INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT CIPROLETA® (CIPROLETA)

Composition:

Active substances: ciprofloxacin, tinidazole;

One film-coated tablet contains ciprofloxacin hydrochloride equivalent to 500 mg of ciprofloxacin and 600 mg of tinidazole;

Excipients: maize starch, microcrystalline cellulose, sodium croscarmellose, sodium starch glycolate (type A), colloidal anhydrous silicon dioxide, talc, magnesium stearate, hydroxypropylmethylcellulose, sorbic acid, titanium dioxide (E 171), polyethylene glycol 6000, polysorbate 80, dimethicone, Opadry 13 F80003 white.

Pharmaceutical form. Film-coated tablets.

Main physicochemical properties: white or almost white, oval-shaped, film-coated tablets with a break line on one side and a smooth surface on the other.

Pharmacotherapeutic group. Combined antibacterial agents. Fluoroquinolones in combination with other antibacterial agents. ATC code J01RA04.

Pharmacological properties.

Pharmacodynamics. The pharmacological properties of the drug Ciprolet**®** A are determined by the pharmacological properties of each of its components. The mechanism of action of ciprofloxacin is due to inhibition of the bacterial enzyme DNA gyrase in bacteria. This inhibition results in disruption of the three-dimensional structure of bacterial DNA and prevents further division of bacterial cells. Ciprofloxacin is active against both gram-positive and gram-negative bacteria.

The spectrum of ciprofloxacin activity includes the following microorganisms:

Aerobic gram-negative bacteria – Escherichia coli, Klebsiella pneumoniae, Salmonella typhi, Proteus mirabilis, Proteus vulgaris, Shigella sonnei, Shigella boydii, Shigella dysenteriae, Shigella flexneri, Enterobacter cloacae, Morganella morganii, Providencia rettgeri, Providencia stuartii, Citrobacter diversus, Citrobacter freundii, Serratia marcescens, Campylobacter jejuni, Pseudomonas aeruginosa, Neisseria gonorrhoeae, Haemophilus influenzae, Haemophilus parainfluenzae, Bacillus anthracis, Moraxella catarrhalis;

Aerobic gram-positive bacteria – staphylococci, including penicillinase-producing strains and methicillin-resistant strains, streptococci, including Streptococcus pneumoniae, Listeria monocytogenes, Corynebacterium spp.

Tinidazole is a 5-nitroimidazole derivative with a substituted imidazole component capable of acting against anaerobic bacteria and protozoa. The mechanism of action of tinidazole against anaerobic bacteria and protozoa is associated with penetration of the drug into microbial cells and damage to DNA or inhibition of its synthesis.

Tinidazole is active against both protozoa and obligate anaerobic bacteria. Protozoan microorganisms sensitive to tinidazole include Trichomonas vaginalis, Entamoeba histolytica, and Giardia lamblia.

Tinidazole is active against Gardnerella vaginalis and against most anaerobic bacteria, including Bacteroides fragilis, Bacteroides melaninogenicus, Bacteroides spp., Clostridium spp., Eubacterium spp., Fusobacterium spp., Peptococcus spp., Peptostreptococcus spp., and Veillonella spp.

Pharmacokinetics.

Ciprofloxacin is rapidly absorbed after oral administration. Bioavailability is approximately 70%. Food does not affect the extent of ciprofloxacin absorption but may slow the rate of absorption. Maximum plasma concentration of ciprofloxacin is reached within 1–2 hours. Ciprofloxacin achieves therapeutic concentrations in nearly all body tissues and fluids. Plasma protein binding is low – 20–40%. Elimination half-life is 3–5 hours. Tinidazole is rapidly and completely absorbed after oral administration.

After a 2 g oral dose of tinidazole, serum concentrations peak at 40–51 mcg/mL within 2 hours and decline to 11–19 mcg/mL within 24 hours. The elimination half-life of tinidazole in plasma is 12–14 hours. Tinidazole actively distributes throughout all body tissues and penetrates the blood-brain barrier. Approximately 12% of tinidazole in plasma is protein-bound. Tinidazole is eliminated via both the liver and kidneys. Within 5 days, 60–65% of the administered dose is excreted by the kidneys, of which 20–25% is excreted unchanged. Approximately 12% of the dose is excreted in feces.

Clinical characteristics.

Indications. Infections caused by drug-susceptible microorganisms, including mixed aerobic-anaerobic infections and protozoal infections: respiratory tract – pleurisy, pleural empyema, lung abscess; ENT organs – chronic sinusitis, mastoiditis; skin and soft tissues – infected ulcers, abscesses, cellulitis, soft tissue infections in patients with diabetes mellitus; gastrointestinal tract – bacterial diarrhea, dysentery, amoebiasis, other mixed gastrointestinal infections; intra-abdominal infections; gynecological infections; bone infections – chronic osteomyelitis; dental infections.

Contraindications. Hypersensitivity to ciprofloxacin or other fluoroquinolones, hypersensitivity to tinidazole or other 5-nitroimidazole derivatives, organic neurological disorders, history of blood disorders, pregnancy or lactation, pediatric age. Concomitant use of ciprofloxacin and tizanidine is contraindicated (see section "Interaction with other medicinal products and other forms of interactions").

Interaction with other medicinal products and other forms of interactions.

Concomitant administration of the drug Ciprobay®A with iron preparations, sucralfate, antacids containing magnesium, aluminium, calcium, and products with high buffering capacity (e.g., antiretroviral agents) reduces the absorption rate of ciprofloxacin. Therefore, Ciprobay®A should be administered 1–2 hours before or 4 hours after intake of these agents. This restriction does not apply to H2-receptor blockers.

Theophylline

Concomitant use of theophylline and ciprofloxacin leads to increased plasma concentration and prolonged half-life of theophylline, which may result in adverse reactions. In individual cases, such adverse reactions may be life-threatening or fatal. If concomitant use of these drugs cannot be avoided, serum theophylline concentration should be monitored and the dose appropriately reduced (see section "Special precautions for use").

Cyclosporine

When used concomitantly with cyclosporine, an increase in serum creatinine levels has been observed in some cases. Therefore, frequent monitoring (twice weekly) of plasma creatinine concentration is required in these patients.

Oral anticoagulants

Ciprobay**®**A may increase the concentration and prolong the half-life of oral anticoagulants.

Concomitant use of ciprofloxacin and vitamin K antagonists may enhance the anticoagulant effect of vitamin K antagonists. The degree of risk may vary depending on the type of infection, age, and general condition of the patient, making it difficult to precisely assess the impact of ciprofloxacin on the increase in International Normalized Ratio (INR). Frequent monitoring of INR is recommended during and immediately after concomitant use of ciprofloxacin and vitamin K antagonists (e.g., warfarin, acenocoumarol, phenprocoumon, or fluindione).

Tizanidine

Tizanidine must not be administered concomitantly with ciprofloxacin (see section "Contraindications"). In a clinical study involving healthy volunteers, concomitant administration of ciprofloxacin and tizanidine resulted in increased plasma concentration of tizanidine (increase in Cmax by 7-fold, range 4–21 times; increase in AUC by 10-fold, range 6–24 times). Elevated serum tizanidine concentrations are associated with hypotensive and sedative adverse reactions.

Methotrexate

Concomitant administration of ciprofloxacin may slow tubular transport (renal metabolism) of methotrexate, potentially increasing methotrexate plasma concentration. This may increase the risk of methotrexate-induced toxic adverse reactions. Concomitant use is not recommended.

Ropinirole.

Clinical studies have shown that concomitant use of ropinirole with ciprofloxacin, a moderate inhibitor of CYP450 1A2 isoenzyme, increases AUC and Cmax of ropinirole by 60% and 84%, respectively. Monitoring for ropinirole-related adverse effects and appropriate dose adjustment are recommended during and immediately after concomitant use with ciprofloxacin (see section "Special precautions for use").

Clozapine.

After concomitant administration of 250 mg ciprofloxacin with clozapine for 7 days, serum concentrations of clozapine and N-desmethylclozapine increased by 29% and 31%, respectively. Clinical monitoring and appropriate dose adjustment of clozapine are recommended during and immediately after concomitant use with ciprofloxacin (see section "Special precautions for use").

QT-prolonging agents.

Ciprobay®A, like other fluoroquinolone-containing medicinal products, should be administered with caution to patients receiving drugs that prolong the QT interval (e.g., class IA and III antiarrhythmics, tricyclic antidepressants, macrolides, antipsychotics) (see section "Special precautions for use").

Metoclopramide.

Metoclopramide accelerates the absorption of ciprofloxacin, resulting in faster achievement of maximum plasma concentration. No effect on ciprofloxacin bioavailability has been observed.

Omeprazole.

Concomitant use of ciprofloxacin and medicinal products containing omeprazole results in a slight reduction in ciprofloxacin Cmax and AUC.

Lidocaine.

It has been demonstrated that in healthy subjects, concomitant use of ciprofloxacin, a moderate inhibitor of cytochrome P450 1A2 isoenzymes, and lidocaine-containing medicinal products reduces the clearance of intravenous lidocaine by 22%. Despite normal tolerability of lidocaine treatment, interaction with ciprofloxacin associated with adverse reactions may occur when these agents are used concomitantly.

Sildenafil.

Cmax and AUC of sildenafil increased approximately 2-fold in healthy volunteers after oral administration of 50 mg sildenafil and concomitant administration of 500 mg ciprofloxacin. Therefore, caution is advised when co-administering Ciprobay®A with sildenafil, and the risk-benefit ratio should be considered.

Oral hypoglycemic agents.

Ciprobay®A may increase the concentration and prolong the half-life of oral hypoglycemic agents. Hypoglycemia has been reported when ciprofloxacin is used concomitantly with oral antidiabetic agents, particularly sulfonylureas (e.g., glyburide, glimepiride), likely due to potentiation of the antidiabetic effect by ciprofloxacin (see section "Adverse reactions"). Therefore, frequent monitoring of blood glucose levels is required in such patients.

Duloxetine.

Clinical studies have shown that concomitant use of duloxetine with strong CYP450 1A2 inhibitors, such as fluvoxamine, may increase AUC and Cmax of duloxetine. Although clinical data on potential interaction with ciprofloxacin are lacking, similar effects may be expected when these agents are used concomitantly (see section "Special precautions for use").

Nonsteroidal anti-inflammatory drugs (NSAIDs).

Animal studies have shown that a combination of very high doses of quinolones (gyrase inhibitors) and certain nonsteroidal anti-inflammatory drugs (except acetylsalicylic acid) may provoke seizures.

Ciprofloxacin affects caffeine metabolism, leading to prolonged elimination half-life. Changes in serum phenytoin levels (increases or decreases) have been reported with concomitant use of ciprofloxacin and phenytoin. Concomitant use of Ciprobay®A and probenecid is associated with increased plasma concentration of ciprofloxacin. Metoclopramide accelerates the absorption of Ciprobay®A, thereby reducing the time to reach maximum plasma concentration of ciprofloxacin (without affecting its bioavailability).

Special precautions for use.

Ciprofloxacin should be avoided in patients who have previously experienced serious adverse reactions to fluoroquinolones. Treatment with ciprofloxacin in such patients should be initiated only if no alternative treatment options are available and after careful benefit–risk assessment (see section "Contraindications").

Alcoholic beverages should not be consumed during treatment due to the potential for a disulfiram-like reaction (flushing, abdominal cramps, vomiting, tachycardia). Alcohol should also be avoided for 72 hours after discontinuation of the drug.

Ciprolet®A should be prescribed only when strictly indicated in patients with epilepsy, history of seizures, cerebrovascular disease, or organic brain disorders due to the risk of central nervous system (CNS) adverse reactions. If CNS-related adverse reactions occur during treatment, the drug should be discontinued. In case of severe and persistent diarrhea during or after treatment with Ciprolet®A, pseudomembranous colitis should be ruled out, which requires immediate discontinuation of the drug and initiation of appropriate therapy.

In patients with impaired hepatic and/or renal function, monitoring of ciprofloxacin plasma concentrations is recommended. Dose adjustment is not required for elderly patients. Hypersensitivity and allergic reactions may occur after the first dose of ciprofloxacin. In very rare cases, life-threatening anaphylactic reactions may develop. In such cases, ciprofloxacin must be discontinued immediately and appropriate medical treatment initiated. Any signs of tendinitis (e.g., painful swelling, inflammation) require immediate discontinuation of the drug and avoidance of physical exertion. Ciprofloxacin may cause photosensitivity reactions; therefore, direct sunlight exposure should be avoided during treatment. If photosensitivity reactions occur, ciprofloxacin therapy should be discontinued. Patients taking Ciprolet®A should maintain adequate fluid intake to prevent crystalluria.

Severe and/or mixed infections caused by gram-positive or anaerobic bacteria

For treatment of severe infections or infections caused by staphylococci or anaerobic bacteria, ciprofloxacin should be used in combination with appropriate antibacterial agents according to approved protocols.

Streptococcal infections (including Streptococcus pneumoniae)

Ciprofloxacin is not recommended for the treatment of streptococcal infections due to insufficient efficacy.

Urinary tract infections

Orchiepididymitis and inflammatory diseases of the pelvic organs may be caused by fluoroquinolone-resistant Neisseria gonorrhoeae. Ciprofloxacin should be administered concomitantly with other appropriate antibacterial agents, except in clinical situations where ciprofloxacin-resistant Neisseria gonorrhoeae strains have been ruled out. If no clinical improvement is observed within 3 days, therapy should be re-evaluated.

Intra-abdominal infections

Data on the efficacy of ciprofloxacin in the treatment of postoperative intra-abdominal infections are limited.

Traveler’s diarrhea

When selecting the drug, information on ciprofloxacin resistance of relevant microorganisms in the countries visited by the patient should be taken into account.

Bone and joint infections

Ciprofloxacin should be used in combination with other antimicrobial agents based on microbiological test results.

Pulmonary form of anthrax

Use in humans is based on in vitro susceptibility data, animal studies, and limited clinical experience. The physician should follow national and/or international anthrax treatment guidelines.

Antibiotic-associated diarrhea

Cases of antibiotic-associated diarrhea have been reported with antibacterial agents, varying in severity from mild diarrhea to severe forms. The most common cause is Clostridium difficile. The medicinal product Ciprolet A contains tinidazole, which in most cases is active against Clostridium difficile; therefore, the likelihood of antibiotic-associated diarrhea with Ciprolet A is minimal, but not excluded (in case of tinidazole-resistant Clostridium difficile). The physician should carefully evaluate the patient's clinical data and, if necessary, correct fluid and electrolyte imbalances, consider administration of protein preparations, and use antibacterial agents to which Clostridium difficile is susceptible.

Complicated urinary tract infections and pyelonephritis

Treatment of urinary tract infections with ciprofloxacin should be considered only when other treatments are not feasible. Therapy should be based on microbiological test results.

Other specific severe infections

Ciprofloxacin use may be justified based on microbiological test results for other infections according to official recommendations or after careful benefit–risk assessment when alternative treatments are not possible or standard therapy has proven ineffective. The use of ciprofloxacin for specific severe infections not mentioned above has not been evaluated in clinical trials, and clinical experience is limited. Therefore, treatment of patients with such infections should be approached with caution.

Hypersensitivity to the drug

Hypersensitivity and allergic reactions may occur after the first dose of ciprofloxacin (see section "Adverse reactions"), and patients should be advised to inform their physician immediately. In rare cases, anaphylactic/anaphylactoid reactions may progress to life-threatening shock. These reactions may occur after the first dose. In such cases, drug administration must be discontinued immediately and appropriate medical treatment initiated (treatment of anaphylactic shock).

Musculoskeletal system

Ciprofloxacin should generally not be used in patients with a history of tendon disorders associated with quinolone use. However, in rare cases, after microbiological identification of the pathogen and benefit–risk assessment, ciprofloxacin may be prescribed for treatment of certain severe infections—particularly when standard therapy is ineffective or bacterial resistance justifies its use based on microbiological results. Tendinitis or tendon rupture (especially Achilles tendon), sometimes bilateral, may occur during ciprofloxacin therapy, even within the first 48 hours of treatment. Cases of tendon rupture have been reported several months after discontinuation of the drug. The risk of tendinopathy may be increased in elderly patients, patients with renal impairment, organ transplant recipients, and those receiving concomitant corticosteroids; therefore, concomitant use of corticosteroids with this medicinal product should be avoided (see section "Adverse reactions"). If any signs of tendinitis (e.g., painful swelling, inflammation) occur, ciprofloxacin should be discontinued and alternative treatments considered. The affected limb should be rested, and corticosteroids should not be used in cases of tendinopathy.

Ciprofloxacin should be used with caution in patients with myasthenia gravis (see section "Adive reactions").

Photosensitivity

Ciprofloxacin has been shown to cause photosensitivity reactions. Patients taking ciprofloxacin are advised to avoid direct sunlight and UV radiation during treatment (see section "Adverse reactions").

Central nervous system

Quinolones may cause seizures or lower the seizure threshold. Ciprofloxacin should be used with caution in patients with CNS disorders predisposing to seizures. If seizures occur, the drug should be discontinued (see section "Adverse reactions"). Psychotic reactions may occur even after the first dose of ciprofloxacin. In rare cases, depression or psychosis may progress to suicidal thoughts or actions, including suicide or attempted suicide. In such cases, the drug should be discontinued and appropriate measures taken according to the clinical situation.

Peripheral neuropathy

Cases of sensory or sensorimotor polyneuropathy have been reported in patients receiving ciprofloxacin, manifesting as paresthesia, hypesthesia, dysesthesia, or weakness (based on neurological symptoms such as pain, burning, sensory disturbances, or muscle weakness, alone or in combination). Ciprofloxacin should be discontinued in patients experiencing symptoms of neuropathy—including pain, burning, tingling, numbness, and/or weakness—and a physician should be consulted before continuing treatment to prevent irreversible conditions (see section "Adverse reactions").

Cardiac disorders

Ciprofloxacin has been associated with cases of QT interval prolongation (see section "Adverse reactions").

Since women generally have a longer QT interval than men, they may be more susceptible to drugs that prolong the QT interval. Elderly patients may also be more sensitive to the effects of drugs on QT interval duration. Caution is required when co-administering ciprofloxacin with drugs that may prolong the QT interval (e.g., class IA and III antiarrhythmics, tricyclic antidepressants, macrolides, antipsychotics) (see section "Interaction with other medicinal products and other forms of interaction") or in patients with risk factors for QT prolongation or development of torsades de pointes (e.g., congenital long QT syndrome, uncorrected electrolyte imbalances such as hypokalemia or hypomagnesemia, and cardiac diseases including heart failure, myocardial infarction, or bradycardia).

Gastrointestinal tract

If severe and persistent diarrhea occurs during or after treatment (even weeks after therapy), the physician should be informed immediately, as this symptom may indicate a serious gastrointestinal condition (e.g., pseudomembranous colitis, which may be fatal) requiring immediate treatment (see section "Adverse reactions"). In such cases, the drug should be discontinued and appropriate therapy initiated (e.g., vancomycin 4 × 250 mg/day orally). Medicinal products that inhibit peristalsis are contraindicated.

Kidney and urinary system

During treatment with Ciprolet®A, patients should have their renal function monitored, including serum creatinine levels (twice weekly). Crystalluria associated with ciprofloxacin use has been reported (see section "Adverse reactions"). Patients taking ciprofloxacin should maintain adequate fluid intake. Excessive alkalinity of urine should be avoided.

Hepatobiliary system

Cases of hepatic necrosis and life-threatening liver failure have been reported with ciprofloxacin use (see section "Adverse reactions"). If any signs or symptoms of liver disease occur (e.g., anorexia, jaundice, dark urine, pruritus, or abdominal distension), treatment should be discontinued. Transient increases in transaminases and alkaline phosphatase, as well as cholestatic jaundice, may also occur, particularly in patients with pre-existing liver damage receiving ciprofloxacin (see section "Adverse reactions").

Glucose-6-phosphate dehydrogenase deficiency

Hemolytic reactions have been reported in patients with glucose-6-phosphate dehydrogenase deficiency receiving ciprofloxacin. Ciprofloxacin should be avoided in such patients unless the potential benefit outweighs the potential risk. In such cases, monitoring for possible hemolysis is required.

Resistance

Resistant bacteria may be isolated during or after ciprofloxacin therapy, with or without clinically evident superinfection. There is a potential risk of emergence of ciprofloxacin-resistant bacteria during prolonged treatment courses and in the treatment of hospital-acquired infections and/or infections caused by Staphylococcus and Pseudomonas species.

Cytochrome P450

Ciprofloxacin moderately inhibits CYP450 1A2 and may therefore increase plasma concentrations of concurrently administered drugs metabolized by this enzyme (e.g., theophylline, methylxanthines, caffeine, duloxetine, clozapine, olanzapine, ropinirole, tizanidine). Concomitant administration of ciprofloxacin and tizanidine is contraindicated. Increased plasma concentrations associated with drug-specific adverse reactions result from inhibition of metabolic clearance by ciprofloxacin. Patients receiving these drugs concomitantly with ciprofloxacin should be closely monitored for signs of overdose. Therapeutic drug monitoring (e.g., theophylline levels) may also be necessary (see section "Interaction with other medicinal products and other forms of interaction").

Methotrexate

Concomitant administration of ciprofloxacin and methotrexate is not recommended (see section "Interaction with other medicinal products and other forms of interaction").

Effect on laboratory test results

Ciprofloxacin may in vitro affect culture results for Mycobacterium spp. by inhibiting mycobacterial growth, potentially leading to false-negative culture results in patients receiving ciprofloxacin.

Risk of aortic aneurysm and dissection following fluoroquinolone use

Epidemiological studies report an increased risk of aortic aneurysm and dissection following fluoroquinolone use, particularly in elderly patients. Therefore, fluoroquinolones should be used only after careful benefit–risk assessment and consideration of alternative therapies in patients with a positive family history of aneurysm disease, diagnosed aortic aneurysm and/or aortic dissection, or other risk factors or conditions predisposing to aortic aneurysm and dissection (e.g., Marfan syndrome, Ehlers-Danlos syndrome, Takayasu arteritis, giant cell arteritis, Behçet’s disease, hypertension, atherosclerosis).

In case of sudden abdominal, chest, or back pain, patients should seek immediate medical attention at an emergency department.

Fluctuations in blood glucose levels

Fluoroquinolones may cause disturbances in blood glucose levels, including hyperglycemia and hypoglycemia (see section "Adverse reactions"), usually in diabetic patients receiving concomitant therapy with oral hypoglycemic agents (e.g., glibenclamide) or insulin. Severe cases of hypoglycemia leading to coma have been reported. Close monitoring of blood glucose levels is recommended for such patients.

Prolonged, disabling, potentially irreversible serious adverse reactions.

Very rare cases of prolonged (from several months to years), disabling, potentially irreversible serious adverse reactions affecting multiple organ systems (musculoskeletal, nervous system, psychiatric, and sensory organs), sometimes simultaneously, have been reported in patients receiving quinolone and fluoroquinolone therapy, regardless of age or previously identified risk factors. Ciprofloxacin should be discontinued immediately at the first signs or symptoms of any serious adverse reactions, and medical advice should be sought immediately.

Use during pregnancy or breastfeeding. The drug is contraindicated during pregnancy or breastfeeding.

Ability to affect reaction speed when driving or operating machinery. Patients should refrain from driving and/or operating machinery requiring high concentration and rapid psychomotor responses during treatment.

Dosage and Administration

The usual dose of Ciprolet®A for adults is 1 tablet twice daily. Administer orally to adults 1 hour before or 2 hours after meals. Tablets should be swallowed whole with a small amount of liquid.

For patients with creatinine clearance of 30–60 mL/min, the maximum daily dose should be 2 tablets. For patients with creatinine clearance of 30 mL/min or less, the maximum daily dose is 1 tablet per day.

In severe infections of the abdominal organs or respiratory tract, and in chronic osteomyelitis, the maximum daily dose is 3 tablets per day.

The duration of treatment depends on the severity of infection and results of bacteriological studies. The usual course of treatment for acute infections is 5–7 days; however, for chronic recurrent infections, the treatment course is 10–14 days. It is recommended to continue taking the medication for at least 3 days after normalization of body temperature or resolution of infection symptoms.

Children. The efficacy and safety of the drug in pediatric practice have not been established; therefore, it should not be used in children.

Overdose

Symptoms of overdose may include dizziness, tremor, headache, fatigue, seizures, hallucinations, confusion, abdominal discomfort, renal and hepatic failure, as well as crystalluria and hematuria. In cases of acute overdose, reports of renal toxicity have been documented. No specific antidote is known. In case of overdose, gastric lavage should be performed. Close monitoring and supportive therapy are required, including monitoring of kidney function and administration of antacids containing magnesium, aluminum, or calcium, which may reduce the absorption of ciprofloxacin. Adequate hydration should be maintained. Tinidazole is readily removed during dialysis. Ciprofloxacin is only slightly eliminated (less than 10%) by hemodialysis or peritoneal dialysis.

Side effects.

Infections and infestations: fungal superinfections/candidiasis, including oral candidiasis and vaginal candidiasis, cutaneous candidiasis, thrush, vaginitis, antibiotic-associated/pseudomembranous colitis with potentially fatal outcome.

Gastrointestinal disorders: nausea, diarrhea, elevated liver enzymes (ALT, AST), alkaline phosphatase, vomiting, dyspeptic symptoms, heartburn, abnormal liver function tests, anorexia, constipation, flatulence, bilirubinemia, jaundice, cholestatic jaundice, pseudomembranous colitis, hepatic necrosis (very rarely progressing to life-threatening liver failure), pancreatitis, non-infectious hepatitis, metallic taste in mouth, abdominal pain, coated tongue, glossitis, stomatitis.

*Nervous system disorders: dizziness, sleep disorders, agitation, confusion, migraine, hallucinations, increased sweating, paresthesia, dysesthesia, hypoesthesia, emotional disturbances (restlessness, fear, anxiety), sleep disturbances, seizures, somnolence, insomnia, pathological/nightmarish dreams, lethargy, intracranial hypertension, depression, tremor, unsteady gait, psychosis, increased intracranial pressure, ataxia, twitching, headache, sensory disturbances, peripheral neuropathy and polyneuropathy.

Cardiovascular disorders: arrhythmias (including extrasystoles, atrial flutter, ventricular arrhythmia, tachycardia, palpitations, bidirectional ventricular tachycardia), syncope (fainting), vasodilation, flushing sensation, decreased/increased blood pressure, vasculitis, QT interval prolongation.

Hematopoietic and lymphatic system disorders: eosinophilia, leukopenia, anemia, neutropenia, leukocytosis, altered prothrombin levels, thrombocytopenia, thrombocytosis, hemolytic anemia, petechiae, agranulocytosis, pancytopenia (life-threatening), bleeding, methemoglobinemia, monocytosis, bone marrow suppression (life-threatening).

*Psychiatric disorders: psychomotor agitation/anxiety, restlessness, agitation, anxiety, pathological dreams, confusion and disorientation, depression, hallucinations, psychoses, psychotic reactions (mania, phobias, depersonalization), delirium, irritability.

*Musculoskeletal and connective tissue disorders: limb pain, arthralgia, joint dysfunction, myalgia, joint swelling, myasthenia, exacerbation of myasthenia symptoms, myoclonus, tendon injury, tendinitis, tendon ruptures (predominantly Achilles), tendon damage, gout attack, back, neck, chest pain.

Renal and urinary system disorders: increased creatinine levels, increased blood urea nitrogen, renal failure, impaired kidney function, vaginal candidiasis, hematuria, crystalluria, polyuria, urinary retention, urethral bleeding, candiduria, cylinduria, albuminuria, exacerbation of urolithiasis, tubulointerstitial nephritis, darkening of urine.

Reproductive system disorders: discomfort in mammary glands, gynecomastia.

Endocrine disorders: hyperglycemia, hypoglycemia, hypoglycemic coma, syndrome of inappropriate antidiuretic hormone secretion (SIADH).

Respiratory system disorders: dyspnea (including asthmatic conditions), laryngeal edema.

Hypersensitivity reactions. Skin and subcutaneous tissue disorders: skin rash, pruritus, maculopapular rash, skin redness, urticaria, photosensitivity reactions, appearance of nonspecific blisters, allergic reactions, drug eruption, anaphylactoid/anaphylactic reactions (including anaphylactic shock), serum sickness-like reaction, petechiae, erythema multiforme, nodular erythema, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, hyperpigmentation, angioneurotic edema (including facial, lip, neck, conjunctival, hand swelling).

*Eye disorders: visual disturbances, impaired color vision, blurred vision, achromatopsia.

*Sensory organ and balance disorders: taste disturbances, tinnitus, temporary deafness, hearing impairment, vision disturbances, diplopia, chromatopsia, parosmia, olfactory disturbances/loss of smell.

*General disorders: abdominal pain, candidiasis, asthenia, limb pain, back pain, chest pain, flushing. Nonspecific pain syndrome, malaise, increased fatigue, weakness, elevated body temperature; lymphadenopathy, edema, increased sweating (hyperhidrosis); gait disturbances.

Metabolism and nutrition disorders: edema, hyperglycemia, increased amylase activity, increased lipase activity.

* Very rare reports have been received about long-term (from several months to several years), disabling, potentially irreversible serious adverse reactions leading to loss of work capacity, affecting various organ systems and sensory organs, sometimes simultaneously (including such reactions as tendinitis, tendon rupture, arthralgia, limb pain, gait disturbances, neuropathies associated with paresthesia, depression, fatigue, memory impairment, sleep disorders, hearing, vision, taste and smell disturbances) in patients treated with quinolones and fluoroquinolones, regardless of previously identified risk factors.

Shelf life. 3 years.

Storage conditions. Store in original packaging to protect from light at a temperature not exceeding 25°C.

Packaging. 10 tablets in a blister, 1 blister per box.

Prescription status. Prescription only.

Manufacturer. Dr. Reddy’s Laboratories Ltd, FTO – II

Manufacturer's address and place of business.
Plot No. 42R, 43, 44R, 45R, 46R, 53, 54, 83, Bachupally, Bachupally Mandal, Medchal Malkajgiri District – 500090, Telangana State, India

To report an adverse reaction or lack of efficacy during the use of the medicinal product, please call (24/7):
+38(044) 207-51-97 or +38 (050) 414-39-39; or send an email to: [email protected]

Cipralet® a