Tolperisone (Tablets) Instructions for Use
ATC Code
M03BX04 (Tolperisone)
Active Substance
Tolperisone (Rec.INN registered by WHO)
Clinical-Pharmacological Group
Centrally acting muscle relaxant
Pharmacotherapeutic Group
Muscle relaxants; centrally acting muscle relaxants; other centrally acting muscle relaxants
Pharmacological Action
A centrally acting muscle relaxant. The reduction of pathologically increased skeletal muscle tone is explained by the ability of tolperisone to suppress spinal polysynaptic reflexes and its inhibitory effect on the caudal part of the reticular formation.
It has central n-cholinoblocking properties. It does not have a significant effect on the peripheral parts of the nervous system. It has a weak antispasmodic and vasodilatory effect.
Indications
Spinal and cerebral palsies (hypertonia, muscle spasm, spinal automatism; limb contractures).
Diseases accompanied by dystonia, rigidity, muscle spasm; obliterating arterial diseases: obliterating atherosclerosis of limb vessels, diabetic angiopathy, obliterating thromboangiitis (Buerger’s disease), Raynaud’s syndrome.
Consequences of vascular innervation disorders (acrocyanosis, intermittent angioneurotic dysbasia).
Extrapyramidal disorders (postencephalitic and atherosclerotic parkinsonism).
Postthrombotic disorders of lymph circulation and venous circulation, trophic leg ulcer, infantile spastic paralysis (Little’s disease), epilepsy, vascular encephalopathy; hypertonia combined with another type of muscle tone disorder.
ICD codes
| ICD-10 code | Indication |
| G21.3 | Postencephalitic parkinsonism |
| G21.4 | Vascular parkinsonism |
| G24 | Dystonia (including dyskinesia) |
| G40 | Epilepsy |
| G80 | Cerebral palsy |
| G81.1 | Spastic hemiplegia |
| G82.1 | Spastic paraplegia |
| G82.4 | Spastic tetraplegia |
| G93.4 | Unspecified encephalopathy |
| I73.0 | Raynaud's syndrome |
| I73.1 | Obliterative thromboangiitis [Buerger's disease] |
| I73.8 | Other specified peripheral vascular diseases |
| I73.9 | Peripheral vascular disease, unspecified (including intermittent claudication, arterial spasm) |
| I79.2 | Peripheral angiopathy in diseases classified elsewhere (including diabetic angiopathy) |
| I87.0 | Postthrombotic syndrome |
| L98.4 | Chronic skin ulcer, not elsewhere classified |
| R25.2 | Cramp and spasm |
| ICD-11 code | Indication |
| 4A44.8 | Thromboangiitis obliterans |
| 7A82 | Sleep related leg cramps |
| 8A00.23 | Vascular parkinsonism |
| 8A00.2Y | Other specified secondary parkinsonism |
| 8A02.Z | Dystonic disorders, unspecified |
| 8A6Z | Epilepsy or epileptic seizures, unspecified |
| 8D2Z | Cerebral palsy, unspecified |
| 8E47 | Encephalopathy, not elsewhere classified |
| 8E4A.0 | Paraneoplastic or autoimmune disorders of the central nervous system, including brain and spinal cord |
| 8E63 | Post-cardiopulmonary bypass encephalopathy |
| BD42.0 | Raynaud's disease |
| BD42.1 | Raynaud's syndrome |
| BD42.Z | Raynaud's phenomenon, unspecified |
| BD4Z | Chronic obliterative arterial diseases, unspecified |
| BD53.Y | Other specified secondary involvement of arteries and arterioles |
| BD5Z | Diseases of arteries or arterioles, unspecified |
| BD74.Z | Chronic venous insufficiency of lower extremities, unspecified |
| EA40 | Tropical phagedenic ulcer |
| EF60 | Ischemic ulceration of the skin |
| EG00 | Dilation of skin vessels of the extremities |
| EM0Z | Unspecified skin disorder |
| MB40.7 | Acroparesthesia |
| MB47.3 | Convulsion or spasm |
| MB50.1 | Spastic tetraplegia |
| MB53.2 | Spastic hemiplegia |
| MB56 | Paraplegia |
| ME60.2 | Ulcerative skin lesion of unspecified nature |
Dosage Regimen
| The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen. |
Administer tablets orally with a full glass of water, preferably during or immediately after a meal to minimize potential gastrointestinal discomfort.
Initiate treatment with an initial dose of 50 mg taken two to three times daily.
Gradually titrate the dosage upward based on individual patient tolerance and therapeutic response.
The standard maintenance dose for adults is 150 mg two to three times per day.
Do not exceed the maximum daily dose of 450 mg.
For elderly patients or those with hepatic impairment, initiate therapy at the lower end of the dosage range and titrate cautiously.
Monitor patients closely for signs of adverse reactions, particularly during the initial phase of treatment and subsequent dose escalations.
The duration of therapy is determined by the treating physician based on the underlying condition and clinical progress; do not discontinue abruptly without medical consultation.
Adverse Reactions
Possible headache, myasthenia, arterial hypotension, nausea, vomiting, gastralgia, allergic reactions (anaphylactic shock, bronchospasm, urticaria, erythematous rashes, skin itching).
Contraindications
Myasthenia gravis, pregnancy, lactation period, children and adolescents under 18 years of age, hypersensitivity to tolperisone.
Use in Pregnancy and Lactation
Contraindicated during pregnancy and lactation.
Pediatric Use
Contraindicated in children under 1 year of age.
Special Precautions
Effect on the ability to drive vehicles and operate machinery
Use with caution in patients whose activities require increased attention and speed of psychomotor reactions.
Drug Interactions
The effect of tolperisone is enhanced when used concomitantly with drugs for general anesthesia, peripheral muscle relaxants, psychoactive drugs, and with clonidine.
Storage Conditions
Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.
Dispensing Status
Rx Only
Important Safety Information
This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.
Medical DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Film-coated tablets, 50 mg: 7, 10, 14, 20, 21, 28, 30, 35, 40, 42, 50, 56, 60, 70, 80, 90, 100, 120, 140, 150, 200, or 300 pcs.
Film-coated tablets, 150 mg: 7, 10, 14, 20, 21, 28, 30, 35, 40, 42, 50, 56, 60, 70, 80, 90, 100, 120, 140, 150, 200, or 300 pcs.
Marketing Authorization Holder
Atoll LLC (Russia)
Manufactured By
Ozon, LLC (Russia)
Or
Ozon Pharm, LLC (Russia)
Dosage Forms
 |
Tolperisone | Film-coated tablets, 50 mg: 7, 10, 14, 20, 21, 28, 30, 35, 40, 42, 50, 56, 60, 70, 80, 90, 100, 120, 140, 150, 200, or 300 pcs. |
| Film-coated tablets, 150 mg: 7, 10, 14, 20, 21, 28, 30, 35, 40, 42, 50, 56, 60, 70, 80, 90, 100, 120, 140, 150, 200, or 300 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets white or almost white, round, biconvex, with a characteristic odor.
| 1 tab. | |
| Tolperisone hydrochloride | 50 mg |
Excipients: microcrystalline cellulose – 72.6 mg, lactose monohydrate (milk sugar) – 45.1 mg, croscarmellose sodium – 7.6 mg, hypromellose – 1.9 mg, citric acid monohydrate – 1.5 mg, magnesium stearate – 1.3 mg.
Film coating composition: hypromellose – 3 mg, macrogol 4000 – 0.75 mg, titanium dioxide – 1.25 mg.
7 pcs. – contour cell packaging (1) – cardboard packs.
7 pcs. – contour cell packaging (2) – cardboard packs.
7 pcs. – contour cell packaging (3) – cardboard packs.
7 pcs. – contour cell packaging (4) – cardboard packs.
7 pcs. – contour cell packaging (5) – cardboard packs.
7 pcs. – contour cell packaging (10) – cardboard packs.
10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.
10 pcs. – contour cell packaging (3) – cardboard packs.
10 pcs. – contour cell packaging (4) – cardboard packs.
10 pcs. – contour cell packaging (5) – cardboard packs.
10 pcs. – contour cell packaging (10) – cardboard packs.
14 pcs. – contour cell packaging (1) – cardboard packs.
14 pcs. – contour cell packaging (2) – cardboard packs.
14 pcs. – contour cell packaging (3) – cardboard packs.
14 pcs. – contour cell packaging (4) – cardboard packs.
14 pcs. – contour cell packaging (5) – cardboard packs.
14 pcs. – contour cell packaging (10) – cardboard packs.
20 pcs. – contour cell packaging (1) – cardboard packs.
20 pcs. – contour cell packaging (2) – cardboard packs.
20 pcs. – contour cell packaging (3) – cardboard packs.
20 pcs. – contour cell packaging (4) – cardboard packs.
20 pcs. – contour cell packaging (5) – cardboard packs.
20 pcs. – contour cell packaging (10) – cardboard packs.
25 pcs. – contour cell packaging (1) – cardboard packs.
25 pcs. – contour cell packaging (2) – cardboard packs.
25 pcs. – contour cell packaging (3) – cardboard packs.
25 pcs. – contour cell packaging (4) – cardboard packs.
25 pcs. – contour cell packaging (5) – cardboard packs.
25 pcs. – contour cell packaging (10) – cardboard packs.
30 pcs. – contour cell packaging (1) – cardboard packs.
30 pcs. – contour cell packaging (2) – cardboard packs.
30 pcs. – contour cell packaging (3) – cardboard packs.
30 pcs. – contour cell packaging (4) – cardboard packs.
30 pcs. – contour cell packaging (5) – cardboard packs.
30 pcs. – contour cell packaging (10) – cardboard packs.
Film-coated tablets white or almost white, round, biconvex, with a characteristic odor.
| 1 tab. | |
| Tolperisone hydrochloride | 150 mg |
Excipients: microcrystalline cellulose – 70 mg, lactose monohydrate (milk sugar) – 43.5 mg, croscarmellose sodium – 12 mg, hypromellose – 3 mg, citric acid monohydrate – 4.5 mg, magnesium stearate – 2 mg.
Film coating composition: hypromellose – 4.8 mg, macrogol 4000 – 1.2 mg, titanium dioxide – 2 mg.
7 pcs. – contour cell packaging (1) – cardboard packs.
7 pcs. – contour cell packaging (2) – cardboard packs.
7 pcs. – contour cell packaging (3) – cardboard packs.
7 pcs. – contour cell packaging (4) – cardboard packs.
7 pcs. – contour cell packaging (5) – cardboard packs.
7 pcs. – contour cell packaging (10) – cardboard packs.
10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.
10 pcs. – contour cell packaging (3) – cardboard packs.
10 pcs. – contour cell packaging (4) – cardboard packs.
10 pcs. – contour cell packaging (5) – cardboard packs.
10 pcs. – contour cell packaging (10) – cardboard packs.
14 pcs. – contour cell packaging (1) – cardboard packs.
14 pcs. – contour cell packaging (2) – cardboard packs.
14 pcs. – contour cell packaging (3) – cardboard packs.
14 pcs. – contour cell packaging (4) – cardboard packs.
14 pcs. – contour cell packaging (5) – cardboard packs.
14 pcs. – contour cell packaging (10) – cardboard packs.
20 pcs. – contour cell packaging (1) – cardboard packs.
20 pcs. – contour cell packaging (2) – cardboard packs.
20 pcs. – contour cell packaging (3) – cardboard packs.
20 pcs. – contour cell packaging (4) – cardboard packs.
20 pcs. – contour cell packaging (5) – cardboard packs.
20 pcs. – contour cell packaging (10) – cardboard packs.
25 pcs. – contour cell packaging (1) – cardboard packs.
25 pcs. – contour cell packaging (2) – cardboard packs.
25 pcs. – contour cell packaging (3) – cardboard packs.
25 pcs. – contour cell packaging (4) – cardboard packs.
25 pcs. – contour cell packaging (5) – cardboard packs.
25 pcs. – contour cell packaging (10) – cardboard packs.
30 pcs. – contour cell packaging (1) – cardboard packs.
30 pcs. – contour cell packaging (2) – cardboard packs.
30 pcs. – contour cell packaging (3) – cardboard packs.
30 pcs. – contour cell packaging (4) – cardboard packs.
30 pcs. – contour cell packaging (5) – cardboard packs.
30 pcs. – contour cell packaging (10) – cardboard packs.
Film-coated tablets, 50 mg: 30 pcs.
Film-coated tablets, 150 mg: 30 pcs.
Marketing Authorization Holder
Severnaya Zvezda NAO (Russia)
Dosage Forms
|
Tolperisone-SZ | Film-coated tablets, 50 mg: 30 pcs. |
| Film-coated tablets, 150 mg: 30 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets white or almost white, round, biconvex; on the cross-section, the tablet core is white or almost white.
| 1 tab. | |
| Tolperisone (as hydrochloride) | 50 mg |
Excipients: lactose monohydrate (milk sugar), microcrystalline cellulose 102, corn starch, kollidon 30 (medium molecular weight polyvinylpyrrolidone), citric acid, magnesium stearate, talc.
Coating composition: hypromellose, polysorbate-80 (tween-80), talc, titanium dioxide (E171).
10 pcs. – contour cell packaging (3) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
30 pcs. – polymer bottles (1) – cardboard packs.
Film-coated tablets white or almost white, round, biconvex; on the cross-section, the tablet core is white or almost white.
| 1 tab. | |
| Tolperisone (as hydrochloride) | 150 mg |
Excipients: lactose monohydrate (milk sugar), microcrystalline cellulose 102, corn starch, kollidon 30 (medium molecular weight polyvinylpyrrolidone), citric acid, magnesium stearate, talc.
Film coating composition: hypromellose, polysorbate-80 (tween-80), talc, titanium dioxide (E171).
10 pcs. – contour cell packaging (3) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
30 pcs. – polymer bottles (1) – cardboard packs.
Film-coated tablets, 50 mg: 5, 7, 10, 14, 15, 20, 21, 28, 30, 40, 42, 45, 56, 60, 80, 90, or 120 pcs.
Film-coated tablets, 150 mg: 5, 7, 10, 14, 15, 20, 21, 28, 30, 40, 42, 45, 56, 60, 80, 90, or 120 pcs.
Marketing Authorization Holder
Aliym, JSC (Russia)
Dosage Forms
|
Tolperisone-OBL | Film-coated tablets, 50 mg: 5, 7, 10, 14, 15, 20, 21, 28, 30, 40, 42, 45, 56, 60, 80, 90, or 120 pcs. |
| Film-coated tablets, 150 mg: 5, 7, 10, 14, 15, 20, 21, 28, 30, 40, 42, 45, 56, 60, 80, 90, or 120 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets white or almost white, biconvex, oblong in shape with rounded ends, with a score line.
| 1 tab. | |
| Tolperisone hydrochloride | 50 mg |
Excipients: citric acid monohydrate, lactose monohydrate, hyprolose (hydroxypropylcellulose), crospovidone, stearic acid, calcium stearate.
Film coating composition: hypromellose (hydroxypropyl methylcellulose), titanium dioxide, macrogol 6000 (polyethylene glycol 6000).
5 pcs. – contour cell packaging (1) – cardboard packs.
5 pcs. – contour cell packaging (2) – cardboard packs.
5 pcs. – contour cell packaging (3) – cardboard packs.
5 pcs. – contour cell packaging (4) – cardboard packs.
7 pcs. – contour cell packaging (1) – cardboard packs.
7 pcs. – contour cell packaging (2) – cardboard packs.
7 pcs. – contour cell packaging (3) – cardboard packs.
7 pcs. – contour cell packaging (4) – cardboard packs.
10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.
10 pcs. – contour cell packaging (3) – cardboard packs.
10 pcs. – contour cell packaging (4) – cardboard packs.
14 pcs. – contour cell packaging (1) – cardboard packs.
14 pcs. – contour cell packaging (2) – cardboard packs.
14 pcs. – contour cell packaging (3) – cardboard packs.
14 pcs. – contour cell packaging (4) – cardboard packs.
20 pcs. – contour cell packaging (1) – cardboard packs.
20 pcs. – contour cell packaging (2) – cardboard packs.
20 pcs. – contour cell packaging (3) – cardboard packs.
20 pcs. – contour cell packaging (4) – cardboard packs.
30 pcs. – contour cell packaging (1) – cardboard packs.
30 pcs. – contour cell packaging (2) – cardboard packs.
30 pcs. – contour cell packaging (3) – cardboard packs.
30 pcs. – contour cell packaging (4) – cardboard packs.
Film-coated tablets white or almost white, biconvex, oblong in shape with rounded ends, with a score.
| 1 tab. | |
| Tolperisone hydrochloride | 150 mg |
Excipients: citric acid monohydrate, lactose monohydrate, hypromellose (hydroxypropylcellulose), crospovidone, stearic acid, calcium stearate.
Film coating composition: hypromellose (hydroxypropyl methylcellulose), titanium dioxide, macrogol 6000 (polyethylene glycol 6000).
5 pcs. – contour cell packaging (1) – cardboard packs.
5 pcs. – contour cell packaging (2) – cardboard packs.
5 pcs. – contour cell packaging (3) – cardboard packs.
5 pcs. – contour cell packaging (4) – cardboard packs.
7 pcs. – contour cell packaging (1) – cardboard packs.
7 pcs. – contour cell packaging (2) – cardboard packs.
7 pcs. – contour cell packaging (3) – cardboard packs.
7 pcs. – contour cell packaging (4) – cardboard packs.
10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.
10 pcs. – contour cell packaging (3) – cardboard packs.
10 pcs. – contour cell packaging (4) – cardboard packs.
14 pcs. – contour cell packaging (1) – cardboard packs.
14 pcs. – contour cell packaging (2) – cardboard packs.
14 pcs. – contour cell packaging (3) – cardboard packs.
14 pcs. – contour cell packaging (4) – cardboard packs.
20 pcs. – contour cell packaging (1) – cardboard packs.
20 pcs. – contour cell packaging (2) – cardboard packs.
20 pcs. – contour cell packaging (3) – cardboard packs.
20 pcs. – contour cell packaging (4) – cardboard packs.
30 pcs. – contour cell packaging (1) – cardboard packs.
30 pcs. – contour cell packaging (2) – cardboard packs.
30 pcs. – contour cell packaging (3) – cardboard packs.
30 pcs. – contour cell packaging (4) – cardboard packs.
Film-coated tablets, 50 mg: 30 or 45 pcs.
Film-coated tablets, 150 mg: 30 or 45 pcs.
Marketing Authorization Holder
Akrikhin Chemical and Pharmaceutical Plant, JSC (Russia)
Dosage Forms
|
Tolperisone-Akrikhin | Film-coated tablets, 50 mg: 30 or 45 pcs. |
| Film-coated tablets, 150 mg: 30 or 45 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets white, round, biconvex, with a faint characteristic odor; on the cross-section, the tablet core is from white to white with a grayish or yellowish tint.
| 1 tab. | |
| Tolperisone hydrochloride | 50 mg |
Excipients: citric acid monohydrate, colloidal silicon dioxide, stearic acid, talc, microcrystalline cellulose (type 101), corn starch, lactose monohydrate, ready-made mixture “Vivacoat” white [colloidal silicon dioxide, titanium dioxide, lactose monohydrate, macrogol 6000, hypromellose].
10 pcs. – contour cell packaging (3) – cardboard packs.
15 pcs. – contour cell packaging (3) – cardboard packs.
Film-coated tablets white, round, biconvex, with a faint characteristic odor; on the cross-section, the tablet core is from white to white with a grayish or yellowish tint.
| 1 tab. | |
| Tolperisone hydrochloride | 150 mg |
Excipients: citric acid monohydrate, colloidal silicon dioxide, stearic acid, talc, microcrystalline cellulose (type 101), corn starch, lactose monohydrate, ready-made mixture “Vivacoat” white [colloidal silicon dioxide, titanium dioxide, lactose monohydrate, macrogol 6000, hypromellose].
10 pcs. – contour cell packaging (3) – cardboard packs.
15 pcs. – contour cell packaging (3) – cardboard packs.
Film-coated tablets, 50 mg: 20, 30, 40, 50, 60, 90, or 100 pcs.
Film-coated tablets, 150 mg: 20, 30, 40, 50, 60, 90, or 100 pcs.
Marketing Authorization Holder
Organika, JSC (Russia)
Dosage Forms
|
Tolperisone Organika | Film-coated tablets, 50 mg: 20, 30, 40, 50, 60, 90, or 100 pcs. |
| Film-coated tablets, 150 mg: 20, 30, 40, 50, 60, 90, or 100 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets white or almost white, round, biconvex; on the cross-section, the core is almost white.
| 1 tab. | |
| Tolperisone hydrochloride | 50 mg |
Excipients: lactose monohydrate – 48.5 mg, corn starch – 28.96 mg, microcrystalline cellulose type 101 – 14 mg, citric acid monohydrate – 0.73 mg, talc – 4.5 mg, stearic acid – 1.31 mg, colloidal silicon dioxide (aerosil) – 0.8 mg, hypromellose (hydroxypropyl methylcellulose) 2910 type 606 – 1.2 mg.
Coating composition Opadry II white (series 30F28359) — 5 mg or another film-forming system with the specified composition: (hypromellose (hydroxypropyl methylcellulose) 2910 — 2 mg, titanium dioxide — 1.25 mg, polyethylene glycol (macrogol) — 0.8 mg, lactose monohydrate — 0.65 mg, triacetin — 0.3 mg).
10 pcs. – contour cell packaging (2) – cardboard packs.
10 pcs. – contour cell packaging (3) – cardboard packs.
10 pcs. – contour cell packaging (4) – cardboard packs.
10 pcs. – contour cell packaging (5) – cardboard packs.
10 pcs. – contour cell packaging (6) – cardboard packs.
10 pcs. – contour cell packaging (9) – cardboard packs.
10 pcs. – contour cell packaging (10) – cardboard packs.
Film-coated tablets white or almost white, round, biconvex; on the cross-section, the core is almost white.
| 1 tab. | |
| Tolperisone hydrochloride | 150 mg |
Excipients: lactose monohydrate – 145.5 mg, corn starch – 86.88 mg, microcrystalline cellulose type 101 – 42 mg, citric acid monohydrate – 2.19 mg, talc – 13.5 mg, stearic acid – 3.93 mg, colloidal silicon dioxide (aerosil) – 2.4 mg, hypromellose (hydroxypropyl methylcellulose) 2910 type 606 – 3.6 mg.
Coating composition Opadry II white (series 30F28359) — 10 mg or another film-forming system with the specified composition: (hypromellose (hydroxypropyl methylcellulose) 2910 — 4 mg, titanium dioxide — 2.5 mg, polyethylene glycol (macrogol) — 1.6 mg, lactose monohydrate — 1.3 mg, triacetin — 0.6 mg).
10 pcs. – contour cell packaging (2) – cardboard packs.
10 pcs. – contour cell packaging (3) – cardboard packs.
10 pcs. – contour cell packaging (4) – cardboard packs.
10 pcs. – contour cell packaging (5) – cardboard packs.
10 pcs. – contour cell packaging (6) – cardboard packs.
10 pcs. – contour cell packaging (9) – cardboard packs.
10 pcs. – contour cell packaging (10) – cardboard packs.
Film-coated tablets, 50 mg: from 7 to 140 pcs.
Film-coated tablets, 150 mg: from 7 to 140 pcs.
Marketing Authorization Holder
Medisorb, JSC (Russia)
Dosage Forms
|
Tolperisone Medisorb | Film-coated tablets, 50 mg: from 7 to 140 pcs. |
| Film-coated tablets, 150 mg: from 7 to 140 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets white, round, biconvex; on the cross-section, the core is white.
| 1 tab. | |
| Tolperisone hydrochloride | 50 mg |
Excipients: citric acid monohydrate, lactose monohydrate, potato starch, microcrystalline cellulose (type 102), colloidal silicon dioxide (aerosil), magnesium stearate.
Coating composition polyvinyl alcohol, titanium dioxide, macrogol (PEG), talc.
From 7 to 14 pcs. – contour cell packaging (from 1 to 10 pcs.) – cardboard packs.
Film-coated tablets white, round, biconvex; on the cross-section, the core is white.
| 1 tab. | |
| Tolperisone hydrochloride | 150 mg |
Excipients: citric acid monohydrate, lactose monohydrate, potato starch, microcrystalline cellulose (type 102), colloidal silicon dioxide (aerosil), magnesium stearate.
Coating composition polyvinyl alcohol, titanium dioxide, macrogol (PEG), talc.
From 7 to 14 pcs. – contour cell packaging (from 1 to 10 pcs.) – cardboard packs.
Film-coated tablets, 50 mg: 30 or 60 pcs.
Film-coated tablets, 150 mg: 30 or 60 pcs.
Marketing Authorization Holder
Canonpharma Production, CJS (Russia)
Dosage Forms
|
Tolperisone Canon | Film-coated tablets, 50 mg: 30 or 60 pcs. |
| Film-coated tablets, 150 mg: 30 or 60 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets white or almost white, round, biconvex; on the cross-section – white or almost white.
| 1 tab. | |
| Tolperisone hydrochloride | 50 mg |
Excipients: corn starch – 29.77 mg, colloidal silicon dioxide – 1 mg, lactose monohydrate – 48.5 mg, citric acid – 0.87 mg, stearic acid – 2 mg, talc – 1.8 mg, microcrystalline cellulose – 46.06 mg.
Film coating composition Opadry 20A28380 white – 6 mg, incl.: hypromellose (hydroxypropylcellulose) – 2.025 mg; hypromellose (hydroxypropyl methylcellulose) – 2.025 mg; talc – 1.2 mg; titanium dioxide – 0.75 mg.
10 pcs. – contour cell packaging (3) – cardboard packs.
10 pcs. – contour cell packaging (6) – cardboard packs.
30 pcs. – contour cell packaging – cardboard packs.
30 pcs. – contour cell packaging (2) – cardboard packs.
30 pcs. – jars – cardboard packs.
60 pcs. – jars – cardboard packs.
Film-coated tablets white or almost white, round, biconvex; on the cross-section – white or almost white.
| 1 tab. | |
| Tolperisone hydrochloride | 150 mg |
Excipients: corn starch – 89.31 mg, colloidal silicon dioxide – 3 mg, lactose monohydrate – 145.5 mg, citric acid – 2.61 mg, stearic acid – 6 mg, talc – 5.4 mg, microcrystalline cellulose – 138.18 mg.
Film coating composition Opadry 20A28380 white – 18 mg, incl.: hypromellose (hydroxypropylcellulose) – 6.075 mg; hypromellose (hydroxypropyl methylcellulose) 6.075 mg; talc – 3.6 mg; titanium dioxide – 2.25 mg.
10 pcs. – contour cell packaging (3) – cardboard packs.
10 pcs. – contour cell packaging (6) – cardboard packs.
30 pcs. – jars – cardboard packs.
60 pcs. – jars – cardboard packs.
![Tolperisone [Tablets] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Tolperisone [Tablets] 2")