LEVOFLOXACIN GENOPTIM

Levofloxacin Genoptim, 500 mg, film-coated tablets
Levofloxacinum
Please read the following leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm someone else, even if their symptoms are identical.
• If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Levofloxacin Genoptim is and what it is used for
2. Important information before taking Levofloxacin Genoptim
3. How to take Levofloxacin Genoptim
4. Possible side effects
5. How to store Levofloxacin Genoptim
6. Contents of the pack and other information

1. What Levofloxacin Genoptim is and what it is used for

The name of the medicine is Levofloxacin Genoptim. Levofloxacin Genoptim contains the active substance called levofloxacin, which belongs to a group of medicines known as antibiotics. Levofloxacin is a "quinolone" antibiotic. It works by killing bacteria that cause infections in the body.

Levofloxacin Genoptim is used to treat the following infections:

• Sinus infections
• Lung infections, in people with chronic respiratory disorders or pneumonia
• Urinary tract infections, including kidneys and bladder
• Prostate gland infections, when the infection is long-lasting
• Skin and subcutaneous tissue infections, including muscles, sometimes referred to as "soft tissues"

In certain situations, Levofloxacin Genoptim may be used to prevent a lung disease called anthrax, which may occur after exposure to bacteria causing anthrax, or may be used in the treatment of this disease.

2. Important information before using Levofloxacin Genoptim

When not to use this medicine and to contact your doctor:

• If the patient has hypersensitivity to levofloxacin, any other quinolone antibiotic such as moxifloxacin, ciprofloxacin or ofloxacin, or to any of the other ingredients of Levofloxacin Genoptim (listed in section 6). Symptoms of an allergic reaction include: rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue.
• If the patient has ever experienced seizures.
• If the patient has ever had tendon problems, such as tendonitis associated with quinolone antibiotic treatment. Tendons are fibrous tissues connecting muscles to bones.
• In children and adolescents during growth phase.
• In pregnant women, women who may become pregnant, or when pregnancy is suspected.
• During breastfeeding.

Do not use this medicine if any of the above statements apply to the patient. In case of
doubt, consult your doctor or
pharmacist before using Levofloxacin Genoptim.
Warnings and precautions
Before starting treatment with Levofloxacin Genoptim, consult your doctor or
pharmacist if:

• the patient is 60 years of age or older

• the patient is taking corticosteroids, sometimes called steroids (see section "Levofloxacin Genoptim and other medicines")

• the patient has undergone organ transplantation

• the patient has ever had seizures (epileptic fits) in the past

• the patient has had brain damage due to stroke or other brain injury in the past

• the patient has kidney disease

• the patient has been diagnosed with glucose-6-phosphate dehydrogenase deficiency. The patient may then be more susceptible to serious blood disorders during treatment with this medicine

• the patient has had mental health problems in the past

• the patient has had heart problems in the past: caution should be exercised during treatment with this medicine if the patient has congenital or familial QT prolongation (seen on ECG, i.e. test of electrical activity of the heart), electrolyte disturbances in blood (especially low potassium or magnesium levels), slow heart rate (called "bradycardia"), impaired heart function (heart failure), previous myocardial infarction (heart attack), if the patient is female or elderly, or if taking other medicines causing atypical changes on ECG (see section "Levofloxacin Genoptim and other medicines")

• the patient has diabetes

• the patient has had liver problems in the past

• the patient suffers from myasthenia gravis

• the patient has nerve damage (peripheral neuropathy)

• the patient has been diagnosed with dilatation of a large blood vessel (aortic aneurysm or large peripheral artery aneurysm)

• the patient has previously experienced aortic dissection (tearing of the aortic wall)

• the patient has been diagnosed with heart valve insufficiency

• there is 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 diseases such as Takayasu arteritis, giant cell arteritis, Behçet's disease, hypertension, confirmed arterial atherosclerosis, rheumatoid arthritis [joint disease], or endocarditis [heart infection])

• the patient has ever experienced severe skin rash, skin peeling, blistering and/or oral mucosal ulcers after taking levofloxacin.

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 center, on the trunk. Oral, throat, nose, genital, and eye ulcers (red, 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 syndrome, flu-like symptoms and facial rash appear initially, followed by widespread rash with high fever, increased liver enzymes and white blood cell count (eosinophilia) in blood tests, and enlarged lymph nodes.

If a severe rash or any of these skin symptoms occur, stop taking
levofloxacin and contact your doctor or seek immediate medical attention.
Do not take antibacterial agents containing fluoroquinolones or quinolones,
including levofloxacin, if the patient has previously experienced any severe adverse reaction during treatment with a quinolone or fluoroquinolone. In such a case, inform your doctor immediately.
If the patient is taking this medicine:

• In case of sudden, severe abdominal, back or chest pain, which may indicate an aortic aneurysm or dissection, seek emergency department care immediately. The risk of such events may be higher when systemic corticosteroids are used.
• In case of sudden shortness of breath, especially when lying down, or if swelling of ankles, feet or abdomen, or palpitations (sensation of rapid or irregular heartbeat) are observed, contact your doctor immediately.
• If sudden, involuntary muscle jerks, tremors or muscle cramps occur, contact your doctor immediately, as these may be symptoms of myoclonus. The doctor may decide to discontinue levofloxacin and initiate appropriate treatment.
• If fatigue, paleness of the skin, bruising, uncontrolled bleeding, fever, sore throat, significant worsening of general health or feeling of reduced immunity occur—contact your doctor immediately, as these may be symptoms of blood disorders. The doctor should monitor the patient's blood count via complete blood count test. If blood count abnormalities occur, the doctor may decide to discontinue treatment.

Rarely, pain and swelling of joints, tendon inflammation or tendon rupture may occur. Risk is
increased in elderly patients (over 60 years), after organ transplantation, in patients with kidney
problems or those receiving corticosteroid treatment. Tendon inflammation and rupture may occur
within the first 48 hours of treatment, and even several months after discontinuation of
Levofloxacin Genoptim. After the first symptoms of tendon pain or inflammation (e.g. in the ankle, wrist, elbow, shoulder or knee) appear, discontinue Levofloxacin Genoptim, contact your doctor and rest the affected area. Avoid excessive physical exertion, as it may increase the risk of tendon rupture.
The patient may rarely experience symptoms of nerve damage (neuropathy), such as pain, burning,
tingling, numbness and/or weakness, especially in feet and legs, and hands and arms.
In such a case, discontinue Levofloxacin Genoptim and inform your doctor immediately to prevent
progression to potentially irreversible disease.
Long-term, disabling and potentially irreversible serious adverse reactions
Antibacterial agents containing fluoroquinolones and/or quinolones, including Levofloxacin
Genoptim, have been associated with very rare but serious adverse reactions. Some of these
reactions were long-lasting (persisting for months or years), disabling or potentially irreversible.
These include: tendon, muscle and joint pain in upper and lower limbs, difficulty walking,
abnormal sensations such as pricking, tingling, tickling, numbness or burning (paresthesias),
sensory disturbances, including vision, taste, smell and hearing disorders, depression, memory
impairment, severe fatigue and severe sleep disturbances.
If any of these adverse reactions occur after taking Levofloxacin Genoptim, contact your doctor
immediately before continuing treatment. The patient and doctor will decide whether to continue
treatment, possibly considering antibiotics from another class.
Levofloxacin Genoptim and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, including those
obtained without a prescription. This is because Levofloxacin Genoptim may affect the action of other
medicines. Likewise, some medicines may affect the way Levofloxacin Genoptim works.
It is especially important to inform your doctor about taking the medicines listed below, as
concomitant use with Levofloxacin Genoptim may increase the risk of adverse reactions.

• Corticosteroids, sometimes called steroids—used in the treatment of inflammation. The patient may be more susceptible to tendon inflammation and/or rupture.
• Warfarin—a blood-thinning agent. The patient may be more prone to bleeding. The doctor may order regular blood coagulation tests.
• Theophylline—used for breathing problems. Concomitant use of Levofloxacin Genoptim with this medicine may increase the risk of seizures (epileptic fits).
• Non-steroidal anti-inflammatory drugs (NSAIDs)—used for pain and inflammation, such as: acetylsalicylic acid, ibuprofen, fenbufen, ketoprofen and indomethacin. The patient may be more susceptible to seizures (epileptic fits) when taking Levofloxacin Genoptim.
• Cyclosporine—used after organ transplantation. The patient may be more susceptible to cyclosporine-related adverse reactions.
• Medicines affecting heart function. These include drugs used for heart rhythm disorders (antiarrhythmics, such as quinidine, hydroquinidine, disopyramide, sotalol, dofetilide, ibutilide and amiodarone), depression (tricyclic antidepressants, such as: amitriptyline and

imipramine), psychiatric disorders (antipsychotics), and bacterial infections
(macrolide antibiotics, such as: erythromycin, azithromycin and clarithromycin).

• Probenecid—used in the treatment of gout. In patients with kidney disease, the doctor may recommend a lower dose.
• Cimetidine—used in the treatment of peptic ulcer disease and heartburn. In patients with kidney disease, the doctor may recommend a lower dose.

Inform your doctor if any of the above points apply to the patient.
Do not take Levofloxacin Genoptim simultaneously with the following medicines,
as this may affect the action of Levofloxacin Genoptim:

• iron-containing medicines (used for anemia), zinc preparations, antacids containing magnesium or aluminium (used for hyperacidity or heartburn), didanosine or sucralfate (used for stomach ulcers). See section 3 below "If the patient is already taking iron-containing medicines, zinc preparations, antacids, didanosine or sucralfate".

Urine tests for opioids
Urine tests detecting strong painkillers called opioids may yield false-positive results in patients
taking Levofloxacin Genoptim. If your doctor orders a urine test, inform them that you are taking this
medicine.
Tuberculosis tests
This medicine may cause false-negative results in certain laboratory tests used to detect bacteria
causing tuberculosis.
Pregnancy and breastfeeding
Do not use this medicine if:

• the patient is pregnant, may become pregnant, or pregnancy is suspected
• the patient is breastfeeding or plans to breastfeed

Driving and operating machinery
After taking this medicine, adverse reactions such as dizziness, drowsiness, vertigo or visual
disturbances may occur. Some of these adverse reactions may impair concentration and reaction
speed. In such cases, do not drive or operate machinery requiring high attention.

3. How to use Levofloxacin Genoptim

Levofloxacin Genoptim must always be taken exactly as prescribed by the doctor. In case of
doubt, consult your doctor or pharmacist.
How to take the medicine

• Take the medicine orally.
• Swallow the tablets whole with water.
• Tablets may be taken during meals or at any time between meals.

If taking iron preparations, zinc supplements, antacids, didanosine, or sucralfate

• Do not take these medicines at the same time as Levofloxacin Genoptim. They should be taken at least 2 hours before or 2 hours after taking Levofloxacin Genoptim. Your doctor may prescribe another medicinal product containing the same active substance in a lower dose due to unavailability of Levofloxacin Genoptim in strengths other than 500 mg. What dose should be used
• Your doctor will decide the appropriate dose of Levofloxacin Genoptim.
• 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 effect of the medicine is too weak or too strong, do not change the dose on your own; consult your doctor.

Adults and elderly patients
Sinusitis
one tablet of Levofloxacin Genoptim 500 mg once daily.
Lung infections in patients with chronic respiratory problems
one tablet of Levofloxacin Genoptim 500 mg once daily.
Pneumonia
one tablet of Levofloxacin Genoptim 500 mg once or twice daily.
Urinary tract infections, including kidneys or bladder
half a tablet or one tablet of Levofloxacin Genoptim 500 mg once daily.
Prostate gland infections
one tablet of Levofloxacin Genoptim 500 mg once daily.
Skin and subcutaneous tissue infections, including muscles
one tablet of Levofloxacin Genoptim 500 mg 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.
Skin protection from sunlight
During treatment with this medicine and for 2 days after stopping it, avoid direct exposure to sunlight. This is because the skin may become more sensitive to sunlight, which could lead to sunburn, tingling sensation, and development of large blisters if the following precautions are not observed:

• Use sunscreen creams with a high UV protection factor
• Always wear a hat and clothing covering arms and legs
• Avoid using sunbeds (solariums)

Taking more Levofloxacin Genoptim than prescribed
If you accidentally take more tablets than prescribed, seek medical advice immediately. Take the medicine package with you so the doctor knows which medicine has been taken. The following symptoms may occur: seizures, confusion, dizziness, disturbances of consciousness, muscle tremors, heart disturbances causing irregular heartbeat, nausea, or heartburn.
If you miss a dose of Levofloxacin Genoptim
If you miss a dose, take it as soon as possible unless it is almost time for the next dose. Do not take a double dose to make up for a missed dose.
Stopping Levofloxacin Genoptim treatment
Do not stop taking Levofloxacin Genoptim, even if you feel better. It is important to complete the full course of treatment prescribed by your doctor. Stopping treatment prematurely may cause the infection to return, worsen your condition, or lead to bacteria becoming resistant to the medicine.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. These
adverse effects are usually mild or moderate in severity and often resolve within a short
period of time.
You must stop taking Levofloxacin Genoptim and immediately contact a doctor or go to
hospital if any of the following adverse effects occur:
Very rare (may 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.

You must stop taking Levofloxacin Genoptim and immediately contact a doctor if any of the
following serious adverse effects occur – immediate treatment may be required:
Rare (may occur in fewer than 1 in 1,000 patients)

• Watery diarrhoea, possibly with blood, accompanied by abdominal cramps and high fever. These symptoms may indicate severe intestinal disorders.
• Pain and inflammation of tendons or ligaments, which may lead to rupture. The Achilles tendon is most commonly affected.
• Seizures (epileptic fits).
• Seeing or hearing things that do not exist (hallucinations, paranoia).
• Feelings of depression, psychiatric disturbances, restlessness (agitation), strange dreams or nightmares.
• Widespread rash, high body temperature, increased liver enzyme activity,

abnormal blood composition (eosinophilia), swollen lymph nodes and other organs
(drug reaction with eosinophilia and systemic symptoms, known as DRESS or drug hypersensitivity syndrome). See also section 2.

• Syndrome associated with impaired water excretion and low sodium concentration (SIADH).
• Decreased blood sugar levels (hypoglycaemia) or decreased blood sugar leading to coma (hypoglycaemic coma). This is important in diabetic patients. Very rare (may occur in fewer than 1 in 10,000 patients)
• Burning, tingling, pain or numbness. These may be symptoms of "neuropathy". Frequency unknown (frequency cannot be estimated from available data)
• Severe skin rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis. These may appear as red, target-like or circular skin lesions, often with central blisters on the trunk, skin peeling, and ulcers in the mouth, throat, nose, genital organs and eyes, 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 liver failure, which may lead to death.
• Changes in thoughts and beliefs (psychotic reactions) with risk of suicidal thoughts or suicide attempts.

If a patient experiences visual disturbances or any changes in the eyes during treatment with
Levofloxacin Genoptim, an ophthalmologist should be consulted immediately.
Administration of quinolone and fluoroquinolone antibiotics has, in rare cases regardless of pre-existing risk factors, very rarely led to long-term (lasting for months or years) or permanent adverse effects, such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as pricking, tingling, tickling, burning, numbness or pain (neuropathy), fatigue, memory and concentration problems, psychiatric disturbances (including sleep disturbances, anxiety, panic attacks, depression and suicidal thoughts), and disturbances in hearing, vision, taste and smell.
In patients receiving fluoroquinolones, cases of arterial wall dilation and weakening or arterial wall damage (aneurysm and dissection) have been reported, which may result in rupture and lead to death, as well as cases of heart valve insufficiency. See also section 2.
Contact a doctor if any of the following adverse effects worsen or persist for more than a few days:
Common (may occur in fewer than 1 in 10 patients)

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

Uncommon (may 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 detected in blood tests (leukopenia, eosinophilia).
Restlessness, confusion, nervousness, drowsiness, tremor, sensation of spinning (vestibular dizziness).
Shortness of breath (dyspnoea).
Changes in taste perception, loss of appetite, stomach upset or indigestion, abdominal pain, bloating with flatulence or constipation.
Itching and skin rash, severe itching or urticaria, excessive sweating.
Joint or muscle pain.
Abnormal blood test results due to liver dysfunction (increased bilirubin levels) or kidney dysfunction (increased creatinine levels).
General weakness.
Rare (may occur in fewer than 1 in 1,000 patients)
Increased tendency to bruising and bleeding due to reduced platelet count (thrombocytopenia).
Reduced white blood cell count (neutropenia).
Excessive immune response (hypersensitivity).
Tingling sensation in hands and feet (paresthesia).
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).
Kidney function abnormalities and, in some cases, kidney failure, which may be caused by an allergic reaction in the kidneys known as interstitial nephritis.
Fever.
Well-defined erythematous lesions with or without blisters, developing within hours after levofloxacin administration. These resolve with post-inflammatory pigmentation. Upon subsequent administration of levofloxacin, the lesions usually reappear in the same location on the skin or mucous membranes.
Memory disturbances.
Frequency unknown (frequency 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 lead to fatigue, reduced ability to fight infections and uncontrolled bleeding (bone marrow failure).
• Persistent fever, sore throat and general malaise. This may be due to reduced white blood cell count (agranulocytosis).
• Circulatory arrest (anaphylactic-like shock).
• Increased blood sugar levels (hyperglycaemia). This is important in diabetic patients.
• Changes in smell, loss of smell or taste (olfactory hallucinations, anosmia, ageusia).
• Intense excitement, elation, agitation or enthusiasm (mania).
• Problems with movement and walking (dyskinesia, extrapyramidal disorders).
• Transient loss of consciousness or fainting (syncope).
• Transient loss of vision, eye inflammation.
• Hearing disturbances or hearing loss.
• Irregular and abnormally fast heart rhythm, life-threatening arrhythmias, including cardiac arrest, changes in heart rhythm (so-called "QT interval prolongation" visible on ECG, i.e. electrocardiogram, the test measuring electrical activity of the heart).
• Breathing difficulties or wheezing (bronchospasm).
• Allergic reactions affecting the lungs.
• Pancreatitis.
• Hepatitis.
• Increased skin sensitivity to sunlight and ultraviolet radiation (photosensitivity), skin discoloration (hyperpigmentation).
• Inflammation of blood vessels due to allergic reaction (vasculitis).
• Inflammation of the mucous membrane lining the mouth (oral mucositis).
• Muscle rupture and breakdown (rhabdomyolysis).
• Redness and swelling of joints (arthritis).
• Pain, including back, chest and limb pain.
• Sudden, involuntary jerks, muscle twitching and muscle spasms (myoclonus).
• Porphyria attacks in patients with porphyria (a very rare metabolic disorder).
• Persistent headache with blurred vision (benign intracranial hypertension).

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: 22 49-21-30
Fax: 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps provide more information on the safety of this medicine.

5. How to store Levofloxacin Genoptim

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

6. Contents of the package and other information

What Levofloxacin Genoptim contains
The active substance is levofloxacin. Each coated tablet contains 500 mg of levofloxacin
in the form of levofloxacin hemihydrate. The other ingredients are:

• Tablet core: crospovidone (type A), hypromellose (15 cP), microcrystalline cellulose, and magnesium stearate.
  • Tablet coating: hypromellose (6 cP) (E 464), titanium dioxide (E 171), macrogol 400, yellow iron oxide (E 172), red iron oxide (E 172), polysorbate 80 (E 433).

What Levofloxacin Genoptim looks like and contents of the pack
Coated tablets: peach-coloured, capsule-shaped, biconvex coated tablets with an embossed mark “ML” and “63” on both sides of the deep central groove, and a break line on the other side.
The tablet can be divided into two equal parts if the doctor recommends taking a half-tablet dose.
Levofloxacin Genoptim 500 mg is available in blisters containing 5, 7, 10, 14 or 200 tablets.
Pack of 5, 7, 10 tablets – each cardboard box contains one blister.
Pack of 14 tablets – each cardboard box contains two blisters.
Pack of 200 tablets – each cardboard box contains 20 blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warszawa
Tel: +48 22 32 16 240

Importer
Synoptis Industrial Sp. z o.o.
ul. Rabowicka 15
62-020 Swarzędz
Formula Pharmazeutische und chemische Entwicklungs GmbH
Goerzallee 305b
D-14167 Berlin
Germany
Terapia SA
Str. Fabricii nr. 124, Cluj-Napoca
Romania

This medicinal product is authorised in the EEA Member States under the following names:
Germany Levoflox-HEC 500 mg Filmtabletten
Poland Levofloxacin Genoptim, 500 mg, coated tablets
Spain Levofloxacino Macleods 500 mg comprimidos recubiertos con película
Romania Tavoflox 500 mg comprimate filmate