This information is intended for use by health professionals

1. Name of the medicinal product

SALBUTAMOL TABLETS BP 2mg

2. Qualitative and quantitative composition

Each tablet contains 2.4mg salbutamol sulfate equivalent to 2mg salbutamol.

Excipients with known effect:

Each 2mg tablet contains:

- 60.05mg Lactose monohydrate

- Carmoisine (E122)

For the full list of excipients, see section 6.1

3. Pharmaceutical form

Tablets for oral administration.

4. Clinical particulars
4.1 Therapeutic indications

Salbutamol Tablets are indicated in adults, adolescents and children aged 2 to 12 years.

1. For the relief of bronchospasm in bronchial asthmas of all types.

2. Chronic bronchitis.

3. Emphysema.

4.2 Posology and method of administration

Posology

Adults:

The usual effective dose is 4mg three or four times per day. If adequate bronchodilation is not obtained each single dose may be gradually increased to as much as 8mg. However, it has been established that some patients obtain adequate relief with 2mg three or four times daily. In elderly patients or in those known to be unusually sensitive to beta-adrenergic stimulant drugs, it is advisable to initiate treatment with 2mg three or four times per day.

Children:

The following doses should be administered three or four times daily.

2-6 years: 1-2mg

6-12 years: 2mg

Over 12 years: 2-4mg

The product is not recommended for children under 2 years of age. The drug is well tolerated by children so that, if necessary, these doses may be cautiously increased.

Method of administration

For oral use.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Salbutamol should not be used for threatened abortion during the first or second trimester of pregnancy.

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

4.4 Special warnings and precautions for use

Bronchodilators should not be the only or main treatment in patients with severe or unstable asthma.

Increasing use of bronchodilators in particular short-acting inhaled beta2-agonists to relieve symptoms indicates deterioration of asthma control. If patients find that short acting relief bronchodilator treatment becomes less effective or they need more inhalations than usual, medical attention must be sought.

Salbutamol causes peripheral vasodilation which may result in reflex tachycardia and increased cardiac output

Hyperthyroidism

Salbutamol should only be administered cautiously to patients suffering from thyrotoxicosis after careful evaluation of the benefits and risks of treatment.

Constant monitoring of potassium levels in patients with severe asthma is essential, potentially serious hypokalaemia may result from beta-2 agonist therapy.

Diabetes

Administration of beta agonists is associated with a rise of blood glucose. Therefore blood glucose and lactate levels should be monitored in diabetics and diabetic treatment adjusted accordingly to meet the needs of the diabetic during tocolysis (see section 4.5). Diabetic patients may be unable to compensate for the increase in blood glucose and the development of ketoacidosis has been reported.

Concurrent administration of corticosteroids can exaggerate this effect.

Cardiovascular effects may be seen with sympathomimetic drugs, including salbutamol. There is some evidence from post-marketing data and published literature of myocardial ischaemia associated with beta agonists.

Respiratory indications

Patients with underlying severe heart disease (e.g. ischaemic heart disease, arrhythmia or severe heart failure) who are receiving salbutamol should be warned to seek medical advice if they experience chest pain or other symptoms of worsening heart disease. Attention should be paid to assessment of symptoms such as dyspnoea and chest pain, as they may be of either respiratory or cardiac origin.

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

Salbutamol tablets contain carmoisine (E122) which may cause allergic reactions

4.5 Interaction with other medicinal products and other forms of interaction

The effects of salbutamol may be altered by guanethidine, reserpine, methyldopa, tricyclic antidepressants and monoamine oxidase inhibitors.

There is an increased risk of hypokalaemia if high doses of theophylline or high doses of corticosteroids are given with higher doses of salbutamol.

Halogenated anaesthetics

Owing to the additional antihypertensive effect, there is increased uterine inertia with risk of haemorrhage; in addition, serious ventricular rhythm disorders due to increased cardiac reactivity, have been reported on interaction with halogenated anaesthetics. Treatment should be discontinued, whenever possible, at least 6 hours before any scheduled anaesthesia with halogenated anaesthetics.

Anti-diabetics

The administration of beta-agonists is associated with a rise of blood glucose, which can be interpreted as an attenuation of anti-diabetic therapy; therefore individual anti-diabetic therapy may need to be adjusted (see section 4.4).

Potassium depleting agents

Owing to the hypokalaemic effect of beta-agonists, concurrent administration of serum potassium depleting agents known to exacerbate the risk of hypokalaemia, such as diuretics, digoxin, methyl xanthines and corticosteroids, should be administered cautiously after careful evaluation of the benefits and risks with special regard to the increased risk of cardiac arrhythmias arising as a result of hypokalaemia (see section 4.4).

4.6 Fertility, pregnancy and lactation

Pregnancy

Salbutamol should only be used during pregnancy if it is considered essential by the physician.

Breast-feeding

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.

4.7 Effects on ability to drive and use machines

None known.

4.8 Undesirable effects

The frequencies of adverse reactions are ranked according to the following MedDRA convention: Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000); Not known (cannot be estimated from the available data).

System organ class

Common

Uncommon

Rare

Very rare

Not known

Immune system disorders

Hypersensitivity reactions including angioedema, urticaria, bronchospasm, hypotension and collapse

Metabolism and nutrition disorders

Lactic acidosis

Hypokalaemia

Nervous system disorders

Headaches

Myoclonus

Cardiac disorders

Peripheral vasodilation and compensatory increase in heart rate*

Cardiac arrhythmias

Myocardial ischemia**

Respiratory, thoracic and mediastinal disorders

Pulmonary oedema

Musculoskeletal and connective tissue disorders

Skeletal muscle tremor***

Tense feeling****

* With doses of salbutamol higher than those recommended or in patients who are unusually sensitive to beta-adrenergic stimulants.

** There have been spontaneously reports of myocardial ischemia in post-marketing experience (frequency unknown, see section 4.4).

*** A fine tremor, which occurs in some patients, usually the hands and the effects are dose related.

**** Due to the effects on skeletal muscle and not to direct CNS stimulation.

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; website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9 Overdose

The preferred antidote for overdosage with salbutamol is a cardioselective beta blocking agent, but beta blocking drugs should be used with caution in patients with a history of bronchospasm.

Hypokalaemia may occur following overdose with salbutamol. Serum potassium levels should be monitored.

5. Pharmacological properties
5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Selective beta-2-adrenoreceptor agonists, ATC code: R03CC02

Salbutamol is a selective Beta-2-adrenergic agonist administered for the symptomatic relief of bronchospasm associated with chronic or acute asthma, bronchitis or other obstructive pulmonary diseases. Because of its relative specificity for β2 receptors, salbutamol relaxes smooth muscle of the bronchi, uterus and vascular supply to the skeletal muscle, but generally has much less stimulant action on the heart than does isoproterenol which has powerful action on all beta receptors.

5.2 Pharmacokinetic properties

Absorption

Salbutamol is readily absorbed from the gastrointestinal tract. Its effects occur within 15 minutes and last for about 14 hours.

The peak plasma concentration of salbutamol and its metabolites is 5.1-11.7μg% at 2.5-3 hours after an oral dose of 4mg. Salbutamol does not cross the blood brain barrier to a significant extent, but it crosses the placental barrier.

Elimination

The drug is excreted in urine in about 24 hours, 50% of the drug being excreted within 4 hours.

5.3 Preclinical safety data

None stated.

6. Pharmaceutical particulars
6.1 List of excipients

The tablets also contain: maize starch, lactose monohydrate, dispersed pink (erythrosine (E127), carmoisine (E122), titanium dioxide (E171)), sodium starch glycollate, talc, magnesium stearate.

6.2 Incompatibilities

None known.

6.3 Shelf life

2 years

6.4 Special precautions for storage

Store below 25°C in a dry place.

6.5 Nature and contents of container

Polypropylene tubes with low density polyethylene caps. Packing material: high density polyethylene film.

28s, 30s, 56s, 60s, 84s, 100s, 250s, 500s, 1000s

Polyethylene container with a polypropylene lid.

28s

6.6 Special precautions for disposal and other handling

No special requirements.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Administrative Data

7. Marketing authorisation holder

Accord-UK Ltd

(Trading style: Accord)

Whiddon Valley

Barnstaple

Devon

EX32 8NS

8. Marketing authorisation number(s)

PL 0142/0485

9. Date of first authorisation/renewal of the authorisation

Date of first authorization: 18 December 1998

Date of latest renewal: 23 October 2000

10. Date of revision of the text

22/08/2019