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ROBAX PLATINUM is a brand name for Methocarbamol, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................3 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Clinical Trial Adverse Drug Reactions Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. Post-Market Adverse Drug Reactions Ibuprofen 56 The following adverse reactions have been noted in patients treated with doses (≥1200 mg/day).
Note:
Reactions listed below under Causal Relationship Unknown are those which occurred under circumstances where a causal relationship could not be established. However, in these reported events, the possibility of a causal relationship to ibuprofen cannot be excluded.
Gastrointestinal The adverse reactions most frequently seen with prescribed ibuprofen therapy involve the gastrointestinal system. Incidence 3 to 9%: nausea, epigastric pain, heartburn. Incidence 1 to 3%: diarrhea, abdominal distress, nausea and vomiting, indigestion, constipation, abdominal cramps or pain, fullness of the gastrointestinal tract (bloating or flatulence).
Incidence less than 1%: gastric or duodenal ulcer with bleeding and/or perforation, gastrointestinal hemorrhage, melena, hepatitis, jaundice, abnormal liver function AST, serum bilirubin and alkaline phosphatase. Allergic Incidence less than 1%: anaphylaxis.
Causal relationship unknown: fever, serum sickness, lupus erythematosus. Central Nervous System Incidence 3 to 9%: dizziness. Incidence 1 to 3%: headache, nervousness. Incidence less than 1%: depression, insomnia. Causal relationship unknown: paresthesias, hallucinations, dream abnormalities.
Haleon Canada ULC Page 13 of 38 Aseptic meningitis and meningoencephalitis, in one case accompanied by eosinophilia in the cerebrospinal fluid, have been reported in patients who took ibuprofen intermittently and did not have any connective tissue disease.
Dermatologic Incidence 3 to 9%: rash (including maculopapular type). Incidence 1 to 3%: pruritus. Incidence less than 1%: vesiculobullous eruptions, urticaria, erythema multiforme. Causal relationship unknown: alopecia, Stevens-Johnson syndrome.
General In common with other anti-inflammatory drugs, ibuprofen may mask the usual signs of infection. Methocarbamol may produce false positive tests for urinary 5-hydroxyindoleacetic acid (5- HIAA) and vanillymandelic acid (VMA). Carcinogenesis and Mutagenesis Not applicable.
56 Dependence/Tolerance Not applicable. Ear/Nose/Throat Patients with complete or partial syndrome of nasal polyps should not use this drug. Serious Warnings and Precautions Use with caution in patients with heart failure, hypertension or other conditions predisposing to fluid retention (See WARNINGS AND PRECAUTIONS, Cardiovascular and Fluid and Electrolyte Balance; and DRUG INTERACTIONS, Antihypertensives).
Use with caution in patients who might be prone to gastrointestinal tract irritation, particularly those with a history of diverticulosis, or other inflammatory disease of the gastrointestinal tract such as ulcerative colitis or Crohn’s disease (See WARNINGS AND PRECAUTIONS, Gastrointestinal and DRUG INTERACTIONS, Coumarin-type anticoagulants).
Use with caution in patients at greatest risk of renal toxicity, such as those with impaired renal function, heart failure, liver dysfunction, those taking diuretics, and the elderly (See WARNINGS AND PRECAUTIONS, Renal). If persistent urinary symptoms, hematuria and cystitis occur, the drug should be stopped immediately (See WARNINGS AND PRECAUTIONS, Genitourinary).
Risk in Pregnancy: Caution should be exercised in prescribing Robax Platinum during the first and second trimesters of pregnancy or breastfeeding. Use of NSAIDS at approximately 20 weeks of gestation or later may cause oligohydramnios, and renal dysfunction including renal failure (See WARNINGS AND PRECAUTIONS).
Ibuprofen is contraindicated for use during the third trimester because of risk of premature closure of the ductus arteriosus and uterine inertia (prolonged parturition) (see CONTRAINDICATIONS). Haleon Canada ULC Page 6 of 38 Endocrine and Metabolism Not applicable.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Cardiovascular Incidence less than 1%: congestive heart failure in patients with marginal cardiac function, elevated blood pressure. Causal relationship unknown: arrhythmias (sinus tachycardia, sinus bradycardia, palpitations). Special Senses Incidence 1 to 3%: tinnitus.
Incidence less than 1%: amblyopia (blurred and/or diminished vision, scotomata and/or changes in colour vision). Any patient with eye complaints during ibuprofen therapy should have an ophthalmological examination. Causal relationship unknown: conjunctivitis, diplopia, optic neuritis.
Hematologic Incidence less than 1%: leukopenia and decreases in hemoglobin and hematocrit. g. purpura, epistaxis, hematuria, menorrhagia). Renal Causal relationship unknown: decreased creatinine clearance, polyuria, azotemia. Like other non-steroidal anti-inflammatory drugs, ibuprofen inhibits renal prostaglandin synthesis, which may decrease renal function and cause sodium retention.
Renal blood flow and glomerular filtration rate decreased in patients with mild impairment of renal function who took 1200 mg/day of ibuprofen for one week. Renal papillary necrosis has been reported. A number of factors appear to increase the risk of renal toxicity (See WARNINGS AND PRECAUTIONS).
Hepatic Incidence less than 1%: hepatitis, jaundice, abnormal liver function (AST, serum bilirubin, and alkaline phosphatase). Haleon Canada ULC Page 14 of 38 Endocrine Causal relationship unknown: gynecomastia, hypoglycemic reaction.
, for three days before menses. Metabolic Incidence 1 to 3%: decreased appetite, edema, fluid retention. Fluid retention generally responds to drug discontinuation. 80 Oral administration of methocarbamol may cause the urine in some patients, following elimination from the body, to turn brown, black, blue or green after a period of time.
Fluid and Electrolyte Balance:
Fluid retention and edema have been observed in patients treated with ibuprofen. Therefore, as with many other NSAIDs, the possibility of precipitating congestive heart failure in elderly patients or those with compromised cardiac function should be borne in mind.
Ibuprofen should be used with caution in patients with heart failure, hypertension or other conditions predisposing to fluid retention. With NSAID treatment there is a potential risk of hyperkalemia, particularly in patients with conditions such as diabetes mellitus or renal failure; elderly patients; or in patients receiving concomitant therapy with β-adrenergic blockers, angiotensin converting enzyme inhibitors or some diuretics.
Serum electrolytes should be monitored periodically during long-term therapy, especially in those who are at risk. Gastrointestinal Serious GI toxicity, such as peptic ulceration, perforation and gastrointestinal bleeding,68 sometimes severe and occasionally fatal, can occur at any time, with or without symptoms in patients treated with NSAIDs including ibuprofen.
Minor upper GI problems, such as dyspepsia, are common, usually developing early in therapy. Physicians should remain alert for ulceration and bleeding in patients treated with nonsteroidal anti-inflammatory drugs, even in the absence of previous GI tract symptoms.
In patients observed in clinical trials of such agents, symptomatic upper GI ulcers, gross bleeding, or perforation appear to occur in approximately 1% of patients treated for 3-6 months and in about 2-4% of patients treated for one year.
The risk continues beyond one year and possibly increases. The incidence of these complications increases with increasing dose. 56 In these cases the physician must weigh the benefits of treatment against the possible hazards. Physicians should inform patients about the signs and/or symptoms of serious GI toxicity and instruct them to contact a physician immediately if they experience persistent dyspepsia or other symptoms or signs suggestive of gastrointestinal ulceration or bleeding.
Because serious GI tract ulceration and bleeding can occur without warning symptoms, physicians should follow chronically treated patients by checking their haemoglobin periodically and by being vigilant for the signs and symptoms of ulceration and bleeding and should inform the patients of the importance of this follow-up.
Haleon Canada ULC Page 7 of 38 If ulceration is suspected or confirmed, or if GI bleeding occurs, Robax Platinum should be discontinued immediately, appropriate treatment instituted and the patient monitored closely. No studies, to date, have identified any group of patients not at risk of developing ulceration and bleeding.
A prior history of serious GI events and other factors such as excess alcohol intake, smoking, age, female gender and concomitant oral steroid and anticoagulant use have been associated with increased risk. Studies to date show that all NSAIDs can cause GI tract adverse events.
Although existing data does not clearly identify differences in risk between various NSAIDs, this may be shown in the future. Genitourinary Some NSAIDs are known to cause persistent urinary symptoms (bladder pain, dysuria, urinary frequency), hematuria or cystitis.
The onset of these symptoms may occur at any time after the initiation of therapy with an NSAID. Some cases have become severe on continued treatment. Should urinary symptoms occur, treatment with ibuprofen/methocarbamol combination must be stopped immediately to obtain recovery.
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