PACKAGE LEAFLET: Information for the user

Levofloxacina Teva 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, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

What is in this leaflet:

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

The name of this medicine is Levofloxacina Teva 250 mg or 500 mg film-coated tablets, but
in the rest of this leaflet it will be referred to as Levofloxacina Teva.

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

The name of this medicine is Levofloxacina Teva.
Levofloxacina Teva contains the active substance called levofloxacin.
This medicine 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 Teva can be used to treat infections of:

the sinuses
the lungs, in patients with chronic respiratory conditions or pneumonia
the urinary tract, including kidneys and bladder
the prostate, where a persistent infection may develop
the skin and subcutaneous tissue, including muscles. These are sometimes referred to as "soft tissues".

In certain special situations, Levofloxacina Teva 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 need to know before taking Levofloxacin Teva

Do not take Levofloxacin Teva:

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.

if you have a history of epilepsy.
if you have previously experienced tendon problems such as tendinitis related to treatment with a "quinolone antibiotic". Tendons are fibrous structures connecting muscles to bones.
if you are a child or adolescent during the growth period.
if you are pregnant, could become pregnant, or think you may be pregnant.
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 Levofloxacin Teva.
Warnings and precautions
Talk to your doctor or pharmacist before taking Levofloxacin Teva:

if you are 60 years old or older.
if you are taking corticosteroids, sometimes called steroids (see section 2: “Other medicines and Levofloxacin Teva”).
if you have ever had seizures.
if you have had brain damage due to 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 ever had mental health problems.
if you have ever 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 electrocardiogram, the heart's electrical tracing), have an electrolyte imbalance in the blood (especially low potassium or magnesium levels), have a very slow heart rate (called “bradycardia”), have a weakened 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 2 “Other medicines and Levofloxacin Teva”).
if you have diabetes.
if you have nerve problems (peripheral neuropathy).
if you have ever had liver problems.
if 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 have previously developed a severe skin reaction, skin peeling, blisters, and/or mouth ulcers after taking any medicine containing levofloxacin.

If you have any doubts whether any of the above may apply to you, consult your doctor or
pharmacist before taking Levofloxacin Teva.
Before taking this medicine
You must not take quinolone/fluoroquinolone antibacterial medicines, including Levofloxacin
Teva, if in the past you have had any serious adverse reaction during treatment with a
quinolone or fluoroquinolone. In such a case, inform your doctor as soon as possible.
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 treatment with Levofloxacin Teva. At the first signs of tendon pain or inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking Levofloxacin Teva, consult your doctor, and rest the affected area. 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. If this happens, stop taking Levofloxacin Teva and inform your doctor immediately to prevent permanent nerve damage.
If you experience sudden abdominal, chest, or back pain, go immediately to the emergency room.
If your vision becomes blurred or you experience other visual disturbances, consult an ophthalmologist immediately (see sections 2: "Driving and use of machines" and 4: "Possible side effects").

Severe skin reactions
Serious skin reactions have been reported with the use of levofloxacin, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS).

SJS and TEN may initially appear on the body as reddish spots or circular patches, often with central blisters. Mouth, throat, nose, genital, and eye ulcers (red 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 complications or death.
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 skin symptoms, stop taking levofloxacin and contact your doctor or seek immediate medical help.
Serious, prolonged, disabling, and potentially irreversible side effects
Fluoroquinolone/quinolone antibacterial medicines, including Levofloxacin Teva, 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, and hearing, depression, memory impairment, severe fatigue, and severe sleep disturbances.
If you experience any of these side effects after taking Levofloxacin Teva, 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 Levofloxacin Teva
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine. This is because Levofloxacin Teva may affect the action of other medicines. Likewise, some medicines may affect the action of Levofloxacin Teva.
In particular, inform your doctor if you are taking any of the following medicines. This is because
concomitant administration with Levofloxacin Teva may increase the likelihood of 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 seizures is higher if you take theophylline together with Levofloxacin Teva.
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 Levofloxacin Teva.
Cyclosporine – used for organ transplants. The risk of experiencing typical cyclosporine side effects 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 (“macrolide” antibiotics 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 Levofloxacin Teva. If you have kidney problems, your doctor may prescribe a lower dose.

Do not take Levofloxacin Teva together with the following medicines. This is because the
mechanism of action of Levofloxacin Teva 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 opiates
In patients taking Levofloxacin Teva, urine tests may give “false-positive” results for strong painkillers called “opiates”. If your doctor considers it necessary to perform urine tests, inform them that you are taking Levofloxacin Teva.
Tuberculosis testing
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 use of machines
Some side effects may occur after taking this medicine, including dizziness, drowsiness, subjective sensation of movement (vertigo), or visual disturbances. Some of these side effects may affect your ability to concentrate and your reaction speed. If this occurs, do not drive or perform activities requiring high attention.
Levofloxacin Teva contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially “sodium-free”.

3. How to take Levofloxacin Teva

Take this medicine exactly as your doctor or pharmacist has told you. If
you have any doubts, consult your doctor or pharmacist.
Taking this medicine

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

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 sunlight and may burn,
itch, or develop serious 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 Levofloxacin Teva. Take the prescribed dose of these medicines at least 2 hours before or after taking Levofloxacin Teva.

How much medicine to take

your doctor will decide how much Levofloxacin Teva 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 but consult your doctor

Adults and elderly
Sinus infections

two tablets of Levofloxacin Teva 250 mg once daily
or, one tablet of Levofloxacin Teva 500 mg once daily

Lung infections, in patients with chronic respiratory problems

two tablets of Levofloxacin Teva 250 mg once daily
or, one tablet of Levofloxacin Teva 500 mg once daily

Pneumonia

two tablets of Levofloxacin Teva 250 mg once or twice daily
or, one tablet of Levofloxacin Teva 500 mg once or twice daily

Urinary tract infections, including kidneys or bladder

one or two tablets of Levofloxacin Teva 250 mg once daily
or, half or one tablet of Levofloxacin Teva 500 mg once daily

Prostate infections

two tablets of Levofloxacin Teva 250 mg once daily
or, one tablet of Levofloxacin Teva 500 mg once daily

Skin and subcutaneous tissue infections, including muscles

two tablets of Levofloxacin Teva 250 mg once or twice daily
or, one tablet of Levofloxacin Teva 500 mg once or twice daily

Adults and elderly with kidney problems
Your doctor may consider it necessary to reduce the dose.
Children and adolescents
This medicine must not be given to children or adolescents.
If you take more Levofloxacin Teva than you should
If you accidentally take more tablets than you should, inform your doctor immediately or seek
medical advice elsewhere. Take 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 Levofloxacin Teva
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 Levofloxacin Teva
Do not stop taking Levofloxacin Teva 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 develop resistance to the medicine.
If you have any questions about using this medicine, ask your doctor, pharmacist, or
nurse.

4. Possible side effects

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

Stop taking Levofloxacina Teva 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 Teva 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 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 there (hallucinations, paranoia), changes in thoughts and behaviour (psychotic reactions), with possible development of suicidal thoughts or suicide attempts
feeling depressed, mental problems, feeling restless (agitation), unusual dreams or nightmares
widespread rash, fever, increased liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes and involvement of other body organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome). See also section 2.
syndrome associated with inadequate water excretion and low sodium levels (SIADH)

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

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

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

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 stomach pain (abdomen). These may be signs of liver problems, which may include fatal liver failure (liver failure that can lead to death)
if your vision becomes blurred or you experience other visual disturbances, consult an ophthalmologist immediately (see section 2: While using Levofloxacina Teva and Driving and use of machines).

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 discomfort or indigestion (dyspepsia), stomach pain, bloating (flatulence), constipation
itching and skin rash, severe itching or hives, excessive sweating (hyperhidrosis)
joint pain or muscle pain
blood tests may show abnormal results due to liver problems (increased bilirubin) or kidney problems (increased creatinine)
generalised weakness

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

bruising and increased tendency to bleed due to reduced 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 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
clearly defined erythematous patches, with or without blister formation, developing within a few hours of levofloxacin administration and healing with redness; these usually recur at the same skin or mucosal site after subsequent exposure to levofloxacin.

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 illness 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
unusually fast heartbeat, irregular heartbeat with life-threatening risk including cardiac arrest, changes in heartbeat rhythm (known as "prolongation of the QT interval" seen on electrocardiogram, electrical activity of the heart)
breathing difficulties 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 the blood vessels carrying blood throughout the body due to an allergic reaction (vasculitis)
inflammation of the internal tissues of the mouth (stomatitis)
muscle breakdown and destruction (rhabdomyolysis)
redness and swelling of the joints (arthritis)
pain, including back pain, chest pain and pain in the limbs
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)

Very rare cases of prolonged (lasting months or years) or permanent adverse drug reactions, such as tendon inflammation, tendon rupture, joint pain, pain in arms or legs, difficulty walking, abnormal sensations such as itching, tingling, prickling, 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 get any side effects, including ones 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 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 Teva

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the carton and blister. 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 Levofloxacina Teva contains

The active substance is levofloxacin hemihydrate, corresponding to 250 mg or 500 mg of levofloxacin.
The excipients are:

Core: silica (anhydrous colloidal), hydroxypropylcellulose, sodium carboxymethylamide, talc,
sodium croscarmellose, magnesium stearate.
Coating: hypromellose, titanium dioxide (E171), macrogol 400, polysorbate, iron oxide
red (E172).
Additionally, the 500 mg tablets contain black and yellow iron oxide (E172).

Description of the appearance of Levofloxacina Teva and package contents

250 mg: terracotta-coloured or pink, film-coated, capsule-shaped tablet with a score line, marked “LX” on the left side and “250” on the right side of the score line. The other side of the tablet is smooth and features a score line. The tablets can be divided into two equal halves.
500 mg: peach-coloured, film-coated, capsule-shaped tablet with a score line, marked “LX” on the left side and “500” on the right side of the score line. The other side of the tablet is smooth and features a score line. The tablets can be divided into two equal halves.
Pack sizes (250 mg tablets): 1, 2, 3, 5, 7, 10, 30, 50, 50 (5x10) and 200 (20x10) tablets.
(500 mg tablets): 1, 2, 5, 7, 10, 14, 30, 50, 50 (5x10) and 200 (20x10), 500 (50 x 10) tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Teva Italia S.r.l. – Piazzale Luigi Cadorna, 4 - 20123 Milano
Teva UK Ltd. - Brampton Road - Hampden Park – BN22 9AG Eastbourne – East Sussex (United Kingdom)
Pharmachemie B.V. - Swensweg 5 – P.O. Box 552 - 2003 RN Haarlem (Netherlands)
Teva Pharmaceutical Works Private Limited Company - Pallagi st. 13 - H-4042 Debrecen (Hungary)
Merckle GmbH - Ludwig-Merckle-Str. 3 - 89134 Blaubeuren (Germany)

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