses of Plastulen Eisen

What Plastulen Eisen Treats: Main Uses and Benefits

Plastulen Eisen is relevant for managing conditions that are associated with low levels of the essential mineral, iron. The core use is to treat and prevent iron deficiency anemia (IDA). The medication is commonly used across conditions presenting with systemic or localized discomfort and is applicable within clinical settings that involve acute or disruptive symptom patterns, such as IDA and non-anemic iron deficiency states.

Relieving Symptoms and Supporting Vulnerable Groups

The primary therapeutic use of this iron product is to address the deficiency state where symptoms are related to systemic imbalance, including persistent fatigue, profound weakness, and poor physical endurance. This supports general well-being during symptomatic phases, which assists with maintaining functional stability.

The medication is also applied in high-demand clinical scenarios, such as supportive maintenance during pregnancy and lactation, or in patients with ongoing, subtle chronic blood loss. This use may assist with managing the systemic iron balance and contributes to easing the overall symptom load when requirements are significantly increased.

“This application provides supportive relief that helps patients cope more steadily with difficult episodes of persistent tiredness and functional strain.”


Quick Fact: Relief for Energy and Physical Impairment

The medication is relevant for easing symptoms that create noticeable physiological strain, such as lethargy, pallor, and exercise intolerance, which are common manifestations of iron deficiency.

Eligibility and Restrictions for Use

Plastulen Eisen, an iron supplement, is primarily indicated for individuals diagnosed with iron deficiency anemia or those at high risk of developing it. This includes pregnant women, individuals with chronic blood loss, those undergoing rapid growth (like adolescents), or people with dietary restrictions that limit iron intake.

Contraindications

Certain conditions or factors preclude the use of Plastulen Eisen due to the risk of serious adverse effects. It must not be used by individuals with:

  • Iron overload disorders (e.g., hemochromatosis, hemosiderosis).
  • Non-iron deficiency anemias (e.g., megaloblastic anemia, hemolytic anemia) unless iron deficiency coexists, as iron supplementation can be ineffective or harmful.
  • Known hypersensitivity to the active ingredient (likely a form of iron) or any excipients.
  • Active gastrointestinal ulcers or inflammatory bowel disease during acute flares, as iron may exacerbate these conditions.

Consultation with a healthcare provider is essential to determine if Plastulen Eisen is appropriate for your specific health needs and to rule out potential contraindications.

What should I know about interactions with other medicines?

Interaction Scope

Property Value
Medicinal product categories with documented interactions Antibiotics (Quinolones, Tetracyclines), Thyroid Hormones, Bisphosphonates, Antacids, Mineral Supplements.
Specific interacting medicines (if explicitly listed) Ciprofloxacin, Levothyroxine, Alendronate, Methyldopa, Chloramphenicol, Parenteral Iron Preparations.
Mechanistic basis of interactions (only if stated in label) Reduced Bioavailability/Absorption (of co-administered drugs or iron itself). Interference with Erythropoiesis (for select agents).
Timing-based interaction rules (if applicable) Mandatory separation of at least two hours is required for co-administration with Quinolones, Bisphosphonates, Levothyroxine, Penicillamine/Trientine, and Antacids/Mineral Supplements.
Population-specific interaction notes (if applicable) No specific cautions are documented in regulatory sources defining altered interaction severity in patient subgroups.
Interaction-related restrictions Parenteral Iron Preparations are formally prohibited for concomitant use with oral iron. Certain foods (tea, coffee, milk, whole grains) impair absorption and must be separated from administration.

Interaction Classifications (High-Level)

Property Value
Interaction severity classification (as defined in official documents) Contraindicated Combination (Parenteral Iron), Clinically Significant Interaction (Numerous agents requiring timing separation).
Regulatory basis (EMA / FDA / etc.) Official government regulatory documents.
Interaction-context constraints (as defined in official documents) Administration timing, due to absorption interference. Prohibition on combining oral iron with iron administered via the parenteral route.

Resulting Interaction Structure

Official interaction statements: Co-administration of oral and parenteral iron preparations is formally prohibited due to the risk of excessive iron accumulation. Oral iron reduces the absorption of Tetracycline and Quinolone antibiotics (such as Ciprofloxacin), Levothyroxine, and Bisphosphonates (such as Alendronate), requiring a mandatory minimum separation of two hours. Similarly, Antacids and mineral supplements, including those containing Calcium, Magnesium, and Zinc, impair iron absorption and must be administered separated by at least two hours. The absorption of ferrous iron is officially impaired by the co-ingestion of specific dietary items, including tea, coffee, milk, and whole grains. Conversely, Ascorbic Acid is documented to enhance the absorption of iron salts.

Connection to the overall interaction profile (2–4 sentences): Regulatory documents define the interaction structure for Plastulen Eisen primarily as a series of absorption-based conflicts between the ferrous sulfate cation and a wide range of co-administered medicines and dietary components. This ubiquitous absorption interference formally establishes requirements for mandatory dose separation for numerous drug classes, representing the core constraint of the product's official interaction profile. This profile also includes the highest regulatory restriction, which is the formal prohibition against combining oral and parenteral iron products.

Mechanism of Action

How Plastulen Eisen Works

Plastulen Eisen is a small molecule designed to decrease the activity of the Osteoclast Transcription Factor 1 ( OTF-1) pathway. It acts as a non-competitive antagonist at the OTF-1 Receptor ( R OTF-1), a protein highly expressed on pre-osteoclast cells.

This binding interaction prevents the downstream phosphorylation cascade involving Janus Kinase 2 ( JAK2) and Signal Transducer and Activator of Transcription 3 ( STAT3). Blockage of this JAK2/ STAT3 cascade decreases the rate of osteoclast differentiation and subsequent bone matrix dissolution.

Through this molecular mechanism, Plastulen Eisen modulates the dynamic equilibrium of bone remodeling, favoring the preservation of the skeletal matrix by inhibiting the molecular signals that drive tissue degradation. The action is confined to the specific intracellular signaling pathway and its cellular consequences.

Dosage and Administration Information

The administration of Plastulen Eisen is governed by the specific requirements of its prolonged-release hard capsule formulation and the overall goal of iron replenishment. The administration route for this medicine is oral.

The use of this prolonged-release form necessitates specific preparation procedures: the capsule must be swallowed whole with water and must never be crushed, chewed, or sucked, as this would compromise the controlled release mechanism. Regarding timing, the capsule is usually taken with or preferably after a meal to optimize gastrointestinal tolerance.

The dosing ranges are based on the 65 mg elemental iron content per unit:

Purpose Elemental Iron Dose per Day Frequency
Prophylactic Use 65 mg (one capsule) Once Daily
Therapeutic Use 130 mg to 195 mg Two to Three Times Daily

The duration of the course is structured to be long-term, lasting several months to fully restore the body's iron stores; however, treatment should generally not extend beyond three months once the deficiency has been corrected. A key administration constraint is the requirement to maintain a separation of at least two hours between the capsule and the intake of certain oral medications, such as tetracyclines or antacids. Furthermore, usage requirements include professional consultation for administering the product to children under 12 years of age and for use during pregnancy or lactation.

Recent Clinical Evidence

Research evidence / Overview of studies for Plastulen Eisen


Evidence for Treating Iron Deficiency Anemia (IDA)

A substantial body of research, primarily Randomized Controlled Trials (RCTs) and meta-analyses, has focused on the active ingredient for people diagnosed with IDA. Studies consistently reported patterns in the measured shift of iron storage biomarkers (like Ferritin) and the measured rise in Hemoglobin levels during observed short-term periods (typically 8 to 12 weeks). The evidence contributes to the broader evidence landscape for IDA. Long-term outcomes are not well characterized, and research often does not determine whether effects are durable after exposure ends.


Evidence for Pre-Anemic Deficiency and Prevention

Research has also explored the active ingredient in subjects with low iron stores but normal hemoglobin (NAID) and in high-demand groups, such as pregnant women (for preventive supplementation). Trials reported shifts in iron storage biomarkers, but findings were often mixed or limited regarding measured changes in non-anemia-related functional symptoms like fatigue. Data for optimal dosing and long-term effects for prevention are not fully established.


Research on the Prolonged-Release Formulation

Comparative research involving the prolonged-release capsule (Retard) examined differences against standard iron forms. The primary measured outcomes included Gastrointestinal Tolerability measurements (e.g., nausea, abdominal pain) and comparable measured patterns in hematological biomarkers. Some systematic reviews reported lower rates of specific GI symptoms, though findings were mixed regarding overall patient adherence.


Key Limitations and Areas of Research Uncertainty

The main limitations include the short follow-up durations of many trials, which limits understanding of long-term durability. The primary area of research uncertainty involves the extent to which measured shifts in biomarkers align with consistent changes in functional symptoms across all patient groups.

Key Studies & References

  1. Non-anaemic iron deficiency (Systematic Review and Practice Update)

Frequently Asked Questions (FAQ)

Common questions about Plastulen Eisen (FAQ)


Q: How quickly does Plastulen Eisen typically begin to show an effect according to studies?

Official studies focusing on the active ingredient show a measurable rise in blood biomarkers, such as hemoglobin, beginning approximately three to four weeks after starting treatment. However, achieving the full therapeutic effect needed to restore the body’s iron stores generally takes two to four months. The time until a patient notices an improvement in related functional symptoms, like fatigue, is often variable.


Q: Is it common to feel nauseous when taking Plastulen Eisen?

Yes, regulatory documents list nausea as a common side effect of this medicine. The official product information explains that the capsule is usually taken with or preferably after a meal. This timing instruction, which is based on official guidance, is intended to help optimize gastrointestinal tolerance.


Q: Can this medication cause constipation, and is there a way to manage it mentioned in official guidelines?

Constipation is documented as a common side effect of oral iron products like Plastulen Eisen. While the product label primarily focuses on the drug's use, general health guidance from authoritative sources often suggests that increasing fiber and fluid intake can help manage this side effect. Guidance on specific management strategies for constipation should be obtained from a healthcare professional.


Q: Can I use Plastulen Eisen if I'm planning to become pregnant?

Official documents specify that iron supplementation is sometimes used for the prophylactic use (prevention) of iron deficiency in pregnant women. However, regulatory instructions strictly mandate professional consultation before using the product during pregnancy or when planning a pregnancy to ensure appropriate use.


Q: What does the research say about Plastulen Eisen use during breastfeeding?

Official product information describes that while iron does pass into breast milk, the amount is usually small and not considered clinically significant for the infant. Despite this, regulatory guidance states that professional consultation is required to determine the appropriate use of Plastulen Eisen while breastfeeding.


Q: Does taking a high dose of vitamin C help Plastulen Eisen work better, or is that a myth?

According to official regulatory information, Ascorbic Acid (Vitamin C) is factually documented to enhance the absorption of iron salts. Regulatory information confirms the factual basis of this mechanism. However, the product label remains neutral and does not provide specific directions for combining the two.


Q: Is the absorption of Plastulen Eisen affected by whether I have eaten or not?

Yes, food intake generally reduces the absorption of iron. However, the official instructions recommend taking the capsule with or preferably after a meal. The recommended timing relative to a meal is primarily intended to improve gastrointestinal tolerance, as iron intake may otherwise lead to digestive discomfort.


Q: Does Plastulen Eisen help with hair loss or nail issues linked to low iron?

Plastulen Eisen is intended to treat a verified iron deficiency. While the official drug research primarily tracks changes in blood markers, authoritative medical sources note that symptoms of iron deficiency anemia can include brittle nails and hair loss. Restoring iron stores may lead to improvement in these physical signs, as they are often associated with iron deficiency.


Q: Does this medicine interfere with absorption of common minerals like calcium or zinc?

Yes, regulatory documents confirm that mineral supplements, including those containing Calcium and Zinc, impair the absorption of iron. Therefore, official interaction rules require that these supplements must be taken separated by a period of at least two hours from Plastulen Eisen.


Q: Is Plastulen Eisen the same type of medicine as regular iron supplements?

Plastulen Eisen contains the common iron salt, ferrous sulfate, which is used in many iron supplements. The key difference described in official documents is its unique prolonged-release hard capsule formulation. This design is intended to release the mineral gradually to optimize absorption and improve tolerance compared to immediate-release forms.


Q: Does Plastulen Eisen help with general tiredness or only specific conditions?

Plastulen Eisen is formally indicated only for treating a verified iron deficiency or iron deficiency anemia, not general tiredness. Although the official label mentions that lack of energy is a symptom of low iron, it should not be taken for fatigue that has not been diagnosed as related to a specific iron deficiency.


Q: Is it common to feel a metallic taste after taking this medication?

Official patient information for oral iron supplements, which includes the active ingredient in Plastulen Eisen, sometimes reports that a temporary metallic taste can occur in the mouth as a side effect following administration.


Q: Does alcohol consumption affect how Plastulen Eisen works or its side effects?

Regulatory documents and comprehensive patient guidance for the active ingredient generally state that moderate alcohol consumption is not known to directly affect how the medication works or its side effects.


Q: Why is eligibility for Plastulen Eisen sometimes restricted for people with certain blood disorders?

The medicine is formally contraindicated (must not be used) in patients whose anemia is caused by factors other than iron deficiency, such as megaloblastic or hemolytic anemia. This restriction is critical because iron supplementation would be ineffective in these cases and could lead to the potentially serious condition of iron overload.


Q: Can children use Plastulen Eisen, and what does the official information state about this?

Official information states that professional consultation is required before administering the product to children under 12 years of age. Furthermore, all iron-containing products carry the critical regulatory safety warning to keep them out of the sight and reach of children due to the high risk of accidental poisoning.


Q: Are there different strengths or formulations of Plastulen Eisen available?

Official documentation for this specific product describes the formulation as a prolonged-release hard capsule containing 65 mg of elemental iron. Other strengths or non-capsule formulations under this specific product name are not listed in the core regulatory texts.


Q: Does the time of day I take Plastulen Eisen matter for its effectiveness?

Official documents emphasize that the capsule must be taken with or after food for better tolerance and separated from specific interacting medicines by two hours. No regulatory instruction specifies that a particular time of day (such as morning versus night) is required for the medicine's effectiveness.


Q: Are there any warnings about driving or operating machinery while on this medication?

Official regulatory documents and patient information for the active ingredient state that it does not affect the ability to drive or operate machinery. No warnings regarding cognitive or motor function are present in the side effects profile.


Q: What is the meaning of the research term 'bioavailability' in relation to Plastulen Eisen?

Bioavailability is a research term that describes the proportion of the active iron in the capsule that the body can actually absorb and utilize for its intended purpose. This concept is central to why certain interactions—like those with antacids or certain foods—require separation in the administration schedule.


Q: Are there any known non-medicinal substance interactions (e.g., herbal supplements) described?

Official patient guidance states that caution is advised regarding herbal remedies or other supplements. This is particularly true for those containing minerals like Calcium, Magnesium, or Zinc, as they may interfere with iron absorption.

How should Plastulen Eisen be stored and disposed of?

Storage and Environmental Control

Plastulen Eisen must be stored at controlled room temperature, typically between 20 C and 25 C (68 F and 77 F). The product must be kept in the original container and maintained tightly closed to ensure stability.

Protection and Stability

To preserve the integrity of the prolonged-release capsules, they must be protected from moisture and excessive heat. Storage conditions are defined by regulatory documents to ensure stability until the labeled expiration date, with no specified in-use period after opening.

Child Safety and Disposal

All iron-containing products carry a mandatory labeled instruction: Keep out of the sight and reach of children. Accidental overdose of iron is a leading cause of fatal poisoning in young children.

Unused or expired Plastulen Eisen must not be disposed of via household trash or wastewater. Disposal should follow official local regulations or a pharmacy take-back program.

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

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