1. Name of the medicinal product
Azithromycin 500 mg Tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains: 500 mg of azithromycin (as monohydrate)
Excipient(s) with known effect:
Each tablet contains 0.36 mg soya lecithin.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet
White to off-white, oblong, film-coated tablet, deep break line on one side and score line on other side. The tablet can be divided into equal doses.
4. Clinical particulars
4.1 Therapeutic indications
Azithromycin tablets can be applied for the treatment of the following infections, when caused by microorganisms sensitive to azithromycin (see sections 4.4 and 5.1):
- acute bacterial sinusitis (adequately diagnosed)
- acute bacterial otitis media (adequately diagnosed)
- pharyngitis, tonsillitis
- acute exacerbation of chronic bronchitis (adequately diagnosed)
- mild to moderately severe community acquired pneumonia
- skin and soft tissue infections
- uncomplicated Chlamydia trachomatis urethritis and cervicitis
Considerations should be given to official guidance on the appropriate use of antibacterial agents.