CHINOPLUS Film-coated tablet Ref.[8257] Active ingredients: Prulifloxacin

Source: European Medicines Agency (EU) 

Therapeutic indications

Chinoplus is indicated for treatment of infections caused by susceptible strains, in the following conditions:

  • Acute uncomplicated lower urinary tract infections (simple cystitis);
  • Complicated lower urinary tract infections;
  • Acute exacerbation of chronic bronchitis;
  • Acute bacterial rhinosinusitis.

Acute bacterial sinusitis should be adequately diagnosed according to the National or local guidelines on the treatment of respiratory infections. For the treatment of bacterial rhinosinusitis, Chinoplus should be used only in patients with a duration of symptoms less than 4 weeks, and when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of this infection or when have failed to resolve the infection.

Local antibiotic susceptibility pattern should be considered in the treatment of patients with infective diseases.

Posology and method of administration

The indicative dosage regimen in adults is the following:

  • Patients with acute uncomplicated lower urinary tract infections (simple cystitis): only one 600 mg tablet is sufficient.
  • Patients with complicated lower urinary tract infections: one 600 mg tablet once a day up to 10- days of maximum treatment.
  • Patients with acute exacerbation of chronic bronchitis: one 600 mg tablet once a day up to 10-days of maximum treatment.
  • Patients with acute bacterial rhinosinusitis: one 600 mg tablet once a day up to 10-days of maximum treatment.

The duration of treatment for complicated lower urinary tract infections and acute exacerbation of chronic bronchitis, depends on the severity of the disease and on the patient’s clinical outcome and should anyway be continued for at least 48-72 hours after remission/recovery of symptoms.

Paediatric population

Chinoplus should not be used in children and adolescent under 18 years of age because of safety concerns (see Sections 4.3 and 5.3).

Method of administration

Chinoplus tablets should be swallowed with water and should be taken considering food intake (see Section 4.5).

Overdose

In mice, rats and dogs (males and females), the oral administration of single doses up to 5000 mg/kg had no lethal effects.

No information on overdose in humans are available; Chinoplus was tested in healthy volunteers up to 1200 mg/die for 12 days showing a good tolerability.

In the event of acute overdose, the stomach should be emptied by inducing vomiting or by gastric lavage, the patient must be carefully observed and given supportive treatment.

Shelf life

Shelf life: 3 years.

Special precautions for storage

Do not store above 30°C.

Store in the original package.

Nature and contents of container

Cardboard box containing 1 blister of 1, 2, 5 film-coated tablets or 2 blisters of 5 film-coated tablets.

Blister made of thermoformed coupled material (Polyamide/aluminium/PVC) and a lidding material (aluminium/PVC).

Not all pack sizes may be marketed

Special precautions for disposal and other handling

No special requirements.

Any unused product or waste material should be disposed of in accordance with local requirements.

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