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INTRODUCTION
TOLPIDOL D TABLET is a combination of Diclofenac and Tolperisone, which belongs to the group of medicines called Non-Steroidal Anti-inflammatory Drugs and Skeletal Muscle relaxants respectively. It is used in adults to treat painful muscle spasms.
It can also be used to treat back pain (Ex. ankylosing spondylitis), joint pain and swelling (Ex. osteoarthritis, rheumatoid arthritis), neck pain, sports injuries and sprains.
Take TOLPIDOL D TABLET with or just after meals. Avoid smoking and consumption of alcohol while undergoing therapy with TOLPIDOL D TABLET to achieve better results. Before taking TOLPIDOL D TABLET, inform your doctor if you have any problems in your lung, liver, kidney, heart or stomach.
You much also inform your doctor if you have diabetes, high blood cholesterol, asthma or COPD, bleeding disorders or any allergic conditions (such as skin rash, itching or watery eyes, repeated sneezing, nasal congestion and nasal itching) as a precaution.
TOLPIDOL D TABLET is not recommended for use in patients with severe bleeding, perforation or ulcers in the stomach or intestines. Do not take this medicine without consulting your doctor if you are pregnant or breastfeeding women.
The most common side effects of taking TOLPIDOL D TABLET dizziness, headache, spinning sensation, nausea, vomiting, indigestion, stomach pain, heartburn, flatulence, loss of appetite, increased liver enzymes and skin rashes. Consult your doctor if any of these side effect worsens.
USES OF TOLPIDOL D TABLET
It is used in adults to treat:
- painful muscle spasms
- joint pain, back pain, neck pain
- sprains, sports injury
HOW TOLPIDOL D TABLET WORKS
TOLPIDOL D TABLET contains two medicines namely diclofenac and Tolperisone. Diclofenac is a pain-relieving medication. It acts by blocking the production of certain chemicals (prostaglandins) in the body that causes pain and inflammation.
Tolperisone is a muscle relaxant. It relaxes skeletal muscles by acting on certain centres of the brain and the spinal cord that controls muscle movements. As a result, TOLPIDOL D TABLET relieves muscle pain and joint pain.
DIRECTIONS FOR USE
Always take TOLPIDOL D TABLET as directed by your physician. Swallow the medicine with a glass of water. Do not crush or chew the medicine. TOLPIDOL D TABLET should be taken with or after food.
Your doctor will decide the correct dose for you depending upon your age, body weight and health condition.
SIDE EFFECTS OF TOLPIDOL D TABLET
COMMON
- dizziness, headache
- spinning sensation
- nausea, vomiting
- indigestion, stomach pain, heartburn, diarrhea,
- flatulence, loss of appetite
- increased liver enzymes
- skin rashes
UNCOMMON
- fast heartbeat
- sleepiness, tiredness, weakness
- dry mouth
RARE
- asthma
- oedema (swelling of body parts)
- lack of sleep
- increased sweating
Stop taking TOLPIDOL D TABLET and contact your doctor immediately if you experience any of the following side effects:
- serious allergic reactions such as skin rash, itching, swelling of the face, lips, mouth, or tongue causing difficulty in breathing or swallowing
- signs of severe skin reactions (such as skin redness, itching, blistering and peeling or skin, red circular patches or pin-point dots with raised bumps accompanied with fever and tiredness)
- bleeding in the gut (signs include bloody stools or vomits)
- sudden, severe chest pain, shortness of breath even while lying down, swelling of legs and feet (signs of heart attack)
- signs of stroke (such as weakness or numbness on one side of the body, vision changes, sudden difficulty in speech, sudden migraine headache)
- yellow skin and eyes, problems in passing urine, sore throat, high temperature, increased bruising
HOW TO MANAGE SIDE EFFECTS
Diarrhea
Hydrate yourself by drinking plenty of fluids, such as water or fruit juices. Consuming ORS can also be beneficial. Do not self-treat diarrhea on your own. Consult your doctor if your diarrhea becomes uncontrollable.
Dizziness Or Drowsiness
Try to rest and relax. Get enough sleep. Avoid driving or operating any tools or machines completely while you are feeling dizzy. Do not consume excessive alcohol, as it could aggravate your dizziness. Consult your doctor if your dizziness worsens.
Nausea And Vomiting
Take TOLPIDOL D TABLET with or just after a meal or a snack. Stick to simple meals. Avoid eating rich or spicy food. Consult your doctor if your nausea worsens.
Indigestion
Eat when you are hungry. Try to eat smaller meals more often than usual. Snack only when you're hungry. Always try to have a nutritious snack that is high in calories and protein, such as dried fruit and nuts.
WARNING & PRECAUTIONS
PREGNANCY
ContraindicatedTOLPIDOL D TABLET should not be taken by pregnant women especially during the last 3 months of pregnancy. Therefore, inform your doctor before taking it.
BREASTFEEDING
ContraindicatedTOLPIDOL D TABLET is not recommended for use in breastfeeding women. Therefore, consult your doctor before taking it.
DRIVING AND USING MACHINES
Use with CautionDo not drive or handle heavy tools or machines if you feel dizzy or drowsy after taking TOLPIDOL D TABLET.
ALCOHOL
Consult your doctorAvoid consumption of alcohol while taking TOLPIDOL D TABLET to avoid the risk of side effects.
KIDNEY
Consult your doctorTOLPIDOL D TABLET is not recommended for use in patients with severe kidney diseases (such as kidney failure). It should be used with caution in patients with other kidney problems. Therefore, consult your doctor before taking it.
LIVER
Consult your doctorTOLPIDOL D TABLET is not recommended for use in patients with severe liver diseases (such as liver failure). It should be used with caution in patients with other liver problems. Therefore, consult your doctor before taking it.
ALLERGY
ContraindicatedDo not take TOLPIDOL D TABLET if you are allergic to Diclofenac or Tolperisone.
LUNGS
Consult your doctorTOLPIDOL D TABLET is not recommended for use in patients with asthma or breathing difficulties. It should be used with caution in patients with infections of the respiratory tract. Therefore, consult your doctor before taking it.
HEART DISEASE
Consult your doctorTOLPIDOL D TABLET is not recommended for use in patients with congestive heart failure, or heart attack. It should be used with caution in patients with high blood pressure. Therefore, consult your doctor before taking it.
USE IN PEDIATRICS
Consult your doctorThe safety and effectiveness of TOLPIDOL D TABLET is not well established in children. Therefore, it is not recommended for use in children and adolescents (aged below 15 years). It can be used in adolescents aged 15 years or above if prescribed by the physician.
USE IN GERIATRICS
Use with CautionTOLPIDOL D TABLET should be used with caution in elderly patients. Therefore, consult your doctor before taking it.
OTHERS
TOLPIDOL D TABLET is not recommended for use if you:
- have myasthenia gravis (severe muscle weakness)
- have bleeding, holes or ulcers in the stomach or intestines
- have peripheral arterial disease
- have problems in blood circulation in the body
- have allergic rhinitis (repeated sneezing, nasal itching, watery eyes)
- have urticaria (skin rash with itching)
Before taking TOLPIDOL D TABLET, inform your doctor if you:
- have high blood cholesterol levels
- have diabetes mellitus
- are a smoker
- have a history of bleeding inside the brain
- have a history of stomach ulcer or inflammation particularly if complicated with haemorrhage (bleeding) or perforation
- have ulcerative colitis or Crohn's disease
- have bleeding problems
- recently had or going to have a surgery in the stomach or intestines
INTERACTIONS
A. Drug-Drug interactions:
Before taking TOLPIDOL D TABLET, inform your doctor if you are taking any of the following medicines such as:
- other medicines used for pain relief (Ex. aspirin, celecoxib, ibuprofen)
- medicines used for blood thinning (Ex. warfarin, clopidogrel, prasugrel)
- medicines used to reduce blood pressure (Ex. enalapril, olmesartan, losartan, metoprolol, nebivolol)
- cardiac glycosides used to treat heart failure (Ex. digoxin, digitoxin)
- potassium sparging diuretics (used to prevent potassium loss) such as spironolactone, aldosterone
- medicines used to treat bacterial infection (such as trimethoprim, ciprofloxacin, ofloxacin, levofloxacin or moxifloxacin)
- medicines used to treat fungal infections (such as voriconazole)
- medicines used to reduce blood sugar levels (such as glibenclamide, glycoside, and tolbutamide)
- oral corticosteroids (used to treat pain and inflammation) Ex. dexamethasone
- medicines used to treat depression (Ex. citalopram, fluoxetine, sertraline, venlafaxine, desipramine
- immunosuppressants (used to suppress immune function) Ex. cyclosporin, tacrolimus
- colestipol, colestyramine (medicines used to control blood cholesterol levels)
- diuretics (used to increase urine output) Ex. furosemide
- lithium (a medicine used to treat mental illness)
- methotrexate (a medicine used to treat auto-immune diseases or cancer)
- mifepristone (birth control pill)
- phenytoin (a medicine used to treat fits)
- thioridazine, perphenazine (medicines used to treat psychiatric illnesses)
- tolterodine (a medicine used for overactive bladder)
- atomoxetine (a medicine used for ADHD)
- dextromethorphan (a cough suppressant)
Overdosage:
If you or anyone else accidentally took more TOLPIDOL D TABLET, contact your doctor immediately. Symptoms of overdosage might include nausea, vomiting, upper stomach pain, headache, gastrointestinal bleeding, diarrhoea, disorientation, excitation, drowsiness, dizziness, tinnitus, hypotension, respiratory depression, fainting and convulsions.
SYNOPSIS
| Drug | : | Diclofenac and Tolperisone |
| Pharmacological Category | : | Preferential COX-2 Inhibitor, Skeletal Muscle Relaxants |
| Therapeutic Indication | : | Muscle pain and spasm, Joint pain |
| Dosage Forms | : | Tablet |
MORE INFORMATION
- Keep TOLPIDOL D TABLET out of reach of children
- Store TOLPIDOL D TABLET at room temperature
FAQs ABOUT TOLPIDOL D TABLET
Q: Can a higher dose of TOLPIDOL D TABLET improve my disease condition?
A: No. Do not take a higher dose of TOLPIDOL D TABLET without consulting your doctor as it may lead to increased risk of unwanted side effects. Only use the dose prescribed to you by your doctor. Your doctor will decide the correct dose for you depending upon your age, body weight and disease condition. If the prescribed dose does not result in effective pain relief, consult your doctor for advice.
Q: Can TOLPIDOL D TABLET cure arthritis?
A: No. TOLPIDOL D TABLET can only be used to relieve pain caused due to arthritis and cannot cure arthritis. Your doctor may prescribe you other medicines along with TOLPIDOL D TABLET to help to treat your disease condition.
Q: How long should I need to take TOLPIDOL D TABLET?
A: It is not advisable to take TOLPIDOL D TABLET for more than 7 days, especially while taking at higher doses. Strictly follow the instructions given by your doctor regarding the duration of the therapy.
Q: Can I stop taking TOLPIDOL D TABLET once my pain is relieved?
A: Yes. TOLPIDOL D TABLET can be discontinued from use once pain is relieved. However, consult your doctor before doing so, as stopping TOLPIDOL D TABLET too early may cause the pain to come back.
Q: Who should take TOLPIDOL D TABLET and who should not?
A: TOLPIDOL D TABLET should be used under medical supervision. Do not take TOLPIDOL D TABLET if you have asthma or bleeding or perforations in the gut. It is also not suitable for use in pregnant or breastfeeding women. Before taking TOLPIDOL D TABLET, inform your doctor if you have any problems in your liver, liver, kidney, heart, or stomach. You much also inform your doctor if you have diabetes, high blood cholesterol, allergic conditions, or bleeding problems as a precaution.
Q: Can TOLPIDOL D TABLET be taken with vitamin B12 supplements?
A: TOLPIDOL D TABLET can be taken together with vitamin supplements as vitamins tends to improve healing of inflammation and reduces pain. However, consult your doctor before taking.
Q: For what conditions TOLPIDOL D TABLET is prescribed?
A: TOLPIDOL D TABLET is given for reliving musculoskeletal pain associated with muscle spasms.
Q: Is TOLPIDOL D TABLET safe for pregnant women?
A: TOLPIDOL D TABLET is not recommended for use in pregnant women especially during the last trimester. Therefore, consult your doctor for advice before taking.
Q: Can I take TOLPIDOL D TABLET with antibiotics?
A: TOLPIDOL D TABLET may interact with certain antibiotics (such as trimethoprim, ciprofloxacin, ofloxacin, levofloxacin or moxifloxacin) and may produce an altered response. Inform your doctor about the medicines which you use currently.
Q: Is TOLPIDOL D TABLET a painkiller?
A: TOLPIDOL D TABLET is an anti-inflammatory medicine with pain relieving properties. It helps in reducing pain and swelling while relaxing the muscles. It can be used for reducing pain caused due to muscle contraction or inflammatory bone conditions.
Q: Does TOLPIDOL D TABLET make you feel sleepy?
A: TOLPIDOL D TABLET may make you feel sleepy. If you feel drowsy/sleepy, do not drive or operate any heavy tools or machines. Avoid consuming alcohol or taking other medicines that can sedate your brain easily such as antidepressants (Ex. citalopram, sertraline). Consult your doctor if you continue to feel sleepy that interferes with your day-to-day activities.
Q: Is TOLPIDOL D TABLET addictive?
A: TOLPIDOL D TABLET is not a habit-forming medicine. However, you might feel better that only if you take TOLPIDOL D TABLET. This is because, TOLPIDOL D TABLET can only reduce pain caused due to inflammatory conditions. It cannot treat the actual cause of the pain. And so, if you stop taking TOLPIDOL D TABLET, your pain may reappear once again. To avoid this, take TOLPIDOL D TABLET only as advised by the physician for the stipulated duration.
Q: Is TOLPIDOL D TABLET a steroid?
A: No. TOLPIDOL D TABLET is not a steroid. It contains Diclofenac which is a non-steroidal anti-inflammatory drug and Tolperisone which is a muscle relaxant. They act by blocking the production of certain chemicals in the body that causes pain, inflammation, and muscle spasms. As a result, it relaxes skeletal muscles and reduces pain associated with musculoskeletal disorders such as muscle spasm, arthritis etc.
Q: Can TOLPIDOL D TABLET be used in children?
A: The safety and effectiveness of TOLPIDOL D TABLET is not well established in children. Therefore, it is not recommended for use in children and adolescents (aged below 15 years). It can be used in adolescents aged 15 years or above if prescribed by the physician.
REFERENCES
1. K.D. Tripathi. Nonsteroidal Anti-inflammatory Drugs and Antipyretic-Analgesics. Essentials of Medical Pharmacology. Seventh edition. Page - 204.
2. Justyna Kolodziejska and Michal Kolodziejczyk. Diclofenac in the treatment of pain in patients with rheumatic diseases. NIH. National Library of Medicine. National Center for Biotechnology Information. PMC. PubMed Central. June 2018. [Accessed on 14th February 2023] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6052370/
3. Dexcel Pharma. Diclofenac sodium 50mg. Electronic Medicines Compendium. [Revised in April 2021]. [Accessed on 14th February 2023] https://www.medicines.org.uk/emc/files/pil.2660.pdf
4. Dexcel Pharma. Dicloflex 75mg SR and Dicloflex Retard 100mg Prolonged Release Tablets. Electronic Medicines Compendium. [Revised in March 2022]. [Accessed on 14th February 2023] https://www.medicines.org.uk/emc/files/pil.2662.pdf
5. Torrent Pharmaceuticals Ltd. Texxa-D. (Tolperisone Hydrochloride Sustained Release 450 mg and Diclofenac Sodium Sustained Release 100 mg Tablets). [Revised in December 2018]. [Accessed on 14th February 2023] https://www.torrentian.com/pisheet/Upload/PI_Sheet/2806.pdf
6. Leeford Healthcare Pvt Ltd. Tolexant-D. [Accessed on 14th February 2023] https://www.leeford.in/product/1118/tolexant-d
7. Central Drugs Standard Control Organization. Tolperisone Hcl IP 150mg + Diclofenac IP 50mg Tablets. December 2011. Tolperisone HCl 450mg + Diclofenac Sodium IP100mg SR tablets (Additional Strength). April 2013. [Accessed on 14th February 2023] https://cdscoonline.gov.in/CDSCO/Drugs
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