LEMAXIL 250 mg Film-Coated Tablets

Зміст інструкції

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

LEMAXIL 250 mg film-coated tablets, 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, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What LEMAXIL is and what it is used for
• 2. What you need to know before you take LEMAXIL
• 3. How to take LEMAXIL
• 4. Possible side effects
• 5. How to store LEMAXIL
• 6. 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 called antibiotics. Levofloxacin is a “quinolone” antibiotic. This
medicine works by killing the bacteria that cause infections in the body.

LEMAXIL can be used for the treatment of infections:

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

In some special situations, Lemaxil tablets can be used to decrease the likelihood of
contracting a lung disease called anthrax or the worsening of the disease after
exposure to the bacterium that causes anthrax.
See 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:

• ifyou are allergic to levofloxacin, to any other quinolone antibiotic such as moxifloxacin, ciprofloxacin or ofloxacin or to any of the other ingredients of this medicine (listed in section 6).
• the signs of an allergic reaction include: skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue
• if you suffer from or have suffered from epilepsy
• if you have had problems with your tendons, such as tendinitis, related to treatment with a “quinolone antibiotic”. Tendons are fibrous structures that connect muscles to the skeleton
• if you are a child or adolescent during the growth period
• if you are pregnant, suspect you are pregnant or are planning to become pregnant
• if you are breastfeeding

Do not take this medicine if the above applies to you. If you have any
doubts, ask your doctor or pharmacist before taking LEMAXIL.

Warnings and precautions
Talk to your doctor or pharmacist before taking LEMAXIL:
if you are 60 years of age or older
if you are taking corticosteroids, sometimes called steroids (see “Other medicines and
Lemaxil”)
if you have had a transplant
if you have had seizures
if you have suffered brain damage following a stroke or other brain damage
if you have kidney problems
if you suffer from a condition known as “glucose-6-phosphate dehydrogenase deficiency”.
Taking this medicine makes the development of serious blood problems more likely
if you have suffered from 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 prolonged QT interval
(seen on an electrocardiogram, the electrical trace of the heart), have an imbalance
of salts in the blood (especially low levels of potassium or magnesium in the blood), have a very slow heart rate (called “bradycardia”), have a weak heart (heart failure), have had a heart attack (myocardial infarction), are a woman or elderly/a or
are taking other medicines that can alter the electrocardiogram (see
section “Other medicines and LEMAXIL”).
if you have diabetes
if you have had liver problems
if you have myasthenia gravis
if you have nerve problems (peripheral neuropathy)
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, Behçet's disease, high blood pressure or known atherosclerosis, rheumatoid arthritis [an autoimmune inflammatory
disease] or endocarditis [inflammation of the heart]).
If you start 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.
In case of fatigue, paleness of the skin, bruising, uncontrolled bleeding, fever, sore
throat and a 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 should monitor the blood with a blood count. In
case of an abnormal blood count, the doctor may need to stop treatment.
if you have developed a severe skin reaction or peeling of the skin, blisters and/or
ulcers in the mouth after taking any medicine containing levofloxacin.
Severe skin reactions
Severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and drug reaction with
eosinophilia and systemic symptoms (DRESS) have been reported with the use of levofloxacin.
SJS and TEN can initially appear on the body as reddish spots or as
circular patches often with central blisters. Ulcers of the mouth, throat, nose, genitals and eyes (red and swollen eyes) can also occur. These severe skin rashes are often preceded by fever and/or flu-like symptoms. The rashes
can progress to widespread peeling of the skin and life-threatening or fatal complications.
DRESS initially presents as flu-like symptoms and a skin rash on the
face, then a widespread rash with fever, an increase in liver enzyme levels in blood tests and an increase in a type of white blood cells (eosinophilia) and
swollen lymph nodes.
If you develop a severe skin rash or any other of these skin symptoms, stop
taking levofloxacin and contact your doctor or seek medical attention immediately.
You should not take antibacterial medicines based on quinolones/fluoroquinolones, including
Lemaxil, if you have previously had any serious adverse reaction during treatment
with a quinolone or fluoroquinolone. In this case, inform your doctor as soon as possible.
Pain and swelling in the joints and inflammation or rupture of
tendons can occur rarely. 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 up to several months after stopping therapy with LEMAXIL. At the first signs of
pain or inflammation in a tendon (for example in the ankle, wrist, elbow, shoulder or
knee), stop treatment with LEMAXIL, see a doctor and keep the painful part at rest. Avoid any unnecessary movement, as the risk of tendon rupture may increase.
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 rarely. In this case, stop treatment with LEMAXIL and inform your doctor immediately to avoid permanent nerve damage.

Serious, 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 are prolonged (lasting months
or years), disabling or potentially irreversible. These include pain in tendons, muscles and joints of arms legs, difficulty walking, abnormal sensations such as
tingling, prickling, itching, numbness or burning (paresthesia), sensory organ disorders such as altered vision, taste, smell and hearing, depression,
impaired memory, severe fatigue and severe sleep disturbances.
If you experience any of these side effects after taking LEMAXIL, 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.
While taking LEMAXIL:

• if you experience sudden, severe 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 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).

If you have any doubts that the above applies to you, ask your doctor
or pharmacist before taking LEMAXIL.

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

In particular, tell your doctor if you are taking any of the following medicines.
This is becausetaking LEMAXIL in combination with other medicines can
increase the possibility that youexperience side effects:
corticosteroids, sometimes called steroids – used to treat inflammation. The possibility that you develop inflammation and/or rupture of the tendons is greater.
warfarin – used to thin the blood. The possibility that you experience bleeding is
greater. Your doctor may ask you to have regular blood tests to
check your blood clotting.
theophylline – used for breathing problems. The possibility that you experience a seizure
is greater if you take theophylline in combination with LEMAXIL.
non-steroidal anti-inflammatory drugs (NSAIDs) – used for pain and inflammation such as
aspirin, ibuprofen, fenbufen, ketoprofen and indometacin. The possibility that you
experience a seizure if taken in combination with LEMAXIL is greater.
cyclosporine – used for organ transplants. The possibility that you experience the side
effects typical of cyclosporine is greater.
medicines known for their effects on the heartbeat. These include medicines used
to treat irregular heart rhythm (antiarrhythmics such as quinidine, hydroquinidine,
disopyramide, sotalol, dofetilide, ibutilide and amiodarone), for depression
(tricyclic antidepressants such as amitriptyline and imipramine), for psychiatric disorders
(antipsychotics) and for bacterial infections (macrolide antibiotics such as erythromycin,
azithromycin and clarithromycin).
probenecid – used 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.
Talk to your doctor if the above applies to you.

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

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

Urine test for opioids
In patients taking LEMAXIL, the determination of “opioids”, strong painkillers, in
urine tests may give false-positive results. If your doctor deems it necessary to have
urine tests performed, inform him/her that you are taking LEMAXIL.

Tuberculosis test
This medicine can cause “false negative” results in some laboratory tests that look for
the bacteria that cause 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 are trying to become pregnant
• you are breastfeeding or are planning to breastfeed

If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this
medicine.

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

3. How to take LEMAXIL

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

How to take this medicine

• take this medicine by mouth
• swallow the tablets whole with some water
• the tablets can be taken during or away from meals.

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

• Do not take these medicines at the same time as 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 the end of treatment. This is because your skin will become much more sensitive to the sun and may burn, itch or serious lesions may occur if you do not observe the following precautions:

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

How much medicine to take

• your doctor will decide how many LEMAXIL tablets you need to take
• the dose will depend on the type of infection you have contracted and the location of the infection in the body
• the duration of treatment will depend on the severity of the infection
• if you feel that the effect of the medicine is too weak or too strong, do not change the dosage yourself but consult your doctor Adults and elderlyFacial sinus infections
• two LEMAXIL 250 mg tablets once a day
• or, one LEMAXIL 500 mg tablet once a day Lung infections, in patients with chronic respiratory problems
• two LEMAXIL 250 mg tablets once a day
• or, one LEMAXIL 500 mg tablet once a day Pneumonia
• two LEMAXIL 250 mg tablets once or twice a day
• or, one LEMAXIL 500 mg tablet once or twice a day Urinary tract infections including kidneys or bladder
• one or two LEMAXIL 250 mg tablets once a day
• or, half or one LEMAXIL 500 mg tablet once a day Prostate infections
• two LEMAXIL 250 mg tablets once a day
• or, one LEMAXIL 500 mg tablet once a day Skin and subcutaneous tissue infections, including muscles
• two LEMAXIL 250 mg tablets once or twice a day
• or, one LEMAXIL 500 mg tablet once or twice a day Adults and elderly with kidney problemsYour doctor may consider it necessary to reduce the dosage.

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

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

If you stop taking LEMAXIL
Do not stop taking LEMAXIL tablets just because you feel better. It is important that you complete the cycle of tablets prescribed by your doctor. If you stop treatment too early, the infection may reappear and your condition may worsen or bacteria may develop resistance to the medicine.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Usually, these effects are mild or moderate and often disappear after a short time.

Stop taking LEMAXIL and seek immediate medical attention or go to hospital if you
notice thefollowing side effect:
Very rare(may affect up to 1 in 10,000 people)
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 LEMAXIL and seek immediate medical attention if you notice any of the
following side effects – you may need to receive urgent medical treatment:
Rare(may affect up to 1 in 1,000 people)

• watery diarrhoea with possible blood, possibly 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
• Seeing or hearing things that are not there (hallucinations, paranoia),
• Feeling of depression, mental problems, feeling restless (agitation), abnormal dreams or nightmares
• Widespread rash, fever, increased liver enzymes, blood abnormalities (eosinophilia), enlarged 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 paragraph 2.
• Syndrome associated with insufficient water excretion and low sodium levels (SIADH).
• Decrease in blood sugar levels (hypoglycemia) or decrease in blood sugar levels leading to coma (hypoglycemic coma). This is important for people who have diabetes.

Very rare(may affect up to 1 in 10,000 people)
burning, tingling, pain or numbness. These signs may be indicative of a
disease called “neuropathy”

Not known (the 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 as circular patches often with blisters in the centre, skin peeling, ulcers of the mouth, throat, nose, genitals and eyes and may be preceded by fever and flu-like symptoms. See also paragraph 2.
• Loss of appetite, yellowing of the skin and eyes, dark urine, itching or stomach pain (abdomen). These may be signs of liver problems which can include fatal liver failure (liver failure that can cause death).
• Changes in beliefs and thoughts (psychotic reactions) with the risk of having suicidal thoughts or suicidal actions
• 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 paragraph 2.

If your vision becomes blurred or if you experience any discomfort in your eyes
when taking LEMAXIL, consult an ophthalmologist immediately.
Very rare cases of prolonged (lasting months or years) or
permanent adverse drug reactions, such as inflammation of the tendons, tendon rupture, joint pain,
pain in arms or legs, difficulty walking, abnormal sensations such as prickling, tingling,
itching, burning, numbness or pain (neuropathy), fatigue, impaired
memory and concentration, effects on mental health (which may include
sleep disorders, anxiety, panic attacks, depression and suicidal ideation), changes
in hearing, vision, taste and smell, have been associated with the use of antibiotics of the
quinolone and fluoroquinolone type, in some cases independently of pre-existing risk
factors.
Cases of dilation and weakening of the aortic wall or tearing of the aortic wall
(aneurysms and dissections), with possible ruptures that can be life-threatening, as well as cases of backflow
of blood through the heart valves, have been reported in patients treated with fluoroquinolones. See
also paragraph 2.

Tell your doctor if any of the following side effects gets worse or lasts longer than
a fewdays:
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 the number of white blood cells shown in some blood tests
(leukopenia, 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), pain in the stomach area, feeling of fullness
(flatulence), constipation
itching and rash, severe itching or hives, excessive sweating (hyperhidrosis)
joint or muscle pain
blood tests may show abnormal results due to liver problems
(increased bilirubin) or kidneys (increased creatinine)
general weakness

Rare(may affect up to 1 in 1,000 people)
bruising and easy bleeding due to a reduction in the number of
platelets in the blood (thrombocytopenia)
low number of white blood cells (neutropenia)
exaggerated immune response (hypersensitivity)
feeling of tingling in the hands and feet (paresthesia)
problems with hearing (tinnitus) or vision (blurred vision)
unusually fast heartbeat (tachycardia) or low blood
pressure (hypotension)
muscle weakness. This is important for patients who suffer from myasthenia gravis
(a rare disease of the nervous system)
changes in kidney function and occasional kidney failure which may be
caused by an allergic reaction in the kidneys called interstitial nephritis
fever
clearly defined reddish patches, with or without blister formation
that develop within a few hours of administration of
levofloxacin and heal leaving the affected area reddened; usually reappear
in the same area of skin or mucosa after subsequent exposure
to levofloxacin
insufficient memory.

Not known (the frequency cannot be estimated from the available data )
decrease in red blood cells (anemia). This can lead to paleness or yellowish
skin due to damage to red blood cells and a decrease in the number of
all types of blood cells (pancytopenia)
the bone marrow stops producing new blood cells, which can 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 (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
unusually fast heartbeat, irregular heartbeat with life-threatening danger
including cardiac arrest, changes in heartbeat (called “QT prolongation” seen on the electrocardiogram, heart electrical activity)
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 areas
of skin (hyperpigmentation)
inflammation of the blood vessels throughout the body due to an
allergic reaction (vasculitis)
inflammation of the inner tissues of the mouth (stomatitis)
rupture and destruction of muscles (rhabdomyolysis)
redness and swelling of the joints (arthritis)
pain, including back pain, chest pain and extremity 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)

Reporting of side effects
If you get any side effects, even if not listed in this leaflet, tell your doctor, pharmacist or nurse. You can also report side effects
directly through 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 but it is better
to store LEMAXIL tablets in the blister and in the original box and in a dry place.
Do not use this medicine after the expiry date which is reported on the box and on the blister
after Exp. The expiry date refers to the last day of that month.
Do not dispose of any medicine in the wastewater and 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 LEMAXIL contains

• The active ingredient 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 ingredients 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
Pack containing a blister of 5 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
S.F. Group S.r.l. – Via Tiburtina, 1143 – 00156 Roma
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)