Summary of Product Characteristics (SmPC) - Folic Acid 5 mg tablets

1 NAME OF THE MEDICINAL PRODUCT

Folic Acid 5 mg Tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains folic acid hydrate equivalent to 5 mg of folic acid.

Excipient with known effect:

Each tablet contains 42.24 mg lactose monohydrate.

For the full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM

Tablet (Uncoated)

Yellow, round tablets (5.50 mm) plain on both sides.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

Folic acid is a component of the B group of vitamins and is necessary for the normal production and maturation of red blood cells.

1. For the treatment of folate-deficient megaloblastic anaemia due to malnutrition, malabsorption syndromes (such as coeliac disease or sprue) and increased utilisation as in pregnancy. It should not be used alone in undiagnosed megaloblastic anaemia including in infancy, pernicious anaemia or macrocytic anaemia of unknown aetiology, unless administered with adequate amounts of hydroxocobalamin.
2. For the prophylaxis of drug induced folate deficiency e.g. caused by administration of phenytoin, phenobarbital and primidone. (See section 4.5).
3. For the prophylaxis against folate deficiency in chronic haemolytic states or in renal dialysis.
4. For the prevention of neural tube defects for woman planning a pregnancy and known to be at risk. (See section 4.6).

4.2 Posology and method of administration

Posology

Adults (including the elderly)

In folate deficient megaloblastic anaemia: 5mg daily for 4 months; up to 15mg daily may be necessary for malabsorption states.

In drug induced folate deficiency: 5mg daily for 4 months; up to 15mg daily may be necessary for malabsorption states.

For prophylaxis in chronic haemolytic states or in renal dialysis: 5mg every

1-7 days depending on underlying disease.

Prevention of neural tube defects in women known to be at risk: 5mg daily started before conception and continued throughout the first trimester.

Pregnancy:

In established folate deficiency: 5mg daily continued to term

Paediatric population

For young children a more suitable dosage form should be used.

In folate deficient megaloblastic anaemia:

Child 1-18 years 5mg daily for 4 months; maintenance 5mg every 1-7 days.

In haemolytic anaemia; metabolic disorders:

Child 1-12 years 2.5mg-5mg once daily.

Child 12-18 years 5-10mg once daily.

Prophylaxis of folate deficiency in renal dialysis:

Child 1-12 years 250 microgram/kg (max 10mg) once daily.

Children 12-18 years 5-10mg once daily.

Other Special population

Renal and Hepatic Impairment: Folic acid is well tolerated in renal and hepatic impairment, with no requirement for dose adjustment in mild to moderate dysfunction.

Elders and Children

It is considered safe in pediatric and elderly populations.

Chronic Disease Management: Folic acid supplementation is used with methotrexate in autoimmune diseases to enhance the therapeutic index while mitigating adverse effects like folate depletion.

Method of Administration

For oral administration.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section

6.1.

Folic acid should never be given alone in the treatment of Addisonian

pernicious anaemia and other vitamin B12 deficiency states because it may precipitate the onset of subacute combined degeneration of the spinal cord.

Folic acid should not be used in malignant disease unless megaloblastic anaemia owing to folate deficiency is an important complication.

Long-term folate therapy is contraindicated in any patient with untreated cobalamin deficiency. This can be untreated pernicious anaemia or other cause of cobalamin deficiency, including lifelong vegetarians. In elderly people, a cobalamin absorption test should be done before long-term folate therapy.

Folate given to such patients for 3 months or longer has precipitated cobalamin neuropathy. No harm results from short courses of folate.

4.4 Special warnings and precautions for use

Patients with vitamin B12 deficiency should not be treated with folic acid unless administered with adequate amounts of hydroxocobalamin, as it can mask the condition but the subacute irreversible damage to the nervous system will continue.

The deficiency can be due to undiagnosed megaloblastic anaemia including in infancy, pernicious anaemia or macrocytic anaemia of unknown aetiology or other cause of cobalamin deficiency, including lifelong vegetarians.

Caution should be exercised when administering folic acid to patients who may have folate dependent tumours.

This product is not intended for healthy pregnant women where lower doses are recommended, but for pregnant women with folic acid deficiency or

women at risk for the reoccurrence of neural tube defects.

Patients with rare hereditary problems of fructose or galactose intolerance, total lactase deficiency or glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

4.5 Interaction with other medicinal products and other forms of interaction

There is a specific interaction between phenytoin and folate such that chronic phenytoin use produces folate deficiency. Correction of the folate deficiency reduces plasma phenytoin with potential loss of seizure control. Similar but less marked relationship exists with all anti-convulsant treatment including sodium valproate, carbamazepine and the barbiturates (including phenobarbital and primidone). Sulfasalazine and triamterene also inhibit absorption.

Folate supplements enhance the efficacy of lithium therapy.

Methotrexate and trimethoprim are specific anti-folates, and the folate deficiency caused by their prolonged use cannot be treated by Folic Acid Tablets BP. Folic acid may interfere with the toxic and therapeutic effects of methotrexate. Folinic acid should be used.

Nitrous oxide anaesthesia may cause an acute folic acid deficiency.

Both ethanol and aspirin increase folic elimination.

Antibacterials – chloramphenicol and co-trimoxazole may interfere with folate metabolism.

Oral Contraceptives: The clinical significance is minor, but reduced folate status may be relevant if pregnancy occurs soon after discontinuation.

Antacids and Proton Pump Inhibitors (PPIs): Antacids and PPIs elevate gastric pH by neutralizing or suppressing stomach acid production, respectively. This increase in pH can impair the absorption of folate, potentially leading to deficiency over prolonged periods.

4.6 Fertility, pregnancy and lactation

Pregnancy

There are no known hazards to the use of folic acid in pregnancy, supplements of folic acid are often beneficial. Non-drug-induced folic acid deficiency, or abnormal folate metabolism, is related to the occurrence of birth defects and some neural tube defects. Interference with folic acid metabolism or folate deficiency induced by drugs such as anticonvulsants and some antineoplastics early in pregnancy results in congenital anomalies. Lack of the vitamin or its metabolites may also be responsible for some cases of spontaneous abortion and intrauterine growth retardation.

Breast-feeding

Folic acid is actively excreted in human breast milk. Accumulation of folate in milk takes precedence over maternal folate needs. Levels of folic acid are relatively low in colostrum but as lactation proceeds, concentrations of the vitamin rise. No adverse effects have been observed in breast fed infants whose mothers were receiving folic acid.

4.7 Effects on ability to drive and use machines

No effect on concentration or co-ordination.

4.8 Undesirable effects

Folic acid intake below the established upper intake level of 1000 mcg daily has not been conclusively linked to adverse health outcomes in the general population.

High-dose folic acid can mask vitamin B12 deficiency, potentially delaying the diagnosis and treatment of neurologic complications. However, this risk is mitigated by routine screening in clinical settings.

Immune system disorders:

Rare (≥1/10,000 to <1/1,000): Allergic reactions, comprising erythema, rash, pruritis, urticaria, dyspnoea, and anaphylactic

reactions (including shock).

Gastrointestinal disorders:

Rare (≥1/10,000 to <1/1,000): Anorexia, nausea, abdominal distension and flatulence.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9 Overdose

There are no specific symptoms of overdosage and similarly no emergency treatment or antidotes. Metabolism and excretion can be rapid.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Antianemic Preparations - Folic Acid and

Derivatives, ATC Code: B03B B01

Folic acid is a member of the vitamin B group which is reduced in the body to tetrahydrofolate, a co-enzyme active in several metabolic processes, and produces a haemopoietic response in nutritional megaloblastic anaemias (but see warning in section 4.4 regarding the need for concomitant use of hydroxocobalamin). Folic acid is rapidly absorbed and widely distributed in body tissues.

It is used in the treatment and prevention of folate deficiency states.

5.2 Pharmacokinetic properties

Absorption – folic acid is rapidly absorbed from the gastrointestinal tract, mainly from the proximal part of the small intestine. Dietary folates are stated to have about half the bioavailability of crystalline folic acid. The naturally occurring folate polyglutamates are largely deconjugated and reduced by dihydrofolate reductase in the intestine to form 5-methyltetrahydrofolate (5MTHF). Folic acid given therapeutically enters the portal circulation largely unchanged, since it is a poor substrate for reduction by dihydrofolate reductases.

Distribution – via portal circulation. 5MTHF from naturally occurring folate is extensively plasma bound. The principal storage site of folate is in the liver; it is also actively concentrated in the CSF. Folate is distributed into breast milk.

Biotransformation – therapeutically given folic acid is converted into the metabolically active form 5MTHF in the plasma and liver. There is an enterohepatic circulation for folate.

Elimination – Folate metabolites are eliminated in the urine and folate in excess of body requirements is excreted unchanged in the urine. Folic acid is removed by haemodialysis.

5.3 Preclinical safety data

There is no preclinical safety data of relevance to the prescriber which is additional to that already included in other sections of the SPC.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Lactose monohydrate

Maize starch

Microcrystalline cellulose

Stearic acid

Magnesium stearate

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

2 years.

6.4 Special precautions for storage

Do not store above 25⁰C. Store in the original package.

6.5 Nature and contents of container

White opaque PVC blister lidded with Aluminium foil.

Pack size: 28,100.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

No special requirements.

7 MARKETING AUTHORISATION HOLDER

Euro-Link Pharma Ltd.,

110 Butterfield,

Great Marlings,

Luton,

Bedfordshire,

LU2 8DL,

UK.

8 MARKETING AUTHORISATION NUMBER(S)

PL 43542/0182

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

26/08/2026

10 DATE OF REVISION OF THE TEXT