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Binozyt

 

1 Name of the medicinal product

Binozyt : 250 mg film-coated tablets

Binozyt : 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 azithromycin
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
Film-coated tablet
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 trachomatis.


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.


Adults
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.


Elderly patients
The same dose range as in younger patients may be used in the elderly.


Children
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 section 4.4).


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).


4.3 Contraindications
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 recommended.


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 4.5).


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 first choice.


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 ceased.


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 rapidly needed.

 

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