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COMPOSITION
Per tablet:
Methocarbamol
. 380 mg.
Paracetamol
. 300 mg.
Excipients: Stearic Acid. Pregelatinized maize starch. Croscarmellose Sodium. Magnesium stearate. Colloidal anhydrous silica. Povidone. Glyceryl distearate. Sodium carboxymethyl starch (Type A). Talc.
PROPERTIES
ROBAXISAL COMPUESTO is indicated for the treatment of osteoarticular pain associated with muscle spasms. Its efficacy is based on the combination of the muscle-relaxant action of methocarbamol and the analgesic and antipyretic action of paracetamol, which complement each other. The preparation has an excellent gastric tolerance
POSOLOGY (unless prescribed otherwise by your doctor)
Adults: The usual dose is 2 tablets four to six times daily depending on the severity of the case.
The administration of this preparation depends on the appearance of pain symptoms. As these start to disappear you should cease taking this medication.
INSTRUCTIONS FOR THE CORRECT ADMINISTRATION OF THE PREPARATION
The ingestion of the tablets may be easier if you swallow the tablets with the help of some water or other non-alcoholic liquid.
CONTRAINDICATIONS
- Hepatic diseases.
- Hypersensitivity to any of the ingredients in this preparation.
- Myasthenia gravis
PRECAUTIONS
Methocarbamol may interfere with certain screening tests for 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).
Prolonged used of Robaxisal compuesto should be avoided in patients with hepatic and / or renal insufficiency, anaemia and compromised cardiac or pulmonary function.
The recommended dose should not be exceeded.
WARNINGS
Caution should be taken when carrying out activities that require mental alertness, such as driving vehicles or operating machinery, because this medication may cause drowsiness.
PREGNANCY AND LACTATION
This medication should not be used in women who are pregnant or breastfeeding unless in the judgement of the physician the potential benefits outweigh the possible hazards.
INTERACTIONS
Robaxisal may potentiate the toxicity of chloramphenicol.
It may also potentiate the effects of central nervous system depressants and stimulants.
INCOMPATIBILITIES
None reported.
SIDE EFFECTS
Exceptionally asthenia, drowsiness, dizziness, ataxia, vertigo, etc. may occur. These symptoms easily disappear when the medication is discontinued or dose decreased.
Methocarbamol may rarely give rise to skin rash and blood disorders such as neutropenia or leucopenia.
Hepatoxicity may occur with high doses or prolonged treatment.
OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Symptoms of overdosage may include dizziness, vomiting, loss of appetite, jaundice and abdominal pain. In the case of an overdose you should go to a hospital immediately, even if you do not experience any symptoms, because the most serious ones are usually manifested as of the third day after ingestion. The ingestion of one dose of more than 6 gr. per kg. of body weight in adults and more than 100 mg. per kg. of body weight in children is considered a paracetamol overdose. Patients on barbiturate treatments or those who suffer chronic alcoholism are more susceptible to the toxicity of a paracetamol overdose.
Treatment consists of aspiration and gastric lavage, activated charcoal taken orally, appropriate intravenous doses of N-acetylcysteine; and, if necessary, haemodialysis. The period, in which treatment is likely to be more effective, is within the 12 hours following the ingestion of the overdose. If you have taken an overdose of this medication or have accidentally taken more than you should contact your local poison centre.
STORAGE CONDITIONS
No special storage conditions are necessary.
PRESENTATION
Robaxisal compuesto, tablets: Pack containing 50 tablets.
ALL MEDICATIONS MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN.
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