Box of 3 blisters of 10 film coated tablets.
Box of 10 blisters of 10 film coated tablets.
Tolperisone hydrochloride 150 mg.
Film coated tablet
Each film coated tablet contains:
Active ingredient: Tolperisone hydrochloride 150 mg.
For the treatment of the pathologically elevated skeletal muscle tone in organic neurological disorders (pyramid tract injury, multiple sclerosis, cerebrovascular event, myelopathy, encephalomyelitis, etc).
For the treatment of muscular hypertonicity, muscle spasms and contractions associated with locomotor diseases (eg, spondylosis, spondylarthrosis, cervical and lumbar syndromes, arthrosis of large joints).
For the treatment of obliterative vascular diseases (artheriosclerosis obliterans, diabetic angiopathy, thromboangiitis obliterans, Raynaud’s disease, diffuse scleroderma) as well as syndromes developing on the basis of impaired vascular innervation (acrocyanosis, dysbasia angioneurotica intermittens).
For the rehabilitation after orthopaedic and traumatological surgery.
For the treatment of Little’s disease and other encephalopathies accompanied by dystonia as special paediatric indications.
DOSAGE AND ADMINISTRATION
Adults: the daily dose by mouth is 150-450 mg divided in 3 equal portions according to the individual needs and tolerance of the patient.
Children under 6 years: the daily dose by mouth is 5-10 mg/kg body weight divided in 3 equal portions. Children 6-14 years: the daily dose by mouth is 4-12 mg/kg body weight divided in 3 equal portions.
Patients with hypersensitivity to any ingredient of this product.
Patients with myasthenia.
Relative contraindications: Pregnancy, especially in the 1st trimester. Tolperisone is not recommended during the period of breastfeeding.
WARNINGS AND PRECAUTIONS
Use in pregnancy and lactation: Due to the absence of relevant clinical data, tolperisone should not be used in pregnancy (particularly not in the 1st trimester) unless its expected benefits would undoubtedly outweigh any possible embryotoxicity. Since it is not known whether tolperisone is excreted with breast milk or not, the administration of tolperisone is not recommended during breastfeeding.
Effects on the ability to drive or operate machinery: Tolperisone has no influence on the ability to drive and use machines.
Tolperisone does not induce drowsiness, therefore the preparation can be combined with hypnotics and tranquillisers.
Tolperisone does not influence the CNS effects of alcohol.
Tolperisone may enhance the CNS effects of methocarbamol.
Tolperisone may enhance the effects of other neuromuscular blocking agents.
Tolperisone potentiates the effect of nifluminic acid, therefore reduction of the dose of nifluminic acid should be considered in case of co-administration.
ADVERSE DRUG REACTIONS
There are usual reactions such as muscular weakness, headache, hypotension, nausea, vomiting and abdominal pain. These adverse effets usually disappear upon dose reduction.
Hypersensitivity reaction (pruritus, erythema, urticaria, angioneurotic oedema, anaphylactic shock, dyspnoea) may occur on rare occasion.
Stop use and ask a doctor if unusual new symptoms occur.
Inform your physician in case of any adverse reaction related to drug use.
PHARMACOLOGY AND PHARMACOKINETICS
Tolperisone hydrochloride, a piperidine derivative, is a centrally acting muscle relaxant. Its mode of action is complex. Owing to its membrane-stabilising and local anaesthetic effects, tolperisone inhibits the conduction in primary afferent nerve fibres and motoneurons whereby it inhibits spinal mono- and polysynaptic reflexes. The secondary mechanism is inhibition of synaptic Ca2+ influx whereby it inhibits transmitter release. In the brain stem, tolperisone inhibits the reticulospinal tracts.
Tolperisone improves peripheral blood flow. The favourable circulatory effects are independent of those seen in the central nervous system. They are probably related to the weak spasmolytic and antiadrenergic effects of tolperisone.
When administered orally, tolperisone is well absorbed from the small intestines. Peak plasma concentration appears within 0.5-1 hour after ingestion. Due to an intensive first-pass metabolism, the bioavailability of tolperisone is about 20%.
Tolperisone is intensively metabolised by the liver and the kidneys. It is almost exclusively eliminated via the kidneys (>99%) as metabolites.
Symptoms: Information on tolperisone overdosage in human is limited.
Treatment: There are no specific antidotes. In case of overdose, supportive and symptomatic treatment should be indicated.
PRESENTATION: Box of 3 blisters of 10 film coated tablets.
Box of 10 blisters of 10 film coated tablets.
STORAGE: store at the temperature not more than 30oC, in a dry place, protect from light.
: 36 months from manufacturing date.
KEEP OUT OF REACH OF CHILDREN
READ CAREFULLY THE LEAFLET BEFORE USE
FOR MORE INFORMATION, CONSULT YOUR PHYSICIAN.
Manufactured by: GLOMED PHARMACEUTICAL Co., INC
Address: 35 Tu Do Boulevard, Vietnam – Singapore Industrial Park, Thuan An District, Binh Duong Province.
Tel: (0650)3768824 - (0650)3768825 Fax: (0650)3769095