TRAMADOL HYDROCHLORIDE

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 400mg active substance should not be exceeded, except in special circumstances.

Unless otherwise prescribed Tramadol Capsules should be administered as follows:

Adults and adolescents aged 12 years and over: Acute pain: An initial dose of 100mg is usually necessary. This can be followed by doses of 50 mg or 100 mg at 4- 6 hourly intervals, 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). 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.

Children:

Tramadol Capsules are not suitable for children below the age of 12 years. Method of administration For oral administration. The capsules are to be taken whole, not divided or chewed, with sufficient liquid, independent of meals. Treatment goals and discontinuation Before initiating treatment with Tramadol Hydrochloride 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).

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 (palpitations, 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). 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) Not known: drug dependence - repeated use of Tramadol Hydrochloride capsules can lead to drug dependence, even at therapeutic doses.

g. pruritus, rash, urticaria) Musculoskeletal and connective tissue disorders: Rare: 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.

g. dyspnoea, bronchospasm, wheezing, angioneurotic oedema) and anaphylaxis.

General disorders and administration site conditions:

Common: fatigue Uncommon: drug withdrawal syndrome 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.

e. confusion, delusions, depersonalisation, derealisation, paranoia). 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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

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 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). 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. 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. 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. Serotonin syndrome is likely when one of the following is observed: • Spontaneous clonus • Inducible or ocular clonus with agitation or diaphoresis • Tremor and hyperreflexia • Hypertonia and body temperature > 38 °C and inducible or ocular clonus 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. 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 Hydrochloride capsules.

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.

Drug withdrawal syndrome Prior to starting treatment with any opioids, a discussion should be held with patients to put in place a withdrawal strategy for ending treatment with Tramadol Hydrochloride. Drug withdrawal syndrome may occur upon abrupt cessation of therapy or dose reduction.

When a patient no longer requires therapy, it is advisable to taper the dose gradually to minimise symptoms of withdrawal. Tapering from a high dose may take weeks to months. The opioid drug withdrawal syndrome is characterised by some or all of the following: restlessness, lacrimation, rhinorrhoea, yawning, perspiration, chills, myalgia, mydriasis and palpitations.

Other symptoms may also develop including irritability, agitation, anxiety, hyperkinesia, tremor, weakness, insomnia, anorexia, abdominal cramps, nausea, vomiting, diarrhoea, increased blood pressure, increased respiratory rate or heart rate.

If women take this […]

Tramadol should not be administered to patients who have previously demonstrated hypersensitivity to it, or to any of the ingredients, or in cases of acute intoxication with alcohol, hypnotics, analgesics, opioids or other psychotroic medicinal drugs.

5). Tramadol should not be given to patients suffering from uncontrolled epilepsy. Tramadol must not be used for narcotic withdrawal treatment.