TRAMADOL HYDROCHLORIDE SUN PHARMA

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 tramadol hydrochloride should not be exceeded, except in special clinical circumstances.

Unless otherwise prescribed, tramadol should be administered as follows:

Adults and adolescents above the age of 12 years: The usual initial dose is 50-100 mg tramadol hydrochloride SUN twice daily, morning and evening. 1). Children Tramadol is 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 impairment 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. In cases of severe renal and/or severe hepatic insufficiency tramadol tablets are not recommended. Method of administration The tablets are to be taken whole, not divided or chewed, with sufficient liquid, independent of meals.

Treatment goals and discontinuation Before initiating treatment with tramadol, 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).

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: ≥1/1000, <1/100 Rare: ≥1/10 000, <1/1000 Very rare: <1/10 000 Not known: cannot be estimated from the available data Cardiac disorders: Uncommon: cardiovascular regulation (palpitation, tachycardia).

These adverse reactions may occur especially on intravenous administration and in patients who are physically stressed.

Rare: bradycardia Investigations:

Rare: increase in 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.

Not known: hiccups Nervous system disorders:

Very common: dizziness Common: headache, somnolence Rare: speech disorders, paraesthesia, tremor, epileptiform convulsions, involuntary muscle contractions, abnormal coordination, syncope. 5).

Not known:

Serotonin syndrome 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 treatment).

g. decision behaviour, perception disorders). Drug dependence may occur. Symptoms of drug withdrawal syndrome, similar to those occurring during opiate withdrawal, may occur as follows: agitation, anxiety, nervousness, insomnia, hyperkinesia, tremor and gastrointestinal symptoms.

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 tramadol 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 of tramadol 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). 9) as the possibility of respiratory depression cannot be excluded in these situations. Sleep-related breathing disorders Opioids can cause sleep-related breathing disorders including central sleep apnea (CSA) and sleep-related hypoxemia.

Opioid use increases the risk of CSA in a dose- dependent fashion. In patients who present with CSA, consider decreasing the total opioid dosage. 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). If concomitant treatment with other serotonergic agents is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose escalations. Symptoms of serotonin syndrome may include mental status changes, autonomic instability, neuromuscular abnormalities and/or gastrointestinal symptoms.

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