Sign up to bookmark this SPC already have an account? Find medicines with the same active ingredients. Find medicines from the same company. Ciprofloxacin mg Film-Coated Tablets 2. Qualitative and quantitative composition Each Ciprofloxacin mg Tablet contains For the full list of excipients, see section 6. Pharmaceutical form Film-coated Tablets. Ciprofloxacin mg tablets are white to off-white, capsule shape, biconvex with beveled edge, film coated tablet with inscription 'CI' on one side and plain on the other side.
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. The duration of treatment depends on the severity of the illness and on the clinical and bacteriological course.
Treatment of infections due to certain bacteria e. Pseudomonas aeruginosa , Acinetobacter or Staphylococci may require higher ciprofloxacin doses and co-administration with other appropriate antibacterial agents.
Treatment of some infections e. Indications Daily dose in mg Total duration of treatment potentially including initial parenteral treatment with ciprofloxacin Infections of the lower respiratory tract mg twice daily to mg twice daily 7 to 14 days Infections of the upper respiratory tract Acute exacerbation of chronic sinusitis mg twice daily to mg twice daily 7 to 14 days Chronic suppurative otitis media mg twice daily to mg twice daily 7 to 14 days Malignant external otitis mg twice daily 28 days up to 3 months Urinary tract infections see section 4.
Drug administration should begin as soon as possible after suspected or confirmed exposure. According to the type of infections Elderly patients. Elderly patients should receive a dose selected according to the severity of the infection and the patient's creatinine clearance. Patients with renal and hepatic impairment.
Recommended starting and maintenance doses for patients with impaired renal function: Tablets are to be swallowed unchewed with fluid. They can be taken independent of mealtimes. If taken on an empty stomach, the active substance is absorbed more rapidly. Ciprofloxacin tablets should not be taken with dairy products e. In severe cases or if the patient is unable to take tablets e. Concomitant administration of ciprofloxacin and tizanidine see section 4.
Ciprofloxacin is not recommended for the treatment of streptococcal infections due to inadequate efficacy. Severe infections and mixed infections with Gram-positive and anaerobic pathogens. Ciprofloxacin monotherapy is not suited for treatment of severe infections and infections that might be due to Gram-positive or anaerobic pathogens.
In such infections ciprofloxacin must be co-administered with other appropriate antibacterial agents. Gonococcal uretritis, cervicitis, epididymo-orchitis and pelvic inflammatory diseases may be caused by fluoroquinolone- resistant Neisseria gonorrhoeae isolates.
Therefore, ciprofloxacin should be administered for the treatment of gonococcal uretritis or cervicitis only if ciprofloxacin-resistant Neisseria gonorrhoeae can be excluded. For epididymo-orchitis and pelvic inflammatory diseases, empirical ciprofloxacin should only be considered in combination with another appropriate antibacterial agent e. If clinical improvement is not achieved after 3 days of treatment, the therapy should be reconsidered. Prescribers are advised to take into account the local prevalence of resistance in Escherichia coli to fluoroquinolones.
The single dose of ciprofloxacin that may be used in uncomplicated cystitis in pre-menopausal women is expected to be associated with lower efficacy than the longer treatment duration. This is all the more to be taken into account as regards to the increasing resistance level of Escherichia coli to quinolones. There are limited data on the efficacy of ciprofloxacin in the treatment of post-surgical intra-abdominal infections.
The choice of ciprofloxacin should take into account information on resistance to ciprofloxacin in relevant pathogens in the countries visited. Infections of the bones and joints. Ciprofloxacin should be used in combination with other antimicrobial agents depending on the results of the microbiological documentation. Use in humans is based on in-vitro susceptibility data and on animal experimental data together with limited human data.
The use of ciprofloxacin in children and adolescents should follow available official guidance. Ciprofloxacin has been shown to cause arthropathy in weight-bearing joints of immature animals. Safety data from a randomised double-blind study on ciprofloxacin use in children ciprofloxacin: Respectively, an incidence of drug-related arthropathy by 1-year follow-up was 9.
The increase of suspected drug related arthropathy cases over time was not statistically significant between groups. Broncho-pulmonary infections in cystic fibrosis. Clinical trials have included children and adolescents aged years. More limited experience is available in treating children between 1 and 5 years of age. Complicated urinary tract infections and pyelonephritis.
Ciprofloxacin treatment of urinary tract infections should be considered when other treatments cannot be used, and should be based on the results of the microbiological documentation. Other specific severe infections. Other severe infections in accordance with official guidance, or after careful benefit-risk evaluation when other treatments cannot be used, or after failure to conventional therapy and when the microbiological documentation can justify ciprofloxacin use.
The use of ciprofloxacin for specific severe infections other than those mentioned above has not been evaluated in clinical trials and the clinical experience is limited. Consequently, caution is advised when treating patients with these infections. Hypersensitivity and allergic reactions, including anaphylaxis and anaphylactoid reactions, may occur following a single dose see section 4.
If such reaction occurs, ciprofloxacin should be discontinued and an adequate medical treatment is required. Tendinitis and tendon rupture especially Achilles tendon , sometimes bilateral, may occur with ciprofloxacin, even within the first 48 hours of treatment.
Inflammation and ruptures of tendon may occur even up to several months after discontinuation of ciprofloxacin therapy. The risk of tendinopathy may be increased in elderly patients or in patients concomitantly treated with corticosteroids see section 4. At any sign of tendinitis e. Care should be taken to keep the affected limb at rest.
Ciprofloxacin should be used with caution in patients with myasthenia gravis see section 4. Ciprofloxacin has been shown to cause photosensitivity reactions. Patients taking ciprofloxacin should be advised to avoid direct exposure to either extensive sunlight or UV irradiation during treatment see section 4. Ciprofloxacin like other quinolones are known to trigger seizures or lower the seizure threshold.
Cases of status epilepticus have been reported. Ciprofloxacin should be used with caution in patients with CNS disorders which may be predisposed to seizure. If seizures occur ciprofloxacin should be discontinued see section 4. Psychiatric reactions may occur even after first administration of ciprofloxacin. In the occurrence of such cases, ciprofloxacin should be discontinued. Cases of polyneuropathy based on neurological symptoms such as pain, burning, sensory disturbances or muscle weakness, alone or in combination have been reported in patients receiving ciprofloxacin.
Caution should be taken when using fluoroquinolones, including ciprofloxacin, in patients with known risk factors for prolongation of the QT interval such as, for example: Class IA and III anti-arrhythmics, tricyclic antidepressants, macrolides, antipsychotics - uncorrected electrolyte imbalance e.
Therefore, caution should be taken when using fluoroquinolones, including ciprofloxacin, in these populations. Hypoglycemia As with other quinolones, hypoglycemia has been reported most often in diabetic patients, predominantly in the elderly population. In all diabetic patients, careful monitoring of blood glucose is recommended see section 4.
The occurrence of severe and persistent diarrhoea during or after treatment including several weeks after treatment may indicate an antibiotic-associated colitis life-threatening with possible fatal outcome , requiring immediate treatment see section 4. In such cases, ciprofloxacin should immediately be discontinued, and an appropriate therapy initiated. Anti-peristaltic drugs are contraindicated in this situation.
Renal and urinary system. Crystalluria related to the use of ciprofloxacin has been reported see section 4. Patients receiving ciprofloxacin should be well hydrated and excessive alkalinity of the urine should be avoided. Since ciprofloxacin is largely excreted unchanged via renal pathway dose adjustment is needed in patients with impaired renal function as described in section 4.
Cases of hepatic necrosis and life-threatening hepatic failure have been reported with ciprofloxacin see section 4. In the event of any signs and symptoms of hepatic disease such as anorexia, jaundice, dark urine, pruritus, or tender abdomen , treatment should be discontinued.
Haemolytic reactions have been reported with ciprofloxacin in patients with glucosephosphate dehydrogenase deficiency. Ciprofloxacin should be avoided in these patients unless the potential benefit is considered to outweigh the possible risk. In this case, potential occurrence of haemolysis should be monitored. During or following a course of treatment with ciprofloxacin bacteria that demonstrate resistance to ciprofloxacin may be isolated, with or without a clinically apparent superinfection.
Ciprofloxacin inhibits CYP1A2 and thus may cause increased serum concentration of concomitantly administered substances metabolised by this enzyme e. Co-administration of ciprofloxacin and tizanidine is contra-indicated. Therefore, patients taking these substances concomitantly with ciprofloxacin should be monitored closely for clinical signs of overdose, and determination of serum concentrations e.
The concomitant use of ciprofloxacin with methotrexate is not recommended see section 4. The in-vitro activity of ciprofloxacin against Mycobacterium tuberculosis might give falsenegative bacteriological test results in specimens from patients currently taking ciprofloxacin. If vision becomes impaired or any effects on the eyes are experienced, an eye specialist should be consulted immediately. Ciprofloxacin, like other fluoroquinolones, should be used with caution in patients receiving drugs known to prolong the QT interval e.
Class IA and III anti-arrhythmics, tricyclic antidepressants, macrolides, antipsychotics see section 4.More...