INTRODUCTION

FLEXURA 400MG TABLET contains Metaxalone which belongs to the group of medicines called Skeletal Muscle Relaxants. It is used with rest, physical therapy and other measures to relax muscles and relieve pain and discomfort caused by strains, sprains and other muscle injuries.

FLEXURA 400MG TABLET is not recommended for use in patients with anaemia (decreased red blood cells), severe liver, kidney dysfunction. FLEXURA 400MG TABLET should be used with caution in patients with fits. Consult your doctor before taking it.

FLEXURA 400MG TABLET is generally not recommended for use in pregnant women unless it is considered clearly necessary. It is not recommended for use in breastfeeding women. Consult your doctor before taking this medicine.

FLEXURA 400MG TABLET is not recommended for use in children younger than 12 years old. It should be used with caution in elderly patients. Consult your doctor before taking this medicine.

The most common side effects of taking FLEXURA 400MG TABLET are drowsiness, dizziness, headache, nervousness or irritability, nausea, vomiting, stomach upset. Consult your doctor if any of the symptoms worsen.

USES OF FLEXURA 400MG TABLET

• To relax muscles and relieve pain and discomfort

HOW FLEXURA 400MG TABLET WORKS

FLEXURA 400MG TABLET works by blocking nerve impulses (or pain sensations) in the brain. This improves helps to relax muscles.

DIRECTIONS FOR USE

Take FLEXURA 400MG TABLET as advised by your physician. Swallow the medicine with water. Do not crush or chew the medicine. Your doctor will decide the correct dose and duration for you depending upon your age, body weight and disease condition.

SIDE EFFECTS OF FLEXURA 400MG TABLET

HOW TO MANAGE SIDE EFFECTS

Headache:

Rest and relax. Drink plenty of fluids such as water or ORS (Oral Rehydrating Solution) and apply a pain-relieving balm on the head if necessary. Contact your doctor if your headache did not improve.

Dizziness:

Try to rest and relax. Get enough sleep. Avoid driving or operate any machines while you are feeling dizzy. Do not drink alcohol, as it can aggravates your dizziness. Contact your doctor if your dizziness did not improve.

Nausea and vomiting:

Take FLEXURA 400MG TABLET, with or just after a meal. Stick to simple meals. Avoid eating oily or spicy food. Contact your doctor if your nausea and vomiting did not improve.

Diarrhoea:

Drink lots of fluids, such as water or fruit juices to keep yourself hydrated. Do not take any medicine on your own for treating diarrhoea. Contact your doctor if your diarrhoea did not improve.

Skin rash:

Avoid hot bath because hot water can irritate your skin further. Do not scratch the affected area. Use sunscreen and wear protective clothing while going outside. Use unscented moisturizers to soothe and hydrate the affected area. Contact your doctor if your rashes worsen.

WARNING & PRECAUTIONS

INTERACTIONS

A. Drug - Drug interactions:

Before taking FLEXURA 400MG TABLET, inform your doctor if you are taking any of the following medicine:

• benzodiazepines (used to treat panic disorders, anxiety, fits) Ex. diazepam, clonazepam
• opioids (used to treat severe pain) Ex. tramadol, fentanyl, meperidine and methadone
• triptans (used to treat migraine, cluster headache) Ex. almotriptan, sumatriptan
• citalopram, amitriptyline, mirtazapine, trazodone, venlafaxine, duloxetine, isocarboxazid, phenelzine (medicines used to treat depression, anxiety, neuropathic pain)
• 5-HT3 receptor antagonists (used to treat nausea and vomiting) Ex. ondansetron
• linezolid (used to treat bacterial infections)
• intravenous methylene blue (used to treat methemoglobinemia)

Overdosage:

If you or anyone else accidentally take too much of this medicine, consult your doctor immediately or visit the nearby hospital.

SYNOPSIS

MORE INFORMATION

• Keep FLEXURA 400MG TABLET out of reach of children
• Store FLEXURA 400MG TABLET below 30°C

FAQs ABOUT FLEXURA 400MG TABLET

Q: Does FLEXURA 400MG TABLET help with pain?

A: FLEXURA 400MG TABLET is used to help relax the muscles in your body and relieve the discomfort caused by acute, painful muscle or bone conditions. However, this medicine does not take the place of rest, exercise, physical therapy or other treatments that your doctor may recommend for your condition. Contact your doctor for advice.

Q: How often Can I take FLEXURA 400MG TABLET?

A: Take FLEXURA 400MG TABLET as advised by your physician. Generally, it is taken three or four times a day. Your doctor will decide the correct dose and duration for you depending upon your age, body weight and disease condition.

Q: Does FLEXURA 400MG TABLET cause drowsiness?

A: The most common side effect of taking FLEXURA 400MG TABLET is drowsiness. Try to rest and relax. Get enough sleep. Avoid driving or operate any machines while you are feeling drowsy. Do not drink alcohol, as it can aggravate your drowsiness. Contact your doctor if your drowsiness did not improve.

Q: What if I forget to take FLEXURA 400MG TABLET?

A: Take the FLEXURA 400MG TABLET as soon as you remember it. However, if it is almost time for your next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Q: Does FLEXURA 400MG TABLET work immediately?

A: FLEXURA 400MG TABLET start to work within one hour after administration and has a duration of action of 4 to 6 hours. Contact your doctor if your symptoms did not improve.

REFERENCES

1. Sean C Sweetman. Muscle Relaxants. Martindale The Complete Drug Reference. 36th edition. 2009. Page - 1897.

2. Robert. J. Kizior, Keith J. Hodgson. Skeletal muscle relaxants. Saunders Nursing Drug Handbook. 2021. 29th edition. 2021. Page - 164c.

3. Bethesda (MD).  Metaxalone. LiverTox: Clinical and Research Information on Drug-Induced Liver Injury. National Institute of Diabetes and Digestive and Kidney Diseases. September 2021. [Accessed on 27th November 2021] https://www.ncbi.nlm.nih.gov/books/NBK548838/

4. Witenko C, Moorman-Li R, Motycka C, Duane K, Hincapie-Castillo J, Leonard P, Valaer C. Considerations for the appropriate use of skeletal muscle relaxants for the management of acute low back pain. NIH National Library of Medicine, National Center for Biotechnology Information. PubMed Central. June 2014. [Accessed on 27th November 2021] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4103716/

5. Bethesda (MD). Metaxalone. Medline Plus. National Library of Medicine: National Institute of Health. June 2020. [Accessed on 27th November 2021] https://medlineplus.gov/druginfo/meds/a682010.html#

6. Metaxalone Tablet. Daily Med: National Library of Medicine: National Institute of Health. [Revised in April 2021] [Accessed on 27th November 2021]. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=b57fcd53-4481-4345-983c-23b7356a69ad

USEFUL DIAGNOSTIC TESTS

• Liver function test