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MAROL 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.
Treatment goals and discontinuation Before initiating treatment with Marol tablets, 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). Route of Administration Oral use Posology The dose should be adjusted to the intensity of the pain and the sensitivity of the individual patient.
Unless otherwise prescribed, Marol tablets should be given as follows:
Adults and adolescents older than 12 years: The usual initial dose is 50-100mg tramadol hydrochloride, twice daily, morning and evening. If pain relief is insufficient, the dose may be titrated upwards to: 150 mg or 200 mg tramadol hydrochloride, twice daily.
For doses not practicable with this strength, other strengths of this medicinal product are available. Marol tablets should be swallowed completely, without breaking or chewing, independent of meals, with sufficient liquid. A daily dose of 400 mg of tramadol should not be exceeded, except in special clinical circumstances.
Under no circumstances should Marol tablets be used for longer than absolutely necessary. If long-term pain treatment with Marol is necessary in view of the nature and severity of the illness, then careful and regular monitoring should be carried out (if necessary with breaks in treatment) to establish whether, and to what extent, further treatment is necessary.
Paediatric Population Marol Tablets are not suitable for children under the age of 12 years. Elderly patients A dose adjustment is not usually necessary, in patients up to 75 years without clinically manifest hepatic or renal insufficiency not associated with clinical manifestation.
In elderly patients (above 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 dose interval should be carefully considered according to the patients requirements.
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).
Cardiovascular 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.
5), respiratory depression may occur. Worsening of asthma has been reported, though a causal relationship has not been established.
Not known: hiccups Nervous system disorders:
Very common: dizziness Common: headache, somnolence Rare: speech disorder, paraesthesia, tremor, epileptiform convulsions, involuntary muscle contractions, abnormal coordination and syncope. 5).
Psychiatric disorders:
Rare: hallucinations, confusion, delirium, anxiety, sleep disturbances and nightmares. Psychic adverse reactions may occur following administration of Marol tablets which vary individually in intensity and nature (depending on personality and duration of treatment).
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) 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 Marol tablets.
Repeated use of Marol tablets 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 Marol tablets 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. 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.
1. 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.
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g. decision behaviour, perception disorders). 4) Eye disorders: Rare: blurred vision, miosis, mydriasis Gastrointestinal disorders: Very common: nausea Common: vomiting, constipation, dry mouth. g. pruritus, rash, urticaria) Musculoskeletal and connective tissue disorders: Rare: motorial weakness Hepato-biliary disorders: In a few isolated cases increase in liver enzyme values has been reported in a temporal connection with the therapeutic use of tramadol.
Renal and urinary system disorders:
Rare: micturition disorders (dysuria and urinary retention). g. dyspnoea, bronchospasm, wheezing, angioneurotic oedema) and anaphylaxis Metabolism and nutrition disorders: Not known: hypoglycaemia General disorders and administration site conditions: Common: fatigue.
Uncommon: drug withdrawal syndrome Symptoms of withdrawal reactions, similar to those occurring during opiate withdrawal, may occur as follows: agitation, anxiety, nervousness, insomnia, hyperkinesia, tremor and gastro intestinal symptoms.
e. confusion, delusions, depersonalisation, derealisation, paranoia). Drug dependence Repeated use of Marol Tablets 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.
If women take this drug during pregnancy, there is a risk that their newborn infants will experience neonatal withdrawal syndrome. Tramadol is not a suitable as a substitute in opioid-dependent patients. Although it is an opioid agonist, tramadol cannot suppress morphine withdrawal symptoms.
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. Marol Tablets may only be used with particular caution in opioid-dependent 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. 9) as the possibility of respiratory depression cannot be excluded in these situations. 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. 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. 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. Convulsions have been reported in patients receiving tramadol at the recommended dose levels. The risk may be increased when doses exceed the recommended upper daily dose limit (400 mg).
In addition, tramadol may increase the seizure risk in patients taking other medicinal products that lowers the seizure threshold. 5). Patients with epilepsy or those susceptible to seizures should only be treated with tramadol if there are compelling circumstances.
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 […]