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

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2022  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 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 may contribute to its analgesic effect are inhibition of neuronal reuptake of noradrenaline and enhancement of serotonin release. Tramadol has an antitussive effect. In contrast to morphine, analgesic doses of tramadol over a wide range have no respiratory depressant effect.

Tramadol and Dexketoprofen

Tramadol hydrochloride is a centrally acting synthetic opioid analgesic. It is a non-selective, partial agonist of μ-, δ- and κ-opioid receptors with a higher affinity for μ-receptors. Tramadol has an antitussive action. In contrast to morphine, analgesic doses of tramadol over a wide range have no respiratory depressant effect. Dexketoprofen is an analgesic, anti-inflammatory and antipyretic drug, which belongs to the non-steroidal anti-inflammatory group of drugs. The mechanism of action of non-steroidal antiinflammatory drugs is related to the reduction of prostaglandin synthesis by the inhibition of cyclooxygenase pathway.

List of Excipients

Tablet Core:

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

Film-coating:

Opadry II white 85F18422 composed of:

Polyvinyl alcohol
itanium 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, Croatia, Ireland, Lithuania, Malta, Poland, Romania, Singapore, United Kingdom, South Africa

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.