INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT MOXIN (MOXIN)

Composition:

Active substance: moxifloxacin;

1 tablet contains 436.8 mg of moxifloxacin hydrochloride, equivalent to 400 mg of moxifloxacin;

Excipients: maize starch, microcrystalline cellulose, talc, colloidal anhydrous silicon dioxide, magnesium stearate, sodium starch glycolate (type A), "Opaglass", "Opadry Pink".

Pharmaceutical form. Film-coated tablets.

Main physico-chemical properties: film-coated tablets, pink in colour, biconvex, elongated in shape (capsule-shaped), with a score line on one side.

Pharmacotherapeutic group. Antimicrobial agents for systemic use. Antibacterial agents of the quinolone group.

ATC code J01MA14.

Pharmacological Properties

Pharmacodynamics

Mechanism of Action

Moxifloxacin is an 8-methoxyfluoroquinolone agent with a broad spectrum of bactericidal activity. In vitro, moxifloxacin is effective against many Gram-positive and Gram-negative microorganisms, anaerobes, acid-fast bacteria, bacteria resistant to β-lactam and macrolide agents, as well as atypical bacteria (e.g., Mycoplasma spp., Chlamydia spp., Legionella spp.).

The bactericidal effect is based on interaction with topoisomerase II and III, which are essential enzymes controlling DNA topology and facilitating DNA replication, repair, and transcription.

Resistance

Resistance mechanisms that inactivate penicillins, cephalosporins, aminoglycosides, macrolides, and tetracyclines do not affect the antibacterial efficacy of moxifloxacin. No cross-resistance has been observed between moxifloxacin and the aforementioned antibiotics. To date, plasmid-mediated resistance has not been observed.

Among quinolones, cross-resistance has been observed. However, some Gram-positive and anaerobic microorganisms resistant to other quinolones remain susceptible to moxifloxacin.

In vitro studies have demonstrated that resistance to moxifloxacin develops slowly due to multiple mutations.

Effect on Intestinal Flora in Humans

Following oral administration of moxifloxacin, the following changes in intestinal flora have been observed: decreased numbers of E. coli, Bacillus spp., Bacteroides vulgatus, Enterococci, Klebsiella spp., and anaerobes such as Bifidobacterium, Eubacterium, and Peptostreptococcus. Their numbers return to normal within two weeks. Clostridium difficile toxin was not detected.

In vitro Susceptibility Data

Moxifloxacin is active against most strains of the following microorganisms:

Gram-Positive Bacteria

Streptococcus pneumoniae (including multidrug-resistant strains, including penicillin-resistant strains and strains resistant to two or more antibiotics from the following classes: penicillins (with minimal inhibitory concentration > 2 mg/L), second-generation cephalosporins (cefuroxime), macrolides, tetracyclines, and trimethoprim/sulfamethoxazole);

Streptococcus pyogenes (Group A)*, Streptococcus milleri, Streptococcus mitior, Streptococcus agalactiae*, Streptococcus dysgalactiae, Streptococcus anginosus*, Streptococcus constellatus*, Staphylococcus aureus (including methicillin-susceptible strains)*, Staphylococcus aureus (methicillin-resistant/ofloxacin-resistant strains) (moderate susceptibility)**, Staphylococcus cohnii, Staphylococcus epidermidis (including methicillin-susceptible strains); Staphylococcus epidermidis (methicillin-resistant/ofloxacin-resistant strains) (moderate susceptibility)**, Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus saprophyticus, Staphylococcus simulans, Corynebacterium diphtheriae, Enterococcus faecalis (only vancomycin- and gentamicin-susceptible strains).*

Gram-Negative Bacteria

Gardnerella vaginalis, Haemophilus influenzae (including β-lactamase-negative and β-lactamase-positive strains)*, Haemophilus parainfluenzae*, Moraxella catarrhalis (including β-lactamase-negative and β-lactamase-positive strains)*, Bordetella pertussis, Escherichia coli*, Klebsiella pneumoniae*, Klebsiella oxytoca, Enterobacter aerogenes, Enterobacter agglomerans, Enterobacter cloacae*, Enterobacter intermedius, Enterobacter sakazakii, Pseudomonas aeruginosa (moderate susceptibility), Pseudomonas fluorescens (moderate susceptibility), Burkholderia cepacia (moderate susceptibility), Stenotrophomonas maltophilia (moderate susceptibility), Proteus mirabilis* (moderate susceptibility), Proteus vulgaris, Morganella morganii, Neisseria gonorrhoeae (moderate susceptibility), Providencia rettgeri, Providencia stuartii.

Anaerobes

Bacteroides distasonis, Bacteroides eggerthii, Bacteroides fragilis*, Bacteroides ovatus, Bacteroides thetaiotaomicron*, Bacteroides uniformis, Fusobacterium spp., Peptostreptococcus spp.*, Porphyromonas spp., Porphyromonas anaerobius, Porphyromonas asaccharolyticus, Porphyromonas magnus, Prevotella spp., Propionibacterium spp., Clostridium perfringens*, Clostridium ramosum.

Atypicals

Chlamydia pneumoniae*, Chlamydia trachomatis*, Mycoplasma pneumoniae*, Mycoplasma hominis, Mycoplasma genitalium, Legionella pneumophila*, Coxiella burnetii.

* /** Clinical efficacy confirmed for strains within approved indications.

Toxic Effect on Reproductive Function

The toxic effect on reproductive function in humans has not been studied.

In animal studies investigating the effect of moxifloxacin on reproductive function, it has been demonstrated that the drug crosses the placenta, with observed cases of reduced fetal weight, increased incidence of abortions, and slight prolongation of gestation period.

Pharmacokinetics

Absorption and Bioavailability

After oral administration, moxifloxacin is rapidly and almost completely absorbed. Absolute bioavailability is approximately 91%.

In the dose range of 50–1200 mg after single doses and at 600 mg daily for 10 days, pharmacokinetics are linear. Steady-state is achieved within three days. After a single 400 mg oral dose, maximum plasma concentration is reached within 0.5–4 hours and amounts to 3.1 mg/L. Maximum and minimum plasma concentrations at steady-state (400 mg once daily) are 3.2 mg/L and 0.6 mg/L, respectively.

When moxifloxacin is taken with food, there is a slight increase in time to maximum concentration (by 2 hours) and a slight reduction in maximum concentration (approximately 16%), while the duration of absorption remains unchanged. Since these changes are not clinically significant, moxifloxacin can be administered independently of food intake.

Distribution

Moxifloxacin rapidly distributes into tissues and organs. Drug exposure, as measured by AUC (AUC_norm = 6 kg·h/L), is high, with a volume of distribution at steady-state of 2 L/kg. Maximum concentrations in saliva may exceed those in plasma. In vitro and ex vivo experiments have shown that protein binding (primarily to albumin) is approximately 45% across a concentration range of 0.02 to 2 mg/L and is independent of drug concentration. Due to this relatively low binding, high concentrations of free (unbound) drug are achieved (>10 × MIC).

Moxifloxacin reaches high concentrations in tissues such as lungs (epithelial lining fluid, alveolar macrophages), sinuses (maxillary and ethmoid sinuses), nasal polyps, and sites of inflammation, where total concentrations exceed plasma concentrations. The drug is present in high concentrations in interstitial fluids (saliva, intramuscular, subcutaneous) in the free, unbound form. Additionally, high concentrations are found in abdominal tissues and fluids and in the female genital tract.

Maximum concentrations and target site-to-plasma concentration ratios for various target tissues show comparable results for both routes of administration after a single 400 mg dose of moxifloxacin.

Metabolism

Moxifloxacin undergoes Phase II biotransformation and is excreted via the kidneys as well as in feces/bile, both unchanged and as inactive sulfate (M1) and glucuronide (M2) metabolites. During in vitro and Phase I clinical studies, no metabolic pharmacokinetic interactions were observed with other drugs involved in Phase I biotransformation mediated by cytochrome P450 enzymes.

Regardless of the route of administration, metabolites M1 and M2 are detected in plasma at lower concentrations than the parent compound. Preclinical studies have adequately covered both metabolites, thereby excluding any potential impact on safety and tolerability.

Elimination

The elimination half-life of the drug is approximately 12 hours. Mean total clearance after a 400 mg dose ranges from 179 to 246 mL/min. Renal clearance is approximately 24–53 mL/min, indicating partial tubular reabsorption of the drug by the kidneys. Concomitant administration of ranitidine and probenecid does not alter the renal clearance of the drug.

Pharmacokinetics in Different Patient Groups

Renal Impairment. No significant changes in moxifloxacin pharmacokinetics have been observed in patients with impaired renal function (including those with creatinine clearance < 30 mL/min/1.73 m²) or in patients undergoing continuous hemodialysis or long-term ambulatory peritoneal dialysis.

Hepatic Impairment. In patients with mild, moderate, or severe hepatic impairment, no clinically significant differences in plasma concentrations of moxifloxacin were observed compared to healthy volunteers or patients with normal hepatic function, respectively.

Elderly Patients. Age does not influence the pharmacokinetic parameters of moxifloxacin.

Clinical characteristics.

Indications.

Treatment of the bacterial infections listed below, caused by microorganisms sensitive to the drug (see sections “Special precautions for use”, “Adverse reactions”, “Pharmacological properties”) in adult patients. Moxifloxacin should be prescribed only when the use of antibacterial agents usually recommended for initial treatment of the infections listed below is inappropriate or when such treatment has been ineffective.

Acute bacterial sinusitis (diagnosed with high probability).
Acute exacerbation of chronic bronchitis (diagnosed with high probability).
Community-acquired pneumonia, except severe community-acquired pneumonia.
Moderate to severe pelvic inflammatory diseases (including infection of the upper genital tract in women, such as salpingitis and endometritis), not associated with tubo-ovarian abscess or pelvic abscesses. The tablet form of Moxin is not recommended for use as monotherapy in moderate to severe pelvic inflammatory diseases, but may be used in combination with other appropriate antibacterial agents (e.g. cephalosporins) due to increasing resistance of moxifloxacin to Neisseria gonorrhoeae (except for moxifloxacin-resistant strains of N. gonorrhoeae) (see sections “Special precautions for use”, “Pharmacological properties”).

The tablet form of the drug is not recommended for initial treatment of any skin and soft tissue infections or in cases of severe community-acquired pneumonia.

Attention should be paid to official guidelines on appropriate use of antibacterial agents.

Contraindications.

Known hypersensitivity to moxifloxacin or to other quinolones or to any of the excipients of the drug.
Age under 18 years.
Pregnancy or breastfeeding.
Patients with a history of tendon disorders related to quinolone therapy.

During preclinical and clinical studies, changes in cardiac electrophysiology, such as QT interval prolongation, were observed after administration of moxifloxacin. Therefore, for safety reasons, the drug is contraindicated in patients with:

Congenital or diagnosed acquired QT interval prolongation;
Electrolyte imbalances, particularly uncorrected hypokalemia;
Clinically significant bradycardia;
Clinically significant heart failure with reduced left ventricular ejection fraction;
History of symptomatic arrhythmias.

The drug should not be used concomitantly with other drugs that prolong the QT interval (see section “Interaction with other medicinal products and other forms of interaction”).

Due to limited clinical data, the drug is also contraindicated in patients with hepatic impairment (Child-Pugh class C) and in patients with elevated transaminase levels (more than 5 times the upper limit of normal).

Interaction with other medicinal products and other forms of interaction.

An additive effect of moxifloxacin and other medicinal products that may cause QT interval prolongation cannot be excluded. This interaction may increase the risk of ventricular arrhythmias, including torsade de pointes. For this reason, the use of moxifloxacin in combination with any of the following medicinal products is contraindicated (see also section “Contraindications”):

Class IA antiarrhythmic agents (e.g. quinidine, hydroquinidine, disopyramide);
Class III antiarrhythmic agents (e.g. amiodarone, sotalol, dofetilide, ibutilide);
Antipsychotic agents (e.g. phenothiazines, pimozide, sertindole, haloperidol, sulpiride);
Tricyclic antidepressants;
Certain antimicrobial agents (saquinavir, sparfloxacin, intravenous erythromycin, pentamidine, antimalarials such as halofantrine);
Certain antihistamines (terfenadine, astemizole, mizolastine);
Others (cisapride, vinca alkaloids IV, bepridil, difemanil).

Moxifloxacin should be prescribed with caution in patients taking drugs that may reduce potassium levels (e.g. loop and thiazide diuretics, enemas and laxatives (at high doses), corticosteroids, amphotericin B), or drugs whose action is associated with clinically significant bradycardia.

An interval of approximately 6 hours should be maintained between the intake of products containing bivalent or trivalent cations (such as antacids containing magnesium or aluminium, didanosine tablets, sucralfate, and iron or zinc-containing preparations) and moxifloxacin.

When co-administered with warfarin, pharmacokinetic parameters, prothrombin time, and other blood coagulation parameters do not change.

The pharmacokinetics of digoxin are only slightly altered by moxifloxacin (after repeated administration of moxifloxacin, an increase in digoxin Cmax of approximately 30% was observed at steady state, without affecting AUC (area under the concentration-time curve)). Therefore, no precautionary measures are required when digoxin is co-administered.

In studies involving volunteers and diabetic patients, concomitant oral administration of moxifloxacin and glyburide resulted in a decrease in peak glyburide concentration of approximately 21%. The combination of glyburide with moxifloxacin may theoretically lead to mild transient hyperglycemia. However, the observed changes in pharmacokinetics did not result in changes in pharmacodynamic parameters (blood glucose levels, insulin levels). Thus, no clinically relevant interaction between moxifloxacin and glyburide has been identified.

In patients receiving anticoagulants in combination with antibiotics, including moxifloxacin, the dose of oral anticoagulant should be adjusted if anticoagulant activity increases.

Concomitant administration of activated charcoal and oral moxifloxacin at a dose of 400 mg reduces systemic bioavailability of the drug by more than 80% due to inhibition of its absorption. Therefore, concomitant use of these two drugs is not recommended (except in cases of overdose; see also section “Overdose”).

Substances for which absence of clinically significant interaction with moxifloxacin has been demonstrated: ranitidine, calcium supplements, theophylline, oral contraceptives, cyclosporine, itraconazole, morphine administered parenterally, probenecid. In vitro studies of human cytochrome P450 enzymes confirmed the above. Based on these results, metabolic interaction via cytochrome P450 enzymes is unlikely.

Absorption of moxifloxacin is not affected by food intake (including dairy products); therefore, moxifloxacin can be administered independently of food.

Special precautions for use

Hypersensitivity and allergic reactions to fluoroquinolones, including moxifloxacin, have been reported after the first dose. Anaphylactic reactions may progress to life-threatening anaphylactic shock, even after the first administration. In such cases, the drug should be discontinued immediately and appropriate therapy (e.g., shock treatment) initiated.

Prolongation of the QT interval on ECG has been observed in some patients receiving moxifloxacin. Analysis of ECG results showed that QTc prolongation with moxifloxacin was 6 ms ± 26 ms – 1.4% compared to baseline values.

Since women generally have a longer QT interval than men, they may be more sensitive to drugs that prolong the QT interval. Elderly patients may also be more susceptible to QT interval-related effects of the drug.

Patients receiving moxifloxacin should use with caution concomitant medications that may lead to hypokalemia.

Moxifloxacin should be prescribed with caution in patients with ongoing proarrhythmic conditions (especially women and elderly patients), such as acute myocardial ischemia or QT prolongation, as this may increase the risk of ventricular arrhythmias, including torsade de pointes and cardiac arrest. The degree of QT prolongation may increase with higher drug concentrations. Therefore, the recommended dose should not be exceeded.

The benefit-risk balance of moxifloxacin therapy should be carefully considered, especially in cases of mild infections (see section "Special precautions for use").

If symptoms of arrhythmia occur during treatment, therapy should be discontinued and an ECG performed.

Cases of fulminant hepatitis potentially leading to liver failure (including fatal outcomes) have been reported with moxifloxacin use. Patients should be advised to seek medical attention before continuing treatment if symptoms suggestive of fulminant hepatitis develop, such as jaundice-associated asthenia, rapidly progressive fatigue, dark urine, bleeding tendencies, or hepatic encephalopathy.

In cases of suspected liver dysfunction, liver function tests and appropriate examinations should be performed.

Cases of severe cutaneous reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported with moxifloxacin use. If skin and/or mucosal reactions occur, patients should be advised to seek immediate medical attention before continuing treatment.

Quinolones are known to provoke seizures. Moxifloxacin should be used with caution in patients with CNS disorders that may predispose to seizures or lower the seizure threshold. If seizures occur, moxifloxacin should be discontinued and appropriate measures taken.

Cases of sensory or sensorimotor polyneuropathy, manifesting as paresthesia, hypoesthesia, dysesthesia, or weakness, have been reported in patients receiving quinolones, including moxifloxacin. Patients receiving moxifloxacin who develop neuropathic symptoms such as pain, burning, tingling, numbness, or weakness should inform their physician before continuing treatment.

Psychiatric reactions may occur even after the first dose of quinolones, including moxifloxacin. In rare cases, depression or psychotic reactions have led to suicidal ideation and self-harming behavior, including suicide attempts (see section "Adverse reactions"). If such reactions occur, moxifloxacin should be discontinued and appropriate measures taken. Moxifloxacin should be prescribed with caution in patients with a history of psychosis or psychiatric disorders.

Due to the use of broad-spectrum antibiotics, including moxifloxacin, cases of antibiotic-associated diarrhea (AAD) and antibiotic-associated colitis (AAC), including pseudomembranous colitis and Clostridium difficile-associated diarrhea, have been reported. The severity ranges from mild diarrhea to fatal colitis. It is therefore important to consider this diagnosis in patients who develop severe diarrhea during or after moxifloxacin therapy. If AAD or AAC is suspected or confirmed, antibacterial therapy, including moxifloxacin, should be discontinued immediately and appropriate therapeutic measures initiated. Infection control measures should also be implemented to reduce transmission risk. Antiperistaltic agents are contraindicated in patients with severe diarrhea.

Moxifloxacin should be used with caution in patients with myasthenia gravis due to the potential for symptom exacerbation.

Tendon inflammation and rupture (particularly of the Achilles tendon), sometimes bilateral, may occur during treatment with quinolones, including moxifloxacin, even within the first 48 hours of therapy. Cases have also been reported months after discontinuation of treatment. Tendon inflammation and rupture may occur during therapy with quinolones, including moxifloxacin, particularly in elderly patients and those receiving concomitant corticosteroid therapy.

At the first signs of tendon pain or inflammation, patients should discontinue moxifloxacin, rest the affected limb(s), and seek immediate medical attention for appropriate management (e.g., splinting of the affected tendon).

Moxifloxacin should be used with caution in elderly patients with renal impairment who are unable to maintain adequate fluid intake, as dehydration may increase the risk of renal failure.

If visual disturbances or other ocular effects occur, patients should seek immediate ophthalmological evaluation.

Photosensitivity reactions have been reported with quinolone use. However, studies indicate that moxifloxacin has a lower risk of photosensitivity. Nevertheless, patients should avoid both ultraviolet radiation and prolonged or intense sunlight exposure during moxifloxacin therapy.

Patients with a personal or family history of glucose-6-phosphate dehydrogenase (G6PD) deficiency may be predisposed to hemolytic reactions during quinolone therapy. Therefore, moxifloxacin should be used with caution in such patients.

Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medication.

Oral moxifloxacin therapy is not recommended in patients with complicated pelvic inflammatory disease (e.g., associated with tubo-ovarian abscess or pelvic abscess) who require intravenous therapy.

Pelvic inflammatory disease may be caused by Neisseria gonorrhoeae resistant to fluoroquinolones. Therefore, empirical use of moxifloxacin in such cases should be combined with another appropriate antibiotic (e.g., a cephalosporin) if resistance to moxifloxacin cannot be fully excluded.

If there is no clinical improvement after 3 days of treatment, the therapy should be re-evaluated.

Moxifloxacin causes cartilage damage in young animals; therefore, its use in children is contraindicated.

Moxifloxacin is not recommended for the treatment of infections caused by methicillin-resistant Staphylococcus aureus (MRSA). In suspected or confirmed MRSA infections, appropriate antibacterial therapy should be initiated.

The clinical efficacy of intravenous moxifloxacin in the treatment of severe infections associated with burns, fasciitis, and diabetic foot with osteomyelitis has not been established.

Moxifloxacin therapy may interfere with the culture-based detection of Mycobacterium spp. due to suppression of microbial growth, potentially leading to false-negative results in samples from patients currently receiving moxifloxacin.

Animal studies have not shown any adverse effects on fertility.

Disturbances of glucose metabolism

As with other fluoroquinolones, alterations in blood glucose levels, including hypoglycemia and hyperglycemia, have been observed with moxifloxacin (Moxin). Dysglycemia occurred predominantly in elderly patients with diabetes who were receiving concomitant therapy with oral hypoglycemic agents (e.g., sulfonylureas) or insulin. Close monitoring of blood glucose levels is recommended in diabetic patients.

Use during pregnancy or breastfeeding

Pregnancy

Moxifloxacin is contraindicated during pregnancy.

Breastfeeding

Moxifloxacin (Moxin) is contraindicated during breastfeeding. A small amount of moxifloxacin may pass into breast milk.

Ability to affect reaction speed when driving or operating machinery

Moxifloxacin, like other fluoroquinolones, may affect reaction speed when driving or operating machinery due to possible central nervous system reactions (e.g., dizziness, acute transient loss of vision, see section "Adverse reactions") or acute transient loss of consciousness (syncope, see section "Adverse reactions"). Patients should be advised to monitor their individual response to moxifloxacin before driving or operating machinery.

Method of Administration and Dosage

Adults

The recommended dose is 1 tablet (400 mg) of moxifloxacin once daily.

The tablets should be swallowed whole with sufficient amount of water. The drug can be taken independently of food intake.

Duration of Therapy

The duration of treatment with Moxin tablets depends on the type of infection and is as follows:

Exacerbation of chronic bronchitis – 5–10 days;
Community-acquired pneumonia – 10 days;
Acute bacterial sinusitis – 7 days;
Moderate to severe pelvic inflammatory disease – 14 days.

The specified dose (400 mg once daily) and the treatment duration for each indication should not be exceeded.

Elderly patients / patients with low body weight

Dose adjustment in elderly patients or patients with low body weight is not required.

Hepatic impairment

Dose adjustment is not required in patients with hepatic impairment (see also section "Special Warnings and Precautions for Use").

Renal impairment

Dose adjustment is not required in patients with mild to moderate renal impairment (including creatinine clearance < 30 mL/min/1.73 m²), as well as in patients undergoing continuous hemodialysis or long-term ambulatory peritoneal dialysis (see section "Pharmacological Properties").

Children

Moxifloxacin is contraindicated in children. The efficacy and safety of Moxin in pediatric patients have not been established.

Overdose

In case of accidental overdose, no specific measures are recommended. In the event of overdose, management should be based on clinical symptoms and include symptomatic and supportive therapy, along with ECG monitoring due to the potential for QT interval prolongation.

Concomitant administration of activated charcoal with a 400 mg oral dose of moxifloxacin reduces systemic bioavailability by more than 80%. In cases of overdose following oral intake of the drug, administration of activated charcoal in the early stages of absorption may be effective in preventing increased systemic exposure to moxifloxacin.

Adverse Reactions

Within each group, adverse events are listed in decreasing order of severity. Frequency is defined as follows: common (≥ 1/100, <1/10), uncommon (≥ 1/1000, <1/100), rare (≥ 1/10,000, <1/1000), very rare (<1/10,000).

Common

Cardiac: QT interval prolongation in patients with hypokalemia.

Gastrointestinal: nausea, vomiting, abdominal pain, diarrhea.

Hepatobiliary disorders: increased transaminase levels.

Sensory organs: altered taste sensation.

Nervous system: dizziness, headache.

Infectious complications: superinfection due to bacterial or fungal resistance, e.g. oral or vaginal candidiasis.

Uncommon

Blood and lymphatic system disorders: anemia, leukopenia, neutropenia, thrombocytopenia, thrombocytosis, eosinophilia; prolonged prothrombin time/increased INR (International Normalized Ratio).

Immune system disorders: allergic reactions.

Metabolism and nutrition disorders: hyperlipidemia.

Psychiatric disorders: anxiety reactions, increased psychomotor activity/agitation.

Nervous system disorders: paresthesia/dysesthesia; taste disturbances (including ageusia in very rare cases); confusion and disorientation, sleep disorders (mainly insomnia), tremor, vertigo; somnolence.

Cardiac: palpitations, tachycardia; QT interval prolongation; vasodilation; atrial fibrillation, angina pectoris.

Gastrointestinal tract: decreased appetite and reduced food intake, constipation, dyspepsia, flatulence, gastritis, increased amylase levels.

Vascular system: vasodilation.

Hepatobiliary disorders: liver function abnormalities (including increased LDH (lactate dehydrogenase)), increased bilirubin levels, increased GGT (gamma-glutamyl transpeptidase), increased alkaline phosphatase levels in blood.

Skin and subcutaneous tissue: pruritus, rash, urticaria, dry skin.

Musculoskeletal system: arthralgia, myalgia.

Eye disorders: visual disturbances, including diplopia and blurred vision (especially during CNS-related reactions).

Respiratory, thoracic and mediastinal disorders: dyspnea (including asthmatic condition).

Renal and urinary system: dehydration.

General disorders: general weakness (mainly asthenia or increased fatigue), pain sensation (including back pain, chest pain, limb pain, pelvic pain), hyperhidrosis.

Rare

Immune system disorders: anaphylaxis, including rare cases of life-threatening shock, allergic edema/angioneurotic edema, including laryngeal edema (potentially life-threatening).

Metabolism and nutrition disorders: hyperglycemia, hyperuricemia.

Psychiatric disorders: mood lability, depression (in rare cases with possible self-aggression such as suicidal ideation/thoughts or suicide attempts); hallucinations.

Nervous system disorders: hypoesthesia; olfactory disturbances (including loss of smell); pathological dreams, coordination disturbances (including gait disturbance due to dizziness or vertigo), seizures with various clinical manifestations (including grand mal seizures); attention disturbances, speech disorders, amnesia, peripheral neuropathy and polyneuropathy.

Ear and labyrinth disorders: tinnitus, hearing disturbances, including deafness (usually reversible).

Cardiac: ventricular tachyarrhythmias, syncope (i.e. acute and transient loss of consciousness).

Vascular system: arterial hypotension, arterial hypertension.

Gastrointestinal tract: dysphagia, stomatitis; antibiotic-associated colitis (including pseudomembranous colitis, in very rare cases associated with life-threatening complications).

Hepatobiliary disorders: jaundice, hepatitis (mainly cholestatic).

Musculoskeletal system: tendonitis, muscle twitching, muscle cramps, muscle weakness.

Renal and urinary system: renal function impairment (including increased plasma creatinine and blood urea nitrogen); renal failure.

General disorders: edema.

Very rare

Blood and lymphatic system disorders: increased prothrombin levels/decreased INR; agranulocytosis.

Metabolism and nutrition disorders: hypoglycemia.

Psychiatric disorders: depersonalization, psychotic reactions (with possible self-aggression such as suicidal ideation/thoughts or suicide attempts).

Nervous system disorders: hyperesthesia.

Eye disorders: transient visual loss (especially during CNS-related reactions).

Cardiac: non-specific arrhythmias; "torsade de pointes" ventricular tachycardia, cardiac arrest.

Hepatobiliary disorders: fulminant hepatitis, potentially leading to life-threatening hepatic failure (including fatal cases).

Skin and subcutaneous tissue: bullous skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis (potentially life-threatening).

Musculoskeletal system: tendon rupture; arthritis, muscle rigidity; exacerbation of myasthenia symptoms.

Very rarely, following treatment with other fluoroquinolones, the following adverse reactions have been reported, which may possibly also occur with moxifloxacin: hypernatremia, hypercalcemia, hemolytic anemia, rhabdomyolysis, photosensitization reactions (see section "Special precautions for use").

Shelf life. 3 years.

Storage conditions. Store in a place protected from light and moisture, out of reach of children, at a temperature not exceeding 25 °C.

Packaging. 5 tablets per blister, 1 blister per cardboard box.

Prescription status. Prescription only.

Manufacturer. Bafna Pharmaceuticals Ltd., India.

Manufacturer's address and place of business.
147, Madhavaram Red Hills Road, Guindy, Village Vadakarai, Chennai, Tamil Nadu IN 600052, India.