Moloxin

Package leaflet: information for the patient

Moloxin, 400 mg, coated tablets
moxifloxacinum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Moloxin and what is it used for

Moloxin contains as the active substance moxifloxacinum, which belongs to a group of antibiotics called fluoroquinolones. Moloxin acts bactericidally against bacteria causing infections.
Moloxin is used in patients aged 18 years and older for the treatment of the bacterial infections listed below, provided they are caused by bacteria sensitive to moxifloxacin. Moloxin may be used to treat these infections only when commonly prescribed antibiotics are not suitable or have proven ineffective:
Sinusitis, acute exacerbation of chronic bronchitis, or community-acquired pneumonia (except severe cases).
Mild to moderate upper genital tract infections (pelvic inflammatory disease), including infections of the fallopian tubes and endometritis. Moloxin used alone is not sufficient for the treatment of these types of infections; therefore, your doctor should prescribe an additional antibacterial agent for the treatment of upper female genital tract infections (see section 2, "Important information before taking Moloxin", "Warnings and precautions", "Before starting Moloxin, discuss this with your doctor or pharmacist").
If improvement has occurred during treatment of the bacterial infections listed below due to intravenous infusion of moxifloxacin, your doctor may also prescribe Moloxin in the form of coated tablets to complete the course of treatment:
community-acquired pneumonia, skin and soft tissue infections.
Moloxin should not be used to initiate treatment for all types of skin and soft tissue infections or for severe lung infections.

2. Important information before using Moloxin

If the patient has any doubts as to whether they belong to any of the groups described below, they should consult their doctor.

When not to use Moloxin

• If the patient is allergic to moxifloxacin, other antibiotics from the quinolone group, or to any of the other ingredients of this medicine (listed in section 6).
• During pregnancy and breastfeeding.
• In patients under 18 years of age.
• If the patient has previously experienced tendon problems associated with treatment with other quinolone antibiotics (see section 2. "Important information before using Moloxin", "Warnings and precautions", and section 4. "Possible side effects").
• If the patient has congenital or acquired conditions such as:
• any disorders related to abnormal heart rhythm (visible on ECG – electrocardiogram recording of the heart's electrical activity),
• electrolyte imbalance (especially low blood potassium or magnesium levels),
• very slow heart rate (bradycardia),
• heart failure,
• previously diagnosed heart rhythm disorders (arrhythmias), or
• if the patient is taking medicines that may cause abnormal changes in the ECG (see section 2. "Important information before using Moloxin", "Moloxin and other medicines"). Moloxin may cause changes in the ECG known as QT interval prolongation, which means delayed conduction of electrical signals in the heart.
• If the patient has severe liver disease or liver enzyme (aminotransferase) activity exceeding five times the upper limit of normal.

Warnings and precautions
Before taking this medicine
Do not take antibacterial medicines containing fluoroquinolones or quinolones, including Moloxin, if the patient has previously experienced any severe adverse reaction while taking a quinolone or fluoroquinolone. In such a case, inform the doctor immediately.
Before starting treatment with Moloxin, discuss this with your doctor or pharmacist.

• Moloxin may alter the heart's ECG, especially in women and elderly patients. If the patient is taking medicines that lower blood potassium levels, consult a doctor before starting Moloxin (see also section 2. "Important information before using Moloxin", "When not to use Moloxin", and "Moloxin and other medicines").
• If the patient has been diagnosed with a dilated blood vessel (aortic aneurysm or large peripheral artery).
• If the patient has previously experienced aortic dissection (tearing of the aortic wall).
• If the patient has been diagnosed with heart valve insufficiency.
• If 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, 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 atherosclerosis, rheumatoid arthritis (joint disease), or endocarditis).
• If the patient has epilepsy or conditions that may provoke seizures, consult a doctor before starting Moloxin.
• If the patient has or has ever had mental health problems, consult a doctor before starting Moloxin.
• If the patient has myasthenia gravis (a type of muscle weakness that may lead to paralysis in severe cases), taking Moloxin may worsen symptoms. If this occurs, consult a doctor immediately.
• If the patient or someone in their family has glucose-6-phosphate dehydrogenase deficiency (a rare inherited disorder), inform the doctor, who will assess whether Moloxin is appropriate.
• If a female patient has a complicated upper genital tract infection (e.g. tubo-ovarian abscess, pelvic abscess), the doctor may consider intravenous moxifloxacin necessary, as oral Moloxin tablets are not suitable.
• For the treatment of mild to moderate upper genital tract infections, the doctor should prescribe, in addition to Moloxin, another antibacterial medicine. If symptoms do not begin to improve within the first 3 days of treatment, the patient should see a doctor. If the patient has diabetes, blood glucose levels should be monitored carefully, as moxifloxacin may affect blood sugar levels.
• If the patient has ever experienced severe skin rash, skin peeling, blistering, and/or oral mucosal ulceration after taking moxifloxacin.

While taking Moloxin

• If palpitations or irregular heartbeat occur during treatment, contact a doctor immediately. The doctor may wish to perform an ECG to check heart rhythm.

• The risk of heart function disorders may increase with higher doses. Therefore, follow the recommended dosage.

• There is a small risk of severe, sudden allergic reaction (anaphylactic reaction or anaphylactic shock), even after the first dose, with symptoms such as chest tightness, dizziness, feeling weak or faint, and dizziness upon standing. If these occur, stop taking Moloxin immediately and seek medical advice.

• Moloxin may cause rapid and severe hepatitis, which may lead to life-threatening liver failure (including death; see section 4. "Possible side effects"). Contact a doctor before continuing treatment if symptoms such as rapid deterioration in general health and/or condition associated with yellowing of the whites of the eyes, dark urine, skin itching, tendency to bleed, or brain dysfunction due to liver disease (signs of impaired liver function or rapidly progressive and severe hepatitis) occur.

• Antibiotics from the quinolone group, including Moloxin, may cause seizures. If seizures occur, stop taking Moloxin immediately and consult a doctor.

• Long-term, disabling, and potentially irreversible serious adverse effects.

• Antibacterial medicines containing fluoroquinolones or quinolones, including Moloxin, have been associated with very rare but serious adverse effects. Some of these were long-lasting (persisting for months or years), disabling, or potentially irreversible. These include: tendon, muscle, and joint pain in the upper and lower limbs, difficulty walking, abnormal sensations such as pricking, tingling, tickling, numbness, or burning (paresthesia), sensory disturbances including vision, taste, smell, and hearing disorders, depression, memory problems, severe fatigue, and severe sleep disturbances. If any of these adverse effects occur after taking Moloxin, contact a doctor immediately before continuing treatment. The patient and doctor will decide whether to continue treatment, possibly considering antibiotics from another group.

• The patient may rarely experience symptoms of nerve damage (neuropathy), such as pain, burning, tingling, numbness, and/or weakness, especially in the feet and legs, and hands and arms. In such a case, stop taking Moloxin and inform the doctor immediately to prevent the development of potentially irreversible disease.

• Psychiatric problems may occur, even during first use of quinolone antibiotics, including Moloxin. In very rare cases, depression or psychiatric problems may lead to suicidal thoughts and self-harming behaviors, including suicide attempts (see section 4. "Possible side effects"). If such reactions occur, stop taking Moloxin immediately and consult a doctor.

• Diarrhea may occur during or after treatment with antibiotics, including Moloxin. If diarrhea is severe or prolonged, or if blood or mucus is observed in the stool, stop taking Moloxin immediately and consult a doctor. In such cases, do not use medicines that inhibit or slow intestinal motility (peristalsis).

• Rarely, joint pain and swelling, inflammation, or tendon rupture may occur. The risk is increased in elderly patients (over 60 years), organ transplant recipients, patients with kidney problems, or those receiving corticosteroids. Tendon inflammation and rupture may occur within the first 48 hours of treatment or even several months after stopping Moloxin. At the first signs of tendon pain or inflammation (e.g. in the ankle, wrist, elbow, shoulder, or knee), stop taking Moloxin, contact a doctor, and rest the affected area. Avoid excessive physical exertion, as this may increase the risk of tendon rupture (see section 2. "Important information before using Moloxin", "When not to use Moloxin", and section 4. "Possible side effects").

• If sudden severe abdominal, back, or chest pain occurs, which may indicate aortic aneurysm or dissection, seek emergency medical help immediately. The risk may be higher in patients receiving systemic corticosteroids.

• If sudden shortness of breath, especially when lying down, or swelling of the ankles, feet, or abdomen, or palpitations (feeling of rapid or irregular heartbeat) occur, seek medical help immediately.

• Fluoroquinolone antibiotics may cause blood glucose levels to rise above normal (hyperglycemia) or fall below normal (hypoglycemia), potentially leading to loss of consciousness (hypoglycemic coma) in severe cases (see section 4. "Possible side effects"). Blood glucose levels should be closely monitored in diabetic patients.

• Elderly patients with kidney function disorders should drink adequate fluids, as dehydration may increase the risk of kidney failure.

• If vision deteriorates or other visual disturbances occur during treatment with Moloxin, seek immediate advice from an ophthalmologist (see section 3. "How to use Moloxin", "Driving and using machines", and section 4. "Possible side effects").

• Quinolone antibiotics may increase skin sensitivity to sunlight or UV radiation. During treatment with Moloxin, avoid prolonged sun exposure, intense sunlight, and use of sunbeds or other UV radiation sources (see section 4. "Possible side effects").

• The efficacy of moxifloxacin in treating severe burns, deep tissue infections, and diabetic foot infections with osteomyelitis (bone marrow infection) has not been established.

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

• SJS/TEN may initially present as reddish, target-like spots or circular lesions, often with blisters on the trunk. Oral, throat, nasal, genital, and eye mucosal ulcers may also occur (red and swollen eyes). These severe skin rashes are often preceded by fever and/or flu-like symptoms. Skin rashes may progress to widespread skin peeling and life-threatening complications or even death.

• AGEP rash typically appears early in treatment as a red, scaly, generalized rash with subcutaneous nodules and blisters, accompanied by fever. The most common sites are skin folds, trunk, and upper limbs.

• DRESS initially presents with flu-like symptoms and facial rash, followed by widespread rash with high fever. Blood tests show increased liver enzyme activity and elevated white blood cell count (eosinophilia), as well as enlarged lymph nodes. If severe rash or any of these skin symptoms occur, discontinue moxifloxacin and contact a doctor or seek immediate medical help.

Children and adolescents
This medicine should not be used in children and adolescents under 18 years of age, as the efficacy and safety of its use have not been established in this age group (see section 2. "Important information before using Moloxin", "When not to use Moloxin").

Moloxin and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines planned for future use.
When taking Moloxin, be aware that:

• The risk of heart rhythm disorders is increased when Moloxin is taken with other medicines affecting heart function. Therefore, do not take Moloxin simultaneously with the following medicines:
• medicines belonging to the antiarrhythmic group (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide),
• antipsychotic medicines (e.g. phenothiazines, pimozide, sertindole, haloperidol, sulpiride),
• tricyclic antidepressants,
• some medicines used in infections (e.g. saquinavir, sparfloxacin, intravenous erythromycin, pentamidine, antimalarials, especially halofantrine),
• some antihistamines (e.g. terfenadine, astemizole, mizolastine),
• other medicines (e.g. cisapride, intravenous vincamine, bepridil, difemanil).
• Inform the doctor if taking medicines that may reduce blood potassium levels (e.g. certain diuretics, certain laxatives and purgatives [in high doses], or glucocorticosteroids [anti-inflammatory medicines], amphotericin B) or slow heart rate, as this may increase the risk of severe heart rhythm disorders while taking Moloxin.
• Medicines containing magnesium or aluminium (such as antacids used for digestive disorders), medicines containing iron or zinc, medicines containing didanosine, and medicines containing sucralfate (used for gastrointestinal disorders) may reduce the effectiveness of Moloxin. Therefore, a 6-hour interval should be maintained between taking Moloxin and these medicines.
• Concurrent administration of a charcoal-containing medicine and Moloxin reduces the effectiveness of Moloxin. Therefore, simultaneous use of both medicines is not recommended.
• If taking blood-thinning medicines (oral anticoagulants such as warfarin) concurrently, the doctor may order blood clotting time tests.

Moloxin with food and drink
Moloxin can be taken independently of meals (including dairy meals).

Pregnancy, breastfeeding, and fertility
Do not use Moloxin during pregnancy or breastfeeding.
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Animal studies have not shown any effect on fertility with moxifloxacin use.

Driving and using machines
Moloxin may cause dizziness, lightheadedness, sudden transient loss of vision, or brief fainting. If such symptoms occur, do not drive or operate machinery.

Moloxin contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Moloxin

This medicine should always be taken as directed by your doctor or pharmacist. If you are unsure,
you should consult your doctor or pharmacist.
The usual dose for adults is 1 film-coated tablet of 400 mg once daily.
Moloxin tablets are taken orally. The tablet should be swallowed whole (to mask its bitter taste)
with plenty of fluid. Moloxin may be taken regardless of meals.
It is recommended to take the medicine at the same time each day.
There is no need to adjust the dose in elderly patients, patients with low body weight, or patients
with impaired kidney function.
The duration of treatment depends on the type of infection. Unless otherwise directed by your doctor,
the recommended duration of treatment with Moloxin is:

• Acute exacerbation of chronic bronchitis: 5 to 10 days
• Lung infections (pneumonia), excluding hospital-acquired pneumonia: 10 days
• Acute sinusitis (acute bacterial sinusitis): 7 days
• Mild to moderate upper genital tract infections (pelvic inflammatory disease), including
  salpingitis and endometritis: 14 days

If Moloxin is used to complete a treatment course initiated with moxifloxacin infusion solution,
the recommended duration of treatment is:

• Community-acquired pneumonia: 7–14 days

In most patients with pneumonia, the switch to oral moxifloxacin in the form of film-coated tablets
occurred within 4 days.

• Skin and soft tissue infections: 7–21 days

In most patients with skin and soft tissue infections, the switch to oral moxifloxacin in the form of
film-coated tablets occurred within 6 days.
It is important to complete the full course of treatment, even if you start feeling better after a few days.
If this medicine is stopped too early, the infection may not be completely cured, may recur or worsen,
and bacterial resistance to Moloxin may develop.
Do not exceed the recommended dose or prolong the duration of treatment (see section 2., "Information
before using Moloxin", "Warnings and precautions").
Taking more than the recommended dose of Moloxin
If more than the prescribed number of tablets is taken in one day, seek medical help immediately.
If possible, bring any remaining tablets, the medicine packaging, and this leaflet to show to the doctor
or pharmacist.
Missing a dose of Moloxin
If a patient forgets to take a tablet at the usual time, they should take it as soon as they remember
on the same day. If a dose is missed for one day, take the usual dose (one tablet) the next day.
Do not take a double dose to make up for a missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.
Stopping Moloxin treatment
If treatment is stopped too early, the infection may not be completely cured. If it is necessary to
stop taking the medicine earlier than planned, consult your doctor.
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.
The most serious adverse effects observed during treatment with moxifloxacin
are listed below.
If any of the following adverse effects occur:

• irregularly fast heartbeat (uncommon adverse effect),
• rapid deterioration in general condition, yellowing of the whites of the eyes, dark urine, itching of the skin, tendency to bleed, and disturbances in thinking or insomnia [these may be signs and symptoms of fulminant hepatitis which can lead to life-threatening liver failure, including fatal outcome (very rare adverse effect)],
• severe skin rash, including Stevens-Johnson syndrome and toxic epidermal necrolysis. This may present as reddish target-like spots or circular lesions, often with blisters on the trunk, skin peeling, ulceration in the mouth, throat, nose, genital organs and eyes, and may be preceded by fever and flu-like symptoms (very rare adverse effects, potentially life-threatening),
• red, peeling, generalized rash with subcutaneous nodules and blisters, accompanied at the beginning of treatment by fever (acute generalized exanthematous pustulosis) (frequency of this adverse effect is "unknown frequency" – frequency cannot be estimated from available data),
• widespread rash, high fever, increased liver enzyme activity, blood abnormalities (eosinophilia), swollen lymph nodes and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome) (frequency of this adverse effect is "unknown frequency"),
• syndrome related to impaired water excretion and low sodium levels (SIADH) (very rare adverse effect),
• loss of consciousness due to significantly low blood sugar levels (hypoglycaemic coma) (very rare adverse effect),
• inflammation of blood vessels (symptoms may include red spots on the skin, usually on the lower legs, or tendon pain) (very rare adverse effect),
• severe, rapidly generalizing allergic reaction, including very rarely life-threatening anaphylactic shock (e.g. difficulty breathing, drop in blood pressure, rapid pulse) (uncommon adverse effect),
• swelling, including swelling of the airways (uncommon adverse effect, potentially life-threatening),
• seizures (uncommon adverse effect),
• nervous system-related problems such as pain, burning sensation, tingling, numbness and (or) weakness of limbs (uncommon adverse effect),
• depression (very rarely leading to self-harm, e.g. hallucinations or suicidal thoughts or suicide attempts) (uncommon adverse effect),
• psychiatric disorders (potentially leading to self-harm, e.g. hallucinations or suicidal thoughts or suicide attempts) (very rare adverse effect),
• severe diarrhoea with blood and (or) mucus in stool (antibiotic-associated colitis, including pseudomembranous colitis), which very rarely may lead to life-threatening complications (uncommon adverse effects),
• tendon pain and swelling (tendinitis) (uncommon adverse effect) or tendon rupture (very rare adverse effect),
• muscle weakness, tenderness or pain, especially if accompanied by malaise, high fever or dark urine. This may be due to abnormal breakdown of muscle tissue, which can be life-threatening and lead to kidney problems (a condition known as rhabdomyolysis) (frequency of this adverse effect is "unknown frequency"), you must stop taking Moloxin and contact your doctor immediately, as immediate medical assistance may be required.

Additionally, if the following occur:

• transient loss of vision (very rare adverse effect),
• eye discomfort or pain, particularly on exposure to light (very rare adverse effect), you must contact an ophthalmologist immediately.

If the patient experiences life-threatening irregular heartbeat ( torsade de pointes ) or
cardiac arrest while taking Moloxin (very rare adverse effect), you must immediately inform the treating physician that the patient is taking
Moloxin and must not restart treatment.
Exacerbation of myasthenia symptoms has been very rarely observed. If myasthenia symptoms worsen in a patient, seek immediate medical advice.
If a diabetic patient experiences increased or decreased blood glucose levels (uncommon or very rare adverse effect), contact the doctor immediately.
If an elderly patient with impaired kidney function develops reduced urine volume, swelling of the feet, ankles or legs, fatigue, nausea, drowsiness, shortness of breath or confusion (these may be signs and symptoms of kidney failure; uncommon adverse effect), seek immediate medical advice.
Other adverse effects observed during moxifloxacin treatment are listed below,
according to their frequency of occurrence:
Common adverse effects (may occur in less than 1 in 10 people):

• nausea
• diarrhoea
• central dizziness
• stomach and abdominal pain
• vomiting
• headache
• increased blood levels of certain liver enzymes (aminotransferases)
• infections caused by resistant bacteria or fungi, e.g. oral or vaginal candidiasis caused by Candida
• heart rhythm disturbances (visible on ECG) in patients with low blood potassium levels

Uncommon adverse effects (may occur in less than 1 in 100 people):

• rash
• gastrointestinal disturbances (dyspepsia and heartburn)
• taste disturbances (in very rare cases, loss of taste)
• sleep disturbances (mainly insomnia)
• increased blood levels of certain liver enzymes: gamma-glutamyltransferase and (or) alkaline phosphatase
• low count of certain white blood cells (leukocytes, neutrophils)
• constipation
• itching
• dizziness (sensation of spinning or falling)
• drowsiness
• flatulence
• heart rhythm disturbances (visible on ECG)
• liver function disorders, including increased blood levels of liver enzyme (LDH)
• decreased appetite and food intake
• low white blood cell count
• minor complaints such as back, chest, pelvic or limb pain
• increased platelet count necessary for blood clotting
• excessive sweating
• increased number of certain white blood cells (eosinophils)
• anxiety
• malaise (mainly weakness or fatigue)
• tremor
• joint pain
• palpitations
• irregular and rapid heartbeat
• breathing difficulties, including asthma-like symptoms
• increased blood levels of a digestive enzyme called amylase
• restlessness, especially motor restlessness, or agitation
• tingling and (or) numbness
• urticaria
• blood vessel dilation
• confusion and disorientation
• decreased platelet count necessary for blood clotting
• visual disturbances, including double or blurred vision
• reduced blood clotting
• increased blood lipid levels
• low red blood cell count (anaemia)
• muscle pain
• allergic reaction
• increased blood bilirubin levels
• inflammation of the gastric mucosa
• dehydration
• severe heart rhythm disturbances
• dry skin
• angina pectoris

Rare adverse effects (may occur in less than 1 in 1,000 people):

• muscle tremor
• muscle cramps
• hallucinations
• high blood pressure
• swelling (hands, feet, ankles, lips, mouth or throat)
• kidney function disorders, including increased values in diagnostic tests for kidney function such as urea and creatinine levels
• hepatitis
• inflammation of the oral mucosa
• ringing or noise in the ears (tinnitus)
• jaundice (yellowing of the whites of the eyes and skin)
• disturbances in skin sensation
• unusual dreams
• difficulty concentrating
• difficulty swallowing
• smell disturbances, including loss of smell
• balance disorders and poor coordination (due to dizziness)
• partial or complete memory loss
• hearing disturbances, including deafness (usually transient)
• increased blood uric acid levels
• emotional lability
• speech disturbances
• fainting
• muscle weakness

Very rare adverse effects (may occur in less than 1 in 10,000 people):

• arthritis
• heart rhythm disturbances
• increased skin photosensitivity
• depersonalization (feeling of loss of self-identity)
• increased blood coagulation
• muscle stiffness
• marked decrease in a specific type of white blood cells (agranulocytosis)
• decreased number of red and white blood cells and platelets (pancytopenia)

Frequency unknown (frequency cannot be estimated from available data)

• Increased sensitivity of the skin to sunlight or UV radiation (see also section 2, Warnings and precautions).
• Acute, well-demarcated, erythematous lesions with or without blisters, appearing within hours after moxifloxacin administration and healing with post-inflammatory residual pigmentation; usually recurring at the same site of skin or mucosa upon subsequent exposure to moxifloxacin.

Administration of quinolone and fluoroquinolone antibiotics, in some cases
regardless of pre-existing risk factors, has very rarely led to long-term
(persisting for months or years) or permanent adverse effects such as tendonitis,
tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as
pricking, tingling, tickling, burning, numbness or pain (neuropathy), fatigue,
memory and concentration disturbances, psychiatric health effects (which may include:
sleep disturbances, anxiety, panic attacks, depression, suicidal ideation), and disturbances
in hearing, vision, taste and smell.
In patients receiving fluoroquinolones, cases of aortic aneurysm and dissection due to
aortic wall dilation and weakening have been reported, which may result in rupture and
lead to death, as well as cases of cardiac valve regurgitation. See also section 2.
Additionally, the following adverse effects have been very rarely reported during treatment
with other quinolone antibiotics and may also occur during treatment with Moloxin:

• increased intracranial pressure (symptoms include headache, vision problems, including blurred vision, "blind" spots, double vision, vision loss)
• increased blood sodium levels
• increased blood calcium levels
• a specific type of reduced red blood cell count (haemolytic anaemia)

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

5. How to store Moloxin

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after the abbreviation
"EXP". The expiry date refers to the last day of the stated month.
The batch number is indicated on the packaging after the abbreviation "Lot".
Store in the original packaging to protect from moisture.
No special precautions regarding storage temperature are required.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such measures will help
protect the environment.

6. Contents of the pack and other information

What Moloxin contains

• The active substance is moxifloxacin. Each coated tablet contains moxifloxacin hydrochloride equivalent to 400 mg of moxifloxacin.
• The other ingredients are: microcrystalline cellulose, sodium croscarmellose, and magnesium stearate in the tablet core; and hypromellose 6 mPa·s, macrogol 4000, titanium dioxide (E171), and red iron oxide (E172) in the tablet coating. See section 2. "Moloxin contains sodium".

What Moloxin looks like and contents of the pack
Dark pink, biconvex, film-coated tablets in a capsule shape, with dimensions: length 15.9 mm – 16.6 mm and thickness 5.8 mm – 7.0 mm.

Pack sizes: Blister packs containing 5, 7, 10, 14, 25, 28, 30, 50, 70, 80, 100 or 120 film-coated tablets in a cardboard carton.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
KRKA, d. d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer
KRKA, d. d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
KRKA-FARMA d.o.o., V. Holjevca 20/E, 10 450 Jastrebarsko, Croatia

This medicinal product is authorised for marketing in the European Economic Area countries under the following names:

For more detailed information, please contact the representative of the responsible entity:
KRKA-POLSKA Sp. z o.o.
Równoległa Street 5
02-235 Warsaw
Phone: 22 57 37 500