Folsyra Evolan

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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 Folsyra Evolan

Quick Facts

Property Description
Active ingredient Folic Acid (Pteroylglutamic acid, Vitamin B9)
Form Tablet (Oral preparation)
Pharmacological class Haematinic Agent
General purpose Support for cell division and blood formation
Origin Synthetic

The Identity and Classification of Folsyra Evolan

Folsyra Evolan is an oral monopreparation presented in tablet form, featuring the active ingredient Folic Acid, which is chemically defined as Pteroylglutamic acid. This compound is the synthetic version of the naturally occurring essential nutrient, Folate, and is also universally known as Vitamin B9. The product, distributed by Evolan Pharma AB, is formally categorized within the pharmacological group of haematinic agents, a class recognized for supporting the body's machinery responsible for maintaining healthy blood composition.

Folic Acid: Essential Role and General Purpose

The fundamental function of Folsyra Evolan is to supply this necessary B-vitamin to the body, as Folic Acid acts as an essential cofactor for numerous single-carbon transfers. This role is critically involved in the synthesis of DNA and RNA, the genetic material required for all cellular growth and division. This function is vital, particularly in rapidly proliferating tissues, most notably supporting the proper maturation of red blood cells or erythropoiesis. The medicine’s general purpose, therefore, is to ensure the continuous supply of this nutrient, thereby preventing the state of deficiency and sustaining normal physiological processes.

What side effects are possible with Folsyra Evolan?

Possible Side Effects and Safety Information

The safety profile of Folsyra Evolan (Folic Acid) is primarily characterized by the officially documented risk of hypersensitivity reactions and a major regulatory constraint concerning its use with an existing deficiency. All side effect listings are derived from official government regulatory documents.


Official Adverse Reactions by Frequency

Classification System-Organ Class Affected Examples of Reactions
Rare (1/10,000 to <1/1,000) Immune System, Skin and Subcutaneous Tissue Fever, skin rash, pruritus (itching), erythema (redness).
Not Known (Cannot be estimated) Immune System, Gastrointestinal Disorders Anaphylaxis (serious allergic reaction), nausea, flatulence, abdominal distension.

Key Safety Restrictions and Considerations

Folsyra Evolan is contraindicated in individuals with a known hypersensitivity to Folic Acid or any of its excipients.

Crucially, Folic Acid must not be used alone in patients with untreated Vitamin B12 deficiency (such as pernicious anemia). Official safety labeling states that providing Folic Acid in isolation may correct the associated blood symptoms (haematological effects) while failing to halt the progression of severe and irreversible neurological damage (subacute combined degeneration of the spinal cord), thereby masking the underlying B12 deficiency.

High doses of Folic Acid may also lower the effectiveness of certain anticonvulsants (like phenytoin) and reverse the therapeutic effects of folic acid antagonists (like methotrexate), a safety consequence documented in official interaction notes.

Overdose and Emergency Response

Overdose and when to seek Help

The official regulatory classification for Folsyra Evolan (Folic Acid) indicates that the substance has low acute toxicity. Consequently, an acute overdosage does not typically result in immediate symptoms according to the Summary of Product Characteristics (SmPC).

However, specific risks and mandatory emergency actions are documented in official regulatory labeling. If an accidental or excessive intake occurs, including if a child has taken the medicine, official guidance requires contacting a doctor or hospital immediately for a risk assessment and advice.

A major concern cited in the regulatory information involves prolonged, high-dose administration. Folic Acid can potentially mask the blood-related signs of undiagnosed Vitamin B12 deficiency (pernicious anemia), which may allow the silent progression of severe nervous system damage (neurological changes).

Additionally, high daily exposure may result in non-acute manifestations such as gastrointestinal effects (nausea, abdominal distention) and Central Nervous System effects (irritability, difficulty concentrating).

Emergency Medical Attention is Required Immediately if any signs of a severe allergic reaction (such as swelling of the face or throat, wheezing, or difficulty breathing) are observed. In overdose situations, treatment consists of symptomatic and supportive measures, which are generally required only in exceptional cases.

Therapeutic Uses of Folsyra Evolan

The therapeutic scope for Folsyra Evolan encompasses several key areas of nutritional support.

Folsyra Evolan is commonly used to help with conditions presenting with systemic imbalance, including established folate deficiency and megaloblastic anemia. The medication is also relevant in contexts involving heightened systemic burden, offering supportive relief for specific fetal development concerns and for managing high-risk nutritional contexts, such as malabsorption conditions or concurrent long-term drug treatments.

In these situations, Folsyra Evolan provides support that helps ease the overall symptom burden associated with deficiency. This primarily includes managing symptoms that interfere with daily comfort like chronic fatigue, weakness, and pallor, which are symptoms that create noticeable physiological strain. It assists with maintaining functional stability in patients with increased physiological needs.


Quick Fact Block

Quick Fact: Supportive Management for Deficiency Symptoms
Symptom Clusters: Fatigue, weakness, shortness of breath, mucosal issues (sore tongue).
Condition Categories: Established folate deficiency, megaloblastic anemia, high-risk pregnancy, malabsorption syndromes.
Primary Benefit: Supports the patient with functional stability and helps ease the overall symptom load.

Eligibility and Restrictions for Use

Official Population Eligibility for Folsyra Evolan

Folsyra Evolan eligibility is defined by official regulatory documentation, primarily establishing which populations are contraindicated and which are permitted under standard labeled conditions.

Category Regulatory Status
Contraindicated Populations Patients with known hypersensitivity to Folic Acid or any excipients; those with undiagnosed megaloblastic anaemia (including pernicious anaemia) when used as the sole treatment.
Excipient-Based Restriction Contraindicated in patients with rare hereditary issues like total lactase deficiency or galactose intolerance due to the tablet containing lactose monohydrate.
Age-Related Eligibility Adults are permitted. Children mathbf10-18 years are eligible for treatment, but the 5 mg strength is often unsuitable for the required low doses for young children, necessitating an alternative product.
Pregnancy and Lactation Use is permitted. The medicine is specifically indicated for prophylaxis and treatment of folate deficiency during pregnancy and is allowed during lactation.

The official eligibility profile mandates that Folsyra Evolan must not be used alone in anaemia of unknown cause to prevent the masking of severe, irreversible neurological damage associated with concurrent Vitamin B12 deficiency. Caution is also advised for patients with folate-dependent tumours.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official interaction profile for Folsyra Evolan (Folic Acid) is structured around pharmacodynamic and pharmacokinetic constraints documented by government regulatory authorities.

Contraindications and Antagonistic Effects

The most critical regulatory constraint is the formal contraindication against administering Folic Acid alone for the treatment of megaloblastic anemia when Cobalamin (Vitamin B12) deficiency has not been excluded or treated. Folic Acid is officially known to mask the hematological signs of B12 deficiency while allowing irreversible neurological damage to advance.

Folic Acid may interfere with the therapeutic and toxic effects of folate antagonists like Methotrexate, and co-administration with specific Antineoplastic Agents (e.g., Fluorouracil, Capecitabine) is officially restricted due to the potential for increased toxicity.

Exposure and Timing Requirements

Folic Acid may reduce the serum concentration of certain Antiepileptic Drugs (e.g., Phenytoin, Phenobarbital, Primidone), which carries a regulatory risk of loss of seizure control.

Conversely, the absorption of Folic Acid may be reduced by co-administered substances such as Sulfasalazine, Cholestyramine, and certain Antacids (containing aluminium or magnesium). To mitigate this pharmacokinetic effect, mandatory timing rules are officially documented, requiring the administration of Folic Acid to be separated from these agents by several hours. Additionally, Ethanol (Alcohol) consumption is documented to increase folic elimination from the body.

Mechanism of Action

Enzyme-Mediated Metabolic Conversion to Active Cofactor

Folsyra Evolan (Folic Acid) functions as an inactive precursor that is activated inside the body via the enzyme dihydrofolate reductase (DHFR), which converts it into Tetrahydrofolate (THF). This initial step is critical as it provides the essential active coenzyme required for all subsequent biosynthetic reactions.

Folate Pathway Involvement in Nucleotide Synthesis

The active THF derivatives are integral to the one-carbon metabolism pathway, acting as donors for the crucial atoms required to synthesize purines and thymidylate, which are the building blocks of DNA. This supply supports the processes required for rapidly dividing cells to replicate their genetic material.

Mechanism's Consequence on Progenitor Cell Division (Erythropoiesis)

The supported DNA synthesis allows precursor cells, particularly those in the bone marrow, to complete the nuclear maturation and cell division required for blood cell production. This systemic cascade affects the morphology of precursor cells and supports the processes required for functional blood cell formation.

Mechanistic Limitation: The B12 Co-Factor Link

The functional capacity of Folic Acid is dependent on the required presence of Cobalamin (Vitamin B12), which is essential for recycling the folate derivative back into the active THF pool. The mechanism is therefore co-factor dependent and subject to the availability of B12.

Dosage and Administration Information

Folsyra Evolan is a 5 mg folic acid tablet intended for oral administration. The medicine must be used exactly according to the specific instructions provided by a healthcare professional and is generally taken daily.

Administration Procedure

The tablet should be swallowed whole with water. The 5 mg tablet features a score line, meaning it can be divided into two equal halves (2.5 mg each) to facilitate specific dose requirements. There is no specific instruction indicating the tablet must be taken with or without food.

Official Dosing Rules by Patient Group

The following dosages are provided for guidance; the dose prescribed by your doctor may differ based on individual need.

Patient Group Context Labeled Dosing Regimen Duration (Minimum)
Adults Anaemia due to Folic Acid Deficiency (Remission) 5 mg (one whole tablet) once daily Approximately two weeks
Adults High-Risk Prophylaxis (Pre- and During Pregnancy) 5 mg (one whole tablet) once daily 4 weeks prior to conception and 12 weeks thereafter
Adults General Prophylaxis (Pre-pregnancy) 1/2 tablet (2.5 mg) every other to every third day Not specified
Children (Age 10–18 years) Folic Acid Deficiency 1 mg daily Not specified

Note: The 5 mg tablet strength is not compatible with all standardized doses, such as the 1 mg daily dose often used for maintenance or children, and a different product must be selected for those specific dosages.

Course Duration and Missed Doses

For the initial treatment of anaemia, the 5 mg daily dose is typically continued for approximately two weeks. Subsequent maintenance therapy often involves a lower dose. If a dose is missed, specific instructions are not provided here; consult a healthcare professional for guidance.

Recent Clinical Evidence

Evidence for Correcting Established Folate Deficiency and Megaloblastic Anemia

Research was studied for its role in established folate deficiency and related megaloblastic anemia, primarily based on older, foundational clinical trials and biochemical studies. These studies monitored outcomes related to physical symptoms and physiological strain, specifically tracking how blood cell parameters, like cell size, were measured during the study period. Trials reported measurements of changes in blood cell morphology and corresponding shifts in biomarkers, such as serum folate levels. The evidence structure has limitations due to the absence of modern Randomized Controlled Trials (RCTs) in contemporary populations.


Evidence for Use in High-Risk Periconceptional Contexts

Folsyra Evolan (Folic Acid) was studied for its role in the periconceptional period in research examining NTD outcomes (Neural Tube Defects) in offspring. The core evidence comes from foundational RCTs and large observational cohort studies that tracked the occurrence of NTDs. Foundational trials conducted before mandatory food fortification data show patterns related to the occurrence of NTDs among women receiving the supplement compared to control groups. Research explored specific high-risk cohorts, such as women with a history of an NTD-affected pregnancy.


Evidence in Nutritional Contexts and Special Populations

Folsyra Evolan was evaluated in specific patient groups dealing with a high systemic burden that may relate to deficiency, such as those with malabsorption disorders or those receiving long-term drug treatments. This research involved observational studies that monitored serum and red blood cell folate status over extended monitoring periods. Evidence quality varies across studies and is often derived from modest sample sizes.


Research Gaps and Areas of Uncertainty

Major limitations include the lack of modern Randomized Controlled Trials comparing the supplement against placebo or alternative regimens for monitoring deficiency. Comparative evidence is lacking for different high-dose regimens in periconceptional populations, meaning research often relies on consensus and physiological extrapolation in these areas. Furthermore, long-term monitoring is often restricted to observational cohorts, meaning the long-term effects are not fully established for certain outcomes, and data for certain groups remain insufficient.

Key Studies & References

  1. Prevention of neural tube defects: results of the Medical Research Council Vitamin Study.
  2. Folic Acid Deficiency (StatPearls, authoritative review on megaloblastic anemia and treatment).

Frequently Asked Questions (FAQ)

Common questions about Folsyra Evolan (FAQ)


Q: Do I need to take Folsyra Evolan with food or on an empty stomach?

Official product information indicates that folic acid tablets can generally be taken with or without food. However, regulatory documents suggest separating your dose by at least two hours from antacids that contain aluminum or magnesium, in order to help prevent reduced absorption.


Q: What should I do with my unused or expired Folsyra Evolan tablets?

To protect the environment, unused or expired tablets must not be thrown away with household waste or wastewater. According to regulatory instructions, the medicine should be returned to a pharmacy for proper disposal or handled following local pharmaceutical waste regulations.


Q: What is the maximum number of tablets I can take in a day (maximum dose)?

The maximum dose for certain conditions is defined in the product characteristics. Official product documents indicate that for specific conditions like malabsorption states, doses may be prescribed up to a maximum of 15 mg daily under a doctor's supervision.


Q: What happens if I accidentally take too much Folsyra Evolan (overdose)?

Folic acid is generally well-tolerated, even at higher doses. However, official information on undesirable effects notes that taking a very large amount has been linked to rare occurrences of gastrointestinal problems, sleep disturbances, agitation, and depression. If more than the prescribed amount is taken, guidance should be sought from a healthcare professional.


Q: How long does it take for Folsyra Evolan to start working?

Studies and official information indicate that folic acid is rapidly and readily absorbed by the body after administration. When treating conditions like folate deficiency anemia, the onset of physiological effects is observed, which may take a few weeks.


Q: Can I drink alcohol while taking this medicine?

Regulatory documents concerning drug interactions state that Ethanol (alcohol) consumption is known to increase the rate at which folic acid is eliminated from the body. Patients are advised to discuss their alcohol intake with their prescribing doctor.

How should Folsyra Evolan be stored and disposed of?

Storage and Disposal Requirements

Folsyra Evolan (folic acid) must be stored and handled according to specific regulatory requirements to maintain its stability and ensure environmental safety.

Requirement Category Condition
Maximum Temperature Do not store above 25 °C (seventy-seven degrees Fahrenheit).
Environmental Protection Store in the original package to protect it from light.
Child Safety Keep out of the sight and reach of children.
Shelf-Life Rule Do not use the tablets after the expiry date printed on the carton and blister.

Regarding disposal, unused or expired tablets must not be thrown away via wastewater or household waste. The medicine should be returned to a pharmacy or disposed of following local pharmaceutical waste regulations.

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

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