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LEVOFLOXACIN 500MG FILM COATED TABLETS

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Warnings and precautions
Talk to your doctor before taking Levofoxacin Tablets if you:
• have previously had epilepsy or have had brain damage in the past (such as a stroke) as
you may have an increased chance of having seizures (fits). Make sure you have told your
doctor all of your medical history.
• have a rare and inherited condition which affects the enzyme glucose-6-phosphate
dehydrogenase (G-6-PD), as you may be more likely to suffer from blood problems if you
are given levofloxacin.
• have kidney disease/damage, as the doctor may want to give you a lower dose of
levofloxacin.
• are taking drugs to stop your blood clotting (such as warfarin), as your doctor will want to
monitor how well your blood clots whilst you are also taking levofloxacin.
• have ever had mental health problems
• have ever had heart problems (see below section Heart problems)
• are diabetic
• have ever had liver problems
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
Levofloxacin Tablets).
Other warnings
• Levofloxacin may rarely cause pain and inflammation in tendons, particularly if you are
elderly or are taking steroid medicines (such as cortisone or hydrocortisone). If you have
any problems with your tendons whilst or shortly after taking levofloxacin, seek medical
advice at once and rest the affected limb (leg or arm). Do not take the next dose of
levofloxacin unless your doctor tells you to.
• If you start having severe, persistent and/or bloody diarrhoea during or after treatment
with levofloxacin, tell your doctor immediately. This could mean you have serious
inflammation of your bowel (pseudomembranous colitis), which can sometimes occur
after antibiotic treatment. You may need to stop taking levofloxacin and for your doctor
to give you another medicine.
• Whilst taking Levofloxacin Tablets you are advised to stay out of strong sunlight and not
to use a sun lamp. This is because some patients may become more sensitive to light
whilst taking the tablets and get a sun-burn like reaction.
Other medicines and Levofloxacin Tablets
You must tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription. Especially:
• sucralfate or medicines containing iron salts, magnesium or aluminium, as these can
interfere with the absorption of levofloxacin and should not be taken at the same time.
You should take sucralfate two hours after levofloxacin and medicines containing iron,
aluminium or magnesium either two hours before or two hours after levofloxacin.
• non-steroidal anti-inflammatory drugs (such as fenbufen, ibuprofen or naproxen which
are often used as painkillers or to treat joint problems)
• theophylline as the risks of having a seizure (fit) may be increased.
• probenecid and cimetidine can reduce the kidneys’ ability to get rid of levofloxacin from
the body.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Levofloxacin 250 mg film-coated Tablets
Levofloxacin 500 mg film-coated Tablets
Levofloxacin
Read all of this leaflet carefully before you start taking this medicine because it
contains inportant 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. This includes any possible
side effects not listed in this leaflet.
In this leaflet:
1 What Levofloxacin Tablets are and what they are used for
2 What you need to know before you take Levofloxacin Tablets
3 How to take Levofloxacin Tablets
4 Possible side effects
5 How to store Levofloxacin Tablets
6 Contents of the pack and other information

1. What Levofloxacin Tablets are and what they are used for
Levofloxacin is an antibiotic which is used to treat bacterial infections of the
• sinuses
• lungs
• kidneys and waterworks
• prostate gland
• skin and soft tissues (including fat and muscle).

2. Before you take Levofloxacin Tablets
Do not take Levofloxacin Tablets if you
• are allergic (hypersensitive) to levofloxacin or to any of the other ingredients in the
tablets (listed in section 6) or are allergic to similar antibiotic medicines such as
ciprofloxacin or ofloxacin
• have epilepsy
• have taken levofloxacin or a similar medicine before and had problems with your
tendons (e.g. tendonitis)
• are a child or a growing teenager
• are pregnant, trying to become pregnant or are breast-feeding.

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3. How to take Levofloxacin Tablets
Always take this medicine exactly as your doctor has told you. Check with your doctor or
pharmacist if you are not sure. Swallow the tablets with a glass of water. The tablets may be
taken with or without food.
Usual doses
Most people need 1 or 2 tablets per day.
Patients with kidney disease may need lower doses.
How long you take Levofloxacin Tablets will depend on what type of infection you have and
how bad it is.
If you take more Levofloxacin Tablets than you should
If you accidentally take one tablet too many, nothing is likely to happen. If you accidentally
take several tablets too many, tell your doctor or go to your nearest casualty at once. If
possible, take the tablets and box with you to show the doctor. If you take too many tablets,
you can develop confusion, dizziness, lose consciousness, seizures (fits) and heart disorders
(irregular heart beats).
If you forget to take Levofloxacin Tablets
If you forget to take a dose, take it as soon as you remember, unless it is nearly time for your
next dose. Do not take a double dose to make up for a forgotten dose.
If you stop taking Levofloxacin Tablets
It is important to take the full course of tablets. Do not stop before you have finished all the
tablets, even if you begin to feel better. If you stop taking the tablets too soon, the infection
may come back or get worse. If you feel you have to stop taking them because of a side
effect, talk to your doctor for advice before the next dose is due.

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• ciclosporin, as levofloxacin can make the effect of ciclosporin last longer.
• Vitamin K antagonists (such as warfarin) you may be more likely to bleed. Your doctor
may need to take regular blood tests to check how well your blood can clot.
• Medicines that can alter your heart rhythm: medicines that belong to the group of antiarrythmics (e.g. quinidine hydroquinidine, disopyramide, amiodarone sotalol, dofetilide,
ibutilide), tricyclic antidepressants (such as amitriptyline and imipramine), some
antimicrobials (that belong to the group of 'macrolide' antibiotics such as erythromycin,
azithromycin and clarithromycin), and some antipsychotics.
Levofloxacin Tablets with food and drink
Take without regard to meals. Take with water, drink with plenty of water.
Urine tests for opiates
Urine tests may show ‘false-positive’ results for strong painkillers called ‘opiates’ in people
taking Levofloxacin Tablets. If your doctor asks you to take a urine test, tell them you are
taking Levofloxacin Tablets.
Pregnancy and breast-feeding and fertility
You must not take Levofloxacin Tablets if you are pregnant, trying to become pregnant or
are breast-feeding.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a
baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Levofloxacin can cause dizziness, drowsiness, visual problems and confusion. If you are
affected, do not drive, operate machinery or carry out any potentially dangerous activity.

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4. Possible side effects

6. Contents of the pack and other iInformation

Very rare (affects less than 1 user in 10,000) and not known (frequency cannot be
estimated from the available data)
• sudden drop in blood pressure or collapse (shock)
• lowering of blood sugar (particularly in patients with diabetes)
• rupture of tendons
• muscle weakness
• severe decreases in white blood cells leading to symptoms such as fever, sore throat and
feeling more ill again
• fever
• hepatitis (inflammation of the liver)
• severe kidney disturbances (including kidney failure)
• Loss of circulation (anaphylactic like shock)
• increased skin sensitivity to light
• severe blistering or destructive reactions to the skin and mucous membranes (lining of
mouth or bowel)
• vision and hearing disorders
• changes in senses of taste and smell
• numbness
• hallucinations (seeing or hearing things that are not there)
• Suicidal thoughts or actions
• 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)
• destruction of muscle
• decrease in red blood cells (anaemia) or in the number of all types of blood cells
• allergic lung reactions
Some side effects have been reported occurring with similar antibiotics to levofloxacin.
These include:
• Lowering in red blood cells (anaemia). This can make the skin pale or yellow due to
damage of the red blood cells and lowering in the number of all types of blood cells
• Exaggerated immune response (hypersensitivity)
• Sweating too much (hyperhidrosis)
• Pain, including pain in the back, chest and extremities
• problems with co-ordination
• allergic inflammation of small blood vessels
• attacks of porphyria (in patients with porphyria)
If you get any side effects talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you get any of the following rare effects, contact your doctor at once.
• Sudden wheezing, difficulty in breathing or dizziness
• Swelling of the eyelids, face, lips, tongue or throat
• Peeling and blistering of the skin, mouth, eyes and genitals
• Rash affecting your whole body
• Bloody diarrhoea (this could be a sign of the more serious condition,
pseudomembranous colitis – see Section 2)
• Tendon pain and swelling (tendonitis).
• Burning, tingling, pain or numbness. These may be signs of something called
‘neuropathy’
• 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.
Tell your doctor if you notice any of the following side effects, they get worse or if you
notice any effects not listed
Common (affects 1 to 10 users in 100)
• feeling sick
• increase in blood levels of liver enzymes (this would be found by a blood test)
• diarrhoea
Uncommon (affects 1 to 10 users in 1,000)
• itching
• loss of appetite, being sick
• headache, dizziness
• growth of other bacteria and fungi which are not destroyed by levofloxacin
• skin rash
• stomach pains, indigestion
• drowsiness or difficulty sleeping
• general weakness
• increases or decreases in white blood cells
• blood test changes due to liver or kidney damage
Rare (affects 1 to 10 users in 10,000)
• seizures (fits)
• mental problems, such as hallucinations (seeing or hearing things that are not there)
and/or delusions (an unshakable belief in something untrue)
• fast heart beat
• decreases in white blood cells
• Wheezing, difficulty in breathing, or shortness of breath
• itchy skin rash
• tingling in the hands and feet
• trembling
• anxiety, depression
• agitation, confusion
• low blood pressure
• muscle pain, joint pain
• tendency to bruise and bleed easily due to a decrease in the number of blood platelets

What Levofloxacin Tablets contain
The active ingredient is levofloxacin. The tablets contain 256.23 mg or 512.46 mg of
levofloxacin hemihydrate which is equivalent to 250 mg or 500 mg levofloxacin.
The other ingredients are
Tablet core: povidone, crospovidone type B, microcrystalline cellulose, magnesium stearate,
colloidal anhydrous silica
Tablet coating: hypromellose, talc, titanium dioxide (E171), macrogol, red iron oxide (E172)
and yellow iron oxide (E172).
What Levofloxacin Tablets look like and the contents of the pack
Two strengths of Levofloxacin Tablets are available: 250 mg and 500 mg
The 250 mg tablets are pink, capsule shaped, biconvex, film coated tablet with break line on
both sides. Debossed ‘L’ and ‘F’ either side of the break line on one face.
The 500 mg tablets are pink, capsule shaped, biconvex, film coated tablet with break line on
both sides. Debossed ‘L’ and ‘V’ either side of the break line on one face.
The tablet can be divided into equal doses.
Levofloxacin Tablets are packed in blister strips and are available in pack sizes of 1, 5, 7 or 10
tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Jenson Pharmaceutical Services Ltd, Carradine House, 237 Regents Park Road, London, N3
3LF, United Kingdom.
This leaflet was last reviseded in 07/2012.

5. How to store Levofloxacin Tablets
Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the carton and blister strip
after EXP. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. These measures will help to protect the
environment.

Proof

01

Job No: F418C

Date: 25.08.10

Client: Creo Pharma
Tel: 01245 237 512

Software: CS3

Contact: Guy Clarke
Email: lukehart@creopharma.com

PLEASE CHECK THE LOGO PROOF/S CAREFULLY
BEFORE SIGN-OFF, PLEASE INDICATE YOUR
OPTION BELOW AND RETURN TO FRESH CREATIVE.
SHOULD YOU REQUIRE ANY FURTHER CHANGES
THEN PLEASE CONTACT FRESH IMMEDIATELY.

IT IS IMPORTANT THAT YOU CHECK DESIGN/S, IMAGE/S, LOGO/S,
FONT/S, SIZE, COLOUR REFS, ALL TEXT ETC CAREFULLY.
PLEASE NOTE THE COLOUR IS NOT COLOUR EXACT DUE TO
PRINTERS AND COLOURS MAY AND CAN CHANGE TO A
DEGREE AT THE PRINTERS. IF USING SPOT COLS PLEASE MAKE
SURE TO CHECK COLOUR REFS WITH PANTONE SWATCH BOOK.

File: Levofloxacin Pil

Barcode:

Printer: TBC

Contact:

Size: 210 x 420 mm 6 pg

Material: 0.5mm

Features:

Print Process:

Deliver:

Proof Output Device:

1
black

Signature
CUTTER

Date

creative design

Qty:

Fresh Creative Ltd
8 Redwood
Chorley
Lancs
PR7 3BW
01257 232 392

Expand Transcript

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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