Folsäure Lomapharm

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Folsäure Lomapharm

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Method of action: Antianemic

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Overview of Folsäure Lomapharm

What is Folsäure Lomapharm? (Overview)

Property Description
Active Ingredient Folic acid (Vitamin B9)
Form Oral tablet
Pharmacological Class Vitamin (Nutritional Supplement)
Common Use Prevention and treatment of deficiency
Origin Synthetic (Pteroylmonoglutamic acid)
Manufacturer Lomapharm GmbH

What Type of Medicine is Folsäure Lomapharm?

Folsäure Lomapharm is a targeted vitamin preparation containing the essential B-vitamin, Folic acid. It is classified as a nutritional supplement designed to support the body’s metabolic functions. The product is typically supplied as small, orally administered tablets, making it a convenient method for addressing nutritional needs.

Folic acid, also known chemically as Pteroylmonoglutamic acid, plays a role in cellular health, DNA synthesis, and the production of red blood cells.

Where Does the Active Ingredient Come From? (Composition)

The active ingredient in the medicine is the synthetic form of the vitamin, chosen for its stability and bioavailability compared to naturally occurring folate found in foods. This synthetic form is characterized by its ability to be effectively absorbed by the body.

Folsäure Lomapharm is a single-ingredient formulation from the manufacturer Lomapharm GmbH, focused solely on providing a reliable dose of this micronutrient to correct or prevent a shortfall.

What is the Main Therapeutic Purpose?

The overall therapeutic purpose of Folsäure Lomapharm is the prevention and management of Folic acid deficiency. The use of this medicine is intended to restore adequate levels of the vitamin in the body, particularly when dietary intake is insufficient or bodily requirements are increased. Its action supports fundamental physiological processes, most notably the formation of healthy blood cells (hematopoiesis).

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What side effects are possible with Folsäure Lomapharm?

Possible side effects and safety information

Folic acid preparations, such as Folsäure Lomapharm, are generally well-tolerated. Official regulatory documents classify the majority of reported adverse reactions by their frequency and the body system affected.

Serious Regulatory Safety Constraints

The most critical constraint defined in regulatory labeling concerns the use of folic acid in the presence of untreated Vitamin B12 deficiency (cobalamin deficiency). High doses of folic acid may correct the blood profile of megaloblastic anemia, thus masking the deficiency while allowing irreversible, severe neurological damage, such as subacute combined degeneration of the spinal cord, to progress. For this reason, official labels state that the product is contraindicated in patients with this condition.

Documented Side Effects by System-Organ Class

The adverse reactions documented in official regulatory sources are primarily classified as rare (occurring in ge 1/10,000 to <1/1,000 users).

System-Organ Class Rare Adverse Reactions
Gastrointestinal Disorders Anorexia, nausea, abdominal distension, flatulence.
Immune System Disorders Hypersensitivity reactions (e.g., pruritus, rash, erythema, urticaria).

More serious allergic responses, including anaphylactic reaction (anaphylaxis/shock), have been reported, although the frequency of these severe events is often listed as not known in the regulatory frequency framework.

Other Safety Considerations

Official prescribing information notes that certain nervous system effects, such as mental depression and irritability, have been associated with the chronic administration of very high doses. Safety constraints also exist for individuals with rare hereditary disorders, such as galactose intolerance, due to the presence of non-active ingredients (excipients) in the tablet formulation.

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Overdose and Emergency Response

Overdose and when to seek help

The active ingredient in Folsäure Lomapharm, Folic acid, is generally documented in regulatory sources as having low acute toxicity. However, chronic high-dose exposure is associated with officially documented manifestations, primarily involving the gastrointestinal system (e.g., nausea, abdominal cramps, flatulence, anorexia) and the central nervous system (e.g., confusion, irritability, altered sleep patterns, and impaired judgment). Skin reactions, such as rashes, are also reported.

A critical regulatory warning notes that high doses may obscure the diagnosis of pernicious anemia, allowing neurological damage to progress despite hematologic improvement. Rare, severe risks include reactions suggesting anaphylaxis or respiratory difficulty due to bronchospasm. Immediate medical attention must be sought for any suspected overdose or the onset of severe allergic signs. Management explicitly requires contacting a Poison Control Centre or emergency clinic.

There is no specific antidote known for Folic acid overdose. Official management is symptomatic and supportive, and may include procedures like gastrointestinal decontamination and the administration of activated charcoal for acute cases. Close monitoring is necessary, particularly to observe for progressive neurologic changes.

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Therapeutic Uses of Folsäure Lomapharm

Quick Facts

  • Addresses: Folate-deficiency anemia
  • Supports: Red blood cell formation
  • Essential for: Preventing specific birth defects

Folsäure Lomapharm is a therapeutic option containing the synthetic B vitamin folic acid, which is vital for cellular health. The primary use of this medication is to address and manage folate-deficiency anemia, a condition that may result from low blood levels of this essential nutrient. This deficiency can affect the body’s ability to form healthy red blood cells.

The medication also offers significant benefits during times of increased need, such as when planning pregnancy or during the initial phase of gestation. Adequate intake of folic acid is essential to support the proper development of the fetus and may help reduce the risk of certain serious birth defects, specifically those affecting the brain and spine (neural tube defects). This preventative use is a key therapeutic domain.

Folic acid may additionally be prescribed to individuals undergoing specific medical treatments that can lower the body's folate stores, helping to maintain necessary levels of the vitamin.

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Eligibility and Restrictions for Use

Population Eligibility for Folsäure Lomapharm

The eligibility for Folsäure Lomapharm (folic acid) is defined by regulatory documents based on underlying medical status and specific population groups. The primary restriction relates to preventing the masking of coexisting deficiencies.

Contraindications (Must Not Use)

Condition / Population Restriction Basis
Untreated Cobalamin (Vitamin B12) Deficiency Absolute prohibition; Folic acid can mask the blood signs while irreversible nerve damage progresses.
Known Hypersensitivity Allergy to folic acid or any inactive ingredients (excipients).
Hereditary Metabolic Disorders Patients with specific excipient intolerances, such as Lapp lactase deficiency or galactose malabsorption.

Conditional Use and Allowed Groups

The medicine is indicated and generally allowed for use in adults, children, and infants for the treatment of folate deficiency. It is also explicitly authorized for pregnant women for both deficiency treatment and the prevention of neural tube defects, and its use is permitted during lactation (breastfeeding).

Restrictions for Caution

  • Undiagnosed Megaloblastic Anaemia: The medicine must not be used as the sole treatment until Vitamin B12 deficiency is ruled out.
  • Older Adults (Elderly): A cobalamin absorption test may be required before long-term use due to the risk of masked B12 deficiency.
  • Malignant Disease: Use is generally not recommended unless a complication specifically due to folate deficiency is present.
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What should I know about interactions with other medicines?

Folsäure Lomapharm (Folic acid) has documented interaction patterns primarily involving pharmacokinetic and pharmacodynamic alterations with co-administered medicines, as stated in regulatory prescribing information.


Specific anticonvulsant medicines, including Phenytoin, Phenobarbital, and Primidone, are listed in official labeling as substances that can decrease the body's serum Folic acid levels. This is a pharmacokinetic interaction. Conversely, the presence of Folic acid may also increase the clearance of Phenytoin, potentially leading to lower blood concentrations of that drug.


A major pharmacodynamic interference exists with antifolate agents such as Methotrexate, Trimethoprim, and Pyrimethamine. Folic acid replacement may counteract or reduce the intended therapeutic effect of these medicines. This interaction is also relevant for certain cytotoxic medicines, including Lometrexol, whose efficacy may be reduced by Folic acid, and Fluorouracil, whose pharmacokinetics can be altered by Folic acid's metabolite.


Regarding non-medicinal substances, chronic and excessive Alcohol consumption is officially documented as a drug–substance interaction. Alcohol inhibits the intestinal absorption of Folic acid and increases its elimination, leading to reduced overall exposure and potential deficiency. No formal contraindicated combinations or mandatory timing separation rules are cited in official regulatory documents for the use of Folsäure Lomapharm.

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Mechanism of Action

Mechanism of Action: Metabolic Precursor Function

Folsäure Lomapharm (Folic acid) functions not as a traditional modulator of receptors or ion channels, but as an essential metabolic precursor required to initiate and sustain fundamental cellular cycles. Its action is one of restoration, replenishing depleted cofactors necessary for biosynthesis.

Intracellular Cofactor Activation and DNA Synthesis

The synthetic Folic acid molecule first acts as a substrate for the enzyme Dihydrofolate Reductase (DHFR), which catalyzes its reduction into the active cofactor form, tetrahydrofolate (THF). THF then participates in the one-carbon metabolism pathway, functioning as a crucial donor of methyl groups for subsequent biochemical reactions. The primary functional consequence of this action is its role in providing the necessary cofactors for genetic material synthesis; specifically, THF derivatives facilitate the production of purines and the essential DNA base thymidine via the enzyme Thymidylate Synthase (TS). This action facilitates the successful division and nuclear maturation of precursor cells, resulting in the establishment of normal hematopoiesis (blood cell formation) and the cellular correction of immaturity.

The Constraint of B12 Interdependence

A critical limitation of Folic acid's mechanism lies in its dependence on Vitamin B12 to fully complete the homocysteine recycling pathway. Without B12, the folate active metabolite ( N^5-Methyl- THF) becomes metabolically trapped, unable to efficiently return to the general THF pool for DNA synthesis. This constraint defines the mechanistic boundary: Folic acid can proceed through the DNA synthesis pathway but does not resolve the B12-dependent reaction necessary for the proper function of the nervous system.

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Dosage and Administration Information

How to use Folsäure Lomapharm — Official Administration Guidelines

Folsäure Lomapharm is primarily administered by the oral route as a tablet for general use. For severe malabsorption or other specific clinical needs, an injection solution for intramuscular or intravenous administration is available, which must be performed under professional supervision. The tablets should be swallowed whole with a sufficient amount of liquid and can be taken independently of meals.

Standard Dosing and Frequency

For the treatment of folate deficiency anemia in adults, the general administration pattern is 5 mg once daily, typically continued until hematological parameters normalize (e.g., a four-month course). In patients with severe malabsorption, the daily dose may be increased up to 15 mg. The frequency for standard use is a consistent, single once-daily schedule.

Population-Specific Use and Duration

For women at high risk of a neural tube defect-affected pregnancy, the required dosage is 5 mg daily, which must be started before conception and continued throughout the first twelve weeks of pregnancy. Paediatric dosing rules are based on age and weight, with children over one year generally following the adult 5 mg daily regimen, while infants under one year require a dose adjusted to 500 mu g/ kg once daily.

Missed Dose Protocol

If a scheduled once-daily dose is missed, the protocol is to take the forgotten tablet as soon as it is remembered. However, if it is almost time for the next scheduled dose, the missed dose must be skipped, and the regular schedule resumed. Patients are instructed not to take a double dose to make up for a missed quantity.

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Recent Clinical Evidence

Research Evidence / Overview of Studies

This section provides a strictly neutral overview of the studies that have evaluated the compound, Folic Acid. It is not a guide for treatment or a replacement for medical advice.


Initial Research Focus

The core research examined the biological activity of the compound. Research focused on the observable effects of the compound. Research has explored its use in patient groups with specific symptom patterns.


Clinical Research Data

Phase I & II Trials

The earliest trials focused primarily on compound tolerability and dose-finding. The initial clinical trials found that the compound demonstrated a measurable difference compared to placebo across a specific patient population.

  • Dose Response: Studies examined the relationship between increased dosage and the measured outcome, which was associated with an increase in observed side effects.
  • Duration of Observation: Trials examined the time period over which the compound's effect was sustained.

Phase III and Comparative Studies

Research examined the compound in larger, long-term studies, primarily focusing on differences in patient outcomes compared to placebo or an active comparator.

  • Against Standard Therapy: A recent meta-analysis evaluated the findings from studies involving other compounds. Findings from these comparisons are available in the full research publications.
  • Concurrent Administration: Studies evaluated the results of concurrent administration with standard therapy. Research was conducted involving cohorts who were receiving existing therapies.

Tolerability and Observed Events

Data on tolerability was compiled across all phases of clinical development.

  • Adult Population: Research evaluated the compound's tolerability in adults, and studies have examined its use in patients with pre-existing conditions, including liver function impairment.
  • Observed Events: Common adverse events (AEs) observed in the studies included nausea, headache, and fatigue. Research protocols defined the study duration; the observed outcomes were related to treatment completion. Further details on rare and serious AEs are available in the prescribing information.
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Frequently Asked Questions (FAQ)

Common questions about Folsäure Lomapharm (FAQ)


Q: Are there different strengths of Folsäure Lomapharm available?

The active ingredient, folic acid, is generally available in multiple strengths and formulations from manufacturers. Official product information often focuses on the 5 mg tablet strength for Folsäure Lomapharm, but notes that lower doses may be available. The specific dose is determined by the prescribing healthcare provider.


Q: What happens if a person occasionally misses taking Folsäure Lomapharm?

Regulatory guidance provides clear instructions for a missed dose. If a dose is forgotten, the official instruction is to skip the forgotten tablet and simply resume the regular schedule at the next scheduled time. Official guidelines state that a double dose should not be taken to make up for a missed quantity.


Q: Are there any long-term effects associated with continuous use of Folsäure Lomapharm?

The most important constraint for continuous, long-term use is noted in official warnings regarding the potential to mask an underlying Vitamin B12 deficiency. Folic acid can correct the blood picture of this condition while allowing irreversible nerve damage to continue progressing. The prescribing healthcare provider typically rules out a B12 deficiency before long-term use is initiated.


Q: Do any official documents describe the effects of Folsäure Lomapharm on mood or energy?

Official product information notes that effects on the nervous system, including sleep disturbances, agitation, and depression, have been documented in rare cases. These effects are generally associated with the chronic administration of very high doses, rather than standard therapeutic use.


Q: How quickly does Folsäure Lomapharm start to affect the body?

The active ingredient, folic acid, is rapidly absorbed by the body once it is taken. While the absorption into the bloodstream is fast, the time it takes to restore deficiencies and observe full therapeutic changes may take several weeks, particularly when treating anemia.


Q: Can Folsäure Lomapharm be taken with other vitamin supplements?

Folic acid is an essential B vitamin, and many multi-vitamins and supplements also contain it. Therefore, awareness of the total amount of folic acid consumed across all supplements is relevant. Official sources also mention that high doses of folic acid may affect the body's utilization of the mineral zinc.


Q: Is it possible to take too much Folsäure Lomapharm?

Taking amounts above the established Tolerable Upper Intake Level (UL) for adults from supplements and fortified foods is cautioned against by official health bodies. This limit is set to 1 mg ( 1,000mu g) daily, primarily to minimize the risk that excess folic acid could mask an underlying B12 deficiency.


Q: Are there any specific foods or drinks that should be avoided with Folsäure Lomapharm?

Regulatory documents specifically note that excessive and chronic alcohol consumption may interfere with the body's absorption and increase the elimination of folic acid. Apart from this, there are no mandatory food restrictions; the tablets are generally advised to be taken with or without food.


Q: Can older adults typically use Folsäure Lomapharm?

The medicine is generally permitted for use in the adult population, which includes older adults. However, official warnings recommend that a test for Vitamin B12 deficiency should be conducted before initiating long-term therapy in older patients. This is to avoid the complication of masking the deficiency.


Q: Is Folsäure Lomapharm used for male health or only female health issues?

Folsäure Lomapharm is indicated for the treatment of deficiency states that affect all adults, including both men and women. While it has a highly recognized use in pregnancy-related prophylaxis, its therapeutic purpose for correcting deficiency is not limited by sex.


Q: How long might a person typically continue to use Folsäure Lomapharm?

Regulatory documents state that for the treatment of deficiency anemia, use is generally continued until blood parameters have returned to normal levels. For certain chronic underlying medical conditions that lead to ongoing deficiency, a continuous, long-term, or maintenance therapy may be required.


Q: Are there common signs that the medicine is working as intended?

The efficacy of the treatment is primarily assessed through laboratory testing as determined by a healthcare provider. These tests check for the restoration of normal blood cell production. If treating a deficiency, the gradual resolution of the associated symptoms is an expected outcome.


Q: Does this medicine require any special monitoring by a healthcare provider?

Yes, monitoring is required. Official guidance states that a Vitamin B12 test must be performed to rule out a deficiency before starting treatment for megaloblastic anemia. Follow-up blood tests are often necessary to monitor the patient's response to the treatment.


Q: Can Folsäure Lomapharm affect blood test results?

Yes, the use of Folsäure Lomapharm can directly affect the measured levels of folate in the bloodstream. For this reason, official sources emphasize that the healthcare provider should be informed of the medicine's use before certain blood tests are conducted.


Q: Does Folsäure Lomapharm contain any common allergens like lactose or gluten?

Official regulatory documents confirm that the tablet formulation contains lactose (lactose monohydrate) as an inactive ingredient, or excipient. This component is relevant due to the restriction noted for patients with known hereditary problems of lactose intolerance. Information on other excipients can be found in the product documentation.


Q: Is Folsäure Lomapharm typically used short-term or long-term?

The medicine is used in two ways: as a short-term treatment course to correct a temporary deficiency, or as long-term maintenance or prophylaxis (prevention). The specific duration depends entirely on the condition being addressed and the instructions provided by a healthcare professional.


Q: Are there any specific warnings about driving or operating machinery while taking Folsäure Lomapharm?

Official product regulatory information does not typically list specific warnings concerning the ability to drive or operate machinery. The compound is not generally associated with effects on concentration or alertness when taken at standard therapeutic doses.


Q: What is the process for reporting a potential side effect of Folsäure Lomapharm?

Official patient information instructs that any experienced adverse reaction or suspected side effect should be reported to a doctor or pharmacist. These healthcare professionals are then responsible for submitting the necessary safety report to the national drug authority, which monitors the safety of medicines.

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How should Folsäure Lomapharm be stored and disposed of?

How to Store and Dispose of Folsäure Lomapharm?

Folsäure Lomapharm must be stored according to official regulatory labeling to maintain the stability of the folic acid tablets.


Required Storage and Child Safety

Requirement Official Regulatory Statement
Environmental Protection Must be stored in the original packaging to protect the contents from light and moisture (Feuchtigkeit).
Child Safety The medicine must be kept out of the sight and reach of children (für Kinder unzugänglich aufbewahren).
Shelf-Life Do not use after the expiration date (Verfallsdatum) printed on the outer carton and blister packs.

Disposal

Specific instructions for discarding unused or expired Folsäure Lomapharm are not explicitly detailed in the product label. Therefore, the unused product should be disposed of in accordance with local pharmaceutical waste regulations, typically by returning it to a pharmacy or designated collection site, and not by disposal into household trash or wastewater.

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

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