INTRODUCTION

ESSFOL TABLET is a combination of L-Methylfolate, Methylcobalamin, and Pyridoxal Phosphate which belongs to the group of medicines called Vitamins. It is used to treat endothelial dysfunction (large blood vessels on the heart's surface narrow instead of widening) or hyperhomocysteinemia (high levels of an amino acid called homocysteine) in patients who present with lower extremity ulceration.

ESSFOL TABLET can also be used to promote optimum health and protect nerve cells in diabetic peripheral neuropathy. Diabetic neuropathy is nerve damage that occurs over time because of high sugar and fat levels in the blood due to diabetes. Symptoms depend on the type of neuropathy, such as pain and numbness in your feet or problems with organ functions like those of your heart and bladder.

Avoid smoking and drinking during treatment with ESSFOL TABLET. ESSFOL TABLET has not been proven safe or effective in children, so consult your doctor before using it. Before taking ESSFOL TABLET, inform your doctor if you have any other conditions or if you are taking any medicines. In pregnant and breastfeeding women, ESSFOL TABLET should be used with caution. Consult your doctor if you experience any side effects or if your symptoms worsen.

USES OF ESSFOL TABLET

• Treats endothelial dysfunction or hyperhomocysteinemia
• Promotes optimum health
• Promotes nerve cells in diabetic peripheral neuropathy

HOW ESSFOL TABLET WORKS

ESSFOL TABLET helps protect nerve cells where L-methyl folate is a form of folate that increases levels of nitric oxide vasodilator, thus increasing blood flow to the peripheral nerves, methylcobalamin participates in many processes like the production of red and white blood cells, and regeneration of RNA and DNA, synthesis of proteins, nerve cell and sheath maintenance and maintenance of bone marrow, and pyridoxal-5-phosphate takes part in a wide range of biochemical reactions like the metabolism of amino acids and glycogen, the synthesis of nucleic acids, haemoglobin, and certain neurotransmitters.

DIRECTIONS FOR USE

Take ESSFOL TABLET as advised by your physician. Swallow with a glass of water. Do not crush or chew the medicine. Your doctor will decide the correct dose and duration of ESSFOL TABLET for you according to your age, body weight and disease condition.

SIDE EFFECTS OF ESSFOL TABLET

HOW TO MANAGE SIDE EFFECTS

Loss Of Appetite

Eat when you are hungry. Eat smaller meals more often than usual. Snack only when you're hungry. Eat a nutritious snack rich in calories and protein, such as dried fruit and nuts. If your appetite does not improve, contact your doctor.

Diarrhea

Drink lots of fluids, like water or fruit juice to keep yourself hydrated. Ask your doctor before taking any medicine for diarrhoea. If diarrhoea does not improve, contact your doctor.

Nausea And Vomiting

Take ESSFOL TABLET with, or just after meals. Stick to simple meals. Avoid eating oily or spicy foods. If nausea does not improve, contact your doctor.

Skin Rash Or Itching

Avoid hot showers because hot water can irritate your skin further. Do not scratch the affected area. Use protective clothing when going outdoors. Regularly moisturize your skin. Consult your doctor if your skin rash worsens.

Headache

Drink an ample amount of water. Get adequate rest. Try to be relaxed and stress-free. Ask your doctor before taking any medicine for headaches. If the headache does not improve, contact your doctor.

WARNING & PRECAUTIONS

PREGNANCY

Use with Caution

ESSFOL TABLET should be used with caution in pregnant women. Consult your doctor before taking it.

BREASTFEEDING

Consult your doctor

There is no information available about the distribution of ESSFOL TABLET in breast milk. Consult your doctor before taking it.

DRIVING AND USING MACHINES

Use with Caution

Do not drive or use any machines if you feel disturbed mental alertness and motor coordination after taking ESSFOL TABLET.

ALCOHOL

Consult your doctor

Avoid consumption of alcohol while taking ESSFOL TABLET.

KIDNEY

Consult your doctor

There is no information available about the use of ESSFOL TABLET in patients with kidney failure. Consult your doctor before taking it.

LIVER

Consult your doctor

There is no information available about the use of ESSFOL TABLET in patients with liver impairment. Consult your doctor before taking it.

ALLERGY

Contraindicated

Do not take ESSFOL TABLET if you are allergic to L-Methylfolate, Methylcobalamin, Pyridoxal Phosphate, or any of the other ingredients of this medicine.

USE IN PEDIATRICS

Consult your doctor

The safety and effectiveness of ESSFOL TABLET in children have not been established. Consult your doctor before taking it.

USE IN GERIATRICS

Consult your doctor

The safety and effectiveness of ESSFOL TABLET in elderly patients have not been established. Consult your doctor before taking it.

INTERACTIONS

A. Drug-Drug interactions:

Before taking ESSFOL TABLET, inform your doctor if you are taking any of the following medicines:

• pyrimethamine, pentamidine (used to treat parasitic infection)
• medicines used to treat fits (Ex. carbamazepine, fosphenytoin, phenytoin, phenobarbital, primidone, valproic acid, valproate, lamotrigine)
• levodopa (used for Parkinson’s disease)
• medicines used to treat bacterial infections (Ex erythromycin, cefixime)
• cholestyramine, colestipol (used to control blood cholesterol levels)
• colchicine (used to treat gout)
• metformin (used to treat diabetes)
• potassium chloride (used to prevent potassium deficiency)
• nitrous oxide (used as general anaesthesia)
• methotrexate (used in certain types of cancer)
• sulfasalazine (used to treat inflammatory diseases like Crohn’s)
• pancreatic enzymes (pancrelipase, pancreatin)
• triamterene (used to treat fluid retention)
• trimethoprim (used to treat bacterial infections)
• warfarin (used to thin blood)

Overdosage:

If you or anyone else accidentally took too much of ESSFOL TABLET, contact your doctor immediately.

SYNOPSIS

MORE INFORMATION

• Keep ESSFOL TABLET out of reach from children
• Store in a cool place

FAQs ABOUT ESSFOL TABLET

Q: Can I take other medicines with ESSFOL TABLET?

A: Before taking ESSFOL TABLET, inform your doctor if you are taking, have taken, or might take any other medicine, including prescription, non-prescription, or any herbal medicine, as these might interact with each other and cause serious side effects. The influence that Silymarin (one of the ingredients in this medicine) has on liver function should be considered when other medicines are given concomitantly.

Q: Can I drive a car after taking ESSFOL TABLET?

A: Activities like driving a car or operating machinery should be done cautiously after taking ESSFOL TABLET as they require complete mental alertness and motor coordination. Your doctor will tell you about these activities after assessing your response to the medicine.

Q: Does ESSFOL TABLET cause vomiting?

A: Vomiting is a possible side effect of ESSFOL TABLET. ESSFOL TABLET. In such a case, get adequate rest and drink lots of fluids, especially water. Have small sips if you feel sick. Eat when you feel like it; you do not need to eat or avoid any specific foods. Do not take any medicine for vomiting without asking your doctor. Tell your doctor if you have continuous vomiting.

Q: Can ESSFOL TABLET be given to children?

A: The safety and efficacy of ESSFOL TABLET in children have yet to be determined. Your doctor will determine the correct dose or select a suitable alternative treatment for your child.

Q: What if I forget to take a dose of ESSFOL TABLET?

A: If you forget to take a dose of ESSFOL TABLET, take it as soon as you remember. However, omit the missed dose if it is almost time for the next one. Do not take the medicine twice to make up for the forgotten dose.

Q: Can ESSFOL TABLET be stopped?

A: Continue taking ESSFOL TABLET until your doctor tells you to stop, unless you experience any unwanted effects, a worsening of your condition, or any new symptoms. Contact your doctor in such a case.

Q: Can ESSFOL TABLET be crushed?

REFERENCES

1. KD Tripathi. Drugs Affecting Blood and Blood Formation. Essentials of Medical Pharmacology. Seventh edition. 2013. Page – 608.

2. Trippe BS, Barrentine LW, Curole MV, Tipa E. Nutritional management of patients with diabetic peripheral neuropathy with L-methyl folate-methylcobalamin-pyridoxal-5-phosphate: results of a real-world patient experience trial. NIH National Library of Medicine, National center for biotechnology information. Pubmed.gov. 2016. [Accessed on 28th July May 2022] https://pubmed.ncbi.nlm.nih.gov/26439233/

3. Pure and Cure Healthcare Pvt. Ltd. L-Methylfolate + Methylcobalamin + Pyridoxal phosphate. [Revised in January 2022] [Accessed on 28th July 2022] https://www.centaurpharma.com/downloads/2022/neurology/NURING%20ACTIVE.pdf

4. DM Pharma. L-Methylfolate + Methylcobalamin + Pyridoxal phosphate + Vitamin D3. [Accessed on 28th July 2022] http://dmpharma.co.in/Methylcobalamin,%20L-Methylfolate,%20Pyridoxal-5-phosphate,%20Vitamin%20D3%20Tablet.html