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OFLOXACIN 200MG TABLETS

Active substance(s): OFLOXACIN

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Pharma code 570

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

• 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
Package leaflet: Information for the user
Read all of this leaflet carefully before you start taking this medicine because it • 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
contains important information for you.
risk of anemia with ciprofloxacin
• Keep this leaflet. You may need to read it again.

do not expose yourself to long periods in strong sunlight whilst taking these
• If you have any further questions, ask your doctor or pharmacist.
tablets. Use a sun protection cream if you cannot avoid strong sunlight
• This medicine has been prescribed for you only. Do not pass it on to others. It
• do not use a sun-lamp or solarium
may harm them, even if their symptoms are the same as yours.
• If you get any of the side effects talk to your doctor or pharmacist. This
• you may be more susceptible to infection with other organisms
includes any possible side effects not listed in this leaflet. See section 4.
• let your doctors know you are taking Ofloxacin if you are undergoing any
What is in this leaflet:
medical tests, as it may interfere with the results
1. What Ofloxacin is and what it is used for
• your doctor may want to monitor you with blood tests if you are taking
2. What you need to know before you take Ofloxacin
Ofloxacin for longer than 2 weeks
3. How to take Ofloxacin
• you may experience skin rection problems such as Stevens-Johnson syndrome
4. Possible side effects
a rare, serious disorder of your skin and mucous membrane or toxic necrolysis
5. How to store Ofloxacin
skin's outermost layer, to detach from the layers of skin below.
6. Contents of the pack and other information
Other medicines and Ofloxacin:
What Ofloxacin is and what it is used for
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines
Ofloxacin belongs to a group of antibacterial medicines known as fluoroquinolones.
• anticoagulants (tablets that stop your blood clotting, e.g. warfarin), as bleeding
Ofloxacin is used to treat infections of:
times may be longer
• the bladder or the kidneys
• antacids, sucralfate, didanosine, aluminium, iron, magnesium or zinc
• the lungs, including pneumonia
preparations (see section 3, How to take Ofloxacin)
• the skin and soft tissue
• medicines to control your blood sugar (e.g. glibenclamide), as concentrations
• the male and female genital organs when the infections involve the cervix
of these medicines in the blood may be increased and they may have a greater
(neck of the womb) in women and the genital organs in men. Ofloxacin can be
effect
used to treat both gonorrhoea and some other genital infections
• theophylline or non-steroidal anti-inflammatory drugs (NSAIDs), e.g. ibuprofen,
diclofenac or fenbufen, as some people have fits when these are taken with
What you need to know before you take Ofloxacin
Ofloxacin
Do not take Ofloxacin:
• drugs that may affect your kidney function (e.g. cimetidine, furosemide,
• if you are allergic to ofloxacin or any of the other ingredients of this medicine
probenecid or methotrexate), as they can sometimes increase blood levels of
• if you have previously had an allergic reaction to a quinolone antibiotic, if you
Ofloxacin.
have had a reaction to any type of antibiotic in the past, check with your doctor You must tell your doctor if you are taking other medicines that can alter your
before taking Ofloxacin.
heart rhythm: medicines that belong to the group of anti-arrhythmics (e.g.
• if you have a history of inflammation of the tendons (tendonitis) when you have quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide,
taken fluoroquinolone antibiotics in the past
procainamide), tricyclic antidepressants e.g. amitriptyline, clomipramine, some
• if you have epilepsy or have you ever had a seizure or fit
antimicrobials (that belong to the group of macrolides e.g. erythromycin or
• if you suffer from glucose-6-phosphate dehydrogenase deficiency (this is an
azithromycin), some antipsychotics (e.g. olanzapine, quetiapine).
inherited disorder that affects the red blood cells), If Ofloxacin is taken the red
Please tell your doctor or pharmacist if you are taking or have recently taken any
blood cells may break down causing anaemia and jaundice
other medicines, including medicines obtained without a prescription.
• if you are pregnant or breast-feeding
Ofloxacin with food, drink and alcohol
• if you are under the age of 18, or are over 18 years old but think you are still
Do not drink alcohol while taking Ofloxacin as it may make any side effects worse.
growing
• if you have a rare hereditary problem of galactose intolerance, Lapp lactase
Ofloxacin contains lactose:
deficiency or glucose-galactose malabsorption. Ofloxacin is not suitable for
Patients who are intolerant to lactose should note that Ofloxacin tablets contain a
people who have inherited disorders that give them problems when they take
small amount of lactose. If you have been told by your doctor that you have an
these sugars.
intolerance to some sugars, contact your doctor before taking this medicinal
• if you suffer from methicillin-resistant staphylococcus aureus (MRSA) infection product.
• if you suffer from vision disorder
Pregnancy, breast-feeding and fertility
Warnings and precautions
If you are pregnant, think you may be pregnant or are planning to have a baby, ask
your doctor or pharmacist for advice before taking this medicine
Heart problems
Caution should be taken when using this kind of medicine, if you were born with or Driving and using machines
have family history of prolonged QT interval (seen on ECG, electrical recording of Ofloxacin may make you feel sleepy, dizzy or could affect your eyesight, which
the heart), have salt imbalance in the blood (especially low level of potassium or
may impair your ability to concentrate. If affected do not drive or operate
magnesium in the blood), have a very slow heart rhythm (called ‘bradycardia’),
machinery.
have a weak heart (heart failure), have a history of heart attack (myocardial
How to take Ofloxacin
infarction), you are female or elderly or you are taking other medicines that result
in abnormal ECG changes (see section Taking other medicines).
Always take this medicine exactly as your doctor has told you. Check with your
Talk to your doctor before taking Ofloxacin:
doctor or pharmacist if you are not sure.
• if you suffer from or have a history of mental illness
Your doctor will decide how much Ofloxacin you need to take each day. A dose up
• if you have problems with your liver or kidneys. Make sure you tell your doctor to 400 mg can be taken as a single dose in the morning. A dose higher than 400 mg
about any liver or kidney problems before you start taking Ofloxacin because
should be divided into two separate doses, and can be taken as one dose in the
the dose may need to be lowered.
morning and one dose in the evening. Your doctor will tell you how long your
• if you have an illness of the nervous system called myasthenia gravis (a
treatment with Ofloxacin will last. Treatment should not exceed 2 months. Return
disorder in which the muscles are weak and tire easily)
to your doctor if you still feel unwell after finishing your course of tablets.
• if you are elderly or have been prescribed corticosteroids (used to treat asthma
The tablets should be swallowed preferably with a drink of water. Ofloxacin
and other chronic lung diseases) as this may cause swelling and pain of your
tablets may be taken before or with food.
tendons
The usual dose is:
• if you are diabetic
Adults (including the elderly):
• if you are taking fenbufen or other NSAIDS, vitamin K antagonists
Your dose will depend on the type and severity of infection you have. The dosage
• if you are taking theophylline.
range is 200 mg to 800 mg a day.
While you are taking Ofloxacin
• To treat simple bladder or kidney infections
• you may experience severe, sudden allergic reaction (an anaphylactic
The usual dose is 200 mg or 400 mg of Ofloxacin a day. Treatment usually
reaction/shock). Even with the first dose, there is a chance that you may
lasts for 3 days. To treat kidney infections, your doctor may increase the
experience a severe allergic reaction with the following symptoms: tightness in
dose to 400 mg twice a day and you may need to take Ofloxacin for 7-10
the chest, feeling dizzy, feeling sick or faint, or experience dizziness on
days.
standing. If this happens, stop taking Ofloxacin and contact your doctor
• To treat gonorrhoea of the genital organs
immediately
A single dose of 400 mg of Ofloxacin in the morning is usually enough.
• you may experience psychiatric reactions after first administration of
To treat other infections of the genital organs for which Ofloxacin is a
Ofloxacin. If you suffer from depression or psychosis, your symptoms may
suitable antibiotic, the dose is usually 400 mg a day, taken for 7-10 days.
become worse under treatment with Ofloxacin. If this happens, stop taking
• To treat lung infections
Ofloxacin and contact your doctor immediately
The usual dose is 400 mg of Ofloxacin a day. If necessary, your doctor may
• you may experience symptoms of liver problems such as loss of appetite,
increase this to 400 mg twice a day. Treatment may last from 7-10 days.
yellowing of the skin or whites of the eyes, dark urine, itching or tender of
• To treat skin and soft tissue infections
stomach, Ofloxacin should be stopped immediately
The usual dose is 400 mg of Ofloxacin twice a day. Treatment may last from
• diarrhoea may develop while you are on antibiotics, including Ofloxacin, or
7-10 days.
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 Use in children and adolescents:
Ofloxacin Tablets should not be given to children or growing adolescents.
immediately. Ofloxacin treatment will have to be stopped immediately, as this
can be life-threatening

Ofloxacin 200 mg and 400 mg Tablets

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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, increases in QT interval, the alleged
perception of an object when no object is present, involuntary shaking of the body
or limbs, 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.
If you have any further questions on the use of this medicine, ask your doctor or
pharmacist.

Not known (frequency cannot be estimated from the available data)
• severe reduction in the number of white blood cells which makes infections
more likely
• low blood sugar levels (especially in diabetics)
• 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)
• inflammation of the lungs which causes breathlessness, cough and raised
temperature (allergic pneumonitis)
• severe shortness of breath
• acute generalised exanthematous pustulosis (red swollen area with numerous
small pustules)
• pain or muscle weakness, abnormal muscle breakdown which can lead to
kidney problems
• muscle tear, muscle rupture
• inflammation of the kidney which can cause swollen ankles or high blood
pressure
• ofloxacin may trigger an attack of porphyria in susceptible patients.
• increase in blood sugar levels (especially in diabetics)
• nervousness
• involuntary shaking of the body or uncontrollable movement of the upper body
or lower extremities
• loss of taste functions of the tongue
• temporary loss of consciousness caused by a fall in blood pressure
• fever
• painful, difficult, or disturbed digestion, which may be accompanied by
Possible side effects
symptoms such as nausea and vomiting, heartburn, bloating, and stomach
discomfort, the accumulation of gas in the alimentary canal, painful defecation,
Like all medicines, this medicine can cause side effects, although not everybody
inflammation of the pancreas
gets them.
• inflammation of the mouth and lips
If the following happens, stop taking the tablets and tell your doctor immediately
• inflammation and stiffness of the joints
or go to the casualty department at your nearest hospital:
• loss or lack of bodily strength including pain in back,chest and extremities
• 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
• an allergic reaction sometimes even after taking your first dose, which may
platelets)
include swelling of the lips, face or neck leading to severe difficulty in
• inflammation of the eye (uveitis)
breathing, skin rash or hives, fast heart rate, low blood pressure, fever,
• skin redness with extensive scaling (exfoliative dermatitis)
burning of the eyes, throat irritation, coughing, wheezing, shock or blood
disorders
Reporting of side effects:
• skin disorder that comes from an allergic reaction or infection (drug
If you get any side effects, talk to your doctor or pharmacist . This includes any
eruption), visible accumulations of fluid within or beneath the skin
possible side effects not listed in this leaflet. You can also report side effects
(vesiculobullous rash), skin rashes caused by sunlight (photosensitivity
directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
reaction), inflammatory skin eruption (erythema multiforme)
By reporting side effects you can help provide more information on the safety of
• inflammation and ulceration of the mouth, eyes, gut and genitals; these may this medicine
be due to Stevens-Johnson Syndrome or toxic epidermal necrolysis, which
How to store Ofloxacin
are serious illnesses
• tendon discomfort, including inflammation and rupture, particularly if you are
Keep this medicine out of the sight and reach of children.
elderly or also taking corticosteroids e.g. prednisolone
Keep the container in the outer carton supplied to protect these tablets from light.
• fits, agitation, nightmares, anxiety, depression, hallucinations, feeling of
Do not transfer them to another container. Do not use Ofloxacin after the expiry
wanting to harm yourself and other disturbances of the mind, confusion,
date that is stated on the outer packaging. The expiry date refers to the last day of
ringing in the ears, unsteadiness, shaking, disturbance of sensation,
numbness, pins-and-needles, blurred, double or odd colour vision problems, that month.
problems with or loss of hearing, taste or smell
Do not throw away any medicine via wastewater or household waste. Ask your
• diarrhoea containing blood.
pharmacist how to dispose of medicines no longer required. These measures will
• inflammation of liver, which may be severe. Loss of appetite, skin and eyes
help to protect the environment.
becoming yellow in colour, dark-coloured urine, itching, or tender stomach
Contents of the pack and other information
(abdomen). These may be signs of liver problems which may include a fatal
failure of the liver
What Ofloxacin tablets contain:
The following side effects have been reported at the approximate frequencies
• The active ingredient is Ofloxacin.
shown:
• The other ingredients are lactose monohydrate, pregelatinised starch,
hypromellose, croscarmellose sodium, colloidal anhydrous silica, magnesium
Uncommon (may affect up to 1 in 100 people):
stearate, titanium dioxide (E171), macrogol 3000 and triacetin.
• fungal infection, resistance to pathogens
• headache, dizziness, sleep disturbances and restlessness
What Ofloxacin tablets look like and contents of the pack:
• eye irritation, vertigo, cough, inflammation of nose
• The 200 mg tablets are white, round, film-coated tablets, scored on both sides.
• feeling sick or being sick, diarrhoea, stomach pain
One side of the tablet is marked “FXN” on one side of the breakline and “200”
• rashes, itching
on the other side.
• The 400 mg tablets are white, oval, film-coated tablets marked ‘FXN 400’ on one
Rare (may affect up to 1 in 1000 people):
side and scored on the other side.
• loss of appetite
• The 200 mg and 400 mg tablets are available in pack sizes of 5, 10, 20 and 50
• sleepiness
tablets.
• faster heart rate (tachycardia)
Not all pack sizes may be marketed.
• low blood pressure
• difficult in breathing or wheezing, shortness of breath
Marketing Authorisation Holder and Manufacturer
• inflammation of bowel, which may cause bleeding
Marketing Authorisation Holder and company responsible for manufacture:
• impairment of liver function with abnormal liver blood test results
TEVA UK Limited, Eastbourne, BN22 9AG, England.
• hives (nettle rash)
This leaflet was last revised in June 2016
• menstrual disturbance (such as hot flushes), excessive sweating, pustular rash PL 00289/0353-0354
• increased creatinine levels in the blood.
Very rare (may affect up to 1 in 10,000 people):
• 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
• abnormal dreams or mental illness
• 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
• failure to circulate blood around the body
• flushing
• bruise like rash
• inflammation of blood vessels, often with skin rash
• muscle weakness, joint and muscle pain
• effects on kidney function, which may lead to kidney failure
85149-Y
• unbalanced walk

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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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