COMPOSITION

Each film coated tablet contains ciprofloxacin hydrochloride equivalent to 500 mg of ciprofloxacin and 500 mg of ornidazole.

THERAPEUTIC INDICATIONS

Orcipol is indicated for treatment of the following infections caused by strains sensitive to the combination of ciprofloxacin and ornidazole:
- Infectious and inflammatory diseases of pelvic minor organs including post- operative and post-abortion prophylaxis;
- Infections of urogenital system: chronic and acute pyelonephritis, cystitis, urethritis, prostatitis, epididymitis, including complicated and recurrent;
- Sexually transmitted infections: chlamidiosis, mycoplasmosis, gonorrhea, trichomoniasis, mixed infections;
- Infections of respiratory tracts – acute bronchitis, chronic bronchitis exacerbation, pneumonia, infected bronchiectasis, lung abscess, pleural empyema;
- Infections of ENT organs: sinusitis, external otitis and otitis media, mastoiditis.
- Skin, soft tissues, joint and bone infections.
- Infections of abdominal cavity: diarrhea, caused by bacterial or protozoal microorganisms.

CONTRAINDICATIONS

- Hypersensitivity to ciprofloxacin or ornidazole.
- Pregnancy and lactation;
- Infancy and adolescence younger 15 years.
- Central nerve system diseases, acute neurological diseases.

ADVERSE EFFECTS

Nausea, vomiting, diarrhea, abdominal pains, headaches, vertigo, sleep disturbances, cosinophilia, leucopenia, granulopenia, change of thrombocyte numbers, allergic reactions may be reported. Seldom photosensitization.

PRECAUTIONS

The dosage adjustment is required for patients with renal dysfunction. Orcipol is cautiously administered in elder patients, in case of cerebral atherosclerosis, cerebral circulation disorder, epilepsy, and spastic syndrome of unknown etiology.

DRUG INTERACTIONS

Theophylline: the co-administration of ciprofloxacin with theophylline results in increasing of theophylline plasma concentrations, owing to competitive inhibition in binding site of cytochrome P450, results in increasing of theophylline half-time and increasing of toxic action, associated with theophylline.
Anticoagulants: ornidazole potentiates indirect anticoagulants effect and increases the duration of vecuronium bromide effect.
Warfarin: the co-administration of ciprofloxacin with warfarin increases the risk of bleeding.
The co-administration with antacids and drugs containing ions of Al, Zn, Fe and Mg; may cause decreasing of ciprofloxacin absorption that is why the dosage interval between these drugs should be not less than 4 hours.

DOSAGE AND ADMINISTRATION

1 tablet of Orcipol should be orally administered 2 times/daily.
Tablets should be administered without chewing and with the sufficient quantity of liquid. Orcipol may be used before meal or 2 hours after it.

MANUFACTURED FORM

Box containing 10 film coated tablets.