Rancif 500 mg 10 tablets 

Trade name:

Rancif 500 mg 

10 film-coated tablets 

Composition:

Each film-coated tablet contains 500 mg ciprofloxacin (as hydrochloride).

Medical Description

An antibiotic belonging to the group of fluoroquinolones used in the treatment of pneumonia, prostatitis, salmonella infection, shigella infection, urinary tract infection, surgical site infection, artificial joint infection, bacterial meningitis, diabetic foot infection and disease.

Indication of Use:

Rancif 500 mg film-coated tablets are indicated for the treatment of the following infections.

• Lower respiratory tract infections due to Gram-negative bacteria

– exacerbations of chronic obstructive pulmonary disease

– broncho-pulmonary infections in cystic fibrosis or in bronchiectasis

– pneumonia

• Chronic suppurative otitis media
• Acute exacerbation of chronic sinusitis especially if these are caused by Gram-negative bacteria
• Urinary tract infections
• Genital tract infections when thought or known to be due to Neisseria gonorrhoeae it is particularly important to obtain local information on the prevalence of resistance to ciprofloxacin and to confirm susceptibility based on laboratory testing.

– gonococcal uretritis and cervicitis due to susceptible Neisseria gonorrhoeae

– epididymo-orchitis including cases due to susceptible Neisseria gonorrhoeae

– pelvic inflammatory disease including cases due to susceptible Neisseria gonorrhoeae

• Infections of the gastro-intestinal tract (e.g. travellers’ diarrhoea)
• Intra-abdominal infections
• Infections of the skin and soft tissue caused by Gram-negative bacteria
• Malignant external otitis
• Infections of the bones and joints
• Prophylaxis of invasive infections due to Neisseria meningitidis
• Inhalation anthrax (post-exposure prophylaxis and curative treatment)

Contraindications:

• To treat infections that might get better without treatment or are not severe (such as throat infections);
• To treat non-bacterial infections, e.g. non-bacterial (chronic) prostatitis;
• For preventing traveller’s diarrhoea or recurring lower urinary tract infections (urine infections that do not extend beyond the bladder);
• To treat mild or moderate bacterial infections unless other, antibacterial medicines commonly recommended for these infections cannot be used.

Children and adolescents

• Broncho-pulmonary infections in cystic fibrosis caused by Pseudomonas aeruginosa
• Complicated urinary tract infections and pyelonephritis
• Inhalation anthrax (post-exposure prophylaxis and curative treatment)

Ciprofoxacin may also be used to treat severe infections in children and adolescents when this is considered to be necessary. 

Method of administration:

The dosage is determined by the indication, the severity and the site of the infection, the susceptibility to ciprofloxacin of the causative organism(s), the renal function of the patient and, in children and adolescents the body weight.

Dosage:

Infections of the lower respiratory tract: 500 mg twice daily to 750 mg twice daily 7 to 14 days

Infections of the upper of respiratory tract:

Acute exacerbation chronic sinusitis 500 mg twice daily to 750 mg 7 to 14 days twice daily

Chronic suppurative otitis media 500 mg twice daily to 750 mg 7 to 14 days

Malignant external otitis 750 mg twice daily 28 days up to 3 months

Urinary tract infections: 

Uncomplicated cystits 250 mg twice daily to 500 mg twice daily 3 days

Complicated cystitis, Uncomplicated pyelonephritis 500 mg twice daily 7 days

Complicated pyelonephritis 500 mg twice daily to 750 mg twice daily  at least 10 days, it can be continued for longer than 21 days in some specific circumstances (such as abscesses)

Prostatitis 500 mg twice daily to 750 mg twice daily 2 to 4 weeks (acute) to 4 to 6 weeks (chronic)

Genital tract infections:

Gonocaccal uretritis and cervicitis 500 mg as a single dose 1 day (single dose)

Epididymo-orchitis and pelvic inflammatory diseases 500 mg twice daily to 750 mg twice dally at least 14 days.

Infections of the Castro-intestinal tract and intra-abdominal infections:

Diarrhoea caused by bacterial pathogens including Shigella spp. other than Shigolla dysenteriae type 1 and empirical treatment of severe travellers’ diarrhoea 500 mg twice daily 1 day.

Diarrhoea caused by Shigella dysenteriae type 1 500 mg twice daily 5 days

Diarrhoea caused by Vibrio cholera 500 mg twice daily 3 days

Typhoid fever 500 mg twice daily 7 days

Intra-abdominal infections due to Gram-negative bacteria 500 mg twice daily to 750 mg 5 to 14 days.

Infections of the skin and soft tissue: 500 mg twice dally to 760 mg 7 to 14 days.

Bone and Joint Infections: 500 mg twice daily to 750 mg max of 3 months.

Pregnancy and lactation:

Pregnancy:

As a precautionary measure, it is preferable to avoid the use of ciprofloxacin during pregnancy.

Breast-feeding:

Ciprofloxacin is excreted in breast milk. Due to the potential risk of articular damage, ciprofioxacin should not be used during breast-feeding.

Side effects:

-Aneurysm, arthropathy, hepatotoxicity, peripheral neuropathy, photosensitivity, tendonopathy/tendon rupture. -Abdominal pain, diarrhea, indigestion, nausea, vomiting, vulvarvovaginal candidiasis, injection site reactions, dizziness, drowsiness, headache, insomnia, nervousness, asthma, fever, acute myocardial infarction, angina, redness, hypertension, tachycardia, thrombophlebitis, vasculitis, vasodilation, sweating, exfoliative dermatitis, macular rash , itching, sensitivity to light, Stevens-Johnson syndrome, necrotizing dermatitis, hyperglycemia, hypoglycemia, anorexia, difficult colitis, constipation, indigestion, flatulence, gastrointestinal bleeding, intestinal obstruction, ulcers of the oral mucosa, pancreatitis, dry mouth, vaginitis, angioedema, arthralgia, asthenia, joint stiffness, tremor, blurred Vision, decreased visual acuity, double vision, tinnitus, acute kidney injury, shortness of breath, laryngeal edema.

Storage:

Store in dry place at temperature not exceeding 30C

Keep away of reach of children.

Package:

A Carton Box contains 10 film-coated tablets, instructions