INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo ROBAXISAL® TABLETS

SCHEDULING STATUS:
S2

PROPRIETARY NAME:
(and dosage form)

ROBAXISAL® TABLETS

COMPOSITION:
Each tablet contains:

Methocarbamol 400 mg
Aspirin 325 mg

PHARMACOLOGICAL CLASSIFICATION:
A.2.9 Other Analgesics.

PHARMACOLOGICAL ACTION:
Robaxisal has analgesic, anti-inflammatory, anti-pyretic and muscle-relaxant properties.
Methocarbamol
Methocarbamol is a muscle relaxant whose mechanism of action in humans has not been established, but may be due to general central nervous system (CNS) depression. It has no direct action on the contractile mechanism of striated muscle, the motor end plate or the nerve fibre.
Aspirin
Aspirin is a mild analgesic with anti-inflammatory and antipyretic activity. Aspirin inhibits the biosynthesis of prostaglandins. It produces analgesia through a peripheral action by blocking pain impulse generation as well as by a central action.

INDICATIONS:
Robaxisal is indicated as an adjunct to rest, physical therapy, and other measures for the relief of muscle spasm associated with acute, painful musculoskeletal conditions.

CONTRA-INDICATIONS:
Hypersensitivity to methocarbamol or aspirin, other salicylates, non-steroidal anti-inflammatory agents or tartrazine dye.
Methocarbamol is contra-indicated in patients with CNS depressed, coma or pre-coma states, brain damage, myasthenia gravis or in patients with a history of epilepsy.
Aspirin is contra-indicated in patients with angioedema, peptic ulcers, haemorrhagic disorders such as haemophilia, thrombocytopenia or platelet function disorders, gout, asthma and patients receiving oral anticoagulant therapy.

PREGNANCY:
Safe use of ROBAXISAL has not been established. Not to be taken during the first or last three months of pregnancy unless prescribed by a doctor.
Nursing mothers:
Nursing should not be undertaken while a patient is being treated with this medicine.

WARNINGS:
Do not use continuously for more than 10 days without consulting your doctor.
Aspirin has been implicated in Reye's syndrome, a rare but serious illness, in children and teenagers with chickenpox and influenza. A doctor should be consulted before aspirin is used by such patients.
If ringing in the ears or loss of hearing occurs, consult a doctor before taking any more of this medicine.
Consult a doctor if pain or fever persists or gets worse, if new symptoms occur or if redness and swelling is present, as these could be signs of a serious condition.
Regular use of NSAID's during the third trimester of pregnancy may result in premature closure of the foetal ductus arteriosus in utero and possibly in persistent pulmonary hypertension of the new-born. The onset of labour may be delayed and its duration increased.
To be used with caution in patients with liver or renal disease and only under the supervision of a doctor.
Toxic effects are more likely in the elderly and those suffering from dehydration, due to reduced renal function.
Do not take this product if you are presently taking a prescription medicine for anticoagulation, diabetes, gout or arthritis unless directed by a doctor.
Aspirin should be discontinued several days before scheduled surgical procedures.

DOSAGE AND DIRECTIONS FOR USE:
Adults and children of 12 years of age
Two tablets four times daily.
Three tablets four times daily must be used in severe conditions for one to three days in patients who are able to tolerate salicylates. These dosage recommendations provide respectively 3,2 g and 4,8 g of methocarbamol per day.
Elderly: Half the maximum recommended adult dose or less, may be sufficient to produce a therapeutic response in the elderly.
Children: Not Recommended.
Gastric irritation may be reduced by taking doses after food.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects:
Side-effects reported with methocarbamol include lightheadedness, anorexia, dizziness, drowsiness, nausea and vomiting, allergic manifestations, such as urticaria, pruritis, rash, angioneurotic oedema, conjunctivitis with nasal congestion, blurred vision, headache and fever.
Methocarbamol may rarely give rise to leucopenia, restlessness, anxiety, vertigo, tremor, confusion, and convulsions.
The most common adverse effects occurring with therapeutic doses of aspirin are gastrointestinal disturbances such as nausea, dyspepsia, and vomiting. Irritation of the gastric mucosa with erosion, ulceration, haematemesis and melaena may occur. Slight blood loss may occur in about 70 % of patients with aspirin preparations, whether buffered, soluble, or plain, and often this is not accompanied by dyspepsia. Slight blood loss is not usually of clinical significance but may, in a few patients, cause iron-deficiency anaemia during long-term therapy. Some persons, especially those with asthma, chronic urticaria or chronic rhinitis, exhibit notable sensitivity to aspirin which may provoke various reactions including urticaria and other skin eruptions, angioneurotic oedema, rhinitis, worsening of asthma and severe, even fatal, paroxysmal bronchospasm and dyspnoea. Aspirin may cause hepatoxicity in patients with systemic lupus erthematosus or other connective tissue diseases. Aspirin increases the bleeding time, decreases platelet adhesiveness, and, in large doses, may cause hypoprothrombinaemia. It may cause other blood disorders, including thrombocytopenia.
Special precautions:
Aspirin should be cautiously employed, if at all, in patients prone to dyspepsia or known to have a lesion of the gastric mucosa. Gastrointestinal discomfort may be minimised by taking ROBAXISAL with food.
ROBAXISAL should be used with caution in patients with compromised cardiac function or hypertension, renal and hepatic insufficiency. Toxic effects are more likely in the elderly and those suffering from dehydration, due to reduced renal function.
Use in activities requiring mental alertness: ROBAXISAL may rarely cause drowsiness. Until the patient's response has been determined, he should be cautioned against the operation of motor vehicle or dangerous machinery.
Paediatric use:
Safety and effectiveness in children 12 years of age and below has not been established.
Interactions:
The effects of methocarbamol may be potentiated by concomitant administration of other CNS depressants and stimulants including alcohol, barbiturates, anaesthetics and appetite suppressants. The effects of anorectics, anticholinergics (e.g. atropine), and some psychotropic agents may be potentiated by methocarbamol.
Some effects of aspirin on the gastrointestinal tract are chanced by alcohol.
Aspirin may enhance the activity of anticoagulants. The haemorrhagic effects of aspirin on the gastric mucosa may be enhanced by other platelet aggregation inhibitors (cefamandole, penicillins, valproic acid, dipyridamole), thrombolytic agents and heparin.
Prolonged and concurrent use of paracetamol with salicylates increases the risk of adverse real effects.
Concurrent or sequential administration of vancomycin and aspirin should be avoided because the potential for ototoxicity may be increased.
Aspirin may decrease the plasma concentration of other non-steroidal anti-inflammatory agents (NSAIDs), e.g. indomethacin, fenbufen and piroxicam. Concurrent use of NAIDs and corticosteroids increases the risk of gastrointestinal side-effects.
The excretion of salicylates may be increased by corticosteroids so that a higher dose is required to achieve a therapeutic effect. This may lead to signs of salicylate toxicity on withdrawal of corticosteroids. Concurrent use of corticosteroids increases the risk of gastrointestinal side-effects.
Urinary alkalisers increase salicylate excretion so reducing the effectiveness of salicylates.
Anti-diabetic drugs including insulin may be potentiated by salicylates.
Salicylates displace methotrexate from its binding sites and reduce its renal clearance leading to toxic plasma levels.
Aspirin diminishes the effects of uricosuric agents such as probenecid and sulphinpyrazone.
Laboratory value alterations:
Methocarbamol may cause colour interference and falsely increase values in certain screening tests for 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).
Salicylates may produce falsely increased results for blood creatine, orate (low dose aspirin), and urea. Falsely decreased results may be obtained for blood thyroxine and orate (>4g/day aspirin) and for urinary
5-HIAA (with nitrosonapthol method). Urinary VMA levels may be falsely increased or decreased depending on the method of analysis. Urinary glucose oxidase: aspirin may cause a false negative test in the presence of glycosuria.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Symptoms of overdosage
Methocarbamol:
Extreme drowsiness.
Aspirin:
Symptoms of mild salicylate intoxication (which occurs after repeated administration of high doses) include dizziness, tinnitus, deafness, sweating, nausea and vomiting, headache, and mental confusion, and may be controlled by reduced dosage. Symptoms of more severe intoxication or of acute overdosage include hyperventilation, fever, restlessness, ketosis, and respiratory alkalosis and metabolic acidosis. Depression of the central nervous system may lead to coma, cardiovascular collapse, and respiratory failure. In children drowsiness and metabolic acidosis commonly occur, hypoglycaemia may be severe.
Treatment of overdosage:
Gastric lavage is recommended with appropriate symptomatic and supportive therapy for at least 24 hours as methocarbamol is excreted at that time.
If salicylate overdosage occurs, especially in children, the stomach should be emptied by aspiration and lavage. Repeated doses of oral suspensions of activated charcoal should be administered to remove unabsorbed actives. In patients with mild intoxication should be encouraged to drink plenty of fluids. Patients with more severe intoxication forced alkaline diuresis may be required. Plasma electrolytes, especially potassium, and the acid-base balance should be monitored regularly. In the presence of cardiac or renal impairment or in severe intoxication, haemodialysis or haemoperfusion may need to be considered.

IDENTIFICATION:
A pink and white flat, bevelled tablet, "CE" engraved on the white side and bisected on the pink side.

PRESENTATION:
“Blister" Packs of 30 tablets.
Securitainers of 100 tablets.

STORAGE INSTRUCTIONS:
Store below 25°C. Protect from light and moisture.
KEEP OUT OF REACH OF CHILDREN.

REFERENCE NUMBER:
B.1553 (Act 101/1965).

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
PHARMACARE LIMITED
(Co. Reg. No. 04/00252/06)
7 Fairclough Avenue
Port Elizabeth
6014

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
6 November 1979

Updated on this site: October 2004
Source: Pharmaceutical Industry

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