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OFLOXACIN 200MG TABLETS

Active substance: OFLOXACIN

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PAGE 1: FRONT FACE (INSIDE OF REEL)



PACKAGE LEAFLET: INFORMATION
FOR THE USER
Read all of this leaflet carefully before you start taking this medicine. •
• 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. Do not pass it on to
others. It may harm them, even if their symptoms are the same as •
yours.
• If any of the side effects get serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.


IN THIS LEAFLET:
Pharma code 570

1. What Ofloxacin is and what it is used for
2. Before you take Ofloxacin
3. How to take Ofloxacin
4. Possible side effects
5. How to store Ofloxacin
6. Further information

1

WHAT OFLOXACIN IS AND WHAT IT IS USED FOR

Ofloxacin belongs to a group of antibacterial medicines known as
fluoroquinolones.
Ofloxacin is used to treat infections of:
• the bladder or the kidneys
• the lungs, including pneumonia
• the skin and soft tissue
• the male and female genital organs when the infections involve
the cervix (neck of the womb) in women and the genital organs in
men. Ofloxacin can be used to treat both gonorrhoea and some
other genital infections.

2

BEFORE YOU TAKE OFLOXACIN

Do NOT take Ofloxacin if you:
• are allergic (hypersensitive) to ofloxacin or any of the other
ingredients of this medicine
• 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.
• have a history of inflammation of the tendons (tendonitis) when
you have taken fluoroquinolone antibiotics in the past
• have epilepsy or have you ever had a seizure or fit
• suffer from glucose-6-phosphate dehydrogenase deficiency (this
is an inherited disorder that affects the red blood cells), If
Ofloxacin is taken the red blood cells may break down causing
anaemia and jaundice
• are pregnant or breast-feeding
• are under the age of 18, or are over 18 years old but think you are
still growing
• have a rare hereditary problem of galactose intolerance, Lapp
lactase deficiency or glucose-galactose malabsorption. Ofloxacin
is not suitable for people who have inherited disorders that give
them problems when they take these sugars.
Take special care with Ofloxacin
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 Taking
other medicines).
Tell your doctor before you start to take this medicine if you:
• suffer from or have a history of mental illness
• 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.
• have an illness of the nervous system called myasthenia gravis (a
disorder in which the muscles are weak and tire easily)
• are elderly or have been prescribed corticosteroids (used to treat
asthma and other chronic lung diseases) as this may cause
swelling and pain of your tendons
• are diabetic
• are taking fenbufen or other NSAIDS, vitamin K antagonists
• are taking theophylline.






diarrhoea may develop while you are on antibiotics, including
Ofloxacin, or even several weeks after you have stopped using
them. If it becomes severe or persistent or you notice that your
stool contains blood or mucus tell your doctor immediately.
Ofloxacin treatment will have to be stopped immediately, as this
can be life-threatening
pain and swelling in the joints, and tendonitis may occur
occasionally, particularly if you are elderly and are also being
treated with corticosteroids. At the first sign of any pain or
inflammation Oflaxacin should be stopped
tell your doctor if you or a member of your family is known to
have a deficiency in glucose-6-phosphate dehydrogenase (G6PD),
since you may experience a risk of anemia with ciprofloxacin
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
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 than 2 weeks.

Taking other medicines
Talk to your doctor if you are taking any of the following:
• anticoagulants (tablets that stop your blood clotting, e.g. warfarin),
as bleeding times may be longer
• antacids, sucralfate, didanosine, aluminium, iron, magnesium or
zinc preparations (see section 3, How to take)
• medicines to control your blood sugar (e.g. glibenclamide), as
concentrations of these medicines in the blood may be increased
and they may have a greater effect
• theophylline or non-steroidal anti-inflammatory drugs (NSAIDs),
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 they 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-arrhythmic (e.g. quinidine, hydroquinidine, disopyramide,
amiodarone, sotalol, dofetilide, ibutilide, procainamide), tricyclic
antidepressants e.g. amitriptyline, clomipramine, some
antimicrobials (that belong to the group of macrolides e.g.
erythromycin or azithromycin), some antipsychotics.
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription.
Taking Ofloxacin with food and drink
Do not drink alcohol while taking Ofloxacin as it may make any side
effects worse.
Important information about some of the ingredients of Ofloxacin
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.
Pregnancy and breast-feeding
Do not take Ofloxacin if you are pregnant, think you may be
pregnant, or are breast-feeding.
Driving and using machines
Ofloxacin may make you feel sleepy, dizzy or could affect your
eyesight, which may impair your ability to concentrate. If affected do
not drive or operate machinery.

3

HOW TO TAKE OFLOXACIN

Always take Ofloxacin exactly as your doctor has told you. You
should 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 together once a day or
half the dose 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.
The tablets should be swallowed preferably with a drink of water.
Ofloxacin tablets may be taken before or with food.

The usual dose is:
Adults (including the elderly):
Your dose will depend on the type and severity of infection you have.
The dosage range is 200 mg to 800 mg a day.
• To treat simple bladder or kidney infections
The usual dose is 200 mg or 400 mg of Ofloxacin a day. Treatment
While you are taking Ofloxacin
usually lasts for 3 days. To treat kidney infections, your doctor
• you may experience severe, sudden allergic reaction (an
may increase the dose to 400 mg twice a day and you may need
anaphylactic reaction/shock). Even with the first dose, there is a
to take Ofloxacin for 7-10 days
chance that you may experience a severe allergic reaction with
• To treat gonorrhoea of the genital organs
the following symptoms: tightness in the chest, feeling dizzy,
A single dose of 400 mg of Ofloxacin in the morning is usually
feeling sick or faint, or experience dizziness on standing. If this
enough.
happens, stop taking Ofloxacin and contact your doctor immediately
To treat other infections of the genital organs for which Ofloxacin
• you may experience psychiatric reactions after first administration
is a suitable antibiotic, the dose is usually 400 mg a day, taken for
of Ofloxacin. If you suffer from depression or psychosis, your
7-10 days
symptoms may become worse under treatment with Ofloxacin. If
• To treat lung infections
this happens, stop taking Ofloxacin and contact your doctor
The usual dose is 400 mg of Ofloxacin a day. If necessary, your
immediately
doctor may increase this to 400 mg twice a day. Treatment may
• you may experience symptoms of liver problems such as loss of
last from 7-10 days
appetite, yellowing of the skin or whites of the eyes, dark urine,
• To treat skin and soft tissue infections
itching or tenderness of the stomach, Ofloxacin should be stopped
The usual dose is 400 mg of Ofloxacin twice a day. Treatment may
immediately
last from 7-10 days.

Top of page cut-off to middle of registration mark: 44 mm.

OFLOXACIN 200 mg and
400 mg TABLETS

PAGE 2: REAR FACE (OUTSIDE OF REEL)


Children and adolescents:
Ofloxacin Tablets should not be given to children or growing adolescents. •
Patients with kidney or liver problems:
Your doctor may tell you to take a lower dose of Ofloxacin than the
usual dose.
Taking Ofloxacin in combination with antacids, sucralfate,
didanosine, 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.
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. An
overdose is likely to cause dizziness, confusion, fits, loss of
consciousness, nausea and severe stomach problems. 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 dose.
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.


















abnormal dreams or mental illness
a disorder of the nerves which can cause weakness, tingling or
numbness
fits (convulsions)
impairment of voluntary movement i.e. tremors, tics. Changes in
muscle tone, slowness of movement
an allergic reaction in the eye or on the skin around the eye
ringing in the ears, problems hearing or loss of hearing
failure to circulate blood around the body
flushing
severe diarrhoea containing blood and/or mucus (antibiotic
associated diarrhoea)
jaundice (yellowing of the skin), severe liver damage
serious illness with blistering of the skin, rash on exposure to
strong sunlight, skin discolouration, peeling or detachment of
nails, blisters, blisters with bleeding, ulcers, flushing, widespread
red rashes, small lumps in the skin that can form ulcers and
scabs, bleeding into the skin and other organs (drug eruption)
bruise like rash
inflammation of blood vessels, often with skin rash
muscle weakness, joint and muscle pain
swelling or discomfort in your tendons such as in the achilles
tendon, which may occur within 48 hours of treatment
effects on kidney function, which may lead to kidney failure
unbalanced walk.

Other side effects
• severe reduction in the number of white blood cells which makes
If you have any further questions on the use of this product, ask your
infections more likely
doctor or pharmacist.
• an impairment in blood cell production which can result in
anaemia, reduced ability to fight infection and bruising or bleeding
POSSIBLE SIDE EFFECTS
• low blood sugar levels (especially in diabetics)
• severe depression or mental illness. Some people who are
Like all medicines, Ofloxacin can cause side effects, although not
depressed think of harming or killing themselves
everybody gets them.
• abnormal fast heart rhythm, life-threatening irregular heart
rhythm, alteration of the heart rhythm (called ‘prolongation of QT
If the following happens, stop taking the tablets and tell your doctor
interval’, seen on ECG, electrical activity of the heart)
immediately or go to the casualty department at your nearest hospital:
• inflammation of the lungs which causes breathlessness, cough
• an allergic reaction sometimes even after taking your first dose,
and raised temperature (allergic pneumonitis)
which may include swelling of the lips, face or neck leading to
• severe shortness of breath
severe difficulty in breathing, skin rash or hives, fast heart rate,
• inflammation of liver, which may be severe
low blood pressure, fever, burning of the eyes, throat irritation,
• serious illness with blistering of the skin, mouth, eyes and
coughing, wheezing, shock or blood disorders
genitals (Stevens-Johnson syndrome)
• inflammation and ulceration of the mouth, eyes, gut and genitals;
• acute generalised exanthematous pustulosis (red swollen area
these may be due to Stevens-Johnson Syndrome or toxic
with numerous small pustules)
epidermal necrolysis, which are serious illnesses
• tendon discomfort, including inflammation and rupture, particularly • pain or muscle weakness, abnormal muscle breakdown which can
lead to kidney problems
if you are elderly or also taking corticosteroids e.g. prednisolone
• muscle tear, muscle rupture
• fits, agitation, nightmares, anxiety, depression, hallucinations,
feeling of wanting to harm yourself and other disturbances of the • inflammation of the kidney which can cause swollen ankles or
high blood pressure
mind, confusion, ringing in the ears, unsteadiness, shaking,
• ofloxacin may trigger an attack of porphyria in susceptible patients.
disturbance of sensation, numbness, pins-and-needles, blurred,
double or odd colour vision problems, problems with or loss of
If any of the side effects get serious, or if you notice any side effects
hearing, taste or smell
not listed in this leaflet, please tell your doctor or pharmacist.
• diarrhoea containing blood.
These are very serious but very rare or rare side effects. You may
HOW TO STORE OFLOXACIN
need urgent medical attention or hospitalisation.
Keep out of the reach and sight of children. Keep the container in the
The following side effects have been reported at the approximate
outer carton supplied to protect these tablets from light. Do not
frequencies shown:
transfer them to another container. Do not use Ofloxacin after the
Common (affecting fewer than one person in 10 but more than one
expiry date that is stated on the outer packaging. The expiry date
person in 100):
refers to the last day of that month. Medicines should not be
• stomach upsets.
disposed of via wastewater or household waste. Ask your pharmacist
Uncommon (affecting fewer than one person in 100 but more than
how to dispose of medicines no longer required. These measures will
one person in 1000):
help to protect the environment.
• fungal infection, resistance to pathogens
• headache, dizziness, sleep disturbances and restlessness
FURTHER INFORMATION
• eye irritation, vertigo, cough, inflammation of nose
• feeling sick or being sick, diarrhoea, stomach pain
What Ofloxacin tablets contain:
• rashes, itching.
• The active ingredient is Ofloxacin.
• The other ingredients are lactose monohydrate, pregelatinised
Rare (affecting fewer than one person in 1000 but more than one
starch, hypromellose, croscarmellose sodium, colloidal anhydrous
person in 10,000):
silica, magnesium stearate, titanium dioxide (E171), macrogol
• serious allergic reaction which causes difficulty in breathing,
3000 and triacetin.
dizziness, swelling of the face or throat
• loss of appetite
What Ofloxacin tablets look like and contents of the pack:
• feeling confused or anxious, nightmares, seeing things that are
• The 200 mg tablets are white, round, film-coated tablets, scored
not there, depression
on both sides. One side of the tablet is marked “FXN” on one side
• sleepiness
of the breakline and “200” on the other side.
• numbness
• The 400 mg tablets are white, oval, film-coated tablets marked
• changes in or loss of your sense of taste or smell
‘FXN 400’ on one side and scored on the other side.
• drowsiness
• The 200 mg and 400 mg tablets are available in pack sizes of 5, 10,
• visual disturbances such as double vision or blurred vision
20 and 50 tablets.
• faster heart rate (tachycardia)
Not all pack sizes may be marketed.
• low blood pressure
Marketing Authorisation Holder and Manufacturer
• difficulty in breathing or wheezing, shortness of breath
Marketing Authorisation Holder and company responsible for
• inflammation of bowel, which may cause bleeding
manufacture: TEVA UK Limited, Eastbourne, BN22 9AG, England.
• impairment of liver function with abnormal liver blood test results
This leaflet was last revised: March 2011
• hives (nettle rash)
• menstrual disturbance (such as hot flushes), excessive sweating,
PL 00289/0353-0354
rash
• inflammation of tendons
• increased creatinine levels in the blood.

4

5

6

Very rare (affecting fewer than one person in 10,000):
• anaemia (reduction in red blood cells causing pale or yellow skin,
unusual tiredness or weakness)
• other blood disorders when the numbers of different types of cells
in the blood may fall. Symptoms can include fever, chills, sore
throat, ulcers in the mouth and throat, unusual bleeding or
unexplained bruising
• increase in blood sugar levels (especially in diabetics)

85149-V
200 x 323

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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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