ZYDOL 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. The total daily doses of 400 mg tramadol hydrochloride should not be exceeded, except in special clinical circumstances.

Unless otherwise prescribed, ZYDOL SR should be administered as follows:

Adults and adolescents above the age of 12 years: The usual initial dose is 50-100 mg tramadol hydrochloride twice daily, morning and evening. 1).

Children:

ZYDOL SR 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 ZYDOL SR prolonged-release 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 ZYDOL 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.

4).

The most commonly reported adverse reactions are nausea and dizziness, both occurring in more than 10 % of patients. g. dyspnoea, bronchospasm, wheezing, angioneurotic oedema) and anaphylaxis 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.

Nervous system disorders:

Very common: dizziness Common: headache, somnolence Rare: speech disorders, paraesthesia, tremor, epileptiform convulsions, involuntary muscle contractions, abnormal coordination, syncope. Convulsions occurred mainly after administration of high doses of tramadol or after concomitant treatment with medicinal products which can lower the seizure threshold.

5).

Not known:

Serotonin syndrome Metabolism and nutrition disorders: Rare: changes in appetite Not known: hypoglycaemia 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.

e. confusion, delusions, depersonalisation, derealisation, paranoia). 5), respiratory depression may occur. Worsening of asthma has been reported, though a causal relationship has not been established. Not known: hiccups. g. pruritus, rash, urticaria) Musculo-skeletal 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.

Renal and urinary disorders:

Rare: micturition disorders (dysuria and urinary retention) General disorders: Common: fatigue Drug dependence: Repeated use of ZYDOL SR can lead to drug dependence, even at therapeutic doses. 4). 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 tramadol should only be used with caution. Concomitant use of ZYDOL SR 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 ZYDOL SR concomitantly with sedating medicinal products, the lowest effective dose of ZYDOL SR 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). 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. 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 hydrochloride exceed the recommended upper daily dose limit (400 mg). 5). Patients with epilepsy or those susceptible to seizures should only be 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.

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 ZYDOL SR.

Repeated use of ZYDOL SR 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 ZYDOL SR 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.

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

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. 9% 1% to 2% Post-operative use Do not use for acute post-operative pain owing to the increased risk of persistent post- operative opioid use (PPOU) and opioid-induced ventilatory impairment (OIVI).

If opioids are required for post-operative pain, then the immediate […]

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