Moxican 400 mg film-coated tablets are indicated for the treatment of the following bacterial
infections in patients of 18 years and older caused by bacteria susceptible to Moxican (see
sections 4.4, 4.8 and 5.1). Moxican should be used only when it is considered inappropriate to
use antibacterial agents that are commonly recommended for the initial treatment of these
infections or when these have failed:
- Acute bacterial sinusitis (adequately diagnosed)
- Acute exacerbations of chronic bronchitis (adequately diagnosed)
- Community acquired pneumonia, except severe cases
- Mild to moderate pelvic inflammatory disease (i.e. infections of female upper genital tract,
including salpingitis and endometritis), without an associated tubo-ovarian or pelvic abscess.
Moxican 400 mg film-coated tablets are not recommended for use in monotherapy of mild to
moderate pelvic inflammatory disease but should be given in combination with another
appropriate antibacterial agent (e.g. a cephalosporin) due to increasing Moxican resistance of
Neisseria gonorrhoeae unless Moxican-resistant Neisseria gonorrhoeae can be excluded (see
sections 4.4 and 5.1).
Moxican 400 mg film-coated tablets may also be used to complete a course of therapy in
patients who have shown improvement during initial treatment with intravenous Moxican for
the following indications:
- Community-acquired pneumonia
- Complicated skin and skin structure infections
Moxican 400 mg film-coated tablets should not be used to initiate therapy for any type of skin
and skin structure infection or in severe community-acquired pneumonia.
Consideration should be given to official guidance on the appropriate use of antibacterial
agents.
 

Adults
The recommended dose is one 400 mg film-coated tablet once daily.
Renal/hepatic impairment
No adjustment of dosage is required in patients with mild to severely impaired renal function or
in patients on chronic dialysis i.e. haemodialysis and continuous ambulatory peritoneal dialysis
(see section 5.2 for more details).
There is insufficient data in patients with impaired liver function (see section 4.3).
Other special populations
No adjustment of dosage is required in the elderly and in patients with low bodyweight.
Paediatric population
Moxican is contraindicated in children and adolescents (< 18 years). Efficacy and safety of
Moxican in children and adolescents have not been established (see section 4.3).
Method of administration
The film-coated tablet should be swallowed whole with sufficient liquid and may be taken
independent of meals.
Duration of administration
Moxican 400 mg film-coated tablets should be used for the following treatment durations:
- Acute exacerbation of chronic bronchitis 5 - 10 days
- Community acquired pneumonia 10 days
- Acute bacterial sinusitis 7 days
- Mild to moderate pelvic inflammatory disease 14 days
Moxican 400 mg film-coated tablets have been studied in clinical trials for up to 14 days
treatment.
Sequential (intravenous followed by oral) therapy
In clinical studies with sequential therapy most patients switched from intravenous to oral
therapy within 4 days (community-acquired pneumonia) or 6 days (complicated skin and skin
structure infections). The recommended total duration of intravenous and oral treatment is 7 -
14 days for community-acquired pneumonia and 7 - 21 days for complicated skin and skin
structure infections.
The recommended dose (400 mg once daily) and duration of therapy for the indication being
treated should not be exceeded.
 

- Hypersensitivity to Moxican, other quinolones or to any of the excipients listed in section 6.1. - Pregnancy and lactation (see section 4.6). - Patients below 18 years of age. - Patients with a history of tendon disease/disorder related to quinolone treatment. Both in preclinical investigations and in humans, changes in cardiac electrophysiology have been observed following exposure to Moxican, in the form of QT prolongation. For reasons of drug safety, Moxican is therefore contraindicated in patients with: - Congenital or documented acquired QT prolongation - Electrolyte disturbances, particularly in uncorrected hypokalaemia - Clinically relevant bradycardia - Clinically relevant heart failure with reduced left-ventricular ejection fraction - Previous history of symptomatic arrhythmias Moxican should not be used concurrently with other drugs that prolong the QT interval (see also section 4.5). Due to limited clinical data, Moxican is also contraindicated in patients with impaired liver function (Child Pugh C) and in patients with transaminases increase > 5fold ULN.

The benefit of Moxican treatment especially in infections with a low degree of severity should
be balanced with the information contained in the warnings and precautions section.
Prolongation of QTc interval and potentially QTc-prolongation-related clinical conditions
Moxican has been shown to prolong the QTc interval on the electrocardiogram in some
patients. In the analysis of ECGs obtained in the clinical trial program, QTc prolongation with
Moxican was 6 msec ± 26 msec, 1.4% compared to baseline. As women tend to have a longer
baseline QTc interval compared with men, they may be more sensitive to QTc-prolonging
medications. Elderly patients may also be more susceptible to drug-associated effects on the
QT interval.
Medication that can reduce potassium levels should be used with caution in patients receiving
Moxican (see also sections 4.3 and 4.5).
Moxican should be used with caution in patients with ongoing proarrhythmic conditions
(especially women and elderly patients), such as acute myocardial ischaemia or QT
prolongation as this may lead to an increased risk for ventricular arrhythmias (incl. torsade de
pointes) and cardiac arrest (see also section 4.3). The magnitude of QT prolongation may
increase with increasing concentrations of the drug. Therefore, the recommended dose should
not be exceeded.
If signs of cardiac arrhythmia occur during treatment with Moxican, treatment should be
stopped and an ECG should be performed.
Hypersensitivity/allergic reactions
Hypersensitivity and allergic reactions have been reported for fluoroquinolones including
Moxican after first administration. Anaphylactic reactions can progress to a life-threatening
shock, even after the first administration. In these cases Moxican should be discontinued and
suitable treatment (e.g. treatment for shock) initiated.
Severe liver disorders
Cases of fulminant hepatitis potentially leading to liver failure (including fatal cases) have been
reported with Moxican (see section 4.8). Patients should be advised to contact their doctor
prior to continuing treatment if signs and symptoms of fulminant hepatic disease develop such
as rapidly developing asthenia associated with jaundice, dark urine, bleeding tendency or
hepatic encephalopathy.
Liver function tests/investigations should be performed in cases where indications of liver
dysfunction occur.
Serious bullous skin reactions
Cases of bullous skin reactions like Stevens-Johnson syndrome or toxic epidermal necrolysis
have been reported with Moxican (see section 4.8). Patients should be advised to contact their
doctor immediately prior to continuing treatment if skin and/or mucosal reactions occur.
Patients predisposed to seizures
Quinolones are known to trigger seizures. Use should be with caution in patients with CNS
disorders or in the presence of other risk factors which may predispose to seizures or lower the
seizure threshold. In case of seizures, treatment with Moxican should be discontinued and
appropriate measures instituted.
Peripheral neuropathy
Cases of sensory or sensorimotor polyneuropathy resulting in paraesthesias, hypoaesthesias,
dysaesthesias, or weakness have been reported in patients receiving quinolones including
Moxican. Patients under treatment with Moxican should be advised to inform their doctor prior
to continuing treatment if symptoms of neuropathy such as pain, burning, tingling, numbness,
or weakness develop (see section 4.8).
Psychiatric reactions
Psychiatric reactions may occur even after the first administration of quinolones, including
Moxican. In very rare cases depression or psychotic reactions have progressed to suicidal
thoughts and self-injurious behaviour such as suicide attempts (see section 4.8). In the event
that the patient develops these reactions, Moxican should be discontinued and appropriate
measures instituted. Caution is recommended if Moxican is to be used in psychotic patients or
in patients with history of psychiatric disease.
Antibiotic-associated diarrhoea incl. colitis
Antibiotic-associated diarrhoea (AAD) and antibiotic-associated colitis (AAC), including
pseudomembranous colitis and Clostridium difficile-associated diarrhoea, has been reported in
association with the use of broad spectrum antibiotics including Moxican and may range in
severity from mild diarrhoea to fatal colitis. Therefore it is important to consider this diagnosis
in patients who develop serious diarrhoea during or after the use of Moxican. If AAD or AAC is
suspected or confirmed, ongoing treatment with antibacterial agents, including Moxican,
should be discontinued and adequate therapeutic measures should be initiated immediately.
Furthermore, appropriate infection control measures should be undertaken to reduce the risk
of transmission. Drugs inhibiting peristalsis are contraindicated in patients who develop serious
diarrhoea.
Patients with myasthenia gravis
Moxican should be used with caution in patients with myasthenia gravis because the symptoms
can be exacerbated.
Tendon inflammation, tendon rupture
Tendon inflammation and rupture (especially Achilles tendon), sometimes bilateral, may occur
with quinolone therapy including Moxican, even within 48 hours of starting treatment and have
been reported up to several months after discontinuation of therapy. The risk of tendinitis and
tendon rupture is increased in elderly patients and in those treated concurrently with
corticosteroids. At the first sign of pain or inflammation, patients should discontinue treatment
with Moxican, rest the affected limb(s) and consult their doctor immediately in order to initiate
appropriate treatment (e.g. immobilisation) for the affected tendon (see sections 4.3 and 4.8).
Patients with renal impairment
Elderly patients with renal disorders should use Moxican with caution if they are unable to
maintain adequate fluid intake, because dehydration may increase the risk of renal failure.
Vision disorders
If vision becomes impaired or any effects on the eyes are experienced, an eye specialist should
be consulted immediately (see sections 4.7 and 4.8).
Prevention of photosensitivity reactions
Quinolones have been shown to cause photosensitivity reactions in patients. However, studies
have shown that Moxican has a lower risk to induce photosensitivity. Nevertheless patients
should be advised to avoid exposure to either UV irradiation or extensive and/or strong sunlight
during treatment with Moxican.
Patients with glucose-6-phosphate dehydrogenase deficiency (G6PD)
Patients with a family history of or actual glucose-6-phosphate dehydrogenase deficiency are
prone to haemolytic reactions when treated with quinolones. Therefore, Moxican should be
used with caution in these patients.
Patients with galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or
glucose-galactose malabsorption should not take this medicine.
Patients with pelvic inflammatory disease
For patients with complicated pelvic inflammatory disease (e.g. associated with a tubo-ovarian
or pelvic abscess), for whom an intravenous treatment is considered necessary, treatment with
Moxican 400 mg film-coated tablets is not recommended.
Pelvic inflammatory disease may be caused by fluoroquinolone-resistant Neisseria
gonorrhoeae. Therefore in such cases empirical Moxican should be co-administered with
another appropriate antibiotic (e.g. a cephalosporin) unless Moxican-resistant Neisseria
gonorrhoeae can be excluded. If clinical improvement is not achieved after 3 days of treatment,
the therapy should be reconsidered.
Patients with special cSSSI
Clinical efficacy of intravenous Moxican in the treatment of severe burn infections, fasciitis and
diabetic foot infections with osteomyelitis has not been established.
Interference with biological tests
Moxican therapy may interfere with the Mycobacterium spp. culture test by suppression of
mycobacterial growth causing false negative results in samples taken from patients currently
receiving Moxican.
Patients with MRSA infections
Moxican is not recommended for the treatment of MRSA infections. In case of a suspected or
confirmed infection due to MRSA, treatment with an appropriate antibacterial agent should be
started (see section 5.1).
Paediatric population
Due to adverse effects on the cartilage in juvenile animals (see section 5.3) the use of Moxican
in children and adolescents < 18 years is contraindicated (see section 4.3).
 

Interactions with medicinal products
An additive effect on QT interval prolongation of Moxican and other medicinal products that
may prolong the QTc interval cannot be excluded. This might lead to an increased risk of
ventricular arrhythmias, including torsade de pointes. Therefore, co-administration of Moxican
with any of the following medicinal products is contraindicated (see also section 4.3):
- anti-arrhythmics class IA (e.g. quinidine, hydroquinidine, disopyramide)
- anti-arrhythmics class III (e.g. amiodarone, sotalol, dofetilide, ibutilide)
- antipsychotics (e.g. phenothiazines, pimozide, sertindole, haloperidol, sultopride)
- tricyclic antidepressive agents
- certain antimicrobial agents (saquinavir, sparfloxacin, erythromycin IV, pentamidine,
antimalarials particularly halofantrine)
- certain antihistaminics (terfenadine, astemizole, mizolastine)
- others (cisapride, vincamine IV, bepridil, diphemanil).
Moxican should be used with caution in patients who are taking medication that can reduce
potassium levels (e.g. loop and thiazide-type diuretics, laxatives and enemas [high doses],
corticosteroids, amphotericin B) or medication that is associated with clinically significant
bradycardia.
An interval of about 6 hours should be left between administration of agents containing
bivalent or trivalent cations (e.g. antacids containing magnesium or aluminium, didanosine
tablets, sucralfate and agents containing iron or zinc) and administration of Moxican.
Concomitant administration of charcoal with an oral dose of 400 mg Moxican led to a
pronounced prevention of drug absorption and a reduced systemic availability of the drug by
more than 80%. Therefore, the concomitant use of these two drugs is not recommended
(except for overdose cases, see also section 4.9).
After repeated dosing in healthy volunteers, Moxican increased Cmax of digoxin by
approximately 30% without affecting AUC or trough levels. No precaution is required for use
with digoxin.
In studies conducted in diabetic volunteers, concomitant administration of oral Moxican with
glibenclamide resulted in a decrease of approximately 21% in the peak plasma concentrations
of glibenclamide. The combination of glibenclamide and Moxican could theoretically result in a
mild and transient hyperglycaemia. However, the observed pharmacokinetic changes for
glibenclamide did not result in changes of the pharmacodynamic parameters (blood glucose,
insulin). Therefore no clinically relevant interaction was observed between Moxican and
glibenclamide.
Changes in INR
A large number of cases showing an increase in oral anticoagulant activity have been reported
in patients receiving antibacterial agents, especially fluoroquinolones, macrolides, tetracyclines,
cotrimoxazole and some cephalosporins. The infectious and inflammatory conditions, age and
general status of the patient appear to be risk factors. Under these circumstances, it is difficult
to evaluate whether the infection or the treatment caused the INR (international normalised
ratio) disorder. A precautionary measure would be to more frequently monitor the INR. If
necessary, the oral anticoagulant dosage should be adjusted as appropriate.
Clinical studies have shown no interactions following concomitant administration of Moxican
with: ranitidine, probenecid, oral contraceptives, calcium supplements, morphine administered
parenterally, theophylline, cyclosporine or itraconazole.
In vitro studies with human cytochrome P450 enzymes supported these findings. Considering
these results a metabolic interaction via cytochrome P450 enzymes is unlikely.
Interaction with food
Moxican has no clinically relevant interaction with food including dairy products.
 

(Pregnancy category C)
The safety of Moxican in human pregnancy has not been evaluated. Animal studies have shown
reproductive toxicity (see section 5.3). The potential risk for humans is unknown. Due to the
experimental risk of damage by fluoroquinolones to the weight-bearing cartilage of immature
animals and reversible joint injuries described in children receiving some fluoroquinolones,
Moxican must not be used in pregnant women (see section 4.3).
Breastfeeding
There is no data available in lactating or nursing women. Preclinical data indicate that small
amounts of Moxican are secreted in milk. In the absence of human data and due to the
experimental risk of damage by fluoroquinolones to the weight-bearing cartilage of immature
animals, breast-feeding is contraindicated during Moxican therapy (see section 4.3).
Fertility
Animal studies do not indicate impairment of fertility (see section 5.3).
 

No studies on the effects of Moxican on the ability to drive and use machines have been
performed. However, fluoroquinolones including Moxican may result in an impairment of the
patient's ability to drive or operate machinery due to CNS reactions (e.g. dizziness; acute,
transient loss of vision, see section 4.8) or acute and short lasting loss of consciousness
(syncope, see section 4.8). Patients should be advised to see how they react to Moxican before
driving or operating machinery.
 

Adverse reactions based on all clinical trials with Moxican 400 mg (oral and sequential therapy)
sorted by frequencies are listed below:
Apart from nausea and diarrhoea all adverse reactions were observed at frequencies below 3%.
Within each frequency grouping, undesirable effects are presented in order of decreasing
seriousness. Frequencies are defined as:
- common (≥ 1/100 to < 1/10)
- uncommon (≥ 1/1,000 to < 1/100)
- rare (≥ 1/10,000 to < 1/1,000)
- very rare (< 1/10,000)

No specific countermeasures after accidental overdose are recommended. In the event of
overdose, symptomatic treatment should be implemented. ECG monitoring should be
undertaken, because of the possibility of QT interval prolongation. Concomitant administration
of charcoal with a dose of 400 mg oral Moxican will reduce systemic availability of the drug by
more than 80%. The use of charcoal early during absorption may be useful to prevent excessive
increase in the systemic exposure to Moxican in cases of oral overdose.
 

Pharmacotherapeutic group: Quinolone antibacterials, fluoroquinolones, ATC code: J01MA14
Mechanism of action
Moxican has in vitro activity against a wide range of Gram-positive and Gram-negative
pathogens.
The bactericidal action of Moxican results from the inhibition of both type II topoisomerases
(DNA gyrase and topoisomerase IV) required for bacterial DNA replication, transcription and
repair. It appears that the C8-methoxy moiety contributes to enhanced activity and lower
selection of resistant mutants of Gram-positive bacteria compared to the C8-H moiety. The
presence of the bulky bicycloamine substituent at the C-7 position prevents active efflux,
associated with the norA or pmrA genes seen in certain Gram-positive bacteria.
Pharmacodynamic investigations have demonstrated that Moxican exhibits a concentration
dependent killing rate. Minimum bactericidal concentrations (MBC) were found to be in the
range of the minimum inhibitory concentrations (MIC).
Effect on the intestinal flora in humans
The following changes in the intestinal flora were seen in volunteers following oral
administration of Moxican: Escherichia coli, Bacillus spp., Enterococcus spp., and Klebsiella spp.
were reduced, as were the anaerobes Bacteroides vulgatus, Bifidobacterium spp., Eubacterium
spp., and Peptostreptococcus spp.. For Bacteroides fragilis there was an increase. These
changes returned to normal within two weeks.
Mechanism of resistance
Resistance mechanisms that inactivate penicillins, cephalosporins, aminoglycosides, macrolides
and tetracyclines do not interfere with the antibacterial activity of Moxican. Other resistance
mechanisms such as permeation barriers (common in Pseudomonas aeruginosa) and efflux
mechanisms may also effect susceptibility to Moxican.
In vitro resistance to Moxican is acquired through a stepwise process by target site mutations in
both type II topoisomerases, DNA gyrase and topoisomerase IV. Moxican is a poor substrate for
active efflux mechanisms in Gram-positive organisms.
Cross-resistance is observed with other fluoroquinolones. However, as Moxican inhibits both
topoisomerase II and IV with similar activity in some Gram-positive bacteria, such bacteria may
be resistant to other quinolones, but susceptible to Moxican.
Breakpoints
EUCAST clinical MIC and disk diffusion breakpoints for Moxican (01.01.2012):

 

Absorption and Bioavailability
Following oral administration Moxican is rapidly and almost completely absorbed. The absolute
bioavailability amounts to approximately 91%.
Pharmacokinetics are linear in the range of 50 - 800 mg single dose and up to 600 mg once daily
dosing over 10 days. Following a 400 mg oral dose peak concentrations of 3.1 mg/l are reached
within 0.5 - 4 h post administration. Peak and trough plasma concentrations at steady-state
(400 mg once daily) were 3.2 and 0.6 mg/l, respectively. At steady-state the exposure within
the dosing interval is approximately 30% higher than after the first dose.
Distribution
Moxican is distributed to extravascular spaces rapidly; after a dose of 400 mg an AUC of 35
m∙gh/l is observed. The steady-state volume of distribution (Vss) is approximately 2 l/kg. In vitro
and ex vivo experiments showed a protein binding of approximately 40 - 42% independent of
the concentration of the drug. Moxican is mainly bound to serum albumin.
The following peak concentrations (geometric mean) were observed following administration of
a single oral dose of 400 mg Moxican:

Biotransformation
Moxican undergoes Phase II biotransformation and is excreted via renal and biliary/faecal
pathways as unchanged drug as well as in the form of a sulpho-compound (M1) and a
glucuronide (M2). M1 and M2 are the only metabolites relevant in humans, both are
microbiologically inactive.
In clinical Phase I and in vitro studies no metabolic pharmacokinetic interactions with other
drugs undergoing Phase I biotransformation involving cytochrome P450 enzymes were
observed. There is no indication of oxidative metabolism.
Elimination
Moxican is eliminated from plasma with a mean terminal half life of approximately 12 hours.
The mean apparent total body clearance following a 400 mg dose ranges from 179 to 246
ml/min. Renal clearance amounted to about 24 - 53 ml/min suggesting partial tubular
reabsorption of the drug from the kidneys.
After a 400 mg dose, recovery from urine (approximately 19% for unchanged drug,
approximately 2.5% for M1, and approximately 14% for M2) and faeces (approximately 25% of
unchanged drug, approximately 36% for M1, and no recovery for M2) totalled to approximately
96%.
Concomitant administration of Moxican with ranitidine or probenecid did not alter renal
clearance of the parent drug.
Elderly and patients with low body weight
Higher plasma concentrations are observed in healthy volunteers with low body weight (such as
women) and in elderly volunteers.
Renal impairment
The pharmacokinetic properties of Moxican are not significantly different in patients with renal
impairment (including creatinine clearance > 20 ml/min/1.73 m2). As renal function decreases,
concentrations of the M2 metabolite (glucuronide) increase by up to a factor of 2.5 (with a
creatinine clearance of < 30 ml/min/1.73 m2).
Hepatic impairment
On the basis of the pharmacokinetic studies carried out so far in patients with liver failure (Child
Pugh A, B), it is not possible to determine whether there are any differences compared with
healthy volunteers. Impaired liver function was associated with higher exposure to M1 in
plasma, whereas exposure to parent drug was comparable to exposure in healthy volunteers.
There is insufficient experience in the clinical use of Moxican in patients with impaired liver
function.
 

Effects on the haematopoetic system (slight decreases in the number of erythrocytes and
platelets) were seen in rats and monkeys. As with other quinolones, hepatotoxicity (elevated
liver enzymes and vacuolar degeneration) was seen in rats, monkeys and dogs. In monkeys CNS
toxicity (convulsions) occurred. These effects were seen only after treatment with high doses of
Moxican or after prolonged treatment.
Moxican, like other quinolones, was genotoxic in in vitro tests using bacteria or mammalian
cells. Since these effects can be explained by an interaction with the gyrase in bacteria and - at
higher concentrations - by an interaction with the topoisomerase II in mammalian cells, a
threshold concentration for genotoxicity can be assumed. In in vivo tests, no evidence of
genotoxicity was found despite the fact that very high Moxican doses were used. Thus, a
sufficient margin of safety to the therapeutic dose in man can be provided. Moxican was noncarcinogenic in an initiation-promotion study in rats.
Many quinolones are photoreactive and can induce phototoxic, photomutagenic and
photocarcinogenic effects. In contrast, Moxican was proven to be devoid of phototoxic and
photogenotoxic properties when tested in a comprehensive programme of in vitro and in vivo
studies. Under the same conditions other quinolones induced effects.
At high concentrations, Moxican is an inhibitor of the rapid component of the delayed rectifier
potassium current of the heart and may thus cause prolongations of the QT interval.
Toxicological studies performed in dogs using oral doses of ≥ 90 mg/kg leading to plasma
concentrations ≥ 16 mg/l caused QT prolongations, but no arrhythmias. Only after very high
cumulative intravenous administration of more than 50fold the human dose (> 300 mg/kg),
leading to plasma concentrations of ≥ 200 mg/l (more than 40fold the therapeutic level),
reversible, non-fatal ventricular arrhythmias were seen.
Quinolones are known to cause lesions in the cartilage of the major diarthrodial joints in
immature animals. The lowest oral dose of Moxican causing joint toxicity in juvenile dogs was
four times the maximum recommended therapeutic dose of 400 mg (assuming a 50 kg
bodyweight) on a mg/kg basis, with plasma concentrations two to three times higher than
those at the maximum therapeutic dose.
Toxicity tests in rats and monkeys (repeated dosing up to six months) revealed no indication
regarding an oculotoxic risk. In dogs, high oral doses (≥ 60 mg/kg) leading to plasma
concentrations ≥ 20 mg/l caused changes in the electroretinogram and in isolated cases an
atrophy of the retina.
Reproductive studies performed in rats, rabbits and monkeys indicate that placental transfer of
Moxican occurs. Studies in rats (p.o. and i.v.) and monkeys (p.o.) did not show evidence of
teratogenicity or impairment of fertility following administration of Moxican. A slightly
increased incidence of vertebral and rib malformations was observed in foetuses of rabbits but
only at a dose (20 mg/kg i.v.) which was associated with severe maternal toxicity. There was an
increase in the incidence of abortions in monkeys and rabbits at human therapeutic plasma
concentrations. In rats, decreased foetal weights, an increased prenatal loss, a slightly increased
duration of pregnancy and an increased spontaneous activity of some male and female
offspring was observed at doses which were 63 times the maximum recommended dose on a
mg/kg basis with plasma concentrations in the range of the human
 

- Tablet core: Microcrystalline cellulose, Croscarmellose sodium, and Magnesium
stearate.
- Film coating: Hypromellose, Lactose monohydrate, Titanum dioxide , Triacetin, Red
Yellow & Black Iron oxide.
 

Not applicable
 

2 years

Store below 30°C.
Store in the original package
 

Moxican is packaged in cartons containing opaque aluminum /aluminum blisters.
Packs of 7 film coated tablets
 

No special requirements