OFLOXACIN TEVA 200 MG

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Patient leaflet in accordance with the Pharmacists' Regulations

(Preparations) - 1986

This medicine is dispensed with a doctor’s prescription only

Ofloxacin Teva 200 mg

Tablets

Each tablet contains:

Ofloxacin 200 mg

For information about inactive ingredients and allergens in the medicine, see

section 2 – "Important information about some of this medicine’s ingredients" and

section 6 – "Additional information".

Read the entire leaflet carefully before you start using this medicine. This

leaflet contains concise information about this medicine. If you have any further

questions, consult your doctor or pharmacist.

This medicine has been prescribed to treat your illness. Do not pass it on to

others. It may harm them, even if it seems to you that their medical condition is

similar to yours.

1. What is this medicine intended for?

The medicine is intended for treatment of bacterial infections caused by bacteria

susceptible to ofloxacin: respiratory tract infections, pneumonia, ear, nose or

throat

infections,

infections

kidney,

urinary

tract

genital

organs

(including gonorrhea, a sexually transmitted disease), gastrointestinal infections

including bacterial colitis, soft tissue and skin infections, bone and joint infections.

Therapeutic group:

Antibiotic medicine belonging to the fluoroquinolone group.

2. Before using this medicine:

Do not use this medicine if:

you are sensitive (allergic) to the active ingredient or to any of the other

ingredients of this medicine (see section 6 – "Additional information").

Signs of an allergic reaction include rash, swallowing or breathing

problems, swelling of the lips, face, throat or tongue.

you have previously had an allergic reaction to a quinolone antibiotic. If

you have had an allergic reaction to any antibiotic in the past, consult

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the doctor before taking Ofloxacin Teva.

you have had inflammation of the tendons (tendinitis) after taking

fluoroquinolone antibiotics in the past.

you have epilepsy or have had a seizure or convulsion in the past.

you are pregnant or breastfeeding.

you are under the age of 18 years, or if you are over the age of 18

years, but think you are still in the stages of growth.

Special warnings about using this medicine:

Before using Ofloxacin Teva 200 mg, tell your doctor if:

you suffer or have suffered from a mental illness in the past.

you have liver or kidney problems. Make sure you tell the doctor about

any liver or kidney problem before you start taking Ofloxacin Teva,

because the dose may need to be lowered.

you have an illness of the nervous system called myasthenia gravis, in

which the muscles are weak and tire easily, as this medicine may

make the symptoms worse.

you have heart problems. Caution should be taken when using this

medicine if you were born with or have a family history of prolonged

QT interval (seen on ECG, recording of the electrical activity of the

heart),

have

salt

imbalance

blood

(especially

level

potassium or magnesium in the blood), have a very slow heart rhythm

(called bradycardia), have a weak heart (heart failure), have had a

heart attack (myocardial infarction) in the past, you are a woman or

elderly, or you are taking other medicines causing abnormal ECG

changes (see section "Drug interactions").

you have been prescribed corticosteroids (used to treat asthma and

other chronic lung diseases), as they may increase the risk of swelling

and pain in the tendons.

you have diabetes.

you have a medical condition which makes you likely to have seizures

(convulsions).

have

problem

with

blood

cells

called

“glucose-6-

phosphate-dehydrogenase deficiency”.

you have been diagnosed with an enlargement or "bulge" of a large

blood vessel (aortic aneurysm or large vessel peripheral aneurysm).

you have experienced a previous episode of aortic dissection (a tear in

the aorta wall).

you have a family history of aortic aneurysm or aortic dissection, or

other risk factors or predisposing conditions (e.g. connective tissue

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disorders

such

Marfan

syndrome,

vascular

Ehlers-Danlos

syndrome, or vascular disorders such as Takayasu arteritis, giant cell

arteritis,

Behcet’s

disease,

high

blood

pressure,

known

atherosclerosis).

If you feel sudden, severe pain in your abdomen, chest or back, go

immediately to the emergency room.

Do not take antibacterial medicines of the fluoroquinolone/quinolone

group,

including

Ofloxacin

Teva

have

previously

experienced

severe

side

effect

while

taking

fluoroquinolones or

quinolones. In such case, inform your doctor as soon as possible.

During the treatment with Ofloxacin Teva 200 mg:

Pain and swelling of the joints or tendon rupture inflammation may rarely

occur. Your risk is increased if you are elderly (above the age of 60 years),

have received an organ transplant, have kidney problems or if you are

being treated with corticosteroids. Tendon inflammation and ruptures may

occur during the first 48 hours after starting the treatment and even

several months after discontinuing treatment with Ofloxacin Teva 200 mg.

With

onset of

the first

sign of

tendon

pain

or inflammation

(for

example, in the ankle, wrist, shoulder or knee), stop taking Ofloxacin Teva

200 mg, contact your doctor and let the painful area rest. Refrain from

unnecessary physical activity, since it may increase the risk of tendon

rupture.

You may rarely experience symptoms of nerve damage (neuropathy) such

as pain, burning, tingling, numbness and/or weakness especially in the

feet and legs or hands and arms. If this happens, stop taking Ofloxacin

Teva

inform

your

doctor

immediately

prevent

development of potentially irreversible medical condition.

Do not expose yourself to long periods of strong sunlight while taking the

tablets. Use a sun protection cream if you cannot avoid strong sunlight.

Do not use a sun-lamp or solarium.

You may be more susceptible to infection with other bacteria. If severe or

bloody

diarrhea

develops,

bowel

inflammation

(pseudomembraneous

colitis) is suspected, and treatment should be discontinued.

Inform the doctor that you are taking Ofloxacin Teva if you are supposed

to undergo any medical tests, as the medicine may affect the results.

If your eyesight becomes impaired or if your eyes seem to be otherwise

affected, consult an ophthalmology specialist immediately.

Prolonged, disabling and potentially irreversible serious side effects:

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Antibacterial

medicines

fluoroquinolone/quinolone

group,

including

Ofloxacin Teva 200 mg, have been associated with very rare but serious side

effects, some of which are persistent (lasting for months or years), disabling or

potentially irreversible. This includes tendon, muscle and joint pain of the upper

and lower limbs, difficulty in walking, abnormal tenderness such as sensation of

"pins and needles", sensation of tingling, tickling, numbness or burning sensation

(paresthesia), sensory disorders including impairment of vision, sense of taste,

smell and hearing, depression, memory impairment, severe fatigue and severe

sleep problems.

If you experience any of these side effects after taking Ofloxacin Teva 200 mg,

contact your doctor immediately before further treatment. You and your doctor

will decide whether to continue the treatment, considering other group antibiotics

as well.

Tests and follow up:

The doctor may want you to perform blood tests for follow up if you are

taking Ofloxacin Teva for a long period.

Drug interactions:

If you are taking or have recently taken other medicines, including non-

prescription medications and dietary supplements, tell your doctor or

pharmacist. Particularly if you are taking:

Medicines preventing blot clotting (anticoagulants), such as warfarin, as

bleeding time may be longer.

Antacids (medicines for treating gastrointestinal disorders), sucralfate,

didanosine, aluminum, iron, magnesium or zinc preparations (see section

3- "How to use this medicine").

Medicines

control

blood

sugar

levels

(e.g.

glibenclamide),

concentrations of these medicines in the blood may be increased and

cause a greater decrease in blood sugar levels.

Theophylline (used for treatment of breathing problems) or non-steroidal

anti-inflammatory

drugs

(NSAIDs,

used

relief

pain

inflammation), e.g. ibuprofen, diclofenac or fenbufen, as some people

experience seizures when taking these medicines with Ofloxacin.

Medicines

that

affect

your

kidney

function

(e.g.

cimetidine,

furosemide,

probenecid

methotrexate),

these

medicines

sometimes increase the blood levels of Ofloxacin.

You must inform your doctor if you are taking other medicines that may

alter

your

heart

rhythm:

medicines

belonging

group

anti-

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arrhythmics (e.g. quinidine, hydroquinidine, disopyramide, amiodarone,

sotalol, dofetilide, ibutilide), tricyclic antidepressants, certain antibiotics

(belonging to the group of macrolides), certain antipsychotics.

Pregnancy, breastfeeding and fertility:

Do not take this medicine if you are pregnant, can become pregnant, think you

may be pregnant or if you are breastfeeding. If you become pregnant while taking

Ofloxacin Teva, stop taking the tablets and contact the doctor immediately (see

section 2 – "Do not use this medicine if"). Consult the doctor or pharmacist before

taking the medicine.

Driving and using machines:

Ofloxacin may make you feel sleepy, dizzy or may affect your eyesight and

reaction time. If you feel affected, do not drive or operate machines. Drinking

alcohol may make these symptoms worse.

Important information about some of this medicine's ingredients:

Patients who are intolerant to lactose should note that Ofloxacin Teva tablets

contain a small amount of lactose. If you have been told by the doctor that you

have an intolerance to certain sugars, contact the doctor before taking this

medicine.

This medicine contains less than 23 mg sodium per tablet, and is therefore

considered "sodium free".

3. How to use this medicine?

Always use this medicine according to your doctor's instructions. Check with your

doctor or pharmacist if you are not sure about your dose or about how to take

this medicine.

Only

your

doctor

will

determine

your

dose

should

take

this

medicine.

Do not take the medicine more than 8 weeks continuously.

Patients with liver disease and impaired renal function will have their dosage

adjusted by the doctor depending on their condition.

Do not exceed the recommended dose.

Taking the medicine:

Swallow the tablets whole with a full glass of water.

Do not chew or crush the tablets.

The tablet may be split at the score line into 2 equal doses.

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Taking Ofloxacin Teva in combination with antacids, sucralfate, aluminum,

iron, magnesium or zinc preparations:

Wait for at least 2 hours between the intake of Ofloxacin Teva and the intake of

any of the above medicines; otherwise, Ofloxacin Teva may not work properly.

If you have accidentally taken a higher dose:

If you have taken an overdose, or if a child has accidentally swallowed some

medicine, immediately see a doctor or go to a hospital emergency room and

bring the medicine package with you.

Overdose of Ofloxacin Teva may cause dizziness, confusion, seizures, loss of

consciousness, nausea and severe problems in the stomach.

If you forget to the take the medicine:

If you forget to take a tablet, take one as soon as you remember, unless it is

nearly time to take the next tablet. Do not take a double dose to compensate for

the forgotten dose.

Take the next dose at the usual time and consult the doctor.

Adhere to the treatment as recommended by your doctor.

If you stop taking this medicine:

Even if your health improves, do not stop taking this medicine without consulting

your doctor. If you fail to do so, the symptoms may return.

Do not take medicines in the dark! Check the label and dose every time you

take a medicine. Wear glasses if you need them.

If you have any further questions about using this medicine, consult your

doctor or pharmacist.

4. Side effects

Like with all medicines, using Ofloxacin Teva may cause side effects in some

users. Do not be alarmed by this list of side effects; you may not experience any

of them.

If

the

following

side

effects

occur,

stop

taking

Ofloxacin

Teva

and

immediately contact the doctor or go to the hospital:

Uncommon side effects: effects that occur in 1-10 out of 1,000 users:

Agitation, excessive sleepiness.

Rare side effects: effects that occur in 1-10 out of 10,000 users:

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An allergic reaction, sometimes even after taking the first dose, which may

include swelling of the lips, face or neck leading to severe difficulties

breathing, skin rash or hives, fast heart rate, low blood pressure, fever,

burning of the eyes, throat irritation, cough, wheezing, shock or blood

problems.

Tendon discomfort (usually in the Achilles tendon), including inflammation

or rupture, particularly if you are elderly or are also taking corticosteroids

e.g. prednisolone.

Fast heart beat.

Inflammation of the colon causing abdominal pain.

Persistent diarrhea and/or diarrhea containing blood.

Nightmares, anxiety, depression, hallucinations, confusion, sensation of

"pins and needles", blurred vision, double vision or odd color vision,

problems with or loss of the sense of smell.

Very rare side effects: effects that occur in less than 1 out of 10,000 users:

Severe blistering, peeling of the skin, or inflammation and ulceration of the

mouth, eyes, gut and genitals. These may be due to Stevens-Johnson

syndrome or toxic epidermal necrolysis, which are serious illnesses.

Convulsions,

ringing

ears,

unsteadiness,

shaking,

numbness,

disturbance of sensation, problems with hearing or hearing loss.

Other blood disorders in which the numbers of different blood cell types

may decrease. Symptoms can include weakness, fever, chills, sore throat,

ulcers in the mouth and throat, unusual bleeding or unexplained bruising.

Jaundice (yellowing of the skin).

Side effects of unknown frequency (the frequency of these effects has not

been established yet):

Irregular or slow heart beat, fainting.

Abnormal

fast

heart

rhythm,

life-threatening

irregular

heart

rhythm,

alteration of the heart rhythm (called "prolongation of QT interval", seen on

ECG, recording of the electrical activity of the heart).

If you are diabetic on treatment and feel signs of low blood sugar levels –

feeling weak, sweating and/or trembling.

Feeling of desire to harm yourself or other mental disturbances, problems

with or loss of the sense of taste.

Loss of appetite, yellowing of the skin and eyes, dark-colored urine,

irritation or tenderness in the abdomen. All these may be signs of liver

problems, which may include fatal liver failure.

Inflammation of pancreas causing severe abdominal pain.

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You may need urgent medical observation or hospitalization. These reactions

may occur in patients after taking the first dose of Ofloxacin Teva, or even after

treatment discontinuation.

The following side effects have been reported at the relative frequencies

described below:

Uncommon side effects: effects that occur in 1-10 out of 1,000 users:

Nausea

vomiting,

diarrhea,

abdominal

pain,

indigestion

other

gastrointestinal disorders.

Headache, dizziness, a spinning feeling (vertigo), sleep disturbances and

restlessness.

Skin rash, itching.

Irritation of the eye.

Cough, inflammation of nose and throat.

Fungal infections.

Increase in the number of other bacteria, which may require treatment.

Rare side effects: effects that occur in 1-10 out of 10,000 users:

Loss of appetite.

Low blood pressure.

Shortness of breath, wheezing.

Fast, irregular heart beat.

Hot flushes, hives (called urticaria), excessive sweating (hyperhidrosis),

pustular rash.

Liver function problems with abnormal blood test results.

Kidney function problems with abnormal blood test results.

Very rare side effects: effects that occur in less than 1 out of 10,000 users:

Anemia (reduction in the number of red blood cells causing unusual

tiredness or weakness).

Rash upon exposure to strong sunlight and other severe skin reactions.

Inflammation

your

tubes

that

carry

blood

around

your

body

(inflammation of the blood vessels) due to an allergic reaction.

Discoloration, peeling or loss of nails.

Acute kidney failure.

Joint and muscle pains.

Moving and walking problems.

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Side effects of unknown frequency (the frequency of these effects has

not been established yet):

Sudden kidney failure, which may be due to an allergic kidney reaction

called interstitial nephritis.

It is also possible that Ofloxacin Teva may trigger an attack of porphyria

(deficiency

specific

enzymes

body,

which

lead

discoloration of the urine (lighter color), serious skin disorders, anemia,

abdominal pain and severe mental illnesses) in patients who are at risk of

developing this medical condition.

Abnormal muscle breakdown, muscle weakness, muscle rupture (partial

or full).

Allergic lung inflammation, severe loss of breath.

Gastrointestinal disorders, excessive flatulence (gas), constipation.

Feeling of weakness, elevation of body temperature, pain (including pain

in back, chest, arms and legs).

Bone marrow failure, which may lead to pancytopenia (a medical condition

in which there is a reduction in the number of red and white blood cells, as

well as platelets).

Inflammation of the eye (uveitis).

Extensive skin redness (exfoliative dermatitis).

Very rare cases of long lasting ( up to months or years) or permanent side effects

of the medicine, such as tendon inflammations, tendon rupture, joint pain, pain in

the limbs, difficulty in walking, abnormal sensations such as sensation of "pins

needles",

tingling,

tickling,

burning

sensation,

numbness

pain

(neuropathy), depression, fatigue, sleep disorders, memory impairment as well

as impairment of hearing, vision and sense of taste and smell have been

associated with administration of antibiotics of the quinolone or fluoroquinolone

group, in some cases irrespective of pre-existing risk factors.

Return to your doctor if you still feel unwell at the end of treatment.

If you experience any side effect, if any side effect gets worse, or if you

experience a side effect not mentioned in this leaflet, consult your doctor.

Reporting side effects:

You can report side effects to the Ministry of Health by following the link

‘Reporting Side Effects of Drug Treatment’ on the Ministry of Health home page

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(www.health.gov.il) which links to an online form for reporting side effects. You

can also use this link: https://sideeffects.health.gov.il

5.

How to store the medicine?

Avoid poisoning! To avoid poisoning, keep this, and all other medicines, in a

closed place, out of the reach and sight of children and/or infants. Do not induce

vomiting unless explicitly instructed to do so by a doctor.

Do not use the medicine after the expiry date (exp. date) which is stated on the

package. The expiry date refers to the last day of that month.

Storage conditions:

Store in a dry place below

6.

Additional information

In addition to the active ingredient, this medicine also contains:

Lactose

monohydrate,

pregelatinized

starch,

hypromellose,

croscarmellose

sodium,

magnesium

stearate,

colloidal

anhydrous

silica,

titanium

dioxide,

macrogol, triacetin.

What the medicine looks like and contents of the pack:

White, round, film coated tablets, breakline on both sides. One side of the tablet

debossed “FXN” on one side of the breakline and “200” on the other side.

Pack sizes: 10 or 20 tablets.

Not all pack sizes may be marketed.

Registration holder’s name and address:

Abic Ltd., POB 8077, Netanya

Manufacturer’s name and address:

Teva Pharmaceutical Industries Private Company Ltd., Debrecen, Hungary.

The leaflet was revised in March 2020.

Registration number of the medicine in the National Drug Registry of the

Ministry of Health:

30147.98.121

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SUMMARY OF PRODUCT CHARACTERISTICS

1.

NAME OF THE MEDICINAL PRODUCT

Ofloxacin Teva 200mg, Tablets

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each film-coated tablet contains 200 mg of ofloxacin.

Excipients with known effect:

This product contains lactose monohydrate.

For the full list of excipients, see section 6.1.

3.

PHARMACEUTICAL FORM

Tablets

White, round film-coated tablets, 11 mm 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 Teva is indicated for the treatment of bacterial infections due to ofloxacin-

susceptible microorganisms, such as:

Acute, chronic, or recurrent lower respiratory tract infections (bronchitis),

pneumonia (not for the treatment of first choice in pnemonia caused by

pneumococci).

Chronic and recurrent infections of the ear, nose, and throat. Ofloxacin is in

general

indicated

treatment

acute

tonsillitis

caused

betahaemolytic streptococci.

Infections of soft tissues and skin.

Infections of the bones and joints.

Abdominal infections including infections in the pelvis minor and bacterial

enteritis.

Infections of the kidney, urinary tract, and genital organs, gonorrhoea.

Prevention of infections due to ofloxacin-susceptible pathogens in patients with a

significant reduction in resistance to infections (e.g. in neutropenic state).

4.2 Posology and method of administration

Duration of treatment

The duration of treatment depends on the response of the pathogen and the clinical

condition. Basically, it is advisable to continue the treatment for at least three days

after the resolution of fever and the disappearance of symptoms.

In acute infections, treatment for 7 to 10 days is usually sufficient. The usual duration

of treatment is 7-8 days for salmonellosis, 3-5 days for shigellosis and 3 days for

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Ofloxacin-Teva-200mg-tablets-SPC- 09-2020

intestinal infections with Escherichia coli.

Treatment

with

mg ofloxacin per

days

is usually

sufficient for

uncomplicated lower urinary tract infections. A single dose of 400 mg ofloxacin is

adequate for the treatment of uncomplicated gonorrhea.

In the case of bone infections, the treatment lasts 3-4 weeks or even longer in some

cases.

If infections with beta-hemolytic streptococci of proven sensitivity (e.g. erysipelas) are

treated, this treatment must last for at least 10 days in order to prevent late

complications such as rheumatic fever or glomerulonephritis. However, since the

sensitivity of beta-hemolytic streptococci to ofloxacin varies, treatment of these

infections requires sensitivity to be established in each individual case.

Until further experience is gained, it is advisable not to exceed a treatment time of 2

months.

Method of administration

Ofloxacin Teva 200 mg tablet should be swallowed whole, not chewed, and taken

with adequate liquid (1/2 to 1 glass). They can be taken on an empty stomach or at

mealtimes.

Up to 400 mg ofloxacin can be administered as a single dose. The daily dose is

usually divided into two equal doses (morning and evening). It is important to ensure

that the intervals between doses are similar in length. Single doses of up to 1

Ofloxacin Teva 400 mg tablet daily are best taken in the morning.

Indications

Single and daily doses

Uncomplicated

lower

urinary

tract

infections

2 x ½ Ofloxacin Teva 200 mg tablet daily

Uncomplicated gonorrhea

1 x 400 mg ofloxacin as a single daily

dose,

corresponding

Ofloxacin

Teva 200 mg tablets

Infections of the kidneys, urinary tract

and reproductive organs

ofloxacin

daily,

corresponding to 2x1 Ofloxacin Teva 200

mg tablet

Infections of the respiratory tract and of

the ears, nose and throat

ofloxacin

daily,

corresponding to 2x1 Ofloxacin Teva 200

mg tablet

Infections of the skin and soft tissues

ofloxacin

daily,

corresponding to 2x1 Ofloxacin Teva 200

mg tablet

Infections of the bones

ofloxacin

daily,

corresponding to 2x1 Ofloxacin Teva 200

mg tablet

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Ofloxacin-Teva-200mg-tablets-SPC- 09-2020

Indications

Single and daily doses

Infections of the abdominal cavity

(incl. bacterial diarrheas)

ofloxacin

daily,

corresponding to 2x1 Ofloxacin Teva 200

mg tablet

In individual cases it may be necessary to increase the dose in the event of

pathogens with different sensitivities, in severe infections (e.g. of the respiratory tract

or bones) and if the patient's response is insufficient. In these cases the dose can be

increased to 2 x 400 mg ofloxacin daily. The same applies to infections with

concomitant complicating factors.

For the prophylaxis of infection in severely immunocompromised patients, 400 to 600

mg ofloxacin daily are recommended.

Dosage in patients with impaired kidney function

For patients with moderate to severe impairment of renal function as judged by

creatinine clearance or serum creatinine it is advisable to use Ofloxacin Teva 200 mg

tablets as they can be divided into two half tablets, each containing 100 mg ofloxacin.

The first dose depends on the nature and severity of the disease and is the same as

for patients with normal renal function.

The maintenance dose should be reduced as follows:

Creatinine clearance

Serum creatinine

Maintenance dose

50 to 20 ml/min

1.5 to 5 mg/dl

100 to 200 mg ofloxacin daily

20 ml/min

5 mg/dl

100 mg ofloxacin daily

Hemodialysis or peritoneal

dialysis

100 mg ofloxacin daily

In some cases (see above) it may be necessary to increase the above-mentioned

dose.

Dosage in patients with impaired liver function

The excretion of ofloxacin may be diminished in patients with severe impairment of

liver function (e.g. in the case of cirrhosis of the liver with ascites). It is therefore

advisable not to exceed a maximum daily dose of 400 mg ofloxacin in such cases.

Children:

Ofloxacin Teva is not indicated for use in children or growing adolescents.

4.3 Contraindications

Ofloxacin must not be used

patients

hypersensitive

ofloxacin,

other

quinolones,

excipients

in patients with history of epilepsy or with any existing central nervous system

disorder that is associated with a lower seizure threshold

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Ofloxacin-Teva-200mg-tablets-SPC- 09-2020

patients

with

history

tendon

disorders

related

fluoroquinolone

administration

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.

Ofloxacin should not be given to patients with latent or actual defects in glucose-6-

phosphate dehydrogenase activity because they are prone to haemolytic reactions

when treated with quinolone antibacterial agents.

4.4 Special warnings and precautions for use

The use of ofloxacin should be avoided in patients who have experienced serious

adverse reactions in the past when using quinolone or fluoroquinolone containing

products (see section 4.8). Treatment of these patients with ofloxacin should only

be initiated in the absence of alternative treatment options and after careful

benefit/risk assessment (see also section 4.3).

Methicillin-resistant

S.

aureus

very

likely

possess

co-resistance

fluoroquinolones, including ofloxacin. Therefore ofloxacin is not recommended for

the treatment of known or suspected MRSA infections unless laboratory results

have

confirmed

susceptibility

organism

ofloxacin

(and

commonly

recommended antibacterial agents for the treatment of MRSA-infections are

considered inappropriate).

Prolonged,

disabling

and

potentially

irreversible

serious

adverse

drug

reactions

Very rare cases of prolonged (continuing months or years), disabling and potentially

irreversible serious adverse drug reactions affecting different, sometimes multiple,

body

systems

(musculoskeletal,

nervous,

psychiatric

senses)

have

been

reported in patients receiving quinolones and fluoroquinolones irrespective of their

age and pre-existing risk factors. Ofloxacin should be discontinued immediately at

the first signs or symptoms of any serious adverse reaction and patients should be

advised to contact their prescriber for advice.

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 Stevens-Johnson 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.

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Hypersensitivity and allergic reactions have been reported for fluoroquinolones

after first administration. Anaphylactic and anaphylactoid reactions can progress

to life-threatening shock, even after the first administration. In these cases

ofloxacin should be discontinued and suitable treatment (e.g treatment for shock)

should be initiated. The physician should inform the patient of this risk.

Ofloxacin

Teva

drug

first

choice

pneumonia

caused

Pneumococci

Mycoplama,

angina

tonsillaris

caused

-haemolytic

Streptococci.

Clostridium difficile-associated disease

Diarrhoea, particularly if severe, persistent and/or bloody, during or up to 10 weeks

after treatment with Ofloxacin Tablets, may be a symptom of Clostridium difficile

enterocolitis,

most

severe form

being pseudomembraneous

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

metronidazole).

Medicinal

products

that

inhibit

peristalsis are contra-indicated in such cases.

Patients predisposed to seizures

Fluoroquinolones, including ofloxacin, have been associated with an increased risk of

seizures

(convulsions),

increased

intracranial

pressure

(pseudotumor

cerebri),

dizziness, and tremors.

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 antiinflammatory drugs

or with drugs which lower the cerebral seizure threshold, such as theophylline (see

section 4.5).

As with all fluoroquinolones, use ofloxacin with caution in epileptic patients and

patients with known or suspected CNS disorders that may predispose to seizures or

lower the seizure threshold (for example, severe cerebral arteriosclerosis, previous

history of convulsion, reduced cerebral blood flow, altered brain structure, or stroke),

or in the presence of other risk factors that may predispose to seizures or lower the

seizure threshold (for example, certain drug therapy, renal dysfunction).

In case of convulsive seizures, treatment with ofloxacin should be discontinued.

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Tendinitis and tendon rupture

Tendinitis

tendon

rupture

(especially,

limited

Achilles

tendon),

sometimes bilateral, may occur as early as within 48 hours of starting treatment with

quinolones and fluoroquinolones and have been reported to occur even up to several

months after discontinuation of treatment. The risk of tendinitis and tendon rupture is

increased in older patients, patients with renal impairment, patients with solid organ

transplants,

those

treated

concurrently

with

corticosteroids.

Therefore,

concomitant use of corticosteroids should be avoided.

At the first sign of tendinitis (e.g. painful swelling, inflammation) the treatment with

ofloxacin should be discontinued and alternative treatment should be considered.

affected

limb(s)

should

appropriately

treated

(e.g.

immobilisation).

Corticosteroids should not be used if signs of tendinopathy occur.

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).

Patients with history of psychotic disorder

Psychotic

reactions

have

been

reported

patients

receiving

fluoroquinolones,

including ofloxacin, including: toxic psychosis, psychotic reactions progressing to

suicidal ideations/thoughts, hallucinations, or paranoia; depression, or self-injurious

behavior such as attempted or completed suicide; anxiety, agitation, or nervousness;

confusion,

delirium,

disorientation,

disturbances

attention;

insomnia

nightmares; memory impairment. In some cases these have progressed to suicidal

thoughts or self-endangering behavior including suicide attempt, sometimes after a

single dose of ofloxacin (see section 4.8). Advise patients receiving ofloxacin to

inform their healthcare provider immediately if these reactions occur.

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 hepatic impairment

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).

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).

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Myasthenia gravis

Fluoroquinolones, including ofloxacin, have neuromuscular blocking activity and may

exacerbate muscle weakness in patients with myasthenia gravis. Post-marketing

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

been

reported

with

ofloxacin

(see

section

4.8).

recommended that patients should avoid strong sunlight or artificial UV radiation (e.g.

sunray

lamp, solarium), during treatment and for 48 hours following treatment

discontinuation in order to prevent photosensitization

Superinfection

As with other antibiotics, the use of ofloxacin, especially if prolonged, may result in

overgrowth of non-susceptible organisms, especially enterococci, resistant strains of

some organisms

candida.

Repeated

evaluation

the patient's

condition

essential. If secondary infection occurs during therapy,, appropriate and alternative

treatment should be given.

Cardiac disorders

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

women

more

sensitive

QTc-prolonging

medications.

Therefore,

caution

should

taken

when

using

fluoroquinolones, including ofloxacin, in these populations.

uncorrected electrolyte imbalance (e.g. hypokalaemia, hypomagnesaemia)

congenital long QT syndrome

acquired QT prolongation

cardiac disease (e.g. heart failure, myocardial infarction, bradycardia)

concomitant use of drugs that are known to prolong the QT interval (e.g.

Class

antiarrhythmics,

tricyclic

antidepressants,

macrolides,

antipsychotics).

(See also section 4.2, section 4.5, section 4.8 and section 4.9).

Aortic aneurysm and dissection

Epidemiologic studies report an increased risk of aortic aneurysm and dissection

after intake of fluoroquinolones, particularly in the older population.

Therefore,

fluoroquinolones

should

only

used

after

careful

benefit-risk

assessment and after consideration of other therapeutic options in patients with

positive family history of aneurysm disease, or in patients diagnosed with preexisting

aortic aneurysm and/or aortic dissection, or in presence of other risk factors or

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Ofloxacin-Teva-200mg-tablets-SPC- 09-2020

conditions predisposing for aortic aneurysm and dissection (e.g. Marfan syndrome,

vascular Ehlers-Danlos syndrome, Takayasu arteritis, giant cell arteritis, Behcet's

disease, hypertension, known atherosclerosis).

In case of sudden abdominal, chest or back pain, patients should be advised to

immediately consult a physician in an emergency department.

Dysglycaemia

As with all quinolones, disturbances in blood glucose, including both hypoglycaemia

hyperglycaemia have been

reported

(see

section 4.8),

usually

in diabetic

patients receiving concomitant treatment with an oral hypoglycaemic agent (e.g.,

glibenclamide) or with insulin. Cases of hypoglycaemic coma or death have been

reported. In diabetic patients, careful monitoring of blood glucose is recommended.

hypoglycemic

reaction

occurs

patient

being

treated

with

ofloxacin,

discontinue ofloxacin and initiate appropriate therapy immediately.

Peripheral neuropathy

Cases

sensory

sensorimotor

polyneuropathy

resulting

paraesthesia,

hypaesthesia, dysesthesia, or weakness have been reported in patients receiving

quinolones and fluoroquinolones. Patients under treatment with ofloxacin should be

advised to inform their doctor prior to continuing treatment if symptoms of neuropathy

such as pain, burning, tingling, numbness, or weakness develop in order to prevent

the development of potentially 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.

Ofloxacin should therefore be administered with caution in such patients.

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:

Determination of opiates or porphyrins in urine may give false-positive results during

treatment with ofloxacin. It may be necessary to confirm positive opiate or porphyrin

screens by more specific methods.

Excipients

This medicinal product contains

lactose.

Patients

with

rare

hereditary

problems

galactose

intolerance,

total

lactase

deficiency, or glucose-galactose malabsorption should not take this medicine.

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Sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say

essentially ‘sodium-free’.

During prolonged therapy (more than two weeks and up to two months), regular

monitoring of haematological parameters and blood chemistry is recommended.

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 anti-inflammatory 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

given

concurrently

with

theophylline,

nonsteroidal

anti-

inflammatory drugs, or other agents, which lower the seizure threshold. However,

ofloxacin

does

cause

relevant

changes

theophylline

plasma

concentrations.

Drugs known to prolong QT interval:

Ofloxacin, like other fluoroquinolones, should be used

with caution in patients

receiving

drugs

known

prolong

interval

(e.g.

Class

antiarrhythmics, tricyclic antidepressants, macrolides, antipsychotics) (see section

4.4).

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 should be monitored in patients

treated with vitamin K antagonists (see section 4.4) because of a possible increase in

the effect of coumarin derivatives.

Glibenclamide:

Ofloxacin may cause a slight increase in serum concentrations of glibenclamide

administered concurrently; it is therefore recommended that patients treated with this

combination should be closely monitored as hypoglycaemia is more likely to occur.

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 and methotrexate.

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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).

The safety of this medicinal product for use in human pregnancy has not been

established. Reproduction studies performed in rats and rabbits did not reveal any

evidence of teratogenicity, impairment of fertility or impairment of peri- and post-natal

development. However, as with other quinolones, ofloxacin has been shown to cause

arthropathy in immature animals.

Breast-feeding

Studies in rats have indicated that ofloxacin is secreted in milk.

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).

4.7 Effects on ability to drive and use machines

Some adverse reactions (e.g. dizziness/vertigo, drowsiness, visual disturbances)

may impair the patients 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), patients should know how they react to ofloxacin before

they drive or operate machinery.

These effects may be enhanced by alcohol.

4.8 Undesirable effects

The overall frequency of adverse reactions from the clinical trial data base is about

7%. The commonest events involved the gastrointestinal system (about 5.0%) and

the nervous system (about 2.0%).

The frequencies of adverse events are ranked according to the following: very

common (> 1/10), common (> 1/100 to < 1/10), uncommon (> 1/1000 to < 1/100),

rare (> 1/10 000 to < 1/1000), very rare (< 1/10,000), not known (cannot be estimated

from the available data) including isolated reports.

The information given below is based on data from clinical studies and on extensive

post marketing experience.