INTRODUCTION

SYNAPTOL 100MG TABLET contains Tolperisone which belongs to the group of medicines called Muscle Relaxants. It is used to relieve painful muscle spasms of the skeletal muscles. Muscle spasms (muscle cramps) are painful contractions and tightening of the muscles. Symptoms include muscular weakness, tingling or prickling sensation, pain or discomfort.

SYNAPTOL 100MG TABLET is not recommended for use in patients with severe liver or kidney impairment, galactose intolerance, the Lapp lactase deficiency or glucose-galactose-malabsorption and myasthenia gravis. SYNAPTOL 100MG TABLET should be used with caution in patients with liver or kidney impairment.

SYNAPTOL 100MG TABLET should be used with caution during pregnancy only if clearly advised by the doctor and it is not recommended for use in breastfeeding women. SYNAPTOL 100MG TABLET should be used with caution in children (from 3 months to 14 years of age) and in elderly patients.

The most common side effects of taking SYNAPTOL 100MG TABLET are muscle weakness, headache, nausea, indigestion and dry mouth. Consult your doctor if any of the above side effects worsen.

USES OF SYNAPTOL 100MG TABLET

• Relieves painful muscle spasms of the skeletal muscles

HOW SYNAPTOL 100MG TABLET WORKS

GBNKEYWORD] works by blocking the voltage-gated sodium channel in the brain stem thereby causing muscle relaxation and stopping the pain signals between nerve and brain. It also relieves pain by increasing the blood supply to skeletal muscles.

DIRECTIONS FOR USE

Take SYNAPTOL 100MG TABLET as advised by your physician. Swallow the medicine with plenty of water. Do not crush or chew the medicine. Your physician will decide the correct dose and duration for you depending upon your age, body weight and disease condition. Do not stop taking SYNAPTOL 100MG TABLET unless your doctor advises you to stop.

SIDE EFFECTS OF SYNAPTOL 100MG TABLET

HOW TO MANAGE SIDE EFFECTS

Nausea or vomiting:

Stick to simple meals while taking this medicine. Avoid eating oily rich, fried or spicy foods. Do not lie down or sleep immediately after eating. Consult your doctor if the symptom does not improve.

Headache:

Drink ample amount of water and avoid skipping meals. Get adequate rest. Try to be relaxed and stress-free. Apply pain relieving balm on your forehead if necessary. Consult your doctor if the symptom does not improve.

Constipation:

Eat plenty of fibre-rich foods such as fresh fruits, vegetables and cereals and drink plenty of water. Exercise more regularly. If the symptom does not improve, consult your doctor.

Stomach pain:

Try to take rest and relax. Eat and drink slowly or try to have smaller and more frequent meals. Keep a heating pad on your stomach. If the symptom does not improve, consult your doctor.

Dry mouth:

Sip water regularly and other sugar-free liquids. Do not use mouthwashes that contain alcohol because they can make your mouth dry, use mouthwash that is used only for dry mouth. Limit your caffeine intake. Avoid smoking or using tobacco products. Consult your doctor if the symptom does not improve.

WARNING & PRECAUTIONS

INTERACTIONS

A. Drug-Drug interactions:

Before taking SYNAPTOL 100MG TABLET, inform your doctor if you are taking any of the following medicines:

• benzodiazepines such alprazolam, diazepam (used to treat anxiety and insomnia)
• medicines used to treat pain and inflammation (ibuprofen, diclofenac, niflumic acid)
• medicines used to treat schizophrenia (Ex. thioridazine, perphenazine)
• tolterodine (used to treat overactive bladder)
• atomoxetine (used in attention deficit hyperactivity disorder)
• desipramine, venlafaxine (used to treat depression)
• dextromethorphan (used to relieve cough and cold)
• medicines used to treat high blood pressure (Ex. metoprolol, nebivolol)

Overdosage:

If you or anyone else accidentally take too much of SYNAPTOL 100MG TABLET, consult your doctor immediately or visit the nearby hospital. Overdosage symptoms of SYNAPTOL 100MG TABLET are sleepiness, gastrointestinal symptoms (nausea, vomiting and epigastric pain), increased heart rate, low blood pressure, slow movements, vertigo, seizures and coma.

SYNOPSIS

MORE INFORMATION

• Keep SYNAPTOL 100MG TABLET out of reach of children
• Store at room temperature

FAQs ABOUT SYNAPTOL 100MG TABLET

How does SYNAPTOL 100MG TABLET work?

SYNAPTOL 100MG TABLET works by blocking the voltage-gated sodium channel in the brain stem thereby causing muscle relaxation and stopping the pain signals between nerve and brain. It also relieves pain by increasing the blood supply to skeletal muscles.

Can SYNAPTOL 100MG TABLET be used in pregnant women?

SYNAPTOL 100MG TABLET should be used with caution during pregnancy only if clearly advised by the doctor. Consult your doctor before taking SYNAPTOL 100MG TABLET if you are pregnant or planning to get pregnant.

Does SYNAPTOL 100MG TABLET cause dry mouth?

Yes, SYNAPTOL 100MG TABLET may cause dry mouth in some individuals. To manage this effect, sip water regularly and other sugar-free liquids. Do not use mouthwashes that contain alcohol because they can make your mouth dry, use mouthwash that is used only for dry mouth. Limit your caffeine intake. Avoid smoking or using tobacco products. Consult your doctor if the symptom does not improve.

Can SYNAPTOL 100MG TABLET be taken by patients with liver disease?

SYNAPTOL 100MG TABLET is not recommended for use in patients with severe liver impairment. It should be used with caution in patients with liver impairment due to increased risk of adverse events and the dose may be adjusted by monitoring the patient’s condition and liver function in patients with moderate liver impairment. Consult your doctor before taking SYNAPTOL 100MG TABLET.

 What if I forget to take a dose of SYNAPTOL 100MG TABLET?

If you forget to take a dose of SYNAPTOL 100MG 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 medicine two times to make up for the missed dose.

REFERENCES

1. Sean C Sweetman. Muscle Relaxants. Martindale The Complete Drug Reference. 36th edition. Page- 1899.

2. Stefan Quasthoff, Claudia Mockel, Walter Zieglgansberger and Wolfgang Schreibmayer. Tolperisone: Typical Representative of a Class of Centrally Acting Muscle Relaxants with Less Sedative Side Effects. NIH National Library of Medicine, National center for biotechnology information. Pubmed Central. May 2008. [Accessed on 25th July 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6494009/

3. Srinivas Nalamachu, Joseph Pergolizzi, Randall Kaye. Tolperisone for the Treatment of Acute Muscle Spasm of the Back: Results from the Dose-Ranging Phase 2 STAR Study (NCT03802565). Dove press. November 2020. [Accessed on 25th July 2022] https://www.dovepress.com/tolperisone-for-the-treatment-of-acute-muscle-spasm-of-the-back-result-peer-reviewed-fulltext-article-JPR

4. Agam Vora. Tolperisone. Journal of the Association of the Physicians of India. February 2010. [Accessed on 25th July 2022] https://www.japi.org/s2c46464/tolperisone

5. National Institute of Pharmacy, Budapest. Tolperisone. November 2009. [Accessed on 25th July 2022] https://ogyei.gov.hu/kiseroirat/ph/ph_0000027197.pdf

6. DHG Pharma. Mynarac (Tolperisone). [Revised in July 2018] [Accessed on 25th July 2022] https://www.dhgpharma.com.vn/en/muscular-osteoarticular/mynarac-detail

7. Leeford. Tolexant 150 (Tolperisone). [Accessed on 25th July 2022] https://www.leeford.in/product/1117/tolexant-150#:~:text=DESCRIPTION%3A,after%20orthopaedic%20and%20trauma%20surgery

8. Tolperisone. Central Drugs Standard Control Organisation (CDSCO). [Accessed on 25th July 2022] https://cdscoonline.gov.in/CDSCO/Drugs

USEFUL DIAGNOSTIC TESTS

• Liver function test
• Kidney function test