Clarithromycin 500 mg film-coated tablets
Each film-coated tablet contains 500 mg of clarithromycin
For the full list of excipients, see section 6.1.
Film-coated tablet
Light yellow coloured, oval shaped, biconvex film-coated tablets, with 'D' debossed on one side and '63' on the other side. The size is 18.5 mm x 8.1 mm.
Clarithromycin film-coated tablets are indicated for the treatment of the following bacterial infections, when caused by clarithromycin-susceptible bacteria (see section 4.4 and 5.1).
• Bacterial pharyngitis
• Mild to moderate community acquired pneumonia
• Acute bacterial sinusitis (adequately diagnosed)
• Acute exacerbation of chronic bronchitis
• Skin infections and soft tissue infections of mild to moderate severity,
• In appropriate combination with antibacterial therapeutic regimens and an appropriate ulcer healing agent for the eradication of Helicobacter pylori in patients with Helicobacter pylori associated ulcers (see section 4.2).
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Posology
The dosage of Clarithromycin film-coated tablets depends on the type and severity of the infection and has to be defined in any case by the physician.
Clarithromycin 500 mg film-coated tablet is not suitable for doses below 500 mg. There are other options for this strength available on the market.
Adults and adolescents (12 years and older)
• Standard dosage: The usual dose is 250 mg twice daily (in the morning and in the evening)
• High dosage treatment (severe infections): The usual dose may be increased to 500 mg twice daily in severe infections.
Children younger than 12 years:
Use of Clarithromycin film-coated tablets is not recommended for children younger than 12 years with a body weight less than 30 kg. Clinical trials have been conducted using clarithromycin pediatric suspension in children 6 months to 12 years of age. Therefore, children under 12 years of age should use clarithromycin paediatric suspension.
For children with a body weight of more than 30kg, the dose for adults apply.
Dosage in renal functional impairment:
In patients with renal impairment with creatinine clearance less than 30 mL/min, the dosage of clarithromycin should be reduced by one-half, i.e. 250 mg once daily, or 250 mg twice daily in more severe infections. Treatment should not be continued beyond 14 days in these patients.
Patients with hepatic impairment:
Caution should be exercised when administrating clarithromycin in patients with hepatic impairment (see section 4.3 and 4.4).
H. pylori eradication in peptic ulcer disease
For the eradication of H. pylori the selection of antibiotics should consider the individual patient's drug tolerance, and should be undertaken in accordance with national, regional and local resistance patterns and treatment guidelines.
Usually clarithromycin is administered in combination with another antibiotic and a proton-pump inhibitor for one week.
The therapy may be repeated if the patient is still H. pylori-positive
Duration of therapy:
The duration of therapy with Clarithromycin film-coated tablets depends on the type and severity of the infection and has to be defined in any case by the physician.
• The usual
