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Tolmex SR 450mg Tablet 10'S
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INTRODUCTION
TOLMEX SR 450MG 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.
TOLMEX SR 450MG 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. TOLMEX SR 450MG TABLET should be used with caution in patients with liver or kidney impairment.
TOLMEX SR 450MG 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. TOLMEX SR 450MG 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 TOLMEX SR 450MG TABLET are muscle weakness, headache, nausea, indigestion and dry mouth. Consult your doctor if any of the above side effects worsen.
USES OF TOLMEX SR 450MG TABLET
- Relieves painful muscle spasms of the skeletal muscles
HOW TOLMEX SR 450MG TABLET WORKS
TOLMEX SR 450MG 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.
DIRECTIONS FOR USE
Take TOLMEX SR 450MG 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 TOLMEX SR 450MG TABLET unless your doctor advises you to stop.
SIDE EFFECTS OF TOLMEX SR 450MG TABLET
COMMON
- muscle weakness
- headache
- low blood pressure
- nausea, vomiting, indigestion, dry mouth
UNCOMMON
- sleepiness, dizziness
- abdominal discomfort or pain
- fatigue
- lassitude (physical or mental tiredness)
- weakness
RARE
- constipation, gastrointestinal disturbance, diarrhea
- increased sweating
- sleep disturbance
Stop taking TOLMEX SR 450MG TABLET and contact your doctor immediately if you experience this side effect:
- hypersensitivity reactions (signs include rash, redness of the skin, itching, shortness of breath, swelling underneath the skin, increased heart rate or low blood pressure)
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
PREGNANCY
TOLMEX SR 450MG TABLET should be used with caution during pregnancy only if considered clearly necessary. Consult your doctor before taking TOLMEX SR 450MG TABLET.
BREASTFEEDING
TOLMEX SR 450MG TABLET is not recommended for use in breastfeeding women. Consult your doctor before taking TOLMEX SR 450MG TABLET.
DRIVING AND USING MACHINES
TOLMEX SR 450MG TABLET may cause dizziness, sleepiness, attention disturbance, muscle weakness, fits or blurred vision after taking TOLMEX SR 450MG TABLET. If you experience any such side effects consult your doctor for advice.
KIDNEY
TOLMEX SR 450MG TABLET is not recommended for use in patients with severe kidney impairment. It should be used with caution in patients with kidney impairment due to increased risk of adverse events and dose may be adjusted by monitoring the patient’s condition and kidney function in patients with moderate kidney impairment. Consult your doctor before taking TOLMEX SR 450MG TABLET.
LIVER
TOLMEX SR 450MG 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 TOLMEX SR 450MG TABLET.
ALLERGY
TOLMEX SR 450MG TABLET is not recommended for use if you are allergic to Tolperisone or any other ingredients of this medicine. It should be used with caution in patients who are allergic to lidocaine (due to cross-reactions).
OTHERS
TOLMEX SR 450MG TABLET is not recommended for use if you have:
- galactose intolerance
- the Lapp lactase deficiency or glucose-galactose-malabsorption
- myasthenia gravis
Use in pediatrics:
TOLMEX SR 450MG TABLET should be used with caution in children (from 3 months to 14 years of age). Your child’s doctor may adjust the dose depending upon age and body weight. Consult your child’s doctor for advice.
Use in geriatrics:
The dose of the TOLMEX SR 450MG TABLET should be adjusted in the elderly. Consult your doctor before taking it.
INTERACTIONS
A. Drug-Drug interactions:
Before taking TOLMEX SR 450MG 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 TOLMEX SR 450MG TABLET, consult your doctor immediately or visit the nearby hospital. Overdosage symptoms of TOLMEX SR 450MG TABLET are sleepiness, gastrointestinal symptoms (nausea, vomiting and epigastric pain), increased heart rate, low blood pressure, slow movements, vertigo, seizures and coma.
SYNOPSIS
| Drug | : | Tolperisone |
| Pharmacological Category | : | Muscle Relaxant |
| Therapeutic Indication | : | Muscle spasm of skeletal muscles |
| Dosage Forms | : | Tablet |
MORE INFORMATION
- Keep TOLMEX SR 450MG TABLET out of reach of children
- Store at room temperature
FAQs ABOUT TOLMEX SR 450MG TABLET
How does TOLMEX SR 450MG TABLET work?
TOLMEX SR 450MG 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 TOLMEX SR 450MG TABLET be used in pregnant women?
TOLMEX SR 450MG TABLET should be used with caution during pregnancy only if clearly advised by the doctor. Consult your doctor before taking TOLMEX SR 450MG TABLET if you are pregnant or planning to get pregnant.
Does TOLMEX SR 450MG TABLET cause dry mouth?
Yes, TOLMEX SR 450MG 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 TOLMEX SR 450MG TABLET be taken by patients with liver disease?
TOLMEX SR 450MG 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 TOLMEX SR 450MG TABLET.
What if I forget to take a dose of TOLMEX SR 450MG TABLET?
If you forget to take a dose of TOLMEX SR 450MG 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
AUTHOR DETAILS
Written By Dr. R. Dinesh John Rajkumar, Pharm.D
Last updated on 22 Sep 2022 | 06:31 PM(IST)
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