Levofloxacin Sandoz: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Levofloxacina Sandoz 250 mg film-coated tablets

Generic medicine
Please read 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, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Levofloxacina Sandoz is and what it is used for
What you need to know before taking Levofloxacina Sandoz film-coated tablets
How to take Levofloxacina Sandoz film-coated tablets
Possible side effects
How to store Levofloxacina Sandoz film-coated tablets
Contents of the pack and other information

1. What Levofloxacina Sandoz is and what it is used for

The name of this medicine is Levofloxacina Sandoz film-coated tablets. Levofloxacina Sandoz film-coated tablets contain the active substance called levofloxacin. Levofloxacina Sandoz 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.

Levofloxacina Sandoz film-coated tablets can be used to treat infections:

of the sinuses
of the lungs, in patients with chronic respiratory conditions 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, Levofloxacina Sandoz film-coated 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.

2. What you should know before taking Levofloxacina Sandoz film-coated tablets

Do not take this medicine and inform your doctor 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
you have had epilepsy
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
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

Do not take this medicine if any of the above applies to you. If you have any doubts, consult your doctor or pharmacist before taking Levofloxacina Sandoz.

Warnings and precautions
Before taking this medicine
You must not take quinolone/fluoroquinolone antibacterial medicines, including Levofloxacina Sandoz, if you have previously experienced any serious adverse reaction during treatment with a quinolone or fluoroquinolone. In such cases, inform your doctor as soon as possible.

Consult your doctor or pharmacist before taking Levofloxacina Sandoz if:

you are 60 years old or older
you are taking corticosteroids, sometimes called steroids (see "Other medicines and Levofloxacina Sandoz")
you have had 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". Taking this medicine increases the likelihood of developing serious blood-related problems
you have suffered from mental health problems
you have had heart conditions: you should be cautious when using this medicine if you were born with or have a family history of prolonged QT interval (detectable by electrocardiogram, an electrical recording of the heart), 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 weak heart function (heart failure), have a history of heart attacks (myocardial infarction), if you are female or elderly, or if you are taking other medicines that cause abnormal ECG changes (see section "Other medicines and Levofloxacina Sandoz").
you have diabetes
you have had liver problems
you have myasthenia gravis
- 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 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 syndrome, known high blood pressure or atherosclerosis).

If you experience sudden pain in the abdomen, chest, or back, go immediately to the emergency room.

If you have any doubts whether any of the above may apply to you, consult your doctor or pharmacist before taking Levofloxacina Sandoz.

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), 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 Levofloxacina Sandoz. At the first signs of tendon pain or inflammation (e.g. in the ankle, wrist, elbow, shoulder or knee), stop taking Levofloxacina Sandoz, consult your doctor, and rest the affected area. Avoid any unnecessary movement, as the risk of tendon rupture may increase.

Rarely, symptoms of nerve damage (neuropathy) may occur, such as pain, burning, tingling, numbness and/or weakness, particularly in the feet and legs or hands and arms. If this happens, stop taking Levofloxacina Sandoz and inform your doctor immediately to prevent permanent nerve damage.

Serious, prolonged, disabling and potentially irreversible side effects
Fluoroquinolone/quinolone antibacterial medicines, including Levofloxacina Sandoz, 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, 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 Levofloxacina Sandoz, consult your doctor immediately before continuing treatment. Your doctor will decide together with you whether to continue treatment and will consider using an antibiotic from another class.

Other medicines and Levofloxacina Sandoz
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine. This is because Levofloxacina Sandoz may affect the action of other medicines. Likewise, some medicines may affect the action of Levofloxacina Sandoz.

In particular, inform your doctor if you are taking any of the following medicines. This is because
concomitant administration with Levofloxacina Sandoz may increase the likelihood of 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 seizures is higher if you take theophylline together with Levofloxacina Sandoz.
non-steroidal anti-inflammatory drugs (NSAIDs) – used for pain and inflammation, such as aspirin, ibuprofen, fenbufen, ketoprofen and indomethacin. The risk of seizures is higher when taken together with Levofloxacina Sandoz.
cyclosporine – used for organ transplants. The risk of experiencing typical cyclosporine side effects is higher.
medicines known to affect 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, and cimetidine – used for ulcers and heartburn. Particular caution is required when using any of these medicines together with Levofloxacina Sandoz. If you have kidney problems, your doctor may prescribe a lower dose.

Do not take Levofloxacina Sandoz film-coated tablets together with the following
medicines. This is because the effectiveness of Levofloxacina Sandoz film-coated 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 salt tablets, zinc supplements, antacids, didanosine or sucralfate".

Urine test for opioids
In patients taking Levofloxacina Sandoz, urine tests may give "false-positive" results for strong painkillers called "opioids". If your doctor considers it necessary to perform a urine test, inform them that you are taking Levofloxacina Sandoz.

Tuberculosis test
This medicine may cause "false-negative" results in certain laboratory tests used to detect the bacterium 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 impair your concentration and reaction speed. If this occurs, do not drive or operate machinery requiring high attention levels.

Levofloxacina Sandoz film-coated tablets contain lactose.
This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

Levofloxacina Sandoz film-coated tablets contain sodium.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially "sodium-free".

3. How to take Levofloxacina Sandoz film-coated tablets

Take this medicine exactly as directed 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

The tablet may be divided into equal doses.
Protect your skin from sunlight
Do not expose yourself to direct sunlight during treatment with this medicine and for 2 days after
treatment has ended. This is because your skin will become much more sensitive to sunlight and may burn,
itch, or develop severe lesions if you do not follow the precautions listed below:

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

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

Do not take these medicines at the same time as Levofloxacina Sandoz. Take the prescribed dose of these medicines at least 2 hours before or after taking Levofloxacina Sandoz film-coated tablets.

How much medicine to take

your doctor will decide how much Levofloxacina Sandoz film-coated 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 that the effect of the medicine is too weak or too strong, do not change the dose yourself but consult your doctor

Adults and elderly

Sinus infections
 two Levofloxacina Sandoz 250 mg tablets once daily

or, one Levofloxacina Sandoz 500 mg tablet once daily

Lung infections, in patients with chronic respiratory problems

two Levofloxacina Sandoz 250 mg tablets once daily
or, one Levofloxacina Sandoz 500 mg tablet once daily

Pneumonia

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

Urinary tract infections, including kidneys or bladder

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

Prostate infections

two Levofloxacina Sandoz 250 mg tablets once daily
or, one Levofloxacina Sandoz 500 mg tablet once daily

Skin and subcutaneous tissue infections, including muscles

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

Adults and elderly with kidney problems
Your doctor may consider it necessary to reduce the dose.
Use in children and adolescents
Levofloxacina Sandoz film-coated tablets must not be given to children or adolescents.
If you take more Levofloxacina Sandoz film-coated tablets than you should
If you accidentally take more tablets than you should, inform your doctor immediately or seek medical
advice. Take the medicine pack with you. This will allow the doctor to see 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 feeling unwell (nausea) or stomach burning.
If you forget to take Levofloxacina Sandoz film-coated tablets
If you forget to take a dose, take it as soon as you remember, unless it is almost time to take the next
dose. Do not take a double dose to make up for the forgotten dose.
If you stop taking Levofloxacina Sandoz film-coated tablets
Do not stop taking Levofloxacina Sandoz 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 bacteria may become resistant to the medicine.
If you have any questions about how to use 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 to moderate in severity and often disappear after a short time.

Stop taking Levofloxacina Sandoz 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 Levofloxacina Sandoz and contact your doctor immediately 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
seeing or hearing things that are not real (hallucinations, paranoia), changes in thinking and mood (psychotic reactions), possibly leading to suicidal thoughts or actions, feeling depressed, mental problems, feeling restless (agitation), unusual dreams or nightmares

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

burning, tingling, pain or numbness. These symptoms may be signs of a condition called "neuropathy"

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

severe skin rash which may include sores or peeling of the skin around the lips, eyes, mouth, nose and genitals
loss of appetite, yellowing of the skin and eyes, dark-coloured urine, itching or abdominal pain. These may be signs of liver problems, including fatal liver failure (liver failure that can lead to death)

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

Tell 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 known as 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 area 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 platelet count in the blood (thrombocytopenia)
low white blood cell count (neutropia)
exaggerated immune response (hypersensitivity)
low blood sugar levels (hypoglycaemia). This is important for people with diabetes
tingling sensation in the 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

Side effects 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)
fever, sore throat and a persistent feeling of being unwell. 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
changes in the smell of things, loss of smell or taste (parosmia, anosmia, ageusia)
difficulty moving or walking (dyskinesia, extrapyramidal disorders)
temporary loss of consciousness or posture (syncope)
temporary loss of vision
worsening or loss of hearing
abnormally fast heartbeat, life-threatening irregular heartbeat including cardiac arrest, changes in heart rhythm (known as "QT interval prolongation" visible on electrocardiogram, a recording of the heart's electrical activity)
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)
inflammation of blood vessels 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 the joints (arthritis)
pain, including back, chest and limb pain
attacks of porphyria in patients who already have porphyria (a very rare metabolic disorder)
persistent headache with or without blurred vision (benign intracranial hypertension)
syndrome associated with impaired water excretion and low sodium levels (SIADH)

Very rare cases of prolonged (lasting months or years) or permanent adverse reactions to the drug, 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), depression, fatigue, sleep disturbances, memory impairment, 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 Levofloxacin Sandoz film-coated tablets

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and outer packaging, after
EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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 Levofloxacina Sandoz film-coated tablets contain

The active substance is levofloxacin. Each tablet contains 250 mg of levofloxacin (as hemihydrate).
The other components are:
Tablet core: monohydrate lactose, povidone K30, sodium starch glycolate (type A), talc, anhydrous colloidal silica, croscarmellose sodium, glycerol dibehenate.

Coating:
hypromellose,
hydroxypropylcellulose,
macrogol 6000,
titanium dioxide (E171),
yellow iron oxide (E172),
red iron oxide (E172),
talc.

Description of the appearance of Levofloxacina Sandoz film-coated tablets and package contents
The film-coated tablets are octagonal, light pink-orange in colour, biconvex, with a break line on both sides.
The film-coated tablets are packaged in PVC/TE/PVDC/Al blisters placed in a cardboard box.
Pack sizes:
Blister packs: 1, 3, 4, 5, 7, 10, 14, 20, 28, 30, 50, 60, 90 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz S.p.A. Largo U. Boccioni 1 21040 Origgio, Varese, Italy

Manufacturer
Lek Pharmaceuticals d.d. Verovškova 57 1526 Ljubljana, Slovenia
Salutas Pharma GmbH Dieselstrasse 5 70839 Gerlingen, Germany
Salutas Pharma GmbH Otto-von-Guericke-Allee 1 39179 Barleben, Germany

This medicinal product has been authorised in the European Economic Area countries under the following names:
Austria: Levofloxacin Sandoz 250 mg - Filmtabletten
Belgium: Levofloxacine Sandoz 250 mg – filmomhulde tabletten
Italy: Levofloxacina Sandoz 250 mg compresse rivestite con film
Netherlands: Levofloxacine Sandoz 250 mg – filmomhulde tabletten
Slovenia: Levofloksacin Lek 250 mg filmsko obložene tablete
United Kingdom: Levofloxacin 250 mg Film-coated Tablets

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Levofloxacina Sandoz 500 mg film-coated tablets

Equivalent medicine
Please read this leaflet carefully before 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, consult your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Levofloxacina Sandoz is and what it is used for
What you need to know before taking Levofloxacina Sandoz film-coated tablets
How to take Levofloxacina Sandoz film-coated tablets
Possible side effects
How to store Levofloxacina Sandoz film-coated tablets
Contents of the pack and other information

1. What Levofloxacina Sandoz is and what it is used for

The name of this medicine is Levofloxacina Sandoz. Levofloxacina Sandoz film-coated tablets contain
the active substance called levofloxacin. Levofloxacina Sandoz belongs to a group of medicines called
antibiotics. Levofloxacin is a "quinolone" antibiotic. This medicine works by killing the bacteria
responsible for infections in the body.
Levofloxacina Sandoz film-coated tablets can be used to treat the following infections:

of the sinuses
of the lungs, in patients with chronic respiratory conditions 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 circumstances, Levofloxacina Sandoz film-coated tablets may be used to reduce the risk of developing a lung disease called anthrax or to prevent worsening of the disease after exposure to the bacterium that causes anthrax.

2. What you need to know before taking Levofloxacina Sandoz film-coated tablets

Do not take this medicine and inform your doctor 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: rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue
you have had epilepsy
you have had tendon problems such as tendinitis related to treatment with a "quinolone antibiotic". Tendons are fibrous structures that connect muscles to the skeleton
you are a child or adolescent during the growth period
you are pregnant, could become pregnant, or think you might be pregnant
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 Levofloxacina Sandoz.

Warnings and precautions

Before taking this medicine

You must not take quinolone/fluoroquinolone antibacterial medicines, including Levofloxacina Sandoz, if you have previously experienced any serious adverse reaction during treatment with a quinolone or fluoroquinolone. In such cases, inform your doctor as soon as possible.

Consult your doctor or pharmacist before taking Levofloxacina Sandoz if:

you are aged 60 years or older
you are taking corticosteroids, sometimes called steroids (see "Other medicines and Levofloxacina Sandoz")
you have had 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 suffered from mental health problems
you have had heart conditions: you should be cautious when using this medicine if you were born with or have a family history of prolonged QT interval (visible on electrocardiogram, an electrical recording of the heart), 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 a history of heart attacks (myocardial infarction), if you are female or elderly, or if you are taking other medicines that cause abnormal ECG changes (see section "Other medicines and Levofloxacina Sandoz").
you have diabetes
you have had liver problems
you have myasthenia gravis
- 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 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 suffer from vascular diseases such as Takayasu arteritis, giant cell arteritis, Behcet's syndrome, high blood pressure, or known atherosclerosis). If you experience sudden abdominal, chest, or back pain, go immediately to the emergency room.
If you have any doubts whether any of the above may apply to you, consult your doctor or pharmacist before taking Levofloxacina Sandoz.

When to take this medicine

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 Levofloxacina Sandoz. At the first signs of tendon pain or inflammation (e.g. in the ankle, wrist, elbow, shoulder, or knee), stop treatment with Levofloxacina Sandoz, consult your doctor, and rest the affected area. Avoid 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, particularly in the feet and legs or hands and arms, may occur. If this happens, stop treatment with Levofloxacina Sandoz and inform your doctor immediately to prevent permanent nerve damage.

Serious, prolonged, disabling, and potentially irreversible side effects

Fluoroquinolone/quinolone antibacterial medicines, including Levofloxacina Sandoz, 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, 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 Levofloxacina Sandoz, consult your doctor immediately before continuing treatment. Your doctor will decide with you whether to continue treatment and may consider using an antibiotic from another class.

Other medicines and Levofloxacina Sandoz

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because Levofloxacina Sandoz may affect the action of other medicines. Likewise, some medicines may affect the action of Levofloxacina Sandoz.

corticosteroids, sometimes called steroids – used to treat inflammation. The risk of developing tendon inflammation and/or rupture is increased.
warfarin – used to thin the blood. The risk of bleeding is increased. Your doctor may ask you to have regular blood tests to monitor blood clotting.
theophylline – used for respiratory problems. The risk of seizures (epileptic fits) is increased if you take theophylline together with Levofloxacina Sandoz.
non-steroidal anti-inflammatory drugs (NSAIDs) – used for pain and inflammation, such as aspirin, ibuprofen, fenbufen, ketoprofen, and indomethacin. The risk of seizures (epileptic fits) is increased if taken together with Levofloxacina Sandoz.
ciclosporin – used in organ transplantation. The risk of experiencing typical ciclosporin side effects is increased.
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 amitriptiline and imipramine), for psychiatric disorders (antipsychotics), and for bacterial infections (antibiotics "macrolides" such as erythromycin, azithromycin, and clarithromycin).
probenecid – used to treat gout, and cimetidine – used for ulcers and heartburn. Particular caution is required when using any of these medicines together with Levofloxacina Sandoz. If you have kidney problems, your doctor may prescribe a lower dose.

Do not take Levofloxacina Sandoz film-coated tablets concomitantly with the following
medicines. This is because the action of Levofloxacina Sandoz film-coated tablets could be affected:

iron salts in tablets (for anaemia), 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 test for opiates

In patients taking Levofloxacina Sandoz, urine tests may give "false-positive" results for strong painkillers called "opiates". If your doctor considers it necessary to perform a urine test, inform them that you are taking Levofloxacina Sandoz.

Tuberculosis test

This medicine may cause "false-negative" results in certain laboratory tests used to detect the bacterium causing tuberculosis.

Pregnancy and breastfeeding

Do not take this medicine if:

you are pregnant, could become pregnant, or think you might be pregnant
you are breastfeeding or think you might 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 concentration and reaction speed. If this occurs, do not drive or operate machinery requiring high attention levels.

Levofloxacina Sandoz film-coated tablets contain lactose.

This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

Levofloxacina Sandoz contains sodium.

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

3. How to take Levofloxacina Sandoz film-coated tablets

Take this medicine exactly as directed 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

The tablet may be divided into equal doses.
Protect your skin from sunlight
Avoid direct sunlight during treatment with this medicine and for 2 days after treatment has ended. This is because your skin will become much more sensitive to sunlight and may burn, itch, or develop severe lesions if you do not follow these precautions:

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

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

Do not take these medicines at the same time as Levofloxacina Sandoz. Take the prescribed dose of these medicines at least 2 hours before or after taking Levofloxacina Sandoz film-coated tablets.

How much medicine to take

your doctor will decide how much Levofloxacina Sandoz film-coated 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 yourself—consult your doctor

Adults and elderly patients
Sinus infections  two tablets of Levofloxacina Sandoz 250 mg once daily

or, one tablet of Levofloxacina Sandoz 500 mg once daily
Lung infections in patients with chronic respiratory problems - two tablets of Levofloxacina Sandoz 250 mg once daily
or, one tablet of Levofloxacina Sandoz 500 mg once daily
Pneumonia - two tablets of Levofloxacina Sandoz 250 mg once or twice daily
or, one tablet of Levofloxacina Sandoz 500 mg once or twice daily
Urinary tract infections, including kidneys or bladder - one or two tablets of Levofloxacina Sandoz 250 mg once daily
or, half or one tablet of Levofloxacina Sandoz 500 mg once daily
Prostate infections  two tablets of Levofloxacina Sandoz 250 mg once daily
or, one tablet of Levofloxacina Sandoz 500 mg once daily
Skin and soft tissue infections, including muscles - two tablets of Levofloxacina Sandoz 250 mg once or twice daily
or, one tablet of Levofloxacina Sandoz 500 mg once or twice daily

Adults and elderly patients with kidney problems
Your doctor may consider it necessary to reduce the dose.
Use in children and adolescents
Levofloxacina Sandoz film-coated tablets must not be given to children or adolescents.
If you take more Levofloxacina Sandoz film-coated tablets than you should
If you accidentally take more tablets than you should, inform your doctor immediately or seek medical advice. Bring the medicine packaging with you. This will allow the doctor to know what you have taken. The following side effects may occur: seizures (epileptic 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 Levofloxacina Sandoz film-coated tablets
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 Levofloxacina Sandoz film-coated tablets
Do not stop taking Levofloxacina Sandoz 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 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 everybody will experience them. Usually, these effects are mild or moderate in severity and often disappear after a short time.

Stop taking Levofloxacina Sandoz 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 Levofloxacina Sandoz and contact your doctor immediately 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
seeing or hearing things that are not real (hallucinations, paranoia), changes in thinking and behaviour (psychotic reactions), with possible development of suicidal thoughts or suicide attempts
feeling depressed, mental problems, feeling restless (agitation), unusual dreams or nightmares

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

burning, tingling, pain or numbness. These symptoms may be signs of a condition called "neuropathy"

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

severe skin rash which may include lesions or peeling of the skin around the lips, eyes, mouth, nose and genitals
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 could include fatal liver failure (liver failure that can cause death)

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

Tell 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)
change in taste, loss of appetite, stomach upset or indigestion (dyspepsia), stomach area 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 platelet count in the blood (thrombocytopenia)
low white blood cell count (neutropenia)
exaggerated immune response (hypersensitivity)
decreased blood sugar levels (hypoglycaemia). This is important for people with diabetes
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

Side effects 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)
fever, sore throat and a general feeling of being unwell 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 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)
difficulty moving or walking (dyskinesia, extrapyramidal disorders)
temporary loss of consciousness or posture (syncope)
temporary loss of vision
worsening or loss of hearing
abnormally fast heartbeat, dangerous irregular heart rhythm including cardiac arrest, changes in heart rhythm (called "prolongation of the QT interval" visible on an electrocardiogram, a recording of the heart's electrical activity)
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)
inflammation of blood vessels 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 the 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)
syndrome associated with impaired water excretion and low sodium levels (SIADH)

Very rare cases of adverse drug reactions that are prolonged (lasting for months or years) or permanent, 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), depression, fatigue, sleep disturbances, memory impairment, and changes in hearing, vision, taste and smell, have been associated with the use of quinolone and fluoroquinolone antibiotics. In some cases, these occurred regardless of pre-existing risk factors.

Reporting of side effects

If you experience any side effects, 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 Levofloxacin Sandoz film-coated tablets

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and packaging, following
EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine 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 Levofloxacina Sandoz film-coated tablets contain

The active substance is levofloxacin. Each tablet contains 500 mg of levofloxacin (as hemihydrate).
The other components are: Tablet core: lactose monohydrate, povidone K30, sodium starch glycolate (type A), talc, anhydrous colloidal silicon dioxide, sodium croscarmellose, glycerol dibehenate. Coating: hypromellose, hydroxypropylcellulose, macrogol 6000, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), talc.

Description of the appearance of Levofloxacina Sandoz film-coated tablets and pack contents

The film-coated tablets are octagonal, light pink-orange in colour, biconvex, with a breakline on one side.
The film-coated tablets are packed in PVC/TE/PVDC/Al blisters placed in cardboard boxes.
Pack sizes:
Blister: 1, 3, 4, 5, 7, 8, 10, 14, 20, 28, 30, 50, 60, 90, 100, 200, 500 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz S.p.A. Largo U. Boccioni 1 21040 Origgio Varese

Manufacturer
Lek Pharmaceuticals d.d. Verovškova 57 1526 Ljubljana Slovenia
Salutas Pharma GmbH Dieselstrasse 5 70839 Gerlingen Germany
Salutas Pharma GmbH Otto-von-Guericke-Allee 1 39179 Barleben Germany

This medicinal product has been authorised in the Member States of the European Economic Area under the following names:
Austria: Levofloxacin Sandoz 500 mg - Filmtabletten
Belgium: Levofloxacine Sandoz 500 mg – filmomhulde tabletten
Bulgaria: FLEXID 500 mg film-coated tablets
Finland: Levofloxacin Sandoz 500 mg kalvopäällysteinen en tabletti
France: Levofloxacine Sandoz 500 mg, comprimé pelliculé sécable
Hungary: Levofloxacin Sandoz 500 mg filmtabletta
Italy: Levofloxacina Sandoz 500 mg compresse rivestite con film
Netherlands: Levofloxacine Sandoz 500 mg – filmomhulde tabletten
Slovenia: Levofloksacin Lek 500 mg filmsko obložene tablete
Spain: Levofloxacino Sandoz 500 mg comprimidos recubiertos con película EFG
United Kingdom: Levofloxacin 500 mg Film-coated Tablets