MYDOFLEX Film-coated tablet (2020)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Mydoflex tablets.
2. Qualitative and quantitative composition
The active substance of both products is tolperisone (INN) hydrochloride. Mydoflex tablets containing 150 mg tolperisone hydrochloride. For excipients, see §6.1.
3. Pharmaceutical form
Film-coated tablets.
4.1. Therapeutic indications
Symptomatic treatment of post-stroke spasticity in adults.
4.2. Posology and method of administration
The recommended dosage to initiate the treatment in adults is one tablet at 150 mg (Mydoflex) three times a day (i.e. a daily dose of 450 mg). In known difficult cases a dosage of four times a tablet at ...
4.3. Contraindications
Myasthenia gravis. Hypersensitivity to the active substance tolperisone or to the chemically similar eperisone or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Hypersensitivity reactions During post marketing experience with tolperisone the most frequently reported adverse reactions were hypersensitivity reactions. Hypersensitivity reactions ranged from mild ...
4.5. Interaction with other medicinal products and other forms of interaction
Pharmacokinetic drug interaction studies with the CYP2D6 substrate dextromethorphan indicate that tolperisone co-administration may increase the blood levels of drugs which are metabolised dominantly by ...
4.6. Pregnancy and lactation
For tolperisone no clinical data on exposed pregnancies are available. Thus – and although animal studies do not indicate direct or indirect harmful effects with respect to pregnancy and embryonal/fœtal ...
4.7. Effects on ability to drive and use machines
In a study in healthy subjects Mydoflex at doses of one tablet at 50 mg three times a day or 150 mg three times a day did not induce drowsiness and did not prolong reaction time, even after sensitisation ...
4.8. Undesirable effects
Less than 5% of patients can be expected to experience adverse reactions. In most cases they are of mild intensity and treatment can be continued, sometimes after reduction of the initial dose. Following ...
4.9. Overdose
Adynamia and coma were the symptoms in the reported cases of accidental ingestion and suicide attempts. Gastric lavage may be helpful to eliminate tablet remains. Vital signs must be monitored and, if ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> muscle relaxants, centrally acting agents <b>ATC code:</b> M03BX04 Mechanism of action As a skeletal muscle relaxant whose prototype is mephenesine, tolperisone induces ...
5.2. Pharmacokinetic properties
Tolperisone (INN).HCL (2,4' dimethyl-3-piperidino propiophenone hydrochloride) has a molecular mass of 281.8. The compound is water soluble. Pharmacokinetics of tolperisone after administration of Mydoflex. ...
5.3. Preclinical safety data
The LD<sub>50</sub> in mice and rats is about 1400 mg/kg tolperisone hydrochloride (200 times the daily initial dose in human). Death results from respiratory paralysis. The six month oral toxicity study ...
6.1. List of excipients
<u>Tablet core:</u> Citric acid anhydrous Povidone Microcrystalline cellulose Purified water Colloidal silicone dioxide Crospovidone Magnesium stearate <u>Coating:</u> Polyvinyl alcohol-part. hydrolysed ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
Shelf life of Mydoflex as packaged for sale is 2 years.
6.4. Special precautions for storage
Store Mydoflex in a dry place, in their original package (blister and carton) to protect them from moisture and light.
6.5. Nature and contents of container
Aluminium/blister. <u>Pack sizes:</u> 30 tablets.
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
M. K. Stavrinos ltd., 3 Irakleous Str., 1046 Nicosia, Cyprus Tel.: 22434490, Fax: 22434485, E-mail: mkstavco@cytanet.com.cy
8. Marketing authorization number(s)
16780
9. Date of first authorization / renewal of the authorization
15 November 1996.
10. Date of revision of the text
May 2020
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