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OFLOXACIN 400MG TABLETS

Active substance(s): OFLOXACIN

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Ofloxacin 400mg Tablets
Your medicine is known by the above name, but will be referred to as
Ofloxacin tablets throughout this leaflet.

• If your eyesight becomes impaired or if your eyes seem to be otherwise
affected, consult an eye specialist immediately.

Patient Information Leaflet

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 antiinflammatory 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.

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) What Ofloxacin is and what it is used for
2) What you need to know before you take Ofloxacin
3) How to take Ofloxacin
4) Possible side effects
5) How to store Ofloxacin
6) 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-6phosphate-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.

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.

• 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

Use in children and adolescents:
Ofloxacin Tablets should not be given to children or growing adolescents.

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

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

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 or search for MHRA Yellow Card in the Google
Play or Apple App Store. By reporting side effects you can help provide
more information on the safety of this medicine.

5) How to store Ofloxacin tablets
• Keep out of the sight and reach of children.
• Do not use after the expiry date printed on the carton or blister label after
‘EXP’. The expiry date refers to the last day of that month.
• Keep the blisters in the outer carton in order to protect from light.
• Store in the original package.
• If the tablets become discoloured or show any other signs of deterioration,
you should seek the advice of your pharmacist who will tell you what to do.
• Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.

6) Contents of the pack and other information
What Ofloxacin tablets contain
The active substance is ofloxacin. Each tablet contains 400mg 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 look like and contents of the pack
Ofloxacin tablets are white, oval, film-coated tablets marked ‘FXN 400’ on
one side and scored on the other side.
They are available in blister packs containing 5 and 10 tablets.
PL 46420/0021

Ofloxacin 400mg Tablets

POM

Who makes and repackages your medicine?
Your medicine is manufactured by Teva Pharmaceutical Works Ltd, Pallai
Street 13, H-4042 Debrecen, Hungary. Procured from within the EU by the
Product Licence holder: Suerte Pharma Ltd, 4/5 Northolt Trading Estate,
Belvue Road, Northolt, Middlesex, UB5 5QS and repackaged by Primecrown
Ltd, Northolt, UB5 5QS.
Leaflet date: 15.02.2018

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