Package leaflet: Information for the user

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

levofloxacin
Generic medicine
Please read all of this leaflet carefully before you start 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 they have the same symptoms as yours, because it may be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What LEMAXIL is and what it is used for

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

of the sinuses
of the lungs, in patients with chronic respiratory disorders 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 referred to as "soft tissues"

In certain special situations, Lemaxil tablets may be used to reduce the likelihood of developing a lung disease called anthrax or to prevent worsening of the disease after exposure to the bacterium that causes anthrax.
Talk to your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking LEMAXIL

Do not take LEMAXIL:

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).
signs of an allergic reaction include: skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue
if you suffer from or have previously suffered from epilepsy
if you have previously experienced tendon problems, 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, suspect you may be pregnant, or are planning a pregnancy
if you are breastfeeding

Do not take this medicine if any of the above apply to you. If you have any
doubts, consult your doctor or pharmacist before taking LEMAXIL.
Warnings and precautions
Consult your doctor or pharmacist before taking LEMAXIL: if you are aged 60 years or older
if you are taking corticosteroids, sometimes called steroids (see "Other medicines and
Lemaxil")
if you have undergone an organ transplant
if you have had seizures
if you have suffered brain damage due to a stroke or other brain injury
if you have kidney problems
if 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
if you have previously experienced mental health problems
if 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
(as seen on electrocardiogram, the heart's electrical trace), 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 may alter the electrocardiogram (see section “Other medicines and LEMAXIL”).
if you have diabetes
if you have previously had liver problems
if you have myasthenia gravis
if you have nerve problems (peripheral neuropathy)
if you have been diagnosed with 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 or aortic dissection, or 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, known high blood pressure or atherosclerosis, rheumatoid arthritis [an autoimmune inflammatory disease] or endocarditis [inflammation of the heart]).
If you begin to experience sudden involuntary jerks, muscle twitching or contractions –
seek medical advice immediately, as these could be signs of myoclonus. Your doctor
may need to discontinue treatment with levofloxacin and initiate appropriate therapy.
In case of 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 – seek medical advice immediately, as these could be signs of a blood disorder. Your doctor should monitor your blood with a complete blood count. If blood counts are abnormal, your doctor may need to discontinue treatment.
if you have developed a severe skin reaction or skin peeling, blisters and/or mouth ulcers after taking any medicine containing levofloxacin.
Severe skin reactions
Severe 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 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 with 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 assistance.
You must not take quinolone/fluoroquinolone antibacterial medicines, including Lemaxil, if you have previously experienced any serious adverse reaction during treatment with a quinolone or fluoroquinolone. In such a case, inform your doctor as soon as possible.
Rarely, joint pain and swelling, and tendon inflammation or rupture may occur. The risk is higher if you are elderly (over 60 years of age), have received an organ transplant, have kidney problems, or 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 LEMAXIL. At the first sign of tendon pain or inflammation (e.g., in the ankle, wrist, elbow, shoulder or knee), discontinue treatment with LEMAXIL, consult your doctor and keep the affected area at rest. Avoid unnecessary movements, as the risk of tendon rupture may increase.
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, discontinue treatment with LEMAXIL and inform your doctor immediately to prevent permanent nerve damage.
Severe, prolonged, disabling and potentially irreversible side effects
Fluoroquinolone/quinolone antibacterial medicines, including LEMAXIL, have been associated with very rare but serious side effects, some of which may be prolonged (lasting months or years), disabling, or may not improve. These include tendon, muscle and joint pain in arms and legs, difficulty walking, abnormal sensations such as pricking, tingling, tickling, numbness or burning (paresthesia), sensory organ disturbances such as changes in vision, taste, smell and hearing, depression, memory impairment, severe fatigue and severe sleep disturbances.
If you experience any of these side effects after taking LEMAXIL, seek immediate medical advice before continuing treatment. Your doctor will decide together with you whether to continue treatment and will also consider using an antibiotic from another class.
While taking LEMAXIL:

if you experience sudden, severe pain in the abdomen, chest or back, which may be a symptom of aortic aneurysm and 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 rapid 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 experience nausea, general malaise, severe discomfort or persistent pain or worsening pain in the stomach area, or vomiting, contact your doctor immediately, as these may be signs of inflammation of the pancreas (acute pancreatitis).

If you have any doubts about whether any of the above may apply to you, consult your doctor
or pharmacist before taking LEMAXIL.
Other medicines and LEMAXIL
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine. This is because LEMAXIL may affect the way other medicines work. Likewise, some medicines may affect the way LEMAXIL works.
In particular, inform your doctor if you are taking any of the following medicines.
This is because taking LEMAXIL 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 thin the blood. 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 experiencing a seizure (epileptic fit) is higher if you take theophylline together with LEMAXIL.
non-steroidal anti-inflammatory drugs (NSAIDs) – used for pain and inflammation such as aspirin, ibuprofen, fenbufen, ketoprofen and indomethacin. The risk of experiencing a seizure (epileptic fit) is higher when taken together with LEMAXIL.
cyclosporine – used for organ transplants. The risk of experiencing typical side effects of cyclosporine is higher.
medicines known for their effects on heart rhythm. 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 (antibiotics “macrolides” 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 apply to you.
Do not take LEMAXIL together with the following medicines. This is because the mechanism of action of LEMAXIL tablets 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”.

Urine testing for opioids
In patients taking LEMAXIL, testing for "opioids", strong painkillers, in urine tests may give false-positive results. If your doctor considers it necessary to perform urine tests, inform them that you are taking LEMAXIL.
Tuberculosis testing
This medicine may cause "false negative" results in certain laboratory tests that detect the bacteria causing tuberculosis.
Children and adolescents
LEMAXIL is contraindicated in children and adolescents during the growth period.
Pregnancy and breastfeeding
Do not take this medicine if:

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

If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
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 impair concentration and reaction speed. If this occurs, do not drive or perform activities requiring high attention.

3. How to take LEMAXIL

Take this medicine exactly as directed by your doctor or pharmacist. 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 during or apart from meals.

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

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

Protect your skin from sunlight
Do not expose yourself to direct sunlight during treatment with this medicine and for 2 days after treatment ends. This is because your skin will become much more sensitive to sunlight and may burn, itch, or develop serious lesions if you do not follow these precautions:

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

How much medicine to take

your doctor will decide how many LEMAXIL tablets 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 on your own but consult your doctor

Adults and elderly patients
Sinus infections

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

Lung infections in patients with chronic respiratory problems

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

Pneumonia

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

Urinary tract infections, including kidneys or bladder

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

Prostate infections

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

Skin and subcutaneous tissue infections, including muscles

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

Adults and elderly patients with kidney problems
Your doctor may consider it necessary to reduce the dosage.

If you take more LEMAXIL 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 allow the doctor to know 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 heartbeat and feelings of discomfort (nausea) or stomach burning.

If you forget to take LEMAXIL
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 a forgotten dose.

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

If you have any questions about the use of this medicine, consult 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.

Stop taking LEMAXIL and go immediately to the 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 LEMAXIL and go immediately to the 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 bowel problem.
Pain and inflammation of tendons or ligaments which in some cases may rupture. The Achilles tendon is most commonly affected.
Seizures.
Seeing or hearing things that are not there (hallucinations, paranoia).
Feeling depressed, mental disturbances, feeling restless (agitation), unusual dreams or nightmares.
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 excretion of water and low sodium levels (SIADH).
Decreased blood sugar levels (hypoglycaemia) or decreased blood sugar leading to coma (hypoglycaemic coma). This is important for people with diabetes.

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):

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.
Loss of appetite, yellowing of the skin and eyes, dark-coloured urine, itching or abdominal pain. These may be signs of liver problems, which may include fatal liver failure (liver failure that can lead to death).
Changes in thoughts and behaviour (psychotic reactions) with risk of suicidal thoughts or actions.
Nausea, general feeling of unwellness, stomach discomfort or pain, or vomiting. These could be signs of inflammation of the pancreas (acute pancreatitis). See section 2.

If your vision becomes blurred or you experience any eye discomfort while taking LEMAXIL, consult an ophthalmologist immediately.

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

Cases of aortic wall dilation and weakening or aortic wall rupture (aneurysms and dissections), potentially leading to fatal rupture, as well as cases of blood regurgitation from heart valves, have been reported in patients treated with fluoroquinolones. See also section 2.

Tell your doctor if any of the following side effects worsen or last longer than a few days:

Common (may affect up to 1 in 10 people):

Sleep disturbances
Headache, dizziness
Feeling unwell (nausea, vomiting) and diarrhoea
Increased liver enzyme levels 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, vertigo
Shortness of breath (dyspnoea)
Change in taste, loss of appetite, stomach upset or indigestion (dyspepsia), stomach pain, bloating (flatulence), constipation
Itching and 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 bleeding tendency due to reduced platelet count in the blood (thrombocytopenia)
Low white blood cell count (neutropenia)
Exaggerated immune response (hypersensitivity)
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 disorder of the nervous system)
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 spots, with or without blister formation, developing within hours of levofloxacin administration and healing with redness; these usually recur at the same skin or mucosal site after subsequent exposure to levofloxacin
Poor memory

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

Decrease in 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 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 (hyperglycaemia) or decreased blood sugar 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 heart rhythm (known as "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 rupture and muscle breakdown (rhabdomyolysis)
Redness and swelling of the joints (arthritis)
Pain, including back, chest and extremity pain
Sudden involuntary jerks, fasciculations or muscle contractions (myoclonus)
Acute 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)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. 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 LEMAXIL

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions; however, it is preferable to
store LEMAXIL tablets in the original blister and packaging in a dry place.
Do not use this medicine after the expiry date stated on the carton and blister 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 LEMAXIL contains

The active substance is levofloxacin. Each LEMAXIL 250 mg tablet contains 250 mg of levofloxacin and each LEMAXIL 500 mg tablet 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, macrogol 400, talc, yellow iron oxide, red iron oxide.

Description of the appearance of LEMAXIL and contents of the pack
Carton containing a blister of 5 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
S.F. Group S.r.l. – Via Tiburtina, 1143 – 00156 Rome, Italy
Manufacturer
PSI Supply nv
Axxes Business Park, Guldensporenpark 22, Block C
9820 Merelbeke
Belgium
Special Product’s Line SpA
Via Fratta Rotonda Vado Largo, 1
03012 Anagni (FR), Italy