Moxifloxacin Genoptim

Package Leaflet: Information for the User

Moxifloxacin Genoptim, 400 mg, Film-Coated Tablets

Moxifloxacin

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, as you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medication has been prescribed specifically for you. Do not pass it on to others. The medication may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package Leaflet:

• 1. What is Moxifloxacin Genoptim and What is it Used For
• 2. Important Information Before Taking Moxifloxacin Genoptim
• 3. How to Take Moxifloxacin Genoptim
• 4. Possible Side Effects
• 5. How to Store Moxifloxacin Genoptim
• 6. Contents of the Package and Other Information

1. What is Moxifloxacin Genoptim and What is it Used For

Moxifloxacin Genoptim contains the active substance moxifloxacin, which belongs to a group of antibiotics called fluoroquinolones. Moxifloxacin Genoptim acts bactericidally on bacteria that cause infections.
Moxifloxacin Genoptim is used in adults aged 18 and over to treat the following bacterial infections, if they are caused by bacteria susceptible to moxifloxacin:
Moxifloxacin should only be used when other antibacterial medications are not appropriate or when they have been ineffective:

• acute bacterial sinusitis (properly diagnosed),
• acute exacerbation of chronic bronchitis (properly diagnosed),
• community-acquired pneumonia, except for severe cases,
• mild to moderate pelvic inflammatory disease (e.g., upper genital tract infections, including salpingitis and endometritis), without tubo-ovarian or pelvic abscess. Due to increasing resistance of Neisseria gonorrhoeae (gonorrhea) to moxifloxacin, Moxifloxacin Genoptim, 400 mg, film-coated tablets are not recommended for the treatment of mild to moderate pelvic inflammatory disease as monotherapy; it should be used in combination with another appropriate antibacterial agent (e.g., cephalosporin), unless it is certain that the infection was not caused by moxifloxacin-resistant Neisseria gonorrhoeae (see "Warnings and Precautions" in section 2).

Moxifloxacin Genoptim, 400 mg, film-coated tablets can be used in the following indications, to complete the treatment of patients who have shown improvement in the initial phase of treatment with moxifloxacin administered intravenously:

• community-acquired pneumonia,
• complicated skin and soft tissue infections.

Moxifloxacin Genoptim, 400 mg, film-coated tablets should not be used to initiate treatment of any type of skin and soft tissue infection or severe community-acquired pneumonia.

2. Important Information Before Taking Moxifloxacin Genoptim

If the patient has any doubts about the information below, they should consult their doctor.

When Not to Take Moxifloxacin Genoptim

• In case of hypersensitivity to the active substance moxifloxacin, other quinolone antibiotics, or any of the other ingredients of the medication (see section 6).
• During pregnancy and breastfeeding.
• In patients under 18 years of age.
• If the patient has a history of tendon disease related to treatment with quinolone antibiotics (see "Warnings and Precautions" in section 2 and section 4).
• If the patient has: congenital or acquired abnormal heart rhythm (visible on an electrocardiogram (ECG) - a record of the heart's electrical activity); electrolyte imbalance (especially low potassium or magnesium levels in the blood); very slow heart rate (bradycardia); weakened heart function (heart failure); or a history of heart rhythm disorders (arrhythmias) or is taking medications that may cause specific changes in the ECG (see "Moxifloxacin Genoptim and Other Medications"). Moxifloxacin Genoptim may cause changes in the ECG called QT interval prolongation, which means delayed conduction of electrical signals in the heart.
• If the patient has liver disease or liver enzyme activity (aminotransferases) exceeding 5 times the upper limit of normal.

Warnings and Precautions

Before starting treatment with Moxifloxacin Genoptim, the patient should consult their doctor if:

• The patient has been diagnosed with heart valve regurgitation.
• There is a history of aortic aneurysm or aortic dissection in the family, or congenital heart valve disease, or other risk factors or conditions (e.g., 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, or confirmed atherosclerosis, rheumatoid arthritis [joint disease] or endocarditis [heart infection]).
• Moxifloxacin Genoptim may change the heart's ECG, especially in women and the elderly. If the patient is taking medications that lower potassium levels in the blood, they should consult their doctor before starting Moxifloxacin Genoptim (see also "When Not to Take Moxifloxacin Genoptim" and "Moxifloxacin Genoptim and Other Medications").
• If the patient has epilepsyor conditions that may cause seizures, they should inform their doctor before starting Moxifloxacin Genoptim.
• If the patient has or has had mental health problems, they should consult their doctor before starting Moxifloxacin Genoptim.
• If the patient has myasthenia gravis (muscle weakness), taking Moxifloxacin Genoptim may worsen the symptoms of the disease. If this happens, the patient should consult their doctor immediately.
• If the patient or a family member has glucose-6-phosphate dehydrogenase deficiency(a rare inherited disease), they should inform their doctor, who will assess whether Moxifloxacin Genoptim is a suitable medication.
• If the patient has complicated upper genital tract infections(e.g., tubo-ovarian or pelvic abscess), the doctor may consider it necessary to administer the medication intravenously, as taking Moxifloxacin Genoptim in tablet form is not appropriate.
• To treat mild or moderate upper genital tract infections, the doctor should prescribe an additional antibacterial medication to the patient, in addition to Moxifloxacin Genoptim. If the symptoms do not improve within the first 3 days of treatment, the patient should consult their doctor.

During Treatment with Moxifloxacin Genoptim

• In case of sudden severe abdominal, back, or chest pain, which may be a sign of aortic aneurysm or dissection, the patient should immediately go to the emergency department. The risk of these changes may be higher in patients treated with systemic corticosteroids.
• In case of sudden shortness of breath, especially when lying down, or swelling of the ankles, feet, or abdomen, or palpitations (feeling of rapid or irregular heartbeat), the patient should immediately consult their doctor.
• If the patient experiences palpitations or irregular heartbeat, they should immediately inform their doctor. The doctor may order an ECG to check the heart rhythm.
• The risk of heart rhythm disordersmay increase with increasing doses. Therefore, it is recommended to follow the prescribed dosage of the medication.
• There is a small risk of severe, sudden allergic reactions(anaphylactic or anaphylactoid reactions), even after taking the first dose of the medication, with symptoms such as chest tightness, dizziness, nausea, or fainting, and a feeling of spinning when standing up. If such symptoms occur, the patient should immediately stop taking the medication

Moxifloxacin Genoptim and Consult a Doctor.

• Moxifloxacin Genoptim may cause liver inflammation with a rapid and severe course, which can lead to life-threatening liver failure (including fatal outcomes, see section 4). If symptoms such as rapid deterioration of well-being, yellowing of the whites of the eyes, dark urine, itching of the skin, tendency to bleed, and disorders of thinking or insomnia occur, the patient should consult their doctor before taking the next dose.
• If skin or mucous membrane changes, including blisters and peelingoccur (see section 4), the patient should immediately consult their doctor before taking the next dose.
• Fluoroquinolone antibiotics, including Moxifloxacin Genoptim, may cause seizures. If seizures occur, the patient should immediately stop taking Moxifloxacin Genoptim and consult their doctor.
• If neuropathy symptomssuch as pain, burning, tingling, numbness, and (or) weakness occur, especially in the feet and legs or hands and arms, the patient should immediately consult their doctor before taking the next dose.
• Mental health problemsmay occur, even with the first use of fluoroquinolone antibiotics, including Moxifloxacin Genoptim. In very rare cases, depression or mental health problems may lead to suicidal thoughts and self-destructive behaviors, such as suicide attempts (see section 4). If the patient experiences such reactions, they should immediately stop taking Moxifloxacin Genoptim and consult their doctor.
• During or after treatment with antibiotics, including Moxifloxacin Genoptim, diarrheamay occur. If it worsens or persists, or if blood or mucus appears in the stool, the patient should immediately stop taking Moxifloxacin Genoptim and consult their doctor. In such cases, the patient should not take medications that slow down or stop intestinal movement (peristalsis).

should not be taken.

• Moxifloxacin Genoptim may occasionally cause tendon pain and inflammation, even within 48 hours of starting treatment and up to several months after stopping treatment with Moxifloxacin Genoptim. The risk of tendon inflammation and rupture is higher in the elderly and in patients treated with corticosteroids. If the patient experiences the first symptoms of pain or inflammation, they should stop taking Moxifloxacin Genoptim, rest the affected limb (limbs), and immediately consult their doctor. The patient should avoid unnecessary exercise, as it may increase the risk of tendon rupture. Tendon inflammation and rupture may occur even 7 months after stopping treatment with Moxifloxacin Genoptim (see "When Not to Take Moxifloxacin Genoptim" in section 2 and section 4).
• Elderly patients with renal impairmentshould drink an adequate amount of fluids, as dehydration may increase the risk of renal failure.
• If the patient's vision worsens or other visual disturbancesoccur during treatment with Moxifloxacin Genoptim, they should immediately consult an ophthalmologist (see "Driving and Operating Machines" in section 2 and section 4).
• Fluoroquinolone antibiotics may cause blood sugar disorders, including both low blood sugar (hypoglycemia) and high blood sugar (hyperglycemia) (see section 4). In patients treated with moxifloxacin, blood sugar disorders occur mainly in the elderly when treated with oral antidiabetic medications that lower blood sugar (e.g., sulfonylurea) or insulin. In diabetic patients, blood sugar levels should be closely monitored
• and adjusted as necessary (see "Moxifloxacin Genoptim and Other Medications").
• Fluoroquinolone antibiotics may increase sensitivity of the skin to sunlight and UV radiation. During treatment with Moxifloxacin Genoptim, the patient should avoid prolonged exposure to sunlight, strong sunlight, and use of sunbeds or other sources of UV radiation.
• The efficacy of Moxifloxacin Genoptim has not been established in the treatment of severe burns, deep tissue infections, and diabetic foot infections with osteomyelitis (bone infection).

Children and Adolescents

This medication should not be used in children and adolescents under 18 years of age, as its efficacy and safety have not been established for this age group (see "When Not to Take Moxifloxacin Genoptim").

Moxifloxacin Genoptim and Other Medications

The patient should tell their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take.
When taking Moxifloxacin Genoptim, the patient should be aware that:

• Taking Moxifloxacin Genoptim with other medications that affect heart function may increase the risk of heart rhythm disorders. Therefore, Moxifloxacin Genoptim should not be taken with the following medications: antiarrhythmic medications (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), antipsychotic medications (e.g., phenothiazines, pimozide, sertindole, haloperidol, sultopride), tricyclic antidepressants, certain antibacterial medications (e.g., saquinavir, sparfloxacin, intravenous erythromycin, pentamidine, antimalarial medications, especially halofantrine), certain antihistamines (e.g., terfenadine, astemizole, mizolastine), and other medications (e.g., cisapride, intravenous vincamine, bepridil, and difemanil).
• The patient should inform their doctor if they are taking other medications that may lower potassium levels in the blood (e.g., certain diuretics, certain laxatives, and enemas [large doses] or corticosteroids [anti-inflammatory medications], amphotericin B) or slow down the heart rate, as they may increase the risk of serious heart rhythm disorders when taking Moxifloxacin Genoptim.

heart rhythm disorders.

• All medications containing magnesium or aluminum, such as antacids used to treat digestive disorders, and all medications containing iron or zinc, medications containing didanosine, and medications containing sucralfate used to treat gastrointestinal disorders may reduce the effectiveness of Moxifloxacin Genoptim tablets. Therefore, a 6-hour interval should be maintained between taking Moxifloxacin Genoptim tablets and other medications.
• Concomitant oral administration of activated charcoal and Moxifloxacin Genoptim tablets reduces the effectiveness of Moxifloxacin Genoptim. Therefore, it is not recommended to take both medications at the same time.
• If the patient is taking oral anticoagulant medications (e.g., warfarin), the doctor may order blood coagulation tests.

Moxifloxacin Genoptim with Food and Drink

Food, including dairy products, does not affect the action of Moxifloxacin Genoptim.

Pregnancy, Breastfeeding, and Fertility

Moxifloxacin Genoptim should not be taken during pregnancy and breastfeeding.
If the patient is pregnant, breastfeeding, thinks they may be pregnant, or plans to become pregnant, they should consult their doctor or pharmacist before taking this medication.
Animal studies do not indicate any adverse effect of this medication on fertility.

Driving and Operating Machines

Moxifloxacin Genoptim may cause dizziness and lightheadedness, sudden transient loss of vision, or may cause brief fainting spells. If such symptoms occur, the patient should not drive vehicles or operate any machines.

Moxifloxacin Genoptim Contains Sodium.

The medication contains less than 1 mmol (23 mg) of sodium per film-coated tablet, which means it is considered "sodium-free".

3. How to Take Moxifloxacin Genoptim

The patient should always take the medication as directed by their doctor or pharmacist. In case of doubts, they should consult their doctor or pharmacist again.
The recommended dose for adults is 1 film-coated tablet of 400 mg once daily.
Moxifloxacin Genoptim tablets should be taken orally. The tablet should be swallowed whole (to mask the bitter taste), with a large amount of fluid. Moxifloxacin Genoptim can be taken with or without food. It is recommended to take the tablet at the same time every day.
There is no need to adjust the dose in elderly patients, those with low body weight, or those with renal impairment.
The duration of treatment depends on the type of infection. Unless the doctor has prescribed otherwise, the recommended duration of treatment with Moxifloxacin Genoptim film-coated tablets is:

• acute exacerbation of chronic bronchitis (chronic bronchitis exacerbation) - 5 to 10 days
• community-acquired pneumonia, except for severe cases - 10 days
• acute bacterial sinusitis - 7 days
• mild to moderate upper genital tract infections (pelvic inflammatory disease), including salpingitis and endometritis - 14 days

The following are the recommended total treatment durations for patients who are taking Moxifloxacin Genoptim film-coated tablets to complete treatment started with Moxifloxacin Genoptim solution for infusion.

• Community-acquired pneumonia
• 7 – 14 days

For most patients with community-acquired pneumonia, the route of administration was changed from intravenous to oral within 4 days.

• Skin and soft tissue infections
• 7 – 21 days For most patients with skin and soft tissue infections, the route of administration was changed from intravenous to oral within 6 days.

It is essential to complete the full treatment cycle, even if the patient's condition improves within a few days. If the patient stops taking the medication too early, the infection may not be completely cured, the disease may worsen, or the bacteria may develop resistance to the antibiotic.
The patient should not exceed the recommended dose or prolong the treatment duration (see "Warnings and Precautions" in section 2).

Taking More Than the Recommended Dose of Moxifloxacin Genoptim

If the patient takes more than one prescribed tablet per day, they should immediately seek medical attention and, if possible, bring all remaining tablets, the medication packaging, and this package leaflet to show the doctor or pharmacist.

Missing a Dose of Moxifloxacin Genoptim

If the patient forgets to take a tablet at the usual time, they should take it as soon as they remember that day. If the patient misses a dose one day, they should take the usual dose (one tablet) the next day. The patient should not take a double dose to make up for the missed dose.
In case of doubts about taking the medication, the patient should consult their doctor or pharmacist.

Stopping Treatment with Moxifloxacin Genoptim

If the patient stops taking the medication too early, the infection may not be completely cured. If the patient needs to stop treatment early, they should consult their doctor.
In case of further doubts about taking this medication, the patient should consult their doctor or pharmacist.

4. Possible Side Effects

Like all medications, Moxifloxacin Genoptim can cause side effects, although not everybody gets them.
Patients taking fluoroquinolones have reported cases of aortic aneurysm or aortic dissection, which can be fatal, as well as cases of heart valve regurgitation. See also section 2.
The most serious side effectsobserved during treatment with moxifloxacin are listed below.
If the patient experiences any of the following side effects:

• abnormal heart rhythm (rare side effect),
• rapid deterioration of well-being, yellowing of the whites of the eyes, dark urine, itching of the skin, tendency to bleed, and disorders of thinking or insomnia [these may be symptoms of severe liver inflammation that can lead to life-threatening liver failure, including fatal outcomes (very rare side effect)],
• skin and mucous membrane changes, such as painful blisters in the mouth or nose and on the penis or in the vagina, which can be life-threatening - Stevens-Johnson syndrome or toxic epidermal necrolysis [Lyell's syndrome] (very rare side effect),
• vasculitis (may manifest as red bumps on the skin, usually on the lower legs, or joint pain) (very rare side effect),
• severe, potentially life-threatening allergic reactions, including anaphylaxis (rare side effect),

shortness of breath, especially when lying down, or swelling of the ankles, feet, or abdomen, or palpitations (feeling of rapid or irregular heartbeat) (rare side effect, potentially life-threatening),

• seizures (rare side effect),
• nervous system problems, such as pain, burning, tingling, numbness, and (or) weakness (rare side effect),
• depression (very rarely leading to self-harm, e.g., suicidal thoughts or behaviors, or suicide attempts) (rare side effect),
• psychiatric disorders (may lead to self-harm, e.g., suicidal thoughts or behaviors, or suicide attempts) (very rare side effect),
• severe diarrhea with blood and (or) mucus in the stool (antibiotic-associated colitis, including pseudomembranous colitis), which can very rarely be associated with life-threatening complications (rare side effects),
• pain and inflammation of the tendons (tendinitis) (rare side effect) or tendon rupture (very rare side effect) the patient should stop taking Moxifloxacin Genoptim and immediately consult their doctor, as immediate medical attention may be necessary.

In case of transient loss of vision (very rare side effect), the patient should immediately consult an ophthalmologist.
If the patient experiences life-threatening irregular heartbeat (torsades de pointes) or cardiac arrest while taking Moxifloxacin Genoptim (very rare side effect), they should immediately inform their treating doctor that they are taking Moxifloxacin Genoptim and not resume treatment.
Very rarely, worsening of myasthenia gravis symptoms has been observed. If the patient's myasthenia gravis symptoms worsen, they should immediately consult their doctor.
If the patient experiences an increase or decrease in blood sugar levels (rare or very rare side effects), they should inform their doctor(see also "Warnings and Precautions" in section 2).

Other side effectsobserved during treatment with moxifloxacin are listed below, according to their frequency:

Common (may occur in up to 1 in 10 people)

• nausea
• diarrhea
• dizziness
• abdominal pain
• vomiting
• headache
• increased liver enzyme activity in the blood
• infections caused by resistant bacteria or fungi, e.g., oral thrush (candidiasis) and vaginal candidiasis
• heart rhythm disorders (visible on ECG) in patients with low potassium levels in the blood

Uncommon (may occur in up to 1 in 100 people)

• rash
• gastrointestinal disorders (dyspepsia or heartburn)
• taste disorders (very rarely, loss of taste)
• sleep disorders (mainly insomnia)
• increased activity of liver enzymes in the blood: gamma-glutamyltransferase and (or) alkaline phosphatase

liver enzymes

• low white blood cell count, low neutrophil count (a type of white blood cell)
• constipation
• itching
• feeling of dizziness (vertigo or spinning)
• drowsiness
• flatulence
• heart rhythm disorders (visible on ECG)
• liver function disorders, including increased LDH (liver enzyme) activity in the blood
• decreased appetite and food intake
• low white blood cell count
• back pain, chest pain, pelvic pain, and limb pain
• decreased or increased platelet count
• sweating
• increased eosinophil count (a type of white blood cell)
• anxiety
• general malaise (mainly weakness or fatigue),
• tremors
• joint pain
• palpitations
• irregular and rapid heart rate
• breathing difficulties (including asthma)
• increased amylase activity in the blood (a digestive enzyme)
• restlessness or agitation
• tingling or numbness
• hives
• vasodilation
• confusion and disorientation
• decreased platelet count
• visual disturbances (including double or blurred vision)
• decreased blood clotting
• increased blood lipid levels
• low red blood cell count
• muscle pain
• allergic reactions
• increased bilirubin levels in the blood
• gastritis
• dehydration
• severe heart rhythm disorders,
• dry skin
• angina pectoris

Rare (may occur in up to 1 in 1000 people)

• muscle tremors
• muscle cramps
• hallucinations
• high blood pressure
• edema (of hands, feet, ankles, lips, mouth, or throat)
• low blood pressure
• kidney function disorders (including increased results of certain kidney function tests, such as urea and creatinine levels)
• liver inflammation
• oral mucositis
• ringing or noise in the ears,
• jaundice (yellowing of the whites of the eyes or skin),
• skin sensation disorders
• unusual dreams
• concentration disorders
• difficulty swallowing
• smell disorders (including loss of smell)
• balance and coordination disorders (due to dizziness)
• partial or complete memory loss
• hearing disorders, including deafness (usually temporary)
• increased uric acid levels in the blood
• emotional instability
• speech disorders
• fainting
• muscle weakness

Very Rare (may occur in up to 1 in 10,000 people)

• arthritis
• abnormal heart rhythm,
• increased skin sensitivity
• depersonalization (feeling of loss of one's identity)
• increased blood clotting,
• muscle stiffness
• significant decrease in the number of certain white blood cells (agranulocytosis) vasculitis

In addition, the following very rare side effects have been reported during treatment with Moxifloxacin Genoptim and other fluoroquinolone antibiotics: increased sodium levels in the blood, increased calcium levels in the blood, increased breakdown of red blood cells (hemolytic anemia), muscle reactions with muscle cell damage, increased sensitivity of the skin to sunlight and UV radiation.

Reporting Side Effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Medicinal Product Monitoring, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa
Phone: +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 authorization holder.
Reporting side effects will help gather more information on the safety of the medication.

5. How to Store Moxifloxacin Genoptim

The medication should be stored out of sight and reach of children.
Do not use this medication after the expiry date stated on the blister pack and carton after EXP and on the carton after Expiry Date (EXP). The expiry date refers to the last day of the month stated.
There are no special storage instructions for the medication.
Medications should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the Package and Other Information

What Moxifloxacin Genoptim Contains

• The active substance of the medication is moxifloxacin. Each film-coated tablet contains 400 mg of moxifloxacin in the form of moxifloxacin hydrochloride monohydrate.
• The other ingredients are: microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica, povidone (K-30), magnesium stearate; tablet coating: hypromellose 6cPs, macrogol 400, macrogol 6000, titanium dioxide (E171), iron oxide red (E172).

What Moxifloxacin Genoptim Looks Like and Contents of the Package

Pink, bilayer, film-coated tablets in the shape of a capsule, measuring 17.1 mm × 7.1 mm, with the inscription "T75" on one side and smooth on the other side.
Moxifloxacin Genoptim is packaged in cartons containing blisters made of OPA/Aluminum/PVC/Aluminum foil.
Moxifloxacin Genoptim is available in packages containing 5, 7, or 10 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder

Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warszawa

Manufacturer/Importer

Synoptis Industrial Sp. z o.o.
ul. Rabowicka 15
62-020 Swarzędz

Date of Last Revision of the Package Leaflet: