METHOCARBAMOL NEURAXPHARM Film-coated tablet Ref.[7674] Active ingredients: Methocarbamol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Publisher: neuraxpharm Arzneimittel GmbH, Elisabeth-Selbert-Str.23, 40764, Langenfeld, Germany

Product name and form

Methocarbamol neuraxpharm 750 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

White, oblong film-coated tablets with a score line on one side, size: 19.1 ± 0.2 mm x 8.1 ± 0.2 mm.

The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Qualitative and quantitative composition

Each film-coated tablet contains 750 mg methocarbamol.

Excipients with known effect: Each film-coated tablet contains 22.37 mg lactose (as monohydrate) and 0.875 mg soya lecithin.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Methocarbamol

Methocarbamol is a centrally acting muscle relaxant. Its muscle relaxing action is the result of the inhibition of polysynaptic reflexes in the spinal marrow and subcortical centres.

List of Excipients

Tablet core:

Lactose monohydrate
Croscarmellose sodium
Sodium dodecyl sulfate
Povidone K 29/32
Silica, colloidal anhydrous
Magnesium stearate (Ph.Eur.)

Film-coating:

Polyvinyl alcohol
Titanium dioxide (E171)
Talc
Macrogol 3350
Soya lecithin

Pack sizes and marketing

PVC/ACLAR//Al blisters.

Pack sizes:

20, 50 or 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

neuraxpharm Arzneimittel GmbH, Elisabeth-Selbert-Str.23, 40764, Langenfeld, Germany

Marketing authorization dates and numbers

PL 48035/0023

Date of first authorisation: 11.09.2018

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