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BRIMISOL PR 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.
4). 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, Brimisol PR 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 Brimisol PR is not suitable for children below the age of 12 years. Geriatric patients A dose adjustment is not usually necessary in elderly 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 Insufficiency 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 patients requirements. In cases of severe renal and/or severe hepatic insufficiency Brimisol PR 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 Brimisol PR, 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). Duration of administration Tramadol should under no circumstances be administered for longer than absolutely necessary. If long-term pain treatment with tramadol 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.
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 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. 5).
Not known:
Serotonin syndrome Psychiatric disorders: Rare: hallucinations, confusion, sleep disturbance, delirium, anxiety and nightmares. Psychic adverse reactions may occur following administration of Brimisol PR which vary individually in intensity and nature (depending on personality and duration of treatment).
g. decision behaviour, perception disorders). 5), respiratory depression may occur. Worsening of asthma has been reported, though a causal relationship has not been established. g. pruritus, rash, urticaria) Musculoskeletal 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.
Brimisol PR 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 the product should only be used with caution. Risk from concomitant use of sedative medicines such as benzodiazepines or related drugs: Concomitant use of tramadol 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 tramadol concomitantly with sedating medicinal products, the lowest effective dose of tramadol 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). 9) as the possibility of respiratory depression cannot be excluded in these situations. 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 Brimisol PR.
Repeated use of Brimisol PR 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 Brimisol PR 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.
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.
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g. dyspnoea, bronchospasm, wheezing, angioneurotic oedema) and anaphylaxis Metabolism and nutrition disorders: Rare: changes in appetite Not known: hypoglycaemia General disorders and administration site conditions: Common: fatigue Uncommon: drug withdrawal syndrome 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). Drug dependence Repeated use of Brimisol PR 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. 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. Tramadol is not suitable as a substitute in opioid-dependent patients. Although it is an opioid agonist, tramadol cannot suppress morphine withdrawal symptoms.
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.
Serotonin syndrome is likely when one of the following is observed: − Spontaneous clonus − Inducible or ocular clonus with agitation or diaphoresis − Tremor and hyperreflexia − Hypertonia and body temperature > 38°C and inducible or ocular clonus 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. 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. 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 […]