Land: Malta
Språk: engelsk
Kilde: Malta Medicines Authority
CIPROFLOXACIN
TAD Pharma GmbH Heinz-Lohmann-Strasse 5, 27472 Cuxhaven, Germany
J01MA02
CIPROFLOXACIN 500 mg
FILM-COATED TABLET
CIPROFLOXACIN 500 mg
POM
ANTIBACTERIALS FOR SYSTEMIC USE
Licence number in the source country: NOT APPLICAPABLE
Authorised
2021-12-02
PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE PATIENT CIPRINOL 250 MG FILM-COATED TABLETS CIPRINOL 500 MG FILM-COATED TABLETS ciprofloxacin 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Ciprinol is and what it is used for 2. What you need to know before you take Ciprinol 3. How to take Ciprinol 4. Possible side effects 5. How to store Ciprinol 6. Contents of the pack and other information 1. WHAT CIPRINOL IS AND WHAT IT IS USED FOR Ciprinol is an antibiotic belonging to the fluoroquinolone family. Ciprofloxacin works by killing bacteria that cause infections. It only works with specific strains of bacteria. _Adults _ Ciprinol is used in adults to treat the following bacterial infections: - respiratory tract infections - long lasting or recurring ear or sinus infections - urinary tract infections - genital tract infections in men and women - gastro-intestinal tract infections and intra-abdominal infections - skin and soft tissue infections - bone and joint infections - to prevent infections due to the bacterium _Neisseria meningitidis _ - anthrax inhalation exposure Ciprofloxacin may be used in the management of patients with low white blood cell counts (neutropenia) who have a fever that is suspected to be due to a bacterial infection. If you have a severe infection or one that is caused by more than one type of bacterium, you may be given additional antibiotic treatment in addition to Ciprinol. _ _ _Children and adolescents _ Ciprinol is used in children and adolescents, under speciali Les hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Ciprinol 250 mg film-coated tablets Ciprinol 500 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Ciprinol film-coated tablets 250 mg Each film-coated tablet contains 291.0 mg ciprofloxacin hydrochloride monohydrate equivalent to 250 mg ciprofloxacin. Ciprinol film-coated tablets 500 mg Each film-coated tablet contains 582.0 mg ciprofloxacin hydrochloride monohydrate equivalent to 500 mg ciprofloxacin. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet Ciprinol 250 mg film-coated tablets The tablets are white, round, film-coated, plain on one side, with a score line on the reverse. The tablet can be divided into equal doses. Ciprinol 500 mg film-coated tablets The tablets are white, oval, film-coated, plain on one side, with a score line on the reverse. The tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _ _ Ciprinol 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 exacerbation of chronic obstructive pulmonary disease, ciprofloxacin 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 - Urinary tract infections - uncomplicated acute cystitis In uncomplicated acute cystitis ciprofloxacin should be used only when it is cons Les hele dokumentet