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CHINOPLUS Film-coated tablet

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Chinoplus 600 mg film-coated tablets.

Qualitative and quantitative composition

Each film-coated tablet contains 600 mg of prulifloxacin. Excipients with known effect: Each film-coated tablet contains 76 mg of lactose. For the full list of excipients, see section 6.1.

Pharmaceutical form

Film-coated tablet. Yellow, oblong, film-coated tablets. The tablet can be divided into equal doses.

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 ...

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 ...

Contraindications

Hypersensitivity to prulifloxacin, to other antibacterial agents from the quinolone-type or to any of the excipients listed in section 6.1. Pre-pubertal children or adolescents below the age of 18 years ...

Special warnings and precautions for use

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 ...

Interaction with other medicinal products and other forms of interaction

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 ...

Fertility, pregnancy and lactation

Pregnancy 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 ...

Effects on ability to drive and use machines

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. ...

Undesirable effects

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 ...

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 ...

Pharmacodynamic properties

Pharmacotherapeutic group: Fluoroquinolones ATC code: J01MA17 Prulifloxacin is a wide spectrum antibacterial agents belonging to the fluoroquinolone group and provided with high efficacy. After oral administration, ...

Pharmacokinetic properties

Prulifloxacin is the pro-drug of the active metabolite, ulifloxacin. Absorption Prulifloxacin is rapidly absorbed in humans (Tmax = about 1h) and turned into ulifloxacin; after a 600 mg single administration, ...

Preclinical safety data

Repeated toxicity The main target organs in repeated dose toxicity studies were articular cartilage, kidneys, gastro-intestinal tract and liver. No toxic effects have been observed on articular cartilage ...

List of excipients

Core: Lactose monohydrate Microcrystalline cellulose Sodium croscarmellose Povidone Silica, colloidal anhydrous Magnesium stearate Coating: Hypromellose Propylene glycol Titanium dioxide (E171) Talc Ferric ...

Incompatibilities

Not applicable.

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 ...

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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