LEFLOGARD 500 mg film-coated tablets
\nLevofloxacin
\nRead all of this leaflet carefully before you start taking this medicine as it may contain important
\ninformation for you.
\n\uf02d Keep this leaflet. You may need to read it again.
\n\uf02d If you have any further questions, ask your doctor or pharmacist.
\n\uf02d This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if
\ntheir symptoms are the same as yours.
\n\uf02d If you get any side effects, contact your doctor or pharmacist. This includes any possible side
\neffects not listed in this leaflet. See section 4.
\nIn this leaflet:
\n1. What LEFLOGARD tablets are and what they are used for
\n2. What you need to know before you take LEFLOGARD tablets
\n3. How to take LEFLOGARD tablets
\n4. Possible side effects
\n5. How to store LEFLOGARD tablets
\n6. Contents of the pack and other information.
\n1. What LEFLOGARD tablets are and what they are used for
\nThe name of your medicine is LEFLOGARD. LEFLOGARD tablets contain a medicine called
\nlevofloxacin. It belongs to a group of medicines called quinolone antimicrobial agents and works by
\nkilling the bacteria that cause infections.
\nLEFLOGARD tablets can be used to treat infections of the:
\n\uf02d sinuses;
\n\uf02d lungs, in people with long-term breathing problems or pneumonia;
\n\uf02d urinary tract, including kidneys or bladder;
\n\uf02d prostate gland, where you have a long lasting infection;
\n\uf02d skin and underlying tissues, including muscles (sometimes called soft tissue).
\nIn some special situations, Levor tablets may be used to lessen the chances of getting a pulmonary disease
\nnamed anthrax or worsening of the disease after you are exposed to the bacteria causing anthrax.
\n2. What you need do know before you take LEFLOGARD tablets:
\nDo not take LEFLOGARD:
\n\uf02d if you are allergic (hypersensitive) to levofloxacin, any other quinolones such as moxifoxacin,
\nciprofloxacin or ofloxacin or any of the other ingredients of this medicine (listed in section 6). Signs
\nof an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips,
\nface, throat or tongue.
\n\uf02d if you have ever had epilepsy;
\n\uf02d if you have ever had a problem with your tendons such as tendonitis that was related to treatment
\nwith antibacterial agent of the quinolone group. A tendon is the cord that joins your muscle to
\nyour skeleton.
\n\uf02d if you are a child or a growing teenager;
\n3
\n\uf02d if you are pregnant, might become pregnant or think you may be pregnant;
\n\uf02d if you are breast-feeding.
\nDo not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor
\nor pharmacist before taking LEFLOGARD.
\nWarnings and precautions
\nTalk to your doctor or pharmacist before taking LEFLOGARD:
\n\uf02d if you are 60 years of age or older;
\n\uf02d if you are using corticosteroids, sometimes called steroids (see section \u201cOther medicines and
\nLEFLOGARD\u201d);
\n\uf02d if you have received a transplantation;
\n\uf02d if you have ever had a fit (seizure);
\n\uf02d if you have had damage to your brain due to a stroke or other brain injury;
\n\uf02d if you have kidney problems;
\n\uf02d if you have something known as glucose \u2013 6 \u2013 phosphate dehydrogenase deficiency. You are more
\nlikely to have serious problems with your blood when taking this medicine;
\n\uf02d if you have ever had mental health problems;
\n\uf02d if you have ever had heart problems: caution should be taken when using this kind of medicine,
\nif you were born with or have family history of prolonged QT interval (seen on ECG, electrical
\nrecording of the heart), have salt imbalance in the blood (especially low level of potassium or
\nmagnesium), have a very slow heart rhythm (bradycardia), have a weak heart (heart failure), have
\na history of heart attack (myocardial infarction), you are female or elderly or you are taking other
\nmedicines that result in abnormal ECG changes (see section \u201c Other medicines and LEFLOGARD
\ntablets\u201d);
\n\uf02d if you are diabetic;
\n\uf02d if you have ever had liver problems;
\n\uf02d if you have myasthenia gravis;
\n\uf02d if you have nerve problems (peripheral neuropathy);
\n\uf02d if you have been diagnosed with an enlargement or \u201cbulge\u201d of a large blood vessel (aortic aneurysm
\nor large vessel peripheral aneurysm);
\n\uf02d if you have experienced a previous episode of aortic dissection (a tear in the aorta wall);
\n\uf02d if you have been diagnosed with leaking heart valves (heart valve regurgitation);
\n\uf02d if you have a family history of aortic aneurysm or aortic dissection or congenital heart valve disease,
\nor other risk factors or predisposing conditions (e.g. connective tissue disorders such as Marfan
\nsyndrome, or vascular Ehlers-Danlos syndrome, Turner syndrome, Sjogren\u2019s syndrome [an
\ninflammatory autoimmune disease] or vascular disorders such as Takayasu arteritis, giant cell arteritis,
\nBehcet\u2019s disease, high blood pressure, or known atherosclerosis, or rheumatoid arthritis [a disease of
\njoints], or endocarditis [an infection of the heart]);
\n\uf02d if you have ever developed a severe skin rash or skin peeling, blistering and\/or mouth
\nsores after taking levofloxacin.
\nSerious skin reactions
\nSerious skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction
\nwith eosinophilia and systemic symptoms (DRESS) have been reported with the use of levofloxacin.
\n\uf0b7 SJS\/TEN can appear initially as reddish target-like spots or circular patches often with central blisters
\non the trunk. Also, ulcers of mouth, throat, nose, genitals and eyes (red and swollen eyes) can occur.
\nThese serious skin rashes are often preceded by fever and\/or flu-like symptoms. The rashes may
\n4
\nprogress to widespread peeling of the skin and life-threatening complications or be fatal.
\n\uf0b7 DRESS appears initially as flu-like symptoms and a rash on the face then an extended rash with a high
\nbody temperature, increased levels of liver enzymes seen in blood tests and an increase in a type of
\nwhite blood cell (eosinophilia) and enlarged lymph nodes.
\nIf you develop a serious rash or another of these skin symptoms, stop taking levofloxacin and contact your
\ndoctor or seek medical attention immediately.
\nYou should not take fluoroquinolone\/quinolone antibacterial medicines, including Levofloxacin, if you have
\nexperienced any serious adverse reaction in the past when taking a quinolone or fluoroquinolone. In this
\nsituation, you should inform your doctor as soon as possible.
\nWhen taking this medicine
\nIf you feel sudden, severe pain in your abdomen, chest or back, which can be symproms of aortic aneurysm
\nand dissection, go immediately to an emergency room. Your risk may be increased if you are being treated
\nwith systemic corticosteroids.
\nIf you start experiencing a rapid onset of shortness of breath, especially when you lie down flat in your bed,
\nor you notice swelling of your ankles, feet or abdomen, or a new onset of heart palpitations (sensation of
\nrapid or irregular heartbeat), you should inform your doctor immediately.
\nPain and swelling in the joints and inflammation or rupture of tendons may occur rarely. Your risk is
\nincreased if you are elderly (above 60 years of age), have received an organ transplant, have kidney problems,
\nreceive daily doses of 1,000 mg levofloxacin or if you are being treated with corticosteroids. Inflammation
\nand ruptures of tendons may occur within the first 48 hours of treatment and even up to several months after
\nstopping of LEFLOGARD therapy. At the first sign of pain or inflammation of a tendon (for example in
\nyour ankle, wrist, elbow, shoulder or knee), stop taking LEFLOGARD , contact your doctor and rest the
\npainful area. Avoid any unnecessary exercise as this might increase the risk of a tendon rupture.
\nYou may rarely experience symptoms of nerve damage (neuropathy) such as pain, burning, tingling,
\nnumbness and\/or weakness especially in the feet and legs or hands and arms. If this happens, stop taking
\nLEFLOGARD and inform your doctor immediately in order to prevent the development of potentially
\nirreversible condition.
\nProlonged, disabling and potentially irreversible serious side effects
\nFluoroquinolone\/quinolone antibacterial medicines, including LEFLOGARD , have been associated with
\nvery rare but serious side effects, some of them being long lasting (continuing months or years), disabling
\nor potentially irreversible. This includes tendon, muscle and joint pain of the upper and lower limbs,
\ndifficulty in walking, abnormal sensations such as pins and needles, tingling, tickling, numbness or burning
\n(paraesthesia), sensory disorders including impairment of vision, taste and smell, and hearing, depression,
\nmemory impairment, severe fatigue, and severe sleep disorders.
\nIf you experience any of these side effects after taking LEFLOGARD , contact your doctor immediately
\nprior to continuing treatment. You and your doctor will decide on continuing the treatment considering also
\nan antibiotic from another class.
\nIf you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking
\nLEFLOGARD tablets.
\nOther medicines and LEFLOGARD
\nTell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines,
\nbecause LEFLOGARD may affect the way they work. Also some medicines can affect the way
\n5
\nLEFLOGARD work.
\nIn particular, tell your doctor if you are taking any of the following medicines, as this may increase
\nthe chance of getting side effects, when you take LEFLOGARD tablets:
\n\uf02d Corticosteroids, sometimes called steroids \u2013 used for inflammation. You may be more likely
\nto have inflammation and\/or rupture of your tendons.
\n\uf02d Warfarin – used to thin the blood. You may be more likely to have a bleed. Your doctor may
\nneed to take regular blood tests to check how well your blood can clot.
\n\uf02d Theophylline – used for breathing problems. You are more likely to have a fit (seizure) if taken
\nwith LEFLOGARD tablets.
\n\uf02d Non-steroidal anti-inflammatory drugs (NSAIDs) – used for pain and inflammation such as
\nacetylsalicylic acid, ibuprofen, fenbufen, ketoprofen and indomethacin. You are more likely to have a fit
\n(seizure) if taken with LEFLOGARD tablets.
\n\uf02d Ciclosporin – used after organ transplants. You may be more likely to get the side effects of
\nciclosporin.
\n\uf02d Medicines known to affect the way your heart beats. This includes medicines used for abnormal
\nheart rhythm (antiarrhythmics such as quinidine, hydroquinidine, disopyramide, sotalol, dofetilide,
\nibutilide and amiodarone), for depression (tricyclic antidepressants such as amitriptyline and imipramine),
\nfor psychiatric disorders (antipsychotics), and for bacterial infections (macrolide antibiotics such as
\nerythromycin, azithromycin and clarithromycin)
\n\uf02d Probenecid \u2013 used for gout. If you have kidney problems, your doctor may want to give you a
\nlower dose.
\n\uf02d Cimetidine \u2013 used for ulcers and heartburn. If you have kidney problems, your doctor may want to
\ngive you a lower dose.
\nTalk to your doctor if any of the above applies to you.
\nDo not take LEFLOGARD tablets at the same time as the following medicines as this can affect the
\nway LEFLOGARD tablets work:
\n\uf02d Iron tablets (for anemia), zinc supplements, magnesium or aluminum-containing antacids (for acid
\nor heartburn), didanosine, or sucralfate (for stomach ulcers). See section 3 \u201cIf you are already taking
\niron tablets, zinc supplements, antacids, didanosine or sucralfate\u201d.
\nUrine tests for opiates
\nUrine tests may show false positive results for strong painkillers called opiates in people taking
\nLEFLOGARD. If your doctor has prescribed a urine test, tell your doctor you are taking LEFLOGARD.
\nTuberculosis tests
\nThis medicine may cause false negative results for some tests used in laboratory to search for the bacteria
\ncausing tuberculosis.
\nPregnancy, breast-feeding and fertility
\nDo not take LEFLOGARD if:
\n\uf02d you are pregnant, planning to become pregnant or think you may be pregnant;
\n\uf02d you are breast-feeding or intend to breast-feed.
\nDriving and using machines
\nYou may get side effects after taking this medicine, including feeling dizzy, sleepy, a spinning feeling
\n(vertigo) or changes to your eyesight. Some of these side effects can affect you being able to concentrate
\nand your reaction speed. If this happens, do not drive or carry out any work that requires a high level of
\nattention.
\n6
\nLEFLOGARD tablets contain sunset yellow
\nThis medicinal product contains the colouring agent FD&C Yellow No. 6\/ sunset yellow aluminum-based
\npigment (E110) which may cause allergic reactions.
\n3. How to take LEFLOGARD tablets
\nAlways take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist
\nif you are not sure.
\nTaking LEFLOGARD tablets
\n\uf02d Take this medicine by mouth
\n\uf02d Swallow the tablets whole with a drink of water
\n\uf02d The tablets may be taken during meals or at any time between meals
\nIf you are already taking iron tablets, zinc supplements, antacids, didanosine or sucralfate
\n\uf02d Do not take these medicines at the same time as LEFLOGARD. Take your dose of these medicines at
\nleast 2 hours before or after LEFLOGARD.
\nHow much to take
\n\uf02d Your doctor will decide on how many LEFLOGARD tablets you should take.
\n\uf02d The dose will depend on the type of infection you have and where the infection is in your body.
\n\uf02d The length of your treatment will depend on how serious your infection is.
\n\uf02d If you feel the effect of your medicine is too weak or strong, do not change the dose yourself, but ask
\nyour doctor.
\nAdults and the elderly
\nSinuses infection
\n\uf02d One tablet of LEFLOGARD 500 mg, once each day
\nLungs infection, in people with long-term breathing problems
\n\uf02d One tablet of LEFLOGARD 500 mg, once each day
\nPneumonia
\n\uf02d One tablet of LEFLOGARD 500 mg, once each day
\nInfection of urinary tract, including your kidneys or bladder
\n\uf02d One tablet of LEFLOGARD 500 mg, once each day
\nProstat gland infection
\n\uf02d One tablet of LEFLOGARD 500 mg, once each day
\nInfection of skin and underneath the skin, including muscles
\n\uf02d One tablet of LEFLOGARD 500 mg, once or twice each day
\nAdults and the elderly with kidney problems
\nYour doctor may need to give you a lower dose
\nChildren and teenagers
\nThis medicine must not be given to children or teenagers.
\nProtect your skin from sunlight
\nKeep out of direct sunlight while taking this medicine and for 2 days after you stop taking it. This is
\nbecause your skin will become much more sensitive to the sun and may burn, tingle or severely blister if
\nyou do not take the following precautions:
\n\uf02d use high factor sun cream;
\n\uf02d always wear a hat and clothes which cover your arms and legs;
\n7
\n\uf02d avoid sun beds.
\nIf you take more LEFLOGARD tablets than you should
\nIf you accidentally take more tablets than you should, tell a doctor or get other medical advice
\nstraight away. Take the medicine pack with you. This is so the doctor knows what you have taken. The
\nfollowing effects may happen: convulsive fits (seizures), feeling confused, dizzy, less conscious, having
\ntremor and heart problems – leading to uneven heart beats as well as feeling sick (nausea) or having
\nstomach burning.
\nIf you forget to take LEFLOGARD tablets
\nIf you forgot to take a dose, take it as soon as you remember unless it is nearly time for your next dose.
\nDo not double-up the next dose to make up for the missed dose.
\nIf you stop taking LEFLOGARD tablets
\nDo not stop taking LEFLOGARD just because you feel better. It is important that you complete the course
\nof tablets that your doctor has prescribed for you. If you stop taking the tablets too soon, the
\ninfection may return, your condition may get worse or the microorganisms may become resistant to
\nthe medicine.
\nIf you have any further questions on the use of this product, ask your doctor or pharmacist.
\n4. Possible side effects
\nLike all medicines, this medicine can cause side effects, although not everybody gets them. These effects
\nare normally mild or moderate and often disappear after a short time.
\nStop taking LEFLOGARD and see your doctor or go to a hospital straight away if you notice the
\nfollowing side effects:
\nVery rare (may affect up to 1 in 10 000 patients)
\n\uf02d Allergic reaction. The signs may include: a rash, swallowing or breathing problems, swelling of
\nyour lips, face, throat or tongue.
\nStop taking LEFLOGARD and see your doctor or go to a hospital straight away if you notice the
\nfollowing side effects \u2013 you may need urgent medical treatment:
\nRare (may affect up to 1 in 1 000 patients)
\n\uf02d Watery diarrhoea which may have blood in it, possibly with stomach cramps and a high
\ntemperature. These could be signs of a severe bowel problem
\n\uf02d Pain and inflammation in your tendons or ligaments, which could lead to rupture. The Achilles
\ntendon is affected most often
\n\uf02d Fits (convulsions).
\n\uf02d Seeing or hearing things that are not there (hallucinations, paranoia), change in your opinion and
\nthoughts (psychotic reactions) with a risk of having suicidal thoughts or actions
\n\uf02d Feeling depressed, mental problems, feeling restless (agitation), abnormal dreams or nightmares
\n\uf02d Widespread rash, high body temperature, liver enzyme elevations, blood abnormalities
\n(eosinophilia), enlarged lymph nodes and other body organs involvement (Drug Reaction with
\nEosinophilia and Systemic Symptoms which is also known as DRESS or drug hypersensitivity
\nsyndrome). See also section 2
\n\uf02d Syndrome associated with impaired water excretion and low levels of sodium (SIADH).
\n8
\nVery rare (may affect up to 1 in 10 000 patients)
\n\uf02d Burning, tingling, pain or numbness. These may be signs of something called neuropathy
\nFrequency not known (frequency cannot be estimated from available data)
\n\uf02d Serious skin rashes including Stevens-Johnson syndrome and toxic epidermal necrolysis. These can
\nappear as reddish target-like macules or circular patches often with central blisters on the trunk, skin
\npeeling, ulcers of mouth, throat, nose, genitals and eyes and can be preceded by fever and flu-like
\nsymptoms. See also section 2.
\n\uf02d Loss of appetite, skin and eyes becoming yellow in colour, dark-coloured urine, itching, or tender
\nstomach (abdomen). These may be signs of liver problems which may include a fatal failure of the
\nliver.
\nIf your eyesight becomes impaired or if you have any other eye disturbances whilst taking LEFLOGARD,
\nconsult an eye specialist immediately.
\nVery rare cases of long lasting (even up to months or years) or permanent adverse drug reactions, such as
\ntendon inflammations, tendon rupture, joint pain, pain in the limbs, difficulty in walking, abnormal
\nsensations such as pins and needles, tickling, burning, numbness or pain (neuropathy), depression, fatigue,
\nsleep disorders, memory impairment, as well as impairment of hearing, vision, and taste and smell have
\nbeen associated with administration of quinolone and fluoroquinolone antibiotics in some cases
\nirrespective of pre-existing risk factors.
\nCases of an enlargement and weakening of the aortic wall or a tear in the aortic wall (aneurysms and
\ndissections), which may rupture and may be fatal, and of leaking heart valves have been reported in patients
\nreceiving fluoroquinolone. See also section 2.
\nTell your doctor if any of the following side effects gets serious or lasts longer than a few days:
\nCommon (may affect up to 1 in 10 patients)
\n\uf02d Sleeping problems;
\n\uf02d Headache, feeling dizzy;
\n\uf02d Feeling sick (nausea, vomiting) and diarrhoea;
\n\uf02d Increase in the level of some liver enzymes in your blood.
\nUncommon (may affect up to 1 in 100 patients)
\n\uf02d Changes in the number of other bacteria or fungi, infection by fungi named Candida, which may
\nneed to be treated;
\n\uf02d Changes in the number of white blood cells shown up in the results of some blood tests
\n(leukopenia, eosinophilia);
\n\uf02d Feeling stressed (anxiety), feeling confused, feeling nervous, feeling sleepy, trembling, a spinning
\nfeeling (vertigo);
\n\uf02d Shortness of breath (dyspnoea);
\n\uf02d Changes in the way things taste, loss of appetite, stomach upset or indigestion (dyspepsia), pain in
\nyour stomach area, feeling bloated (flatulence) or constipation;
\n\uf02d Itching and skin rash, severe itching or hives (urticaria), sweating too much (hyperhidrosis);
\n\uf02d Joint pain or muscle pain;
\n\uf02d Blood tests may show unusual results due to liver (bilirubin increased) or kidney (creatinine
\nincreased) problems;
\n\uf02d General weakness.
\nRare (may affect up to 1 in 1 000 patients)
\n9
\n\uf02d Bruising and bleeding easily due to a lowering in the number of blood platelets (thrombocytopenia);
\n\uf02d Low number of white blood cells (neutropenia);
\n\uf02d Exaggerated immune response (hypersensitivity);
\n\uf02d Lowering of your blood sugar levels (hypoglycaemia). This is important for people with diabetes;
\n\uf02d Tingly feeling in your hands and feet (paraesthesia);
\n\uf02d Problems with your hearing (tinnitus) or eyesight (blurred vision);
\n\uf02d Unusual fast beating of your heart (tachycardia) or low blood pressure (hypotension);
\n\uf02d Muscle weakness. This is important in people with myasthenia gravis (a rare disease of the nervous
\nsystem);
\n\uf02d Changes in the way your kidney works and occasional kidney failure which may be due to an
\nallergic kidney reaction called interstitial nephritis;
\n\uf02d Fever;
\n\uf02d Sharply demarcated, erythematous patches with\/without blistering that develop within hours of
\nadministration of levofloxacin and heals with postinflammatory residual hyperpigmentation; it usually
\nrecurs at the same site of the skin or mucous membrane upon subsequent exposure to levofloxacin.
\nFrequency not known (frequency can not be estimated from available data)
\n\uf02d Lowering in red blood cells (anemia): this can make the skin pale or yellow due to damage of the
\nred blood cells; lowering in the number of all types of blood cells (pancytopenia);
\n\uf02d Fever, sore throat and a general feeling of being unwell that does not go away. This may be due to a
\nlowering in the number of white blood cells (agranulocytosis);
\n\uf02d Loss of circulation (anaphylactic like shock);
\n\uf02d Increase of your blood sugar levels (hyperglycaemia) or lowering of your blood sugar levels leading
\nto coma (hypoglycaemic coma). This is important for people that have diabetes;
\n\uf02d Changes in the way things smell, loss of smell or taste (parosmia, anosmia, ageusia);
\n\uf02d Problems moving and walking (dyskinesia, extrapyramidal disorders);
\n\uf02d Temporary loss of consciousness or posture (syncope);
\n\uf02d Temporary loss of vision, inflammation of the eye;
\n\uf02d Impairment or loss of hearing;
\n\uf02d Abnormal fast heart rhythm, life-threatening irregular heart rhythm including cardiac arrest,
\nalteration of the heart rhythm (called prolongation of QT interval, seen on ECG, electrical activity
\nof the heart);
\n\uf02d Difficulty breathing or wheezing (bronchospasm);
\n\uf02d Allergic lung reactions;
\n\uf02d Pancreatitis;
\n\uf02d Inflammation of the liver (hepatitis);
\n\uf02d Increased sensitivity of your skin to sun and ultraviolet light (photosensitivity);
\n\uf02d Inflammation of the blood vessels due to an allergic reaction (vasculitis);
\n\uf02d Inflammation of the tissue inside the mouth (stomatitis);
\n\uf02d Muscle rupture and muscle destruction (rhabdomyolysis);
\n\uf02d Joint redness and swelling (arthritis);
\n\uf02d Pain, including pain in the back, chest and extremities;
\n\uf02d Attacks of porphyria in people who already have porphyria (a very rare metabolic disease);
\n\uf02d Persistent headache with or without blurred vision (benign intracranial hypertension)
\nReporting of side effects
\nIf you get any side effects, contact your doctor or pharmacist. This includes all listed in this leaflet. You
\ncan also report side effects directly via the national reporting system. Reporting of the adverse reactions
\ncontributes to getting more information on the safety of this medicine.
\n1
\n0
\n5. How to store LEFLOGARD tablets
\nKeep out of the sight and reach of children.
\nDo not use LEFLOGARD tablets after the expiry date stated on the carton packaging. The expiry date
\nrefers to the last day of the month.
\nNo special storage conditions are required.
\nDo not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose
\nof medicines you no longer use. These measures will help t protect the environment.
\n6. Contents of the pack and other information
\nWhat LEFLOGARD tablets contain
\n\uf02d The active ingredient is levofloxacin. Each film-coated tablet LEFLOGARD 500 mg contains
\nactive ingredient 500 mg levofloxacin (equivalent to 512.46 mg of levofloxacin hemihydrate).
\n\uf02d The other ingredients are:
\nTablet core: microcrystalline cellulose, hydroxypropylcellulose, crospovidone, magnesium stearate.
\nTablet coating: Opadry orange OY-S-33016 [hypromellose (\u0415464); FD & C blue #2\/ indigo carmine,
\naluminum-based pigment (\u0415132); FD & C yellow #6\/sunset yellow, aluminum-based pigment (\u0415110);
\nred iron oxide (E172); macrogol 4000; titanium dioxide (E171)], yellow iron oxide.
\nWhat LEFLOGARD looks like and contents of the pack
\nLEFLOGARD 500 mg film-coated tablets are orange, oval, convex and scored.
\nEach pack contains on blister with 10 tablets and a patient information leaflet.
\nMarketing Authorization Holder and Manufacturer:
\nManufacturer:
\nPHARMATHEN SA
\nDervenakion 6, Pallini 15351, Attikis, Greece
\nMarketing Authorization Holder:
\nTchaikapharma High Quality Medicines
\nInc. 1 G. M. Dimitrov Blvd., Sofia 1172,
\nBulgaria
\nFor further information on this medicinal product, please contact the Marketing Authorisation Holder:
\nTchaikapharma High Quality Medicines
\nInc. 1 G. M. Dimitrov Blvd., Sofia 1172,
\nBulgaria Phone: +359 2 962 54 54
\nFax: +359 2 9603 703
\ne-mail: info@tchaikapharma.com
\nThis leaflet was last revised in: Januar<\/p>\n","protected":false},"excerpt":{"rendered":"
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