1 Name of the medicinal product
Binozyt : 250 mg film-coated tablets
: 500 mg film-coated tablets
2 Qualitative and quantitative composition
250 mg film-coated tablets:
1 film-coated tablet contains azithromycin monohydrate equivalent to 250 mg
500 mg film-coated tablets:
1 film-coated tablet contains azithromycin monohydrate equivalent to 500 mg
azithromycin For excipients, see section 6.1
3 Pharmaceutical form
250 mg film-coated tablets: white to off-white, oblong, film-coated, plain
on both sides
500 mg film-coated tablets: white to off-white, oblong, film-coated, deep
break line on one side and scoreline on other side.
4 Clinical Particulars
4.1 Therapeutic indications
Azithromycin is indicated for infections caused by susceptible organisms; in
lower respiratory tract infections, including bronchitis and pneumonia, in
skin and soft tissue infections, in acute otitis media and in upper
respiratory tract infections including sinusitis and pharyngitis/tonsillitis.
In sexually transmitted diseases in men and women, azithromycin is indicated
in the treatment of uncomplicated genital infections due to Chlamydia
4.2 Posology and method of administration
Binozyt should be given as a single daily dose. The tablets may be taken
with or without food.
For the treatment of sexually transmitted diseases caused by Chlamydia
trachomatis the dosage is 1000 mg as a single oral dose.
For all other
indications in which the oral formulation is administered, the total dosage
of 1500 mg should be given, 500 mg per day for three consecutive days. As an
alternative the same total dose (1500 mg) can also be administered over a
period of five days with 500 mg on the first day and 250 mg on the second to
the fifth day.
The same dose range as in younger patients may be used in the elderly.
Binozyt tablets should only be administered to children weighing more than
45 kg when normal adult dose should be used. The maximum recommended total
dose for any treatment is 1500mg for children. For children under 45 kg
other pharmaceutical forms of azithromycin, e.g. suspensions, may be used.
In patients with renal impairment:
No dose adjustment is necessary in patients with mild to moderate renal
impairment (GFR 10-80 ml/min) or severe (GFR<10ml/min) renal impairment (see
In patients with hepatic impairment:
The same dosage as in patients with normal hepatic function may be used in
patients with mild to moderate hepatic impairment (see section 4.4).
The use of azithromycin is contraindicated in patients with hypersensitivity
to azithromycin, to other macrolide antibiotics, or to any of the excipients
(see section 4.4).
4.4 Special warnings and special precautions for use
Rare serious allergic reactions including angioneurotic oedema and
anaphylaxis (rarely fatal), have been reported. Some of these reactions with
azithromycin have resulted in recurrent symptoms and required a longer
period of observation and treatment.
Patients with rare congenital abnormalities such as fructose intolerance,
glucosegalactose malabsorption syndrome or sucrose-isomaftase-insufficiency
should not use this medicinal product. Observations for signs of
superinfection with nonsusceptible organisms, including fungi is
Pseudomembranous colitis has been reported with the use of macrolide
antibiotics. This diagnosis should therefore be considered in patients who
get diarrhoea after starting the treatment with azithromycin. Should
pseudomembranous colitis be induced by azithromycin, then anti-peristaltics
should be contraindicated.
There is no experience regarding the safety and efficacy of the long-term
application of azithromycin for the above mentioned indications. In case of
quickly recurring infections, treatment with an other antibacterial agent
should be considered. Due to the theoretical possibility of ergotism,
azithromycin and ergot derivatives should not be coadministered (see section
Prolonged cardiac repolarisation and QT interval, imparting a risk of
developing cardiac arrhythmia and torsades de pointes, have been seen in
treatment with other macrolides. A similar effect with azithromycin cannot
be completely ruled out in patients at increased risk for prolonged cardiac
repolarisation. Therefore azithromycin should not be used:
- in patients with congenital or documented acquired QT prolongation.
- with other active substances that prolong QT interval such as
antiarrhythmics of classes IA and III, cisapride and terfenadine.
- in patients with electrolyte disturbance, particularly in cases of
hypokalaemia and hypomagnesaemia
- in patients with clinically relevant bradycardia, cardiac arrhythmia or
severe cardiac insufficiency.
Azithromycin is not the substance of first choice for the treatment of
pharyngitis and tonsillitis caused by Streptococcus pyogenes. For this and
for the prophylaxis of acute rheumatic fever penicillin is the treatment of
In case of sexually transmitted diseases a concomitant infection by T.
palladium should be excluded. Use in renal impairment: No dose adjustment is
necessary in patients with mild to moderate renal impairment (GFR 10-80
ml/min). Caution is advised in patients with severe renal impairment (GFR<10
ml/min) as systemic exposure may be increased (see section 5.2).
Use in hepatic impairment: Since azithromycin is metabolised in the liver
and excreted in the bile, the medicinal product should not be given to
patients suffering from severe liver disease. No. studies have been
conducted regarding the treatment of such patients with azithromycin. When
severe liver impairment occurs, the treatment with azithromycin should be
Azithromycin should be administered with caution to patients with
neurological or psychiatric disorders.
Azithromycin is not indicated for the treatment of infected burn wounds.
Azithromycin film-coated tablets are not suitable for treatment of severe
infections where a high concentration of the antibiotic in the blood is