Levofloxacin aurovitas: detailed information

Package leaflet: Information for the user

Levofloxacin Aurovitas, 250 mg, coated tablets
Levofloxacin Aurovitas, 500 mg, coated tablets
Levofloxacinum
Please read all of 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 further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Levofloxacin Aurovitas is and what it is used for
The name of this medicine is Levofloxacin Aurovitas. Levofloxacin Aurovitas tablets contain the active substance levofloxacin, which is a “quinolone” antibiotic. It acts bactericidally against bacteria causing infections in the body.
Levofloxacin Aurovitas tablets can be used to treat the following infections:

sinus infections;
lung infections, in patients with long-term breathing problems or pneumonia;
urinary tract infections, including kidneys or bladder;
prostate gland infections, in cases of long-term infection;
skin and subcutaneous tissue infections, including muscles; sometimes referred to as “soft tissues”.

In certain exceptional circumstances, Levofloxacin Aurovitas tablets may be used to treat or prevent a lung disease called anthrax, which may occur after exposure to anthrax-causing bacteria.

2. What you need to know before taking Levofloxacin Aurovitas

When not to take this medicine and contact your doctor

If you are allergic to levofloxacin, 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 lips, face, throat or tongue.
If you have ever had epilepsy.
If you have ever had tendon problems, such as tendonitis, associated with treatment with quinolone antibiotics. A tendon is a band of fibres connecting muscles to bones.
If the medicine has been prescribed for a child or adolescent during growth period.
If you are pregnant, could become pregnant, or suspect you may be pregnant.
If you are breastfeeding.

Do not take this medicine if any of the above apply to you.
If in doubt, speak to your doctor or pharmacist before starting treatment with Levofloxacin Aurovitas.
Warnings and precautions
Before starting Levofloxacin Aurovitas, discuss with your doctor or pharmacist if you:

have previously had a severe skin rash or skin peeling, blistering and (or) mouth ulcers after taking levofloxacin;
are aged 60 years or older;
are taking corticosteroids, sometimes called steroids (see section “Levofloxacin Aurovitas and other medicines”);
have had an organ transplant;
have ever had seizures (epileptic fits);
have previously had brain damage due to stroke or other brain injury;
have kidney problems;
have a condition called “glucose-6-phosphate dehydrogenase deficiency”; you may then be more susceptible to serious blood disorders during treatment with this medicine;
have previously had mental health problems;
have previously had heart problems: caution is needed when taking this medicine if you have a congenital or family history of QT interval prolongation (seen on ECG, i.e. test of electrical activity of the heart), if you have electrolyte imbalances in the blood (especially low potassium or magnesium levels), if you have a slow heart rate (called “bradycardia”), if your heart function is impaired (heart failure), if you have previously had a heart attack (myocardial infarction), if you are female or elderly, or if you are taking other medicines that cause abnormal changes in the ECG (see section “Levofloxacin Aurovitas and other medicines”);
have diabetes;
have previously had liver problems;
have myasthenia gravis;
have nerve damage (peripheral neuropathy);
have been diagnosed with enlargement or "bulging" of a large blood vessel (aortic aneurysm or peripheral large vessel aneurysm);
have previously experienced aortic dissection (formation of a tear in the aortic wall);
if you have heart valve regurgitation (valvular insufficiency).
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 Ehlers-Danlos syndrome, Turner syndrome, Sjögren's syndrome [an autoimmune inflammatory disease], or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet's disease, high blood pressure, diagnosed atherosclerosis, rheumatoid arthritis [joint disease], or endocarditis [heart infection]).

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

SJS or TEN may initially appear as red, target-like, or circular spots, often with blisters in the centre, on the trunk. Mouth, throat, nose, genital, or eye ulcers (red and swollen eyes) may also occur. These severe skin rashes are often preceded by fever and (or) flu-like symptoms. These rashes may lead to extensive skin peeling, which may be life-threatening or fatal.
In DRESS, flu-like symptoms and facial rash initially occur, followed by widespread rash with high fever, increased liver enzyme activity and elevated white blood cell count (eosinophilia) in blood tests, and enlarged lymph nodes.

If you develop a severe rash or any of these skin symptoms, stop taking levofloxacin and contact your doctor or seek immediate medical help.
Quinolone antibiotics may cause blood glucose levels to rise above normal (hyperglycaemia) or fall below normal, potentially leading to loss of consciousness (hypoglycaemic coma) in severe cases (see section 4). This is important for people with diabetes. If you have diabetes, monitor your blood glucose levels closely.
Do not take antibacterial medicines containing fluoroquinolone/quinolone, including Levofloxacin Aurovitas, if you have previously experienced any serious adverse reactions during treatment with a quinolone or fluoroquinolone. In such a case, inform your doctor as soon as possible.
While taking this medicine

If you experience sudden, severe abdominal, chest or back pain, which may be symptoms of aortic aneurysm or dissection, go to the emergency department immediately. Risk may be increased if you are being treated with systemic corticosteroids.
If you develop sudden shortness of breath, especially when lying flat in bed, notice swelling of ankles, feet or abdomen, or new palpitations (feeling of rapid or irregular heartbeat), inform your doctor immediately.
If you experience sudden, involuntary jerking, muscle twitching or muscle cramps, contact your doctor immediately, as these may be symptoms of myoclonus. Your doctor may decide to discontinue levofloxacin and start appropriate treatment.
If you experience nausea, general malaise, severe discomfort or persistent or worsening pain in the stomach area or vomiting – contact your doctor immediately, as this may be a sign of pancreatitis (acute inflammation of the pancreas).
If you experience: fatigue, pale skin, bruising, uncontrolled bleeding, fever, sore throat and significant worsening of health or feeling of reduced immunity to infections – contact your doctor immediately, as these may be symptoms of blood disorders. Your doctor should monitor your blood count with a complete blood count test. If abnormalities in blood count occur, your doctor may decide to discontinue treatment.

Joint pain and swelling, as well as tendon inflammation or rupture, may rarely occur. Risk increases if you are elderly (over 60 years), have had 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, or even several months after stopping treatment with Levofloxacin Aurovitas. At the first sign of tendon pain or inflammation (e.g. in the ankle, wrist, elbow, shoulder or knee), stop taking Levofloxacin Aurovitas, contact your doctor and rest the affected area. Avoid unnecessary exercise, as this may increase the risk of tendon rupture.
Neuropathy symptoms (nerve damage), such as pain, burning, tingling, numbness and (or) weakness, particularly in the feet and legs or hands and arms, may rarely occur. In such a case, stop taking Levofloxacin Aurovitas and inform your doctor immediately to prevent the development of potentially irreversible conditions.
Long-term, disabling and potentially irreversible serious adverse reactions
Fluoroquinolone/quinolone antibacterial medicines, including Levofloxacin Aurovitas, are associated with very rare but serious adverse reactions, some of which are long-term (lasting months or years), causing disability or potentially irreversible. These include tendon, muscle and joint pain in the upper and lower limbs, difficulty in movement, sensory disturbances such as pricking and tingling, burning, tickling, numbness or burning sensations (paresthesias), sensory disturbances including impaired vision, taste and smell, and hearing, depression, memory disturbances, severe fatigue and severe sleep disturbance. If any of these adverse reactions occur after taking Levofloxacin Aurovitas, contact your doctor immediately before continuing treatment. Together with your doctor, decide on continuing treatment, considering also an antibiotic from another class.
If you are unsure whether any of the above points apply to you, speak to your doctor or pharmacist before taking Levofloxacin Aurovitas.
Levofloxacin Aurovitas and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take. This is because Levofloxacin Aurovitas may affect the action of other medicines. Other medicines may also affect the action of Levofloxacin Aurovitas.
In particular, inform your doctor if you are taking any of the following medicines. This is because
the risk of adverse reactions may increase when taking Levofloxacin Aurovitas with the medicines
listed below.

Corticosteroids, sometimes called steroids – used in inflammatory conditions. You may be more susceptible to tendon inflammation and (or) tendon damage.
Warfarin – used to thin the blood. You may be more susceptible to bleeding. Your doctor may order regular blood tests to monitor blood clotting.
Theophylline – used for breathing problems. You may be more susceptible to seizures (epileptic fits) if taking Levofloxacin Aurovitas.
Non-steroidal anti-inflammatory drugs (NSAIDs) – used for pain and inflammation, such as: acetylsalicylic acid, ibuprofen, fenbufen, ketoprofen, indometacin. You may be more susceptible to seizures (epileptic fits) if taking Levofloxacin Aurovitas.
Cyclosporine – used after organ transplantation. You may be more susceptible to cyclosporine adverse effects.
Medicines affecting heart rhythm. This includes medicines used for irregular heart rhythm (antiarrhythmics such as: quinidine, hydroquinidine, disopyramide, sotalol, dofetilide, ibutilide and amiodarone), for depression (tricyclic antidepressants such as: amitriptyline and imipramine), for psychiatric disorders (antipsychotics), and for bacterial infections (macrolide antibiotics such as: erythromycin, azithromycin and clarithromycin).
Probenecid – used for gout. If kidney problems occur, your doctor may recommend a lower dose.
Cimetidine – used to treat peptic ulcer disease and heartburn. If kidney problems occur, your doctor may recommend a lower dose.

Do not take Levofloxacin Aurovitas at the same time as the following medicines,
as they may affect its action.

Iron-containing tablets (used for anaemia), zinc supplements, antacids containing magnesium or aluminium (used for hyperacidity or heartburn), didanosine or sucralfate (used for stomach ulcers). See section 3 below “If you are already taking iron-containing tablets, zinc supplements, antacids, didanosine or sucralfate”.
Urine tests for opioids
Urine tests detecting strong painkillers called opioids may give false positive results in patients taking Levofloxacin Aurovitas. If your doctor orders a urine test, you should inform your doctor that you are taking Levofloxacin Aurovitas.
Tuberculosis detection tests
This medicine may give false negative results in certain laboratory tests used to detect tuberculosis-causing bacteria.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, you should consult your doctor or pharmacist before using this medicine.
Do not take this medicine if you:
are pregnant, could become pregnant or suspect you are pregnant;
are breastfeeding or plan to breastfeed.

Driving and operating machinery
After taking this medicine, you may experience adverse effects such as dizziness, drowsiness, vertigo (spinning sensation) or visual disturbances. Some of these adverse effects may impair your ability to concentrate and your reaction speed. In such a case, you should not drive or perform any work requiring concentration.
Sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially “sodium-free”.

3. How to take Levofloxacin Aurovitas

This medicine should always be taken as directed by your doctor or pharmacist. If you have any
doubts, consult your doctor or pharmacist.
Taking this medicine

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

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

Do not take these medicines at the same time as Levofloxacin Aurovitas. Take your prescribed dose at least 2 hours before or 2 hours after taking Levofloxacin Aurovitas tablets.

Recommended dose

Your doctor will decide how many Levofloxacin Aurovitas tablets you should take.
The dose depends on the type and location of the infection.
The duration of treatment depends on the severity of the infection.
If you feel the medicine's effect is too weak or too strong, do not adjust the dose yourself; instead, consult your doctor.
Adults and elderly patients
Sinusitis
two Levofloxacin Aurovitas 250 mg tablets once daily, or
one Levofloxacin Aurovitas 500 mg tablet once daily

Respiratory infections in patients with chronic breathing problems

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

Pneumonia

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

Urinary tract infections, including kidneys or bladder

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

Prostate infections

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

Skin and soft tissue infections, including muscles

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

Adults and elderly patients with impaired kidney function
Your doctor may recommend a lower dose.
Children and adolescents
This medicine should not be used in children and adolescents.
Protecting skin from sunlight
During treatment and for 2 days after stopping this medicine, avoid direct sunlight exposure. This is because your skin may become more sensitive to sunlight, which could lead to sunburn, tingling sensations, or large blisters if you do not follow these precautions:

Use sunscreen with a high UV protection factor
Always wear a hat and clothing covering arms and legs
Avoid sunbathing

Taking more Levofloxacin Aurovitas than recommended
If you accidentally take more tablets than recommended, contact your doctor or seek medical help immediately. Take the medicine packaging with you so the doctor knows which medicine was taken. Possible symptoms include: seizures (epileptic fit), confusion, dizziness, disturbances in consciousness, muscle tremors, heart rhythm disturbances leading to irregular heartbeat, as well as nausea and heartburn.
Missing a dose of Levofloxacin Aurovitas
If you miss 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 missed dose.
Stopping Levofloxacin Aurovitas treatment
Do not stop taking Levofloxacin Aurovitas just because you feel better. It is important to take all tablets as prescribed by your doctor. Stopping treatment too early may cause the infection to return, your condition may worsen, or bacteria may become resistant to the medicine.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
These side effects are usually mild or moderate in severity and resolve quickly.

Very rare (occur in fewer than 1 in 10,000 patients)

Allergic reaction. Symptoms may include: rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue.

If any of the following side effects occur, stop taking Levofloxacin Aurovitas immediately and contact a doctor straight away – urgent medical assistance may be needed

Rare (occur in fewer than 1 in 1,000 patients)

Widespread rash, high fever, increased liver enzyme activity, abnormal blood counts (eosinophilia), swollen lymph nodes and other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome). See also section 2.
Syndrome related to impaired water excretion and low sodium levels (SIADH).
Watery diarrhoea, which may contain blood, possibly with abdominal cramps and high fever. These may be symptoms of serious intestinal problems.
Pain and inflammation of tendons or ligaments, which may lead to their rupture. Most commonly affects the Achilles tendon.
Seizures (epileptic fits).
Seeing or hearing things that are not there (hallucinations, paranoia).
Feelings of depression, psychiatric problems, feelings of anxiety (agitation), unusual dreams or nightmares.
Low blood sugar levels (hypoglycaemia) or hypoglycaemia leading to unconsciousness (hypoglycaemic coma). This is important for people with diabetes.

Very rare (occur in fewer than 1 in 10,000 patients)

Burning, tingling, pain or numbness. These may be symptoms of "neuropathy".

Frequency not known (cannot be estimated from available data)

Severe skin rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis. These may appear as red, target-like spots or circular patches, often with central blisters on the trunk, 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 whites of the eyes, dark urine, itching, abdominal tenderness. These may be symptoms of liver dysfunction, including fatal liver damage.
Changes in thoughts and beliefs (psychotic reactions) with risk of suicidal thoughts or actions.
Nausea, general malaise, discomfort or pain in the stomach area, or vomiting. These may be symptoms of pancreatitis (acute pancreatitis). See section 2.

If vision deteriorates or other visual disturbances occur during treatment with
Levofloxacin Aurovitas, consult an ophthalmologist immediately.
Very rare cases of long-term (lasting months or years) or permanent adverse effects of the medicine,
such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty moving, sensory disturbances
such as pricking and tingling, burning, tickling, burning sensations, numbness or pain (neuropathy), fatigue,
memory and concentration problems, mental health effects (which may include sleep disturbances, anxiety,
panic attacks, depression and suicidal thoughts), as well as hearing, vision, taste and smell impairment,
have been associated with the use of quinolones and fluoroquinolone antibiotics, in some cases regardless of
pre-existing risk factors.
In patients receiving fluoroquinolones, cases of aortic wall dilation and weakening, as well as aortic dissection
(aortic aneurysm and dissection), which may rupture and lead to death, and cases of heart valve insufficiency
have been reported. See also section 2.
Contact a doctor if any of the following side effects worsen or persist for longer than a few days

Common (occur in fewer than 1 in 10 patients)

Sleep disturbances
Headache, dizziness
Nausea, vomiting and diarrhoea
Increased activity of certain liver enzymes in the blood

Uncommon (occur in fewer than 1 in 100 patients)

Changes in the number of other bacteria or fungi, fungal infection caused by Candida species, which may require treatment
Changes in white blood cell count, visible in blood test results (leukopenia, eosinophilia)
Anxiety, confusion, nervousness, drowsiness, tremors, sensation of spinning (dizziness)
Shortness of breath (dyspnoea)
Changes in taste sensation, loss of appetite, stomach upset or indigestion, stomach pain, bloating with flatulence or constipation
Itching and skin rash, severe itching or hives, excessive sweating
Joint or muscle pain
Abnormal blood test results due to impaired liver function (increased bilirubin levels) or kidney function (increased creatinine levels)
General weakness

Rare (occur in fewer than 1 in 1,000 patients)

Increased tendency to bruising and bleeding due to reduced platelet count (thrombocytopenia)
Low white blood cell count (neutropenia)
Excessive immune response (hypersensitivity)
Tingling sensation in hands and feet (paraesthesia)
Hearing problems (tinnitus) or vision problems (blurred vision)
Unusually rapid heartbeat (tachycardia) or low blood pressure (hypotension)
Muscle weakness. This is important in patients with myasthenia gravis (a rare neurological disorder)
Changes in kidney function and sometimes kidney failure, possibly due to an allergic reaction in the kidneys known as interstitial nephritis
Fever
Well-defined, erythematous spots with or without blisters, developing within hours of levofloxacin administration. These resolve with post-inflammatory pigmentation. Upon re-administration of levofloxacin, these spots usually reappear at the same site on the skin or mucous membranes
Memory disturbances

Frequency not known (cannot be estimated from available data)

Decreased number of red blood cells (anaemia): this may cause paleness or yellowing of the skin due to destruction of red blood cells; decreased number of all blood cell types (pancytopenia).
Cessation of new blood cell production by the bone marrow, which may cause fatigue, reduced ability to fight infections and uncontrolled bleeding (bone marrow failure).
Fever, sore throat and general malaise that does not resolve. This may be due to a reduced number of white blood cells (agranulocytosis).
Circulatory collapse (anaphylactic shock-like reaction).
Increased blood sugar levels (hyperglycaemia). This is important in diabetic patients.
Changes in smell, loss of smell or taste (olfactory hallucinations, anosmia, ageusia).
Feeling of intense excitement, elation, agitation or enthusiasm (mania).
Problems with movement and walking (dyskinesia, extrapyramidal disorders).
Transient loss of consciousness or posture, fainting (syncope).
Transient vision loss, eye inflammation.
Hearing disturbances or hearing loss.
Abnormally fast heart rhythm, life-threatening irregular heartbeat, including cardiac arrest, change in heart rhythm (so-called "QT interval prolongation" visible on ECG, i.e. test of the heart's electrical activity).
Breathing difficulties or wheezing (bronchospasm).
Allergic reactions affecting the lungs.
Pancreatitis.
Hepatitis.
Increased sensitivity of the skin to sunlight and ultraviolet radiation (photosensitivity), skin discoloration (skin hyperpigmentation).
Inflammation of blood vessels due to an allergic reaction (vasculitis).
Inflammation of the lining of the mouth (stomatitis).
Muscle breakdown and disintegration (rhabdomyolysis).
Redness and swelling of joints (arthritis).
Pain, including back, chest and limb pain.
Sudden, involuntary jerks, muscle twitches and muscle spasms (myoclonus).
Acute attacks of porphyria in patients with porphyria (a very rare metabolic disorder).
Persistent headache with blurred vision (benign intracranial hypertension).
Loss of consciousness due to significant drop in blood sugar levels (hypoglycaemic coma). See section 2.

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, inform your doctor or pharmacist.
Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorisation holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Levofloxacin Aurovitas

Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the stated month.
No special requirements for storage of this medicinal product.
Medicines should not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Levofloxacin Aurovitas contains

The active substance is levofloxacin. Each film-coated tablet contains 250 mg or 500 mg of levofloxacin in the form of levofloxacin hemihydrate.
Other components of the medicine
Tablet core: sodium croscarmellose, microcrystalline cellulose (PH-101 and PH-102), hypromellose 5 cP, magnesium stearate.

Tablet coating: hypromellose 6 cP, titanium dioxide (E 171), macrogol 400, talc, iron oxide yellow (E 172), iron oxide red (E 172).

What Levofloxacin Aurovitas looks like and contents of the pack
Film-coated tablet.
Levofloxacin Aurovitas, 250 mg, film-coated tablets
Pink, biconvex, capsule-shaped film-coated tablets with an engraved division line separating the engravings "1" and "5" on one side and "T" on the other side.
The tablet can be divided into equal doses.
Levofloxacin Aurovitas, 500 mg, film-coated tablets
Pink, biconvex, capsule-shaped film-coated tablets with an engraved division line separating the engravings "1" and "4" on one side and "T" on the other side.
The tablet can be divided into equal doses.
Levofloxacin Aurovitas film-coated tablets are packed in blisters.
Pack sizes
250 mg – Blisters containing 5, 7 or 10 film-coated tablets.
500 mg – Blisters containing 5, 7, 10 or 14 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warszawa
Poland

Manufacturer/Importer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta

This medicinal product is authorised in the European Economic Area member states under the following names:
Portugal: Levofloxacina Aurovitas
Poland: Levofloxacin Aurovitas
Spain: LEVOFLOXACINO AUROVITAS 500 mg comprimidos recubiertos con película EFG