Levofloxacin Pensapharma: detailed information

PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER

LEVOFLOXACIN PENSA PHARMA 250 mg film-coated tablets, 500 mg film-coated tablets

Levofloxacin
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

What LEVOFLOXACIN PENSA PHARMA tablets are and what they are used for
What you need to know before taking LEVOFLOXACIN PENSA PHARMA tablets
How to take LEVOFLOXACIN PENSA PHARMA tablets
Possible side effects
How to store LEVOFLOXACIN PENSA PHARMA tablets
Contents of the pack and other information

1. WHAT LEVOFLOXACIN PENSA PHARMA TABLETS ARE AND WHAT THEY ARE USED FOR

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

of the sinuses
of the lungs, in patients with chronic respiratory disorders or pneumonia
of the urinary tract, including kidneys and bladder
of the prostate, where a persistent infection may develop
of the skin and subcutaneous tissue, including muscles. These are sometimes referred to as "soft tissues". In certain special situations, LEVOFLOXACIN PENSA PHARMA 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 LEVOFLOXACIN PENSA PHARMA

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

you are allergic (hypersensitive) to levofloxacin, to any other type of 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-related problems such as tendinitis associated with treatment with a “quinolone antibiotic”. Tendons are fibrous structures connecting muscles to bones
you are a child or adolescent during the growth period
you are pregnant, may become pregnant, or think you might 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, nurse, or pharmacist before taking LEVOFLOXACIN
PENSA PHARMA.
Warnings and precautions
Consult your doctor before taking this medicine if:

you are 60 years old or older
you are taking corticosteroids, sometimes called steroids (see “Other medicines and LEVOFLOXACIN PENSA PHARMA”)
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 issues
you have had heart problems: you should exercise caution when using this type of medicine if you were born with or have a family history of QT interval prolongation (seen on electrocardiogram, the electrical tracing 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 had a heart attack (myocardial infarction), are female or elderly, or are taking other medicines that may alter the electrocardiogram (see section “Taking other medicines”)
you have diabetes
you have had liver problems
you have myasthenia gravis
you have been diagnosed with enlargement or “bulging” of a large blood vessel (aortic aneurysm or peripheral aneurysm of a large blood vessel)
if you have previously experienced episodes of aortic dissection (a tear in the wall of the aorta)
if you have been diagnosed with insufficiency of one of the heart valves (aortic or mitral regurgitation)
if you have a family history of aortic aneurysm or aortic dissection, congenital heart valve disease, or other risk factors or predisposing conditions (e.g. connective tissue disorders such as Marfan syndrome or vascular Ehlers-Danlos syndrome, Turner syndrome, Sjögren’s syndrome [an autoimmune inflammatory disease], or if you suffer from vascular diseases such as Takayasu arteritis, giant cell arteritis, Behcet’s syndrome, known high blood pressure or atherosclerosis, rheumatoid arthritis [an autoimmune inflammatory disease], or endocarditis [inflammation of the heart])
you have developed a severe skin reaction or skin peeling, blisters and/or mouth ulcers after taking any medicine containing levofloxacin.

If you have any doubts whether any of the above may apply to you, consult your doctor or
pharmacist before taking LEVOFLOXACIN PENSA PHARMA.
When taking LEVOFLOXACIN PENSA PHARMA
If your vision decreases or your eyes are otherwise affected in any way, consult an ophthalmologist immediately.
If you experience sudden, severe pain in the abdomen, chest, or back, which may be a symptom
of aortic aneurysm or dissection, go immediately to the emergency room. The risk may
be higher if you are taking systemic corticosteroid medicines.
Inform your doctor immediately if you notice a sudden onset of shortness of breath, especially
when lying down, or swelling of the ankles, feet, or abdomen, or new episodes
of palpitations (sensation of rapid or irregular heartbeat).
If you experience nausea, general malaise, severe or persistent stomach pain, worsening of abdominal pain, or vomiting, contact your doctor immediately, as these may be signs of pancreas inflammation (acute pancreatitis).
If you begin to experience sudden involuntary jerks, muscle fasciculations, or contractions – consult a doctor immediately, as these may be signs of myoclonus. Your doctor may need to stop treatment with levofloxacin and start appropriate therapy.
In case of fatigue, pale skin, bruising, uncontrolled bleeding, fever, sore throat, and severe worsening of your general condition, or if you feel your resistance to infections has decreased – consult a doctor immediately as these may be signs of blood disorders. Your doctor should monitor your blood with a complete blood count. If blood counts are abnormal, your doctor may need to stop treatment.
Rarely, joint pain and swelling, and tendon inflammation or rupture 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
LEVOFLOXACIN PENSA PHARMA. At the first signs of tendon pain or inflammation (e.g. in the ankle, wrist, elbow, shoulder, or knee), stop taking LEVOFLOXACIN PENSA PHARMA, 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. In such cases, stop taking LEVOFLOXACIN PENSA PHARMA and inform your doctor immediately to prevent permanent nerve damage.
Serious, prolonged, disabling, and potentially irreversible side effects
Fluoroquinolone/quinolone antibacterial medicines, including LEVOFLOXACIN PENSA
PHARMA, have been associated with very rare but serious side effects, some of which are prolonged (lasting months or years), disabling, or may not improve. These include tendon, muscle, and joint pain in arms and legs, difficulty walking, unusual sensations such as 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
PENSA PHARMA, consult your doctor immediately before continuing treatment. Your
doctor will decide together with you whether to continue treatment and will also consider using an antibiotic from another class.
Severe skin reactions
Serious skin reactions have been reported with levofloxacin use, 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. Skin eruptions may progress to widespread skin peeling and life-threatening or potentially fatal complications.
DRESS initially presents with flu-like symptoms and a skin rash on the face, followed by widespread skin rash with fever, elevated liver enzyme levels in blood tests, increased levels of a type of white blood cell (eosinophilia), and swollen lymph nodes.

If you develop a severe skin rash or any of these other skin symptoms, stop taking levofloxacin and contact your doctor or seek immediate medical help.
Other medicines and LEVOFLOXACIN PENSA PHARMA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine. This is because LEVOFLOXACIN PENSA PHARMA may affect the action of other medicines. Likewise, some medicines may affect the action of LEVOFLOXACIN PENSA PHARMA.
In particular, inform your doctor if you are taking any of the following medicines. This is because
concomitant administration with LEVOFLOXACIN PENSA PHARMA may increase the risk 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 PENSA PHARMA.
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 PENSA PHARMA.
cyclosporine – used for organ transplants. The risk of experiencing typical side effects of cyclosporine is higher.
medicines known to affect heart rhythm. These include medicines used to treat abnormal heart rhythm (antiarrhythmics such as quinidine, hydroquinidine, disopyramide, 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 PENSA PHARMA. If you have kidney problems, your doctor may prescribe a lower dose.

Do not take LEVOFLOXACIN PENSA PHARMA tablets concomitantly with the following
medicines. This is because the mechanism of action of LEVOFLOXACIN PENSA PHARMA
tablets may be affected:

iron salts in tablet form (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 salts in tablet form, zinc supplements, antacids, didanosine, or sucralfate”

Urine tests for opioids
In patients taking LEVOFLOXACIN PENSA PHARMA, urine tests may
produce “false-positive” results for strong painkillers called ‘opioids’. If your doctor considers
it necessary to perform urine tests, inform them that you are taking LEVOFLOXACIN
PENSA PHARMA.
Tuberculosis testing
This medicine may cause “false-negative” results in certain laboratory tests used to detect the bacterium causing tuberculosis.
Pregnancy, breastfeeding, and fertility
Do not take this medicine if:

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

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 impair concentration and reaction speed. If this occurs, do not drive or operate machinery requiring high attention levels.
Levofloxacin Pensa Pharma 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 PENSA PHARMA TABLETS

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

How to take this medicine

Take this medicine by mouth
Swallow the tablets whole with water
The tablets may be taken with or without food

Protect your skin from sunlight
Do not expose yourself to direct sunlight during treatment with this medicine and for 2 days after stopping treatment. This is because your skin will become much more sensitive to sunlight and you may experience sunburn, itching, or develop severe skin lesions if you do not follow the precautions listed below:

Make sure to use a high-protection sunscreen
Always wear a hat and clothing covering arms and legs
Avoid sunbeds (tanning beds)

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

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

Dosage: How much medicine to take

Your doctor will decide how much LEVOFLOXACIN PENSA PHARMA 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 LEVOFLOXACIN PENSA PHARMA 250 mg once daily
or, one tablet of LEVOFLOXACIN PENSA PHARMA 500 mg once daily

Lung infections in patients with chronic respiratory problems

Two tablets of LEVOFLOXACIN PENSA PHARMA 250 mg once daily
or, one tablet of LEVOFLOXACIN PENSA PHARMA 500 mg once daily

Pneumonia

Two tablets of LEVOFLOXACIN PENSA PHARMA 250 mg once or twice daily
or, one tablet of LEVOFLOXACIN PENSA PHARMA 500 mg once or twice daily

Urinary tract infections, including kidneys or bladder

One or two tablets of LEVOFLOXACIN PENSA PHARMA 250 mg once daily
or, half or one tablet of LEVOFLOXACIN PENSA PHARMA 500 mg once daily

Prostate infections

Two tablets of LEVOFLOXACIN PENSA PHARMA 250 mg once daily
or, one tablet of LEVOFLOXACIN PENSA PHARMA 500 mg once daily

Skin and subcutaneous tissue infections, including muscles

Two tablets of LEVOFLOXACIN PENSA PHARMA 250 mg once or twice daily
or, one tablet of LEVOFLOXACIN PENSA PHARMA 500 mg once or twice daily

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

Use in children and adolescents
This medicine must not be given to children or adolescents.

If you take more LEVOFLOXACIN PENSA PHARMA tablets than you should
If you accidentally take more tablets than prescribed, contact your doctor immediately or seek medical advice. Take the medicine pack with you so the doctor can 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, nausea, or heartburn.

If you forget to take a LEVOFLOXACIN PENSA PHARMA tablet
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 PENSA PHARMA tablets
Do not stop taking LEVOFLOXACIN PENSA PHARMA 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 how to use this medicine, ask your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

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

Stop taking LEVOFLOXACIN PENSA PHARMA and go immediately to the doctor or hospital if you notice the following adverse reaction:

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

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

Stop taking LEVOFLOXACIN PENSA PHARMA and go immediately to the doctor if you notice any of the following adverse reactions – you may require urgent medical treatment:

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

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
Widespread rash, fever, elevated liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes, and involvement of other body organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome). See also section 2.
Syndrome associated with inadequate water excretion and low sodium levels (SIADH)

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

Burning, tingling, pain, or numbness. These symptoms may indicate a condition called “neuropathy”.

Other:

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, and eye ulcers, and may be preceded by fever and flu-like symptoms. See also section 2.
Loss of appetite, yellowing of the skin and eyes, dark-coloured urine, itching, or abdominal pain. These may be signs of liver problems, including potentially fatal liver failure (liver failure that may lead to death).
Nausea, general feeling of illness, stomach discomfort or pain, or vomiting. These may be signs of inflammation of the pancreas (acute pancreatitis). See section 2.

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

Inform your doctor if any of the following adverse reactions worsen or persist for more than a few days:

Common (may affect up to 1 in 10 patients)

Sleep disturbances
Headache, dizziness
Feeling unwell (nausea, vomiting), and diarrhoea
Increased liver enzyme levels in blood tests

Uncommon (may affect up to 1 in 100 patients)

Changes in the number of other bacteria or fungi, fungal infections caused by 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)
Changes 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)
Generalized weakness

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

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 patients with diabetes
Seeing or hearing things that are not real (hallucinations, paranoia), changes in thinking and mood (psychotic reactions), with possible development of suicidal thoughts or suicide attempts
Feeling depressed, mental disturbances, restlessness (agitation), unusual dreams or nightmares
Tingling sensation in hands and feet (paraesthesia)
Hearing problems (tinnitus) or vision problems (blurred vision)
Unusually fast heartbeat (tachycardia) or low blood pressure (hypotension)
Muscle weakness. This is important for patients with myasthenia gravis (a rare nervous system disorder)
Impaired kidney function and occasional kidney failure, which may be caused by an allergic reaction affecting the kidneys called interstitial nephritis
Fever
Well-defined erythematous spots, with or without blistering, developing within hours of levofloxacin administration and healing with residual redness; these usually reappear at the same site on the skin or mucosa after subsequent exposure to levofloxacin

Other adverse reactions include:

Decreased red blood cells (anaemia). This may lead to paleness or yellowish skin due to damage to red blood cells and a reduced number of all types of blood cells (pancytopenia)
The bone marrow stops producing new blood cells, which may cause fatigue, reduced ability to fight infections, and uncontrolled bleeding (bone marrow failure)
Fever, sore throat, and a general feeling of illness that does not go away. This may be due to a reduced number of white blood cells in the blood (agranulocytosis)
Lack of blood flow (anaphylactic shock)
Increased blood sugar levels (hyperglycaemia) or decreased blood sugar levels leading to coma (hypoglycaemic coma). This is important for patients with diabetes
Changes in the smell of things, loss of smell or taste (parosmia, anosmia, ageusia), difficulty moving or walking (dyskinesia, extrapyramidal disorders)
Feeling highly excited, euphoric, agitated, or enthusiastic (mania)
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), darker skin areas (hyperpigmentation)
Inflammation of blood vessels supplying the entire body due to an allergic reaction (vasculitis)
Inflammation of the internal tissues of the mouth (stomatitis)
Muscle breakdown and destruction (rhabdomyolysis)
Redness and swelling of joints (arthritis)
Pain, including back, chest, and extremity pain
Sudden involuntary jerks, fasciculations, or muscle contractions (myoclonus)
Attacks of porphyria in patients who already have porphyria (a very rare metabolic disorder)
Persistent headache with or without blurred vision (benign intracranial hypertension)

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

Very rare cases of prolonged (lasting months or years) or permanent adverse drug reactions, such as tendon inflammation, tendon rupture, joint pain, pain in arms or legs, difficulty walking, abnormal sensations such as pricking, tingling, tickling, burning, numbness, or pain (neuropathy), fatigue, memory and concentration impairment, mental health effects (which may include sleep disorders, anxiety, panic attacks, depression, and suicidal thoughts), 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.

If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist.

Reporting of adverse reactions

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

5. HOW TO STORE LEVOFLOXACIN PENSA PHARMA TABLETS

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions; however, it is advisable to store LEVOFLOXACIN PENSA PHARMA tablets in the original blister and packaging in a dry place.
Do not use this medicine after the expiry date stated on the carton and on the aluminium sheet after "Exp". The expiry date refers to the last day of that month.
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. PACKAGING CONTENTS AND OTHER INFORMATION

What LEVOFLOXACIN PENSA PHARMA tablets contain
The active substance is levofloxacin. Each tablet of LEVOFLOXACIN PENSA PHARMA 250 mg tablets contains 250 mg of levofloxacin and each tablet of LEVOFLOXACIN PENSA PHARMA 500 mg tablets contains 500 mg of levofloxacin.
The other components are:

For the tablet core: crospovidone, hypromellose, microcrystalline cellulose and sodium stearyl fumarate
For the coating: hypromellose, titanium dioxide (E171), talc, macrogol, yellow iron oxide (E172) and red iron oxide (E172).

Description of the appearance of LEVOFLOXACIN PENSA PHARMA tablets and packaging contents
Film-coated tablets for oral use. The tablets are oblong, biconvex, and have a break line, pale yellow-white to reddish-white in colour.
LEVOFLOXACIN PENSA PHARMA 250 mg tablets are available in packs of 5 tablets.
LEVOFLOXACIN PENSA PHARMA 500 mg tablets are available in packs of 5 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Towa Pharmaceutical S.p.A
Via Enrico Tazzoli, 6
20154 Milan - Italy

Manufacturers
DOPPEL FARMACEUTICI SRL
Via Volturno, 48 – 20089 Quinto de' Stampi – Rozzano (MI)
DOPPEL FARMACEUTICI SRL
Via Martiri delle Foibe, 1 – 29016 Cortemaggiore (PC)

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

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