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ZAMADOL is a brand name for Tramadol. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: For the treatment and prevention of moderate to severe pain.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology The dose of Zamadol Capsules 50 mg 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.
Dosage for adults and adolescents aged 12 years and older is:
For acute pain - an initial dose of 100 mg is usually necessary. This can be followed by doses of 50 mg or 100 mg not more frequently than 4 hourly, and duration of therapy should be matched to clinical need. For pain associated with chronic conditions -use in an initial dose of 50 mg and then titrate dose according to pain severity.
4) A total oral daily dose of 400 mg should not be exceeded except in special clinical circumstances. Paediatric population Zamadol Capsules 50 mg should not be taken by children under 12 years of age, since safety and efficacy have not been established.
Elderly patients:
A dose adjustment is usually necessary in patients up to 75 years of age without clinically manifest hepatic or renal insufficiency. In elderly patients over 75 years of age elimination may be prolonged. Therefore, if necessary the dosage interval is to be extended according to the patient’s requirements.
Patients with renal or hepatic impairment:
In patients with renal and/or hepatic insufficiency the elimination of Zamadol 50 mg capsules is delayed. In these patients prolongation of the dosage intervals should be carefully considered according to the patient’s requirements.
• For creatinine clearance <30 ml/min the dosing should be increased to 12 hourly intervals. • For creatinine clearance <10 ml/min (severe renal impairment) Zamadol 50 mg capsules is not recommended. Tramadol is removed very slowly by haemodialysis or haemofiltration and therefore post-dialysis dosing to maintain analgesia is usually unnecessary.
Method of administration The capsules are to be taken whole with sufficient liquid, independently of meals. Swallow the capsules whole with some water without chewing. If you have difficulty in swallowing, you may open the capsules. You must open them very carefully by pulling and twisting each end over a spoon so that all the pellets stay in the spoon.
Do not chew. Swallow all the pellets with water. 4). Treatment goals and discontinuation Before initiating treatment with Zamadol Capsules 50 mg, 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.
Gastrointestinal disorders:
Very common (≥1/10): nausea Common (≥1/100 to <1/10): vomiting, dry mouth and constipation.
Nervous system disorders:
Very common (≥1/10): dizziness Common (≥1/100 to <1/10): headache and drowsiness Rare (≥1/10,000 to <1/1,000) syncope, somnolence, and parasthesia have been reported. g. anti- depressants or anti-psychotics). 4). 4) Rare (≥1/10,000 to <1/1,000): fatigue Eye disorders: Rare (≥1/10,000 to <1/1,000): blurred vision Respiratory, thoracic and mediastinal disorders: Rare (≥1/10,000 to <1/1,000): respiratory depression Frequency unknown: Hiccups Immune system disorders: Rare (≥1/10,000 to <1/1,000) allergic reactions (dyspnoea, wheezing, bronchospasm and worsening of asthma) and anaphylaxis have been reported.
Cardiac disorders:
Uncommon (≥1/1,000 to <1/100): palpitations, tachycardia Rare (≥1/10,000 to <1/1,000): bradycardia Vascular disorders: Uncommon (≥1/1,000 to <1/100): orthostatic hypotension, flushing Rare (≥1/10,000 to <1/1,000): hypertension Metabolism and nutrition disorders: Frequency not known (cannot be estimated from the available data): hypoglycaemia, hyponatraemia.
Skin and subcutaneous tissue disorders:
Common (≥1/100 to <1/10): sweating Rare (≥1/10,000 to <1/1,000): Pruritus, urticaria and skin rashes have been reported.
Renal and urinary system disorders:
Rare (≥1/10,000 to <1/1,000): micturition disorders Blood and lymphatic system disorders: There have also been cases of blood dyscrasias observed with tramadol treatment, but direct causality has not been confirmed.
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. Risk from concomitant use of sedative medicines such as benzodiazepines or related drugs: Concomitant use of Zamadol Capsules 50 mg 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 Zamadol Capsules 50 mg 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). 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. 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 Zamadol Capsules 50 mg.
Repeated use of Zamadol Capsules 50 mg 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 Zamadol Capsules 50 mg may result in overdose and/or death.
1. - Acute intoxication with hypnotics, centrally acting analgesics, opioids, psychotropic drugs or alcohol. - In common with other opioid analgesics, tramadol should not be administered to patients who are receiving monoamine oxidase inhibitors or within 2 weeks of their withdrawal.
- Uncontrolled epilepsy. Tramadol must not be used for narcotic withdrawal treatment.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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4).
Hepatobiliary disorders:
In a few isolated cases increases in liver enzyme values have been reported concurrently with the therapeutic use of tramadol. Drug dependence Repeated use of Zamadol Capsules 50 mg 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.
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. 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.
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% Northern European 1% to 2% Convulsions have been reported at therapeutic doses and the risk may be increased at doses […]