Levofloxacin EG: detailed information

Package leaflet: Information for the user

LEVOFLOXACIN EG 250 mg film-coated tablets

Active substance: Levofloxacin hemihydrate
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 other people, even if they have the same symptoms as you, because 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 LEVOFLOXACIN EG 250 mg is and what it is used for
What you need to know before taking LEVOFLOXACIN EG 250 mg
How to take LEVOFLOXACIN EG 250 mg
Possible side effects
How to store LEVOFLOXACIN EG 250 mg
Contents of the pack and other information

1. What Levofloxacina EG 250 mg is and what it is used for

The medicine is called Levofloxacina EG 250 mg. Levofloxacina EG 250 mg contains a drug
called levofloxacin. It belongs to a group of medicines known as antibiotics. Levofloxacin is
a quinolone antibiotic. It works by killing the bacteria causing infection in your body.
Levofloxacina EG 250 mg is used to treat infections of:

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

In certain special situations, Levofloxacina EG 250 mg 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 Levofloxacina EG 250 mg

DO NOT take LEVOFLOXACINA EG 250 mg

If you are allergic to levofloxacin, to any other quinolone antibiotic such as moxifloxacin, ciprofloxacin or ofloxacin, or to any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction include: skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue.
If you have had 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 in doubt,
consult your doctor or pharmacist before taking Levofloxacina EG 250 mg.
Warnings and precautions
Consult your doctor or pharmacist before taking this medicine if:

you are 60 years old or older;
you are taking corticosteroids, sometimes called steroids (see section “Other medicines and Levofloxacina EG 250 mg”);
you have ever had a seizure (epileptic fit);
you have suffered brain damage due to stroke or other brain injury;
you have kidney problems;
you suffer from a condition known as “glucose-6-phosphate dehydrogenase deficiency”. Taking this medicine increases the likelihood of developing serious blood-related problems;
you have suffered from mental health problems;
you have suffered from 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 trace 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 can alter the electrocardiogram (see section “Other medicines and Levofloxacina EG 250 mg”);
you have diabetes;
you have had liver problems;
you have myasthenia gravis;
if you have been diagnosed with an enlargement or “bulging” of a large blood vessel (aortic aneurysm or peripheral aneurysm of a large blood vessel);
if you have previously experienced episodes of aortic dissection (a tear in the wall of the aorta);
if you have a family history of aortic aneurysm, aortic dissection, or other risk factors or predisposing conditions (e.g. connective tissue disorders such as Marfan syndrome, vascular Ehlers-Danlos syndrome, or if you suffer from vascular diseases such as Takayasu arteritis, giant cell arteritis, Behcet's syndrome, high blood pressure, or known atherosclerosis).

If you experience sudden pain in the abdomen, chest, or back, go immediately to the
emergency room.
If you have any doubts whether any of the above may apply to you, consult your doctor or
pharmacist before taking Levofloxacina EG 250 mg.
Other medicines and Levofloxacina EG 250 mg
Inform your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicine. Levofloxacina EG 250 mg may indeed affect the action of other drugs.
Some medicines may in turn affect the action of Levofloxacina EG 250 mg.
In particular, inform your doctor if you are taking any of the following medicines. This
is because concomitant administration with Levofloxacina EG 250 mg may increase the
likelihood of you experiencing side effects:

Corticosteroids, sometimes called steroids – used for inflammation. You are more likely to develop tendon inflammation and/or tendon rupture.
warfarin – used to thin the blood. Increases the risk of bleeding. Your doctor may need to perform regular blood tests to assess your blood's ability to clot.
Theophylline – used for respiratory problems. Increases the risk of seizures when taken with LEVOFLOXACINA EG 250 mg.
Non-steroidal anti-inflammatory drugs (NSAIDs) – used for pain and inflammation, such as acetylsalicylic acid, ibuprofen, fenbufen, ketoprofen, and indomethacin: increases the risk of seizures when taken with LEVOFLOXACINA EG 250 mg.
Cyclosporine – used after organ transplantation: the likelihood of experiencing typical side effects of cyclosporine is increased.
Medicines known for their effects on heart rhythm. These include medicines used to treat abnormal heart rhythm (antiarrhythmics such as quinidine, hydroquinidine, disopyramide, sotalol, dofetilide, ibutilide, and amiodarone), for depression (tricyclic antidepressants such as 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. Particular caution should be exercised when using any of these medicines in combination with Levofloxacina EG 250 mg. If you have kidney problems, your doctor may prescribe you a reduced dose.

Do not take LEVOFLOXACINA EG 250 mg at the same time as the following medicines. This is
because an interaction may occur with the way LEVOFLOXACINA EG 250 mg works:

Iron tablets (for anaemia), zinc supplements, antacids containing magnesium or aluminium (for acidity or gastric burning), 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 opiates
Urine tests may show 'false positive' results for strong painkillers called 'opiates' in people taking LEVOFLOXACINA EG 250 mg. If your doctor has prescribed urine tests, tell them that you are taking LEVOFLOXACINA EG 250 mg.
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 your baby.

Driving and using machines
Some side effects may occur after taking this medicine, including dizziness, drowsiness, subjective sensation of movement (vertigo), or visual disturbances. Some of these side effects may impair your ability to concentrate and your reaction speed. If this happens, do not drive or perform activities requiring high attention.
Important information about some excipients of LEVOFLOXACINA EG 250 mg
This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Levofloxacin EG 250 mg

Always follow your doctor's instructions carefully when taking this medicine. 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 a glass of water
The tablets may be taken with or without food

Protect your skin from sunlight
Avoid direct sunlight during treatment with this medicine and for 2 days after finishing treatment. Your skin will be more sensitive to sunlight and may burn, tingle or blister if you do not take the following precautions:

make sure to use a high-protection sunscreen;
always wear a hat and clothing covering your arms and legs;
avoid using sunbeds (tanning lamps).

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

Do not take these medicines at the same time as Levofloxacin EG 250 mg. Take the prescribed dose of these medicines at least 2 hours before or after taking Levofloxacin EG 250 mg.

Dosage

Your doctor will decide how much Levofloxacin EG 250 mg you should take.
The dose will depend on the type of infection you have and the part of your body affected.
The duration of treatment will depend on the severity of your 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 infection
Two tablets of Levofloxacin EG 250 mg once daily
or one tablet of Levofloxacin EG 500 mg once daily
Lung infections in patients with chronic respiratory problems
Two tablets of Levofloxacin EG 250 mg once daily
or one tablet of Levofloxacin EG 500 mg once daily
Pneumonia
Two tablets of Levofloxacin EG 250 mg once or twice daily
or one tablet of Levofloxacin EG 500 mg once or twice daily
Urinary tract infections, including kidneys or bladder
One or two tablets of Levofloxacin EG 250 mg daily
or ½ or one tablet of Levofloxacin EG 500 mg daily
Prostate infection
Two tablets of Levofloxacin EG 250 mg once daily
or one tablet of Levofloxacin EG 500 mg once daily
Skin and soft tissue infections, including muscles
Two tablets of Levofloxacin EG 250 mg once or twice daily
or one tablet of Levofloxacin EG 500 mg once or twice daily
Adults and elderly patients with kidney problems
Your doctor may need to reduce your dose.
Children and adolescents
This medicine must not be given to children or adolescents.
If you take more Levofloxacin EG 250 mg than you should
If you accidentally take more tablets than prescribed, contact your doctor immediately or seek medical advice. Bring the medicine pack with you. This will help the doctor identify what has been 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 EG 250 mg
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 one.
If you stop taking Levofloxacin EG 250 mg
Do not stop taking Levofloxacin EG 250 mg 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 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 gets them.
Usually, these effects are mild or moderate in severity and often disappear after a short time.

Stop taking Levofloxacina EG 250 mg 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)

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

Stop taking Levofloxacina EG 250 mg and go immediately to the doctor if you experience any of the following serious side effects – you may need urgent medical care:
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 (convulsions).

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

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

Other:

severe skin rash which may include lesions or peeling of the skin around the lips, eyes, mouth, nose and genitals.
Loss of appetite, yellowing of the skin and eyes, dark-coloured urine, itching or abdominal pain. These may be signs of liver problems, which could include fatal liver failure.

If your vision becomes blurred or if you experience any eye discomfort while taking Levofloxacina EG 250 mg, consult an ophthalmologist immediately.

Inform 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)

Trouble sleeping.
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 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).
Change in taste, loss of appetite, stomach upset or indigestion (dyspepsia), stomach pain, bloating (flatulence) or constipation.
Itching and skin rash, severe itching or hives, excessive sweating (hyperhidrosis).
Joint or muscle pain.
Blood tests 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 increased tendency to bleed due to reduced platelet count in the blood (thrombocytopenia).
Reduced number of white blood cells (neutropenia).
Exaggerated immune response (hypersensitivity).
Decreased blood sugar levels (hypoglycaemia). This is important for people 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, feeling restless (agitation), abnormal dreams or nightmares.
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 disorder of the nervous system).
Changes in kidney function and occasional kidney failure, which may be caused by an allergic reaction affecting the kidneys, known as interstitial nephritis.
Fever.

Other side effects include:

Reduced number of red blood cells (anaemia). This may lead to paleness or yellowish skin due to damage to red blood cells; reduced number of all types of blood cells (pancytopenia).
Fever, sore throat and persistent general malaise. This may be due to a reduced number of white blood cells (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 in movement and 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).
Difficulty breathing or wheezing (bronchospasm).
Allergic lung reactions.
Pancreatitis.
Inflammation of the liver (hepatitis).
Increased sensitivity of the skin to sunlight or ultraviolet rays (photosensitivity).
Inflammation of blood vessels throughout the body due to an allergic reaction (vasculitis).
Inflammation of the internal tissues of the mouth (stomatitis).
Muscle rupture and muscle breakdown (rhabdomyolysis).
Redness and swelling of the joints (arthritis).
Pain, including back, chest and limb pain.
Attacks of porphyria in patients who already suffer from porphyria (a very rare metabolic disorder).
Persistent headache with or without blurred vision (benign intracranial hypertension).

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

5. How to store Levofloxacin EG 250 mg

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and blister after
“EXP.“.
Storage conditions
This medicine does not require any special storage conditions; however, it is recommended to keep it
in the original packaging in a dry place.
Medicines must not be disposed of 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 LEVOFLOXACIN EG 250 mg contains
The active substance is levofloxacin hemihydrate.
1 film-coated tablet contains 256.23 mg of levofloxacin hemihydrate, equivalent to
250 mg of levofloxacin.
The excipients are:
Tablet core: microcrystalline cellulose type 102, powdered cellulose, pregelatinized starch (cereal starch), maize starch, crospovidone type A, povidone K25, sodium stearyl fumarate.
Coating: lactose monohydrate, hypromellose, titanium dioxide (E171), macrogol 4000, yellow iron oxide (E172), red iron oxide (E172) and black iron oxide (E172).

Description of the appearance of LEVOFLOXACIN EG 250 mg and package contents
LEVOFLOXACIN EG 250 mg is a pink, elongated film-coated tablet with a breakline on both sides. The film-coated tablet can be divided into equal doses.
LEVOFLOXACIN EG 250 mg is available in packages containing 2, 5, 7, 10, 20, 30 and 50 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
EG S.p.A., Via Pavia, 6 - 20136 Milan, Italy

Manufacturers
STADA Arzneimittel AG, Stadastrasse 2 – 18, 61118 Bad Vilbel, Germany
Centrafarm Services B.V., Nieuwe Donk 9 Postbus 289, 4879 AC Etten-Leur, Netherlands
Eurogenerics NV/SA, Heizel Esplanade b22 - 1020 Brussels, Belgium
Genus Pharmaceuticals Ltd., Park View House, 65 London Road, Newbury, Berkshire RG14 1JN, United Kingdom
Medinsa - Laboratorios Medicamentos Internationales, S. A., Solana, 26 ES-28850 Torrejón de Ardoz (Madrid), Spain

This medicinal product is authorized in the European Economic Area Member States under the
following names:
BG Vivex 250 mg film coated tablets
IT Levofloxacina EG 250 mg compresse rivestite con film
NL Levofloxacine STADA 250 mg filmomhulde tabletten

Package leaflet: Information for the user

LEVOFLOXACIN EG 500 mg film-coated tablets

Active substance: Levofloxacin hemihydrate
Generic medicine

Please read this entire leaflet carefully before taking this medicine, as it contains important information for you.

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

Contents of this leaflet:

What LEVOFLOXACIN EG 500 mg is and what it is used for
What you need to know before taking LEVOFLOXACIN EG 500 mg
How to take LEVOFLOXACIN EG 500 mg
Possible side effects
How to store LEVOFLOXACIN EG 500 mg
Contents of the pack and other information

1. What Levofloxacina EG 500 mg is and what it is used for

The medicine is called Levofloxacina EG 500 mg. Levofloxacina EG 500 mg contains a drug
called levofloxacin. It belongs to a group of medicines called antibiotics. Levofloxacin is a
quinolone antibiotic. It works by killing the bacteria causing infection in your body.
Levofloxacina EG 500 mg is used to treat infections affecting:

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

In certain special situations, Levofloxacina EG 500 mg 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 EG 500 mg

DO NOT take LEVOFLOXACIN EG 500 mg

If you are allergic to levofloxacin, to any other quinolone antibiotic such as moxifloxacin, ciprofloxacin or ofloxacin, or to any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction include: skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue.
If you have had epilepsy.
If you have previously experienced tendon problems, such as tendonitis, related to treatment with a "quinolone antibiotic". Tendons are fibrous structures that connect 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 in doubt,
consult your doctor or pharmacist before taking Levofloxacin EG 500 mg.
Warnings and precautions
Consult your doctor or pharmacist before taking this medicine if:

you are 60 years old or older;
you are taking corticosteroids, sometimes called steroids (see section “Other medicines and Levofloxacin EG 500 mg”);
you have ever had a seizure (convulsions);
you have suffered brain damage due to stroke or other brain injury;
you have kidney problems;
you suffer from a condition known as “glucose-6-phosphate dehydrogenase deficiency”. Administration of this medicine increases the likelihood of developing serious blood-related problems;
you have suffered from mental health problems;
you have suffered from 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 trace 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 “Other medicines and Levofloxacin EG 500 mg”);
you have diabetes;
you have had liver problems;
you have myasthenia gravis;
if you have been diagnosed with an enlargement or “bulging” of a large blood vessel (aortic aneurysm or peripheral aneurysm of a large blood vessel);
if you have previously experienced episodes of aortic dissection (a tear in the wall of the aorta);
if you have a family history of aortic aneurysm, aortic dissection, or other risk factors or predisposing conditions (e.g., connective tissue disorders such as Marfan syndrome, vascular Ehlers-Danlos syndrome, or if you suffer from vascular conditions such as Takayasu arteritis, giant cell arteritis, Behcet's syndrome, high blood pressure, or known atherosclerosis).
If you experience sudden pain in your abdomen, chest, or back, go immediately to
the emergency room.
If you have any doubts whether any of the above may apply to you, consult your doctor or
pharmacist before taking Levofloxacin EG 500 mg.
Other medicines and Levofloxacin EG 500 mg
Inform your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicine. Levofloxacin EG 500 mg may indeed affect the action of other drugs.
Some medicines may in turn affect the action of Levofloxacin EG 500 mg.
Specifically, inform your doctor if you are taking any of the following medicines. This
is because concomitant administration with Levofloxacin EG 500 mg may increase the
likelihood of you experiencing side effects:
Corticosteroids, sometimes called steroids – used for inflammation. You are more likely to develop tendon inflammation and/or tendon rupture.
warfarin – used to thin the blood. Increases the risk of bleeding. Your doctor may need to perform regular blood tests to monitor your blood’s ability to clot.
Theophylline – used for respiratory problems: increases the risk of seizures when taken with LEVOFLOXACIN EG 500 mg.
Non-steroidal anti-inflammatory drugs (NSAIDs) – used for pain and inflammation such as acetylsalicylic acid, ibuprofen, fenbufen, ketoprofen and indomethacin: increases the risk of seizures when taken with LEVOFLOXACIN EG 500 mg.
Cyclosporine – used after organ transplantation: the likelihood of experiencing typical side effects of cyclosporine is increased.
Medicines known for their effects on heart rhythm. These include medicines used to treat abnormal heart rhythm (antiarrhythmics such as quinidine, hydroquinidine, disopyramide, sotalol, dofetilide, ibutilide and amiodarone), for depression (tricyclic antidepressants such as amitriptyline and imipramine), for psychiatric disorders (antipsychotics), and for bacterial infections (antibiotics “macrolides” such as erythromycin, azithromycin and clarithromycin).
Probenecid – used for gout and cimetidine – used for ulcers and heartburn. Particular caution should be exercised when using any of these medicines in combination with Levofloxacin EG 500 mg. If you have kidney problems, your doctor may prescribe a reduced dose.

Do not take LEVOFLOXACIN EG 500 mg at the same time as the following medicines. This
is because interactions may occur with the mode of action of LEVOFLOXACIN EG 500 mg:

Iron tablets (for anaemia), zinc supplements, antacids containing magnesium or aluminium (for acidity or heartburn), didanosine, or sucralfate (for gastric ulcers). See section 3 “If you are taking iron salts in tablet form, zinc supplements, antacids, didanosine or sucralfate”.

Urine tests for opiates
Urine tests may show 'false positive' results for strong painkillers called 'opiates' in people taking
LEVOFLOXACIN EG 500 mg. If your doctor has prescribed urine tests, tell them that you are taking
LEVOFLOXACIN EG 500 mg.
Tuberculosis testing
This medicine may cause "false negative" results in certain laboratory tests used to detect the bacterium that causes 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 your baby.

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 your concentration and reaction speed. If this occurs, do not drive or perform activities that require high attention.
Important information about some excipients in LEVOFLOXACIN EG 500 mg
This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain
sugars, contact them before taking this medicine.

3. How to take Levofloxacin EG 500 mg

Always follow your doctor's instructions carefully when taking this medicine. If you have any
doubts, consult your doctor or pharmacist.
Taking this medicine

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

Protect your skin from sunlight
Avoid direct sunlight during treatment with this medicine and for 2 days after stopping treatment. Your skin will be more sensitive to sunlight and may burn, sting, or blister if you do not take the following precautions:

make sure to use a high-protection sunscreen;
always wear a hat and clothing covering your arms and legs;
avoid using sunbeds (solariums).

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

Do not take these medicines at the same time as Levofloxacin EG 500 mg. Take the prescribed dose of these medicines at least 2 hours before or after taking Levofloxacin EG 500 mg.

Dosage

Your doctor will decide how much Levofloxacin EG 500 mg you should take.
The dose will depend on the type of infection you have and the part of your body affected.
The duration of treatment will depend on the severity of your 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 infection
Two tablets of Levofloxacin EG 250 mg once daily
or one tablet of Levofloxacin EG 500 mg once daily
Lung infections, in patients with chronic respiratory problems
Two tablets of Levofloxacin EG 250 mg once daily
or one tablet of Levofloxacin EG 500 mg once daily
Pneumonia
Two tablets of Levofloxacin EG 250 mg once or twice daily
or one tablet of Levofloxacin EG 500 mg once or twice daily
Urinary tract infections, including kidneys or bladder
One or two tablets of Levofloxacin EG 500 mg daily
or ½ or 1 tablet of Levofloxacin EG 500 mg daily
Prostate infection
Two tablets of Levofloxacin EG 250 mg once daily
or one tablet of Levofloxacin EG 500 mg once daily
Skin and subcutaneous tissue infections, including muscles
Two tablets of Levofloxacin EG 250 mg once or twice daily
or one tablet of Levofloxacin EG 500 mg once or twice daily
Adults and elderly patients with kidney problems
Your doctor may need to reduce your dose.
Children and adolescents
This medicine must not be given to children or adolescents.
If you take more LEVOFLOXACIN EG 500 mg than you should
If you accidentally take more tablets than prescribed, contact your doctor immediately or seek medical advice. Bring the medicine package with you. This will help the doctor 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 illness (nausea) or heartburn.
If you forget to take LEVOFLOXACIN EG 500 mg
If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose. In that case, continue taking LEVOFLOXACIN EG 500 mg at your usual time and at the dose prescribed by your doctor.
If you stop taking LEVOFLOXACIN EG 500 mg
Do not stop taking Levofloxacin EG 500 mg 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 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 gets them.
Usually, these effects are mild or moderate in severity and often disappear after a short time.

Stop taking Levofloxacina EG 500 mg 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)

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

Stop taking Levofloxacina EG 500 mg and go immediately to the doctor if you experience any of the following serious side effects – you may need urgent medical attention:
Rare (may affect up to 1 in 1,000 people):

watery diarrhoea, possibly with blood, sometimes accompanied by stomach cramps and high fever. This could 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 (convulsions).

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

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

Other:

severe skin rash which may include lesions or peeling of the skin around the lips, eyes, mouth, nose and genitals.
Loss of appetite, yellowing of the skin and eyes, dark-coloured urine, itching or abdominal pain. These may be signs of liver problems, which could include fatal liver failure.

If your vision becomes blurred or if you experience any eye discomfort while taking Levofloxacina EG 500 mg, 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 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).
Change in taste, loss of appetite, stomach upset or indigestion (dyspepsia), stomach pain, bloating (flatulence) or constipation.
Itching and skin rash, severe itching or hives, excessive sweating (hyperhidrosis).
Joint or muscle pain.
Blood tests 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 increased tendency to bleed due to reduced platelet count in the blood (thrombocytopenia).
Reduced number of white blood cells (neutropenia).
Exaggerated immune response (hypersensitivity).
Decreased blood sugar levels (hypoglycaemia). This is important for people with diabetes.
Seeing or hearing things that are not real (hallucinations, paranoia), changes in thinking and reconsideration (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 disorder of the nervous system).
Impaired kidney function and occasional kidney failure, which may be caused by an allergic reaction affecting the kidneys, known as interstitial nephritis.
Fever.

Other side effects include:

Reduced number of red blood cells (anaemia). This may lead to paleness or yellowish skin colour due to damage to red blood cells; reduced 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).
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 smell, loss of smell or taste (parosmia, anosmia, ageusia).
Difficulty in moving and 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 risk of life-threatening complications including cardiac arrest, changes in heart rhythm (known as "prolongation of the QT interval" seen on electrocardiogram, electrical activity of the heart).
Difficulty breathing or wheezing (bronchospasm).
Allergic lung reactions.
Pancreatitis.
Inflammation of the liver (hepatitis).
Increased sensitivity of the skin to sunlight or ultraviolet rays (photosensitivity).
Inflammation of 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 joints (arthritis).
Pain, including back, chest and limb pain.
Attacks of porphyria in patients who already suffer from porphyria (a very rare metabolic disorder).
Persistent headache with or without blurred vision (benign intracranial hypertension).

5. How to store Levofloxacin EG 500 mg

Keep out of the sight and reach of children.
Do not use this medicinal product after the expiry date stated on the packaging and blister after
“EXP.”.
Storage conditions
This medicinal product does not require any special storage conditions; however, it is recommended to keep it
in the original packaging in a dry place.
Medicines must not be disposed of 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 EG 500 mg contains
The active substance is levofloxacin hemihydrate.
One film-coated tablet contains 512.46 mg of levofloxacin hemihydrate, equivalent to
500 mg of levofloxacin.
The excipients are:
Tablet core: microcrystalline cellulose type 102, powdered cellulose, pregelatinized starch (cereal starch), corn starch, crospovidone type A, povidone K25, sodium stearyl fumarate.
Coating: lactose monohydrate, hypromellose, titanium dioxide (E171), macrogol 4000, yellow iron oxide (E 172), red iron oxide (E 172) and black iron oxide (E 172).

Description of the appearance of LEVOFLOXACINA EG 500 mg and package contents
LEVOFLOXACINA EG 500 mg is a pink, elongated film-coated tablet with a score line on both sides. The film-coated tablet can be divided into equal doses.
LEVOFLOXACINA EG 500 mg is available in packages containing 2, 5, 7, 10, 20, 30 and 50 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
EG S.p.A., Via Pavia, 6 - 20136 Milan, Italy

Manufacturers
STADA Arzneimittel AG, Stadastrasse 2 – 18, 61118 Bad Vilbel - Germany
Centrafarm Services B.V., Nieuwe Donk 9 Postbus 289, 4879 AC Etten-Leur - Netherlands
Eurogenerics NV/SA, Heizel Esplanade b22 - 1020 Brussels - Belgium
Genus Pharmaceuticals Ltd., Park View House, 65 London Road, Newbury, Berkshire RG14 1JN - United Kingdom
Medinsa - Laboratorios Medicamentos Internationales, S. A., Solana, 26 ES-28850 Torrejón de Ardoz (Madrid) - Spain

This medicinal product is authorized in the European Economic Area countries under the following names:
BE Levofloxacine EG 500 mg filmomhulde tabletten
BG Vivex 500 mg film coated tablets
IT Levofloxacina EG 500 mg compresse rivestite con film
LU Levofloxacine EG 500 mg filmomhulde tabletten
NL Levofloxacine STADA 500 mg filmomhulde tabletten