Levofloxacin Aurobindo: detailed information

Package leaflet: Information for the user

Levofloxacina Aurobindo 250 mg film-coated tablets, 500 mg film-coated tablets

Equivalent medicine
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 questions, ask 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 may be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

The name of the medicine is Levofloxacina Aurobindo tablets. Levofloxacina Aurobindo tablets contain an active substance called levofloxacin, which belongs to a group of medicines known as antibiotics. Levofloxacin is a quinolone antibiotic. It works by killing the bacteria that cause infections in your body.

Levofloxacina Aurobindo tablets can be used to treat the following infections:

of the sinuses
of the lungs, in people with long-term respiratory problems or pneumonia
of the urinary tract, including the kidneys or bladder
of the prostate, where there is a long-lasting infection
of the skin and subcutaneous tissues, including muscles. These are sometimes referred to as 'soft tissues'

In certain specific situations, Levofloxacina Aurobindo tablets may be used to reduce the risk of developing or worsening a lung disease called anthrax after exposure to the bacteria that cause anthrax.

2. What you should know before taking Levofloxacina Aurobindo

Do not take this medicine:

if you are allergic to levofloxacin, to any other quinolone antibiotic such as moxifloxacin, ciprofloxacin or ofloxacin, or to any of the excipients of this medicine (listed in section 6).
Signs of an allergic reaction include: rash, difficulty breathing or swallowing, swelling of the lips, face, throat or tongue.
if you have had epilepsy.
if you have had tendon problems such as tendonitis related to treatment with a quinolone antibiotic. A tendon is the cord that connects muscle to bone.
if you are a child or growing adolescent.
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 conditions apply to you. If you are unsure, consult your doctor or pharmacist before taking Levofloxacina Aurobindo.

Warnings and precautions

Consult your doctor or pharmacist before taking this medicine if:

you are 60 years of age or older.
you are taking corticosteroids, sometimes called steroids (see section “Other medicines and Levofloxacina Aurobindo”).
you have had seizures.
you have had brain damage due to stroke or other brain injuries.
you have kidney problems.
you have a condition known as 'glucose-6-phosphate dehydrogenase deficiency'. You may be at higher risk of serious blood problems while taking this medicine.
you have had mental health problems.
you have heart problems: caution is needed when using this type of medicine if you were born with or have a family history of prolonged QT interval (seen on ECG, an electrical recording of the heart), if you have an imbalance of salts in the blood (especially low levels of potassium or magnesium in the blood), if you have a very slow heart rate (called 'bradycardia'), if you have a weak heart (heart failure), if you have a history of 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 “Other medicines and Levofloxacina Aurobindo”).
you are diabetic.
you have liver problems.
you have myasthenia gravis.

If you are unsure whether any of the conditions listed above apply to you, consult your doctor or pharmacist before taking Levofloxacina Aurobindo.

Other medicines and Levofloxacina Aurobindo

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because Levofloxacina Aurobindo may affect how some other medicines work. Some medicines can also affect how Levofloxacina Aurobindo works.

In particular, inform your doctor if you are taking any of the following medicines. These may increase the risk of side effects when taken with Levofloxacina Aurobindo:

Corticosteroids, sometimes called steroids – used for inflammation. You may be more likely to experience inflammation and/or rupture of tendons.
Warfarin – used to thin the blood. You may be more likely to experience bleeding. Your doctor may need to perform regular blood tests to monitor how well your blood clots.
Theophylline – used for breathing problems. You may be more likely to have seizures when taken with Levofloxacina Aurobindo.
Non-steroidal anti-inflammatory drugs (NSAIDs) – used for pain and inflammation, such as aspirin, ibuprofen, fenbufen, ketoprofen and indomethacin. You may be more likely to have seizures when taken with Levofloxacina Aurobindo.
Cyclosporine – used after organ transplants. You may be more likely to experience side effects from cyclosporine.
Medicines known to affect heart rhythm. These include medicines used for 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 for gout, and cimetidine – used for ulcers and heartburn. Special care is needed when taking any of these medicines with Levofloxacina Aurobindo. If you have kidney problems, your doctor may decide to prescribe a lower dose.

Do not take the following medicines at the same time as Levofloxacina Aurobindo tablets. This is because they may affect how Levofloxacina Aurobindo tablets work:

Iron tablets (for anaemia), zinc supplements, or antacids containing magnesium or aluminium (for acidity or heartburn), didanosine or sucralfate (for stomach ulcers). See section 3 "If you are already taking iron tablets, zinc supplements, antacids, didanosine or sucralfate" below.

Urine tests for opiates

In people taking Levofloxacina Aurobindo, urine tests may show 'false positive' results for strong painkillers called 'opiates'. If your doctor has prescribed a urine test, inform them that you are taking Levofloxacina Aurobindo.

Tuberculosis testing

This medicine may cause 'false negative' results for certain laboratory tests used to detect bacteria causing tuberculosis.

Pregnancy, breastfeeding and fertility

If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Do not take this medicine if:

you are pregnant, think you may be pregnant, or are planning to become pregnant.
you are breastfeeding or intend to breastfeed.

Driving and using machines

After taking this medicine, you may experience side effects such as dizziness, drowsiness, vertigo or changes in vision. Some of these side effects may affect your ability to concentrate and your reaction speed. If this occurs, do not drive or perform any activity requiring a high level of attention.

3. How to take Levofloxacina Aurobindo

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Taking the medicine
Take the medicine by mouth.
Swallow the tablets whole with a glass of water.
The tablets may be taken during meals or at any time between meals.
Protect your skin from sunlight
Avoid direct sunlight while taking this medicine and for 2 days after you have
stopped taking it. This is because your skin will become much more sensitive to sunlight and may burn, tingle,
or develop severe blisters if you do not take the following precautions:

Make sure to use high-protection sunscreen creams.
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 Aurobindo. Take your dose of these medicines at least 2 hours before or after taking Levofloxacina Aurobindo tablets.

Dosage

Your doctor will decide how many Levofloxacina Aurobindo 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 feel 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 infection

Two Levofloxacina Aurobindo 250 mg tablets once daily
Alternatively, one Levofloxacina Aurobindo 500 mg tablet once daily

Lung infection in people with long-term breathing problems

Two Levofloxacina Aurobindo 250 mg tablets once daily
Alternatively, one Levofloxacina Aurobindo 500 mg tablet once daily

Pneumonia

Two Levofloxacina Aurobindo 250 mg tablets once or twice daily
Alternatively, one Levofloxacina Aurobindo 500 mg tablet once or twice daily

Urinary tract infection, including kidneys and bladder

One or two Levofloxacina Aurobindo 250 mg tablets once daily
Alternatively, ½ or one Levofloxacina Aurobindo 500 mg tablet once daily

Prostate gland infection

Two Levofloxacina Aurobindo 250 mg tablets once daily
Alternatively, one Levofloxacina Aurobindo 500 mg tablet once daily

Skin and soft tissue infection, including muscles

Two Levofloxacina Aurobindo 250 mg tablets once or twice daily
Alternatively, one Levofloxacina Aurobindo 500 mg tablet once or twice daily

Adults and elderly with kidney problems
Your doctor may need to prescribe a lower dose.
Use in children and adolescents
This medicine must not be given to children or adolescents.
If you take more Levofloxacina Aurobindo than you should
If you accidentally take more tablets than you should, inform your doctor or seek immediate medical help.
Take the medicine pack with you so the doctor knows what you have taken. The following effects may occur: seizures (fits), confusion, dizziness, loss of consciousness, tremors, and heart problems leading to irregular heartbeat, as well as feelings of discomfort (nausea) or heartburn.
If you forget to take Levofloxacina Aurobindo
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 forgotten dose.
If you stop taking Levofloxacina Aurobindo
Do not stop taking Levofloxacina Aurobindo just because you feel better. It is important to complete the full course of treatment 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 doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Stop taking Levofloxacina Aurobindo and consult a doctor or go to hospital immediately
if you experience the following side effect:
Very rare (may affect up to 1 in 10,000 people)

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

Stop taking Levofloxacina Aurobindo and contact your doctor immediately if you notice
any of the following side effects – urgent medical treatment may be required:
Rare (may affect up to 1 in 1,000 people)
Watery diarrhoea, which may contain blood, possibly with stomach cramps and high fever. These may be signs of a serious intestinal problem
Pain and inflammation of tendons or ligaments which may lead to rupture. The Achilles tendon is most commonly affected
Seizures (convulsions)
Very rare (may affect up to 1 in 10,000 people)
Burning, tingling, pain or numbness. These may be symptoms of a condition called 'neuropathy'
Other:
Severe skin rashes which may include blisters or peeling of the skin around the lips, eyes, mouth, nose and genital organs
Loss of appetite, yellowing of the skin and eyes, dark-coloured urine, itching or painful stomach (abdomen). These may be signs of liver problems, which may include fatal liver failure.
If your vision begins to deteriorate or you experience other eye problems while taking Levofloxacina Aurobindo, consult an ophthalmologist immediately.

Inform your doctor if any of the following side effects worsen or last longer than a few days:
Common (may affect up to 1 in 10 people)
Sleep disturbances
Headache, dizziness
Feeling unwell (nausea, vomiting) and diarrhoea
Increased levels of certain 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, tremors, dizziness (vertigo)
Shortness of breath (dyspnoea)
Changes in taste, loss of appetite, stomach ache 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 that may show abnormal results due to liver problems (increased bilirubin) or kidney problems (increased creatinine)
General weakness
Rare (may affect up to 1 in 1,000 people)
Bruising and easy bleeding due to reduced platelet count in the blood (thrombocytopenia)
Low white blood cell count (neutropenia)
Exaggerated immune response (hypersensitivity)
Low blood sugar levels (hypoglycaemia). This is important for people with diabetes
Seeing or hearing things that are not there (hallucinations, paranoia), changes in thoughts and beliefs (psychotic reactions) with risk of suicidal thoughts or actions
Feeling depressed, mental disturbances, feeling restless (agitation), abnormal 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 in people with myasthenia gravis (a rare disorder of the nervous system)
Changes in kidney function and occasional kidney failure, which may be due to a kidney allergic reaction called interstitial nephritis
Fever
Other side effects include:
Reduced red blood cells (anaemia): this may make the skin pale or yellow due to damage to red blood cells; reduction in the number of 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 reduced number of white blood cells (agranulocytosis)
Loss of circulation (such as anaphylactic shock)
Increased blood sugar levels (hyperglycaemia) or reduced blood sugar levels leading to coma (hypoglycaemic coma). This is important for people with diabetes
Changes in the sense of smell, loss of smell or taste (parosmia, anosmia, ageusia)
Problems with movement and walking (dyskinesia, extrapyramidal disorders)
Temporary loss of consciousness or posture (syncope)
Temporary loss of vision
Reduction or loss of hearing
Fast, irregular and life-threatening heart rhythm, including cardiac arrest, changes in heart rhythm (called 'QT interval prolongation', seen on ECG, the heart's electrical activity)
Difficulty breathing or wheezing (bronchospasm)
Allergic reactions in the lungs
Pancreatitis
Liver inflammation (hepatitis)
Increased sensitivity of the skin to sunlight and ultraviolet light (photosensitivity)
Inflammation of blood vessels carrying blood throughout the body due to an allergic reaction (vasculitis)
Inflammation of the inner lining of the mouth (stomatitis)
Muscle rupture and muscle breakdown (rhabdomyolysis)
Redness and swelling of joints (arthritis)
Pain, including back, chest and limb pain
Porphyria attacks in people already affected (a very rare metabolic disorder)
Persistent headache with or without blurred vision (benign intracranial hypertension)

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 the website http://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 Aurobindo 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 box/bottle 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 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. Other information

What Levofloxacina Aurobindo contains

The active substance is levofloxacin. Each film-coated tablet contains 250 mg/500 mg of levofloxacin as levofloxacin hemihydrate.
The other components are croscarmellose sodium, microcrystalline cellulose, hypromellose, magnesium stearate. Tablet coating: hypromellose, titanium dioxide (E171), macrogol (PEG 400), talc, yellow iron oxide (E172), red iron oxide (E172).

Description of the appearance of Levofloxacina Aurobindo and contents of the pack
Film-coated tablet.
Levofloxacina Aurobindo 250 mg:
Pink, capsule-shaped, biconvex, film-coated tablets marked with “1” and “5” separated by a score line on one side and “T” on the other side.
The tablet can be divided into two equal doses.
Levofloxacina Aurobindo 500 mg:
Pink, capsule-shaped, biconvex, film-coated tablets marked with “1” and “4” separated by a score line on one side and “T” on the other side.
The tablet can be divided into two equal doses.
Levofloxacina Aurobindo 250 mg:
Blister packs containing 3, 5, 7, 8, 10, 50, 100 and 200 film-coated tablets.
HDPE bottles containing 50 and 1000 film-coated tablets.
Levofloxacina Aurobindo 500 mg:
Blister packs containing 1, 3, 5, 7, 8, 10, 14, 50, 100 and 200 film-coated tablets.
HDPE bottles containing 50 and 1000 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Aurobindo Pharma (Italia) S.r.l.
Via S. Giuseppe 102
21047 Saronno (VA)
Italy

Manufacturer
APL Swift Services (Malta) Limited,
HF26, Hal Far Industrial Estate, Hal Far,
Birzebbugia, BBG3000
Malta

This medicinal product is authorized in the European Economic Area countries under the following names:
France: Levofloxacine Arrow Lab 500 mg comprimé pelliculé sécable
Germany: Levofloxacin Aurobindo 250 mg /500 mg Filmtabletten
Italy: Levofloxacina Aurobindo
Portugal: Levofloxacina Aurobindo
Spain: Levofloxacino Aurobindo 250 mg /500 mg comprimidos recubiertos con película EFG