CIPRONAT

Country: India

Language: English

Source: Central Drugs Standard Control Organization

Active ingredient:

Ciprofloxacin

Available from:

Natco Ph.

INN (International Name):

Ciprofloxacin

Pharmaceutical form:

Tablets

Therapeutic indications:

CIPRONAT® is indicated in the treatment of following infections caused by susceptible strains of bacteria: Acute sinusitis: due to Haemophilus influenzae, Streptococcus pneumoniae, Moraxella catarrhalis. Lower respiratory tract infections: pneumonia, cystic fibrosis and acute exacerbations of chronic bronchitis, due to E.coli, Klebsiella pneumoniae, Enterobacter cloacae, Proteus mirabilis, Pseudomonas aeruginosa, Haemophilus influenzae and parainfluenzae, Streptococcus pneumoniae, Moraxella catarrhalis (bronchitis). Urinary tract infections: due to E. Coli, Klebsiella pneumoniae. Enterobacter cloacae, Serratia marcescens, Proteus mirabilis, Proteus rettgeri, Morganella morganii, Citrobacter diversus and freundii, Pseudomonas aeruginosa, Staphylococcus epidermidis and saprophyticus, Enterococcus faecalis.

Product summary:

Cipronat Film coated Tablets 250 mg ; Cipronat Film coated Tablets 500 mg ; Cipronat Film coated Tablets 750 mg

Patient Information leaflet

PATIENT INFORMATION LEAFLET
CIPRONAT
®
_Ciprofloxacin 750 mg Film-Coated Tablets _
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Keep this
leaflet. You may need to read it again. IF YOU HAVE ANY FURTHER
QUESTIONS, ASK YOUR DOCTOR OR PHARMACIST.
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs of illness are the
same as yours.
1.
WHAT IS CIPRONAT® AND WHAT IT IS USED FOR
Cipronat® contains the active substance ciprofloxacin, an antibiotic
belonging to the fluoroquinolone family. It works by killing
bacteria that cause infections. It only works with specific strains of
bacteria (ATC code: A02BC04). Cipronat® is used in the
treatment of: acute sinusitis, respiratory tract infections;
uncomplicated intra-abdominal infections, infectious diarrhea, typhoid
fever; urinary tract infections, uncomplicated cervical and urethral
gonorrhea; skin and soft tissue infections; bone and joint
infections.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CIPRONAT® TABLETS
_DO NOT TAKE CIPRONAT® IF YOU ARE _younger than 18 years of age,
allergic to the active substance, to other quinolone drugs or to
any of the other ingredients of this medicine _(listed in Section 6)._
_ _
_WARNINGS AND PRECAUTIONS: TALK TO YOUR DOCTOR BEFORE TAKING
CIPRONAT® _if you suffer from epilepsy or other neurological
conditions. Cipronat® is not effective in the treatment of syphilis.
If Cipronat® is administered in high doses for treating
gonorrhoea, symptoms of syphilis may be masked. If you have ever had
kidney problems. If you take Cipronat® you should
avoid direct sunlight or artificial UV radiation. _OTHER MEDICINES AND
CIPRONAT®: _Tell your doctor if you are taking, have recently
taken or might take other medicines. This is very important if you
take phenytoin, anticoagulants (e.g. Warfarin), glyburide,
cyclosporine, antacids or omeprazole (because they can decrease the
effect of Cipronat®). Do not take

Summary of Product characteristics

Ref.: SmPC Cipronat Tablets Version JNa.2016.09.20 Summary of Product
Characteristics
Dafra Pharma GmbH, Mühlenberg 7, 4052 Basel, Switzerland Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
CIPRONAT
®
ciprofloxacine
film coated tablets
1. NAME OF THE MEDICINAL PRODUCT
-
Cipronat
®
Film coated Tablets 250 mg.
-
Cipronat
®
Film coated Tablets 500 mg.
-
Cipronat
®
Film coated Tablets 750 mg.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
2.1 GENERAL DESCRIPTION
Ciprofloxacin is a synthetic fluoroquinolone antibiotic with
bactericidal action which
exhibits antibacterial activity against the majority of gram-positive
and gram-
negative pathogens.
2.2 QUALITATIVE AND QUANTITATIVE COMPOSITION
-
Cipronat
®
Film coated Tablets 250 mg: each tablet contains ciprofloxacin
hydrochloride monohydrate equivalent to 250 mg of ciprofloxacin.
-
Cipronat
®
Film coated Tablets 500 mg: each tablet contains ciprofloxacin
hydrochloride monohydrate equivalent to 500 mg of ciprofloxacin.
-
Cipronat
®
Filmcoated Tablets 750 mg: each tablet contains ciprofloxacin
hydrochloride monohydrate equivalent to 750 mg of ciprofloxacin.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
-
Cipronat
®
Film coated Tablets 250 mg: blister packs of 14 tablets, each
containing
ciprofloxacin 250 mg.
-
Cipronat
®
Film coated Tablets 500 mg: blister packs of 14 tablets, each
containing
ciprofloxacin 500 mg.
-
Cipronat
®
Film coated Tablets 750 mg: blister packs of 14 tablets, each
containing
ciprofloxacin 750 mg.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Cipronat is indicated in the treatment of following infections caused
by susceptible
strains of bacteria:
ACUTE SINUSITIS: due to _Haemophilus influenzae, Streptococcus
pneumoniae, _
_Moraxella catarrhalis. _
Ref.: SmPC Cipronat Tablets Version JNa.2016.09.20 Summary of Product
Characteristics
Dafra Pharma GmbH, Mühlenberg 7, 4052 Basel, Switzerland Page 2 of 15
LOWER RESPIRATORY TRACT INFECTIONS: pneumonia, cystic fibrosis and
acute
exacerbations of chronic bronchitis,