SALAPIN - Salbutamol Syrup 2mg/5ml

Each 5ml contains Salbutamol Sulphate BP equivalent to 2 mg of Salbutamol.

Oral Solution - Raspberry Cola flavoured, sugar-free syrup.

Salbutamol is a selective β₂-agonist broncodilator which provides short acting bronchodilation in reversible airways obstruction. SALAPIN is used to rapidly treat asthma, bronchospasm and reversible airways obstruction by widening the airways of the lungs. SALAPIN – Salbutamol Syrup 2mg/5ml is suitable for children and adults who are unable to use an inhaler device.

For oral administration. Shake the bottle before use. An oral syringe may be used to measure doses less than 5ml.

The usual adult dose is (4mg) two 5 ml spoonfuls (10ml), 3 or 4 times per day which may be increased to a maximum of (8mg) four 5 ml spoonfuls (20ml), 3 or 4 times per day. The minimum starting dose is (2mg) one 5 ml spoonful (5ml), 3 or 4 times per day.

In elderly patients and patients who are unusually sensitive to this class of medicine treatment may be initiated with (2mg) one 5 ml spoonful (5ml), 3 or 4 times per day.

In children specific dosages depending on the child's age are as follows:

For children aged 2 to 6 years: (1-2mg) half - one 5 ml spoonful (2.5–5ml), 3 or 4 times per day.

For children aged 6 to 12 years: (2mg) one 5 ml spoonful (5ml), 3 or 4 times per day.

For children over 12 years: (2-4mg) one - two 5 ml spoonfuls (5-10ml), 3 or 4 times per day.

Although intravenous salbutamol and occasionally salbutamol syrup are used in the management of uncomplicated premature labour, salbutamol presentations should not be used for threatened abortion during the first or second trimester of pregnancy.

Should not be used in patients hypersensitive to any of the product ingredients.

Patients should be warned that if either the usual relief is diminished or the usual duration of action is reduced, they should not increase the dose or its frequency of administration, but should seek medical advice.

Salbutamol causes peripheral vasodilation which may result in reflex tachycardia and increased cardiac output. Caution should be used in patients suffering from angina, severe tachycardia or thyrotoxicosis.

Caution should be exercised in its use with anaesthetic agents such as chloroform, cyclopropane, halothane and other halogenated agents.

SALAPIN should not cause difficulty in micturition (urination) because unlike sympathomimetic drugs such as ephedrine, it does not stimulate α-adrenoceptors. However, there have been reports of difficulty in micturition in patients with prostatic enlargement.

SALAPIN should only be used during pregnancy if considered essential by the physician.

Use with caution in diabetic patients as this product may cause an increase in blood sugar levels. The development of ketoacidosis has been reported as diabetic patients may be unable to compensate for the increase in blood glucose. This effect can be exaggerated by concurrent administration of corticosteroids.

SALAPIN does not contain sugars.

This product should not be diluted.

In patients with severe or unstable asthma, bronchodilators should not be the only or main treatment. With severe asthma regular medical assessment is necessary, including lung-function testing as patients are at risk of severe attacks or possibly death. For the treatment of such patients, physicians should consider using the max recommended dose of inhaled corticosteroids and/or oral corticosteroids.

β₂-agonist therapy (from parenteral and nebulised administration) may result in potentially serious hypokalaemia. Special caution is required in acute severe asthma as this effect may be potentiated by hypoxia and by concomitant treatment with xanthine derivatives, diuretics and steroids. It is important to monitor serum potassium levels in such situations.

Patients taking SALAPIN may also be using short-acting inhaled bronchodilators to alleviate symptoms. A decrease in asthma control is indicated by an increase in the use of bronchodilators in particular short acting inhaled β-agonists. In such cases medical advice should be sought. Higher doses of inhaled corticosteroids or a course of oral corticosteroids may be considered.

Severe exacerbations of asthma must be treated in the usual manner.

This medicinal product contains small amounts of ethanol (alcohol), less than 100mg per 5ml dose.

Caution should be exercised during use with anaesthetic agents such as chloroform, cyclopropane, halothane and other halogenated agents.

The effects of this product may be altered by guanethidine, reserpine, methyldopa, tricyclic antidepressants.

Salbutamol oral preparations and beta-blocking drugs, such as propranolol should not usually be prescribed together.

SALAPIN is not contraindicated in patients under treatment with monoamine oxidase inhibitors (MAOI's)

SALAPIN should only be used in pregnancy and lactation if considered essential by the physician.

SALAPIN should only be used during pregnancy/lactation if the expected benefits to the mother are greater than any potential risks to the foetus/neonate.

As salbutamol is probably secreted in breast milk its use in nursing mothers requires careful consideration. It is not known whether salbutamol has a harmful effect on the neonate, and so its use should be restricted to situations where it is felt that the expected benefit to the mother is likely to outweigh any potential risk to the neonate.

Not applicable

The most common side effect of SALAPIN is fine tremor of the hands, which may interfere with precise manual work. Tension, restlessness and a rapid heart beat may also occur. There have been very rare reports of muscle cramps. Hypersensitivity reactions such as angiodema, urticaria, bronchospasm, hypotension and collapse have rarely been reported. Potentially serious hypokalaemia may result from β₂-agonist therapy. Occasional headaches have also been reported. As with other drugs in this class rare reports of hyperactivity in children have been reported.

The preferred antidote for overdose with salbutamol sulphate is a cardioselective beta-blocking agent, which should be used with caution in patients with a history of bronchospasm. SALAPIN overdose may lead to Hypokalaemia (abnormally low potassium concentration in the blood). Serum potassium levels should therefore be monitored.

As a beta-adrenergic stimulant for relief of bronchospasm such as occurs with asthma, bronchitis, emphysema. It has a highly selective action on the receptors in bronchial muscle and in therapeutic dosage, little or no action on the cardiac receptors.

There are no preclinical data of relevance to the prescriber which are additional to that in other sections of the SmPC.

As with the majority of drugs, there is little published evidence of its safety in the elderly stages of human pregnancy, but in animal studies there was evidence of some harmful effects on the foetus at very high dose levels.

Xanthan Gum (E415)

Glycerol (E422)

Sodium Citrate (E331)

Saccharin Sodium (E954)

Sodium Benzoate (E211)

Citric Acid Monohydrate

Raspberry Cola Flavour HSE (containing Ethanol, Propylene Glycol, Polysorbate (E432), Nutmeg Oil, Safrole and Cinnamic aldehyde)

Purified Water

Not applicable

36 months - amber glass bottle and HDPE bottle

Do not store above 25°C. Store in the original container.

100 ml, 150 ml and 200 ml type III amber glass bottle with Pilfer-Proof cap, screw cap or child resistant closure.

100 ml and 150 ml HDPE bottle with screw cap, tamper evident cap or child resistant closure.

No special instructions.

Pinewood Laboratories Limited,

Trading as: Pinewood healthcare

Ballymacarbry,

Clonmel,

Co. Tipperary

Ireland

PL 04917/0033

02/12/2008

02/09/2009