CLAREX 3D Box

Clarex ®

Clarithromycin 500 mg

Tablets for oral use

Product leaflet summary

Therapeutic Indications:

 

CLAREX is indicated for the treatment of the following infections caused by clarithromycin susceptible organisms.

  • Bacterial pharyngitis
  • Mild to moderate community-acquired pneumonia
  • Acute bacterial sinusitis (adequately diagnosed)
  • Acute exacerbation of chronic bronchitis
  • Skin and soft tissue infections of mild to moderate severity.
  • Indicated in appropriate combination with antibacterial therapeutic regimens and an appropriate ulcer healing medicinal product for the eradication of Helicobacter pylori in adult patients with Helicobacter pylori-associated peptic ulcers.

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

 

Dosage And Administration:

The dosage of CLAREX depends on the type and severity of the infection and has to be defined in any case by the physician.

 

Contraindications:

  • CLAREX is contra-indicated in patients with known hypersensitivity to clarithromycin, to any other macrolide antibiotics, or to any of the excipients.
  • CLAREX is contraindicated in patients with serious hepatic failure.
  • CLAREX and ergot derivatives should not be co-administered.
  • Concomitant administration of CLAREX and any of the following active substances is contraindicated: Cisapride, Pimozide and Terfenadine.
  • Concomitant administration with Simvastatin is contraindicated.
  • CLAREX should not be administered to hypokalemic patients (prolongation of QT-time)

 

Pregnancy And Lactation:

Pregnancy:

Data on the use of clarithromycin during the first trimester of more than 200 pregnancies show no clear evidence of teratogenic effects or adverse effects on the health of the neonate. Pregnant women exposed in the first trimester indicate a possible increased risk of abortions. To date, no other relevant epidemiological data are available.

Data from animal studies have shown reproductive toxicity. The risk for humans is unknown. Clarithromycin should only be used during pregnancy after a careful benefit/risk assessment.

 

Lactation:

CLAREX and its active metabolite are excreted in breast milk. Therefore, diarrhea and fungus infection of the mucous membranes could occur to the breastfed infant, so that nursing might have to be discontinued. The possibility of sensitization should be kept in mind. The benefit of treatment of the mother should be weighed against the potential risk for the infant.

 

Ability To Drive And Use Machinery:

No studies on the effects on the ability to drive and use machines have been performed. When performing these activities the possible occurrence of the adverse reactions dizziness, vertigo, confusion and disorientation should be taken into account.

 

Package Presentation:

– A box of 14 tablets each contains 500 mg Clarithromycin.