TRAMADOL HYDROCHLORIDE

As with all analgesic drugs, the dose of tramadol hydrochloride should be adjusted according to the intensity of the pain and the sensitivity of the individual patient. The lowest effective dose for analgesia should generally be selected.

Adults and children aged 12 years and over:

Acute pain - An initial dose of 100mg is usually necessary. This can be followed by doses of 50 or 100mg not more frequently than 4 hourly, and duration of therapy should be matched to clinical need. Pain associated with chronic conditions - Use an initial dose of 50mg and then titrate dose according to pain severity.

4 - "Special Warnings and Precautions for Use"). A total oral daily dose of 400mg should not be exceeded except in special clinical circumstances. 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. It should be noted that in volunteers aged over 75 years the elimination halflife of tramadol was increased by approximately 17% following oral administration.

Renal insufficiency /renal dialysis/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. For patients with creatinine clearance of less than 30ml/min, the dosage interval should be increased to 12 hours.

Tramadol is not recommended for patients with severe renal impairment where the creatinine clearance is less than 10ml/min. As tramadol is only removed very slowly by haemodialysis or haemofiltration, post-dialysis administration to maintain analgesia is not usually necessary.

In severe hepatic impairment the dosage interval should be increased to 12 hours.

Children under 12 years:

Tramadol hydrochloride capsules are not intended for administration to children under 12 years of age. 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.

Method of administration For oral administration. The capsules should be swallowed whole and not chewed. They should be taken with a little water before or after 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.

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The most commonly reported adverse reactions are nausea and dizziness, both occurring in more than 10 % of patients. 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); not known: cannot be estimated from the available data Cardiovascular disorders: Uncommon: Cardiovascular regulation (palpitation, tachycardia, postural hypotension cardiovascular collapse.

These adverse reactions may occur especially on intravenous administration and in patients who are physically stressed Rare: increase in blood pressure, bradycardia Eye disorders: Rare: blurred vision, miosis, mydriasis Gastro-intestinal disorders: Very common: nausea Common: vomiting, constipation, dry mouth Uncommon: retching; gastrointestinal irritation (a feeling of pressure in the stomach, bloating), diarrhoea 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.

5), respiratory depression may occur. 5). 5), respiratory depression may occur. Unknown: worsening of existing asthma, though a causal relationship has not been established, hiccups General disorders and administration site conditions: Common: fatigue Psychiatric disorders: Rare: confusion, hallucination, 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).

Dependence may occur Drug dependence:

Repeated use of Tramadol can lead to drug dependence, even at therapeutic doses. 4).

Physical dependence:

Dependence, abuse and withdrawal reactions have been reported. 2 – “Posology and Method of Administration”). e. confusion, delusions, depersonalisation, derealisation, paranoia). g. g. pruritus, skin rash, urticaria) Renal and urinary disorders: Rare: micturition disorder (difficulty in passing urine, dysuria and urinary retention) Vascular disorders: Rare: flushing, orthostatic hypotension, Blood and lymphatic system disorders: Cases of blood dyscrasias have been rarely observed during treatment with tramadol but causality has not been established.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard.

9Overdose Symptoms of overdosage are typical of other opioid analgesics (centrally acting), and include miosis, vomiting, cardiovascular collapse, sedation and consciousness disorders up to coma, seizures and respiratory depression up to respiratory arrest.

Serotonin syndrome has also been reported. Treatment - The general emergency measures apply. Supportive measures such as maintaining the patency of the airway and maintaining cardiovascular function should be instituted; Naloxone should be used to reverse respiratory depression.

In animal experiments naloxone had no effect on convulsions, in such cases fits can be controlled with diazepam (intravenously). In case of intoxication orally, gastrointestinal decontamination with activated charcoal or by gastric lavage is only recommended within 2 hours after tramadol intake.

Gastrointestinal decontamination at a later time point may be useful in case of intoxication with exceptionally large quantities or prolongedrelease formulations. Tramadol is minimally eliminated from the serum by haemodialysis or haemofiltration.

Therefore treatment of acute tramadol intoxication with haemodialysis or haemofiltration alone is not suitable for detoxification. 1Pharmacodynamic properties Tramadol is a centrally acting analgesic. It is a non-selective pure agonist at mu (μ), delta and kappa opioid […]

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.

At therapeutic doses withdrawal symptoms have been reported at a reporting frequency of 1 in 8,000. Tramadol should be used with caution in opioid-dependent patients, patients with head injury, a reduced level of consciousness of uncertain origin, disorders of the respiratory centre or function, increased intracranial pressure, severe impairment of hepatic and renal function and in patients prone to convulsive disorders or in shock.

In patients sensitive to opiates the product should only be used with caution. Sleep-related breathing disorders Opioids can cause sleep-related breathing disorders including central sleep apnoea (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. Adrenal insufficiency Opioid analgesics may occasionally cause reversible adrenal insufficiency requiring monitoring and glucocorticoid replacement therapy.

g. severe abdominal pain, nausea and vomiting, low blood pressure, extreme fatigue, decreased appetite, and weight loss. Tramadol should be prescribed with special care in patients with hypotension, prostatic hypertrophy and obstructive or inflammatory bowel disease.

Convulsions have been reported at therapeutic doses and the risk may be increased at doses exceeding the usual upper daily dose limit (400mg). Patients with a history of epilepsy or those susceptible to seizures should only be treated with tramadol if there are compelling reasons.

5 - Interactions with Other Medicinal Products and Other Forms of Interactions). 9) as the possibility of respiratory depression cannot be excluded in these situations. At therapeutic doses respiratory depression has infrequently been reported.

In one study using a nitrous oxide/opioid (tramadol) anaesthetic technique (with only intermittent administration of enflurane “as required”) tramadol was reported to enhance intra-operative recall. Hence its use during potentially very light planes of general anaesthesia should be avoided.

Two recent studies of tramadol administration during anaesthesia comprising continuous administration of isoflurane did not show clinically significant lightening of anaesthetic depth or intra-operative recall. Therefore providing the current practice of administering continuous, potent (volatile or intravenous) anaesthetic agent is followed, tramadol may be used intraoperatively in the same way as other analgesic agents are routinely used.

This product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. 1% of the WHO recommended maximum daily intake for sodium (2g).

6% of the WHO recommended. Tramadol Hydrochloride 50mg Effervescent Tablets are considered high in sodium This should be taken into account for those on a low salt diet. 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. If serotonin syndrome is suspected, a dose reduction or discontinuation of therapy should be considered depending on the severity of the symptoms.

Withdrawal of the serotonergic drugs usually brings about a rapid improvement.

1 • in cases of acute intoxication with alcohol, hypnotics, centrally acting analgesics, opioids or psychotropic drugs • in conjunction with monoamine oxidase inhibitor administration, or within two weeks of its withdrawal • in patients with epilepsy not adequately controlled by treatment • for use in narcotic withdrawal treatment • in patients with porphyria • during an asthmatic attack