Treatment of moderate to severe pain.
Prolonged-release tablet. Round, biconvex, film-coated tablets, marked with the manufacturer's logo on one side 100 mg tablet: white coloured, marked T1 on the other side
Nobligan retard 100 mg prolonged-release tablets 1 prolonged-release tablet contains 100 mg tramadol hydrochloride. Excipient: Each prolonged-release tablet contains 2.5 mg lactose monohydrate (See Special Precaution
17 August 2009
The dose should be adjusted to the intensity of the pain and the sensitivity of the individual patient. Unless otherwise prescribed, Nobligan retard 100 mg should be administered as follows: Adults and adolescents above the age of 12 years: 1 or 2 Nobligan retard 100 mg prolonged release tablets are to be taken twice daily, preferably morning and evening.
The tablets are to be taken whole, not divided or chewed, with sufficient liquid, independent of meals. The lowest analgesically effective dose should generally be selected. Daily doses of 400 mg active substance should not be exceeded, except in special clinical circumstances. Nobligan retard 100 mg should under no circumstances be administered for longer than absolutely necessary.
If long-term pain treatment with Nobligan retard is necessary in view of the nature and severity of the illness, then careful and regular monitoring should be carried out (if necessary with breaks in treatment) to establish whether and to what extent further treatment is necessary.
Renal Insufficiency/Dialysis and Hepatic Insufficiency In patients with severe renal and/or hepatic insufficiency Nobligan retard is not recommended. In moderate cases prolongation of the dosage interval should be carefully considered.
Nobligan retard 100 mg is not suitable for children below the age of 12 years.
A dose adjustment is not usually necessary in elderly patients (up to 75 years) without clinically manifest hepatic or renal insufficiency. In elderly patients (over 75 years) elimination may be prolonged. Therefore, if necessary the dosage interval is to be extended according to the patient's requirements.
Nobligan retard may only be used with particular caution in opioid-dependent patients, patients with head injury, shock, a reduced level of consciousness of uncertain origin, disorders of the respiratory centre or function, increased intracranial pressure. In patients sensitive to opiates the product should only be used with caution.
Convulsions have been reported in patients receiving tramadol at the recommended dose levels. The risk may be increased when doses of tramadol exceed the recommended upper daily dose limit (400 mg). In addition, tramadol may increase the seizure risk in patients taking other medicinal products that lowers the seizure threshold (See Interactions).
Patients with epilepsy or those susceptible to seizures should be only treated with tramadol if there are compelling circumstances. Tramadol has a low dependence potential. On long-term use tolerance, psychic and physical dependence may develop. In patients with a tendency to drug abuse or dependence, treatment with Nobligan retard should only be carried out for short periods under strict medical supervision. Tramadol is not suitable as a substitute in opioid-dependent patients.
Although it is an opioid agonist, tramadol cannot suppress morphine withdrawal symptoms. This medicinal product contains lactose Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
The most commonly reported adverse reactions are nausea and dizziness, both occurring in more than 10 % of patients. Cardiovascular disorders: uncommon (=1/1000, <1/100): cardiovascular regulation (palpitation, tachycardia, postural hypotension or cardiovascular collapse). These adverse reactions may occur especially on intravenous administration and in patients who are physically stressed. rare (=1/10000, <1/1000):bradycardia, increase in blood pressure Nervous system disorders: very common (=1/10): dizziness common (=1/100, <1/10): headache, somnolence rare (=1/10000, <1/1000): changes in appetite, paraesthesia, tremor, respiratory depression, epileptiform convulsions, involuntary muscle contractions, abnormal coordination, syncope. If the recommended doses are considerably exceeded and other centrally depressant substances are administered concomitantly (See Interactions), respiratory depression may occur.
Epileptiform convulsions occurred mainly after administration of high doses of tramadol or after concomitant treatment with medicinal products which can lower the seizure threshold (See Special Precautions and Interactions). Psychiatric disorders: rare (=1/10000, <1/1000): hallucinations, confusion, sleep disturbance, anxiety and nightmares. Psychic adverse reactions may occur following administration of Nobligan retard which vary individually in intensity and nature (depending on personality and duration of treatment). These include changes in mood (usually elation, occasionally dysphoria), changes in activity (usually suppression, occasionally increase) and changes in cognitive and sensorial capacity (e.g. decision behaviour, perception disorders). Dependence may occur. Eye disorders: rare (=1/10000, <1/1000): blurred vision Respiratory disorders: rare (=1/10000, <1/1000): dyspnoea Worsening of asthma has been reported, though a causal relationship has not been established. Gastrointestinal disorders: very common (=1/10): nausea common (=1/100, <1/10): vomiting, constipation, dry mouth uncommon (=1/1000, <1/100): retching; gastrointestinal irritation (a feeling of pressure in the stomach, bloating), diarrhoea Skin and subcutaneous disorders: common (=1/100, <1/10): sweating uncommon (=1/1000, <1/100): dermal reactions (e.g. pruritus, rash, urticaria) Musculoskeletal disorders: rare (=1/10000, <1/1000): motorial weakness Hepatobiliary disorders: In a few isolated cases an increase in liver enzyme values has been reported in a temporal connection with the therapeutic use of tramadol. Renal and urinary disorders: rare (=1/10000, <1/1000): micturition disorders (difficulty in passing urine, dysuria and urinary retention) General disorders: common (1-10%): fatigue rare (=1/10000, <1/1000): Allergic reactions (e.g. dyspnoea, bronchospasm, wheezing, angioneurotic oedema) and anaphylaxis; Symptoms of withdrawal reactions, similar to those occurring during opiate withdrawal, may occur as follows: agitation, anxiety, nervousness, insomnia, hyperkinesia, tremor and gastrointestinal symptoms. Other symptoms that have very rarely been seen with tramadol discontinuation include: panic attacks, severe anxiety, hallucinations, paraesthesias, tinnitus and unusual CNS symptoms.
Nobligan retard is contraindicated - in hypersensitivity to tramadol or any of the excipients, - in acute intoxication with alcohol, hypnotics, analgesics, opioids, or psychotropic medicinal products, - in patients who are receiving MAO inhibitors or who have taken them within the last 14 days (See Interactions), - in patients with epilepsy not adequately controlled by treatment, - for use in narcotic withdrawal treatment.