Adwifloxacen 400mg

Indication :

To treat infections that might get better without treatment or are not severe (such as throat infections);

To treat non-bacterial infections, e.g. non-bacteria! (Chronic) prostatitis;

For preventing traveller’sdiarrhoea or recurring lower urinary tract infections (urine infections that do not extend beyond the bladder);

To treat mild or moderate bacterial infections unless other antibacterial medicines commonly recommended for these infections cannot be used.

Adwifloxacen 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.

Adwifloxacen 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).

Adwifloxacen 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

Adwifloxacen 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

Composition :

1 film-coated tablet contains 400 mg moxifloxacin (as hydrochloride).436.8 mg

Excipient with known effect:Microcrystalline Cellulose PH 102 - Magnesium Stearate- Croscarmellose Sodium - Hydroxypropyl methyl cellulose- Polyethylene Glycol 6000- Titanium dioxide- Talc purified