Ventolin 2 mg/5 ml Oral Solution

Section 4.1:

Simplified indication and added:

Ventolin Oral Solution is indicated for the treatment or prevention of bronchospasm. It provides short acting bronchodilation in reversible airways obstruction due to asthma and chronic obstructive pulmonary disease (COPD) such as chronic bronchitis and emphysema.

 

Section 4.3:

Revised to read ‘Hypersensitivity to the active substance or any of the excipients listed in section 6.1’

 

All reference to obstetric use has been deleted as requested by HPRA.

 

Section 4.4:

Updated the warning ‘Bronchodilators should not be the only or main treatment in patients with persistent asthma...’, to read:

Bronchodilators should not be the only or main treatment in patients with persistent asthma. In patients with persistent asthma unresponsive to salbutamol, treatment with inhaled corticosteroids is recommended to achieve and maintain control. Failing to respond to treatment with salbutamol may signal a need for urgent medical advice or treatment.

 

Added the excipient statements ‘Ventolin Oral Solution contains 5.6 mg sodium in each 5 ml of Oral Solution.  This should be taken into consideration by patients on a controlled sodium diet.  Ventolin Oral Solution is sugar free’.

 

Section 4.6:

Added the following statement regarding Fertility: ‘There is no information on the effects of salbutamol on human fertility. There were no adverse effects on fertility in animals (see section 5.3)’.

 

Section 4.9:

Added statement regarding Lactic acidosis: ‘Lactic acidosis has been reported in association with high therapeutic doses as well as overdoses of short-acting beta-agonist therapy, therefore monitoring for elevated serum lactate and consequent metabolic acidosis (particularly if there is persistence or worsening of tachypnea despite resolution of other signs of bronchospasm such as wheezing) may be indicated in the setting of overdose’.

 

Regarding the treatment of overdose, updated the statement ‘Further management should be as clinically indicated or as recommended by the national poisons centre, where available’

 

Section 5.1:

Updated the following statement to include duration of affect and indication and to remove the statement ‘with little or no action on the beta-1 adrenoceptors of the heart’, to read: ‘Salbutamol is a selective beta-2 adrenoceptor agonist. At therapeutic doses it acts on the beta-2 adrenoceptors of bronchial muscle providing short acting (4 to 6 hour) bronchodilation in reversible airways obstruction’.

 

Section 5.3:

Added ‘Reproduction studies in rats demonstrated no evidence of impaired fertility at oral doses of salbutamol up to 50 mg/kg’.

 

Section 6.2:

Added the following statement ‘Dilution of Ventolin Oral Solution with syrup BP or sorbitol solution is not recommended as this may result in precipitation of the cellulose thickening agent’.

 

Section 6.6:

Added the following instruction ‘to avoid the possibility of introducing excessive microbial contamination, the Purified Water used for dilution should be recently prepared or alternatively it should be boiled and cooled immediately before use’.

 

Editorial updates to amend the spelling of ‘sulphate’ to ‘sulfate’ and to re-position texts in following sections :  2,  4.8 and 5.2

 

Update to MA holder contact details - Address change

Section 4.3 - Replaced the statement regarding use in obstetrics to the clearer ‘non-intravenous formulations of salbutamol must not be used to arrest uncomplicated premature labour or threatened abortion’.

 

Section 7: Removal of  Allen and Hanbury trading style.  This not a 'new' SPC but had to retire the A&H SPC from Medicines.ie and add the 'new' GSK Ireland Limited SPC.