6S-5-Methyltetrahydrofolate is indicated for:

• Use during pregnancy and lactation
• Prevention of neural tube defects in babies when taken by pregnant women
• Dietary supplementation in adults and older individuals
• Reducing the risk of spontaneous abortion
• Normalizing homocysteine levels in postmenopausal women, thereby supporting the management of hot flashes as well as cardiovascular and bone health
• Management of folate deficiency caused by certain medications (e.g., antiepileptic drugs such as phenytoin, phenobarbital, and primidone)
• Management of folate deficiency resulting from chronic red blood cell destruction or long-term kidney dialysis
• Adjunctive support in depression, cognitive impairment, dementia, and Alzheimer's disease

6S-5-Methyltetrahydrofolate is a water-soluble form of vitamin B that functions as a coenzyme or co-substrate in DNA and RNA synthesis as well as amino acid metabolism. Folate deficiency is common during pregnancy and may result in fetal abnormalities, including neural tube defects. Poor maternal folate status has also been associated with low birth weight, preterm birth, and impaired fetal growth. Among neural tube defects (NTDs), spina bifida and anencephaly are the most frequently observed conditions. Folic acid supplementation before conception and during the first trimester of pregnancy has been shown to reduce the recurrence of neural tube defects in women at risk. It is also used in the treatment of megaloblastic anemia during pregnancy. 6S-5-Methyltetrahydrofolate is a fourth-generation folate derivative composed of 6S-5-methyltetrahydrofolate and glucosamine salt. It is biologically active in its administered form and offers the advantages of improved bioavailability, enhanced stability, and a favorable safety profile.

1-2 Capsule daily or as directed by the physician.

6S-5-Methyltetrahydrofolate may interact with certain medications. The anticonvulsant effect of phenytoin may be reduced by folic acid supplementation. Folate deficiency may occur due to increased folate loss, such as during renal dialysis, or because of interference with folate metabolism by medications including folic acid antagonists (e.g., methotrexate). The use of anticonvulsants such as phenytoin, primidone, and barbiturates, excessive alcohol intake (particularly in alcoholic cirrhosis), as well as pyrimethamine and nitrofurantoin, may also contribute to folate deficiency. Concurrent use of folate (6S-5-methyltetrahydrofolate) with amiodarone may increase the risk of photosensitivity reactions, including sunburn, blistering, or skin rashes on areas exposed to sunlight. Folate supplementation may also increase the metabolism of phenobarbital, potentially reducing its therapeutic effectiveness.

6S-5-Methyltetrahydrofolate is contraindicated in patients with known hypersensitivity to any of its ingredients.

6S-5-Methyltetrahydrofolate is generally well tolerated. Gastrointestinal disturbances and hypersensitivity reactions have been reported only rarely. However, administration of high doses may cause the following:

• Gastrointestinal disorders: Anorexia, diarrhea, nausea, abdominal distension, and flatulence.
• Hypersensitivity reactions: Allergic reactions including erythema, rash, pruritus, urticaria, and anaphylactic reactions (including anaphylactic shock).

The use of 6S-5-Methyltetrahydrofolate during pregnancy is generally considered safe. Folic acid is actively secreted into breast milk, and supplementation may be required in lactating women with inadequate nutritional intake that leads to maternal folate deficiency or megaloblastic anemia. The American Academy of Pediatrics considers folic acid to be compatible with breastfeeding.

Folic acid alone is not an adequate treatment for pernicious anemia or other megaloblastic anemias associated with vitamin B12 deficiency. Daily doses above 0.1 mg may mask the hematological signs of pernicious anemia while neurological complications continue to progress. When prescribing this nutritional supplement to pregnant women, nursing mothers, or women planning pregnancy, their medical condition as well as the use of any medications, herbal products, or dietary supplements should be carefully evaluated.

In the event of accidental overdose, seek immediate medical attention or contact the nearest healthcare facility.

Herbal and nutraceutical preparation.

Store below 25°C in a dry place, protected from light. Keep out of the reach of children.