SKUDEXA Film-coated tablet Ref.[10705] Active ingredients: Dexketoprofen Tramadol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Menarini International Operations Luxembourg S.A., 1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg

Product name and form

Skudexa 75 mg/25 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

Skudexa: almost white to slightly yellow, oblong, film-coated tablets with a break-mark on one side and a debossed “M” on the other side. The dimension of the film-coated tablet is ca. 14 mm lengths and ca. 6 mm width.

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

Qualitative and quantitative composition

Each tablet contains: 75 mg of tramadol hydrochloride and 25 mg of dexketoprofen.

Excipients with known effects: each tablet contains 33.07 mg croscarmellose sodium and 1.83 mg sodium stearyl fumarate.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Dexketoprofen

Dexketoprofen belongs to the non-steroidal anti-inflammatory group of drugs. The mechanism of action of Dexketoprofen is related to the reduction of prostaglandin synthesis by the inhibition of cyclooxygenase pathway. Furthermore, the inhibition of the synthesis of prostaglandins could affect other inflammation mediators such as kinins, causing an indirect action which would be additional to the direct action.

Tramadol

Tramadol, a cyclohexanol derivative, is a centrally acting opioid analgesic. It is a non-selective pure agonist at μ, δ and κ opioid receptors with a higher affinity for the μ receptor. Other mechanisms which contribute to its analgesic effect are inhibition of neuronal reuptake of noradrenaline and enhancement of serotonin release.

List of Excipients

Tablet Core:

  • Microcrystalline cellulose
  • Maize Starch, pregelatinised
  • Croscarmellose sodium
  • Sodium stearyl fumarate
  • Silica colloidal, anhydrous

Film-coating:

  • Polyvinyl alcohol
  • Titanium dioxide
  • Macrogol/PEG 3350
  • Talc

Pack sizes and marketing

Film-coated tablets are provided in blister packs, in three alternative materials:

PA/Aluminium/PVC//Aluminium blister;

PVC/PE/PVDC//Aluminium blister;

PVC/PVDC//Aluminium blister

Skudexa: 2, 4, 10, 15, 20, 30, 50, 100 film-coated tablets/pack or multipacks containing 500 (5 packs of 100) film-coated tablets/pack.

Not all pack sizes may be marketed.

Marketing authorization holder

Menarini International Operations Luxembourg S.A., 1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg

Marketing authorization dates and numbers

PL 16239/0041

02/02/2016

Drugs

Drug Countries
SKUDEXA Austria, Cyprus, Ecuador, Estonia, Finland, Hong Kong, Ireland, Lithuania, Malta, Poland, Romania, Singapore, United Kingdom, South Africa

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