SKUDEXA

This brand name is authorized in Austria, Cyprus, Ecuador, Estonia, Finland, Hong Kong, Croatia, Ireland, Lithuania, Malta, Poland, Romania, Singapore, United Kingdom, South Africa

Active ingredients

The drug SKUDEXA contains a combination of these active pharmaceutical ingredients (APIs):

1 Tramadol
UNII 9N7R477WCK - TRAMADOL HYDROCHLORIDE

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.

Read about Tramadol
2 Dexketoprofen
UNII 6KD9E78X68 - 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.

Read about Dexketoprofen

Medication package inserts

Below package inserts are available for further reading:

Title Information Source Document Type  
SKUDEXA Film-coated tablet Medicines & Healthcare Products Regulatory Agency (GB) MPI, EU: SmPC

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC code Group title Classification
N02AJ14 Tramadol and dexketoprofen N Nervous system → N02 Analgesics → N02A Opioids → N02AJ Opioids in combination with non-opioid analgesics
Discover more medicines within N02AJ14

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country Identification scheme Identifier(s)
Country: EC Agencia Nacional de Regulación, Control y Vigilancia Sanitaria Identifier(s): 7461-MEE-0822
Country: EE Ravimiamet Identifier(s): 1674042, 1674064, 1674075, 1674086, 1674109, 1674110, 1674121, 1727063, 1732687, 1740192, 1740204, 1740215, 1740226, 1740237, 1740248, 1740259, 1740260
Country: FI Lääkealan turvallisuus- ja kehittämiskeskus Identifier(s): 093126
Country: GB Medicines & Healthcare Products Regulatory Agency Identifier(s): 350291, 350292
Country: HK Department of Health Drug Office Identifier(s): 65491
Country: IE Health Products Regulatory Authority Identifier(s): 69801, 69802
Country: LT Valstybinė vaistų kontrolės tarnyba Identifier(s): 1075389, 1080167, 1080168, 1080169, 1080170, 1080171, 1080172, 1080789, 1081165, 1085265, 1085266, 1085267, 1085268, 1085269, 1085270, 1085271, 1085272
Country: MT Medicines Authority Identifier(s): MA204/00701, MA204/00703
Country: PL Rejestru Produktów Leczniczych Identifier(s): 100336412, 100389101
Country: RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale Identifier(s): W63725001, W63725002, W63725003, W63725004, W63725005, W63725006, W63725007, W63725008, W63725009, W63725010, W63725011, W63725012, W63725013, W63725014, W63725015, W63725016, W63725017, W63725018, W63725019, W63725020, W63725021, W63725022, W63725023, W63725024, W63725025, W63725026, W63725027, W65395001, W65395002, W65395003, W65395004, W65395005, W65395006, W65395007, W65395008
Country: SG Health Sciences Authority Identifier(s): 15394P
Country: ZA Health Products Regulatory Authority Identifier(s): 54/2.8/0538

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