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OFLOXACIN 200MG TABLETS

Active substance(s): OFLOXACIN

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PAGE 1: FRONT FACE (INSIDE OF REEL)



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Pharma code 570

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

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.
PACKAGE LEAFLET: INFORMATION
Ofloxacin treatment will have to be stopped immediately, as this
FOR THE USER
can be life-threatening
Read all of this leaflet carefully before you start taking this medicine • pain and swelling in the joints, and tendonitis may occur
because it contains important information for you.
occasionally, particularly if you are elderly and are also being
treated with corticosteroids. At the first sign of any pain or
• Keep this leaflet. You may need to read it again.
inflammation Oflaxacin should be stopped
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on • tell your doctor if you or a member of your family is known to
to others. It may harm them, even if their symptoms are the same
have a deficiency in glucose-6-phosphate dehydrogenase (G6PD),
as yours.
since you may experience a risk of anemia with ciprofloxacin
• If you get any of the side effects talk to your doctor or pharmacist. • do not expose yourself to long periods in strong sunlight whilst
This includes any possible side effects not listed in this leaflet.
taking these tablets. Use a sun protection cream if you cannot
See section 4.
avoid strong sunlight
• do not use a sun-lamp or solarium
IN THIS LEAFLET:
• you may be more susceptible to infection with other organisms
1. What Ofloxacin is and what it is used for
• let your doctors know you are taking Ofloxacin if you are
2. What you need to know before you take Ofloxacin
undergoing any medical tests, as it may interfere with the results
3. How to take Ofloxacin
• your doctor may want to monitor you with blood tests if you are
4. Possible side effects
taking Ofloxacin for longer than 2 weeks.
5. How to store Ofloxacin
• You may experience skin rection problems such as
6. Contents of the pack and other information
Stevens-Johnson syndrome a rare, serious disorder of your skin
and mucous membrane or toxic necrolysis skin's outermost layer,
WHAT OFLOXACIN IS AND WHAT IT IS USED FOR
to detach from the layers of skin below.
Taking other medicines
Ofloxacin belongs to a group of antibacterial medicines known as
fluoroquinolones.
Talk to your doctor or pharmacist if you are taking, have recently
taken or might take any of the following:Ofloxacin is used to treat infections of:
• anticoagulants (tablets that stop your blood clotting, e.g.
• the bladder or the kidneys
warfarin), as bleeding times may be longer
• the lungs, including pneumonia
• antacids, sucralfate, didanosine, aluminium, iron, magnesium or
• the skin and soft tissue
zinc preparations (see section 3, How to take)
• the male and female genital organs when the infections involve
the cervix (neck of the womb) in women and the genital organs in • medicines to control your blood sugar (e.g. glibenclamide), as
concentrations of these medicines in the blood may be increased
men. Ofloxacin can be used to treat both gonorrhoea and some
and they may have a greater effect
other genital infections
• theophylline or non-steroidal anti-inflammatory drugs (NSAIDs),
e.g. ibuprofen, diclofenac or fenbufen, as some people have fits
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
when these are taken with Ofloxacin
OFLOXACIN
• drugs that may affect your kidney function (e.g. cimetidine,
furosemide, probenecid or methotrexate), as they can sometimes
Do NOT take Ofloxacin if you:
increase blood levels of Ofloxacin.
• are allergic to ofloxacin or any of the other ingredients of this
medicine
You must tell your doctor if you are taking other medicines that can
• have previously had an allergic reaction to a quinolone antibiotic, alter your heart rhythm: medicines that belong to the group of
if you have had a reaction to any type of antibiotic in the past,
anti-arrhythmic (e.g. quinidine, hydroquinidine, disopyramide,
check with your doctor before taking Ofloxacin.
amiodarone, sotalol, dofetilide, ibutilide, procainamide), tricyclic
• have a history of inflammation of the tendons (tendonitis) when
antidepressants e.g. amitriptyline, clomipramine, some
you have taken fluoroquinolone antibiotics in the past
antimicrobials (that belong to the group of macrolides e.g.
• have epilepsy or have you ever had a seizure or fit
erythromycin or azithromycin), some antipsychotics.
• suffer from glucose-6-phosphate dehydrogenase deficiency (this
Please tell your doctor or pharmacist if you are taking or have
is an inherited disorder that affects the red blood cells), If
recently taken any other medicines, including medicines obtained
Ofloxacin is taken the red blood cells may break down causing
without a prescription.
anaemia and jaundice
Taking Ofloxacin with food and drink
• are pregnant or breast-feeding
Do not drink alcohol while taking Ofloxacin as it may make any side
• are under the age of 18, or are over 18 years old but think you are effects worse.
still growing
Important information about some of the ingredients of Ofloxacin
• have a rare hereditary problem of galactose intolerance, Lapp
Patients who are intolerant to lactose should note that Ofloxacin
lactase deficiency or glucose-galactose malabsorption. Ofloxacin
tablets contain a small amount of lactose. If you have been told by
is not suitable for people who have inherited disorders that give
your doctor that you have an intolerance to some sugars, contact
them problems when they take these sugars.
your doctor before taking this medicinal product.
• suffer from methicillin-resistant staphylococcus aureus (MRSA)
Pregnancy, breast-feeding and fertility
infection
If you are pregnant, think you may be pregnant or are planning to
• suffer from vision disorder
have a baby, ask your doctor or pharmacist for advice before taking
Warnings and precautions
this medicine
Heart problems
Driving and using machines
Caution should be taken when using this kind of medicine, if you
were born with or have family history of prolonged QT interval (seen Ofloxacin may make you feel sleepy, dizzy or could affect your
eyesight, which may impair your ability to concentrate. If affected do
on ECG, electrical recording of the heart), have salt imbalance in the
blood (especially low level of potassium or magnesium in the blood), not drive or operate machinery.
have a very slow heart rhythm (called ‘bradycardia’), have a weak
HOW TO TAKE OFLOXACIN
heart (heart failure), have a history of heart attack (myocardial
infarction), you are female or elderly or you are taking other
Always take Ofloxacin exactly as your doctor has told you. You
medicines that result in abnormal ECG changes (see section Taking
should check with your doctor or pharmacist if you are not sure.
other medicines).
Your doctor will decide how much Ofloxacin you need to take each
Talk to your doctor before taking Ofloxacin if you:
day and whether you can take the dose all together once a day or
• suffer from or have a history of mental illness
half the dose in the morning and half in the evening. Your doctor will
• have problems with your liver or kidneys. Make sure you tell your tell you how long your treatment with Ofloxacin will last. Treatment
doctor about any liver or kidney problems before you start taking should not exceed 2 months. Return to your doctor if you still feel
Ofloxacin because the dose may need to be lowered.
unwell after finishing your course of tablets.
• have an illness of the nervous system called myasthenia gravis (a The tablets should be swallowed preferably with a drink of water.
disorder in which the muscles are weak and tire easily)
Ofloxacin tablets may be taken before or with food.
• are elderly or have been prescribed corticosteroids (used to treat
The usual dose is:
asthma and other chronic lung diseases) as this may cause
Adults (including the elderly):
swelling and pain of your tendons
Your dose will depend on the type and severity of infection you have.
• are diabetic
The dosage range is 200 mg to 800 mg a day.
• are taking fenbufen or other NSAIDS, vitamin K antagonists
• To treat simple bladder or kidney infections
• are taking theophylline.
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
• severe, sudden allergic reaction (an anaphylactic reaction/shock).
may increase the dose to 400 mg twice a day and you may need
Even with the first dose, there is a chance that you may
to take Ofloxacin for 7-10 days.
experience a severe allergic reaction with the following
• To treat gonorrhoea of the genital organs
symptoms: tightness in the chest, feeling dizzy, feeling sick or
A single dose of 400 mg of Ofloxacin in the morning is usually
faint, or experience dizziness on standing. If this happens, stop
enough.
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 tender of stomach, Ofloxacin should be stopped
The usual dose is 400 mg of Ofloxacin twice a day. Treatment may
immediately
last from 7-10 days.

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, 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 product, ask your
doctor or pharmacist.

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POSSIBLE SIDE EFFECTS

Like all medicines, Ofloxacin can cause side effects, although not
everybody gets them.
If the following happens, stop taking the tablets and tell your doctor
immediately or go to the casualty department at your nearest
hospital:
• 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
• 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
• tendon discomfort, including inflammation and rupture,
particularly if you are elderly or also taking corticosteroids e.g.
prednisolone
• fits, agitation, nightmares, anxiety, depression, hallucinations,
feeling of wanting to harm yourself and other disturbances of the
mind, confusion, ringing in the ears, unsteadiness, shaking,
disturbance of sensation, numbness, pins-and-needles, blurred,
double or odd colour vision problems, problems with or loss of
hearing, taste or smell
• diarrhoea containing blood.
These are very serious but very rare or rare side effects. You may
need urgent medical attention or hospitalisation.
The following side effects have been reported at the approximate
frequencies shown:
Common (affecting fewer than one person in 10 but more than one
person in 100):
• stomach upsets.
Uncommon (affecting fewer than one person in 100 but more than
one person in 1000):
• fungal infection, resistance to pathogens
• headache, dizziness, sleep disturbances and restlessness
• eye irritation, vertigo, cough, inflammation of nose
• feeling sick or being sick, diarrhoea, stomach pain
• rashes, itching
Rare (affecting fewer than one person in 1000 but more than one
person in 10 000):
• serious allergic reaction which causes difficulty in breathing,
dizziness, swelling of the face or throat
• loss of appetite
• feeling confused or anxious, nightmares, seeing things that are
not there, depression.
• sleepiness
• numbness
• changes in or loss of your sense of taste or smell
• drowsiness
• visual disturbances such as double vision or blurred vision
• faster heart rate (tachycardia)
• low blood pressure
• difficult in breathing or wheezing, shortness of breath
• inflammation of bowel, which may cause bleeding
• impairment of liver function with abnormal liver blood test results
• hives (nettle rash)
• menstrual disturbance (such as hot flushes), excessive sweating, rash
• inflammation of tendons
• increased creatinine levels in the blood.
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
• 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
infections more likely
• an impairment in blood cell production which can result in
anaemia reduced ability to fight infection and bruising or bleeding
• low blood sugar levels (especially in diabetics)
• severe depression or mental illness. Some people who are
depressed think of harming or killing themselves
• 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
• inflammation of liver, which may be severe
• serious illness with blistering of the skin, mouth, eyes and
genitals (Stevens- Johnson syndrome)
• 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.
• Loss of hearing
• painful, difficult, or disturbed digestion, which may be
accompanied by symptoms such as nausea and vomiting,
heartburn, bloating, and stomach discomfort, the accumulation of
gas in the alimentary canal, painful defecation, inflammation of
the pancreas
• inflammation of the mouth and lips
• inflammation and stiffness of the joints
• Loss or lack of bodily strength including pain in back,chest and
extremities
Reporting of side effects:
If you get any side effects, talk to your doctor or pharmacist . 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

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HOW TO STORE OFLOXACIN

Keep out of the sight and reach of children.
Keep the container in the outer carton supplied to protect these
tablets from light.
Do not transfer them to another container. Do not use Ofloxacin after
the expiry date that is stated on the outer packaging. The expiry date
refers to the last day of that month.
Do not throw away any medicine via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.

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CONTENTS OF THE PACK AND OTHER INFORMATION

What Ofloxacin tablets contain:
• 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 look like and contents of the pack:
• The 200 mg tablets are white, round, film-coated tablets, scored
on both sides. One side of the tablet is 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
Marketing Authorisation Holder and company responsible for
manufacture: TEVA UK Limited, Eastbourne, BN22 9AG, England.
This leaflet was last revised: June 2015
PL 00289/0353-0354
85149-X
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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