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TAVANIC 250MG FILM-COATED TABLETS

Active substance(s): LEVOFLOXACIN HEMIHYDRATE

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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 (only for the UK)
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
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)
 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
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 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 give you a lower dose if you have
kidney problems.
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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 aluminium-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.
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
Lungs infection, in people with long-term breathing problems
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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, ½ 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 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.
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:
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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

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)
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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

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, inflammation of the eye

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.

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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 to 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.
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 53432
Email: uk-medicalinformation@sanofi-aventis.com
Manufacturer
Sanofi Winthrop Industrie, 56, Route de Choisy au Bac, F-60205 Compiègne, 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 03/2015
© Sanofi-aventis, 2015

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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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