MYDOFLEX Film-coated tablet Ref.[11045] Active ingredients: Tolperisone

Source: Υπουργείο Υγείας (CY)  Revision Year: 2020  Publisher: M. K. Stavrinos ltd., 3 Irakleous Str., 1046 Nicosia, Cyprus Tel.: 22434490, Fax: 22434485, E-mail: mkstavco@cytanet.com.cy

Product name and form

Mydoflex tablets.

Pharmaceutical Form

Film-coated tablets.

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.

Active Ingredient Description
Tolperisone

As a skeletal muscle relaxant whose prototype is mephenesine, tolperisone induces ataxia and muscle weakness in animal models by acting on the central nervous system at the spinal level. In fact it inhibits polysynaptic and monosynaptic reflexes with little action on non-reflex muscle response and without potentiating the phenobarbital sleep.

List of Excipients

Tablet core:

Citric acid anhydrous
Povidone
Microcrystalline cellulose
Purified water
Colloidal silicone dioxide
Crospovidone
Magnesium stearate

Coating:

Polyvinyl alcohol-part. hydrolysed
Titanium dioxide
Polyethylene glycol
Talc

Pack sizes and marketing

Aluminium/blister.

Pack sizes: 30 tablets.

Marketing authorization holder

M. K. Stavrinos ltd., 3 Irakleous Str., 1046 Nicosia, Cyprus

Tel.: 22434490, Fax: 22434485, E-mail: mkstavco@cytanet.com.cy

Marketing authorization dates and numbers

16780

15 November 1996.

Drugs

Drug Countries
MYDOFLEX Cyprus

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