TAVANIC 500MG TABLETS

Active substance: LEVOFLOXACIN HEMIHYDRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
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TAVANIC 500mg TABLETS
(levofloxacin)
 You have something known as ‘glucose – 6 - phosphate
dehydrogenase deficiency’. You are more likely to have serious
problems with your blood when taking this medicine
 You have ever had mental health problems
 You have ever had 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
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section “Other medicines and Tavanic 500mg Tablets ”)
 You are diabetic
 You have ever had liver problems
 You have myasthenia gravis
If you are not sure if any of the above applies to you, talk to your doctor or
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pharmacist before taking Tavanic 500mg Tablets.

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. This
includes any possible side effects not listed in this leaflet. See section
4.
Please note that one more strength of this product (250mg) is available
and its information is covered in this leaflet.
What is in this leaflet:
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1. What Tavanic 500mg Tablets are and what they are used for
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2. What you need to know before you take Tavanic 500mg Tablets
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3. How to take Tavanic 500mg Tablets
4. Possible side effects
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5. How to store Tavanic 500mg Tablets
6. Contents of the pack and other information

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Other medicines and Tavanic 500mg Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or
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might take any other medicines. This is because Tavanic 500mg Tablets
can affect the way some other medicines work. Also some medicines can
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affect the way Tavanic 500mg Tablets work.

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1. WHAT TAVANIC 500MG TABLETS ARE AND WHAT THEY ARE
USED FOR
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The name of your medicine is Tavanic 500mg Tablets. Tavanic 500mg
Tablets contain a medicine called levofloxacin. This belongs to a group of
medicines called antibiotics.

In particular, tell your doctor if you are taking any of the following
medicines. This is because it can increase the chance of you getting
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side effects, when taken with Tavanic 500mg Tablets.

Levofloxacin is a ‘quinolone’ antibiotic. It works by killing the bacteria that
cause infections in your body.

 Corticosteroids, sometimes called steroids – used for inflammation.
You may be more likely to have inflammation and/or rupture of your
tendons.
 Warfarin -used to thin the blood. You may be more likely to have a
bleed. Your doctor may need to take regular blood tests to check how
well your blood can clot.
 Theophylline -used for breathing problems. You are more likely to have
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a fit (seizure) if taken with Tavanic 500 mg tablets
 Non-steroidal anti-inflammatory drugs (NSAIDS) -used for pain and
inflammation such as aspirin, ibuprofen, fenbufen, ketoprofen and
indomethacin. You are more likely to have a fit (seizure) if taken with
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Tavanic 500mg Tablets
 Ciclosporin -used after organ transplants. You may be more likely to
get the side effects of ciclosporin
 Medicines known to affect the way your heart beats. This includes
medicines used for abnormal heart rhythm (antiarrhythmics such as
quinidine, hydroquinidine, disopyramide, sotalol, dofetilide, ibutilide and
amiodarone), for depression (tricyclic antidepressants such as
amitriptyline and imipramine), for psychiatric disorders (antipsychotics),
and for bacterial infections (“macrolide” antibiotics such as
erythromycin, azithromycin and clarithromycin)
 Probenecid - used for gout. Your doctor may want to use a lower dose,
if you have kidney problems.
 Cimetidine - used for ulcers and heartburn. Your doctor may want to
use a lower dose, if you have kidney problems.
Tell your doctor if any of the above applies to you.

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Tavanic 500mg Tablets can be used to treat infections of the:
Sinuses
Lungs, in people with long-term breathing problems or pneumonia
Urinary tract, including your kidneys or bladder
Prostate gland, where you have a long lasting infection
Skin and underneath the skin, including muscles. This is sometimes
called ‘soft tissue’.
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In some special situations, Tavanic 500mg Tablets may be used to
lessen the chances of getting a pulmonary disease named anthrax or
worsening of the disease after you are exposed to the bacteria causing
anthrax.






2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TAVANIC
500MG TABLETS

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Do not take this medicine and tell your doctor if:
 You are allergic to levofloxacin, any other quinolone antibiotic such as
moxifloxacin, ciprofloxacin or 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
 You have ever had epilepsy
 You have ever had a problem with your tendons such as tendonitis that
was related to treatment with a ‘quinolone antibiotic'. A tendon is the
cord that joins your muscle to your skeleton
 You are a child or a growing teenager
 You are pregnant, might become pregnant or think you may be
pregnant
 You are breast-feeding
Do not take this medicine if any of the above applies to you. If you are not
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sure, talk to your doctor or pharmacist before taking Tavanic 500mg
Tablets.

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Do not take Tavanic 500mg Tablets at the same time as the
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following medicines. This is because it can affect the way Tavanic
500mg Tablets work:
 Iron tablets (for anaemia), zinc supplements, magnesium or aluminiumcontaining antacids (for acid or heartburn), didanosine, or sucralfate
(for stomach ulcers). See section 3 ‘If you are already taking iron
tablets, zinc supplements, antacids, didanosine or sucralfate’ below.
Urine tests for opiates
Urine tests may show ‘false-positive’ results for strong painkillers called
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‘opiates’ in people taking Tavanic 500mg Tablets. If your doctor has
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prescribed a urine test, tell your doctor you are taking Tavanic 500mg
Tablets.

Warnings and precautions
Talk to your doctor or pharmacist before taking your medicine if:
 You are 60 years of age or older
 You are using corticosteroids, sometimes called steroids (see section
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“Other medicines and Tavanic 500mg Tablets” )
 You have ever had a fit (seizure)
 You have had damage to your brain due to a stroke or other brain injury
 You have kidney problems

Tuberculosis tests
This medicine may cause “false-negative” results for some laboratory
tests that search for the bacteria that cause tuberculosis.
Continued overleaf

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Pregnancy and breast-feeding

sensitive to the sun and may burn, tingle or severely blister if you do not
take the following precautions:
 Make sure you use high factor sun cream
 Always wear a hat and clothes which cover your arms and legs
 Avoid sun beds

Do not take this medicine if:
 You are pregnant, might become pregnant or think you may be
pregnant.
 You are breast-feeding or planning to breast-feed

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If you take more Tavanic 500mg Tablets than you should
Driving and using machines
If you accidentally take more tablets than you should, tell a doctor or get
other medical advice straight away. Take the medicine pack with you.
This is so the doctor knows what you have taken. The following effects
may happen: convulsive fits (seizures), feeling confused, dizzy, less
conscious, having tremor and heart problems – leading to uneven heart
beats as well as feeling sick (nausea) or having stomach burning.

You may get side effects after taking this medicine, including feeling
dizzy, sleepy, a spinning feeling (vertigo) or changes to your eyesight.
Some of these side effects can affect you being able to concentrate and
your reaction speed. If this happens, do not drive or carry out any work
that requires a high level of attention.

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If you forget to take Tavanic 500mg Tablets

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3. HOW TO TAKE TAVANIC 500MG TABLETS

If you forgot to take a dose, take it as soon as you remember unless it is
nearly time for your next dose. Do not double-up the next dose to make
up for the missed dose.

Always take this medicine exactly as your doctor has told you. Check with
your doctor or pharmacist if you are not sure.

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If you stop taking Tavanic 500mg Tablets
Taking this medicine

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Do not stop taking Tavanic 500mg Tablets just because you feel better.
It is important that you complete the course of tablets that your doctor has
prescribed for you. If you stop taking the tablets too soon, the infection
may return, your condition may get worse or the bacteria may become
resistant to the medicine.

 Take this medicine by mouth
 Swallow the tablets whole with a drink of water
 The tablets may be taken during meals or at any time between meals
If you are already taking iron tablets, zinc supplements, antacids,
didanosine or sucralfate

If you have any further questions on the use of this medicine, ask your
doctor or pharmacist.

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 Do not take these medicines at the same time as Tavanic 500mg
Tablets. Take your dose of these medicines at least 2 hours before or
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after Tavanic 500mg Tablets.

4. POSSIBLE SIDE EFFECTS

How much to take

Like all medicines, this medicine can cause side effects, although not
everybody gets them. These effects are normally mild or moderate and
often disappear after a short time.

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 Your doctor will decide on how many Tavanic 500mg Tablets you
should take
 The dose will depend on the type of infection you have and where the
infection is in your body.
 The length of your treatment will depend on how serious your infection
is.
 If you feel the effect of your medicine is too weak or strong, do not
change the dose yourself, but ask your doctor.

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Stop taking Tavanic 500mg Tablets and see a doctor or go to a
hospital straight away if you notice the following side effect:
Very rare (may affect up to 1 in 10,000 people)
 You have an allergic reaction. The signs may include: a rash,
swallowing or breathing problems, swelling of your lips, face, throat, or
tongue

Adults and the elderly
Sinuses infection

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 Two tablets of Tavanic 250mg, once each day
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 Or, one tablet of Tavanic 500mg, once each day

Stop taking Tavanic 500mg Tablets and see a doctor straight away
if you notice any of the following serious side effects - you may need
urgent medical treatment:

Lung infections, in people with long-term breathing problems

Rare (may affect up to 1 in 1,000 people)

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 Two tablets of Tavanic 250mg, once each day
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 Or, one tablet of Tavanic 500mg, once each day

 Two tablets of Tavanic 250mg, once or twice each day
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 Or, one tablet of Tavanic 500mg, once or twice each day

 Watery diarrhoea which may have blood in it, possibly with stomach
cramps and a high temperature. These could be signs of a severe
bowel problem
 Pain and inflammation in your tendons or ligaments, which could lead
to rupture. The Achilles tendon is affected most often
 Fits (convulsions)

Infection of urinary tract, including your kidneys or bladder

Very rare (may affect up to 1 in 10,000 people)

Pneumonia
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 One or two tablets of Tavanic 250mg, once each day
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 Or, ½ or one tablet of Tavanic 500mg, once each day

 Burning, tingling, pain or numbness. These may be signs of something
called ‘neuropathy’

Prostate gland infection

Not known (frequency cannot be estimated from the available data):

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 Severe skin rashes which may include blistering or peeling of the skin
around your lips, eyes, mouth, nose and genitals
 Loss of appetite, skin and eyes becoming yellow in colour, darkcoloured urine, itching, or tender stomach (abdomen). These may be
signs of liver problems which may include a fatal failure of the liver
If your eyesight becomes impaired or if you have any other eye
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disturbances whilst taking Tavanic 500mg Tablets, consult an eye
specialist immediately.

 Two tablets of Tavanic 250mg, once each day
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 Or, one tablet of Tavanic 500mg, once each day
Infection of skin and underneath the skin, including muscles
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 Two tablets of Tavanic 250mg, once or twice each day
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 Or, one tablet of Tavanic 500mg, once or twice each day
Adults and the elderly with kidney problems
Your doctor may need to give you a lower dose.

Tell your doctor if any of the following side effects gets serious or
lasts longer than a few days:

Children and Teenagers
This medicine must not be given to children or teenagers.

Common (may affect up to 1 in 10 people)

Protect your skin from sunlight






Keep out of direct sunlight while taking this medicine and for 2 days after
you stop taking it. This is because your skin will become much more

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Sleeping problems
Headache, feeling dizzy
Feeling sick (nausea, vomiting) and diarrhoea
Increase in the level of some liver enzymes in your blood

Uncommon (may affect up to 1 in 100 people)

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.

 Changes in the number of other bacteria or fungi, infection by fungi
named Candida, which may need to be treated
 Changes in the number of white blood cells shown up in the results of
some blood tests (leukopenia, eosinophilia)
 Feeling stressed (anxiety), feeling confused, feeling nervous, feeling
sleepy, trembling, a spinning feeling (vertigo)
 Shortness of breath (dyspnoea)
 Changes in the way things taste, loss of appetite, stomach upset or
indigestion (dyspepsia), pain in your stomach area, feeling bloated
(flatulence) or constipation
 Itching and skin rash, severe itching or hives (urticaria), sweating too
much (hyperhidrosis)
 Joint pain or muscle pain
 Blood tests may show unusual results due to liver (bilirubin increased)
or kidney (creatinine increased) problems
 General weakness

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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5. HOW TO STORE TAVANIC 500MG TABLETS
 Keep out of the sight and reach of children.
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 No special precautions are required but it is best to keep Tavanic
500mg Tablets in the original strips and box in a dry place.
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 Do not use Tavanic 500mg Tablets after the expiry date (This is
printed on both the carton label and blister).
 If your tablets show signs of deterioration or discolouration, you should
seek the advice of your pharmacist who will tell you what to do.
 Medicines should not be disposed of via waterwaste or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.

Rare (may affect up to 1 in 1,000 people)
 Bruising and bleeding easily due to a lowering in the number of blood
platelets (thrombocytopenia)
 Low number of white blood cells (neutropenia)
 Exaggerated immune response (hypersensitivity)
 Lowering of your blood sugar levels (hypoglycaemia). This is important
for people that have diabetes.
 Seeing or hearing things that are not there (hallucinations, paranoia),
change in your opinion and thoughts (psychotic reactions) with a risk of
having suicidal thoughts or actions
 Feeling depressed, mental problems, feeling restless (agitation),
abnormal dreams or nightmares
 Tingly feeling in your hands and feet (paraesthesia)
 Problems with your hearing (tinnitus) or eyesight (blurred vision)
 Unusual fast beating of your heart (tachycardia) or low blood pressure
(hypotension)
 Muscle weakness. This is important in people with myasthenia gravis (a
rare disease of the nervous system).
 Changes in the way your kidney works and occasional kidney failure
which may be due to an allergic kidney reaction called interstitial
nephritis.
 Fever

6. CONTENTS OF THE PACK AND OTHER INFORMATION
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What Tavanic 500mg Tablets contain
Each tablet contains 500mg of the active ingredient levofloxacin (as the
hemihydrate).
Also contains crospovidone, hypromellose, microcrystalline cellulose,
sodium stearyl fumarate, titanium dioxide (E171), macrogol 8000, talc, red
ferric oxide E172 and yellow ferric oxide E172.
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What Tavanic 500mg Tablets look like and the contents of the pack
Each pink oval film-coated tablet has a breakline on both sides.
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Tavanic 500mg Tablets are available as blister packs of 10 tablets.
Who manufactured your medicine
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Tavanic 500mg Tablets are manufactured by Hoechst Marion Roussel,
Deutschland GmbH, D-65926 Frankfurt is Main, Germany and is procured
from within the EU and repackaged by the Product Licence Holder:
Beachcourse Limited, 20 Alliance Court, Alliance Road, London W3 0RB.

Not known (frequency cannot be estimated from the available data)
 Lowering in red blood cells (anemia): this can make the skin pale or
yellow due to damage of the red blood cells; lowering in the number of
all types of blood cells (pancytopenia)
 Fever, sore throat and a general feeling of being unwell that does not
go away. This may be due to a lowering in the number of white blood
cells (agranulocytosis).
 Loss of circulation (anaphylactic like shock)
 Increase of your blood sugar levels (hyperglycaemia) or lowering of
your blood sugar levels leading to coma (hypoglycaemic coma). This is
important for people that have diabetes.
 Changes in the way things smell, loss of smell or taste (parosmia,
anosmia, ageusia)
 Problems moving and walking (dyskinesia, extrapyramidal disorders)
 Temporary loss of consciousness or posture (syncope)
 Temporary loss of vision
 Impairment or loss of hearing
 Abnormal fast heart rhythm, life-threatening irregular heart rhythm
including cardiac arrest, alteration of the heart rhythm (called
‘prolongation of QT interval’, seen on ECG, electrical activity of the
heart)
 Difficulty breathing or wheezing (bronchospasm)
 Allergic lung reactions
 Pancreatitis
 Inflammation of the liver (hepatitis)
 Increased sensitivity of your skin to sun and ultraviolet light
(photosensitivity)
 Inflammation of the vessels that carry blood around your body due to
an allergic reaction (vasculitis)
 Inflammation of the tissue inside the mouth (stomatitis)
 Muscle rupture and muscle destruction (rhabdomyolysis)
 Joint redness and swelling (arthritis)
 Pain, including pain in the back, chest and extremities
 Attacks of porphyria in people who already have porphyria (a very rare
metabolic disease)
 Persistent headache with or without blurred vision (benign intracranial
hypertension)

PL:

16378/ 0253

POM

Revision date: 10. 10. 2013
Leaflet reference: TAV500U/T
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Tavanic is a registered trade mark of Sanofi-aventis

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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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