Avelox 400 mg film-coated tablets

Each film-coated tablet contains 400 mg moxifloxacin as hydrochloride.

Excipient: The film-coated tablet contains lactose monohydrate (see section 4.4).

For a full list of excipients, see section 6.1.

Film-coated tablet

Dull red tablets marked with “M400” on one side and “BAYER” on the reverse.

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, 4.8 and 5.1). Moxifloxacin should be used only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of these infections or when these have failed:

- Acute bacterial sinusitis (adequately diagnosed)

- Acute exacerbations of chronic bronchitis (adequately diagnosed)

- Community acquired pneumonia, except severe cases

- Mild to moderate pelvic inflammatory disease (i.e. infections of female upper genital tract, including salpingitis and endometritis), without an associated tubo-ovarian or pelvic abscess.

Avelox 400 mg film-coated tablets are not recommended for use in monotherapy of mild to moderate pelvic inflammatory disease but should be given in combination with another appropriate antibacterial agent (e.g. a cephalosporin) due to increasing moxifloxacin resistance of Neisseria gonorrhoeae unless moxifloxacin-resistant Neisseria gonorrhoeae can be excluded (see sections 4.4 and 5.1).

Avelox 400 mg film-coated tablets may also be used to complete a course of therapy in patients who have shown improvement during initial treatment with intravenous moxifloxacin for the following indications:

- Community-acquired pneumonia

- Complicated skin and skin structure infections

Avelox 400 mg film-coated tablets should not be used to initiate therapy for any type of skin and skin structure infection or in severe community-acquired pneumonia.

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Dosage (adults)

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 or in patients on chronic dialysis i.e. haemodialysis and continuous ambulatory peritoneal dialysis (see section 5.2 for more details).

There is insufficient data in patients with impaired liver function (see section 4.3).

Other special populations

No adjustment of dosage is required in the elderly and in patients with low bodyweight.

Children and adolescents

Moxifloxacin is contraindicated in children and adolescents (< 18 years). Efficacy and safety of moxifloxacin in children and adolescents have not been established (see section 4.3).

Method of administration

The film-coated tablet should be swallowed whole with sufficient liquid and may be taken independent of meals.

Duration of administration

Avelox 400 mg film-coated tablets should be used for the following treatment durations:

Avelox 400 mg film-coated tablets have been studied in clinical trials for up to 14 days treatment.

The recommended dose (400 mg once daily) and duration of therapy for the indication being treated should not be exceeded.

- Hypersensitivity to moxifloxacin, other quinolones or to any of the excipients.

- Pregnancy and lactation (see section 4.6).

- Patients below 18 years of age.

- Patients with a history of tendon disease/disorder related to quinolone treatment.

Both in preclinical investigations and in humans, changes in cardiac electrophysiology have been observed following exposure to moxifloxacin, in the form of QT prolongation. For reasons of drug safety, moxifloxacin is therefore contraindicated in patients with:

- Congenital or documented acquired QT prolongation

- Electrolyte disturbances, particularly in uncorrected hypokalaemia

- Clinically relevant bradycardia

- Clinically relevant heart failure with reduced left-ventricular ejection fraction

- Previous history of symptomatic arrhythmias

Moxifl