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OFLOXACIN TEVA 200 MG TABLETS

Active substance: OFLOXACIN

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Ofloxacin Teva 200 mg Tablets

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Film-coated Tablet contains 400 mg of Ofloxacin.
Excipient(s) with known effect
This product contains lactose monohydrate
For the full list of excipients, see section 6.1.

3

PHARMACEUTICAL FORM
Film-coated Tablets
White, round Film-coated Tablets, 11mm diameter, scored on both sides. One side of
the tablet is debossed “FXN” on one side of the breakline and “200” on the other side.
The tablet can be divided into equal doses.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Ofloxacin is indicated for the treatment of the following infections when
caused by sensitive organisms (see section 5.1):
- upper and lower urinary tract infections;
- lower respiratory tract infections such as acute exacerbation of chronic
bronchitis or pneumonia if caused by Gram-negative bacteria. Ofloxacin is
not the treatment of choice for community acquired pneumonia;
- uncomplicated urethral and cervical gonorrhoea;
- non-gonococcal urethritis and cervicitis.
Consideration should be given to official guidance on the appropriate use of
anti-bacterial
agents.

4.2

Posology and method of administration
Posology
General dosage recommendations:
The dose of ofloxacin should be determined by the type and severity of the infection.
The dosage range for adults is 200 mg to 800 mg daily. Up to 400 mg may be given
as a single dose, preferably in the morning. In individual cases it may be necessary to
increase the dose to 600 mg (or even to a maximum total dose of 800 mg daily) for
treatment of severe infections or in overwweight patients. Daily doses of more then
400 mg must be divided into two separate doses and be given at approximately equal
intervals..
Indications

Single and daily doses

Uncomplicated lower urinary
tract infections
Complicated infections of the
kidneys and urinary tract

200–400 mg daily

Lower
respiratory
infections

tract

Uncomplicated gonorrhoea
Non-gonococcal urethritis and
cervicitis

400 mg daily, increasing
necessary, to 400 mg twice
day
400 mg daily, increasing,
necessary, to 400 mg twice
day
400 mg
400 mg daily

Usual duration
therapy
3 days
if
a

7-10 days

if
a

7-10 days

Single dose
7-10 days

Posology in patients with renal insufficiency:
In patients with impaired renal function, the following oral or I.V dosages are
recommended:
Creatinine
clearance
50 - 20 ml/min
< 20 ml/min**
or haemodialysis
or peritoneal
dialysis

Unit dose
mg*
100 – 200
100
or
200

Number
/24 hours
1
1

Intervals
hours
24
24

1

48

*
According to indication or dose interval
**
The serum concentration of ofloxacin should be monitored in patients with
severe renal impairment and dialysis patients

When creatinine clearance cannot be measured, it can be estimated with reference to
the serum creatinine level using the following Cockcroft's formula for adults:

of

Posology in patients hepatic insufficiency (e.g. cirrhosis with ascites)
It is recommended that a maximum daily dose of 400 mg of ofloxacin be not
exceeded, because of possible reduction of excretion.
Elderly:
Age in itself does not impose to adapt the dosage of ofloxacin. However, special
attention to renal and liver function should be paid in elderly patients, and the dosage
should be adapted accordingly. (See section ‘4.4 QT interval prolongation’).
Paediatric population:
Ofloxacin is not indicated for use in children or growing adolescents.
Type and duration of treatment
A daily dose of up to 400mg ofloxacin may be given as a single dose. In this case, it
is preferable to administer ofloxacin in the morning.
Daily doses of more than 400mg must be divided into two separate doses and be
given at approximately equal intervals.
Duration of treatment:
Duration of treatment is dependent on the severity of the infection and the response to
treatment.
The usual durations of treatment are stated in the table.
As with antibiotic therapy in general, administration of ofloxacin should be continued
for a minimum of 48 to 72 hours after the patient has become afebrile or evidence of
bacterial eradication has been obtained.
In some instances, a minimum of 5 days treatment may be sufficient.
Treatment should not exceed 2 months duration.
Method of administration:
Ofloxacin Tablets are to be swallowed with sufficient amount of liquids. They may be
taken on an empty stomach or with meals. Concomitant administration with antacids
should be avoided (see section 4.5: Interactions).

4.3

Contraindications

Ofloxacin must not be used
- in patients with known hypersensitivity to ofloxacin, to other 4-quinolone
antibacterials or to any of the excipients listed in section 6.1..
- in patients with a history of tendon disorders related to fluoroquinolone
administration.
- in patients with epilepsy.
- in children or adolescents in the growth phase*
- during pregnancy*
- in breast-feeding women*
* because, judging from animal experiments, a risk of damage to the growth-plate
cartilage in the growing organism cannot be entirely excluded.

Special warnings and precautions for use
Ofloxacin is not the drug of first choice for pneumonia caused by Pneumococci or
Mycoplasma, or angina tonsillaris caused by -haemolytic Streptococci.

β

4.4

Methicillin-resistant S. aureus are very likely to possess co-resistance to
fluoroquinolones, including ofloxacin. Therefore ofloxacin is not recommended for
the treatment of known or suspected MRSA infections unless laboratory results have
confirmed susceptibility of the organism to ofloxacin (and commonly recommended
antibacterial agents for the treatment of MRSA-infections are considered
inappropriate).
Resistance to fluoroquinolones of E. coli – the most common pathogen involved in
urinary tract infections – varies across the European Union. Prescribers are advised to
take into account the local prevalence of resistance in E. coli to fluoroquinolones.
Severe bullous reactions Cases of severe bullous skin reactions such as StevensJohnson syndrome or toxic epidermal necrolysis have been reported with ofloxacin
(see section 4.8). Patients should be advised to contact their doctor immediately prior
to continuing treatment if skin and/or mucosal reactions occur.
Hypersensitivity and allergic reactions have been reported for fluoroquinolones after
first administration. Anaphylactic and anaphylactoid reactions can progress to lifethreatening shock, even after the first administration. In these cases ofloxacin should
be discontinued and suitable treatment (e.g. treatment for shock) should be initiated.

Clostridium difficile-associated disease

Diarrhea, particularly if severe, persistent and/or bloody, during or after treatment
with ofloxacin (including several weeks after treatment), may be symptomatic of
pseudo-membranous colitis (CDAD). CDAD may range in severity from mild to life
threatening, the most severe form of which is pseudomembranous colitis (see section
4.8). It is therefore important to consider this diagnosis in patients who develop
serious diarrhoea during or after treatment with ofloxacin. If pseudo-membranous
colitis is suspected, ofloxacin must be stopped immediately. Appropriate specific
antibiotic therapy must be started without delay (e.g. oral vancomycin, oral
teicoplanin or metronidazole). Products inhibiting the peristalsis are contraindicated
in this clinical situation.
Patients predisposed to seizures
Quinolones may lower the seizure threshold and may trigger seizures. Ofloxacin is
contraindicated in patients with a history of epilepsy (see section 4.3) and, as with
other quinolones, ofloxacin should be used with extreme caution in patients
predisposed to seizures.
Such patients may be patients with pre-existing central nervous system lesions,
concomitant treatment with fenbufen and similar non-steroidal anti-inflammatory
drugs or with drugs which lower the cerebral seizure threshold, such as theophylline.
(See section 4.5: Interactions)
In case of convulsive seizures, treatment with ofloxacin should be discontinued.
Tendonitis
Tendonitis, rarely observed with quinolones, may occasionally lead to rupture
involving Achilles tendon in particular. Tendinitis and tendon rupture, sometimes
bilateral, may occur within 48 hours of starting treatment with ofloxacin and have
been reported up to several months after discontinuation of. The risk of tendinitis and
tendon rupture is increased in patients aged over 60 years and in patients using
corticosteroids. The daily dose should be adjusted in elderly patients based on
creatinine clearance (see section 4.2). Close monitoring of these patients is therefore
necessary if they are prescribed ofloxacin. All patients should consult their physician
if they experience symptoms of tendinitis. If tendinitis is suspected, treatment with
ofloxacin must be halted immediately, and appropriate treatment (e.g. immobilisation)
must be initiated for the affected tendon (see sections 4.3 and 4.8).
Patients with renal impairment
Since ofloxacin is mainly excreted by the kidneys, the dose of ofloxacin should be
adjusted in patients with renal impairment (see section 4.2: Dosage and
administration).
Patients with history of psychotic disorder
Psychotic reactions have been reported in patients receiving fluoroquinolones
including ofloxacin. In some cases these have progressed to suicidal thoughts or selfendangering behavior including suicide attempt, sometimes after a single dose of
ofloxacin (see section 4.8). In the event that a patient develops these reactions,
ofloxacin should be discontinued and appropriate measures instituted. Ofloxacin
should be used with caution in patients with a history of psychotic disorder or in
patients with psychiatric disease.
Patients with impaired liver function
Ofloxacin should be used with caution in patients with impaired liver function, as
liver damage may occur. Cases of fulminant hepatitis potentially leading to liver
failure (including fatal cases) have been reported with fluoroquinolones. Patients

should be advised to stop treatment and contact their doctor if signs and symptoms of
hepatic disease develop such as anorexia, jaundice, dark urine, pruritis or tender
abdomen (see section 4.8 Undesirable effects).
Patients treated with vitamin K antagonists
Due to possible increase in coagulation tests (PT/INR) and/or bleeding in patients
treated with fluoroquinolones, including ofloxacin, in combination with a vitamin K
antagonist (e.g. warfarin), coagulation tests should be monitored when these drugs are
given concomitantly (see section 4.5).
Myasthenia gravis
Fluoroquinolones, including ofloxacin, have neuromuscular blocking activity and
may exacerbate muscle weakness in patients with myasthenia gravis. Postmarketing
serious adverse reactions, including deaths and the requirement for respiratory
support, have been associated with fluoroquinolone use in patients with myasthenia
gravis. Ofloxacin is not recommended in patients with a known history of myasthenia
gravis.
Prevention of photosensitisation
Photosensitisation has been reported with ofloxacin (see section 4.8). It is
recommended that patients should not expose themselves unnecessarily to strong
sunlight or to artificial UV rays (e.g. sunray lamp, solarium), during treatment and for
48 hours following treatment discontinuation in order to prevent photosensitisation.
Super infection
As with other antibiotics, the use of ofloxacin, especially if prolonged, may result in
overgrowth of non-susceptible organisms. Repeated evaluation of the patient's
condition is essential. If secondary infection occurs during therapy, appropriate
measures should be taken.








QT interval prolongation
Very rare cases of QT interval prolongation have been reported in patients taking
fluoroquinolones. Caution should be taken when using fluoroquinolones, including
ofloxacin, in patients with known risk factors for prolongation of the QT interval such
as, for example:
elderly patients and women may be more sensitive to QTc-prolonging medications.
Therefore, caution should be taken when using fluoroquinolones, including ofloxacin,
in these populations.
uncorrected electrolyte imbalance (e.g. hypokalemia, hypomagnesemia)
congenital long QT syndrome
cardiac disease (e.g. heart failure, myocardial infarction, bradycardia)
concomitant use of drugs that are known to prolong the QT interval (e.g. class IA and
III antiarrrhythmics, tricyclic antidepressants, macrolides, antipsychotics).
See also section 4.2 Elderly and section 4.5, section 4.8 and section 4.9.
Dysglycaemia
As with all quinolones, disturbances in blood glucose, including both hypoglycemia
and hyperglycaemia have been reported, usually in diabetic patients receiving
concomitant treatment with an oral hypoglycemic agent (e.g., glibenclamide) or with
insulin. Cases of hypoglycaemic coma have been reported.In these diabetic patients,
careful monitoring of blood glucose is recommended. (see section 4.8)
Peripheral neuropathy
Sensory or sensorimotor peripheral neuropathy has been reported in patients receiving
fluoroquinolones, including ofloxacin, which can be rapid in its onset. Ofloxacin

should be discontinued if the patient experiences symptoms of neuropathy. This
would minimize the possible risk of developing an irreversible condition (see section
4.8).
Patients with glucose-6-phosphate-dehydrogenase deficiency
Patients with a latent or diagnosed glucose-6-phosphate-dehydrogenase deficiency
may be predisposed to haemolytic reactions if they are treated with quinolones.
Therefore, if ofloxacin has to be used in these patients, potential occurrence of
haemolysis should be monitored.
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).
Interference with laboratory tests
In patients treated with ofloxacin, determination of opiates in urine may give falsepositive results. It may be necessary to confirm positive opiate screens by more
specific method.
Patients with rare hereditary disorders
Patients with rare hereditary disorders of galactose intolerance, the Lapp lactase
deficiency or glucose-galactose malabsorption should not take this medicine.

4.5

Interaction with other medicinal products and other forms of interaction
Antacids, Sucralfate, Metal Cations
Antacids containing aluminium (including sucralfate) and magnesium hydroxides,
aluminium phosphate, zinc, iron, are liable to reduce the absorption of ofloxacin
tablets. Ofloxacin should be administered approximately 2 hours apart from antacids.
Theophylline, fenbufen or similar non-steroidal antiinflammatory drugs
No pharmacokinetic interactions of ofloxacin were found with theophylline in a
clinical study. However, a pronounced lowering of the cerebral seizure threshold may
occur when quinolones are given concurrently with theophylline, nonsteroidal
antiinflammatory drugs, or other agents, which lower the seizure threshold.
Drugs known to prolong QT interval
Ofloxacin, like other fluoroquinolones, should be used with caution in patients
receiving drugs known to prolong the QT interval (e.g. class IA and III
antiarrhythmics, tricyclic antidepressants, macrolides, antipsychotics). (See section
4.4 QT interval prolongation’).
Vitamin K antagonists
Increased coagulation tests (PT/INR) and/or bleeding, which may be severe, have
been reported in patients treated with ofloxacin in combination with a vitamin K
antagonist (e.g. warfarin). Coagulation tests,therefore, should be monitored in patients
treated with vitamin K antagonists (see section 4.4).
Glibenclamide
Ofloxacin may cause a slight increase in serum concentrations of glibenclamide
administered concurrently; it is therefore recommended that patients treated
concomitantly with ofloxacin and glibenclamide be monitored particularly closely.

Probenecid, cimetidine, furosemide, or methotrexate
Probenecid decreased the total clearance of ofloxacin by 24%, and increased AUC by
16%. The proposed mechanism is a competition or inhibition for active transport at
the renal tubular excretion. Caution should be exercised when ofloxacin is
coadministered with drugs that affect the tubular renal secretion such as probenecid,
cimetidine, furosemide or methotrexate.

4.6

Fertility, pregnancy and lactation
Pregnancy
Based on a limited amount of human data, the use of fluoroquinolones in the first
trimester of pregnancy has not been associated with an increased risk of major
malformations or other adverse effects on pregnancy outcome. Animal studies have
shown damage to the joint cartilage in immature animals but no teratogenic effects.
Therefore ofloxacin should not be used during pregnancy (see section 4.3
Contraindications).
Breast-feeding
Ofloxacin is excreted into human breast milk in small amounts. Because of the
potential for arthropathy and other serious toxicity in the nursing infant, breast
feeding should be discontinued during treatment with ofloxacin (see section 4.3
Contraindications).

4.7

Effects on ability to drive and use machines
Some adverse reactions (e.g. dizziness/vertigo, drowsiness, visual disturbances) may
impair the patient’s ability to concentrate and react, and therefore may constitute a
risk in situations where these abilities are of special importance (e.g. driving a car or
operating machinery).

4.8

Undesirable effects
The information given below is based on data from clinical studies and on extensive
post marketing experience.

Uncommon
( 1/1,000 to
<1/100)





Infections and
infestations

Common
( 1/100 to
<1/10 )

Fungal
infection,
Pathogen
resistance

Rare
( 1/10,000 to
<1/1,000)



System organ
class

Very rare
(< 1/10,000)

Not known
(cannot be
estimated from
available data)*

Uncommon
( 1/1,000 to
<1/100)



Common
( 1/100 to
<1/10 )

Rare
( 1/10,000 to
<1/1,000)





System organ
class

Blood and the
lymphatic
system
disorders

Very rare
(< 1/10,000)

Anaemia
Haemolytic
anaemia,
Leukopenia,
Eosinophilia,
Thrombocytopenia

Immune system
disorders

Anaphylactic
reaction*,
Anaphylactoid
reaction*,
Angioedema*

Metabolism and
Nutrition
disorders

Anorexia

Psychiatric
disorders

Agitation,
Sleep disorder,
Insomnia

Psychotic
disorder (for
e.g.
hallucination),
Anxiety,
Confusional
state,
Nightmares,
Depression

Nervous system
disorders

Dizziness,
Headache

Somnolence,
Paraesthesia,
Dysgeusia,
Parosmia

Eye disorders

Eye irritation

Visual
disturbance

Not known
(cannot be
estimated from
available data)*
Agranulocytosis
Bone marrow
failure
Bone marrow
failure may lead to
pancytopenia

Anaphylactic
shock* ,
Anaphylactoid
shock*
Hypoglycaemia in
diabetics treated
with
hypoglycaemic
agents (see section
4.4)
Hyperglycaemia
Hypoglycaemic
coma
Psychotic disorder
and depression
with selfendangering
behaviour
including suicidal
ideation or suicide
attempt (see
section 4.4)
Nervousness

Peripheral
Tremor Dyskinesia
sensory
Ageusia Syncope
neuropathy*
Peripheral
sensory motor
neuropathy*
Convulsion* ,
Extra-pyramidal
symptoms or
other disorders of
muscular
coordination

Gastrointestinal
disorders

Hepato-bilary
disorders



Vascular
disorders
Respiratory,
thoracic and
mediastinal
disorders

Uncommon
( 1/1,000 to
<1/100)

Rare
( 1/10,000 to
<1/1,000)

Not known
(cannot be
estimated from
available data)*
Tinnitus, Hearing Hearing impaired
loss

Tachycardia



Ear and
labyrinth
disorders
Cardiac
disorders

Common
( 1/100 to
<1/10 )

Ventricular
arrhythmias,
torsades de pointes
(reported
predominantly in
patients with risk
factors for QT
prolongation),
ECG QT
prolonged (see
section 4.4 and
4.9)



System organ
class

Vertigo

Very rare
(< 1/10,000)

Hypotension
Cough, Nasopharyngitis

Dyspnoea,
Bronchospasm

Abdominal
pain,
Diarrhoea,
Nausea,
Vomiting

Enterocolitis,
sometimes
haemorrhagic

Hepatic
enzymes
increased
(ALAT, ASAT,
LDH, gammaGT and/or
alkaline
phosphatase)
Blood bilirubin
increased

Allergic
pneumonitis,
Severe dyspnoea

Pseudomembranous
colitis* Jaundice
cholestatic

Dyspepsia
Flatulence
Constipation
Pancreatitis
Hepatitis, which
may be severe*

Uncommon
( 1/1,000 to
<1/100)

Rare
( 1/10,000 to
<1/1,000)

Pruritus, Rash

Urticaria, Hot
flushes,
Hyperhidrosis
Pustular rash





Skin and
subcutaneous
tissue disorders

Common
( 1/100 to
<1/10 )



System organ
class

Musculoskeleta
l and
Connective
tissue disorders

Tendonitis

Renal and
Urinary
disorders
Congenital and
familial/
genetic
disorders

Serum
creatinine
increased

General
disorders and
administration
site conditions

Very rare
(< 1/10,000)

Not known
(cannot be
estimated from
available data)*
Stevens-Johnson
syndrome; Acute
generalized
exanthemous
pustulosis; drug
rash
Stomatitis

Erythema
multiforme,
Toxic epidermal
necrolysis,
Photo-sensitivity
reaction* , Drug
eruption
Vascular
purpura,
Vasculitis, which
can lead in
exceptional cases
to skin necrosis
Arthralgia,
Rhabdomyolysis
Myalgia, Tendon and/or Myopathy,
rupture (e.g.
Muscular
Achilles tendon) weakness Muscle
which may occur
tear, muscle
within 48 hours
rupture
of treatment start Ligament rupture
and may be
Arthritis
bilateral.
Acute renal
Acute interstitial
failure
nephritis
Attacks of
porphyria in
patients with
porphyria
Asthenia Pyrexia
Pain (including
pain in back, chest,
and extremities)

* postmarketing experience
Except in very rare instances (e.g. exceptional cases of smell, taste and hearing
disorders) the adverse effects observed subsided after discontinuation of ofloxacin.

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is
important. It allows continued monitoring of the benefit/risk balance of the medicinal
product. Healthcare professionals are asked to report any suspected adverse reactions
via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9

Overdose
Symptoms of overdose
The most important signs to be expected following acute overdosage are CNS
symptoms such as confusion, dizziness, impairment of consciousness and seizures
increases in QT interval as well as gastrointestinal reactions such as nausea and
mucosal erosions.
CNS effects including confusional state, convulsion, hallucination, and tremor have
been observed in post marketing experience.
Treatment of overdose
In the event of overdose symptomatic treatment should be implemented. ECG
monitoring should be undertaken because of the possibility of QT-interval
prolongation. Antacids may be used for protection of gastric mucosa. A fraction of
ofloxacin may be removed from the body with haemodialysis. Peritoneal dialysis and
CAPD are not effective in removing ofloxacin from the body. No specific antidote
exists.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Pharmacotherapeutic group: fluoroquinolones
ATC code: J01 MA 01
Mechanism of action
Ofloxacin inhibits bacterial DNA replication in a range of gram-positive and gramnegative pathogenic bacteria by inhibiting bacterial topoisomerases, particularly DNA
gyrase and topoisomerase IV.
The NCCLS MIC breakpoint recommendations are as follows :
S ≤ 2 mg/l and R ≥ 8 mg/l
Intermediate susceptibility at 4 mg/l
Haemophilus influenzae and Neisseria gonorrhoea are exceptions with breakpoints at
S ≤ 0.25 mg/l and R ≥ 1 mg/l
The BSAC general recommendations are S ≤ 2 mg/l and R ≥ 4 mg/l
According to DIN 58 940, the following limits apply for ofloxacin:
S 1 mg/L, I =2 mg/L, R ≥ 4 mg/L.
The prevalence of resistance may vary geographically and with time for selected
species and local information on resistance is desirable, particularly when treating
severe infections. This information gives only an approximate guidance on
probabilities whether micro-organisms will be susceptible to ofloxacin or not.



The prevalence of acquired resistance may vary geographically and with time for
selected species and local information on resistance is desirable, particularly when
treating severe infections, As necessary, expert advice should be sought when the

local prevalence of resistance is such that the utility of the agent in at least some types
of infections is question

European range of acquired bacterial
resistance to ofloxacin
Commonly susceptible species
Aerobic Gram-positive micro
organisms
Providentia*
S. aureus – methicillin-sensitive
S. pneumoniae*
S. pyogenes
Aerobic Gram-negative micro
organisms
Acinetobacter spp
Citrobacter spp
E. Faecalis*
Enterobacter spp
E.coli
H. influenzae
Klebsiella spp
Morazella spp
N. gonorrhoeae
P. aeruginosa*
Proteus spp
Serratia marcescens
Serratia spp*
Stenotrophomonas maltophilia*
Others
Chlamydia spp
L. pneumophila
Mycoplasma spp*
Ureaplasma spp*
Inherently resistant organisms
Anaerobic bacteria
S. aureus – methicillin-resistant
T. pallidum

17.1%
0.3-12.6%
70%
2-5%

0.3-7.3%
3-15%
2-13%
1-8%
1%
1-10%
0-0.2%
25%
20-30%
1-15%
2-2.4%
20-40%
5.1-11%

0-5.3%
0-2.1%

69.2-85.7%

*These species show natural intermediate susceptibility ( in the absence of
acquired mechanisms of resistance) to Ofloxacin.
The main mechanism of bacterial resistance to ofloxacin involves one or more
mutations in the target enzymes, which generally confer resistance to other
active substances in the class. Efflux pump and impermeability mechanisms of
resistance have also been described and may confer variable resistance to
active substances in other classes.

5.2

Pharmacokinetic properties
Absorption:
Ofloxacin is absorbed rapidly and almost completely when administered to fasting
volunteers. The mean peak plasma concentration following a single oral dose of 200
mg is 2.6 µg/ml and is achieved within an hour. The plasma concentration does not
increase significantly with multiple dosing (accumulation factor with twice daily
dosage: 1.5).
Distribution:
The apparent volume of distribution is 120 litres. Plasma protein binding is
approximately 25%.
Biotransformation:
Ofloxacin is less than 5% biotransformed. The two principal metabolites found in the
urine are N-desmethyl-ofloxacin and ofloxacin-N-oxide. Ofloxacin is found as the
glucuronide in the bile.
Elimination:
Elimination is primarily by the renal route in that 80 to 90 % of the dose is excreted
unchanged in the urine. The plasma elimination half-life is 5.7 to 7.0 hours,
irrespective of dose.
Patients with impaired renal function:
The plasma elimination half-life is prolonged in individuals with impaired renal
function; total and renal clearance decrease in accordance with creatinine clearance.

5.3

Preclinical safety data
Ofloxacin exhibits a neurotoxic potential and causes reversible testicular alterations at
high doses. Aside from this, preclinical studies with single and repeated use in adult
animals as well as safety pharmacological investigations, yielded no indications of
further specific risks in connection with the administration of ofloxacin.
Like other gyrase inhibitors, ofloxacin can also cause damage to large weight-bearing
joints of juvenile animals during the growth period. The extent of the cartilage
damage caused is dependent on age, species, and dose. In addition, stress relief of the
joints considerably reduces cartilage damage.
Ofloxacin has no influence on fertility or perinatal and postnatal development and has
no teratogenic or other embryotoxic effects in animal experiments, if administered at
therapeutic doses.
Ofloxacin has not been evaluated in long-term carcinogenicity studies. In-vitro and
in-vivo studies showed that ofloxacin is not mutagenic. Phototoxicity,
photomutagenicity, and photocarcinogenicity data of ofloxacin indicate only slight
photomutagenic and phototumorigenic effects in vitro and/or in vivo, as compared to
other fluoroquinolones.

There are no indications of cataractogenic or co-cataractogenic effects following
exposure to ofloxacin.
Preclinical investigations performed with ofloxacin have, to date, demonstrated only a
slight QT-prolonging potential.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Lactose monohydrate
Pregelatinised starch
Hypromellose
Croscarmellose sodium
Colloidal anhydrous silica
Magnesium stearate
Titanium dioxide E171
Macrogol 3000
Triacetin.

6.2.

Incompatibilities
Not applicable

6.3

Shelf life
3 years

6.4

Special precautions for storage
Keep container in the outer carton to protect the tablets from light. Store in the
original package.

6.5

Nature and contents of container
Transparent PVC/PVdC-aluminium blisters / white opaque PVC/PVdC-aluminium
blisters
Blister packs of 5, 10, 20 and 50 tablets
Not all pack sizes may be marketed.

6.6

Special precautions for disposal and other handling
No special requirements

7

MARKETING AUTHORISATION HOLDER
UK
Teva Pharma B.V.
Swensweg 5,
2031 GA Haarlem,
The Netherlands

8

MARKETING AUTHORISATION NUMBER
PL 14776/0054

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
09/07/2006

10

DATE OF REVISION OF THE TEXT
16/07/2015

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Source: Medicines and Healthcare Products Regulatory Agency

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