GRAY 250 mg Tabletki Powlekane

Treść ulotki

1. GRAY 500 mg film-coated tablets
   1. What is GRAY 500 mg and what is it used for
   2. What you need to know before taking GRAY 500 mg
   3. How to take GRAY 500 mg
   4. Possible side effects
   5. How to store GRAY 500 mg
   6. Contents of the pack and other information
2. GRAY 250 mg film-coated tablets
   1. What is GRAY 250 mg and what is it used for
   2. What you need to know before taking GRAY 250 mg
   3. How to take GRAY 250 mg
   4. Possible side effects
   5. How to store GRAY 250 mg
   6. Contents of the pack and other information

GRAY 500 mg film-coated tablets

Levofloxacin
Generic medicine

Read this leaflet carefully before you start taking this medicine as 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 because it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What GRAY 500 mg is and what it is used for
• 2. What you need to know before you take GRAY 500 mg
• 3. How to take GRAY 500 mg
• 4. Possible side effects
• 5. How to store GRAY 500 mg
• 6. Contents of the pack and other information

1. What is GRAY 500 mg and what is it used for

GRAY 500 mg is a broad-spectrum antibiotic, which means that GRAY 500 mg works by eliminating
many types of bacteria that can cause infections (pathogens). GRAY 500 mg contains the active
ingredient levofloxacin. This active ingredient belongs to the class of antibiotics called quinolones.
In adults with mild or moderate infections GRAY 500 mg is used for the treatment
of infections against which the drug is active, such as:

• sinus infections
• lung and lower airway infections (lower respiratory tract): acute cases of chronic bronchitis or pneumonia
• complicated urinary tract infections (e.g. with kidney involvement)
• chronic bacterial infection of the prostate (prostatitis)
• skin and soft tissue infections.

2. What you need to know before taking GRAY 500 mg

DO NOT take GRAY 500 mg

• if you are allergic (hypersensitive) to levofloxacin, to any of the excipients of GRAY 500 mg (see section 6) or to other quinolone antibiotics such as moxifloxacin, ciprofloxacin or ofloxacin.
• if you suffer from epilepsy
• if you have a history of tendon problems related to treatment with an antibiotic of the quinolone class
• during pregnancy
• during breastfeeding.

These tablets should not be given to children or adolescents in a growth phase.

Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine:

• if you have developed a severe skin reaction or skin peeling, blisters and/or ulcers in the mouth after taking any medicine containing levofloxacin.
• 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 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 Ehlers-Danlos syndrome, Turner syndrome, Sjögren's syndrome [an autoimmune inflammatory disease], or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behcet's disease, high blood pressure or known atherosclerosis, rheumatoid arthritis [an autoimmune inflammatory disease] or endocarditis [inflammation of the heart]).
• you should not take antibacterial medicines based on quinolones/fluoroquinolones, including GRAY 500 mg, if you have had any serious adverse reactions in the past during treatment with a quinolone or fluoroquinolone. In this case, inform your doctor as soon as possible.
• in the most severe cases of pneumoniacaused by certain pathogens (e.g. S. Pneumoniae). Ask your doctor for advice, as GRAY 500 mg may not be the optimal therapy.
• in infections contracted in a hospital environmentcaused by certain pathogens (e.g. Pseudomonas aeruginosa). Consult your doctor, as these may require combination therapy.
• in infections caused by certain pathogens (so-called MRSA).Consult your doctor, as these may require combination therapy.
• if you have severe, persistent and/or bloody diarrheaduring or after treatment with GRAY 500 mg. Inform your doctor immediately, as this diarrhea may be a symptom of a severe intestinal inflammation (enterocolitis), which can occur following antibiotic treatment. Stop taking GRAY 500 mg. Your doctor will change your treatment. Do not take anti-diarrheal medications that slow down bowel movements. Consult your doctor or pharmacist for this.
• if you are prone to a greater predisposition to seizures. During treatment with GRAY 500 mg, the risk of epileptic seizures may be higher if you have previously suffered brain damage such as a stroke or severe brain injury. You must inform your doctor if you have experienced such events in the past. You should not take the tablets if you suffer from epilepsy. The tendency to convulsions may also be greater during concomitant treatment with fenbufen and other similar non-steroidal anti-inflammatory drugs used for pain and inflammation such as aspirin, ibuprofen, ketoprofen and indometacin or theophylline (see also “Use with other medicines”). If convulsions occur, treatment should be discontinued.
• if you suffer from glucose-6-phosphate dehydrogenase deficiency(an inherited metabolic defect). Patients with this disease may tend to have red blood cell destruction (hemolysis) when treated with quinolone antibacterial agents. Therefore, GRAY 500 mg should be used with caution in these patients.
• if you suffer from renal impairment. Ask your doctor how the dose should be adjusted (see section 3 “How to take GRAY 500 mg”).
• if you experience severe allergic (hypersensitivity) reactions(sometimes following the initial dose). Seek immediate medical attention or go to the nearest hospital. Stop treatment with GRAY 500 mg.
• if you are using oral hypoglycemic drugs(e.g. glibenclamide) or insulin. Your blood sugar levels need to be carefully monitored, as your blood sugar levels may drop too low. Symptoms may include: increased appetite, nervousness, sweating, tremors.
• if you are exposed to strong sunlight or ultraviolet rays.Photosensitization (hypersensitivity to light with sunburn-like reactions) is a rare event with levofloxacin. However, it is recommended to avoid unnecessary exposure to strong sunlight or artificial ultraviolet rays (e.g. sunbeds, solariums) to prevent photosensitization.
• if you are being treated concomitantly with a vitamin K antagonist(certain agents with an effect on blood clotting time, e.g. warfarin, phenprocoumon). Blood clotting time values and the tendency to bleed may be increased. Blood clotting tests should be monitored (see also section “Use with other medicines”).
• if you suffer from psychosis or have previously suffered from a psychiatric illness.Psychotic reactions have been reported in patients treated with quinolones, including levofloxacin. In very rare cases, these progress to suicidal thoughts and self-harming behaviors - sometimes after a single dose of levofloxacin. If these reactions occur, stop treatment and inform your doctor. He will decide on appropriate measures and further treatment.

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 may initially appear on the body as reddish spots or circular patches often with central blisters. Ulcers in the mouth, throat, nose, genitals and eyes (red and swollen eyes) may also occur. These severe skin rashes are often preceded by fever and/or flu-like symptoms. The rashes may progress to widespread skin peeling and life-threatening or fatal complications.
• DRESS initially presents as flu-like symptoms and a skin rash on the face, then a widespread 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 immediate medical attention.

Before taking Gray 500 mg

• Heart problems Particular attention should be paid when using this type of medicine if you were born with or have a family history of prolonged QT interval (displayed on an ECG, an electrical recording of the heart), have a salt imbalance in the blood (especially a low level of potassium or magnesium in the blood), have a very slow heart rate (called bradycardia), have a weak heart (heart failure), have a history of heart attack (myocardial infarction), if you are a woman or an elderly patient or if you are taking other medicines that can cause abnormal changes on the ECG (see section Taking with other medicines)
• if you have symptoms of nerve injury,such as sensory disturbances in the hands and feet. In this case, consult your doctor immediately. Stop GRAY 500 mg to prevent possible damage.
• if a laboratory urine test for opioidsis planned for you. The test may give a false positive result. It may be necessary to confirm a positive result using more specific methods.
• if you have symptoms of liver disease,such as jaundice, dark urine, itching, loss of appetite (anorexia) and soft abdomen. Stop treatment with GRAY 500 mg and consult your doctor.
• in cases of myasthenia gravis

During the taking of GRAY:

• if you experience severe, 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, or swelling of the ankles, feet or abdomen, or new episodes of palpitations (feeling of a rapid or irregular heartbeat).
• If you begin to experience sudden involuntary jerks, fasciculations or muscle contractions - see a doctor immediately as these may be signs of myoclonus. The doctor may need to stop treatment with levofloxacin and start appropriate treatment.
• If you experience nausea, a general feeling of unwellness, severe or persistent abdominal discomfort or pain, or vomiting, contact your doctor immediately as these may be a sign of inflammation of the pancreas (acute pancreatitis).
• In case of fatigue, paleness of the skin, bruising, uncontrolled bleeding, fever, sore throat and severe worsening of your general condition, or if you feel that your resistance to infections has decreased - see a doctor immediately as these may be signs of a blood disease. The doctor must monitor the blood with a blood count. If the blood count is abnormal, the doctor may need to stop treatment.

Pain and swelling in the joints and inflammation or rupture of the tendons can rarely 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 GRAY 500 mg. At the first signs of pain or inflammation in a tendon (for example in the ankle, wrist, elbow, shoulder or knee), stop treatment with GRAY 500 mg, see a 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, especially in the feet and legs or hands and arms, can occur. In this case, stop treatment with GRAY 500 mg and immediately inform the doctor to prevent nerve damage from becoming permanent.
If your vision should decrease or your eyes should be compromised in any other way, consult an ophthalmologist immediately.

Serious, prolonged, disabling and potentially irreversible side effects
Antibacterial medicines based on fluoroquinolones/quinolones, including GRAY 500 mg, have been associated with very rare but serious side effects, some of which are prolonged (lasting months or years), disabling or potentially irreversible. These include pain in tendons, muscles and joints of arms and legs, difficulty walking, abnormal sensations such as tingling, prickling, itching, numbness or burning (paresthesia), sensory organ disorders such as alteration of vision, taste, smell and hearing, depression, impairment of memory, severe fatigue and severe sleep disorders.
If you experience any of these side effects after taking GRAY 500 mg, contact your doctor immediately before continuing treatment. The doctor will decide together with you whether to continue treatment and will also consider using an antibiotic from another class.

Children
Children or adolescents in a growth phase should not take GRAY 500 mg, as the risk of damage to joint tissues cannot be excluded.

Elderly
Renal impairment is frequently found in this group. You should therefore ask your doctor if a dose adjustment may be necessary (see section 3. “How to take GRAY 500 mg”).

Other medicines and GRAY 500 mg
You must inform your doctor if you are taking other medicines that can alter your heart rhythm:
medicines that belong to the class of antiarrhythmics (for example quinidine, hydroquinidine,
disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some
antimicrobials (which belong to the class of macrolides), some antipsychotics.

• Corticosteroids,sometimes called steroids - used for inflammation. You are more likely to have inflammation and/or tendon ruptures.
• Vitamin K antagonists, e.g. warfarin, phenprocoumon - used to thin the blood. Increases the risk of bleeding. Your doctor may need to have regular blood tests to assess whether your blood is able to coagulate.
• Theophylline- used for breathing problems: increases the likelihood that you will have a seizure (epileptic fit) if taken with GRAY 500 mg.
• Non-steroidal anti-inflammatory drugs (NSAIDs)- used for pain and inflammation such as aspirin, ibuprofen, fenbufen, ketoprofen and indometacin: Increases the likelihood that you will have a seizure (epileptic fit) if taken with GRAY 500 mg.
• Cyclosporine- used after an organ transplant: the effect of cyclosporine may be prolonged if used in association with GRAY 500 mg .
• Probenecid- used for gout and cimetidine- used for ulcers and heartburn: the elimination (renal clearance) of levofloxacin is slightly reduced. However, this is unlikely to affect your treatment. Nevertheless, be careful when taking GRAY 500 mg together with drugs such as probenecidand cimetidine, which affect renal elimination. If you have kidney problems, your doctor may prescribe a reduced dose.

Do not take GRAY 500 mg at the same time as the following medicines. This is because
an interaction with the mode of action of GRAY 500 mg may occur:

• Iron tablets(for anemia), zinc supplements, antacids containing magnesium or aluminum(for acidity or heartburn), didanosine or sulcralfate(for gastric ulcers). Therefore, you must take GRAY 500 mg at least 2 hours before or after using these medicines.

Urine tests for opioids
Urine tests may show ‘false positive’ results for strong painkillers called
‘opioids’ in people taking GRAY 500 mg. If your doctor is about to prescribe urine tests, tell them that you are taking GRAY 500 mg.

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

GRAY 500 mg with food, beverages and alcohol
Do not drink alcohol during treatment with GRAY 500 mg.

Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
You must not take GRAY 500 mg if you are pregnant, if you are trying to become pregnant, if you are breastfeeding
or planning to do so. Tell your doctor if you discover you are pregnant while taking GRAY 500
mg.

Driving and using machines
Some undesirable effects of GRAY 500 mg such as dizziness, drowsiness, visual disturbances (see also
section “4. Possible side effects”) may impair your ability to concentrate and react and may therefore constitute a risk in situations where these
abilities are particularly important. Do not drive, do not use machines or perform activities without
secure support if you notice that these abilities are impaired. Be particularly careful when
drinking alcohol.

Gray contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially
“sodium-free”

3. How to take GRAY 500 mg

Take this medicine following exactly the instructions of your doctor. If you have doubts
consult your doctor or pharmacist.

The recommended dose is:see Table 1

Since levofloxacin is mainly excreted by the kidneys, the dose must be adjusted in
patients with reduced renal function. See the details in table 2:

Table 2: Dosage in patients with reduced renal function
Dosage regimen
250 mg/24 hours 500 mg/24 hours 500 mg/12 hours

Creatinine clearanceFirst dose: 250 First dose: 500 First dose: 500
mg

• 50 – 20 ml/min then: 125 mg/24 hours then: 250 mg /24 hours then: 250 mg/12 hours
• 19 – 10 ml/min then: 125 mg/48 hours then: 125 mg/24 hours then: 125 mg/12 hours <10 ml/min (including hemodialysis and mg mg

then: 125 mg/48 hours then: 125 mg/24 hours then: 125 mg/24 hours
CAPD)
= No additional doses are required after hemodialysis or continuous ambulatory peritoneal dialysis
(CAPD).
No dosage adjustment is required if you have reduced liver function. Levofloxacin
is only marginally metabolized in the liver.

Taking this medicine
Swallow the film-coated tablets without chewing and with sufficient liquid
(e.g. from ½ to 1 glass of water). If you need to adjust the dose, you can break the
film-coated tablets along the breaking line. You can take the film-coated tablets during
meals or at any time between meals.
See also section “Other medicines and GRAY 500 mg”.

Duration of treatment
The duration of treatment will depend on the severity of your infection. Your doctor will decide the optimal duration
of treatment.
If you notice that the effect of GRAY 500 mg is too strong or too weak, inform your doctor or pharmacist.

If you take more GRAY 500 mg than you should
If you accidentally take one too many film-coated tablet of GRAY 500 mg,
nothing will probably happen. In case you accidentally take several
too many film-coated tablets, contact your doctor immediately. You may experience the
following symptoms:

• symptoms at the level of the central nervous system (confusion, dizziness, decreased state of consciousness and seizures)
• gastrointestinal reactions such as nausea and erosion of the mucous membranes
• certain changes in cardiac function (prolongation of the QT interval). Therefore, your cardiac function must be monitored by your doctor (ECG) in case of overdose. The doctor will adopt a treatment according to your symptoms (e.g. gastric lavage or administration of antacids). Levofloxacin is not removed from the body by dialysis. There is no specific antidote.

If you forget to take GRAY 500 mg
Take the forgotten dose as soon as you remember, unless it is almost time to take the
next dose. In this case, continue taking GRAY 500 mg at the usual time, at the dose prescribed by
your doctor. Do not take a double dose to make up for the forgotten tablet

If you stop taking GRAY 500 mg
Do not stop taking GRAY 500 mg without your doctor's approval. The treatment may fail,
if you stop it too early.
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 everybody gets them.
Usually, these effects are mild or moderate and often disappear after a short time.
The assessment of the frequency of side effects is based on the following classification:

Very common:may affect more than 1 in 10 people

Common:may affect up to 1 in 10 people

Uncommon:may affect up to 1 in 100 people

Rare:may affect up to 1 in 1,000 people

Very rare:may affect up to 1 in 10,000 people

Frequency not known:the frequency cannot be estimated on the basis of the available data
Cases of dilation and weakening of the aortic wall or rupture of the aortic wall
(aneurysms and dissections), with possible ruptures that can cause death, as well as cases of regurgitation
of blood from the heart valves, have been reported in patients treated with fluoroquinolones. See
also section 2.

Stop taking GRAY and see your doctor or go to hospital immediately if you notice the
following side effect:
Very rare

• you have an allergic reaction. Signs may include: skin rash, difficulty swallowing or difficulty breathing, swelling of the lips, face, throat or tongue

Stop taking GRAY and see your doctor immediately if you notice any of the
following side effects – you may need urgent medical treatment:
Rare

• watery diarrhea with possible blood, sometimes accompanied by stomach cramps and high fever. This may be a sign of a serious intestinal problem
• pain and inflammation of tendons or ligaments which may sometimes rupture. The Achilles tendon is most often affected.
• Convulsions
• Extensive 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)

Very rare

• burning, tingling, pain or numbness. These signs may be indicative of a disease called “neuropathy”

Not known

• Severe skin rashes including Stevens-Johnson syndrome and toxic epidermal necrolysis. These can appear on the body as red spots or as circular patches often with blisters in the centre, peeling of the skin, 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 problems with the

liver which may include fatal liver failure (liver failure that can
cause death).

• Nausea, general feeling of being unwell, discomfort or pain in the stomach area or vomiting. These may be signs of inflammation of the pancreas (acute pancreatitis). See section 2.

If your vision becomes blurred or if you experience any discomfort in your eyes while taking
GRAY, consult an ophthalmologist immediately.
Tell your doctor if any of the following side effects worsen or lasts for more than a few
days:
Common

• problems sleeping
• headache, dizziness
• Continuous, watery stools (diarrhea), feeling unwell (nausea, vomiting)
• Increased levels in the blood of certain liver enzymes

Uncommon

• changes in the number of other bacteria or fungi, fungal infection called Candida, which may require the initiation of treatment
• Reduction in the number of white blood cells (leukopenia), increase in the number of certain blood cells (eosinophilia)
• feeling of stress (anxiety), feeling of confusion, feeling of nervousness, drowsiness, tremor, dizziness
• shortness of breath (dyspnea)
• change in the taste of things, loss of appetite, stomach upset or indigestion (dyspepsia), stomach pain, feeling of fullness (flatulence), constipation
• Signs of reduced kidney function (elevated blood creatinine levels)
• itching and rash, severe itching or hives, excessive sweating (hyperhidrosis)
• joint or muscle pain
• General weakness
• Signs of reduced liver function (elevated blood bilirubin levels)

Rare

• Fast heartbeat (tachycardia)
• Decrease in the number of platelets (thrombocytopenia), which leads to a tendency to bruising and bleeding
• Decrease in the number of certain white blood cells (neutropenia)
• exaggerated immune response (hypersensitivity)
• decrease in blood sugar levels (hypoglycemia). This is important for those who suffer from diabetes
• seeing or hearing things that do not exist (hallucinations, paranoia), changes in opinion and rethinking (psychotic reactions) with the possibility of developing suicidal thoughts or acts
• feeling of depression, mental problems, feeling of restlessness (agitation), abnormal dreams or nightmares
• feeling of tingling in the hands and feet (paresthesia)
• problems with hearing (tinnitus) or vision (blurred vision)
• Drop in blood pressure
• muscle weakness. This is important for patients who suffer from myasthenia gravis (a rare disease of the nervous system)
• alterations in kidney function and occasional kidney failure which may be caused by an allergic reaction in the kidneys called interstitial nephritis
• fever
• Erythematous patches clearly defined, with or without blister formation that develop within a few hours of administration of levofloxacin and heal leaving the reddened part; usually reappear in the same area of skin or mucous membrane after subsequent exposure to levofloxacin.

Not known:

• Heart problems: abnormally fast heart rate, dangerously irregular heart rhythm, alteration of heart rhythm (called prolongation of the QT interval, shown on ECG, heart electrical activity)
• Decrease in the number of all types of blood cells (pancytopenia); decrease in red blood cells due to damage to blood cells (hemolytic anemia)
• The bone marrow stops producing new blood cells, which can cause fatigue, reduced ability to fight infections and uncontrolled bleeding (bone marrow failure).
• Severe decrease in the number of certain white blood cells (agranulocytosis). This leads to serious symptoms (persistent or recurring fever, sore throat and worsening of general health)
• Anaphylactic shock (severe hypersensitivity reaction, see section “Pay particular attention with GRAY 500 mg”). Anaphylactic and similar hypersensitivity reactions can sometimes occur even after the first dose.
• increase in blood sugar levels (hyperglycemia) or decrease in 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)
• Feeling very excited, euphoric, agitated or enthusiastic (mania)
• difficulty moving and walking (dyskinesia, extrapyramidal disorders)
• temporary loss of consciousness or posture (syncope)
• temporary loss of vision, inflammation of the eyes
• worsening or loss of hearing
• difficulty breathing or wheezing (bronchospasm)
• allergic reactions in the lungs
• pancreatitis
• inflammation of the liver (hepatitis)
• increased sensitivity of the skin to the sun or ultraviolet rays (photosensitivity), darker skin areas (hyperpigmentation)
• inflammation of the vessels carrying blood throughout the body due to an allergic reaction (vasculitis)
• inflammation of the inner tissues of the mouth (stomatitis)
• muscle damage (rhabdomyolysis)
• redness and swelling of the joints (arthritis)
• pain (including back, chest and limb pain)
• Sudden involuntary jerks, fasciculations or muscle contractions (myoclonus)
• attacks of porphyria in patients who already suffer from porphyria (a very rare metabolic disease)
• persistent headache with or without blurred vision (benign intracranial hypertension)

Very rare cases of adverse drug reactions, prolonged (lasting months or years) or permanent,
such as inflammation of the tendons, tendon rupture, joint pain, arm or leg pain,
difficulty walking, abnormal sensations such as tingling, prickling, itching, burning,
numbness or pain (neuropathy), fatigue, memory and
concentration disorders, effects on mental health (which may include sleep disorders, anxiety,
panic attacks, depression and suicidal ideation) as well as hearing, vision, taste and
smell disorders, have been associated with the use of antibiotics of the quinolone and fluoroquinolone type, in some
cases independently of pre-existing risk factors.

Reporting of side effects
If you get any side effects, even if not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly
through the national reporting system at www.agenziafarmaco.gov.it/content/come-
segnalare-una-sospetta-reazione-avversa. By reporting side effects you can help provide more information on the safety of this medicine
Seek immediate medical attention if a side effect occurs suddenly or
worsens rapidly, as certain medicinal adverse reactions (e.g. pseudomembranous colitis, some blood alterations, severe anaphylactic or anaphylactoid reactions, severe
liver disorders and severe skin alterations) can be life-threatening. In such cases do
not continue to take the medicine without medical advice.

5. How to store GRAY 500 mg

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date that is reported on the package after Scad..
The expiry date refers to the last day of that month
This medicine does not require any particular storage conditions but it is better
to store GRAY 500 mg in the blister and in the original box and in a dry place.
Do not dispose of any medicine in the wastewater or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help to protect the environment.

6. Contents of the pack and other information

What GRAY 500 mg contains
The active ingredient is levofloxacin. Each GRAY 500 mg tablet contains 500 mg of
levofloxacin.
The other ingredients are:

• For the tablet core: crospovidone, hypromellose, microcrystalline cellulose and sodium stearyl fumarate
• For the coating: hypromellose, titanium dioxide (E171), talc, macrogol, yellow iron oxide (E172) and red iron oxide (E172).

Description of the appearance of GRAY 500 mg and contents of the pack
Film-coated tablets, for oral use. The tablets are oblong and have a fracture line of pale yellow-white to reddish-white color.
For GRAY 500 mg, the tablets are available in packs of 5 tablets.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Marketing authorisation holder
Aurora Biofarma S.r.l. Via Nicola Antonio Porpora 127, 20131 Milano, Italy
Manufacturer
GENETIC S.P.A. – Contrada Canfora – 84084 Fisciano (SA)
If you require further information or have any doubts, please ask your doctor or pharmacist.

GRAY 250 mg film-coated tablets

Levofloxacin
Generic medicine

Read this leaflet carefully before you start taking this medicine as 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 because it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What GRAY 250 mg is and what it is used for
• 2. What you need to know before you take GRAY 250 mg
• 3. How to take GRAY 250 mg
• 4. Possible side effects
• 5. How to store GRAY 250 mg
• 6. Contents of the pack and other information

1. What is GRAY 250 mg and what is it used for

GRAY 250 mg is a broad-spectrum antibiotic, which means that GRAY 250 mg works by eliminating
many types of bacteria that can cause infections (pathogens). GRAY 250 mg contains the active
ingredient levofloxacin. This active ingredient belongs to the class of antibiotics called quinolones.
In adults with mild or moderate infections GRAY 250 mg is used for the treatment
of infections against which the drug is active, such as:

• sinus infections
• lung and lower airway infections (lower airways): acute cases of chronic bronchitis or pneumonia
• urinary tract infections (both complicated and uncomplicated, e.g. with kidney involvement)
• chronic bacterial infection of the prostate (prostatitis)
• skin and soft tissue infections.

2. What you need to know before taking GRAY 250 mg

DO NOT take GRAY 250 mg

• if you are allergic (hypersensitive) to levofloxacin, to any of the excipients of GRAY 250 mg (see section 6) or to other quinolone antibiotics such as moxifloxacin, ciprofloxacin or ofloxacin.
• if you suffer from epilepsy
• if you have a history of tendon problems related to treatment with an antibiotic of the quinolone class
• during pregnancy
• during breastfeeding. These tablets should not be given to children or adolescents who are growing.

Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine:

• if you have developed a severe skin reaction or skin peeling, blisters and/or ulcers in the mouth after taking any medicine containing levofloxacin.
• 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 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 Ehlers-Danlos syndrome or Turner syndrome, Sjögren's syndrome [an autoimmune inflammatory disease], or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behcet's disease, high blood pressure or known atherosclerosis, rheumatoid arthritis [an autoimmune inflammatory disease] or endocarditis [inflammation of the heart]).
• You should not take antibacterial medicines based on quinolones/fluoroquinolones, including GRAY 250 mg, if you have previously had any serious adverse reactions during treatment with a quinolone or fluoroquinolone. In this case, inform your doctor as soon as possible.
• in the most severe cases of pneumoniacaused by certain pathogens (e.g. S.Pneumoniae). Ask your doctor for advice, as GRAY 250 mg may not be the optimal therapy.
• in infections contracted in a hospital settingcaused by certain pathogens (e.g. Pseudomonas aeruginosa). Consult your doctor, as these may require combination therapy.
• in infections caused by certain pathogens (so-called MRSA).Consult your doctor, as these may require combination therapy.
• if you have severe, persistent and/or bloody diarrheaduring or after treatment with GRAY 250 mg. Tell your doctor immediately, as this diarrhea may be a symptom of a severe intestinal inflammation (enterocolitis), which can occur following antibiotic treatment. Stop taking GRAY 250 mg. Your doctor will change your treatment. Do not take anti-diarrheal medications that slow down bowel movements. Consult your doctor or pharmacist for this.
• if you are prone to a greater predisposition to seizures.

During treatment with GRAY 250 mg, the risk of seizures may be greater if
you have previously suffered brain damage such as a stroke or severe brain injury. You must
inform your doctor if you have experienced such events in the past. You should not take the tablets if you suffer
from epilepsy.
The tendency to convulsions may also be greater during concomitant treatment with
fenbufen and other similar non-steroidal anti-inflammatory drugs used for pain and
inflammation such as aspirin, ibuprofen, ketoprofen and indometacin or theophylline
(see also “Use with other medicines”). If convulsions occur, treatment should be
stopped.

• if you suffer from glucose-6-phosphate dehydrogenase deficiency(a hereditary metabolic defect). Patients with this disease may tend to have red blood cell destruction (hemolysis) when treated with quinolone antibacterial agents. Therefore, GRAY 250 mg should be used with caution in these patients.
• if you suffer from renal impairment. Ask your doctor how the dose should be adjusted (see section 3 “How to take GRAY 250 mg”).
• if you experience severe allergic (hypersensitivity) reactions(sometimes after the initial dose). Contact your doctor or the nearest hospital immediately. Stop treatment with GRAY 250 mg.
• if you are using oral hypoglycemic drugs(e.g. glibenclamide) or insulin. Your blood sugar levels must be carefully monitored, as your blood sugar levels may drop too low. Symptoms may include: ravenous appetite, nervousness, sweating, tremor.
• if you are exposed to strong sunlight or ultraviolet rays.Photosensitization (hypersensitivity to light with sunburn-like reactions) is a rare event with levofloxacin. However, it is recommended to avoid unnecessary exposure to strong sunlight or artificial ultraviolet rays (e.g. sunbeds, solariums) to prevent photosensitization.
• if you are being treated concomitantly with a vitamin K antagonist(certain agents with an effect on bleeding time, e.g. warfarin, phenprocoumon). Bleeding time values and the tendency to bleed may be increased. Bleeding time tests should be monitored (see also section “Use with other medicines”).
• if you suffer from psychosis or have previously suffered from mental illness.Psychotic reactions have been reported in patients treated with quinolones, including levofloxacin. In very rare cases, these have a progression towards suicidal thoughts and self-harming behaviors - sometimes after a single dose of levofloxacin. If these reactions occur, stop treatment and inform your doctor. He will decide on the appropriate measures and further treatment.

Serious 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 in the mouth, throat, nose, genitals and eyes (red and swollen eyes) may also occur. These severe skin rashes are

often preceded by fever and/or flu-like symptoms. The rashes may progress to
extensive skin peeling and life-threatening or life-threatening complications.
DRESS initially presents as flu-like symptoms and a skin rash on the face, then an extensive skin 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 another of these skin symptoms, stop taking levofloxacin and contact your doctor or seek medical attention immediately.

Before taking Gray 250 mg

• Heart problems Particular attention should be paid when using this type of medicine if you were born with or have a family history of prolonged QT interval (displayed on the ECG, an electrical recording of the heart), have a salt imbalance in the blood (especially a low level of potassium or magnesium in the blood), have a very slow heart rate (called bradycardia), have a weak heart (heart failure), have a history of heart attack (myocardial infarction), if you are a woman or an elderly patient or if you are taking other medicines that can cause abnormal changes in the ECG (see section Taking with other medicines)
• if you have symptoms of nerve injury,such as sensory disturbances in the hands and feet. In this case, consult your doctor immediately. Stop GRAY 250 mg to prevent possible damage.
• if a laboratory analysis of urine for opioidsis planned for you. The analysis may give a false positive result. It may be necessary to confirm a positive result using more specific methods.
• if you have symptoms of liver disease,such as jaundice, dark urine, itching, loss of appetite (anorexia) and soft abdomen. Stop treatment with GRAY 250 mg and consult your doctor.
• in cases of myasthenia gravis

During the taking of GRAY:

• if you experience severe, 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, or swelling of the ankles, feet or abdomen, or new episodes of palpitations (feeling of a fast or irregular heartbeat).
• If you begin to experience sudden involuntary jerks, fasciculations or muscle contractions - see a doctor immediately as these may be signs of myoclonus. The doctor may need to stop treatment with levofloxacin and start appropriate treatment.
• If you experience nausea, a general feeling of unwellness, severe or persistent abdominal discomfort or worsening abdominal pain, or vomiting, contact your doctor immediately as these may be a sign of inflammation of the pancreas (acute pancreatitis).
• In case of fatigue, paleness of the skin, bruising, uncontrolled bleeding, fever, sore throat and severe worsening of your condition - see a doctor immediately as these may be signs of blood disease. The doctor should monitor the blood with a blood count. If the blood count is abnormal, the doctor may need to stop treatment.

Rarely, pain and swelling in the joints and inflammation or rupture of the
tendons may 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. Tendon inflammation and
rupture may occur within the first 48 hours of treatment and up to several months after
the end of therapy with GRAY 250 mg. At the first signs of pain or inflammation in a tendon (for
example in the ankle, wrist, elbow, shoulder or knee), stop treatment with
GRAY 250mg, see a doctor and keep the painful part at rest. Avoid any unnecessary movement, because the risk of tendon rupture could increase.
Rarely, symptoms of nerve damage (neuropathy) such as pain, burning,
tingling, numbness and/or weakness, especially in the feet and legs or hands and
arms may occur. In this case, stop treatment with GRAY 250mg and immediately inform
your doctor, to prevent nerve damage from becoming permanent.
If your vision should decrease or your eyes should otherwise be
compromised, consult an ophthalmologist immediately.

Serious, prolonged, disabling and potentially non-reversible adverse reactions
Antibacterial medicines based on fluoroquinolones/quinolones, including GRAY 250 mg,
have been
associated with very rare but serious adverse reactions, some of which are prolonged (lasting months or
years), disabling or potentially non-reversible. These include pain in tendons, muscles and
joints of arms and legs, difficulty walking, abnormal sensations such as tingling,
formication, itching, numbness or burning (paresthesia), disorders of the senses such as
alteration of vision, taste, smell and hearing, depression, impairment of
memory, severe fatigue and severe sleep disorders.
If you experience any of these adverse reactions after taking GRAY 250 mg, 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.

Children
Children or adolescents in a growth phase should not take GRAY 250 mg, as the risk
of damage to joint tissues cannot be excluded.

Elderly
In this group, renal impairment is frequently found. You should therefore ask your
doctor whether dose adjustment may be necessary (see section 3. “How to
take GRAY 250 mg”).

Other medicines and GRAY 250 mg
You must inform your doctor if you are taking other medicines that can alter your heart rhythm:
medicines that belong to the class of antiarrhythmics (for example quinidine, hydroquinidine,
disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some
antimicrobials (that belong to the class of macrolides), some antipsychotics

• Corticosteroids,sometimes called steroids - used for inflammation. You are more likely to have inflammation and/or tendon ruptures.
• Vitamin K antagonists, e.g. warfarin, phenprocoumon - used to thin the blood. Increases the risk of bleeding. Your doctor may need to have regular blood tests to assess whether your blood is able to coagulate.
• Theophylline- used for breathing problems: increases the likelihood that you will have a seizure (epileptic fit) if taken with GRAY 250 mg.
• Non-steroidal anti-inflammatory drugs (NSAIDs)- used for pain and inflammation such as aspirin, ibuprofen, fenbufen, ketoprofen and indometacin: Increases the likelihood that you will have a seizure (epileptic fit) if taken with GRAY 250 mg.
• Cyclosporine- used after an organ transplant: the effect of cyclosporine may be prolonged if used in combination with GRAY 250 mg .
• Probenecid- used for gout and cimetidine- used for ulcers and heartburn: the elimination (renal clearance) of levofloxacin is slightly reduced. However, this is unlikely to affect your treatment. Nevertheless, be careful when taking GRAY 250 mg together with drugs such as probenecidand cimetidine, which affect renal elimination. If you have kidney problems, your doctor may prescribe a reduced dose.

Do not take GRAY 250 mg at the same time as the following medicines. This is because
an interaction with the mode of action of GRAY 250 mg may occur:

• Iron tablets(for anemia), zinc supplements, antacids containing magnesium or aluminum(for acidity or heartburn), didanosine or sucralfate(for stomach ulcers). Therefore, you must take GRAY 250 mg at least 2 hours before or after using these medicines.

Urine tests for opioids
Urine tests may show ‘false positive’ results for strong painkillers called
‘opioids’ in people taking GRAY 250 mg. If your doctor is about to prescribe urine tests, tell them that you are taking GRAY 250 mg.

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

GRAY 250 mg with food, drinks and alcohol
Do not drink alcohol while being treated with GRAY 250 mg.

Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
You should not take GRAY 250 mg if you are pregnant, if you are trying to become pregnant, if you are breastfeeding
or planning to. Tell your doctor if you discover you are pregnant while taking GRAY 250
mg.

Driving and using machines
Some undesirable effects of GRAY 250 mg such as dizziness, drowsiness, visual disturbances (see also
section “4. Possible side effects”) may impair your ability to concentrate and react and may therefore
constitute a risk in situations where these abilities are of particular importance. Do not drive, do not use
machines or perform activities without secure support if you notice that these abilities are impaired. Be
particularly careful when drinking alcohol.

Gray contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially
“sodium-free”

3. How to take GRAY 250 mg

Take this medicine following exactly the instructions of your doctor. If you have doubts
consult your doctor or pharmacist.

The recommended dose is:see Table 1

Since levofloxacin is excreted mainly by the kidneys, the dose must be adjusted in
patients with reduced renal function. See the leaflet at table 2 for details:

Table 2: Dosage in patients with reduced renal function
Dosage regimen
250 mg/24 hours 500 mg/24 hours 500 mg/12 hours

Creatinine clearanceFirst dose: 250 First dose: 500 First dose: 500
mg

• 50 – 20 ml/min then: 125 mg/24 hours then: 250 mg /24 hours then: 250 mg/12 hours
• 19 – 10 ml/min then: 125 mg/48 hours then: 125 mg/24 hours then: 125 mg/12 hours mg mg

<10 ml/min (including hemodialysis and then: 125 mg/48 hours then: 125 mg/24 hours then: 125 mg/24 hours
CAPD)
= No additional doses are required after hemodialysis or continuous ambulatory peritoneal dialysis
(CAPD).
No dosage adjustment is required if you have reduced liver function. Levofloxacin
is only marginally metabolized in the liver.

Taking this medicine
Swallow the film-coated tablets whole with sufficient liquid
(e.g. from ½ to 1 glass of water). If you need to adjust the dose, you can break the
film-coated tablets along the score line. You can take the film-coated tablets during meals or
at any time between meals.
See also section “Other medicines and GRAY 250 mg”.

Duration of treatment
The duration of treatment will depend on the severity of your infection. The doctor will decide the optimal duration
of treatment.
If you notice that the effect of GRAY 250 mg is too strong or too weak, inform your doctor or pharmacist.

If you take more GRAY 250 mg than you should
If you accidentally take one too many film-coated tablets of GRAY 250 mg,
nothing will probably happen. However, if you accidentally take several
film-coated tablets too many, seek immediate medical attention. You may experience the
following symptoms:

• symptoms at the level of the central nervous system (confusion, dizziness, decreased level of consciousness and seizures)
• gastrointestinal reactions such as nausea and erosion of the mucous membranes
• certain changes in heart function (prolongation of the QT interval). Therefore, your heart function must be monitored by a doctor (ECG) in case of overdose. The doctor will adopt a treatment according to your symptoms (e.g. gastric lavage or administration of antacids). Levofloxacin is not removed from the body by dialysis. There is no specific antidote.

If you forget to take GRAY 250 mg
Take the forgotten dose as soon as you remember, unless it is almost time to take the
next dose. In this case, continue taking GRAY 250 mg at the usual time, at the dose prescribed by
your doctor. Do not take a double dose to make up for the missed tablet

If you stop taking GRAY 250 mg
Do not stop taking GRAY 250 mg without your doctor's approval. The treatment may fail,
if you stop it too early.
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 gets them.
Usually, these effects are mild or moderate and often disappear after a short time.
The assessment of the frequency of side effects is based on the following classification:

Very common:may affect more than 1 in 10 people

Common:may affect up to 1 in 10 people

Uncommon:may affect up to 1 in 100 people

Rare:may affect up to 1 in 1,000 people

Very rare:may affect up to 1 in 10,000 people

Frequency not known:the frequency cannot be estimated based on the available
data
Cases of dilation and weakening of the aortic wall or rupture of the aortic wall
(aneurysms and dissections), with possible ruptures that can be fatal, as well as cases of regurgitation
of blood from the heart valves, have been reported in patients treated with fluoroquinolones. See
also section 2.

Stop taking GRAY and see your doctor or go to hospital immediately if you notice the
following side effect:
Very rare

• you have an allergic reaction. Signs may include: skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue

Stop taking GRAY and see your doctor immediately if you notice any of the
following side effects – you may need urgent medical treatment:
Rare

• watery diarrhoea with possible blood, sometimes accompanied by stomach cramps and high fever. This may be a sign of a serious intestinal problem
• pain and inflammation of tendons or ligaments which may, in some cases, rupture. The Achilles tendon is most commonly affected.
• convulsions
• Extensive 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 inadequate excretion of water and low sodium levels (SIADH)

Very rare

• burning, tingling, pain or numbness. These signs may be indicative of a disease called “neuropathy”

Not known

• Severe skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis. These can appear on the body as reddish spots or blotches

circular often with central blisters, skin peeling, mouth, throat, nose, genitals and eye ulcers 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).
• Nausea, general feeling of unwellness, discomfort or pain in the stomach area, or vomiting. These may be signs of inflammation of the pancreas (acute pancreatitis). See section 2.

If your vision becomes blurred or you experience any discomfort in your eyes while taking
GRAY, consult an ophthalmologist immediately.
Tell your doctor if any of the following side effects worsen or last for more than a few
days:
Common

• difficulty sleeping
• headache, dizziness
• Continuous, watery stools (diarrhoea), feeling unwell (nausea, vomiting)
• Increased levels in the blood of certain liver enzymes

Uncommon

• changes in the number of other bacteria or fungi, fungal infection called Candida, which may require treatment
• Reduction in the number of white blood cells (leukopenia), increase in the number of certain blood cells (eosinophilia)
• feeling of stress (anxiety), feeling of confusion, feeling of nervousness, drowsiness, tremor, dizziness
• shortness of breath (dyspnoea)
• change in the taste of things, loss of appetite, stomach upset or indigestion (dyspepsia), stomach pain, feeling of fullness (flatulence), constipation
• Signs of reduced kidney function (elevated blood creatinine levels)
• itching and rash, severe itching or hives, excessive sweating (hyperhidrosis)
• joint or muscle pain
• General weakness
• Signs of reduced liver function (elevated blood bilirubin levels) Rare
• Fast heartbeat (tachycardia)
• Decrease in the number of platelets (thrombocytopenia), leading to a tendency to bruise and bleed
• Decrease in the number of certain white blood cells (neutropenia)
• exaggerated immune response (hypersensitivity)
• decrease in blood sugar levels (hypoglycaemia). This is important for those who suffer from diabetes
• seeing or hearing things that are not there (hallucinations, paranoia), changes in opinion and rethinking (psychotic reactions) with the possibility of developing suicidal thoughts or acts
• feeling of depression, mental problems, feeling of restlessness (agitation), abnormal dreams or nightmares
• feeling of tingling in the hands and feet (paresthesia)
• hearing problems (tinnitus) or vision problems (blurred vision)
• Low blood pressure
• muscle weakness. This is important for patients who suffer from myasthenia gravis (a rare disease of the nervous system)
• alterations in kidney function and occasional kidney failure which can be caused by an allergic reaction in the kidneys called interstitial nephritis
• fever
• Erythematous patches clearly defined, with or without blister formation that develop within a few hours of administration of levofloxacin and heal leaving the reddened part; usually reappear in the same area of skin or mucosa after subsequent exposure to levofloxacin.

Not known:

• Heart problems: abnormally fast heart rate, dangerously irregular heart rhythm, alteration of the heart rhythm (called prolongation of the QT interval, shown on the ECG, electrical activity of the heart)
• Decrease in the number of all types of blood cells (pancytopenia); decrease in red blood cells due to damage to blood cells (hemolytic anemia)
• The bone marrow stops producing new blood cells, which can cause fatigue, reduced ability to fight infections and uncontrolled bleeding (bone marrow failure).
• Severe decrease in the number of certain white blood cells (agranulocytosis). This leads to serious symptoms (persistent or recurrent fever, sore throat and worsening of general health)
• Anaphylactic shock (severe hypersensitivity reaction, see section “Pay particular attention with GRAY 250 mg”). Anaphylactic and similar hypersensitivity reactions can sometimes occur even after the first dose.
• increase in blood sugar levels (hyperglycemia) or decrease in 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)
• Feeling very excited, euphoric, agitated or enthusiastic (mania)
• difficulty moving and walking (dyskinesia, extrapyramidal disorders)
• temporary loss of consciousness or posture (syncope)
• temporary loss of vision, inflammation of the eyes
• worsening or loss of hearing
• difficulty breathing or wheezing (bronchospasm)
• allergic reactions in the lungs
• pancreatitis
• inflammation of the liver (hepatitis)
• increased sensitivity of the skin to the sun or ultraviolet rays (photosensitivity), darker skin areas (hyperpigmentation)
• inflammation of the blood vessels throughout the body due to an allergic reaction (vasculitis)
• inflammation of the internal tissues of the mouth (stomatitis)
• muscle damage (rhabdomyolysis)
• redness and swelling of the joints (arthritis)
• pain (including back, chest and limb pain)
• Sudden involuntary jerks, fasciculations or muscle contractions (myoclonus)
• attacks of porphyria in patients who already suffer from porphyria (a very rare metabolic disease)
• persistent headache with or without blurred vision (benign intracranial hypertension)

Very rare cases of adverse drug reactions, prolonged (lasting months or years) or permanent,
such as inflammation of the tendons, tendon rupture, joint pain, pain in arms or legs,
difficulty walking, abnormal sensations such as tingling, prickling, itching, burning,
numbness or pain (neuropathy), fatigue, memory and concentration disorders, effects on mental health (which may include sleep disorders, anxiety,
panic attacks, depression and suicidal thoughts) as well as disorders of hearing, vision, taste and
smell, have been associated with the use of antibiotics of the quinolone and fluoroquinolone type, in some
cases regardless of pre-existing risk factors.

Reporting of side effects
If you get any side effects, even if not listed in this leaflet, tell your doctor or pharmacist.
You can also report side effects directly through the national reporting system at
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side
effects you can help provide more information on the safety of this medicine.
Seek immediate medical attention if a side effect occurs suddenly or
worsens rapidly, as certain adverse drug reactions (e.g. pseudomembranous colitis, some blood disorders, severe anaphylactic or anaphylactoid reactions, severe
liver disorders and severe skin alterations) can be life-threatening. In such cases do
not continue to take the medicine without medical advice.

5. How to store GRAY 250 mg

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date that is reported on the package after Scad..
The expiry date refers to the last day of that month
This medicine does not require any particular storage conditions but it is better
to store GRAY 250 mg in the blister and in the original box and in a dry place.
Do not dispose of any medicine in the wastewater and household waste. Ask your pharmacist how
to eliminate the medicines that you no longer use. This will help to protect the environment.

6. Contents of the pack and other information

What GRAY 250 mg contains
The active ingredient is levofloxacin. Each GRAY 250 mg tablet contains 250 mg of
levofloxacin.
The other ingredients are:

• For the tablet core: crospovidone, hypromellose, microcrystalline cellulose and sodium stearylfumarate
• For the coating: hypromellose, titanium dioxide (E171), talc, macrogol, yellow iron oxide (E172) and red iron oxide (E172).

Description of the appearance of GRAY 250 mg and contents of the pack
Film-coated tablets, for oral use. The tablets are oblong and with a fracture line of pale yellow-white to reddish-white color.
For GRAY 250 mg, the tablets are available in packs of 5 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Aurora Biofarma S.r.l. Via Nicola Antonio Porpora 127, 20131 Milano, Italy
Manufacturer

DOPPEL FARMACEUTICI SRL
Via Volturno, 48 – 20089 Quinto dè Stampi – Rozzano (MI)
DOPPEL FARMACEUTICI SRL
Vai Martiri delle Foibe,1 – 29016 Cortemaggiore (PC)
(batch control and release)
If you require further information or have any doubts, please ask your doctor or pharmacist.