Myotop P Tablets
Therapy Area
Pain management
1.0 Generic name
Tolperisone Hydrochloride & Paracetamol Tablets [150 mg + 325 mg]
2.0 Qualitative and quantitative composition
Each film coated tablet contains :
Tolperisone Hydrochloride JP 150 mg
Paracetamol IP 325 mg
Excipients q.s.
Colour : Titanium Dioxide IP
3.0 Dosage form and strength
Film coated tablet [150 mg + 325 mg]
4.0 Clinical particulars
4.1 Therapeutic indication
Symptomatic treatment of post stroke spasticity associated with pain in adults.
4.2 Posology and method of administration
One tablet three times a day is the recommended dose for adults or as directed by the Physician.
4.3 Contraindications
Myotop P is contraindicated in patients :
- History of hypersensitivity to any component of the product.
- Suffering from myasthenia gravis.
- Pregnancy and Breast-Feeding
4.4 Special warnings and precautions for use
Close monitoring of renal parameters in patients with advanced renal disease is advisable. The combination should be used with caution in patients with peptic ulcer disease, gastrointestinal perforation and bleeding. Caution should be exercised when administering this combination in patients chronically treated with NSAIDs and in patients with anemia. Precautions have to be taken when Myotop P is used together with other muscle relaxants.
At very rare occasions, hypersensitivity reactions can occur (pruritis, erythema, exanthema, dyspnea, angioneurotic edema and anaphylactic shock).
4.5 Drugs interactions
No known drug-drug interaction.
4.6 Use in special populations Pregnancy and lactation
Myotop P cannot be given in pregnancy (in the first three months of pregnancy) and during breast-feeding. It should be used in pregnancy only if the benefit justifies the potential risk to the fetus.
Paediatrics
There are no studies evaluating the efficacy of the combination of Tolperisone and Paracetamol in children.
Geriatrics
Can be used in the elderly.
4.7 Effects on ability to drive and use machines
Studies on the effects on the ability to drive and use machines have not been performed.
4.8 Undesirable effects
It may cause muscular weakness, headache, nausea, vomiting and other abdominal complaints. Rarely hypersensitivity reactions (itching, skin rash,dyspnoea, angioneurotic edema and anaphylactic shock) can occur. Paracetamol is generally well-tolerated, but may cause mild nausea, vomiting, dyspepsia, skin rashes, Fixed Drug Eruption (FDE) and hepatic disturbances.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via email to : medico@zuventus.com By reporting side effects, you can help provide more information on the safety of this medicine
4.9 Overdose
No data on overdosage of this combination. As in any case of overdose, treatment should be symptomatic and general supportive measures should be utilised.
5.0 Pharmacological properties
5.1 Mechanism of action
Tolperisone is a centrally acting muscle relaxant, reducing the muscle tone.
Paracetamol, a para amino phenol derivative has excellent analgesic, antipyretic activity and has relatively little anti-inflammatory activity
5.2 Pharmacodynamic properties
Tolperisone
Being, centrally acting muscle relaxant, Tolperisone acts at the level of spinal cord by blocking sodium and calcium channels. Tolperisone exerts its spinal reflex inhibitory action predominantly via a pre synaptic inhibition of the transmitter release from the primary afferent endings via a combined action on voltage-gated sodium and calcium channels. Tolperisone increases the blood supply to skeletal muscles; this action is noteworthy since a muscle contracture may compress the small blood vessels and induce an ischemia leading to release of pain stimulating compounds. Tolperisone causes preferential antinociceptive activity against thermal stimulation that is likely to be attributed to its local anesthetic action. Tolperisone causes muscle relaxation by its action on central nervous system. It also leads to membrane stabilization & has analgesic activity. This muscle relaxation is dose dependant.
Paracetamol
Paracetamol has excellent analgesic and antipyretic activity. However, it has negligible anti-inflammatory and anti-rheumatic properties. Paracetamol has been effectively used as an anti-pyretic, analgesic. The mechanism of action of Paracetamol is still not clearly understood. It does not appear to share with NSAIDs the capacity to inhibit peripheral COX activity. There is currently considerable evidence to support the hypothesis of a central anti-nociceptive effect. Experimental evidence suggests that inhibition of prostaglandin biosynthesis contributes to Paracetamol pharmacological actions. The anti-nociceptive action of Paracetamol may be mediated by inhibition of COX-3.
5.3 Pharmacokinetic properties
| Parameters | Tolperisone | Paracetamol |
| Oral bioavailability | 20% | 63 - 89% |
| Tmax | 0.90 ± 0.31 hours | 1.1 hours |
| Cmax | 64.2 - 784.9 ng/ml | 12.3 ng/mL |
| Plasma protein binding | 60 - 75% | 10% to 25% |
| Half-life | 1.5 - 2.5 hours | 2 hours |
| Excretion | Tolperisone and its metabolites are excreted almost entirely through the kidneys. 98% of the administered dose is excreted in the urine within 24 hours | 90 - 100% of the drug is recoverable in the urine as conjugates |
6.0 Nonclinical properties
No Known animal toxicology data.
7.0 Description
Ask the patient to report any adverse events
Not to exceed the stated recommended daily dose
8.0 Pharmaceutical particulars
8.1 Incompatibilities
Not applicable
8.2 Shelf-life
Refer on the pack.
8.3 Packaging information
Alu-Alu blister strip of 10 tablets.
8.4 Storage and handing instructions Store below 25°C. Protect from light & moisture
Keep out of reach of children.
9.0 Patient counselling information
- Ask the patient to report any adverse events.
- Not to exceed the stated recommended daily dose.
12.0 Date of revision
24 February 2023
About Leaflet
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, pharmacist or nurse.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
What is in this leaflet
- What MYOTOP®-P is and what it is used for?
- What you need to know before you take MYOTOP®-P?
- How to take MYOTOP®-P?
- Possible side effects
- How to store MYOTOP®-P?
- Contents of the pack and other information
1. What MYOTOP®-P is and what it is used for
MYOTOP®-P is a fixed dose tablet of a Tolperisone 150mg (skeletal muscle relaxant) and Paracetamol 325 mg (pain killer).
Tolperisone is a muscle relaxant. It works on the centers in the brain and spinal cord to relieve muscle stiffness or spasm and to relieve pain and improve the movement of muscles. Paracetamol is a non-steroidal anti-inflammatory drug (NSAID) which seems to work by blocking the chemical messengers in the brain that tell your body that you have pain.
MYOTOP®-P is used for the treatment of musculoskeletal spasm and pain like strain, sprain, rigidity in adult. It improves the movement of muscles and provides relief from pain and discomfort associated with muscle spasms.
It is also to treat spasticity due to stroke where muscles become tight, stiff, and difficult to control following a stroke.
2. What you need to know before you take MYOTOP®-P
Do not take MYOTOP®-P:
- If you are allergic to any of the ingredients of this medicine.
- In you are suffering from a disease called myasthenia gravis
- If you are pregnant or lactating woman
- If you have stomach ulcer.
- If you have Liver or kidney failure
- If you have heart failure, heart disease, peripheral arterial disease.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking MYOTOP®-P
Take special care with MYOTOP®-P
Tell your doctor before you take this medicine if you:
- If you have advanced liver or renal disease
- If you have peptic ulcer disease, gastrointestinal perforation or bleeding
- If you have impaired renal or liver functions
- If you have blood dyscrasias
- If you have hypersensitivity to aspirin or other NSAIDs
- If you are chronically treated with NSAIDs
- If you are using other muscle relaxants
Tell your doctor immediately if during treatment you suffer from
Hypersensitivity reactions (pruritis, erythema, exanthema, dyspnea, angioneurotic edema)
Other medicines and MYOTOP®-P
Tell your doctor if you are taking or have taken the following medications.
- Aspirin
- Immune-system suppressant: methotrexate, cyclosporine
- Medicines used to treat heart failure: digoxin
- Medicines used to treat high blood pressure- ACE inhibitors, diuretics
- Medicine used to treat mania: lithium
- Medicines that stop blood clotting, such as warfarin
- Neuromuscular blocking agents
Pregnancy, breast-feeding and fertility
You should not take MYOTOP®-P when you are pregnant.
You should not breast-feed when taking MYOTOP®-P.
Driving and using machines
Undesirable effects such as dizziness, drowsiness, fatigue and visual disturbances are possible. If affected, you should not drive or operate machinery.
3. How to take MYOTOP®-P
Adults
Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.
In adults, the recommended dose is one tablet of MYOTOP®-P three times daily. Swallow the tablet whole with some water.
Use in children and adolescents
MYOTOP®-P is not used to treat children and adolescents.
If you take more MYOTOP®-P than you should
Tell your doctor or emergency department in hospital immediately.
If you forget to take MYOTOP®-P
Take the forgotten tablet as soon as you remember. Take the next tablet 24 hours after this and continue taking your tablets every 24 hours. Do not take a double dose to make up for a forgotten tablet.
If you stop taking MYOTOP®-P
Unless your doctor instructs you to stop treatment, it is important to continue taking MYOTOP®-P. If you stop and your original symptoms come back tell your doctor or pharmacist immediately.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them Tell your doctor, nurse or pharmacist immediately if you notice any of these side effects during your treatment with MYOTOP®-P:
Most common side effects include
- Gastrointestinal (GI) upset with abdominal pain
- Heartburn
- Nausea, vomiting
- Diarrhea
- Dyspepsia (persistent or recurrent pain or discomfort in the upper abdomen)
- Flatulence (passing gas)
- GI ulcers
- Bleeding / perforation and dryness of mouth
Other side effects include:
- Changes in some blood test results including those measuring your kidney and liver
- Abnormal renal function
- Edema
- Anemia (low red blood cell)
- Headaches
- Fatigue
- Muscle weakness or transient physical asthenia
- Dizziness
- Increased bleeding time
- Pruritus (Itching), rashes
- Arterial hypotension
- Hypersensitivity and other skin allergic reactions like skin rash, hives
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly: Website: www.zuventus.co.in and click the tab “Safety Reporting” located on the top end of the home page.
By reporting side effects, you can help provide more information on the safety of this medicine. You can also report the side effect with the help of your treating physician.
5. How to store MYOTOP®-P
Keep this medicine out of the sight and reach of children.
Store in a cool and dry place below 250C. Protected from light.
6. Contents of the pack and other information
What MYOTOP®-P contains
Each film coated tablet contains
Tolperisone Hydrochloride 150mg
Paracetamol IP 325mg
Excipient q.s.
Pack size: Alu-Alu blister strips of 10 tablets.
Marketing Authorisation Holder
Zuventus Heathcare Ltd. Zuventus House, Plot Y2, CTS No: 358/A2, Near Nahur Railway Station, Nahur (West), Mumbai 400 078.
This leaflet was last revised in November 2024.
