Država: Malta
Jezik: engleski
Izvor: Malta Medicines Authority
CIPROFLOXACIN
Clonmel Healthcare Limited Waterford Road, Clonmel, Co. Tipperary E91 D768, Ireland
J01MA02
CIPROFLOXACIN 500 mg
FILM-COATED TABLET
CIPROFLOXACIN 500 mg
POM
ANTIBACTERIALS FOR SYSTEMIC USE
Licence number in the source country: NOT APPLICAPABLE
Authorised
2021-12-27
Page 1 of 9 PACKAGE LEAFLET: INFORMATION FOR THE USER PROFLOXIN 250MG FILM-COATED TABLETS PROFLOXIN 500MG FILM-COATED TABLETS ciprofloxacin (as hydrochloride) 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. • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Profloxin is and what it is used for 2. What you need to know before you take Profloxin 3. How to take Profloxin 4. Possible side effects 5. How to store Profloxin 6. Contents of the pack and other information 1. WHAT PROFLOXIN IS AND WHAT IT IS USED FOR Profloxin is an antibiotic belonging to the fluoroquinolone family. The active substance is ciprofloxacin. Ciprofloxacin works by killing bacteria that cause infections. It only works on specific strains of bacteria. _Adults _ Profloxin is used in adults to treat the following bacterial infections: • respiratory tract infections • long lasting or recurring ear or sinus infections • urinary tract infections • infections of the testicles • genital organ infections in women • gastro-intestinal tract infections and intra-abdominal infections • skin and soft tissue infections • bone and joint infections • to treat infections in patients with a very low white blood cell count (neutropenia) • to prevent infections in patients with a very low white blood cell count (neutropenia) • to prevent infections due to the bacterium _Neisseria meningitidis _ • anthrax inhalation exposure If you have a severe infection or one that is caused by more than one type of bacterium, you may be given additional antibiotic treatmen Pročitajte cijeli dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Profloxin 500 mg Film-coated Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One film-coated tablet contains ciprofloxacin hydrochloride equivalent to 500 mg ciprofloxacin. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet White or yellowish 8.2 x 17 mm oval, biconvex, film-coated tablets. Scored on one side and side wall scored, marked C500 on one side. The tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Profloxin 500 mg film-coated tablets are indicated for the treatment of the following infections (see sections 4.4 and 5.1). Special attention should be paid to available information on resistance to ciprofloxacin before commencing therapy. Consideration should be given to official guidance on the appropriate use of antibacterial agents. Adults • Lower respiratory tract infections due to Gram-negative bacteria - exacerbations of chronic obstructive pulmonary disease. In chronic obstructive pulmonary disease, Profloxin should be used only when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the treatment of these infections. − 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. • Uncomplicated acute cystitis In Uncomplicated acute cystitis, Profloxin should be used only when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the treatment of these infections. • Acute pyelonephritis • Complicated urinary tract infections • Bacterial prostatitis • Gonoccocal urethritis and cervicitis due to susceptible Neisseria gonorrhoeae • Epididymo-orchitis including cases due to Neisseria gonorrhoeae • Pelvic inflammatory disease including cases due to Neisseria gonorrhoeae In the above gen Pročitajte cijeli dokument