Source: European Medicines Agency (EU)
As for other quinolones, Chinoplus should be taken with caution in patients with CNS disorders, that may predispose to convulsion or lower the convulsion threshold.
As for the administration of other drugs of the same therapeutic group tendonitis may rarely occur. It most frequently involves the Achilles tendon and may lead to tendon rupture. The risk of tendonitis and tendon rupture is increased in the elderly and in patients using corticosteroids.
Patients should be advised to discontinue treatment in case of signs of inflammation of a tendon, myalgia, pain experience or articular inflammation, and to rest the limb or the limbs concerned, until the diagnosis of tendonitis has been excluded.
Fluoroquinolones, including prulifloxacin, have neuromuscular blocking activity and may exacerbate muscle weakness in patients with myasthenia gravis. Prulifloxacin is not recommended in patients with a known history of myasthenia gravis.
Epidemiologic studies report an increased risk of aortic aneurysm and dissection after intake of fluoroquinolones, particularly in the older population.
Therefore, fluoroquinolones should only be used after careful benefit-risk assessment and after consideration of other therapeutic options in patients with positive family history of aneurysm disease, or in patients diagnosed with pre-existing aortic aneurysm and/or aortic dissection, or in presence of other risk factors or conditions predisposing for aortic aneurysm and dissection (e.g. Marfan syndrome, vascular Ehlers-Danlos syndrome, Takayasu arteritis, giant cell arteritis, Behcet’s disease, hypertension, known atherosclerosis).
In case of sudden abdominal, chest or back pain, patients should be advised to immediately consult a physician in an emergency department.
As with other quinolones, exposure to the sun or ultra-violet rays may cause phototoxicity reactions in patients treated with prulifloxacin.
Excessive exposure to the sun or ultra-violet rays should be avoided during treatment with Chinoplus; in case of phototoxicity reactions, the treatment should be discontinued.
Patients with latent or known deficiencies for the glucose-6-phosphate dehydrogenase activity, are predisposed to haemolytic reactions when treated with antibacterial agents of the quinolone group and for this reason Chinoplus should be administered with caution.
As reported for other quinolones, events of rhabdomyolysis characterized by myalgia, asthenia, increase of CPK and myoglobin in plasma values, and rapid deterioration of the renal function, may rarely occur. In these cases, patient should be carefully monitored and appropriate measures must be taken, including the possibility to discontinue the treatment.
The use of quinolones is sometimes correlated to the onset of crystalluria; patients under treatment with this medicinal products belonging to this therapeutic group should maintain an adequate water balance in order to avoid urine concentration.
Tolerability and efficacy of Chinoplus in patients with hepatic impairment have not been assessed. Local and/or national guidelines on the appropriate use of antibacterial drugs should be considered, when prescribing an antibiotic therapy. The medicinal product contains lactose, and therefore patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Tolerability and efficacy of Chinoplus in patients with hepatic impairment have not been assessed. In absence of specific studies, it is not possible to determine the posology in patients with liver impairment. Therefore, for these patients, monitoring of drug plasma levels is the most reliable method for dosage adjustment.
In absence of specific studies, it is not possible to determine the posology in patients with renal function impairment (patients with creatinine clearance < 60 ml/min) Therefore, for these patients, monitoring of drug plasma levels is the most reliable method for dosage adjustment.
Some other substances from the fluoroquinolone class have been associated with cases of QT interval prolongation. Prulifloxacin shows a very low potential for inducing QT interval prolongation.
If vision becomes impaired or any effects on the eyes are experienced, an eye specialist should be consulted immediately.
Diarrhoea, particularly if severe, persistent and/or bloody, during or after treatment with prulifloxacin (including several weeks after treatment), may be symptomatic of Clostridium difficile-associated disease (CDAD). CDAD may range in severity from mild to life threatening, the most severe form of which is pseudomembranous colitis (see section 4.8). It is therefore important to consider this diagnosis in patients who develop serious diarrhoea during or after treatment with prulifloxacin. If CDAD is suspected or confirmed, ongoing treatment with antibacterial agents, including prulifloxacin, should be stopped immediately and appropriate treatment initiated without delay. Anti-peristaltic medicinal products are contraindicated in this clinical situation. Furthermore, appropriate infection control measures should be undertaken to reduce the risk of transmission.
Concomitant treatment with cimetidine, antacids containing Al and Mg or preparations containing iron and calcium reduces the absorption of Chinoplus; therefore, Chinoplus should be administered 2 hours before or at least 4 hours after the administration of these compounds.
Concomitant ingestion of prulifloxacin and milk results in decreased area under the concentration-time curve (AUC) and decreased urinary recovery of prulifloxacin, while ingestion of food delays and reduces peak levels. Prulifloxacin urinary excretion decreases when concomitantly administered with probenecid. The concomitant administration of fenbufen with certain quinolones can cause an increased risk of convulsions, the administration of Chinoplus and fenbufen must therefore be carefully evaluated. Quinolones may cause hypoglycemia in diabetic patients taking hypoglycemic drugs.
Concomitant administration of Chinoplus and theophylline may cause a slight decrease of theophylline clearance which should have no clinical impact. However, as for other quinolones, theophylline plasma levels should be monitored in patients with metabolic disorders or presenting risk factors. Quinolones may enhance the effects of oral anticoagulants such as warfarin and its derivatives; when these medicinal products are administered together with Chinoplus a close monitoring by prothrombin test or other suitable coagulation tests is recommended.
Preclinical data have shown that nicardipine may potentiate the phototoxicity of prulifloxacin. No clinically significant interaction has been observed during the clinical development of Chinoplus after concomitant administration of other medicinal products commonly employed in patients with the pathologies mentioned in section 4.1.
For prulifloxacin no clinical data on exposed pregnancy are available. Animal studies did not show teratogenicity. Other reproductive toxicity effects were only observed in the presence of maternal toxicity (see section 5.3).
In rats, prulifloxacin was found to cross the placenta and to be excreted into maternal milk in high amounts. As with other quinolones, prulifloxacin has been shown to cause arthropathy in juvenile animals, therefore its use during pregnancy and lactation is contraindicated.
Quinolones may cause dizziness and light-headedness; therefore, patient should know how they react to the drug before driving or using machines or starting in activities which require attention and coordination.
The undesired effects reported hereunder can be traced back to clinical trials carried out on Chinoplus, except for adverse reactions with not known frequency. Most of the adverse events have been of slight or moderate intensity.
The following rate values have been used: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000) and Very rare (<1/10,000), not known (cannot be estimated from the available data).
Uncommon: anorexia
Rare: appetite lost
Rare: sleep disorder, drowsiness, confusion
Uncommon: headache, dizziness
Rare: psychomotor agitation, taste perversion
Rare: ocular hyperaemia
Rare: feeling of ear closed
Rare: hot flush
Common: epigastralgia
Uncommon: abdominal pain, diarrhoea, nausea, gastritis, vomit
Rare: abnormal stools, gastrointestinal disorders, eructation, mouth ulcer, angular stomatitis, dyspepsia, flatulence, indigestion, oral cavity discomfort, oral moniliasis, glossitis, gastric dilation
Uncommon: pruritus, skin rash, eruption
Rare: facial eczema, facial erythema, urticaria
Rare: generalized joint pains, pain ankle, muscle disorder, muscle twitching
Unknown: Exacerbation of myasthenia gravis
Rare: Fever
Rare: albumin increased, alkaline posphatase increased, ALT increased, AST increased, blood calcium increased, blood monocytes increased, lymphocytes raised, WBC increased, γ-GT increased, bilirubin increased
The following adverse reactions have been also reported (incidence not known) : anaphylactic/anaphylactoid reaction including angioedema, dyspnea, Steven Johnson syndrome, hypoglycemia, hypoesthesia,paraesthesia, tremor, dermatitis due to drugs, rhabdomiolisis, phototoxicity, tachycardia, pseudomembranous colitis.
The treatment with Chinoplus may be associated with asymptomatic crystalluria with no change in creatinine levels, with alterations in hepatic function parameters and with eosinophilia. In the observed cases, these alterations were asymptomatic and transient in nature.
During treatment with Chinoplus, the development of adverse reactions or alterations in laboratory parameters not mentioned above, but reported for other quinolones, cannot be excluded.
Prulifloxacin post-marketing surveillance data show sporadic reports of tendon disorders (see 4.4. Special warning and special precaution for use).
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V*.
Not applicable.
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