SPC, UK: BAMBEC Tablet (2017)

Therapeutic indications

Management of asthma, bronchospasm and/or reversible airways obstruction.

Posology and method of administration

Posology

Bambec is formulated as a tablet and should be taken once daily, shortly before bedtime. The dose should be individualised.

Patients must receive optimal anti-inflammatory therapy (e.g. inhaled corticosteroids, leukotriene receptor antagonists) when using Bambec for management of asthma.

Adults

The recommended starting doses are 10 mg–20 mg. The 10 mg dose may be increased to 20 mg if necessary after 1–2 weeks, depending on the clinical effect.

In patients who have previously tolerated β2-agonists well, the recommended starting dose, as well as maintenance dose, is 20 mg.

Elderly

Dose adjustment is not required in the elderly.

Hepatic Impairment

Significant hepatic dysfunction: Not recommended because of unpredictable conversion to terbutaline.

Renal impairment

Moderate to severely impaired renal function (GFR<50 ml/min): It is recommended that the starting dose of Bambec should be halved in these patients.

Paediatric population

Until the clinical documentation has been completed, Bambec should not be used in children.

Overdose

Symptoms

Overdosing may result in high levels of terbutaline and therefore the same symptoms and signs as recorded after overdosage with Bricanyl: Headache, anxiety, tremor, nausea, tonic muscle cramps, palpitations, tachycardia and cardiac arrhythmias.

A fall in blood pressure sometimes occurs after terbutaline overdosage.

Laboratory findings: Hyperglycaemia and lactic acidosis sometimes occur. High doses of β2-agonists may cause hypokalemia as a result of redistribution of potassium.

Overdosage with Bambec is likely to cause a considerable inhibition of plasma cholinesterase, that may last for days (see also section 4.5).

Management

Usually no treatment is required. In particularly severe cases of overdosage, the following measures may be considered on a case-by-case basis: Gastric lavage and activated charcoal.

Determine acid-base balance, blood glucose and electrolytes. Monitor heart rate and rhythm and blood pressure. The preferred antidote for haemodynamically significant cardiac arrhythmias is a cardioselective beta-blocking agent, but beta-blocking drugs should be used with caution in patients with a history of bronchospasm. If the β2-mediated reduction in peripheral vascular resistance significantly contributes to the fall in blood pressure, a volume expander should be given.

Shelf life

Shelf life: 3 years.

Special precautions for storage

Do not store above 30°C.

Nature and contents of container

Amber glass bottle with LD-polyethene cap: 7, 14, 28, 30, 56 or 100 tablets.
HDPE container with LD-polyethene cap: 7, 14, 28, 30, 56 or 100 tablets.
HDPE container with polypropylene cap: 7, 14, 28, 30, 56 or 100 tablets.
PVC blisters: 7, 14, 28, 30, 56 or 100 tablets.

Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements.