Ferrograd Folic

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Ferrograd Folic

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Overview of Ferrograd Folic

Quick Facts

Property Description
Active ingredient Ferrous Sulfate and Folic Acid (Vitamin B9)
Form Modified-release tablets
Pharmacological class Haematinic agent, Vitamin-mineral combination
General purpose Nutritional replenishment to support blood formation
Origin Synthetic compounds, replicating essential micronutrients

Ferrograd Folic is a therapeutic medicinal product designed as a fixed-dose combination product for oral administration. It is recognized as both a haematinic agent and a vitamin-mineral combination, serving as a targeted nutritional intervention when specific deficiencies occur. The product's formulation as a modified-release tablet is a distinctive feature, designed for a slow and sustained delivery of the active ingredients.

What Type of Preparation is Ferrograd Folic?

Ferrograd Folic is an anti-anaemic preparation and a combination haematinic agent used to supply two critical micronutrients necessary for healthy red blood cell production. Unlike single-entity preparations, it integrates a mineral and a vitamin, a strategy that is recognized for simultaneously addressing deficiencies that often co-exist. The medication is presented as an oral preparation in a sophisticated modified-release tablet form, which is designed to gradually release its active substances over time. This controlled-release design aims to improve the overall patient tolerance and absorption profile. The product is typically categorized as prescription-only (Rx).

What Active Ingredients Compose Ferrograd Folic?

The core composition features two main active ingredients: the mineral salt Ferrous Sulfate and the vitamin Folic Acid (Vitamin B9). Ferrous Sulfate is a highly bioavailable iron salt and the primary source of elemental iron, which is a non-negotiable component of the oxygen-carrying protein haemoglobin. Elemental iron is recognized as an essential medicine critical for public health. Folic Acid is the synthetic form of the naturally occurring vitamin folate, a vital micronutrient required for the proper synthesis of genetic material and the healthy maturation of new cells.

What is the General Purpose of Ferrograd Folic?

The general purpose of Ferrograd Folic is to provide the simultaneous nutritional replenishment of iron and folic acid to support the body’s ability to form healthy red blood cells. By supplying these two essential elements, the preparation directly supports haematopoiesis, ensuring the body has the components for both oxygen-carrying capacity and proper cell structure. The combined delivery of Ferrous Sulfate and Folic Acid is a standard approach to managing related nutritional deficits. This general approach is widely recognized for restoring the body's physiological balance when these vital micronutrients are depleted, such as supporting increased blood volume needs during pregnancy.

Regulatory References

  1. World Health Organization (WHO) Essential Medicines List
  2. WHO Model List of Essential Medicines
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What side effects are possible with Ferrograd Folic?

Possible Side Effects and Safety Information

The safety profile of ferrous sulfate and folic acid primarily documents effects within the Gastrointestinal Disorders system, which are generally classified as Common. These include expected reactions such as nausea, abdominal pain, vomiting, constipation, and diarrhoea. A common, harmless effect of oral iron is the blackening of stools.


Serious Adverse Reactions and Safety Tiers

Official regulatory documents classify rare but serious adverse reactions, particularly involving the Immune System Disorders. These include severe hypersensitivity events, such as anaphylaxis.

Additionally, the modified-release formulation carries a specific hazard note within the Respiratory, Thoracic and Mediastinal Disorders class: the risk of bronchial ulceration or stenosis if the tablet is aspirated (enters the airways). Furthermore, iron overdose is labeled as a critical toxicity risk, especially in young children.


Safety Considerations for Special Populations and Exposure

Regulatory safety statements highlight specific concerns for certain populations. Older adults and individuals with swallowing difficulties are noted to be at higher risk for aspiration-related damage. The medicine is generally not recommended for children under the age of 12. Use is also restricted in patients with untreated Vitamin B12 deficiency as folic acid may mask the diagnosis of pernicious anaemia, and it is contraindicated in conditions involving iron overload (e.g., haemochromatosis) or active severe intestinal disease. Constipation may be caused by continual administration.

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Overdose and Emergency Response

The official regulatory profile for Ferrograd Folic overdose is centered on the established toxicity of the Ferrous Sulfate component. Accidental overdose of iron-containing products is specifically identified by authorities as a leading cause of fatal poisoning in children under six years of age. For any suspected overdose, immediate emergency medical attention is required.

Documented manifestations typically progress through stages, beginning with severe gastrointestinal effects such as nausea, abdominal pain, vomiting (which may be blood-tinged), and bloody diarrhea. If systemic toxicity occurs, the presentations listed in regulatory sources include hypotension (low blood pressure), tachycardia, and signs of metabolic imbalance like metabolic acidosis.

Severe, life-threatening outcomes officially associated with iron poisoning include circulatory collapse (shock), hepatic necrosis (liver failure), and neurological complications such as coma. The product’s modified-release nature may result in a delayed onset of these severe symptoms.

Regulatory management protocols describe the need for symptomatic and supportive treatment, and the use of the specific chelating agent, Deferoxamine, is documented as an antidote for severe systemic toxicity. Hospital monitoring is required for all significant exposures to observe for this potential progression.

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Therapeutic Uses of Ferrograd Folic

Ferrograd Folic: Main Uses and Benefits

Ferrograd Folic is commonly used to help with the management of conditions characterized by periods of heightened symptoms related to iron deficiency and folate deficiency. The combination is particularly relevant in contexts involving heightened systemic burden, such as during pregnancy and when addressing megaloblastic anaemia associated with folate deficiency. The product is applied in addressing recurrent or episodic manifestations of deficiency.

The medicine may assist with easing symptoms related to physical discomfort such as fatigue and general weakness relevant when supportive symptom management is appropriate. The folic acid component plays a role in managing symptoms associated with acute or episodic changes in red blood cell health. This dual action contributes to easing the overall symptom load in patients presenting with systemic or localized discomfort.

“This support contributes to maintaining a sense of stability when symptoms are more noticeable, applied in scenarios where additional management of discomfort is required.”


Quick Fact: Relief for Fatigue

The medicine supports general well-being during symptomatic phases and is frequently used in settings where short-term symptomatic assistance is needed to address symptom clusters that create noticeable physiological strain.

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Eligibility and Restrictions for Use

Who Can and Cannot Use Ferrograd Folic?

This section outlines the eligibility and non-eligibility criteria for Ferrograd Folic, as detailed in official government regulatory documents. It does not provide medical advice or instructions on how to use the medicine.


Populations Not Eligible (Contraindications)

Ferrograd Folic is contraindicated (must not be used) for individuals with the following conditions:

  • Hypersensitivity or Allergy: Known allergy to Ferrous Sulphate, Folic Acid, or any other ingredients in the product.
  • Iron Overload Syndromes: Conditions involving excessive iron accumulation, such as haemochromatosis or haemosiderosis.
  • Anemia Etiology: Patients diagnosed with anaemia caused by a vitamin B12 deficiency, as folic acid may mask the symptoms of this condition.
  • Gastrointestinal Pathology: Individuals with an intestinal blockage or diverticular disease of the intestine.
  • Concomitant Therapy: Patients who are already taking other medicines containing iron.

Eligibility and Age Restrictions

Population Group Eligibility Status
Children under 12 years Use Not Recommended
Adults and Children over 12 Permitted
Pregnancy Not Recommended during the first 13 weeks; permitted thereafter
Lactation (Breastfeeding) Permitted

Use is restricted during the first 13 weeks of pregnancy and should only occur if advised by a doctor. The medicine is officially indicated for adults and children over 12 years of age.

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What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documentation emphasizes two primary types of interaction: those requiring timing separation to maintain efficacy, and contraindicated combinations due to risk of excessive intake or neurological concern.

Contraindicated Combinations

Combination Official Regulatory Restriction
Parenteral Iron Therapy Co-administration is formally contraindicated to avoid the risk of iron overload (haemosiderosis).
Other Oral Iron Preparations Combination is contraindicated to prevent excessive iron intake.
Untreated Cobalamin Deficiency Long-term Folic Acid use is restricted due to the risk of masking the signs of Pernicious Anaemia while allowing neurological damage to progress.

Exposure-Modifying Interactions Requiring Separation

Interactions involving Ferrous Sulfate often result in reduced absorption of either agent due to chelation in the digestive tract. Separation of doses is mandatory for the following categories:

  • Antibiotics: Tetracyclines and Quinolone anti-infectives require dose separation (typically 2 to 4 hours) to ensure adequate antibiotic absorption.
  • Thyroid Hormones: Absorption of Levothyroxine is reduced by iron; administration must be separated by at least 2 hours.
  • Other Agents: Penicillamine, Bisphosphonates, Antacids, and Mycophenolate all require separation of doses to prevent significant reduction in their absorption.
  • Anticonvulsants: Folic Acid may cause a fall in the serum levels of Phenytoin and Phenobarbital, which represents an exposure-modifying interaction.

Interactions with Food, Beverages, and Supplements

The absorption of Ferrous Sulfate is officially documented to be reduced by tea, coffee, milk, eggs, wholegrain cereals, and dietary fibre. Ferrograd Folic must not be taken within one hour before or two hours after ingestion of these items. Calcium and Zinc supplements may also reduce iron absorption and require separation. Ascorbic Acid ( Vitamin C) may enhance iron absorption.

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Mechanism of Action

How Ferrograd Folic Works

The mechanism of Ferrograd Folic is defined by the coordinated action of its two components, each addressing an independent, necessary step within the body's haematopoiesis (blood formation) pathway.


Enabling DNA Synthesis for Cell Maturation (Folic Acid)

Folic Acid functions as an enzyme co-substrate crucial for the one-carbon metabolism pathway. Once activated to tetrahydrofolate, it facilitates the synthesis of essential purine and pyrimidine bases, the molecular building blocks of DNA. This molecular action directly enables the nuclear maturation and mitosis of erythroid precursor cells, which is required for the generation of new blood cells.


Building the Oxygen-Carrying Molecule (Ferrous Sulfate)

Ferrous Sulfate functions as a nutritional precursor, supplying the elemental ferrous ion ( Fe^2+). This ion is taken up by bone marrow cells via the transferrin receptor and biochemically incorporated into the protoporphyrin ring to form the haem molecule. The incorporation of haem is the central, rate-limiting step for the final construction of haemoglobin, the protein responsible for binding and transporting oxygen.


Synergy and Systemic Oxygen Transport

The combined mechanisms address two independent requirements for red blood cell production: Folic Acid facilitates the cell's division and nuclear maturation, and Iron provides the functional haem component required for oxygen transport. The dual action within the erythroid maturation cascade results in the physiological consequence of increased capacity for systemic O2 transport.

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Dosage and Administration Information

Administration and Dosing Guidelines

Ferrograd Folic is formulated as a prolonged-release, film-coated tablet for oral administration. The standard dosage for adults and the elderly is one tablet taken once daily, which constitutes the maximum recommended daily dose.


Administration Protocol

To ensure proper function of the prolonged-release mechanism and the controlled delivery of the 325 mg Dried Ferrous Sulphate and 0.35 mg Folic Acid, the tablet must be swallowed whole with water. It is a mandatory procedural constraint that the tablet must not be sucked, chewed, or held in the mouth.

For optimal iron absorption, the tablet is generally taken before a meal. However, the dose may be taken during a meal to enhance gastrointestinal tolerance. To prevent reduced absorption, the tablet must be administered at least one hour before or two hours after consuming known inhibitors such as tea, coffee, milk, eggs, whole-grain cereals, and dietary fibre.


Frequency and Duration

The standard once-daily schedule applies uniformly to all adult populations. The medicine is not recommended for use in children under 12 years old. In the context of pregnancy prophylaxis, administration is strictly initiated after the first 13 weeks of pregnancy and is generally continued for a period of one month following delivery. If a dose is missed, the patient should continue with the next scheduled dose; taking a double dose to compensate is explicitly prohibited.

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Recent Clinical Evidence

Research Evidence / Overview of Studies

Ferrograd Folic combines ferrous sulfate (an iron salt) and folic acid (Vitamin B9) and has been widely studied for addressing nutritional deficiencies. The combination is most frequently examined in contexts where dual deficiency is likely, such as during pregnancy or in patients with confirmed iron and folate depletion.


Efficacy for Iron and Folate Status

Studies on the combination of ferrous sulfate and folic acid primarily focus on hemoglobin levels and folate concentrations in blood, which are key indicators of therapeutic effect. Research has explored the role of oral iron supplementation in managing anemia, particularly iron deficiency anemia, in various populations.

  • Iron Component (Ferrous Sulfate): This is the gold standard for oral iron therapy in many global guidelines. Clinical trials generally show that ferrous sulfate supplementation is associated with improvements in iron status, including increased hemoglobin and ferritin levels, especially in compliant patients with iron deficiency anemia.
  • Folic Acid Component: Folic acid supplementation is well-established and recommended internationally for the prevention of certain birth defects, particularly neural tube defects (NTDs), when taken before and during early pregnancy. The combination product supports both iron repletion and adequate folate status simultaneously.

Tolerability and Combination Profile

Research has explored the tolerability profile associated with oral ferrous sulfate, which can include gastrointestinal side effects such as constipation, nausea, and abdominal pain. The specific Gradumet controlled-release system used in Ferrograd Folic is designed to release the iron over a period of hours, a mechanism intended to minimize potential gastric irritation and improve patient adherence compared to conventional immediate-release iron salts.

  • Combination Findings: Evidence from studies that examined the combination of iron and folic acid often centers on managing the prevalence of anemia during pregnancy. These findings align with international recommendations for daily oral iron and folic acid supplementation to address common maternal nutrient deficiencies.
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Frequently Asked Questions (FAQ)

Common questions about Ferrograd Folic (FAQ)


Q: Is Ferrograd Folic commonly prescribed for non-pregnant adults diagnosed with iron deficiency?

A: Official documents state that Ferrograd Folic is intended for use in the prophylaxis (prevention) and treatment of iron and folic acid deficiencies in Adults and the Elderly. The medication is used for diagnosed deficiencies in adult populations. Its use is based on laboratory confirmation of deficiency.


Q: Is it necessary to separate the intake of Ferrograd Folic from other mineral supplements like calcium or zinc?

A: Yes, official product information indicates that the absorption of iron can be significantly reduced by mineral supplements containing calcium or zinc. To maintain the effectiveness of both Ferrograd Folic and these supplements, regulatory principles advise separating their times of administration. A specific time separation should be confirmed with a healthcare professional.


Q: What is the risk associated with taking Ferrograd Folic if a person has an undiagnosed B12 deficiency?

A: Ferrograd Folic is contraindicated (must not be used) in people with untreated Vitamin B12 deficiency. Official warnings state that the folic acid component can mask the blood-related signs of this deficiency (known as Pernicious Anaemia) while failing to halt the irreversible neurological damage that may continue to progress. Use is restricted to cases of confirmed diagnosis.


Q: Does the use of Ferrograd Folic affect the way the body handles levodopa for Parkinson's disease?

A: Regulatory principles note that iron supplements, including Ferrograd Folic, are known to interfere with the absorption of levodopa, a medication used to treat Parkinson's disease. This interference can reduce levodopa’s effectiveness. Regulatory principles indicate that the times of administration for both medications should be separated.


Q: Are there any official notes on taking Ferrograd Folic with methyldopa for high blood pressure?

A: Official documentation based on regulatory principles indicates that iron supplements can impair the absorption of methyldopa, which is a medication for high blood pressure. A minimum separation of two hours between the administration of the two products is indicated to prevent absorption issues.


Q: Does the formulation contain any artificial colors or ingredients known to cause allergic reactions?

A: The official SmPC (Summary of Product Characteristics) lists the colorant Ponceau 4R red (E124) as an excipient. This colorant is known to potentially cause allergic-type reactions, including asthma. The tablet also contains excipients Sucrose and Lactose Monohydrate.


Q: Are nausea and vomiting frequently reported by users starting Ferrograd Folic?

A: Nausea and vomiting are listed as Common undesirable effects in the official regulatory documentation for this medicine. This indicates that a significant number of patients report experiencing these effects when taking the medication.


Q: Do the side effects of Ferrograd Folic typically lessen over time?

A: Information for similar iron and folate products generally indicates that the common gastrointestinal effects associated with oral iron, such as stomach upset or constipation, are usually temporary. These effects may lessen or disappear as the body adjusts to the medication regularly.


Q: Is there a difference in the severity of side effects compared to other iron supplements?

A: The formulation of Ferrograd Folic uses a prolonged-release Gradumet system. This controlled-release design is specifically intended to minimize potential gastric irritation and improve patient tolerance when compared to conventional immediate-release iron salts.


Q: How long is Ferrograd Folic typically prescribed for the treatment of anaemia?

A: For the treatment of iron deficiency anaemia, official regulatory guidance indicates that the course of medication should generally not exceed three months after the anaemia is corrected. The length of treatment is determined by the prescribing healthcare professional.


Q: Is it necessary to continue taking the medication after blood levels return to normal?

A: To ensure the body's iron reserves (stores) are adequately replenished, treatment is often extended for a period of up to three months after the patient's blood levels (such as hemoglobin) have returned to the normal range.


Q: Is there information on the onset of benefits after starting Ferrograd Folic?

A: The official patient leaflet provides guidance on the expected timeline for improvement. It advises that if the symptoms of the deficiency do not improve after four weeks of taking the tablets, the patient leaflet directs that a patient should consult their doctor for further advice and re-evaluation.


Q: Is Ferrograd Folic recommended for men who have been diagnosed with iron deficiency?

A: The medicine is officially indicated for use in Adults and the Elderly (over 12 years of age). Regulatory documents do not impose gender-specific restrictions, meaning it is considered appropriate for men who have been diagnosed with iron deficiency.


Q: Can Ferrograd Folic be taken by individuals with diabetes?

A: The product contains the excipients Sucrose and Lactose Monohydrate, which may be a consideration for individuals managing diabetes. Additionally, medical guidance is noted that pregnant women with diabetes may be prescribed a higher dose of folic acid than the standard prophylactic dose.


Q: How is the elemental iron dose in Ferrograd Folic comparable to a typical daily iron requirement?

A: The tablet provides 105 mg of elemental iron. This amount is significantly higher than the standard Recommended Dietary Allowance (RDA) for iron, which ranges from 8 mg to 18 mg per day for non-deficient adults. This high concentration is generally used for treating documented deficiencies rather than for general dietary supplementation.


Q: What is the recommended advice if symptoms of anaemia do not improve after one month of taking Ferrograd Folic?

A: The official patient leaflet instructs that if the symptoms of the deficiency worsen or do not improve after four weeks (one month) of use, the patient should consult a doctor for a re-evaluation of the condition and treatment plan.


Q: Are there any anticonvulsant medications besides Phenytoin and Phenobarbital that interact with Folic Acid?

A: Regulatory-based data confirms that Folic Acid can interact with other anticonvulsant agents in the same class, such as Primidone. This interaction may cause a fall in the serum levels of the anticonvulsant medication, potentially reducing its effectiveness in controlling seizures.

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How should Ferrograd Folic be stored and disposed of?

Official Storage and Disposal Requirements

Official regulatory documents define strict conditions for the safe storage and disposal of Ferrograd Folic tablets.

Requirement Category Official Regulatory Statement
Storage Temperature Do not store above 25 C
Protection Store in the original package to protect from light
Expiry Date Do not use after the use-by (expiry) date printed on the box
Child Safety Keep out of the reach and sight of children, as iron overdose may be fatal
Disposal Rule Do not dispose of via wastewater or household waste
Disposal Method Ask a pharmacist how to dispose of medicines no longer required

The official profile mandates that the medicine must remain in its original package and be kept at or below 25 C to ensure product stability. Due to the inherent risk of iron, the label strictly requires the product to be stored out of the sight and reach of children. For unused or expired tablets, the mandatory environmental rule is to avoid disposal in household waste or wastewater, and instead, they should be returned to a pharmacist.

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

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