SALBUTAMOL Tablets (2019)
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Περιεχόμενα
Name of the medicinal product
SALBUTAMOL TABLETS BP 2mg.
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, ...
Pharmaceutical form
Tablets for oral administration.
Therapeutic indications
Salbutamol Tablets are indicated in adults, adolescents and children aged 2 to 12 years. For the relief of bronchospasm in bronchial asthmas of all types. Chronic bronchitis. Emphysema.
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 ...
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 ...
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 beta<sub>2</sub>-agonists to relieve ...
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 ...
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 ...
Effects on ability to drive and use machines
None known.
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); ...
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 ...
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 ...
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 ...
Preclinical safety data
None stated.
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
Incompatibilities
None known.
Shelf life
Shelf life: 2 years.
Special precautions for storage
Store below 25°C in a dry place.
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. ...
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.
Marketing authorization holder
Actavis UK Limited (Trading style: Actavis), Whiddon Valley, BARNSTAPLE, N Devon EX32 8NS
Marketing authorization number(s)
PL 0142/0485
Date of first authorization / renewal of the authorization
Date of first authorization: 18 December 1998 Date of latest renewal: 23 October 2000
Date of revision of the text
15/01/2019
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