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SPC, UK: ASMANEX TWISTHALER Inhalation powder (2017)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Asmanex Twisthaler 200 micrograms Inhalation Powder.

Qualitative and quantitative composition

Each delivered dose contains 200 micrograms of mometasone furoate. Excipients with known effect: The maximum recommended daily dose contains lactose 4.64 mg per day. For the full list of excipients, see ...

Pharmaceutical form

Inhalation powder. White to off-white powder agglomerates.

Therapeutic indications

Asmanex Twisthaler 200 micrograms Inhalation Powder is indicated in adults and adolescents 12 years of age and older for regular treatment to control persistent asthma.

Posology and method of administration

Posology Dosage recommendations are based on severity of asthma (see criteria below). Patients with persistent mild to moderate asthma The recommended starting dose for most of these patients is 400 micrograms ...

Contraindications

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

Special warnings and precautions for use

Oral candidiasis During clinical trials, oral candidiasis, which is associated with the use of this class of medicinal product, occurred in some patients. This infection may require treatment with appropriate ...

Interaction with other medicinal products and other forms of interaction

Due to the very low plasma concentration achieved after inhaled dosing, clinically significant drug interactions are unlikely. However, there may be a potential for increased systemic exposure to mometasone ...

Fertility, pregnancy and lactation

Pregnancy There are no or limited amount of data from the use of mometasone furoate in pregnant women. Studies in animals with mometasone furoate, like other glucocorticoids, have shown reproductive toxicity ...

Effects on ability to drive and use machines

Asmanex Twisthaler 200 micrograms Inhalation Powder has no or negligible influence on the ability to drive and use machines.

Undesirable effects

Summary of safety profile In placebo-controlled clinical trials, oral candidiasis was very common (>10%) in the 400 micrograms twice daily treatment group; other common (1-10%), treatment-related undesirable ...

Overdose

Because of the low systemic bioavailability of this product, overdose is unlikely to require any therapy other than observation, followed by initiation of the appropriate prescribed dosage. Inhalation ...

Pharmacodynamic properties

Pharmacotherapeutic group: Other Antiasthmatics, Inhalants, - Glucocorticoids ATC code: R03BA07 Mechanism of action Mometasone furoate is a topical glucocorticoid with local anti-inflammatory properties. ...

Pharmacokinetic properties

Absorption The systemic bioavailability of mometasone furoate following oral inhalation in healthy volunteers is low, due to poor absorption from the lungs and the gut and extensive pre-systemic metabolism. ...

Preclinical safety data

Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to clinical exposure levels and with possible relevance to clinical use were as follows. General Toxicology ...

List of excipients

Lactose anhydrous (which contains trace amounts of milk proteins).

Incompatibilities

Not applicable.

Shelf life

Shelf life As packaged for sale: 2 years. After first opening: 3 months.

Special precautions for storage

Store in original package in order to protect from moisture. Do not refrigerate or freeze. Do not store above 30°C.

Nature and contents of container

Multi-dose powder inhaler. A counter on the device indicates the number of doses remaining. The 200 microgram powder inhaler is coloured white with a pink base, and is a multi-component device composed ...

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

Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU, UK

Marketing authorization number(s)

PL 00025/0588

Date of first authorization / renewal of the authorization

30 April 2001 / 9 August 2006

Date of revision of the text

30<sup>th</sup> November 2017

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