Package leaflet: Information for the user

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

Levofloxacin
Generic medicine
Read this entire leaflet carefully before taking 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Sineflox is and what it is used for
What you need to know before taking Sineflox
How to take Sineflox
Possible side effects
How to store Sineflox
Contents of the pack and other information

1. What Sineflox is and what it is used for

Sineflox contains the active substance called levofloxacin. This medicine belongs to a group of medicines known as antibiotics. Levofloxacin is a "quinolone" antibiotic. This medicine works by killing the bacteria responsible for infections in the body.
Sineflox can be used to treat:

acute bacterial infection of the nose and paranasal sinuses (acute bacterial sinusitis)
acute infection in a respiratory disease called chronic obstructive bronchopneumopathy, which includes chronic bronchitis
community-acquired lung infection (community-acquired pneumonia)
complicated urinary tract infections (cystitis, an infection of the bladder, and urethritis, an infection of the urethra, the tube connecting the bladder to the outside) and acute kidney and upper urinary tract infection (pyelonephritis)
chronic bacterial infections of the prostate (chronic bacterial prostatitis)
bladder infection (uncomplicated cystitis)
skin and subcutaneous tissue infections, including muscles. These are sometimes referred to as "soft tissues"
prevention and treatment of an infection caused by inhalation of anthrax (a bacterium causing skin, lung, and intestinal disorders)

2. What you should know before taking Sineflox

Before taking this medicine
Do not take antibacterial medicines containing quinolones/fluoroquinolones, including Sineflox,
if you have previously experienced any severe adverse reaction during treatment with a
quinolone or fluoroquinolone. In such a case, inform your doctor as soon as possible.
Do not take this medicine and inform your doctor if:

you are allergic (hypersensitive) 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). Signs of an allergic reaction include: skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue
you have had epilepsy
you have had tendon-related problems, such as tendinitis, associated with treatment with a "quinolone antibiotic". Tendons are fibrous structures connecting skeletal muscles
you are a child or adolescent during the growth period
you are pregnant, could become pregnant, or think you may be pregnant
you are breastfeeding with breast milk
you have been diagnosed with an enlargement or "bulging" of a large blood vessel (aortic aneurysm or peripheral aneurysm of a large blood vessel)
you have previously experienced episodes of aortic dissection (a tear in the wall of the aorta)
you have a family history of aortic aneurysm, aortic dissection, or other risk factors or predisposing conditions (e.g. connective tissue disorders such as Marfan syndrome, vascular Ehlers-Danlos syndrome, or if you have vascular diseases such as Takayasu arteritis, giant cell arteritis, Behcet’s disease, known high blood pressure, or atherosclerosis).

If you experience sudden pain in the abdomen, chest, or back, go immediately to
the emergency room.
Do not take this medicine if any of the above may in any way apply to you. If you have any
doubts, consult your doctor, nurse, or pharmacist before taking Sineflox.
When taking this medicine
Rarely, joint pain and swelling, and inflammation or rupture
of tendons may occur. The risk is higher 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 stopping treatment with Sineflox. At the first signs of pain or
inflammation in a tendon (e.g. in the ankle, wrist, elbow, shoulder, or
knee), stop treatment with Sineflox, consult your doctor, and rest the affected area. Avoid any unnecessary physical activity, as the risk of tendon rupture could
increase.
Warnings and precautions
Consult your doctor or pharmacist before taking this medicine if:

you are 60 years old or older
you are taking corticosteroids, sometimes called steroids (see “Other medicines and Sineflox”)
you have had epileptic seizures
you have suffered brain damage due to stroke or other brain injury
you have kidney problems
you suffer from a condition known as “glucose-6-phosphate dehydrogenase deficiency”. Administration of this medicine increases the likelihood of developing serious blood-related problems
you have had mental health issues
you have had heart problems: you should exercise caution when using this type of medicine if you were born with or have a family history of QT interval prolongation (seen on electrocardiogram, the heart's electrical tracing), have an electrolyte imbalance 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 female or elderly, or are taking other medicines that can alter the electrocardiogram (see section “Other medicines and Sineflox”).
if you have been diagnosed with heart valve insufficiency (aortic and mitral regurgitation);
if you have a family history of aortic aneurysm or aortic dissection, congenital heart valve disease, or other risk factors or predisposing conditions (e.g., connective tissue disorders such as Marfan syndrome, Ehlers-Danlos syndrome, Turner syndrome, Sjögren’s syndrome [an autoimmune inflammatory disease], or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet’s disease, high blood pressure, known atherosclerosis, rheumatoid arthritis [an autoimmune inflammatory disease], or endocarditis [inflammation of the heart]).
you have diabetes
you have had liver problems
you have myasthenia gravis
you have developed a severe skin reaction or skin peeling, blisters and/or mouth ulcers after taking any medicine containing levofloxacin.

If you have any doubts whether any of the above may in any way apply to you, consult your doctor or
pharmacist before taking Sineflox.
While taking Sineflox:

if you experience sudden, severe pain in the abdomen, chest, or back, which may be a symptom of aneurysm or aortic dissection, go immediately to the emergency room. The risk may be higher if you are taking systemic corticosteroid medicines.
Inform your doctor immediately if you notice a sudden onset of shortness of breath, especially when lying down, or swelling of the ankles, feet, or abdomen, or new episodes of palpitations (sensation of rapid or irregular heartbeat).
If you begin to experience sudden involuntary jerks, muscle fasciculations, or contractions
consult a doctor immediately, as these may be signs of myoclonus. Your doctor may need to stop treatment with levofloxacin and start appropriate treatment.
If you experience fatigue, pale 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 – consult a doctor immediately, as these may
be signs of blood disorders. Your doctor should monitor your blood with a complete blood count.
If blood tests are abnormal, your doctor may need to stop treatment.
Severe skin reactions
Serious skin reactions have been reported with the use of levofloxacin, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS).
SJS and TEN may initially appear on the body as reddish spots or circular patches, often with central blisters. Mouth, throat, nose, genital, and eye ulcers (red, swollen eyes) may also occur. These serious 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, followed by widespread skin rash with fever, elevated liver enzyme levels in blood tests, increased levels of a type of white blood cell (eosinophilia), and swollen lymph nodes.

If you develop a severe skin rash or any of these other skin symptoms, stop taking levofloxacin and contact your doctor or seek immediate medical help.
Other medicines and Sineflox
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine. This is because Sineflox can affect the action of other medicines. Some medicines can also affect the action of Sineflox.
In particular, inform your doctor if you are taking any of the following medicines. This
is because taking Sineflox together with other medicines may increase the
likelihood of you experiencing side effects:

corticosteroids – sometimes called steroids – used to treat inflammation. The risk of developing tendon inflammation and/or rupture is higher.
warfarin – used to delay blood clotting. The risk of bleeding is higher. Your doctor may ask you to have regular blood tests to monitor blood clotting.
theophylline – used for respiratory problems. The risk of seizures (epileptic episodes) is higher if you take theophylline together with Sineflox.
non-steroidal anti-inflammatory drugs (NSAIDs) – used for pain and inflammation, such as aspirin, ibuprofen, fenbufen, ketoprofen, and indomethacin. The risk of seizures (epileptic episodes) is higher when taken together with Sineflox.
cyclosporine – used for organ transplants. The risk of experiencing typical side effects of cyclosporine is higher.
medicines known to affect heart rhythm. These include medicines used to treat abnormal heart rhythm (antiarrhythmics such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, and ibutilide), depression (tricyclic antidepressants such as amitriptyline and imipramine), psychiatric disorders (antipsychotics), and bacterial infections (macrolide antibiotics such as erythromycin, azithromycin, and clarithromycin).
probenecid – used to treat gout. Your doctor may prescribe a lower dose if you have kidney problems.
cimetidine – used for ulcers and heartburn. Your doctor may prescribe a lower dose if you have kidney problems. Consult your doctor if any of the above may in any way apply to you.

Do not take Sineflox together with the following medicines. This is because the mechanism
of action of Sineflox may be affected:

iron salts in tablets (for anemia), zinc supplements, antacids containing magnesium or aluminium (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”. Rarely, symptoms of nerve damage (neuropathy) such as pain, burning, tingling, numbness, and/or weakness, particularly in the feet and legs or hands and arms, may occur. In such cases, stop treatment with Sineflox and inform your doctor immediately to prevent permanent nerve damage.

Serious, prolonged, disabling, and potentially irreversible side effects

Fluoroquinolone/quinolone antibacterial medicines, including Sineflox, have been associated with very rare but serious side effects, some of which are prolonged (lasting months or years), disabling, or may not improve. These include tendon, muscle, and joint pain in arms and legs, difficulty walking, unusual sensations such as tingling, prickling, itching, numbness, or burning (paresthesia), sensory organ disturbances such as changes in vision, taste, smell, or hearing, depression, memory impairment, severe fatigue, and severe sleep disturbances.
If you experience any of these side effects after taking Sineflox, consult your doctor immediately before continuing treatment. Your doctor will decide together with you whether to continue treatment and may consider using an antibiotic from another class. Urine tests for opiates In patients taking Sineflox, urine tests may give "false-positive" results for strong painkillers called "opiates". If your doctor considers it necessary to perform urine tests, inform them that you are taking Sineflox. Tuberculosis testing This medicine may cause "false-negative" results in certain laboratory tests used to detect the bacteria causing tuberculosis.

Pregnancy and breastfeeding
Do not take this medicine if:

you are pregnant, could become pregnant, or think you may be pregnant
you are breastfeeding or think you may breastfeed

Driving and using machines
Some side effects may occur after taking this medicine, including dizziness, drowsiness, subjective sensation of movement (vertigo), or visual disturbances.
Some of these side effects may affect your ability to concentrate and your reaction speed. If this occurs, do not drive or perform activities requiring a high level of attention.

3. How to take Sineflox

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
How to take this medicine

take this medicine by mouth
swallow the tablets whole with water
the tablets may be taken with or without food

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

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

How much medicine to take

your doctor will decide how much Sineflox you should take
the dose will depend on the type of infection you have and where in the body the infection is located
the duration of treatment will depend on the severity of the infection
if you think the effect of the medicine is too weak or too strong, do not change the dose yourself; consult your doctor

Adults and elderly patients
Bacterial sinusitis

two Sineflox 250 mg tablets once daily
or, one Sineflox 500 mg tablet once daily

Acute exacerbation of chronic obstructive bronchopulmonary disease, including chronic bronchitis

two Sineflox 250 mg tablets once daily
or, one Sineflox 500 mg tablet once daily

Community-acquired pneumonia

two Sineflox 250 mg tablets once or twice daily
or, one Sineflox 500 mg tablet once or twice daily

Complicated urinary tract infections (cystitis and urethritis) and acute pyelonephritis

one or two Sineflox 250 mg tablets once daily
or, half or one Sineflox 500 mg tablet once daily

Uncomplicated cystitis

the recommended dose is one Sineflox 250 mg tablet once daily

Chronic bacterial prostatitis

two Sineflox 250 mg tablets once daily
or, one Sineflox 500 mg tablet once daily

Skin and subcutaneous tissue infections, including muscles

two Sineflox 250 mg tablets once or twice daily
or, one Sineflox 500 mg tablet once or twice daily

Anthrax inhalation

the recommended dose is two Sineflox 250 mg tablets once daily
or, one Sineflox 500 mg tablet once daily

Adults and elderly patients with kidney problems
Your doctor may consider it necessary to reduce the dose.
Children and adolescents
This medicine must not be given to children or adolescents.
Protect your skin from sunlight
Avoid direct sunlight during treatment with this medicine and for 2 days after stopping treatment. This is because your skin will become much more sensitive to sunlight and may burn, itch, or develop severe blistering if you do not follow these precautions:

make sure to use a sunscreen with high sun protection factor
always wear a hat and clothing covering arms and legs
avoid sunbeds

If you take more Sineflox than you should
If you accidentally take more tablets than prescribed, inform your doctor immediately or seek medical advice. Bring the medicine pack with you. This will help the doctor identify what you have taken. The following side effects may occur: seizures (epileptic fits), confusion, dizziness, feeling faint, tremor, and heart problems – which may lead to irregular heartbeats and feelings of discomfort (nausea) or stomach burning.

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

If you stop taking Sineflox
Do not stop taking Sineflox just because you feel better. It is important that you complete the full course of tablets prescribed by your doctor. If you stop taking the tablets too early, the infection may return, your condition may worsen, or the bacteria may become resistant to the medicine.

If you have any questions about how to use this medicine, consult 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 to moderate in severity and often disappear after a short time.
Cases of dilation and weakening of the aortic wall or aortic wall tear (aneurysms and dissections), with possible rupture that may lead to death, as well as cases of blood regurgitation from heart valves, have been reported in patients treated with fluoroquinolones.
See also section 2.

Stop taking Sineflox and go immediately to a doctor or hospital if you notice the following side effect:
Very rare (may affect up to 1 in 10,000 people)

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

Stop taking Sineflox and go immediately to a doctor if you notice any of the following side effects – you may need urgent medical treatment:
Rare (may affect up to 1 in 1,000 people)

watery diarrhoea, possibly with 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 in some cases may rupture. The Achilles tendon is most commonly affected
seizures
- severe skin rashes including Stevens-Johnson syndrome and toxic epidermal necrolysis. These may appear on the body as reddish spots or circular patches, often with central blisters, skin peeling, mouth, throat, nose, genital or eye ulcers, and may be preceded by fever and flu-like symptoms. See also section 2.
- widespread rash, fever, elevated 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 water excretion and low sodium levels (SIADH)

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

burning, tingling, pain or numbness. These signs may indicate a condition called "neuropathy"

Not known (frequency cannot be estimated from the available data)

loss of appetite, yellowing of the skin and eyes, dark-coloured urine, itching or stomach pain (abdomen). These may be signs of liver problems, which may include fatal liver failure (liver failure that may lead to death). If your vision becomes blurred or if you experience any eye discomfort while taking Sineflox, 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)

difficulty 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 treatment
changes in white blood cell count shown in blood test results (leucopenia, eosinophilia)
feeling stressed (anxiety), confusion, nervousness, drowsiness, tremor, dizziness
shortness of breath (dyspnoea)
altered taste, loss of appetite, stomach upset or indigestion (dyspepsia), stomach pain, bloating (flatulence), constipation
itching and skin rash, severe itching or hives, excessive sweating (hyperhidrosis)
joint pain or muscle pain
blood tests may show abnormal results due to liver problems (increased bilirubin) or kidney problems (increased creatinine)
generalised weakness

Rare (may affect up to 1 in 1,000 people)

bruising and increased tendency to bleed due to reduced number of platelets in the blood (thrombocytopenia)
low number of white blood cells (neutropenia)
exaggerated immune response (hypersensitivity)
decreased blood sugar levels (hypoglycaemia). This is important for people with diabetes
seeing or hearing things that are not real (hallucinations, paranoia), changes in thinking and mood (psychotic reactions), with possible development of suicidal thoughts or suicide attempts
feeling depressed, mental problems, feeling restless (agitation), abnormal dreams or nightmares
tingling sensation in hands and feet (paraesthesia)
hearing problems (tinnitus) or vision problems (blurred vision)
unusually fast heartbeat (tachycardia) or low blood pressure (hypotension)
muscle weakness. This is important for patients with myasthenia gravis (a rare nervous system disorder)
changes in kidney function and occasional kidney failure, which may be caused by an allergic reaction affecting the kidneys called interstitial nephritis
fever
- clearly defined erythematous patches, with or without blister formation, developing within a few hours of levofloxacin administration and healing with residual redness; usually recurring at the same skin or mucosal site after subsequent exposure to levofloxacin

Not known (frequency cannot be estimated from the available data)

decreased red blood cells (anaemia). This may lead to paleness or yellowish skin due to damage to red blood cells and a decrease in all types of blood cells (pancytopenia)
Bone marrow stops producing new blood cells, which may cause fatigue, reduced ability to fight infections and uncontrolled bleeding (bone marrow failure)
fever, sore throat and a general feeling of illness that does not go away. This may be due to a reduced number of white blood cells in the blood (agranulocytosis)
lack of blood flow (anaphylactic shock)
increased blood sugar levels (hyperglycaemia) or decreased blood sugar levels leading to coma (hypoglycaemic coma). This is important for people with 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 or walking (dyskinesia, extrapyramidal disorders)
temporary loss of consciousness or posture (syncope)
temporary loss of vision, eye inflammation
worsening or loss of hearing
unusually fast heartbeat, irregular heartbeat with life-threatening risk including cardiac arrest, changes in heartbeat rhythm (called "prolongation of the QT interval" seen on electrocardiogram, electrical activity of the heart)
difficulty breathing or wheezing (bronchospasm)
allergic reactions affecting the lungs
pancreatitis
inflammation of the liver (hepatitis)
increased sensitivity of the skin to sunlight or ultraviolet rays (photosensitivity), darker skin areas (hyperpigmentation)
inflammation of blood vessels carrying blood throughout the body due to an allergic reaction (vasculitis)
inflammation of the internal tissues of the mouth (stomatitis)
muscle breakdown and destruction (rhabdomyolysis)
redness and swelling of joints (arthritis)
pain, including back, chest and limb pain
attacks of porphyria in patients who already suffer from porphyria (a very rare metabolic disorder)
persistent headache with or without blurred vision (benign intracranial hypertension)
sudden involuntary jerks, fasciculations or muscle contractions (myoclonus)

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

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

5. How to store Sineflox

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions; however, it is better to store Sineflox in its original blister and packaging, in a dry place.
Do not use this medicine after the expiry date stated on the carton and on the aluminium sheet after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of medicines 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 Sineflox contains
The active substance is levofloxacin. Each tablet of Sineflox 250 mg contains 250 mg of levofloxacin and each tablet of Sineflox 500 mg contains 500 mg of levofloxacin.
The other components are:

for the tablet core: microcrystalline cellulose, crospovidone, hypromellose, talc, magnesium stearate.
for the coating: hypromellose, titanium dioxide (E171), macrogol 400, talc, yellow iron oxide (E172), red iron oxide (E172).

Description of the appearance of Sineflox and pack sizes
Sineflox tablets are film-coated tablets for oral use.
Carton pack containing one blister with 5 tablets.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
LABORATORIO FARMACEUTICO CT Srl
Via Dante Alighieri, 71 – 18038 Sanremo (IM)
Manufacturer
Special Product’s Line SpA
Via Fratta Rotonda Vado Largo, 1
03012 Anagni (FR)
Italy

This patient information leaflet does not contain all the available information on this medicine. If you need further information or have any questions, please consult your doctor or pharmacist.