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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.

Azithromycin 250mg (Ezecure) - 120 tablets

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