LONDON, February 16 /PRNewswire/ -- From 1st January Grünenthal further builds its pain management portfolio with Tramacet(R) (paracetamol 325mg/tramadol 37.5mg). Tramacet joins Zydol (tramadol) and Versatis (lidocaine 5% medicated plaster) in Grünenthal UK's pain portfolio. Tramacet was launched in the UK in 2004. Grünenthal UK will promote Tramacet from January 2009, initially in partnership with Janssen-Cilag Ltd. who are the current Marketing Authorisation Holders. The product licence and Marketing Authorisation is scheduled to transfer to Grünenthal in mid 2009. Until this time, Janssen-Cilag Ltd. will continue to be responsible for all legal and regulatory aspects and continue a full medical information and pharmacovigilance service.

Tramacet is a combination of tramadol hydrochloride 37.5mg and paracetamol 325mg, licensed for chronic, moderate to severe pain(1) and used most commonly for patients with musculo-skeletal, trauma or post-surgical pain. Tramacet provides effective, fast-acting and lasting pain relief(2) without the complications associated with the use of codeine-containing paracetamol combinations(3,4) or high doses of single component milder opiates(5).

The easy-to-use combination of Tramacet is as effective as codeine and paracetamol but causes significantly less somnolence (11% versus 21%, p0.01) and constipation (17% versus 24%, p = 0.05) (3,4). For patients requiring an opiate, Tramacet has equivalent efficacy to tramadol 50mg but with fewer side-effects(5).

Dr Roger Knaggs, Special Pharmacist in Anaesthesia Pain Management, Nottingham comments: We still have limited options in managing moderate to severe pain and it is important for patients and their healthcare team to be aware of all options and their benefits. Although our primary goal may be to provide rapid pain relief, we should aim to avoid patients experiencing distressing side-effects too. Tramacet may be particularly beneficial in managing the elderly where not only minimising side-effects is a critical concern, but also the issue of reducing the 'pill burden'.

Dr Mark Ritchie, GP with a special interest in pain based in Swansea says: In prescribing for pain management we are too often driven by habit. We need to further our understanding of the benefits of combination analgesics. Whereas some Medicines Management groups may be questioning the direct costs of combination analgesics compared with generic treatments, we need to consider the broader benefits for patients as part of our new patient-centred NHS. If, with combination analgesics, patients can better comply with their treatment strategy; if they can experience fewer side-effects and gain the effective pain relief they are seeking, then ongoing consultation and care costs will be minimised and patients will benefit from improved quality of life. Total health economics including direct drug costs, hospitalisations and quality of life indicators should guide our prescribing.

Within Grünenthal's expanding portfolio, the company announced in November last year the U.S. Food and Drug Administration's (FDA) approval of tapentadol immediate-release tablets for the relief of moderate to severe acute pain. Tapentadol is an oral centrally acting analgesic and will be the first new substance in its class for more than 25 years after successful registration. In the European Union, tapentadol is currently in phase III of the development programme for severe acute and chronic pain. Grünenthal plans the submission in Europe in the second quarter 2009.

About Grünenthal

Grünenthal is an expert in pain therapy and gynaecology and a pioneer in intelligent, user-friendly drug delivery technologies. The company discovers, develops, produces and markets high therapeutic value pharmaceuticals that contribute to patients' ability to control their own lives. Grünenthal is an independent, family-owned German company with companies in 32 countries all over the world. Founded in 1946, the company employs 1,900 people in Germany and 5,300 worldwide. In 2007, Grünenthal achieved revenues of 846 million Euros. More information:

References: 1. Tramacet(R) Summary of Prescribing Characteristics 2. Schnitzer T, European Journal of Anaesthesiology 2003; 20 (Suppl 28):13-18 3. Schug S. Clin Rheumatol 2006; 25 (Suppl 1): S. 16-S. 21 4. William S Mullican MD, and Joseph R Lacy, MD., Clinical Therapeutics Vol. 23; NO. 9, 2001 5. Perrot et al. Clin Ther 2006; 28(10): 1592-606

Tramacet Prescribing Information

ACTIVE INGREDIENT(S): Tramadol hydrochloride and paracetamol.

Please refer to Summary of Product Characteristics (SmPC) before prescribing.

INDICATION(S): For symptomatic treatment of moderate to severe pain; in patients whose moderate to severe pain is considered to require a combination of tramadol and paracetamol. DOSAGE ADMINISTRATION: Adults and Adolescents (12 years or older). Initial dose; two tablets, additional doses as needed, dosing interval not less than 6 hours; not exceeding 8 tablets per day. Assess whether continuation of treatment is necessary during long-term treatment. Children: Not recommended. Elderly: Minimum of 6 hour interval between doses in patients over 75 years old. Renal impairment: Not recommended in severe renal insufficiency (creatinine clearance 10 ml/min). In moderate renal insufficiency (creatinine clearance between 10 and 30 ml/min), the dosing should be increased to 12-hourly intervals. Hepatic impairment: Not recommended in severe hepatic impairment, in moderate cases prolongation of the dosing interval should be considered. CONTRAINDICATIONS: Hypersensitivity to tramadol, paracetamol or any of the excipients. Acute intoxication with alcohol, hypnotic drugs, centrally acting analgesics, opioids, or psychotropic drugs. Current treatment (or cessation of treatment within the last 2 weeks), with monoamine oxidase inhibitors (MAOIs). Severe hepatic impairment. Epilepsy not controlled by treatment. SPECIAL WARNINGS PRECAUTIONS: Care with withdrawal; has potential to cause withdrawal symptoms (see side effects). Rarely, cases of dependence and abuse have been reported. Should not be used in severe hepatic impairment; paracetamol overdosage may cause hepatic toxicity. Not recommended in severe renal insufficiency. Concomitant use of opioid agonists-antagonists is not recommended. Use with caution in patients who are opioid dependent, have cranial trauma, are prone to convulsive disorders, prone to seizures with or without treatment, have biliary tract disorders, are in a state of shock, altered states of consciousness, have problems affecting respiratory function or with an increased intracranial pressure.

SIDE EFFECTS: Very common: dizziness, somnolence, and nausea. Common: headache, trembling, confusion, mood changes, sleep disorders, vomiting, constipation, dry mouth, diarrhoea, abdominal pain, dyspepsia, flatulence, sweating, pruritus. Uncommon: hypertension, palpitations, tachycardia, arrhythmia, involuntary muscular contractions, paraesthesia, tinnitus, depression, hallucinations, nightmares, amnesia, dyspnoea, dysphagia, melaena, hepatic transaminases increase, dermal reactions, (e.g. rash, urticaria) albuminuria, micturition disorders, shivers hot flushes, thoracic pain. Rare: ataxia, convulsions, drug dependence, blurred vision. Very rare: abuse. Post marketing experience from tramadol alone: Postural hypotension, bradycardia, collapse. Rarely: alterations of warfarin effect, including elevation of prothrombin times, allergic reactions with respiratory symptoms and anaphylaxis, changes in appetite, motor weakness, and respiratory depression. Changes in mood, changes in activity, changes in cognitive and sensorial capacity. Worsening of asthma, causal relationship not established. Symptoms of withdrawal similar to those occurring during opiate withdrawal may occur as follows: agitation, anxiety, nervousness, insomnia, hyperkinesia, tremor and gastrointestinal symptoms. Other symptoms very rarely seen if tramadol hydrochloride is discontinued abruptly include: panic attacks, severe anxiety, hallucinations, paraesthesia, tinnitus and unusual CNS symptoms. Post marketing experience from paracetamol alone: rarely hypersensitivity including skin rash, blood dyscrasias, including thrombocytopenia and agranulocytosis. Refer to SmPC for other side effects. PREGNANCY: Should not be used. LACTATION: Should not be used. INTERACTIONS: Concomitant use not recommended with alcohol, carbamazepine and other enzyme inducers, and opioid agonists-antagonists. Consider concomitant use with: serotoninergic medicines such as selective serotonin re-uptake inhibitors (SSRIs) and triptans, other opioid derivatives (including antitussive drugs, substitutive treatments), benzodiazepines and barbiturates, anxiolytics, hypnotics, sedative antidepressants, neuroleptics, centrally-acting antihypertensive drugs and other central nervous system depressants. Concomitant use with medicinal products that reduce the seizure threshold (e.g. bupropion, SSIRs, tricyclic antidepressants and neuroleptics) can increase the risk of convulsions. Evaluate prothrombin time periodically if given with warfarin like compounds. May affect ability to drive or operate machinery. LEGAL CATEGORY: POM. PRESENTATIONS, PACK SIZES, PRODUCT LICENCE NUMBERS BASIC NHS COSTS [37.5 mg tramadol hydrochloride/325 mg paracetamol tablets] (PL 0242/0384), 60: GBP9.68. FURTHER INFORMATION IS AVAILABLE FROM THE MARKETING AUTHORISATION HOLDER: Janssen-Cilag Ltd, Saunderton, High Wycombe, Buckinghamshire HP14 4HJ UK.

(c)Janssen-Cilag Ltd 2009

Prescribing information last revised: 20090126


Information about adverse event reporting can be found at Adverse events should also be reported to Janssen-Cilag Ltd.

For further information, please contact: Janis Troup/Debra Lord at Right Angle Communications: Tel: +44-20-3142-6491/6490 or or Grünenthal medical information department: Tel: +44-870-351-8960 (follow options).