Loading…
INVODOL SR is a brand name for Tramadol. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Treatment of moderate to severe pain
Verbatim from this product's MHRA label. Tap a section to expand.
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.
Adults and adolescents above the age of 12 years:
The recommended doses are intended as a guideline. Patients should always receive the lowest dose that provides effective pain control. Chronic pain management should be preferably given on a fixed dosing schedule. The starting dose is usually 100 mg tramadol hydrochloride as prolonged- release tablet twice daily, in the morning and in the evening.
If the pain relief is not sufficient, the dose may be increased to 150 mg twice daily or 200 mg twice daily. The dose interval must not be less than 8 hours. A total daily dose of 400 mg of tramadol hydrochloride should not be exceeded except in special clinical circumstances.
Tramadol hydrochloride should never be used longer than absolutely necessary for pain control. If the nature and severity of the underlying disease suggest the need for prolonged pain management, continued medical need for tramadol hydrochloride analgesia should be reviewed carefully at short, regular intervals (with breaks in treatment if necessary).
Paediatric population Tramadol prolonged-release tablets are not suitable for children under 12 years of age. Elderly A dose adjustment is not usually necessary in patients up to 75 years without clinically manifest hepatic or renal insufficiency.
In elderly people over 75 years elimination may be prolonged. Therefore, if necessary the dose 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 dose intervals should be carefully considered according to the patient's requirements. In cases of severe renal and/or severe hepatic insufficiency tramadol hydrochloride prolonged- release tablets are not recommended.
Method of administration The prolonged-release tablets must be swallowed whole, not divided or chewed, with sufficient liquid, irrespective of mealtimes. Treatment goals and discontinuation Before initiating treatment with Tilodol 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.
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. Metabolism and nutrition disorders Rare: changes in appetite Not known: hypoglycaemia Psychiatric disorders Rare: hallucination, confusion, delirium, anxiety, sleep disturbances and nightmares.
Psychic adverse reactions may occur following administration of tramadol hydrochloride which vary individually in intensity and nature (depending on personality and duration of treatment). g. decision behaviour, perception disorders).
4). 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. 5). Not known: serotonin syndrome Eye disorders Rare: blurred vision, miosis Cardiac disorders Uncommon: cardiovascular regulation (palpitation, tachycardia,). These adverse reactions may occur especially on intravenous administration of tramadol hydrochloride and in patients who are physically stressed.
Rare: bradycardia Vascular disorders Uncommon: cardiovascular regulation (postural hypotension or cardiovascular collapse). These adverse reactions may occur especially on intravenous administration of tramadol hydrochloride and in patients who are physically stressed.
5), respiratory depression may occur. Not known: hiccups Worsening of asthma has also been reported, though a causal relationship has not been established. Gastrointestinal disorders Very common: nausea Common: constipation, dry mouth, vomiting Uncommon: retching, gastrointestinal discomfort (a feeling of pressure in the stomach, bloating), diarrhoea Hepato-biliary disorders Very rare: An increase in liver enzyme values has been reported in a temporal connection with the therapeutic use of tramadol hydrochloride.
2). In patients sensitive to opiates tramadol hydrochloride should only be used with caution. • • 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 adverse reactions 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% • Northern European • 1% to 2% 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.
Post-operative use in children There have been reports in the published literature that tramadol given post- operatively in children after tonsillectomy and/or adenoidectomy for obstructive sleep apnoea, led to rare, but life-threatening adverse events.
Extreme caution should be exercised when tramadol is administered to children for post-operative pain relief and should be accompanied by close monitoring for symptoms of opioid toxicity including respiratory depression. • Children with compromised respiratory function Tramadol is not recommended for use in children in whom respiratory function might be compromised including neuromuscular disorders, severe cardiac or respiratory conditions, upper respiratory or lung infections, multiple trauma or extensive surgical procedures.
Tramadol hydrochloride is contraindicated • in hypersensitivity to the active substance or to any of the excipients listed in section 6. 5) • in patients with epilepsy not adequately controlled by treatment • for use in narcotic withdrawal treatment
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Tramadol in United Kingdom.
Know a brand we are missing in United Kingdom? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
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).
Skin and subcutaneous tissue disorders Common: hyperhidrosis Uncommon: pruritus, rash, urticaria Musculoskeletal and connective tissue disorders Rare: motorial weakness Renal and urinary disorders Rare: micturition disorders (dysuria and urinary retention) General disorders and administration site conditions Common: fatigue Investigations Rare: increase in blood pressure Drug dependence Repeated use of Tilodol 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.
These factors may worsen symptoms of opioid toxicity. 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 Tilodol SR.
Repeated use of Tilodol 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 Tilodol 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.
. In patients with a tendency to drug abuse or dependence, treatment with tramadol hydrochloride should only be carried out for short periods under strict medical supervision. Tramadol hydrochloride is not suitable as a substitute in opioid dependent patients.
Although it is an opioid agonist, tramadol cannot suppress morphine withdrawal symptoms. When a patient no longer requires therapy with tramadol, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal. 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 a history of epilepsy or those susceptible to seizures should only be treated with tramadol hydrochloride 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 medicinal product usually brings about a rapid improvement.
Care should be taken when treating patients with respiratory depression, or if concomitant CNS-depressant medicinal […]