LEFLOGARD

LEFLOGARD 500 mg film-coated tablets
Levofloxacin
Read all of this leaflet carefully before you start taking this medicine as it may contain 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. Do not pass it on to others. It may harm them, even if
their symptoms are the same as yours.
 If you get any side effects, contact your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
In this leaflet:
1. What LEFLOGARD tablets are and what they are used for
2. What you need to know before you take LEFLOGARD tablets
3. How to take LEFLOGARD tablets
4. Possible side effects
5. How to store LEFLOGARD tablets
6. Contents of the pack and other information.
1. What LEFLOGARD tablets are and what they are used for
The name of your medicine is LEFLOGARD. LEFLOGARD tablets contain a medicine called
levofloxacin. It belongs to a group of medicines called quinolone antimicrobial agents and works by
killing the bacteria that cause infections.
LEFLOGARD tablets can be used to treat infections of the:
 sinuses;
 lungs, in people with long-term breathing problems or pneumonia;
 urinary tract, including kidneys or bladder;
 prostate gland, where you have a long lasting infection;
 skin and underlying tissues, including muscles (sometimes called soft tissue).
In some special situations, Levor 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 do know before you take LEFLOGARD tablets:
Do not take LEFLOGARD:
 if you are allergic (hypersensitive) to levofloxacin, any other quinolones such as moxifoxacin,
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.
 if you have ever had epilepsy;
 if you have ever had a problem with your tendons such as tendonitis that was related to treatment
with antibacterial agent of the quinolone group. A tendon is the cord that joins your muscle to
your skeleton.
 if you are a child or a growing teenager;
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 if you are pregnant, might become pregnant or think you may be pregnant;
 if 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 LEFLOGARD.
Warnings and precautions
Talk to your doctor or pharmacist before taking LEFLOGARD:
 if you are 60 years of age or older;
 if you are using corticosteroids, sometimes called steroids (see section “Other medicines and
LEFLOGARD”);
 if you have received a transplantation;
 if you have ever had a fit (seizure);
 if you have had damage to your brain due to a stroke or other brain injury;
 if you have kidney problems;
 if 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;
 if you have ever had mental health problems;
 if 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), have a very slow heart rhythm (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 LEFLOGARD
tablets”);
 if you are diabetic;
 if you have ever had liver problems;
 if you have myasthenia gravis;
 if you have nerve problems (peripheral neuropathy);
 if you have been diagnosed with an enlargement or “bulge” of a large blood vessel (aortic aneurysm
or large vessel peripheral aneurysm);
 if you have experienced a previous episode of aortic dissection (a tear in the aorta wall);
 if you have been diagnosed with leaking heart valves (heart valve regurgitation);
 if you have a family history of aortic aneurysm or aortic dissection or congenital heart valve disease,
or other risk factors or predisposing conditions (e.g. connective tissue disorders such as Marfan
syndrome, or vascular Ehlers-Danlos syndrome, Turner syndrome, Sjogren’s syndrome [an
inflammatory autoimmune disease] or vascular disorders such as Takayasu arteritis, giant cell arteritis,
Behcet’s disease, high blood pressure, or known atherosclerosis, or rheumatoid arthritis [a disease of
joints], or endocarditis [an infection of the heart]);
 if you have ever developed a severe skin rash or skin peeling, blistering and/or mouth
sores after taking levofloxacin.
Serious skin reactions
Serious skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction
with eosinophilia and systemic symptoms (DRESS) have been reported with the use of levofloxacin.
 SJS/TEN can appear initially as reddish target-like spots or circular patches often with central blisters
on the trunk. Also, ulcers of mouth, throat, nose, genitals and eyes (red and swollen eyes) can occur.
These serious skin rashes are often preceded by fever and/or flu-like symptoms. The rashes may
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progress to widespread peeling of the skin and life-threatening complications or be fatal.
 DRESS appears initially as flu-like symptoms and a rash on the face then an extended rash with a high
body temperature, increased levels of liver enzymes seen in blood tests and an increase in a type of
white blood cell (eosinophilia) and enlarged lymph nodes.
If you develop a serious rash or another of these skin symptoms, stop taking levofloxacin and contact your
doctor or seek medical attention immediately.
You should not take fluoroquinolone/quinolone antibacterial medicines, including Levofloxacin, if you have
experienced any serious adverse reaction in the past when taking a quinolone or fluoroquinolone. In this
situation, you should inform your doctor as soon as possible.
When taking this medicine
If you feel sudden, severe pain in your abdomen, chest or back, which can be symproms of aortic aneurysm
and dissection, go immediately to an emergency room. Your risk may be increased if you are being treated
with systemic corticosteroids.
If you start experiencing a rapid onset of shortness of breath, especially when you lie down flat in your bed,
or you notice swelling of your ankles, feet or abdomen, or a new onset of heart palpitations (sensation of
rapid or irregular heartbeat), you should inform your doctor immediately.
Pain and swelling in the joints and inflammation or rupture of tendons may occur rarely. Your risk is
increased if you are elderly (above 60 years of age), have received an organ transplant, have kidney problems,
receive daily doses of 1,000 mg levofloxacin or if you are being treated with corticosteroids. Inflammation
and ruptures of tendons may occur within the first 48 hours of treatment and even up to several months after
stopping of LEFLOGARD therapy. At the first sign of pain or inflammation of a tendon (for example in
your ankle, wrist, elbow, shoulder or knee), stop taking LEFLOGARD , contact your doctor and rest the
painful area. Avoid any unnecessary exercise as this might increase the risk of a tendon rupture.
You may rarely experience symptoms of nerve damage (neuropathy) such as pain, burning, tingling,
numbness and/or weakness especially in the feet and legs or hands and arms. If this happens, stop taking
LEFLOGARD and inform your doctor immediately in order to prevent the development of potentially
irreversible condition.
Prolonged, disabling and potentially irreversible serious side effects
Fluoroquinolone/quinolone antibacterial medicines, including LEFLOGARD , have been associated with
very rare but serious side effects, some of them being long lasting (continuing months or years), disabling
or potentially irreversible. This includes tendon, muscle and joint pain of the upper and lower limbs,
difficulty in walking, abnormal sensations such as pins and needles, tingling, tickling, numbness or burning
(paraesthesia), sensory disorders including impairment of vision, taste and smell, and hearing, depression,
memory impairment, severe fatigue, and severe sleep disorders.
If you experience any of these side effects after taking LEFLOGARD , contact your doctor immediately
prior to continuing treatment. You and your doctor will decide on continuing the treatment considering also
an antibiotic from another class.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking
LEFLOGARD tablets.
Other medicines and LEFLOGARD
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines,
because LEFLOGARD may affect the way they work. Also some medicines can affect the way
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LEFLOGARD work.
In particular, tell your doctor if you are taking any of the following medicines, as this may increase
the chance of getting side effects, when you take LEFLOGARD tablets:
 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 LEFLOGARD tablets.
 Non-steroidal anti-inflammatory drugs (NSAIDs) – used for pain and inflammation such as
acetylsalicylic acid, ibuprofen, fenbufen, ketoprofen and indomethacin. You are more likely to have a fit
(seizure) if taken with LEFLOGARD tablets.
 Ciclosporin – used after organ transplants. You may be more likely to get the side effects of
ciclosporin.
 Medicines known to affect the way your heart beats. This includes medicines used for abnormal
heart rhythm (antiarrhythmics such as quinidine, hydroquinidine, disopyramide, sotalol, dofetilide,
ibutilide and amiodarone), for depression (tricyclic antidepressants such as amitriptyline and imipramine),
for psychiatric disorders (antipsychotics), and for bacterial infections (macrolide antibiotics such as
erythromycin, azithromycin and clarithromycin)
 Probenecid – used for gout. If you have kidney problems, your doctor may want to give you a
lower dose.
 Cimetidine – used for ulcers and heartburn. If you have kidney problems, your doctor may want to
give you a lower dose.
Talk to your doctor if any of the above applies to you.
Do not take LEFLOGARD tablets at the same time as the following medicines as this can affect the
way LEFLOGARD 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”.
Urine tests for opiates
Urine tests may show false positive results for strong painkillers called opiates in people taking
LEFLOGARD. If your doctor has prescribed a urine test, tell your doctor you are taking LEFLOGARD.
Tuberculosis tests
This medicine may cause false negative results for some tests used in laboratory to search for the bacteria
causing tuberculosis.
Pregnancy, breast-feeding and fertility
Do not take LEFLOGARD if:
 you are pregnant, planning to become pregnant or think you may be pregnant;
 you are breast-feeding or intend 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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LEFLOGARD tablets contain sunset yellow
This medicinal product contains the colouring agent FD&C Yellow No. 6/ sunset yellow aluminum-based
pigment (E110) which may cause allergic reactions.
3. How to take LEFLOGARD tablets
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist
if you are not sure.
Taking LEFLOGARD tablets
 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 LEFLOGARD. Take your dose of these medicines at
least 2 hours before or after LEFLOGARD.
How much to take
 Your doctor will decide on how many LEFLOGARD 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
 One tablet of LEFLOGARD 500 mg, once each day
Lungs infection, in people with long-term breathing problems
 One tablet of LEFLOGARD 500 mg, once each day
Pneumonia
 One tablet of LEFLOGARD 500 mg, once each day
Infection of urinary tract, including your kidneys or bladder
 One tablet of LEFLOGARD 500 mg, once each day
Prostat gland infection
 One tablet of LEFLOGARD 500 mg, once each day
Infection of skin and underneath the skin, including muscles
 One tablet of LEFLOGARD 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:
 use high factor sun cream;
 always wear a hat and clothes which cover your arms and legs;
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 avoid sun beds.
If you take more LEFLOGARD 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 LEFLOGARD 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 LEFLOGARD tablets
Do not stop taking LEFLOGARD 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 microorganisms may become resistant to
the medicine.
If you have any further questions on the use of this product, 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 LEFLOGARD and see your doctor or go to a hospital straight away if you notice the
following side effects:
Very rare (may affect up to 1 in 10 000 patients)
 Allergic reaction. The signs may include: a rash, swallowing or breathing problems, swelling of
your lips, face, throat or tongue.
Stop taking LEFLOGARD and see your doctor or go to a hospital straight away if you notice the
following side effects – you may need urgent medical treatment:
Rare (may affect up to 1 in 1 000 patients)
 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).
 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
 Widespread rash, high body temperature, liver enzyme elevations, blood abnormalities
(eosinophilia), enlarged lymph nodes and other body organs involvement (Drug Reaction with
Eosinophilia and Systemic Symptoms which is also known as DRESS or drug hypersensitivity
syndrome). See also section 2
 Syndrome associated with impaired water excretion and low levels of sodium (SIADH).
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Very rare (may affect up to 1 in 10 000 patients)
 Burning, tingling, pain or numbness. These may be signs of something called neuropathy
Frequency not known (frequency cannot be estimated from available data)
 Serious skin rashes including Stevens-Johnson syndrome and toxic epidermal necrolysis. These can
appear as reddish target-like macules or circular patches often with central blisters on the trunk, skin
peeling, ulcers of mouth, throat, nose, genitals and eyes and can be preceded by fever and flu-like
symptoms. See also section 2.
 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 LEFLOGARD,
consult an eye specialist immediately.
Very rare cases of long lasting (even up to months or years) or permanent adverse drug reactions, such as
tendon inflammations, tendon rupture, joint pain, pain in the limbs, difficulty in walking, abnormal
sensations such as pins and needles, tickling, burning, numbness or pain (neuropathy), depression, fatigue,
sleep disorders, memory impairment, as well as impairment of hearing, vision, and taste and smell have
been associated with administration of quinolone and fluoroquinolone antibiotics in some cases
irrespective of pre-existing risk factors.
Cases of an enlargement and weakening of the aortic wall or a tear in the aortic wall (aneurysms and
dissections), which may rupture and may be fatal, and of leaking heart valves have been reported in patients
receiving fluoroquinolone. See also section 2.
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 patients)
 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 patients)
 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 patients)
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 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 with diabetes;
 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;
 Sharply demarcated, erythematous patches with/without blistering that develop within hours of
administration of levofloxacin and heals with postinflammatory residual hyperpigmentation; it usually
recurs at the same site of the skin or mucous membrane upon subsequent exposure to levofloxacin.
Frequency not known (frequency can not be estimated from 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 blood vessels 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, contact your doctor or pharmacist. This includes all listed in this leaflet. You
can also report side effects directly via the national reporting system. Reporting of the adverse reactions
contributes to getting more information on the safety of this medicine.
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5. How to store LEFLOGARD tablets
Keep out of the sight and reach of children.
Do not use LEFLOGARD tablets after the expiry date stated on the carton packaging. The expiry date
refers to the last day of the month.
No special storage conditions are required.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose
of medicines you no longer use. These measures will help t protect the environment.
6. Contents of the pack and other information
What LEFLOGARD tablets contain
 The active ingredient is levofloxacin. Each film-coated tablet LEFLOGARD 500 mg contains
active ingredient 500 mg levofloxacin (equivalent to 512.46 mg of levofloxacin hemihydrate).
 The other ingredients are:
Tablet core: microcrystalline cellulose, hydroxypropylcellulose, crospovidone, magnesium stearate.
Tablet coating: Opadry orange OY-S-33016 [hypromellose (Е464); FD & C blue #2/ indigo carmine,
aluminum-based pigment (Е132); FD & C yellow #6/sunset yellow, aluminum-based pigment (Е110);
red iron oxide (E172); macrogol 4000; titanium dioxide (E171)], yellow iron oxide.
What LEFLOGARD looks like and contents of the pack
LEFLOGARD 500 mg film-coated tablets are orange, oval, convex and scored.
Each pack contains on blister with 10 tablets and a patient information leaflet.
Marketing Authorization Holder and Manufacturer:
Manufacturer:
PHARMATHEN SA
Dervenakion 6, Pallini 15351, Attikis, Greece
Marketing Authorization Holder:
Tchaikapharma High Quality Medicines
Inc. 1 G. M. Dimitrov Blvd., Sofia 1172,
Bulgaria
For further information on this medicinal product, please contact the Marketing Authorisation Holder:
Tchaikapharma High Quality Medicines
Inc. 1 G. M. Dimitrov Blvd., Sofia 1172,
Bulgaria Phone: +359 2 962 54 54
Fax: +359 2 9603 703
e-mail: info@tchaikapharma.com
This leaflet was last revised in: Januar