QUALITATIVE AND QUANTITATIVE COMPOSITION The product is a pressurised inhalation suspension, each actuation delivers 100 mcg of  salbutamol. 

PHARMACEUTICAL FORM Inhalation aerosol

CLINICAL PARTICULARS Therapeutic indications It is indicated for the relief of bronchospasm in patients with asthma or chronic  obstructive pulmonary disease (reversible obstructive airway disease), and for acute  prophylaxis against exercise-induced asthma or other stimuli known to induce  bronchospasm.  

Posology and method of administration The product is for oral inhalation use only. It may be used with a spacer device by  patients who find it difficult to synchronise aerosol actuation with inspiration of  breath.

Adults: For the relief of acute asthma symptoms including bronchospasm: one inhalation (100  micrograms) may be administered as a single minimum starting dose. This may be  increased to two inhalations if necessary.  To prevent allergen- or exercise-induced symptoms: it should be taken 10-15 minutes  before challenge. For chronic therapy, two inhalations up to four times a day.

Elderly: Initial doses of salbutamol in the elderly should be lower than the recommended adult  dosage. The dose may then be gradually increased if sufficient bronchodilatation is  not achieved.

For the relief of acute asthma symptoms including bronchospasm or before challenge  or exertion: one inhalation (100 micrograms) may be administered as recommended dose, the dose may be increased to two inhalations if required.  For chronic therapy, two inhalations up to four times a day. The spacer device may be used to facilitate administration to children under 5 years of age.

Impaired hepatic function: 

As about 60% of orally administered salbutamol (this includes not only tablet and  syrup preparations but also approximately 90% of an inhaled dose) is metabolised to  an inactive form, impairment of hepatic function may result in accumulation of  unchanged salbutamol.

Impaired renal function: 

About 60-70% of salbutamol administered by inhalation or intravenous injection is  excreted in the urine unchanged. Impairment of renal function may therefore require a  reduction in dosage to prevent exaggerated or prolonged effects. On-demand use of the product should not exceed 8 inhalations in any 24 hours. Reliance on such frequent supplementary use, or a sudden increase in dose, indicates  poorly controlled or deteriorating asthma, overdose of the drug can cause adverse  reactions. Therefore, the dosage or frequency of administration should only be  increased on medical advice (see warnings and precautions).