TAVANIC 250MG FILM-COATED TABLETS

Active substance: LEVOFLOXACIN HEMIHYDRATE

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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)
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.

5. How to store Tavanic tablets
Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage
conditions but it is best to keep Tavanic tablets in the
original strips and box in a dry place.
Do not use this medicine after the expiry date which is
stated on the carton and foil after EXP. The expiry date
refers to the last day of the month.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures
will help protect the environment.

6. Contents of the pack and other information
What Tavanic tablets contain
The active substance is levofloxacin. Each tablet of
Tavanic 250 mg tablets contains 250 mg of
levofloxacin and each tablet of Tavanic 500 mg tablets
contains 500 mg of levofloxacin.
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3. How to take Tavanic tablets
Always take this medicine exactly as your doctor has
told you. Check with your doctor or pharmacist if
you are not sure.
Taking this 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
• Do not take these medicines at the same time as
Tavanic. Take your dose of these medicines at
least 2 hours before or after Tavanic tablets.
How much to take
• Your doctor will decide on how many Tavanic
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.
Adults and the elderly
Sinuses infection
• Two tablets of Tavanic 250 mg, once each day
• Or, one tablet of Tavanic 500 mg, once each day

Package leaflet:
Information for the user

Tavanic 250 mg tablets
Tavanic 500 mg tablets
levofloxacin

Is this leaflet hard to see
or read?
Phone 01483 505515 for help
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.
What is in this leaflet
1. What Tavanic tablets are and what they are used for
2. What you need to know before you take Tavanic tablets
3. How to take Tavanic tablets
4. Possible side effects
5. How to store Tavanic tablets
6. Contents of the pack and other information













Lung infections, in people with long-term
breathing problems
Two tablets of Tavanic 250 mg, once each day
Or, one tablet of Tavanic 500 mg, once each day
Pneumonia
Two tablets of Tavanic 250 mg, once or twice
each day
Or, one tablet of Tavanic 500 mg, once or twice
each day
Infection of urinary tract, including your
kidneys or bladder
One or two tablets of Tavanic 250 mg, once each day
Or, 1/2 or one tablet of Tavanic 500 mg, once each day
Prostate gland infection
Two tablets of Tavanic 250 mg, once each day
Or, one tablet of Tavanic 500 mg, once each day
Infection of skin and underneath the skin,
including muscles
Two tablets of Tavanic 250 mg, once or twice
each day
Or, one tablet of Tavanic 500 mg, once or twice
each day

Adults and the elderly with kidney problems
Your doctor may need to give you a lower dose.
Children and teenagers
This medicine must not be given to children or
teenagers.
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 sensitive to the sun
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1. What Tavanic tablets are and
what they are used for
The name of your medicine is Tavanic tablets. Tavanic
tablets contain a medicine called levofloxacin. This
belongs to a group of medicines called antibiotics.
Levofloxacin is a ‘quinolone’ antibiotic. It works by
killing the bacteria that cause infections in your body.
Tavanic 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’.
In some special situations, Tavanic 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 tablets
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)
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The other ingredients are:
• For the tablet core: crospovidone, hypromellose,
microcrystalline cellulose and sodium stearyl fumarate
• For the tablet coating: hypromellose, titanium
dioxide (E 171), talc, macrogol, yellow ferric oxide
(E 172) and red ferric oxide (E 172)
What Tavanic tablets look like and contents of the pack
Tavanic tablets are film-coated tablets for oral use.
The tablets are oblong and scored with a pale
yellowish-white to reddish-white colour.
For Tavanic 250 mg, the tablets are provided in pack
sizes of 1, 3, 5, 7, 10, 50 and 200 tablets.
For Tavanic 500 mg, the tablets are provided in pack
sizes of 1, 5, 7, 10, 50, 200 and 500 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sanofi-aventis, One Onslow Street, Guildford, Surrey,
GU1 4YS
Tel: 01483 505515
Fax: 01483 535432
Email: uk-medicalinformation@sanofi-aventis.com
Manufacturer
Sanofi Winthrop Industrie, 56, route de Choisy au Bac,
F-60205 Compiégne, France
This medicine is authorised in the Member States of the
EEA under the following names:
Tavanic
This leaflet does not contain all the information about
your medicine. If you have any questions or are not
sure about anything, ask your doctor or pharmacist.
This leaflet was last revised in 05/2013
© Sanofi-aventis, 1997 - 2013

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
If you take more Tavanic tablets than you should
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.
If you forget to take Tavanic 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.
If you stop taking Tavanic tablets
Do not stop taking Tavanic 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.
If you have any further questions on the
use of this medicine, ask your doctor or
pharmacist.

✕ 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 sure, talk to your doctor or
pharmacist before taking Tavanic.








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 “Other medicines and Tavanic”)
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
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 section “Other
medicines and Tavanic”).
▲ 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 pharmacist before taking Tavanic.

Other medicines and Tavanic
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines. This
is because Tavanic can affect the way some other
medicines work. Also some medicines can affect the
way Tavanic works.
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 side effects,
when taken with Tavanic:
• 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 a fit (seizure) if taken with
Tavanic
• 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 Tavanic
• 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.

Do not take Tavanic tablets at the same time as
the following medicines. This is because it can
affect the way Tavanic tablets work:
• Iron tablets (for anemia), zinc supplements,
magnesium or aluminum-containing 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 ‘opiates’ in people taking Tavanic.
If your doctor has prescribed a urine test, tell your
doctor you are taking Tavanic.
Tuberculosis tests
This medicine may cause “false negative” results for
some laboratory tests that search for the bacteria that
cause tuberculosis.
Pregnancy and breast-feeding
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
Driving and using machines
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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4. Possible side effects
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.
Stop taking Tavanic 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
Stop taking Tavanic and see a doctor straight away
if you notice any of the following serious side
effects - you may need urgent medical treatment:
Rare (may affect up to 1 in 1,000 people)
• 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)
Very rare (may affect up to 1 in 10,000 people)
• Burning, tingling, pain or numbness. These may be
signs of something called ‘neuropathy’
Not known (frequency cannot be estimated from the
available data)
• 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, dark-coloured 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 disturbances whilst taking Tavanic, consult
an eye specialist immediately.
Tell your doctor if any of the following side effects
gets serious or lasts longer than a few days:
Common (may affect up to 1 in 10 people)
• 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)
• 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
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• 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
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

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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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