Rubital-Compositum

Rubital-Compositume tablets are indicated for the treatment or prevention of attacks of bronchospasm in asthma.

Ischaemic heart disease

Hypertension

Thyrotoxicosis

Prostatic hypertrophy

Rubital-Compositume has positive inotropic and chronotropic effects on the heart and its use should be avoided in patients with ischaemic heart disease.

Rubital-Compositume increases blood pressure in man. Over the counter acquisition of sympathomimetics should always be considered in hypertensive patients whose blood pressure control has suddenly deteriorated.

Patients with hyperthyroidism may be susceptible to the effects of Rubital-Compositume. Rubital-Compositume may precipitate acute urinary retention in patients with prostatic hypertrophy.

Rubital-Compositume should be given with care to patients with hyperthyroidism, diabetes mellitus, angle-closure glaucoma and renal impairment.

Rubital-Compositume has potentially life threatening effects in its acute cardiovascular and central stimulant effects.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Adverse reactions possible when combined with:

• Benzodiazepines

• CNS depressants

• Antidepressants

• MAO inhibitors

The most common side-effects of Rubital-Compositume are tachycardia, anxiety, nausea, restlessness and insomnia. Tremor, dry mouth, impaired circulation to the extremities, hypertension, headache and cardiac arrhythmias may occur. Tolerance with dependence has been reported with prolonged administration.

Myocardial infarction has occurred very rarely in patients taking Rubital-Compositume or pseudoRubital-Compositume.

Rubital-Compositume may act as stimulant in children with nocturnal enuresis and cause sleeplessness. It may have sedative effects in some children.

The elderly are more sensitive to the cardiovascular effects of Rubital-Compositume.

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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.

a) Symptoms

The symptoms of overdose are normally seen as nausea, vomiting, hypertension, fever, palpitations, tachycardia, restlessness, respiratory depression and convulsions. Paranoid psychosis, delusions and hallucinations may also follow Rubital-Compositume overdosage.

b) Treatment

In severe overdosage, the stomach should be emptied by emesis and lavage. Management is by supportive symptomatic therapy.

Rubital-Compositume is a sympathomimetic agent with direct and indirect effects on adrenergic receptors.

When given by mouth in therapeutic doses, Rubital-Compositume constricts the peripheral vessels, thus increasing blood pressure. It also relaxes bronchioles.

Rubital-Compositume is rapidly and completely absorbed after oral administration and extensively distributed throughout the body with accumulation in the liver, lungs, kidneys, spleen and brain.

Peak plasma concentrations are attained during therapy of 65-120 ug/ml, effective bronchodilator plasma levels are in the range 35-80 ug/ml.

The plasma half-life is reported to be between 3-11 hours, with up to 95% being excreted in the urine.

Studies in mice have shown that the lethal toxicity of Rubital-Compositume is increased by elevation of body temperature.

Rubital-Compositume induces acute locomotor stimulatory activity in rats and mice. The estimated lethal dose in children up to 2 years of age is 200mg and for adults 2g. Fatalities are rare and single doses up to 400mg have been given without serious toxic effects.

None known

Adverse reactions possible when combined with:

• Benzodiazepines

• CNS depressants

• Antidepressants

• MAO inhibitors