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SPC, UK: AVELOX Film-coated tablets (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Avelox 400 mg film-coated tablets.

Qualitative and quantitative composition

1 film-coated tablet contains 400 mg moxifloxacin (as hydrochloride). Excipient with known effect: The film-coated tablet contains 68mg lactose monohydrate (=66.56 mg lactose) (see section 4.4). For the ...

Pharmaceutical form

Film-coated tablet. Dull red film-coated tablet with an oblong, convex shape with facet, a dimension of 17 7 mm, and marked with M400 on one side and BAYER on the other side.

Therapeutic indications

Avelox 400 mg film-coated tablets are indicated for the treatment of the following bacterial infections in patients of 18 years and older caused by bacteria susceptible to moxifloxacin (see sections 4.4, ...

Posology and method of administration

Posology (adults) The recommended dose is one 400 mg film-coated tablet once daily. Renal/hepatic impairment No adjustment of dosage is required in patients with mild to severely impaired renal function ...

Contraindications

Hypersensitivity to moxifloxacin, other quinolones or to any of the excipients listed in section 6.1. Pregnancy and lactation (see section 4.6). Patients below 18 years of age. Patients with a history ...

Special warnings and precautions for use

The benefit of moxifloxacin treatment especially in infections with a low degree of severity should be balanced with the information contained in the warnings and precautions section. Prolongation of QTc ...

Interaction with other medicinal products and other forms of interaction

Interactions with medicinal products An additive effect on QT interval prolongation of moxifloxacin and other medicinal products that may prolong the QTc interval cannot be excluded. This might lead to ...

Fertility, pregnancy and lactation

Pregnancy The safety of moxifloxacin in human pregnancy has not been evaluated.. Animal studies have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown. Due to the ...

Effects on ability to drive and use machines

No studies on the effects of moxifloxacin on the ability to drive and use machines have been performed. However, fluoroquinolones including moxifloxacin may result in an impairment of the patients ability ...

Undesirable effects

Adverse reactions based on all clinical trials and derived from post-marketing reports with moxifloxacin 400 mg (oral and sequential therapy) sorted by frequencies are listed below: Apart from nausea and ...

Overdose

No specific countermeasures after accidental overdose are recommended. In the event of overdose, symptomatic treatment should be implemented. ECG monitoring should be undertaken, because of the possibility ...

Pharmacodynamic properties

Pharmacotherapeutic group: Quinolone antibacterials, fluoroquinolones ATC code: J01MA14 Mechanism of action Moxifloxacin has in vitro activity against a wide range of Gram-positive and Gram-negative pathogens. ...

Pharmacokinetic properties

Absorption and Bioavailability Following oral administration moxifloxacin is rapidly and almost completely absorbed. The absolute bioavailability amounts to approximately 91%. Pharmacokinetics are linear ...

Preclinical safety data

Effects on the haematopoetic system (slight decreases in the number of erythrocytes and platelets) were seen in rats and monkeys. As with other quinolones, hepatotoxicity (elevated liver enzymes and vacuolar ...

List of excipients

Tablet core: Microcrystalline cellulose Croscarmellose sodium Lactose monohydrate Magnesium stearate Film-coat: Hypromellose Macrogol 4000 Ferric oxide (E172) Titanium dioxide (E171)

Incompatibilities

Not applicable.

Shelf life

*Shelf life: 5 years.

Special precautions for storage

Polypropylene/aluminium and polyvinyl chloride/polyvinylidene chloride/aluminium blisters: Do not store above 25°C. Store in the original package in order to protect from moisture. Aluminium/aluminium ...

Nature and contents of container

Cartons containing colourless transparent or white opaque polypropylene/aluminium blisters or colourless transparent polyvinyl chloride/polyvinylidene chloride/aluminium blisters: The film-coated tablets ...

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

Bayer plc, 400 South Oak Way, Reading RG2 6AD

Marketing authorization number(s)

PL 00010/0291

Date of first authorization / renewal of the authorization

13 March 2003/12 February 2010

Date of revision of the text

03/2019

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