TRAMADOL

4). 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. The total daily dose of 400 mg active substance should not be exceeded, except in special circumstances.

Unless otherwise prescribed, Tramadol should be administered as follows:

Adults and adolescents aged 12 years and over Oral administration Acute pain: An initial dose of 100 mg is usually necessary. 1).

Pain associated with chronic conditions:

An initial dose of 50 mg is advised and then titration according to pain severity. 4). Children Tramadol capsules are not suitable for children below the age of 12 years. Geriatric patients 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 insufficiency In patients with renal and/or hepatic insufficiency the elimination of tramadol is delayed.

In these patients prolongation of the dosage intervals should be carefully considered according to the patient's requirements. Method of administration For oral administration The capsules are to be taken whole, not divided or chewed, with sufficient liquid, with or without food.

Treatment goals and discontinuation Before initiating treatment with Tramadol capsules, 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.

4). Duration of administration Tramadol should under no circumstances be administered 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.

The undesirable effects are classified into system organ classes and their frequency is classified as follows: Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).

The most commonly reported adverse reactions are nausea and dizziness, both occurring in more than 10% of patients. Metabolism and nutrition disorders Frequency not known: hypoglycaemia Rare: changes in appetite Psychiatric disorders Rare: hallucinations, confusion, sleep disturbance, delirium, anxiety and nightmares.

Psychic adverse reactions may occur following administration of tramadol, which vary individually in intensity and nature (depending on personality and duration of medication). g. 4) Nervous system disorders Very common: dizziness Common: headache, somnolence Rare: paraesthesia, tremor, epileptiform convulsions, abnormal coordination, involuntary muscle contractions, syncope, speech disorders.

5). Frequency not known: serotonin syndrome Eye disorders Rare: blurred vision, miosis, mydriasis Cardiac disorders Uncommon: cardiovascular regulation (palpitations, tachycardia). These adverse effects may occur especially in connection with intravenous administration and if the patient is experiencing physical stress.

Rare: bradycardia Investigations:

Rare: increased blood pressure. Vascular disorders Uncommon: cardiovascular regulation (postural hypotension or cardiovascular collapse). These adverse reactions may occur especially on intravenous administration and in patients who are physically stressed.

5), respiratory depression may occur. Worsening of asthma has been reported, though a causal relationship has not been established. Frequency not known: hiccups Gastrointestinal disorders Very common: nausea Common: vomiting, constipation, dry mouth Uncommon: retching; gastrointestinal discomfort (a feeling of pressure in the stomach, bloating), diarrhoea Hepatobiliary disorders Frequency not known: In a few isolated cases an increase in liver enzyme values has been reported in a temporal connection with the therapeutic use of tramadol.

Tramadol 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. Concomitant use of Tramadol and sedating medicinal products such as benzodiazepines or related substances may result in sedation, respiratory depression, coma and death.

Because of these risks, concomitant prescribing with these sedating medicinal products should be reserved for patients for whom alternative treatment options are not possible. If a decision is made to prescribe Tramadol concomitantly with sedating medicinal products, the lowest effective dose should be used, and the duration of the concomitant treatment should be as short as possible.

The patients should be followed closely for signs and symptoms of respiratory depression and sedation. 5). 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).

5). Patients with epilepsy or those susceptible to seizures should be only treated with tramadol if there are compelling circumstances. 9) as the possibility of respiratory depression cannot be excluded in these situations. CYP2D6 metabolism Tramadol is metabolised by the liver enzyme CYP2D6.

If a patient has a deficiency or is completely lacking this enzyme an adequate analgesic effect may not be obtained. Estimates indicate that up to 7% of the Caucasian population may have this deficiency. However, if the patient is an ultra-rapid metaboliser there is a risk of developing <side effects> of opioid toxicity even at commonly prescribed doses.

General symptoms of opioid toxicity include confusion, somnolence, shallow breathing, small pupils, nausea, vomiting, constipation and lack of appetite. In severe cases this may include symptoms of circulatory and respiratory depression, which may be life threatening and very rarely fatal.

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