TRAMULIEF SR

Posology The dose should be adjusted to the intensity of the pain and the sensitivity of the individual patient. The lowest effective dose for analgesia should generally be selected. Unless otherwise prescribed, Tramulief SR prolonged-release tablets should be given as follows: Adults and adolescents older than 12 years: The usual initial dose is 50 - 100mg tramadol hydrochloride twice daily, morning and evening.

If pain relief is insufficient, the dose may be titrated upwards to 150 mg or 200 mg tramadol hydrochloride twice daily. For doses not practicable with this strength, other strengths of this medicinal product are available. Tramulief SR prolonged-release tablets should be swallowed completely, without breaking or chewing, independent of meals, with sufficient liquid.

Daily doses of 400 mg of active substance should not be exceeded, except in special clinical circumstances. Under no circumstances should Tramulief SR be used for longer than absolutely necessary. If long-term pain treatment with tramadol 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.

Paediatric population Tramulief SR is not suitable for children under the age of 12 years Elderly A dose adjustment is not usually necessary in 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. Renal insufficiency / dialysis and hepatic impairment In patients with renal and/or hepatic insufficiency the elimination of tramadol is delayed.

In these patients prolongation of the dosage interval should be carefully considered according to the patient’s requirements. Method of administration Oral use Treatment goals and discontinuation Before initiating treatment with Tramulief SR, a treatment strategy including treatment duration and treatment goals, and a plan for end of the treatment, should be agreed together with the patient, in accordance with pain management guidelines.

During treatment, there should be frequent contact between the physician and the patient to evaluate the need for continued treatment, consider discontinuation and to adjust dosages if needed. When a patient no longer requires therapy with tramadol, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal.

The most commonly reported adverse reactions are nausea and dizziness, both occurring in more than 10% of patients.

The frequencies are defined as follows:

Very common: ≥1/10 Common: ≥1/100, <1/10 Uncommon: ≥1/1,000, <1/100 Rare: ≥1/10,000, <1/1,000 Very rare (< 1/10,000) Not known (cannot be estimated from the available data) A tabulated list of undesirable effects is outlined below: System Organ Class Frequency Adverse reactions Metabolism and nutrition disorders Not known Hypoglycaemia Psychiatric disorders Rare Delirium, hallucinations, confusion, sleep disturbance, anxiety, nightmares, changes in mood (elation, occasionally dysphoria), changes in activity (suppression, decision behaviour, perception disorders), Dependence Very common Common Dizziness Headache, somnolence Nervous system disorders Rare Not known changes in appetite, paraesthesia, tremor, respiratory depression, epileptiform convulsions, involuntary muscle contractions, abnormal coordination and syncope Serotonin syndrome, Speech disorders Rare Miosis, blurred visionEye disorders Not known Mydriasis Uncommon Palpitation, tachycardia, postural hypotension or cardiovascular collapse Cardiovascular disorders Rare Bradycardia, increase in blood pressure.

Respiratory thoracic and mediastinal disorders Rare Not known Dyspnoea Hicupps Gastrointestinal disorders: Very common Common Uncommon Nausea Constipation, dry mouth, vomiting Retching, gastrointestinal irritation (a feeling of pressure in the stomach, bloating), diarrhoea Skin and subcutaneous tissue disorders Common Uncommon Sweating Dermal reactions (Pruritus, rash, urticaria) Musculo-skeletal disorders: Rare Motorial weakness Renal and urinary disorders Rare Micturition disorders (difficulty in passing urine, dysuria and urinary retention).

g. ) Panic attacks, severe anxiety, hallucinations, paraesthesia’s, tinnitus, CNS symptoms (confusion, delusions, depersonalization, derealization, paranoia) Drug dependence Repeated use of Tramulief SR can lead to drug dependence, even at therapeutic doses.

Tramulief SR 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. 9) as the possibility of respiratory depression cannot be excluded in these situations. 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). ). Patients with epilepsy or those susceptible to seizures should only be treated with tramadol if there are compelling circumstances.

Tolerance and opioid use disorder (abuse and dependence) Tolerance, physical and psychological dependence, and opioid use disorder (OUD) may develop upon repeated administration of opioids such as tramadol. Repeated use of tramadol can lead to opioid use disorder (OUD).

A higher dose and longer duration of opioid treatment can increase the risk of developing OUD. Abuse or intentional misuse of tramadol may result in overdose and/or death. g. major depression, anxiety and personality disorders). 2). Before and during treatment the patient should also be informed about the risks and signs of OUD.

If these signs occur, patients should be advised to contact their physician. g. too early requests for refills). This includes the review of concomitant opioids and psycho-active drugs (like benzodiazepines). For patients with signs and symptoms of OUD, consultation with an addiction specialist should be considered.

Tramadol is not suitable as a substitute in opioid-dependent patients. Although it is an opioid agonist, tramadol cannot suppress morphine withdrawal symptoms. When a patient no longer requires therapy with tramadol, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal.

5), - in patients with epilepsy not adequately controlled by treatment, - for use in narcotic withdrawal treatment