INTRODUCTION

NEW FOLINAL PLUS 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.

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

USES OF NEW FOLINAL PLUS TABLET

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

HOW NEW FOLINAL PLUS TABLET WORKS

NEW FOLINAL PLUS 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 NEW FOLINAL PLUS 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 NEW FOLINAL PLUS TABLET for you according to your age, body weight and disease condition.

SIDE EFFECTS OF NEW FOLINAL PLUS 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 NEW FOLINAL PLUS 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

NEW FOLINAL PLUS 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 NEW FOLINAL PLUS 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 NEW FOLINAL PLUS TABLET.

ALCOHOL

Consult your doctor

Avoid consumption of alcohol while taking NEW FOLINAL PLUS TABLET.

KIDNEY

Consult your doctor

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

ALLERGY

Contraindicated

Do not take NEW FOLINAL PLUS 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 NEW FOLINAL PLUS TABLET in children have not been established. Consult your doctor before taking it.

USE IN GERIATRICS

Consult your doctor

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

INTERACTIONS

A. Drug-Drug interactions:

Before taking NEW FOLINAL PLUS 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 NEW FOLINAL PLUS TABLET, contact your doctor immediately.

SYNOPSIS

MORE INFORMATION

• Keep NEW FOLINAL PLUS TABLET out of reach from children
• Store in a cool place

FAQs ABOUT NEW FOLINAL PLUS TABLET

Q: Can I take other medicines with NEW FOLINAL PLUS TABLET?

A: Before taking NEW FOLINAL PLUS 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 NEW FOLINAL PLUS TABLET?

A: Activities like driving a car or operating machinery should be done cautiously after taking NEW FOLINAL PLUS 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 NEW FOLINAL PLUS TABLET cause vomiting?

A: Vomiting is a possible side effect of NEW FOLINAL PLUS TABLET. NEW FOLINAL PLUS 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 NEW FOLINAL PLUS TABLET be given to children?

A: The safety and efficacy of NEW FOLINAL PLUS 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 NEW FOLINAL PLUS TABLET?

A: If you forget to take a dose of NEW FOLINAL PLUS 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 NEW FOLINAL PLUS TABLET be stopped?

A: Continue taking NEW FOLINAL PLUS 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 NEW FOLINAL PLUS 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