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OFLOXACIN TEVA 400 MG TABLETS

Active substance(s): OFLOXACIN / OFLOXACIN / OFLOXACIN

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Package leaflet: Information for the user

Ofloxacin 200 mg and 400 mg Film-coated Tablets
Ofloxacin
Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
 Keep this leaflet. You may need to read it again.
 If you have any further questions, ask your doctor or pharmacist.
 This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
 If you get any side effects talk to your doctor or pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.

What is in this leaflet:
1.
2.
3.
4.
5.
6.

What Ofloxacin is and what it is used for
What you need to know before you take Ofloxacin
How to take Ofloxacin
Possible side effects
How to store Ofloxacin
Contents of the pack and other information

1. What Ofloxacin is and what it is used for
Ofloxacin belongs to a group of antibacterial medicines known as fluoroquinolones.
Ofloxacin is an antibiotic that can be used to treat infections of:
 the bladder or the kidneys (urinary tract)
 the lungs and chest, including pneumonia and bronchitis
 the male and female genital organs. Ofloxacin can be used to treat gonorrhoea and some other
genital infections.
2. What you need to know before you take ofloxacin
Ofloxacin is not suitable for everyone. If you are not sure about anything, ask your doctor or
pharmacist before you start to take Ofloxacin.
Do not take Ofloxacin:
 if you are allergic (hypersensitive) to Ofloxacin or any of the other ingredients of this
medicine (listed in section 6). Signs of an allergic reaction include: a rash, swallowing

or breathing problems, swelling of your lips, face, throat or tongue.
 if you have previously had an allergic reaction to a quinolone antibiotic. If you have had a
reaction to any type of antibiotic in the past, check with your doctor before taking Ofloxacin
 if you have a history of inflammation of the tendons (tendinitis) when you have taken
fluoroquinolone antibiotics in the past
 if you have epilepsy or have ever had a seizure or fit
 if you are pregnant or breast-feeding
 if you are under the age of 18, or if you are over 18 but think you are still growing.
Warnings and precautions:
Talk to your doctor or pharmacist before taking Ofloxacin:











if you suffer from or have a history of mental illness
if you have problems with your liver or kidneys. Make sure you tell your doctor about any liver
or kidney problems before you start taking Ofloxacin because the dose may need to be lowered
if you have an illness of the nervous system called myasthenia gravis (a disorder in which the
muscles are weak and tire easily) as this medicine can make the symptoms worse
if you have heart problems. Caution should be taken when using this kind of medicine, if you
were born with or have family history of prolonged QT interval (seen on ECG, electrical
recording of the heart), have salt imbalance in the blood (especially low level of potassium or
magnesium in the blood), have a very slow heart rhythm (called ‘bradycardia’), have a weak heart
(heart failure), have a history of heart attack (myocardial infarction), you are female or elderly or
you are taking other medicines that result in abnormal ECG changes (see section Other medicines
and Ofloxacin)
if you are prescribed corticosteroids (used to treat asthma and other chronic lung diseases) as this
may increase the risk of swelling and pain of your tendons
if you are diabetic
if you have a condition which makes you likely to have fits (convulsions)
if you have a problem with your red blood cells called “glucose-6-phosphate-dehydrogenase
deficiency”

While you are taking Ofloxacin
 do not expose yourself to long periods in strong sunlight whilst taking these 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 organisms and if severe or bloody diarrhoea
develops, bowel inflammation (pseudomembraneous colitis) is suspected, treatment should be
discontinued.
 let your doctors know you are taking Ofloxacin if you are undergoing any medical tests, as it may
interfere with the results.
your doctor may want to monitor you with blood tests if you are taking Ofloxacin for longer
period.
 you may be susceptible to inflammation of the tendon (tendonitis). This usually affects the
Achilles tendon, if you develop pain in the legs stop taking the tablets and tell your doctor as
soon as possible.
 you may experience numbness, tingling, pricking sensations (paresthesia), sensitivity to touch,
pain or muscle weakness in your hands and legs due to damage of peripheral neurons (peripheral
neuropathy). If you do, stop taking the tablets and contact your doctor.
 If your eyesight becomes impaired or if your eyes seem to be otherwise affected, consult an eye
specialist immediately.
Other medicines and Ofloxacin:
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Tell your doctor if you are taking any of the following:
 Medicines that stop your blot clotting (anticoagulants), such as warfarin, as bleeding times may
be longer
 antacids (medicines for an upset stomach), sucralfate, didanosine, aluminium, iron, magnesium
or zinc preparations (see section 3, How to take Ofloxacin).
 medicines to control your blood sugar (e.g. glibenclamide), as concentrations of these
medicines in the blood may be increased and cause a greater fall in the blood sugar levels.

 theophylline (used for breathing problems) or non-steroidal anti-inflammatory drugs (NSAIDs
used for pain relief and inflammation) e.g. ibuprofen, diclofenac or fenbufen, as some people
have fits when these are taken with Ofloxacin
 drugs that may affect your kidney function (e.g. cimetidine, furosemide, probenecid or
methotrexate), as these can sometimes increase blood levels of Ofloxacin.
 you must tell your doctor if you are taking other medicines that can alter your heart rhythm:
medicines that belong to the group of anti-arrhythmics (e.g. quinidine, hydroquinidine,
disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some
antimicrobials (that belong to the group of macrolides), some antipsychotics.
Taking Ofloxacin in combination with antacids, sulcrate, aluminium, iron, magnesium or zinc
preparations:
Take Ofloxacin at least two hours before taking any of the above medicines otherwise Ofloxacin may
not work as well.
Pregnancy, breast-feeding and fertility:
Do not take this medicine if you are pregnant, might become pregnant, think you may be pregnant or
if you are breast-feeding. If you become pregnant while taking Ofloxacin, stop taking the tablets and
contact your doctor immediately (see ‘Do NOT take’). Ask your doctor or pharmacist for advice
before taking any medicine.
Driving and using machines:
Ofloxacin may make you feel sleepy, dizzy or could affect your eyesight and reaction time.
If affected do not drive or operate machinery. Drinking alcohol may make these symptoms worse.
Ofloxacin contains lactose:
Patients who are intolerant to lactose should note that Ofloxacin tablets contain a small amount of
lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact
your doctor before taking this medicinal product.
3. How to take Ofloxacin
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
Your doctor will decide how much Ofloxacin you need to take each day and whether you can take the
dose all at once or should take half in the morning and half in the evening. Your doctor will tell you
how long your treatment with Ofloxacin will last. Treatment should not exceed 2 months. Return to
your doctor if you still feel unwell after finishing your course of tablets. If you are taking Ofloxacin
for longer periodyour doctor may carry out blood tests from time to time to check on your condition.
Swallow the tablets whole with a full glass of water. Do not chew them. Ofloxacin tablets may be
taken before or during meal times.
Ofloxacin 200 mg Film-coated Tablets only:
The tablet can be divided into equal doses.
The recommended dose is:
Adults (including the elderly):
The dose to be taken will depend on the type of infection to be treated. For most infections, the
recommended dose range is 200 mg to 800 mg of Ofloxacin daily.
Up to 400 mg may be given as a single dose, preferably in the morning.

The recommended doses for different infections are shown below. However, your doctor may decide
you need a different dose.


To treat bladder or kidney infections
The recommended dose for a simple bladder or kidney infection is 200 mg or 400 mg of
Ofloxacin a day. Treatment usually lasts for 3 days. To treat complicated kidney infections,
your doctor may increase the dose to 400 mg twice daily and you may need to take Ofloxacin
for 7 to 10 days.



To treat infections of the genital organs
To treat gonorrhoea of the genital organs, a single dose of 400 mg of Ofloxacin in the
morning is usually enough.
To treat other infections of the genital organs for which Ofloxacin is a suitable antibiotic, the
dose is usually 400 mg each day. Treatment may last from 7-10 days.



To treat lung and chest infections
The recommended dose is 400 mg of Ofloxacin daily. If necessary, your doctor may increase
this to 400 mg twice a day. Treatment may last from 7-10 days. For certain types of
pneumonia Ofloxacin may be taken with other medicines.

Patients with kidney or liver problems:
If you have kidney problems (whether or not you need dialysis treatments) or have severe liver
problems, your doctor may tell you to take a lower dose of Ofloxacin each day.
Use in children and adolescents:
Ofloxacin Tablets should not be given to children or growing adolescents.
If you take more Ofloxacin than you should:
If you (or someone else) swallow a lot of the tablets all together, or if you think a child has
swallowed any of the tablets, contact your nearest hospital casualty department or your doctor
immediately.
Overdose of Ofloxacin can cause dizziness, confusion, fits, loss of consciousness, nausea and there
can be severe problems in the stomach. Please take this leaflet, any remaining tablets and the
container with you to the hospital or doctor so that they know which tablets were consumed.
If you forget to take Ofloxacin:
If you forget to take a tablet, take one as soon as you remember, unless it is nearly time to take the
next one. Do not take a double dose to make up for a forgotten tablet. Take the remaining doses at the
correct time.
If you stop taking Ofloxacin
It is important that you complete the full course of treatment as directed by your doctor even if you
feel better. If you don’t do this, your symptoms may reappear.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

If the following happens, stop taking Ofloxacin and tell your doctor immediately or go to the casualty
department at your nearest hospital:

Uncommon: may affect up to 1 in 100 people


Agitation, excessive sleepiness

Rare: may affect up to 1 in 1,000 people








An allergic reaction sometimes even after taking your first dose, which may include swelling of
the lips, face or neck leading to severe difficulty in breathing, skin rash or hives, fast heart rate,
low blood pressure, fever, burning of the eyes, throat irritation, coughing, wheezing, shock or
blood disorders
Tendon discomfort (usually the Achilles tendon), including inflammation and rupture,
particularly if you are elderly or also taking corticosteroids e.g. prednisolone
Fast heart beat
Inflammation of the large intestine causing abdominal pain
Diarrhoea if persistent, and or containing blood
Nightmares, anxiety, depression, hallucinations, confusion, pins and needles, blurred, double or
odd colour vision problems, problems with or loss of smell

Very rare: may affect up to 1 in 10,000 people





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
Fits, ringing in the ears, unsteadiness, shaking, numbness, disturbance of sensation, problems
with or loss of hearing
Other blood disorders where the numbers of different types of cells in the blood may fall.
Symptoms can include weakness, fever, chills, sore throat, ulcers in the mouth and throat,
unusual bleeding or unexplained bruising
Jaundice (yellowing of the skin)

Not known: frequency cannot be estimated from the available data







Irregular or slower 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, electrical activity of the heart)
If you are a diabetic on treatment and feel signs of low blood sugar levels – feeling weak,
sweating and/or trembling
Feeling of wanting to harm yourself and other disturbances of the mind, problems with or loss of
taste
Loss of appetite, skin and eyes becoming yellow in colour, dark-coloured urine, itching, or
tender stomach (abdomen). These may be signs of liver problems which may include a fatal
failure of the liver
Inflammation of pancreas causing severe abdominal pain

You may need urgent medical attention or hospitalisation. These reactions can occur in some
patients after the first dose of Ofloxacin, or even after treatment has stopped.
The following side effects have been reported at the approximate frequencies shown:
Uncommon: may affect up to 1 in 10 people
 Feeling sick or being sick, diarrhoea, stomach pain, indigestion and other stomach upsets.
 Headache, dizziness, a spinning feeling (vertigo), sleep disturbances and restlessness







Skin rashes, itching
Irritation of the eye
Cough, inflammation of nose and throat
Fungal infections,
Increases in the number of other bacteria, which may need to be treated

Rare: may affect up to 1 in 1,000 people
 Loss of appetite
 Low blood pressure
 Shortness of breath, wheezing
 Fast, irregular heart beat
 Hot flushes, hives (called urticaria), sweating too much (hyperhidrosis), rash pustular
 Problems with liver function with abnormal blood test results
 Problems with kidney function with abnormal blood test results
.
Very rare: may affect up to 1 in 10,000 people
 Anaemia (reduction in red blood cells causing unusual tiredness or weakness)
 Rash on exposure to strong sunlight and other severe skin reactions
 Inflammation of your tubes that carry blood around your body (vessels) due to an allergic
reaction
 Discoloration, peeling or loss of nails
 Acute kidney failure
 Joint and muscle pains
 Problems moving and walking
Not known: frequency cannot be estimated from the available data
 Occasional kidney failure which may be due to an allergic kidney reaction called interstitial
nephritis
 It is also possible that Ofloxacin may trigger an attack of porphyria (deficiency of specific
enzymes in the body which can lead to discolouration of the urine, serious skin disorders,
anaemia, stomach pains and severe mental disorders) in patients who are at risk of developing
this condition.
 Abnormal muscle breakdown, muscle weakness, tear, muscle rupture
 Allergic lung inflammation, severe loss of breath




Upset stomach, excessive wind, constipation
Feeling weak, elevate body temperature, pain (including pain in back, chest arma and
legs)



Bone marrow failure 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)
Skin redness with extensive scaling (exfoliative dermatitis)




Return to your doctor if you still feel unwell after finishing your course of tablets.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme
at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Ofloxacin
Keep this medicine out of the sight and reach of children.
Keep container in the outer carton to protect the tablets from light. Store in the original package.
Do not use this medicine after the expiry date that which is stated on the outer packaging. The
expiry date refers to the last day of that month. Do not use this medicine if you notice any defects
or signs of deterioration in the tablets (such as broken tablets), please consult your pharmacist.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Ofloxacin tablets contains:
 The active ingredient is ofloxacin.
 The other ingredients are lactose monohydrate, pregelatinised starch, hypromellose,
croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, titanium dioxide (E171),
macrogol 3000 and triacetin.
What Ofloxacin tablets looks like and contents of the pack:
 The 200 mg tablets are white, round, film-coated tablets, scored on both sides, marked ‘FXN’ on
one side of the breakline and ‘200’ on the other side.
 The 400 mg tablets are white, oval, film-coated tablets marked ‘FXN 400’ on one side and
scored on the other side.
 The 200 mg and 400 mg tablets are available in pack sizes of 5, 10, 20 and 50 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder is Teva Pharma B.V., Swensweg 5, 2031 GA Haarlem, The
Netherlands and company responsible for manufacture is TEVA UK LIMITED, Eastbourne, BN22
9AG.
OR
The Marketing Authorisation holder is Teva Pharma B.V., Swensweg 5, 2031 GA Haarlem,The
Netherlands and the company responsible for manufacture is Pharmachemie B.V., Haarlem, The
Netherlands.
OR
The Marketing Authorisation holder is Teva Pharma B.V., Swensweg 5, 2031 GA Haarlem,The
Netherlands and the company responsible for manufacture is Teva Pharmaceutical Works Company
Limited, Debrecen, Hungary.
This leaflet was last revised in October 2016

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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