Skudexa® 75 mg/25 mg film-coated tablets (tramadol hydrochloride/dexketoprofen). Abbreviated Prescribing Information
Please consult the Summary of Product Characteristics (SmPC) for full prescribing information.
Presentation: Film-coated tablets containing tramadol hydrochloride 75 mg and dexketoprofen 25 mg. Excipients with known effects: croscarmellose sodium and sodium stearyl fumarate.
Use: Symptomatic short term treatment of moderate to severe acute pain in adult patients whose pain is considered to require a combination of tramadol and dexketoprofen.
Dosage: Adults: 1 tablet (75 mg tramadol hydrochloride/ 25 mg dexketoprofen), additional doses as needed with a minimum dosing interval of 8 hours. Maximum daily dose 3 tablets/day. Use lowest effective dose for the shortest duration necessary to control symptoms. Maximum duration of use is 5 days. Patients with mild-moderate hepatic impairment or mild renal impairment: maximum daily dose is 2 tablets/day. Elderly: 1 tablet, additional doses can be taken as needed with the minimum dose interval of 8 hours and not exceeding the total daily dose of 2 tablets/day which can be increased to a maximum of 3 tablets/day after good tolerance established. Use with caution in patients over 75 years. Before initiating treatment a treatment strategy should be agreed together with the patient, in accordance with pain management guidelines. Maintain frequent contact with the patient during treatment to evaluate the need for continued treatment, consider discontinuation and to adjust dosages if needed. Taper the dose gradually upon discontinuation of treatment to prevent withdrawal symptoms. In absence of adequate pain control, the possibility of hyperalgesia, tolerance and progression of underlying disease should be considered.
Contra-indications: Hypersensitivity to any component or other NSAID or excipients. NSAID induced attacks of asthma, bronchospasm, acute rhinitis, or nasal polyps, urticaria or angioneurotic oedema. Known photoallergic or phototoxic reactions during treatment with ketoprofen or fibrates. History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy. Active peptic ulcer/gastrointestinal/haemorrhage or any history of gastrointestinal bleeding, ulceration or perforation, chronic dyspepsia, other active bleeding or bleeding disorders, Crohn’s disease or ulcerative colitis, severe heart failure, moderate-severe renal impairment, severe hepatic impairment, haemorrhagic diathesis and other coagulation disorders, severe dehydration. Acute intoxication with alcohol, hypnotics, analgesics, opioids or psychotropic medicinal products. Concomitantly with MAO inhibitors or within 14 days of having taken them. Inadequately controlled epilepsy. Severe respiratory depression. Pregnancy and lactation.
Warnings and precautions: Dexketoprofen: Caution in allergic conditions. Avoid use with concomitant other NSAIDs including COX-2 selective inhibitors. Gastrointestinal bleeding, ulceration or perforation which can be fatal, have been reported with all NSAIDs at anytime during treatment, with or without warning symptoms or a previous history of serious gastrointestinal events. When gastrointestinal bleeding or ulceration occurs withdraw treatment. The risk of gastrointestinal bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation, and in older people. Ensure cure of oesophagitis, gastritis and/or peptic ulcer before starting treatment. Consider combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors), and in patients requiring concomitant low dose aspirin, or other drugs likely to increase gastrointestinal risk. Monitor patients with a history of gastrointestinal toxicity, particularly when elderly, for unusual abdominal symptoms (especially gastrointestinal bleeding) particularly in the initial stages. Caution in patients receiving oral corticosteroids, anticoagulants, SSRIs or anti-platelet agents. Caution in patients with impairment of renal function, receiving diuretic therapy or those who could develop hypovolaemia. Ensure adequate fluid intake. Caution in liver impairment. Appropriate monitoring and advice required with history of hypertension and/or mild to moderate heart failure. Special caution in patients with cardiac disease, especially episodes of previous heart failure. Only treat patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease after careful consideration. Cases of Kounis syndrome have been reported, defined as cardiovascular symptoms secondary to an allergic or hypersensitive reaction associated with constriction of coronary arteries and potentially leading to myocardial infarction. Similarly for risk factors for cardiovascular disease (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking). Caution in haematopoietic disorders, systemic lupus erythematosus, connective tissue disorders, impairment of hepatic and/or renal functions, history of hypertension and/or heart failure, diuretic therapy, the elderly. Older people are more likely to be suffering from impaired renal, hepatic and cardiovascular function. Serious skin reactions (some of them fatal), including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis were reported very rarely. Dexketoprofen can mask symptoms of infection and has been observed in bacterial community acquired pneumonia and bacterial complications to varicella. Monitoring of infection is advised. It is advisable to avoid use of Skudexa in case of varicella. Particular caution is required in patients with congenital disorder of porphyrin metabolism, dehydration, directly after major surgery. Severe acute hypersensitivity reactions have been observed on very rare occasions. Discontinue treatment at the first signs of severe hypersensitivity reactions. Can cause asthma attacks or bronchospasm, particularly in subjects allergic to acetylsalicylic acid or NSAIDs. Do not use with warfarin, other coumarins or heparin. Tramadol: Use with particular caution in patients with an addiction, head injury, shock, reduced level of consciousness of uncertain origin, disorders of respiratory centre or function or increased intracranial pressure. Use with caution in patients sensitive to opiates. Care should be taken in treating patients with respiratory depression, with concomitant CNS depressant drug administration or significant excess of the recommended dose as resulting respiratory depression cannot be excluded. Convulsions have been reported with recommended doses of tramadol, this risk may increase when exceeding the recommended upper daily dose limit (400mg). Seizure risk increases in patients taking other seizure threshold lowering medications. Only treat patients susceptible to seizures with tramadol if circumstances are compelling. Tolerance, psychic and physical addiction may develop. For patients with abuse/dependence potential only treat for short periods under strict medical supervision. Consider tapering dose gradually when discontinuing treatment to prevent withdrawal symptoms. Tramadol in combination with other serotonergic agents or alone can cause serotonin syndrome. Opioids can cause sleep-related breathing disorders including central sleep apnoea (CSA) and sleep-related hypoxemia consider decreasing the total opioid dosage in patients with CSA. Opioid analgesics may occasionally cause reversible adrenal insufficiency requiring monitoring and glucocorticoid replacement therapy. CYP2D6 deficiency may reduce the analgesic effect, whereas ultra-rapid metabolisers of CYP2D6 incur risk of opioid toxicity even at commonly prescribed doses. Extreme caution and close monitoring for opioid toxicity required when administering tramadol to children for post-operative pain relief. Not recommended in children with compromised respiratory function. Skudexa: Not for use in children and adolescents. Concomitant use with sedative medicines such as benzodiazepines or related drugs should be reserved for patients with no alternative treatment options, using the lowest effective dose and an as short as possible treatment duration while following them closely for signs of respiratory depression and sedation. Tolerance, physical and psychological dependence, and opioid use disorder (OUD) may develop on higher doses. The risk of developing OUD is increased in patients with a personal or a family history of substance use disorders. Before initiating and during treatment, treatment goals and a discontinuation plan should be agreed with the patient. Inform the patient about the risks of OUD. Monitor patients for signs of drug-seeking behaviour.
Interactions: Dexketoprofen: Other NSAIDs, anti-coagulants, heparins, corticosteroids, lithium, methotrexate, hydantoines and sulphonamides, diuretics, ACE inhibitors, antibacterial aminoglycosides and angiotensin II receptor antagonists, pentoxyfilline, zidovudine, sulfonylureas, beta-blockers, cyclosporin and tacrolimus, thrombolytics, anti-platelet agents and SSRIs, probenecid, cardiac glycosides, mifepristone, quinolone antibiotics, tenofovir, deferasirox, pemetrexed. Tramadol: MAOIs, coumarin derivatives (e.g. warfarin), mixed agonists/antagonists opioid receptors (e.g. buprenorphine, nalbuphine, pentacozine), SSRIs, SNRIs, tricyclic antidepressants, antipsychotics and other seizure threshold-lowering medication (e.g. bupropion, mirtazapine, tetrahydrocannabinol), sedative medicines such as benzodiazepines, gabapetinoids, centrally depressant medications or alcohol, cimetidine, carbamazepine, ondansetron (5-HT3 antagonist) and substances inhibiting CYP3A4 (e.g. ketoconazole, erythromycin).
Pregnancy and lactation: Contra-indicated during pregnancy and lactation. Do not use in women attempting to conceive.
Side-effects: Skudexa: Common (≥ 1/100, <1/10): dizziness, somnolence, nausea, vomiting. Unommon (≥ 1/1000, <1/100): thrombocytosis, laryngeal oedema, hypokalaemia, psychotic disorder, amnesia, headache, periorbital oedema, vertigo, tachycardia, hypertensive crisis, hypotension, abdominal discomfort, abdominal distension, constipation, dyspepsia, raised LFTs, face oedema, hyperhidrosis,urticaria, haematuria, asthenia, chills, discomfort, feeling abnormal, malaise, BP increased, increased alk phos, increased LDH. For less frequent side effects and side effects associated with the individual constituents see SmPC.
Pack size: 15 tablets.
Legal category: POM
Marketing authorisation number: PA 865/20/1
Marketing authorisation holder: Menarini International Operations Luxembourg S.A., 1 Avenue de la Gare, L-1611 Luxembourg.
Marketed by: A.Menarini Pharmaceuticals Ireland Ltd Further information is available on request to A Menarini Pharmaceuticals Ireland Ltd, 2nd Floor, Castlecourt, Monkstown Farm, Monkstown, Co. Dublin Co. Dublin, Ireland A96 T924 or may be found in the SmPC.
Date of preparation: January 2026