TAVANIC 500MG TABLETS

Active substance: LEVOFLOXACIN HEMIHYDRATE

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Variation 5 - To add a new manufacturer.
This version replaces PIL dated 1.3.2011
assessed against UK PIl dated
P10657
September 2008.
PACKAGE LEAFLET: INFORMATION FOR THE USER
A Chohan. 21 July 2011
Tavanic® 500mg Tablets
(levofloxacin hemihydrate)
The name of your medicine is Tavanic 500mg Tablets but will be referred
to as Tavanic throughout this leaflet.

Read all of this leaflet carefully before you start
taking this medicine.

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or your
pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their symptoms are the same
as yours.
If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.

In this leaflet:
1.
2.
3.
4.
5.
6.

What Tavanic is and what it is used for
Before you take Tavanic
How to take Tavanic
Possible side effects
How to store Tavanic
Further information

1. What Tavanic is and what it is used for
The name of your medicine is Tavanic. Tavanic contains 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 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’

2. Before you take Tavanic
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 Tavanic (listed in Section 6 below)
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 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 apply to you. If you are not
sure, talk to your doctor or pharmacist before taking Tavanic.

Take special care with Tavanic
Check with your doctor or pharmacist before taking
your medicine if:

You are 65 years of age or older
You are using corticosteroids, sometimes called steroids (see
“Taking other medicines” below)
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
You are diabetic
You have ever had liver problems
If you are not sure if any of the above applies to you, talk to your doctor
or pharmacist before taking Tavanic.

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 Taking other medicines).

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines. This includes medicines you buy without a
prescription, including herbal medicines. This is because Tavanic can
affect the way some other medicines work. Also some medicines can
affect the way Tavanic work.

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 breakage 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 that can alter your heart rhythm: medicines that belong
to the group of anti-arrhythmics (e.g. quinidine, hydroquinidine,
disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic
antidepressants, some antimicrobials (that belong to the group of
macrolides), some antipsychotics.
Probenecid – used for gout, and cimetidine – used for ulcers and
heartburn. Special care should be taken when taking either of
these medicines with Tavanic. If you have kidney problems, your
doctor may want to give you a lower dose.

Do not take Tavanic at the same time as the following
medicines. This is because it can affect the way Tavanic
work:

Iron tablets (for anaemia), magnesium or aluminium-containing
antacids (for acid or heartburn) or sulcralfate (for stomach ulcers).
See Section 3 “If you are already taking iron tablets, antacids or
sulcralfate” below.

Urine tests for opiates

Urine tests may show ‘false-positive’ results for strong painkillers called
‘opiates’ in people taking Tavanic. If your doctor is due to take a urine
test, tell them you are taking Tavanic.

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
Ask your doctor or pharmacist for advice before taking any medicine if
you are pregnant or breast-feeding.

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.

3. How to take Tavanic
Always take Tavanic exactly as your doctor has told you. You should
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

Protect your skin from sunlight

Keep out of direct sunlight while taking this medicine. This is because
your skin will become much more 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

If you are already taking iron tablets, antacids or
sulcralfate

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

Page 1 of 2

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

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

Lungs, in people with long-term breathing
problems

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

Pneumonia

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

Urinary tract, including your kidneys or bladder

One tablet of Tavanic 250mg, each day
Or, ½ tablet of Tavanic 500mg, each day

Prostate gland

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

Skin and underneath the skin, including muscles

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

Adults 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.

If you take more Tavanic 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 and heart problems – leading to uneven heart beats as well as
feeling sick (nausea).

If you forget to take Tavanic

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

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.

4. Possible side effects
Like all medicines, Tavanic 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 effects:
Very rare (affects less than 1 person in 10,000)

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 (affects less than 1 person in 1000)

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. The Achilles tendon is
affected most often and in some cases, the tendon could break
Fits (convulsions)

Very rare (affects less than 1 person in 10,000)

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

Other:

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

Tell your doctor if any of the following side effects gets
serious or lasts longer than a few days:
Common (affects less than 1 person in 10)

Feeling sick (nausea) and diarrhoea
Increase in the level of some liver enzymes in your blood

Uncommon (affects less than 1 person in 100)

Itching and skin rash
Loss of appetite, stomach upset or indigestion (dyspepsia), being
sick (vomiting) or pain in your stomach area, feeling bloated
(flatulence) or constipation
Headache, feeling dizzy, a spinning feeling (vertigo), feeling sleepy,
sleeping problems or feeling nervous
Blood tests may show unusual results due to liver or kidney
problems
Changes in the number of white blood cells shown up in the results
of some blood tests
General weakness
Changes in the number of other bacteria or fungi may increase,
which may need to be treated

Rare (affects less than 1 person in 1,000)

Tingling feeling in your hands and feet (paraesthesia) or trembling
Feeling stressed (anxiety), depressed, mental problems, feeling
restless (agitation) or feeling confused
Unusual fast beating of your heart or low blood pressure
Joint pain or muscle pain
Bruising and bleeding easily due to a lowering in the number of
blood platelets
Low number of white blood cells (called neutropenia)
Difficulty breathing or wheezing (bronchospasm)
Shortness of breath (dyspnoea)
Severe itching or hives (called urticaria)

Very rare (affects less than 1 person in 10,000)

Increased sensitivity of your skin to sun and ultraviolet light
Lowering of your blood sugar levels (hypoglycaemia). This is
important for people that have diabetes
Problems with your hearing or eyesight or changes in the way
things taste and smell
Seeing or hearing things that are not there (hallucinations), change
in your opinion and thoughts (psychotic reactions) with a chance of
having suicidal thoughts or actions
Loss of circulation (anaphylactic like shock)
Muscle weakness. This is important in people with myasthenia
gravis (a rare disease of the nervous system)
Inflammation of the liver, changes in the way your kidney works
and occasional kidney failure which may be due to an allergic
kidney reaction called interstitial nephritis
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
Fever and allergic lung reactions

5. How to store Tavanic
No special precautions are required but it is best to keep Tavanic tablets
in the original strips and box in a dry place.
Keep out of the reach and sight of children.
Do not use the tablets after the expiry date shown on the carton and
blister label.
If your doctor tells you to stop taking the tablets, please take them back
to the pharmacist for safe disposal. Only keep the tablets if your doctor
tells you to.
If the tablets become discoloured or show signs of deterioration, you
should seek the advice of your pharmacist.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.

6. Further information
What Tavanic contains

Each film coated tablet contains 500mg of the active ingredient
levofloxacin (as the hemihydrate).
They also contain the following excipients: crospovidone, hypromellose,
microcrystalline cellulose, sodium stearyl fumarate, titanium dioxide
(E171), talc, macrogol 8000, yellow ferric oxide (E 172) and red ferric
oxide (E 172).

What Tavanic looks like and contents of the pack

Your tablets are pale pink, oblong shaped film-coated tablets with a
scoreline on each side. They are available in blister packs of 5 and 10
tablets.

Manufacturer

Manufactured by: Aventis Pharma Deutschland GmbH,
Frankfurt am Main, Germany.
Procured from within the EU and repackaged by: Doncaster
Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: BR Lewis Pharmaceuticals Ltd., Kirk Sandall,
Doncaster, DN3 1QR.
POM

PL No: 08929/0452

Leaflet revision & issue date (ref): 01.03.11
Tavanic® is a registered trademark of Daiichi Sankyo Company,
Limited.
P10657

Other side effects 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 moving and walking
Attacks of porphyria in people who already have porphyria (a very
rare metabolic disease)
Inflammation of your tubes that carry blood around your body
(vessels) due to an allergic reaction

Not known:

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)

If any of the side effects get serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.

Page 2 of 2

P10658

PACKAGE LEAFLET: INFORMATION FOR THE USER

Levofloxacin 500mg Tablets
(levofloxacin hemihydrate)
The name of your medicine is Levofloxacin 500mg Tablets but will be
referred to as Levofloxacin throughout this leaflet.

Read all of this leaflet carefully before you start
taking this medicine.

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or your
pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their symptoms are the same
as yours.
If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.

In this leaflet:
1.
2.
3.
4.
5.
6.

What Levofloxacin is and what it is used for
Before you take Levofloxacin
How to take Levofloxacin
Possible side effects
How to store Levofloxacin
Further information

1. What Levofloxacin is and what it is used for
The name of your medicine is Levofloxacin. Levofloxacin contains 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.

Levofloxacin 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’

2. Before you take Levofloxacin
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 Levofloxacin (listed in Section 6 below)
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 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 apply to you. If you are not
sure, talk to your doctor or pharmacist before taking Levofloxacin.

Take special care with Levofloxacin
Check with your doctor or pharmacist before taking
your medicine if:

You are 65 years of age or older
You are using corticosteroids, sometimes called steroids (see
“Taking other medicines” below)
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
You are diabetic
You have ever had liver problems
If you are not sure if any of the above applies to you, talk to your doctor
or pharmacist before taking Levofloxacin.

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 Taking other medicines).

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines. This includes medicines you buy without a
prescription, including herbal medicines. This is because Levofloxacin can
affect the way some other medicines work. Also some medicines can
affect the way Levofloxacin work.

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
Levofloxacin:
Corticosteroids, sometimes called steroids – used for inflammation.
You may be more likely to have inflammation and/or breakage 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 Levofloxacin.
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 Levofloxacin.
Ciclosporin – used after organ transplants. You may be more likely
to get the side effects of ciclosporin.
Medicines that can alter your heart rhythm: medicines that belong
to the group of anti-arrhythmics (e.g. quinidine, hydroquinidine,
disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic
antidepressants, some antimicrobials (that belong to the group of
macrolides), some antipsychotics.
Probenecid – used for gout, and cimetidine – used for ulcers and
heartburn. Special care should be taken when taking either of
these medicines with Levofloxacin. If you have kidney problems,
your doctor may want to give you a lower dose.

Do not take Levofloxacin at the same time as the
following medicines. This is because it can affect the
way Levofloxacin work:

Iron tablets (for anaemia), magnesium or aluminium-containing
antacids (for acid or heartburn) or sulcralfate (for stomach ulcers).
See Section 3 “If you are already taking iron tablets, antacids or
sulcralfate” below.

Urine tests for opiates

Urine tests may show ‘false-positive’ results for strong painkillers called
‘opiates’ in people taking Levofloxacin. If your doctor is due to take a
urine test, tell them you are taking Levofloxacin.

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
Ask your doctor or pharmacist for advice before taking any medicine if
you are pregnant or breast-feeding.

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.

3. How to take Levofloxacin
Always take Levofloxacin exactly as your doctor has told you. You should
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

Protect your skin from sunlight

Keep out of direct sunlight while taking this medicine. This is because
your skin will become much more 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

If you are already taking iron tablets, antacids or
sulcralfate

Do not take these medicines at the same time as Levofloxacin.
Take your dose at least 2 hours before or after Levofloxacin

How much to take

Your doctor will decide on how many Levofloxacin 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

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

Lungs, in people with long-term breathing
problems

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

Pneumonia

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

Urinary tract, including your kidneys or bladder

One tablet of Levofloxacin 250mg, each day
Or, ½ tablet of Levofloxacin 500mg, each day

Prostate gland

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

Skin and underneath the skin, including muscles

One or two tablets of Levofloxacin 250mg, once or twice each day
Or, ½ tablet or one tablet of Levofloxacin 500mg, once or twice
each day

Adults 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.

If you take more Levofloxacin 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 and heart problems – leading to uneven heart beats as well as
feeling sick (nausea).

If you forget to take Levofloxacin

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 Levofloxacin

Do not stop taking Levofloxacin 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.

4. Possible side effects
Like all medicines, Levofloxacin 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 Levofloxacin and see a doctor or go to a
hospital straight away if you notice the following side
effects:
Very rare (affects less than 1 person in 10,000)

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 Levofloxacin and see a doctor straight away
if you notice any of the following serious side effects –
you may need urgent medical treatment:
Rare (affects less than 1 person in 1000)

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. The Achilles tendon is
affected most often and in some cases, the tendon could break
Fits (convulsions)

Page 1 of 2

Very rare (affects less than 1 person in 10,000)

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

Other:

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

Tell your doctor if any of the following side effects gets
serious or lasts longer than a few days:
Common (affects less than 1 person in 10)

Feeling sick (nausea) and diarrhoea
Increase in the level of some liver enzymes in your blood

Uncommon (affects less than 1 person in 100)

Itching and skin rash
Loss of appetite, stomach upset or indigestion (dyspepsia), being
sick (vomiting) or pain in your stomach area, feeling bloated
(flatulence) or constipation
Headache, feeling dizzy, a spinning feeling (vertigo), feeling sleepy,
sleeping problems or feeling nervous
Blood tests may show unusual results due to liver or kidney
problems
Changes in the number of white blood cells shown up in the results
of some blood tests
General weakness
Changes in the number of other bacteria or fungi may increase,
which may need to be treated

Rare (affects less than 1 person in 1,000)

Tingling feeling in your hands and feet (paraesthesia) or trembling
Feeling stressed (anxiety), depressed, mental problems, feeling
restless (agitation) or feeling confused
Unusual fast beating of your heart or low blood pressure
Joint pain or muscle pain
Bruising and bleeding easily due to a lowering in the number of
blood platelets
Low number of white blood cells (called neutropenia)
Difficulty breathing or wheezing (bronchospasm)
Shortness of breath (dyspnoea)
Severe itching or hives (called urticaria)

5. How to store Levofloxacin
No special precautions are required but it is best to keep Levofloxacin
tablets in the original strips and box in a dry place.
Keep out of the reach and sight of children.
Do not use the tablets after the expiry date shown on the carton and
blister label.
If your doctor tells you to stop taking the tablets, please take them back
to the pharmacist for safe disposal. Only keep the tablets if your doctor
tells you to.
If the tablets become discoloured or show signs of deterioration, you
should seek the advice of your pharmacist.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.

6. Further information
What Levofloxacin contains

Each film coated tablet contains 500mg of the active ingredient
levofloxacin (as the hemihydrate).
They also contain the following excipients: crospovidone, hypromellose,
microcrystalline cellulose, sodium stearyl fumarate, titanium dioxide
(E171) talc, macrogol 8000, yellow ferric oxide (E 172) and red ferric
oxide (E 172).

What Levofloxacin looks like and contents of the pack
Your tablets are pale pink, oblong shaped film-coated tablets with a
scoreline on each side. They are available in blister packs of 5 and 10
tablets.

Manufacturer

Manufactured by: Aventis Pharma Deutschland GmbH,
Frankfurt am Main, Germany.
Procured from within the EU and repackaged by: Doncaster
Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: BR Lewis Pharmaceuticals Ltd., Kirk Sandall,
Doncaster, DN3 1QR.
POM

PL No: 08929/0452

Leaflet revision & issue date (ref): 01.03.11
P10658

Very rare (affects less than 1 person in 10,000)

Increased sensitivity of your skin to sun and ultraviolet light
Lowering of your blood sugar levels (hypoglycaemia). This is
important for people that have diabetes
Problems with your hearing or eyesight or changes in the way
things taste and smell
Seeing or hearing things that are not there (hallucinations), change
in your opinion and thoughts (psychotic reactions) with a chance of
having suicidal thoughts or actions
Loss of circulation (anaphylactic like shock)
Muscle weakness. This is important in people with myasthenia
gravis (a rare disease of the nervous system)
Inflammation of the liver, changes in the way your kidney works
and occasional kidney failure which may be due to an allergic
kidney reaction called interstitial nephritis
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
Fever and allergic lung reactions

Other side effects 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 moving and walking
Attacks of porphyria in people who already have porphyria (a very
rare metabolic disease)
Inflammation of your tubes that carry blood around your body
(vessels) due to an allergic reaction

Not known:

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)

If any of the side effects get serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.

Page 2 of 2

PACKAGE LEAFLET: INFORMATION FOR THE USER

Tavanic® 500mg Tablets
(levofloxacin hemihydrate)
The name of your medicine is Tavanic 500mg Tablets but will be referred
to as Tavanic throughout this leaflet.

Read all of this leaflet carefully before you start
taking this medicine.

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or your
pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their symptoms are the same
as yours.
If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.

In this leaflet:
1.
2.
3.
4.
5.
6.

What Tavanic is and what it is used for
Before you take Tavanic
How to take Tavanic
Possible side effects
How to store Tavanic
Further information

1. What Tavanic is and what it is used for
The name of your medicine is Tavanic. Tavanic contains 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 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’

2. Before you take Tavanic
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 Tavanic (listed in Section 6 below)
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 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 apply to you. If you are not
sure, talk to your doctor or pharmacist before taking Tavanic.

Take special care with Tavanic
Check with your doctor or pharmacist before taking
your medicine if:

You are 65 years of age or older
You are using corticosteroids, sometimes called steroids (see
“Taking other medicines” below)
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
You are diabetic
You have ever had liver problems
If you are not sure if any of the above applies to you, talk to your doctor
or pharmacist before taking Tavanic.

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 Taking other medicines).

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines. This includes medicines you buy without a
prescription, including herbal medicines. This is because Tavanic can
affect the way some other medicines work. Also some medicines can
affect the way Tavanic work.

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 breakage 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 that can alter your heart rhythm: medicines that belong
to the group of anti-arrhythmics (e.g. quinidine, hydroquinidine,
disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic
antidepressants, some antimicrobials (that belong to the group of
macrolides), some antipsychotics.
Probenecid – used for gout, and cimetidine – used for ulcers and
heartburn. Special care should be taken when taking either of
these medicines with Tavanic. If you have kidney problems, your
doctor may want to give you a lower dose.

Do not take Tavanic at the same time as the following
medicines. This is because it can affect the way Tavanic
work:

Iron tablets (for anaemia), magnesium or aluminium-containing
antacids (for acid or heartburn) or sulcralfate (for stomach ulcers).
See Section 3 “If you are already taking iron tablets, antacids or
sulcralfate” below.

Urine tests for opiates

Urine tests may show ‘false-positive’ results for strong painkillers called
‘opiates’ in people taking Tavanic. If your doctor is due to take a urine
test, tell them you are taking Tavanic.

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
Ask your doctor or pharmacist for advice before taking any medicine if
you are pregnant or breast-feeding.

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.

3. How to take Tavanic
Always take Tavanic exactly as your doctor has told you. You should
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

Protect your skin from sunlight

Keep out of direct sunlight while taking this medicine. This is because
your skin will become much more 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

If you are already taking iron tablets, antacids or
sulcralfate

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

Page 1 of 2

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

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

Lungs, in people with long-term breathing
problems

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

Pneumonia

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

Urinary tract, including your kidneys or bladder

One tablet of Tavanic 250mg, each day
Or, ½ tablet of Tavanic 500mg, each day

Prostate gland

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

Skin and underneath the skin, including muscles

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

Adults 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.

If you take more Tavanic 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 and heart problems – leading to uneven heart beats as well as
feeling sick (nausea).

If you forget to take Tavanic

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

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.

4. Possible side effects
Like all medicines, Tavanic 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 effects:
Very rare (affects less than 1 person in 10,000)

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 (affects less than 1 person in 1000)

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. The Achilles tendon is
affected most often and in some cases, the tendon could break
Fits (convulsions)

Very rare (affects less than 1 person in 10,000)

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

Other:

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

Tell your doctor if any of the following side effects gets
serious or lasts longer than a few days:
Common (affects less than 1 person in 10)

Feeling sick (nausea) and diarrhoea
Increase in the level of some liver enzymes in your blood

Uncommon (affects less than 1 person in 100)

Itching and skin rash
Loss of appetite, stomach upset or indigestion (dyspepsia), being
sick (vomiting) or pain in your stomach area, feeling bloated
(flatulence) or constipation
Headache, feeling dizzy, a spinning feeling (vertigo), feeling sleepy,
sleeping problems or feeling nervous
Blood tests may show unusual results due to liver or kidney
problems
Changes in the number of white blood cells shown up in the results
of some blood tests
General weakness
Changes in the number of other bacteria or fungi may increase,
which may need to be treated

Rare (affects less than 1 person in 1,000)

Tingling feeling in your hands and feet (paraesthesia) or trembling
Feeling stressed (anxiety), depressed, mental problems, feeling
restless (agitation) or feeling confused
Unusual fast beating of your heart or low blood pressure
Joint pain or muscle pain
Bruising and bleeding easily due to a lowering in the number of
blood platelets
Low number of white blood cells (called neutropenia)
Difficulty breathing or wheezing (bronchospasm)
Shortness of breath (dyspnoea)
Severe itching or hives (called urticaria)

Very rare (affects less than 1 person in 10,000)

Increased sensitivity of your skin to sun and ultraviolet light
Lowering of your blood sugar levels (hypoglycaemia). This is
important for people that have diabetes
Problems with your hearing or eyesight or changes in the way
things taste and smell
Seeing or hearing things that are not there (hallucinations), change
in your opinion and thoughts (psychotic reactions) with a chance of
having suicidal thoughts or actions
Loss of circulation (anaphylactic like shock)
Muscle weakness. This is important in people with myasthenia
gravis (a rare disease of the nervous system)
Inflammation of the liver, changes in the way your kidney works
and occasional kidney failure which may be due to an allergic
kidney reaction called interstitial nephritis
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
Fever and allergic lung reactions

5. How to store Tavanic
No special precautions are required but it is best to keep Tavanic tablets
in the original strips and box in a dry place.
Keep out of the reach and sight of children.
Do not use the tablets after the expiry date shown on the carton and
blister label.
If your doctor tells you to stop taking the tablets, please take them back
to the pharmacist for safe disposal. Only keep the tablets if your doctor
tells you to.
If the tablets become discoloured or show signs of deterioration, you
should seek the advice of your pharmacist.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.

6. Further information
What Tavanic contains

Each film coated tablet contains 500mg of the active ingredient
levofloxacin (as the hemihydrate).
They also contain the following excipients: crospovidone, hypromellose,
microcrystalline cellulose, sodium stearyl fumarate, titanium dioxide
(E171), talc, macrogol 8000, yellow ferric oxide (E 172) and red ferric
oxide (E 172).

What Tavanic looks like and contents of the pack

Your tablets are pale pink, oblong shaped film-coated tablets with a
scoreline on each side. They are available in blister packs of 5 and 10
tablets.

Manufacturer

Manufactured by: Sanofi Winthrop Industrie, 56 route de Choisy-au-Bac,
F-60205 Compiegne, France.
Procured from within the EU and repackaged by: Doncaster
Pharmaceuticals Group Ltd, Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: BR Lewis Pharmaceuticals Ltd, Kirk Sandall,
Doncaster, DN3 1QR.
POM

PL No: 08929/0452

Leaflet revision & issue date (ref): 21.07.11
Tavanic® is a registered trademark of Daiichi Sankyo Company,
Limited.

Other side effects 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 moving and walking
Attacks of porphyria in people who already have porphyria (a very
rare metabolic disease)
Inflammation of your tubes that carry blood around your body
(vessels) due to an allergic reaction

Not known:

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)

If any of the side effects get serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.

Page 2 of 2

PACKAGE LEAFLET: INFORMATION FOR THE USER

Levofloxacin 500mg Tablets
(levofloxacin hemihydrate)
The name of your medicine is Levofloxacin 500mg Tablets but will be
referred to as Levofloxacin throughout this leaflet.

Read all of this leaflet carefully before you start
taking this medicine.

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or your
pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their symptoms are the same
as yours.
If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.

In this leaflet:
1.
2.
3.
4.
5.
6.

What Levofloxacin is and what it is used for
Before you take Levofloxacin
How to take Levofloxacin
Possible side effects
How to store Levofloxacin
Further information

1. What Levofloxacin is and what it is used for
The name of your medicine is Levofloxacin. Levofloxacin contains 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.

Levofloxacin 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’

2. Before you take Levofloxacin
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 Levofloxacin (listed in Section 6 below)
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 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 apply to you. If you are not
sure, talk to your doctor or pharmacist before taking Levofloxacin.

Take special care with Levofloxacin
Check with your doctor or pharmacist before taking
your medicine if:

You are 65 years of age or older
You are using corticosteroids, sometimes called steroids (see
“Taking other medicines” below)
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
You are diabetic
You have ever had liver problems
If you are not sure if any of the above applies to you, talk to your doctor
or pharmacist before taking Levofloxacin.

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 Taking other medicines).

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines. This includes medicines you buy without a
prescription, including herbal medicines. This is because Levofloxacin can
affect the way some other medicines work. Also some medicines can
affect the way Levofloxacin work.

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
Levofloxacin:
Corticosteroids, sometimes called steroids – used for inflammation.
You may be more likely to have inflammation and/or breakage 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 Levofloxacin.
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 Levofloxacin.
Ciclosporin – used after organ transplants. You may be more likely
to get the side effects of ciclosporin.
Medicines that can alter your heart rhythm: medicines that belong
to the group of anti-arrhythmics (e.g. quinidine, hydroquinidine,
disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic
antidepressants, some antimicrobials (that belong to the group of
macrolides), some antipsychotics.
Probenecid – used for gout, and cimetidine – used for ulcers and
heartburn. Special care should be taken when taking either of
these medicines with Levofloxacin. If you have kidney problems,
your doctor may want to give you a lower dose.

Do not take Levofloxacin at the same time as the
following medicines. This is because it can affect the
way Levofloxacin work:

Iron tablets (for anaemia), magnesium or aluminium-containing
antacids (for acid or heartburn) or sulcralfate (for stomach ulcers).
See Section 3 “If you are already taking iron tablets, antacids or
sulcralfate” below.

Urine tests for opiates

Urine tests may show ‘false-positive’ results for strong painkillers called
‘opiates’ in people taking Levofloxacin. If your doctor is due to take a
urine test, tell them you are taking Levofloxacin.

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
Ask your doctor or pharmacist for advice before taking any medicine if
you are pregnant or breast-feeding.

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.

3. How to take Levofloxacin
Always take Levofloxacin exactly as your doctor has told you. You should
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

Protect your skin from sunlight

Keep out of direct sunlight while taking this medicine. This is because
your skin will become much more 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

If you are already taking iron tablets, antacids or
sulcralfate

Do not take these medicines at the same time as Levofloxacin.
Take your dose at least 2 hours before or after Levofloxacin

How much to take

Your doctor will decide on how many Levofloxacin 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

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

Lungs, in people with long-term breathing
problems

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

Pneumonia

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

Urinary tract, including your kidneys or bladder

One tablet of Levofloxacin 250mg, each day
Or, ½ tablet of Levofloxacin 500mg, each day

Prostate gland

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

Skin and underneath the skin, including muscles

One or two tablets of Levofloxacin 250mg, once or twice each day
Or, ½ tablet or one tablet of Levofloxacin 500mg, once or twice
each day

Adults 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.

If you take more Levofloxacin 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 and heart problems – leading to uneven heart beats as well as
feeling sick (nausea).

If you forget to take Levofloxacin

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 Levofloxacin

Do not stop taking Levofloxacin 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.

4. Possible side effects
Like all medicines, Levofloxacin 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 Levofloxacin and see a doctor or go to a
hospital straight away if you notice the following side
effects:
Very rare (affects less than 1 person in 10,000)

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 Levofloxacin and see a doctor straight away
if you notice any of the following serious side effects –
you may need urgent medical treatment:
Rare (affects less than 1 person in 1000)

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. The Achilles tendon is
affected most often and in some cases, the tendon could break
Fits (convulsions)

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Very rare (affects less than 1 person in 10,000)

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

Other:

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

Tell your doctor if any of the following side effects gets
serious or lasts longer than a few days:
Common (affects less than 1 person in 10)

Feeling sick (nausea) and diarrhoea
Increase in the level of some liver enzymes in your blood

Uncommon (affects less than 1 person in 100)

Itching and skin rash
Loss of appetite, stomach upset or indigestion (dyspepsia), being
sick (vomiting) or pain in your stomach area, feeling bloated
(flatulence) or constipation
Headache, feeling dizzy, a spinning feeling (vertigo), feeling sleepy,
sleeping problems or feeling nervous
Blood tests may show unusual results due to liver or kidney
problems
Changes in the number of white blood cells shown up in the results
of some blood tests
General weakness
Changes in the number of other bacteria or fungi may increase,
which may need to be treated

Rare (affects less than 1 person in 1,000)

Tingling feeling in your hands and feet (paraesthesia) or trembling
Feeling stressed (anxiety), depressed, mental problems, feeling
restless (agitation) or feeling confused
Unusual fast beating of your heart or low blood pressure
Joint pain or muscle pain
Bruising and bleeding easily due to a lowering in the number of
blood platelets
Low number of white blood cells (called neutropenia)
Difficulty breathing or wheezing (bronchospasm)
Shortness of breath (dyspnoea)
Severe itching or hives (called urticaria)

5. How to store Levofloxacin
No special precautions are required but it is best to keep Levofloxacin
tablets in the original strips and box in a dry place.
Keep out of the reach and sight of children.
Do not use the tablets after the expiry date shown on the carton and
blister label.
If your doctor tells you to stop taking the tablets, please take them back
to the pharmacist for safe disposal. Only keep the tablets if your doctor
tells you to.
If the tablets become discoloured or show signs of deterioration, you
should seek the advice of your pharmacist.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.

6. Further information
What Levofloxacin contains

Each film coated tablet contains 500mg of the active ingredient
levofloxacin (as the hemihydrate).
They also contain the following excipients: crospovidone, hypromellose,
microcrystalline cellulose, sodium stearyl fumarate, titanium dioxide
(E171) talc, macrogol 8000, yellow ferric oxide (E 172) and red ferric
oxide (E 172).

What Levofloxacin looks like and contents of the pack
Your tablets are pale pink, oblong shaped film-coated tablets with a
scoreline on each side. They are available in blister packs of 5 and 10
tablets.

Manufacturer

Manufactured by: Sanofi Winthrop Industrie, 56 route de Choisy-au-Bac,
F-60205 Compiegne, France.
Procured from within the EU and repackaged by: Doncaster
Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: BR Lewis Pharmaceuticals Ltd., Kirk Sandall,
Doncaster, DN3 1QR.
POM

PL No: 08929/0452

Leaflet revision & issue date (ref): 21.07.11

Very rare (affects less than 1 person in 10,000)

Increased sensitivity of your skin to sun and ultraviolet light
Lowering of your blood sugar levels (hypoglycaemia). This is
important for people that have diabetes
Problems with your hearing or eyesight or changes in the way
things taste and smell
Seeing or hearing things that are not there (hallucinations), change
in your opinion and thoughts (psychotic reactions) with a chance of
having suicidal thoughts or actions
Loss of circulation (anaphylactic like shock)
Muscle weakness. This is important in people with myasthenia
gravis (a rare disease of the nervous system)
Inflammation of the liver, changes in the way your kidney works
and occasional kidney failure which may be due to an allergic
kidney reaction called interstitial nephritis
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
Fever and allergic lung reactions

Other side effects 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 moving and walking
Attacks of porphyria in people who already have porphyria (a very
rare metabolic disease)
Inflammation of your tubes that carry blood around your body
(vessels) due to an allergic reaction

Not known:

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)

If any of the side effects get serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.

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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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