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ZYDOL XL 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. These tablets are indicated in adults and adolescents aged 12 years and above.
Verbatim from this product's MHRA label. Tap a section to expand.
Route of administration Oral use Posology The dose should be adjusted to the intensity of the pain and the sensitivity of the individual patient. The lowest effective correct dose for analgesia should generally be selected. The correct dosage per individual patient is that which controls the pain with no or tolerable side effects for a full 24 hours.
Patients transferring from immediate release tramadol preparations should have their total daily dose calculated, and start on the nearest dose in the ZYDOL XL range. It is recommended that patients are slowly titrated to higher doses to minimise transient side effects.
4). A total daily dose of 400 mg should not be exceeded except in special clinical circumstances. 4).
Adults and children over 12 years:
The usual initial dose is one 150 mg tablet daily. If pain relief is not achieved, the dosage should be titrated upwards until pain relief is achieved.
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. As tramadol is only removed very slowly by haemodialysis or by haemofiltration, post-dialysis administration to maintain analgesia is not usually necessary.
Paediatric population under 12 years of age:
ZYDOL XL has not been studied in children. The safety and efficacy of ZYDOL XL has not been established and the product should not be used in children. Method of administration These tablets should be taken at 24-hourly intervals and must be swallowed whole and not broken, crushed or chewed Treatment goals and discontinuation Before initiating treatment with ZYDOL XL, 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.
4) Nervous system disorders Dizziness Somnolence Headache Paraesthesia Psychomotor hyperactivity Cognitive disorder Sensory disturbance Judgement impaired Seizure Sleep apnoea syndrome Hyperalgesia Serotonin syndrome Eye disorders Blurred vision Cardiac disorders Palpitations Tachycardia Bradycardia Vascular disorders Orthostatic hypotension Hypotension Circulatory collapse Hypertension Flushing Respiratory, thoracic and Dyspnoea Worsening of Hiccups mediastinal disorders asthma Respiratory depression.
Bronchospasm Wheezing Gastro- intestinal disorders Nausea Vomiting Dry mouth Retching Constipation Abdominal discomfort Diarrhoea Hepatobiliary disorders Hepatic enzyme increased Skin and subcutaneous tissue disorders Hyperhi- drosis Pruritus Rash Urticaria Angioedema Musculoskeletal and connective tissue disorders Muscular weakness Renal and urinary disorders Micturition disorders Dysuria Urinary retention General disorders and administration site conditions Drug Withdrawal syndrome which may include: • agitation; • anxiety; • nervousness; • insomnia; • hyperkinesia; • tremor; • gastrointestinal symptoms.
Asthenia Drug withdrawal syndrome neonatal Drug tolerance Drug dependence Repeated use of ZYDOL XL can lead to drug dependence, even at therapeutic doses. 4). 6). As these tablets are made using an insoluble matrix from which the active ingredient is gradually released, the patient may notice the matrix in their faeces.
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.
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 even at therapeutic doses.
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. A comprehensive patient history should be taken to document concomitant medications, including over-the-counter medicines and medicines obtained on-line, and past and present medical and psychiatric conditions.
Additional support and monitoring may be necessary when prescribing for patients at risk of opioid misuse. g. too early requests for refills). If these signs occur, patients should be advised to contact their physician. 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. Tolerance Patients may find that treatment is less effective with chronic use and express a need to increase the dose to obtain the same level of pain control as initially experienced.
Patients may also supplement their treatment with additional pain relievers. These could be signs that the patient is developing tolerance. The risks of developing tolerance should be explained to the patient. Overuse and misuse may result in overdose and/or death.
It is important that patients only use medicines that are prescribed for them at the dose they have been prescribed and do not give this medicine to anyone else. The clinical need for analgesic treatment should be reviewed regularly.
3. 1. Acute intoxication with alcohol, hypnotics, centrally acting analgesics, opioids or psychotropic drugs. Tramadol should not be administered to patients who are receiving monoamine oxidase inhibitors or within two weeks of their withdrawal.
Tramadol must not be used for 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.
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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).
Drug withdrawal syndrome 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 drug during pregnancy, there is a risk that their newborn infants will experience neonatal withdrawal syndrome. Hyperalgesia Hyperalgesia may be diagnosed if the patient on long-term opioid therapy presents with increased pain.
This might be qualitatively and anatomically distinct from pain related to disease progression or to breakthrough pain resulting from development of opioid tolerance. Pain associated with hyperalgesia tends to be more diffuse than the pre-existing pain and less defined in quality.
Symptoms of hyperalgesia may resolve with a reduction of opioid dose. Tramadol is not suitable as a substitute in opioid-dependent patients. Although it is an opioid agonist, tramadol cannot suppress morphine withdrawal symptoms. Tramadol should be used with caution in patients with head injury, intracranial lesions, increased intracranial pressure, severe impairment of hepatic or renal function, in patients in shock or with a reduced level of consciousness of uncertain origin, and with constipation.
The primary risk of opioid excess is respiratory depression. 5) are being administered, as the possibility of respiratory depression cannot be excluded in these situations. At therapeutic doses respiratory depression has infrequently been reported.
Concomitant use of tramadol and sedative medicines such as benzodiazepines or related drugs may result in sedation, respiratory depression, coma and death. Because of these risks, concomitant prescribing with these sedative medicines should be reserved for patients for whom alternative treatment options are not possible.
If a decision is made to prescribe tramadol concomitantly with sedative medicines, the lowest effective dose should be used, and the duration of treatment should be as short as possible. The patients should be followed closely for signs and symptoms of respiratory depression and sedation.
5). 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 […]