LEVOXIGRAM 250 mg Tabletki Powlekane

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1. Levoxigram 250 mg film-coated tablets, 500 mg film-coated tablets
   1. WHAT IS LEVOXIGRAM AND WHAT IT IS USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE TAKING LEVOXIGRAM
   3. HOW TO TAKE LEVOXIGRAM
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE LEVOXIGRAM
   6. PACKAGE CONTENTS AND OTHER INFORMATION

Levoxigram 250 mg film-coated tablets, 500 mg film-coated tablets

Levofloxacin
Generic medicine

Read this leaflet carefully before you start to take this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• 1. What Levoxigram is and what it is used for
• 2. What you need to know before you take Levoxigram
• 3. How to take Levoxigram
• 4. Possible side effects
• 5. How to store Levoxigram
• 6. Contents of the pack and other information

1. WHAT IS LEVOXIGRAM AND WHAT IT IS USED FOR

Levoxigram tablets contain the active ingredient levofloxacin. This medicine belongs to a
group of medicines called antibiotics. Levofloxacin is a ”quinolone” antibiotic. This
medicine works by killing the bacteria that cause infections in the body.

Levoxigram tablets can be used for the treatment of infections:

• Of the facial sinuses
• Of the lungs, in patients with chronic respiratory problems or pneumonia
• Of the urinary tract, including kidneys and bladder
• Of the prostate, where a persistent infection may develop
• Of the skin and subcutaneous tissue, including muscles. These are sometimes called “soft tissues”.

2. WHAT YOU NEED TO KNOW BEFORE TAKING LEVOXIGRAM

Do not take Levoxigram:

• if you are allergic to levofloxacin, to any other quinolone antibiotic such as moxifloxacin, ciprofloxacin or ofloxacin or to any of the other ingredients of this medicine (listed in section 6). The signs of an allergic reaction include: skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue.
• if you have ever had epilepsy.
• if you have ever had problems affecting your tendons, such as tendinitis, related to treatment with a “quinolone antibiotic”. Tendons are fibrous structures that connect muscles to the skeleton
• if you are a child or adolescent during the growth period
• if you are pregnant, planning to become pregnant or if you believe you may be pregnant
• if you are breastfeeding Do not take this medicine if you recognize any of the situations above. If you have any doubts, ask your doctor or pharmacist before taking Levoxigram.

Warnings and precautions
Before taking this medicine
You should not take antibacterial medicines based on quinolones/fluoroquinolones, including Levoxigram, if you have previously had any serious adverse reaction during treatment with a quinolone or fluoroquinolone. In such cases, inform your doctor as soon as possible.

When taking this medicine
Rarely, pain and swelling in the joints and inflammation or rupture of the tendons can occur. The risk is greater if you are elderly (over 60 years of age), if you have received an organ transplant, if you have kidney problems or if you are being treated with corticosteroids. Inflammation and rupture of tendons can occur within the first 48 hours of treatment and up to several months after the end of therapy with Levoxigram. At the first signs of pain or inflammation in a tendon (for example in the ankle, wrist, elbow, shoulder or knee), stop treatment with Levoxigram, consult your doctor and keep the painful part at rest. Avoid any unnecessary movement, as the risk of tendon rupture may increase.
Rarely, symptoms of nerve damage (neuropathy) such as pain, burning, tingling, numbness and/or weakness may occur, particularly in the feet and legs or in the hands and arms. In such cases, stop treatment with Levoxigram and inform your doctor immediately, to prevent nerve damage from becoming permanent.

Serious, prolonged, disabling and potentially non-reversible adverse effects
Antibacterial medicines based on fluoroquinolones/quinolones, including Levoxigram, have been associated with very rare but serious adverse effects, some of which are prolonged (lasting months or years), disabling or potentially non-reversible. These include pain in the tendons, muscles and joints of arms and legs, difficulty walking, abnormal sensations such as prickling, tingling, itching, numbness or burning (paresthesia), sensory organ disorders such as alteration of vision, taste, smell and hearing, depression, memory impairment, severe fatigue and severe sleep disturbances.
If you experience any of these adverse effects after taking Levoxigram, contact your doctor immediately before continuing treatment. The doctor will decide together with you whether to continue treatment and will also consider the use of an antibiotic from another class.

Consult your doctor or pharmacist before taking Levoxigram:

• if you have developed a severe skin reaction or peeling of the skin, blisters and/or ulcers in the mouth after taking any medicine containing levofloxacin
• if you are 60 years of age or older
• if you are taking corticosteroids, sometimes called steroids (see “Other medicines and Levoxigram”)
• if you have had seizures (convulsions)
• if you have suffered brain damage following a stroke or other brain damage
• if you have kidney problems
• if you suffer from a disease known as “glucose-6-phosphate dehydrogenase deficiency”. Administration of this medicine makes the development of serious blood problems more likely
• if you have suffered from mental health problems
• if you have been diagnosed with an enlargement or “bulging” of a large blood vessel (aortic aneurysm or peripheral aneurysm of a large blood vessel)
• if you have previously experienced episodes of aortic dissection (a tear in the wall of the aorta)
• if you have been diagnosed with insufficiency of one of the heart valves (aortic and mitral regurgitation)
• if you have a family history of aortic aneurysm, aortic dissection or congenital heart valve disease, or other risk factors or predisposing conditions (e.g. connective tissue diseases such as Marfan syndrome, Ehlers-Danlos syndrome, Turner syndrome, Sjögren's syndrome [an autoimmune inflammatory disease] or if you suffer from vascular diseases such as Takayasu arteritis, giant cell arteritis, Behcet's syndrome, high blood pressure or known atherosclerosis, rheumatoid arthritis [an autoimmune inflammatory disease] or endocarditis [inflammation of the heart]).
• if you have had heart problems: you should use caution when using this type of medicine if you were born with or have a family history of prolongation of the QT interval (seen on an electrocardiogram, the electrical trace of the heart), have an imbalance of salts in the blood (especially low levels of potassium or magnesium in the blood), have a very slow heart rate (called “bradycardia”), have a weak heart (heart failure), have had a heart attack (myocardial infarction), are a

woman or elderly/a and are taking other medicines that can alter the electrocardiogram (see section “Other medicines and Levoxigram”).

• if you have diabetes
• if you have had liver problems
• if you have myasthenia gravis
• if you have or suspect you have an infection with S. Aureusresistant to methicillin (MRSA)

If you have any doubt that any of the above may apply to you, consult your doctor or pharmacist before taking Levoxigram.

During the taking of Levoxigram:

• if you experience sudden abdominal, chest or back pain, which may be a symptom of aneurysm and aortic dissection, go to the emergency room immediately. The risk may be greater if you are taking systemic corticosteroids.
• immediately inform your doctor if you notice a rapid onset of shortness of breath, especially when lying down in bed, or swelling of the ankles, feet or abdomen, or new episodes of palpitations (feeling of rapid or irregular heartbeat).

Severe skin reactions
Severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with the use of levofloxacin.

• SJS and TEN can initially appear on the body as reddish spots or circular patches often with central blisters. Ulcers of the mouth, throat, nose, genitals and eyes (red and swollen eyes) can also occur. These severe rashes are often preceded by fever and/or flu-like symptoms. The rashes can progress to widespread peeling of the skin and life-threatening or fatal complications.
• DRESS initially presents as flu-like symptoms and a skin rash on the face, then an extensive rash with fever, increased levels of liver enzymes in blood tests and an increase in a type of white blood cells (eosinophilia) and swollen lymph nodes.

If you develop a severe skin rash or any other of these skin symptoms, stop taking levofloxacin and contact your doctor or seek medical attention immediately.

Other medicines and Levoxigram
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Levoxigram can affect the mechanism of action of other medicines. Also, some medicines can affect the mechanism of action of Levoxigram.

In particular, inform your doctor if you are taking any of the following medicines. This is because taking Levoxigram in combination with other medicines may increase the possibility that you experience adverse effects:

• corticosteroids, sometimes called steroids - used for the treatment of inflammation. The possibility that you develop inflammation and/or rupture of the tendons is greater.
• warfarin - used to thin the blood. The possibility that you experience bleeding is greater. The doctor may ask you to have regular blood tests to check your blood clotting.
• theophylline - used for breathing problems. The possibility that you experience a seizure (epileptic fit) is greater if you take theophylline in combination with Levoxigram.
• non-steroidal anti-inflammatory drugs (NSAIDs) - used for pain and inflammation such as aspirin, ibuprofen, fenbufen, ketoprofen and indometacin. The possibility that you experience a seizure (epileptic fit) if taken in combination with Levoxigram is greater.
• cyclosporine - used for organ transplants. The possibility that you experience the typical adverse effects of cyclosporine is greater.
• medicines known for their effects on the heartbeat. These include medicines used to treat 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 and cimetidine - used for ulcers and heartburn.

Pay particular attention when taking each of these medicines with Levoxigram. The doctor may prescribe you a lower dosage if you suffer from kidney problems.

Do not take Levoxigram tablets at the same time as the following medicines. This is because the mechanism of action of Levoxigram tablets may be affected:

• iron salts in tablets (for anemia), zinc supplements, antacids containing magnesium or aluminum (for acidity or heartburn), didanosine or sucralfate (for gastric ulcers). See section 3 “if you are taking iron salts in tablets, zinc supplements, antacids, didanosine or sucralfate”.

Urine test for opioids
In patients taking Levoxigram, urine tests may give “false-positive” results for strong painkillers called “opioids”. If the doctor deems it necessary to perform urine tests on you, inform him/her that you are taking Levoxigram.

Tuberculosis test
This medicine may cause “false-negative” results in some laboratory tests that look for the bacteria that cause tuberculosis.

Pregnancy and breastfeeding
Do not take this medicine if:

• you are pregnant, may become pregnant or think you may be pregnant
• you are breastfeeding or think you may be breastfeeding

Driving and using machines
Some adverse effects may occur after taking this medicine and include dizziness, drowsiness, a subjective sensation of movement (vertigo) or visual disturbances. Some of these adverse effects may alter your ability to concentrate and your reaction speed. If this happens, do not drive vehicles or perform activities that require a high level of attention.

Levoxigram tablets contains the colourant sunset yellow (E110)
This medicine contains the colourant sunset yellow (E110) which may cause allergic reactions.

3. HOW TO TAKE LEVOXIGRAM

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
If you are not sure, ask your doctor or pharmacist.

Taking this medicine

• Take this medicine by mouth
• Swallow the tablets whole with a glass of water
• The tablets can be taken during meals or at any time between meals
• The tablets can be divided into two equal parts

Protect the skin from sunlight
Do not expose yourself to direct sunlight during treatment with this medicine and for 2 days after the
end of treatment. This is because the skin will become much more sensitive to the sun and can burn, itch or
become severely blistered, if you do not observe the following precautions:

• Make sure to use sunscreens with a high protection factor
• Always wear a hat and clothes that cover your arms and legs
• Avoid “solariums”.

If you are already taking iron salts in tablets, zinc supplements, antacids, didanosine or
sucralfate

• Do not take these medicines at the same time as Levoxigram tablets. Take the prescribed dose of these medicines at least 2 hours before or after taking Levoxigram tablets.

How much medicine to take

• The doctor will decide how much Levoxigram tablets you should take
• The dose will depend on the type of infection you have contracted and the location of the infection in the body
• The duration of treatment depends on the severity of the infection
• If you think that the effect of the medicine is too weak or too strong, do not change the dosage on your own initiative, but consult your doctor.

Use in adults and the elderly:

Sinus infection

• Two Levoxigram 250 mg tablets once a day
• Or one Levoxigram 500 mg tablet once a day

Lung infections in patients with chronic respiratory problems

• Two Levoxigram 250 mg tablets once a day
• Or one Levoxigram 500 mg tablet once a day

Pneumonia

• Two Levoxigram 250 mg tablets one or two times a day
• Or one Levoxigram 500 mg tablet one or two times a day

Urinary tract infections including kidneys or bladder

• One or two Levoxigram 250 mg tablets once a day
• Or ½ or one Levoxigram 500 mg tablet once a day

Prostate infections

• Two Levoxigram 250 mg tablets once a day
• Or one Levoxigram 500 mg tablet once a day

Skin and subcutaneous tissue infections including muscles

• Two Levoxigram 250 mg tablets one or two times a day
• Or one Levoxigram 500 mg tablet one or two times a day

Use in adults and the elderly with kidney problems:
your doctor may decide to give you a reduced dose.

Use in children and adolescents:
This medicine should not be given to children or adolescents.

If you take more Levoxigram tablets than you should
If you accidentally take more tablets than you should, inform your doctor immediately or seek
immediate medical advice. Bring the medicine packaging with you. This will allow the doctor to
know what you have taken. The following side effects may occur: seizures (epileptic fit), confusion, dizziness, feeling of fainting, tremor and heart problems – which
can lead to irregular heartbeat and a feeling of unwellness (nausea) or heartburn.

If you forget to take Levoxigram tablets
If you forget to take a dose, take it as soon as you remember, unless it is almost time
for the next dose. Do not take a double dose to make up for the missed dose.

If you stop taking Levoxigram tablets
Do not stop taking Levoxigram just because you feel better. It is important that you complete the course of
tablets prescribed by your doctor. If you stop taking the tablets too early,
the infection may return and the condition may worsen or bacteria may develop
resistances to the medicine.
If you have any doubts about 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 everyone will experience them.
Usually, these effects are mild or moderate and often disappear after a short time.

Stop taking Levoxigram and seek immediate medical attention or go to hospital if you notice
the following side effects:
Rare(may affect up to 1 in 1,000 people)

• widespread rash, fever, increased liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes and involvement of other body organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome). See also section 2.
• syndrome associated with insufficient water excretion and low sodium levels (SIADH)
• you have an allergic reaction. Signs may include: skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue
• seeing or hearing things that are not there (hallucinations, paranoia), changes in opinion and reconsideration (psychotic reactions) with the possibility of developing suicidal thoughts or acts

Stop taking Levoxigram and seek immediate medical attention if you notice any of
the following side effects – you may need to receive urgent medical treatment:
Rare

• pain and inflammation of tendons or ligaments which may rupture in some cases. The Achilles tendon is most often affected.
• convulsions

Not known(frequency cannot be estimated based on available data)

• watery diarrhoea with possible blood, sometimes accompanied by stomach cramps and high fever. This may be a sign of a serious intestinal problem
• burning, tingling, pain or numbness. These signs may be indicative of a disease called “neuropathy”
• severe skin rashes including Stevens-Johnson syndrome and toxic epidermal necrolysis. These can appear on the body as reddish spots or as circular patches often with central blisters, skin peeling, ulcers of the mouth, throat, nose, genitals and eyes and may be preceded by fever and flu-like symptoms. See also section 2.
• loss of appetite, yellowing of the skin and eyes, dark urine, itching or stomach pain (abdomen). These may be signs of liver problems that can include fatal liver failure (liver failure that can cause death).

If your vision becomes blurred or if you experience any discomfort in your eyes when taking
Levoxigram, consult an ophthalmologist immediately.

Inform your doctor if any of the following side effects worsen or last for more than a few
days:
Common(may affect up to 1 in 10 people)

• problems sleeping
• headache, dizziness
• feeling unwell (nausea, vomiting) and diarrhoea
• increased levels of liver enzymes in the blood

Uncommon(may affect up to 1 in 100 people)

• changes in the number of other bacteria or fungi, fungal infection called Candida, which may require the initiation of treatment
• changes in the number of white blood cells shown in some blood tests (leukopenia, eosinophilia)
• feeling stressed (anxiety), feeling confused, feeling nervous, drowsiness, tremor, dizziness
• shortness of breath (dyspnea)
• change in the taste of things, loss of appetite, stomach upset or indigestion (dyspepsia), pain in the stomach area, feeling bloated (flatulence), constipation
• itching and rash, severe itching or hives, excessive sweating (hyperhidrosis)
• joint or muscle pain
• blood tests may show abnormal results due to liver (increased bilirubin) or kidney (increased creatinine) problems
• general weakness

Rare(may affect up to 1 in 1000 people)

• bruising and easy bleeding due to a reduction in the number of platelets in the blood (thrombocytopenia)
• low number of white blood cells (neutropenia)
• decrease in blood sugar levels (hypoglycemia). This is important for those who suffer from diabetes
• feeling depressed, mental problems, feeling restless (agitation), abnormal dreams or nightmares
• feeling of tingling in the hands and feet (paresthesia)
• problems with hearing (tinnitus) or vision (blurred vision)
• unusually fast heartbeat (tachycardia) or low blood pressure (hypotension)
• muscle weakness. This is important for patients who suffer from myasthenia gravis (a rare disease of the nervous system)
• changes in kidney function and occasional kidney failure which may be caused by an allergic reaction to the kidneys called interstitial nephritis
• fever
• clearly defined erythematous patches, with or without blister formation that develop within a few hours of levofloxacin administration and heal leaving the reddened part; usually reappear in the same area of the skin or mucosa after subsequent exposure to levofloxacin

Not known:

• decrease in red blood cells (anemia). This can lead to paleness or yellowish skin due to damage to red blood cells and a decrease in the number of all types of cells in the blood (pancytopenia)
• fever, sore throat and a general feeling of unwellness that does not go away. This may be due to a decrease in the number of white blood cells in the blood (agranulocytosis)
• lack of blood flow (anaphylactic shock)
• increased blood sugar levels (hyperglycemia) or decreased blood sugar levels leading to coma (hypoglycemic coma). This is important for those who suffer from diabetes
• change in the smell of things, loss of smell or taste (parosmia, anosmia, ageusia)
• difficulty moving and walking (dyskinesia, extrapyramidal disorders)
• temporary loss of consciousness or posture (syncope)
• temporary loss of vision,
• worsening or loss of hearing
• unusually fast heartbeat, irregular heartbeat with life-threatening risk including cardiac arrest, changes in heartbeat (called “prolongation of the QT interval” seen on the electrocardiogram, electrical activity of the heart)
• difficulty breathing or wheezing (bronchospasm)
• allergic reactions to the lungs
• inflammation of the pancreas (pancreatitis)
• inflammation of the liver (hepatitis)
• increased sensitivity of the skin to the sun or ultraviolet rays (photosensitivity)
• inflammation of the blood vessels throughout the body due to an allergic reaction (vasculitis)
• inflammation of the inner tissues of the mouth (stomatitis)
• breakdown and destruction of muscles (rhabdomyolysis)
• redness and swelling of the joints (arthritis)
• pain, including back pain, chest pain, and extremity pain
• attacks of porphyria in patients already suffering from porphyria (a very rare metabolic disease)
• persistent headache with or without blurred vision (benign intracranial hypertension)

Very rare cases of prolonged (lasting months or years) or permanent adverse drug reactions, such as
inflammation of the tendons, tendon rupture, joint pain, arm or leg pain, difficulty
walking, abnormal sensations such as prickling, tingling, itching, burning, numbness or pain
(neuropathy), depression, fatigue, sleep disorders, impaired memory and alteration
of hearing, vision, taste and smell, have been associated with the use of antibiotics of the
quinolone and fluoroquinolone type, in some cases independently of pre-existing risk factors.
Cases of dilation and weakening of the wall of the aorta or tearing of the aortic wall (aneurysms and
dissections), with possible ruptures that can cause death, as well as cases of backflow of blood from
the heart valves, have been reported in patients treated with fluoroquinolones. See also section 2.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your
doctor or pharmacist. You can also report side effects directly through the national reporting system at
http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can contribute to providing more information on the safety of
this medicine.

5. HOW TO STORE LEVOXIGRAM

Keep this medicine out of the sight and reach of children .
Do not use this medicine after the expiry date stated on the packaging and on the blister after
“SCAD.” or “EXP”. The expiry date refers to the last day of that month.
Keep the blister in the carton to protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. PACKAGE CONTENTS AND OTHER INFORMATION

What Levoxigram contains
The active ingredient is levofloxacin.
Each Levoxigram 250 mg film-coated tablet contains levofloxacin hemihydrate
equivalent to 250 mg of levofloxacin.
Each Levoxigram 500 mg film-coated tablet contains levofloxacin hemihydrate
equivalent to 500 mg of levofloxacin.
The other ingredients are:
Tablet core: Microcrystalline cellulose, hydroxypropylcellulose, crospovidone, magnesium
stearate.
Film coating: Hypromellose, FD&C Blue 2 indigo carmine - aluminum lake (E132), FD&C Yellow
6 sunset yellow - aluminum lake (E110), iron oxide red (E172), macrogol 4000, titanium dioxide
(E171). In addition, the 500 mg tablets contain iron oxide yellow (E172).

Description of the appearance of Levoxigram tablets and package contents
Levoxigram 250 mg tablets are pink, oblong, biconvex with a break line.
Levoxigram 500 mg tablets are orange, oblong, biconvex with a break line.
Levoxigram 250 mg film-coated tablets are packaged in blisters and are available in
packs of 1, 5, 7 and 10 tablets.
Levoxigram 500 mg film-coated tablets are packaged in blisters and are available in
packs of 1, 5, 7 and 10 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Aesculapius Farmaceutici S.r.l.
Via Cefalonia, 70 - 25124 Brescia

Manufacturer:
Pharmathen S.A.
6 Dervenekion str.,
15351 Pallini, Attiki
Greece