BECOTIDE EVOHALER Pressurised inhalation, solution (2021)
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Περιεχόμενα
1. Name of the medicinal product
Becotide Evohaler 50 micrograms, Pressurised Inhalation Solution.
2. Qualitative and quantitative composition
One metered dose contains 50 micrograms of Beclometasone Dipropionate. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Pressurised Inhalation, Solution. Clear and colourless solution in an aluminium canister with a valve.
4.1. Therapeutic indications
Severe asthma requires regular medical assessment as death may occur. Patients with severe asthma have constant symptoms and frequent exacerbations, with limited physical capacity, and PEF values below ...
4.2. Posology and method of administration
Becotide Evohaler is for oral inhalation use only. Patients should be made aware of the prophylactic nature of therapy with inhaled beclometasone dipropionate and that it should be taken regularly even ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in Section 6.1.
4.4. Special warnings and precautions for use
The management of asthma should follow a stepwise programme, and patient response should be monitored clinically and by lung function tests. Increasing use of short-acting inhaled beta-2-agonists to control ...
4.5. Interaction with other medicinal products and other forms of interaction
Beclomethasone is less dependent on CYP3A metabolism than some other corticosteroids, and in general interactions are unlikely; however the possibility of systemic effects with concomitant use of strong ...
4.6. Pregnancy and lactation
Pregnancy There is inadequate evidence of the safety of beclometasone dipropionate or Norflurane (HFA 134a or Tetrafluoroethane) propellant in human pregnancy. In animal reproduction studies with beclometasone ...
4.7. Effects on ability to drive and use machines
Becotide Evohaler has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
Adverse reactions are listed below by system organ class and frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1000 and <1/100), rare (≥1/10,000 and <1/1000), ...
4.9. Overdose
Further management should be as clinically indicated or as recommended by the national poisons centre, where available. There is no specific treatment for an overdose of beclometasone dipropionate. If ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group, ATC code:</b> not yet assigned Beclometasone dipropionate is a pro-drug with weak glucocorticoid receptor binding affinity. It is hydrolysed via esterase enzymes to the active ...
5.2. Pharmacokinetic properties
Absorption When administered via inhalation (via metered dose inhaler), systemic absorption of unchanged beclometasone dipropionate (BDP) occurs through the lungs with negligible oral absorption of the ...
5.3. Preclinical safety data
Preclinical safety studies indicate that beclometasone dipropionate shows negligible systemic toxicity when administered by the inhaled route. The non-CFC propellant, Norflurane (HFA134a), has been shown ...
6.1. List of excipients
Norflurane (Hydrofluoroalkane (HFA) 134a) Ethanol anhydrous Glycerol
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
2 years.
6.4. Special precautions for storage
Do not store above 30°C. Protect from frost and direct sunlight. Do not refrigerate or freeze. As with most inhaled medications in aerosol canisters, the therapeutic effect of this medication may decrease ...
6.5. Nature and contents of container
The inhaler comprises an aluminium can fitted with a 50 microlitre metering valve, plastic actuator and dust cap. Each canister contains 200 metered doses.
6.6. Special precautions for disposal and other handling
Any used medicinal product or waste material should be disposed of in accordance with local requirements. Patients should be carefully monitored in the proper use of their inhaler.
7. Marketing authorization holder
GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
8. Marketing authorization number(s)
PA1077/042/006
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 07 January 2005 Date of last renewal: 07 January 2010
10. Date of revision of the text
December 2021
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