Moxifloxacin Msn

Leaflet accompanying the packaging: information for the user

Moxifloxacin MSN, 400 mg, film-coated tablets

For use in adults.
Moxifloxacin

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of further doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If any of the side effects worsen or if any side effects not mentioned in the leaflet occur, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Moxifloxacin MSN and what is it used for
• 2. Important information before taking Moxifloxacin MSN
• 3. How to take Moxifloxacin MSN
• 4. Possible side effects
• 5. How to store Moxifloxacin MSN
• 6. Package contents and other information

1.

What is Moxifloxacin MSN and what is it used for

Moxifloxacin MSN contains the active substance moxifloxacin, which belongs to a group of
antibiotics called fluoroquinolones. Moxifloxacin MSN has a bactericidal effect on
bacteria that cause infections.
Moxifloxacin MSN is used in patients aged 18 and over to treat the following bacterial infections, if they are caused by bacteria susceptible to moxifloxacin. Moxifloxacin MSN can only be used to treat these infections if the use of commonly administered antibiotics is not possible or if they have been ineffective.
Sinusitis, acute exacerbation of chronic bronchitis or community-acquired pneumonia (except for severe cases).
Mild or moderate upper genital tract infections (pelvic inflammatory disease), including fallopian tube infections and endometritis. Moxifloxacin MSN alone is not sufficient to treat this type of infection, so the doctor should prescribe an additional antibacterial agent to treat upper genital tract infections (see section 2. Important information before taking Moxifloxacin MSN, Warnings and precautions, Before starting treatment with Moxifloxacin MSN, consult a doctor or pharmacist).
If improvement occurs during treatment of the following bacterial infections due to the administration of Moxifloxacin MSN infusion solution, the doctor may also prescribe Moxifloxacin MSN tablets to complete the treatment: community-acquired pneumonia, skin and soft tissue infections. Moxifloxacin MSN tablets should not be used to initiate treatment for any type of skin and soft tissue infection or in severe pneumonia.

2. Important information before taking Moxifloxacin MSN

If the patient has any doubts about belonging to any of the described groups, they should contact their doctor.

When not to take Moxifloxacin MSN

• In case of hypersensitivity to the active substance - moxifloxacin, other quinolone drugs or any of the other ingredients of the drug (listed in 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 other quinolone drugs (see section Warnings and precautions and section 4. Possible side effects).
• If the patient has:
• congenital or acquired abnormal heart rhythm (visible on the electrocardiogram (ECG)
• recording of the heart's electrical activity);
• electrolyte imbalance disorders (especially low potassium or magnesium levels in the blood);
• very slow heart rate (bradycardia);
• heart failure;
• history of heart rhythm disorders (arrhythmias) or
• if the patient is taking drugs that may cause specific changes in the ECG recording (see section Moxifloxacin MSN and other drugs). Moxifloxacin MSN may cause changes in the ECG recording, known as 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 taking the medicine
Do not take antibacterial drugs containing fluoroquinolone/quinolone, including Moxifloxacin MSN, if serious side effects have occurred in the past during the use of quinolone or fluoroquinolone. In such a situation, inform your doctor as soon as possible.

Before starting treatment with Moxifloxacin MSN, consult a doctor.

• Moxifloxacin MSN may change the ECG recording of the heart, especially in women and the elderly. When taking drugs that lower potassium levels in the blood, consult a doctor before starting treatment with Moxifloxacin MSN (see also sections When not to take Moxifloxacin MSN and Moxifloxacin MSN and other drugs).
• If the patient has ever experienced severe skin rash or skin peeling, blistering, and (or) ulcersafter taking moxifloxacin.
• If the patient has epilepsyor conditions that may cause seizures, inform your doctor before starting treatment with Moxifloxacin MSN.
• If the patient has or has had mental health problems, consult a doctor before starting treatment with Moxifloxacin MSN.
• If the patient has myasthenia gravis(muscle weakness leading to weakness, and in severe cases, paralysis), taking Moxifloxacin MSN may exacerbate the symptoms of the disease. If this happens, consult a doctor immediately.
• If the patient has been diagnosed with enlargement or "bulging" of a large blood vessel(aortic or peripheral aneurysm).
• If the patient has experienced an aortic dissection episode(tear in the aortic wall).
• If the patient has been diagnosed with heart valve problems(leaky heart valve).
• If there is a family history of aortic aneurysm or aortic dissection, congenital heart valve problems, 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 [autoimmune inflammatory disease], or vascular disorders, such as Takayasu arteritis, giant cell arteritis, Behçet's disease, high blood pressure, or atherosclerosis, rheumatoid arthritis [joint disease], or endocarditis [heart infection]).
• If the patient has diabetes, as moxifloxacin may increase the risk of changes in blood sugar levels.
• If the patient or anyone in their family has a deficiency of glucose-6-phosphate dehydrogenase(a rare inherited disease), inform your doctor, who will assess whether Moxifloxacin MSN is a suitable medicine.
• If the patient has a complicated upper genital tract infection(e.g., tubo-ovarian abscess, ovarian abscess, or pelvic abscess), the doctor may consider intravenous administration of the drug, as treatment with Moxifloxacin MSN tablets is not appropriate.
• In order to treat mild or moderate upper genital tract infections, the doctor should prescribe an additional antibacterial agent to the patient, in addition to Moxifloxacin MSN. If symptoms do not improve within the first 3 days of treatment, the patient should consult a doctor.

During treatment with Moxifloxacin MSN

• If heart palpitations or irregular heartbeatoccur during treatment, inform your doctor immediately. They may order an ECG to check the heart rhythm.
• Cardiac arrhythmia riskmay increase with increasing dose. Therefore, it is recommended to follow the prescribed dosage of the drug.
• There is a small risk of severe, sudden allergic reactions(anaphylactic or anaphylactoid reactions) even after the first dose of the drug, with symptoms such as chest tightness, dizziness, nausea, or fainting, and a feeling of spinning when standing up. If these symptoms occur, stop taking the drug immediatelyand consult a doctor or seek medical help immediately.

Moxifloxacin MSN and seek medical advice.

• Moxifloxacin MSN may cause liver inflammation with a rapid and severe course, which can lead to life-threatening liver failure (including fatal cases, see section 4. Possible side effects). 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 disturbances of thinking or insomnia occur, consult a doctor before taking the next dose.
• Severe skin reactionsSevere skin reactions have been reported during treatment with moxifloxacin, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP).
• SJS/TEN may initially appear as red spots with a target-like appearance or round spots, often with blisters on the torso. They can also cause ulcers in the mouth, throat, nose, genitals, and eyes (red and swollen eyes). The onset of these severe skin rashes is often preceded by fever and/or flu-like symptoms. The rash can progress to widespread skin peeling and life-threatening complications or lead to death.
• AGEP appears at the beginning of treatment as a red, peeling, generalized rash with papules and blisters, accompanied by fever. The most common location is localized mainly on skin folds, torso, and

upper limbs.
If a severe rash or any of these skin symptoms occur, stop taking moxifloxacin and consult a doctor or seek medical help immediately.

• Quinolone antibiotics, including Moxifloxacin MSN, may cause seizures. If seizures occur, stop taking Moxifloxacin MSN immediately and consult a doctor.
• Long-term, leading to disability and potentially irreversible serious side effectsFluoroquinolone and quinolone antibacterial agents, including Moxifloxacin MSN, have caused very rare but serious side effects, some of which are long-term (lasting months or years) or irreversible. These include tendon, muscle, and joint pain in the upper and lower limbs, difficulty walking, sensory disturbances such as tingling and numbness, paresthesia, sensory disturbances including visual, taste, and smell disturbances, depression, memory impairment, severe fatigue, and severe sleep disturbances. If any of these side effects occur after taking Moxifloxacin MSN, consult a doctor immediately before continuing treatment. The doctor will decide, in consultation with the patient, whether to continue treatment, also considering the use of an antibiotic from another class.
• Rarely, nerve damage symptomsmay occur, such as pain, burning, tingling, numbness, and/or weakness, especially in the feet and legs or hands and arms. Stop taking Moxifloxacin MSN and consult a doctor immediately to avoid potentially irreversible conditions.
• Mental health problemsmay occur, even with the first use of quinolone antibiotics, including Moxifloxacin MSN. 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. Possible side effects). If such reactions occur, stop taking Moxifloxacin MSN immediately and consult a doctor.
• During or after treatment with antibiotics, including Moxifloxacin MSN, diarrheamay occur. If it worsens or persists, or if blood or mucus appears in the stool, stop taking Moxifloxacin MSN and consult a doctor immediately. Do not take drugs that slow down or stop bowel movements.
• Pain, swelling, and inflammation of joints and tendonsmay occur rarely (see section When not to take Moxifloxacin MSN and section 4. Possible side effects). The risk is increased if the patient is elderly (over 60 years), has had an organ transplant, has kidney problems, or is being treated with corticosteroids. Tendon pain and inflammation can occur within 48 hours of starting treatment and up to several months after stopping treatment with Moxifloxacin MSN. If the first symptoms of tendon pain or inflammation occur (e.g., knee, wrist, elbow, shoulder, or ankle), stop taking Moxifloxacin MSN, consult a doctor, and rest the affected limb. Avoid unnecessary exercise, as it may increase the risk of tendon rupture.
• If the patient experiences sudden, severe abdominal, chest, or back pain, which may be a sign of aortic aneurysm or dissection, seek medical help immediately. The risk may be increased if the patient is being treated with systemic corticosteroids.
• If the patient starts to experience sudden shortness of breath, especially when lying down, notices swelling of the ankles, feet, or abdomen, or experiences new heart palpitations (feeling of rapid or irregular heartbeat), inform their doctor immediately.
• Elderly patients with renal impairmentshould drink plenty of fluids while taking Moxifloxacin MSN, as dehydration may increase the risk of kidney failure.
• If vision worsensor other eye problems occur during treatment with Moxifloxacin MSN, seek immediate advice from an ophthalmologist (see section Driving and using machines and section 4. Possible side effects).

Additionally, fluoroquinolone antibiotics may cause increased blood sugar levelsabove normal (hyperglycemia) or decreased blood sugar levelsbelow normal (hypoglycemia), which can lead to loss of consciousness (hypoglycemic coma) in severe cases (see section 4. Possible side effects). This is important for patients with diabetes. Patients with diabetes are advised to carefully monitor their blood sugar levels.

Children and adolescents

This medicine 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 section When not to take Moxifloxacin MSN).

Moxifloxacin MSN and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, and about any medicines you plan to take.
When taking Moxifloxacin MSN, note the following information:

• When taking Moxifloxacin MSN with other medicines that affect heart function, the risk of heart rhythm disorders increases. Therefore, do not take Moxifloxacin MSN at the same time as the following medicines:
• anti-arrhythmic drugs (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide),
• antipsychotic drugs (e.g., phenothiazines, pimozide, sertindole, haloperidol, sultopride),
• tricyclic antidepressants,
• certain antibacterial agents (e.g., saquinavir, sparfloxacin, intravenous erythromycin, pentamidine, antimalarial agents, especially halofantrine),
• certain antihistamines (e.g., terfenadine, astemizole, mizolastine)
• other medicines (e.g., cisapride, intravenous vincamine, bepridil, and difemanil).
• Tell your doctor if you are taking other medicines that may lower potassium levels in the blood [e.g., certain diuretics, certain laxatives, and enemas (high doses) or corticosteroids (anti-inflammatory drugs), amphotericin B] or slow down the heart rate, as they may increase the risk of serious heart rhythm disorders when taking Moxifloxacin MSN.
• All medicines containing magnesium or aluminum, such as antacids used to treat digestive disorders, and all medicines containing iron or zinc, medicines containing didanosine, and medicines containing sucralfateused to treat gastrointestinal disorders, may reduce the effectiveness of Moxifloxacin MSN tablets. Therefore, maintain a 6-hour interval between taking Moxifloxacin MSN tablets and other medicines.
• Concomitant oral administration of activated charcoaland Moxifloxacin MSN tablets reduces the effectiveness of Moxifloxacin MSN. Therefore, it is not recommended to take both medicines at the same time.
• In case of concomitant administration of oral anticoagulant drugs(e.g., warfarin), the doctor may order blood coagulation tests.

Moxifloxacin MSN with food and drink

Moxifloxacin MSN can be taken with or without food (including dairy products).

Pregnancy, breastfeeding, and fertility

Do not take Moxifloxacin MSN during pregnancy and breastfeeding.
If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult a doctor or pharmacist before taking this medicine.
Animal studies do not show any adverse effects on fertility.

Driving and using machines

Moxifloxacin MSN may cause dizziness and a feeling of disorientation, sudden transient loss of vision, or may cause short-term fainting. If such symptoms occur, do not drive vehicles or operate any machines.

Moxifloxacin MSN contains lactose

If your doctor has previously determined that you have an intolerance to some sugars, consult your doctor before taking Moxifloxacin MSN.

Moxifloxacin MSN contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e., the medicine is considered "sodium-free".

3. How to take Moxifloxacin MSN

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, consult your doctor or pharmacist again.
The recommended dose for adults is one 400 mg film-coated tablet once daily.
Moxifloxacin MSN tablets are taken orally. Swallow the tablet whole (to mask the bitter taste) with a large amount of liquid. Moxifloxacin MSN can be taken with or without food. It is recommended to take the tablet at the same time every day.
No dose adjustment is necessary for elderly patients, those with low body weight, or those with renal impairment.
The duration of treatment depends on the type of infection. Unless otherwise advised by your doctor, the recommended duration of treatment with Moxifloxacin MSN film-coated tablets is:

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

The following are the recommended total treatment durations for patients for whom Moxifloxacin MSN film-coated tablets are administered to complete treatment initiated with Moxifloxacin MSN infusion solution.

• community-acquired pneumonia 7-14 days
• Most patients with community-acquired pneumonia had the route of administration changed from intravenous to oral within 4 days.
• skin and soft tissue infections 7-21 days Most patients with skin and soft tissue infections had the route of administration changed from intravenous to oral within 6 days.

It is essential to complete the full treatment course, even if you feel better after a few days. If you stop taking the medicine too soon, the infection may not be completely cured, and the disease may recur or worsen. The bacteria may develop resistance to Moxifloxacin MSN.
Do not exceed the recommended dose or prolong treatment (see section 2. Important information before taking Moxifloxacin MSN, Warnings and precautions).

Taking a higher dose of Moxifloxacin MSN than recommended

If you have taken more than one prescribed tablet per day, seek medical help immediatelyand, if possible, bring all remaining tablets, packaging, and this leaflet to show your doctor or pharmacist.

Missing a dose of Moxifloxacin MSN

If you forget to take a tablet at the usual time, take it as soon as you remember that day. If you miss a dose 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 taking the medicine, consult your doctor or pharmacist.

Stopping treatment with Moxifloxacin MSN

If you stop taking the medicine too soon, the infection may not be completely cured. If you need to stop treatment early, consult your doctor.
If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Moxifloxacin MSN can cause side effects, although not everybody gets them.
The most serious side effectsobserved during treatment with moxifloxacin are presented below.
If any of the following side effects occur:

• 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 disturbances of thinking or insomnia [these may be signs of severe liver inflammation that can lead to life-threatening liver failure, including fatal cases (very rare side effect)],
• severe skin rash, including Stevens-Johnson syndrome and toxic epidermal necrolysis. It may appear as red spots with a target-like appearance or round spots, often with blisters on the torso, peeling skin, ulcers in the mouth, throat, nose, genitals, and eyes, and may be preceded by fever and flu-like symptoms (very rare side effects, potentially life-threatening),
• red, peeling, generalized rash with papules and blisters, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis) (frequency of this side effect is unknown),
• syndrome associated with water retention and low sodium levels (SIADH) (very rare side effect),
• loss of consciousness due to significantly decreased blood sugar levels (hypoglycemic coma) (very rare side effect),
• inflammation of blood vessels (may manifest as red spots on the skin, usually on the lower legs, or joint pain) (very rare side effect),
• severe, life-threatening allergic reactions, including anaphylaxis (rare side effect),
• swelling, including swelling of the airways (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) (rare side effect),
• psychiatric disorders (may lead to self-harm, e.g., suicidal thoughts or behaviors) (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 swelling of tendons (tendinitis) (rare side effect) or tendon rupture (very rare side effect),
• weakness, tenderness, or pain in muscles, 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 side effect is unknown). Stop taking Moxifloxacin MSN and consult a doctor immediately, as emergency medical attention may be necessary.

Additionally:

• transient loss of vision (very rare side effect),
• discomfort or pain in the eyes, especially due to exposure to light (very rare or rare side effect) consult an ophthalmologist immediately.

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

• Common(may affect up to 1 in 10 people)
• nausea,
• diarrhea,
• dizziness,
• abdominal pain and stomach discomfort,
• vomiting,
• headache,
• increased liver enzyme activity in the blood (liver enzymes),
• infections caused by resistant bacteria or fungi, e.g., oral thrush (candidiasis) and vaginal candidiasis (yeast infection),
• heart rhythm disorders (visible on ECG) in patients with low potassium levels in the blood.

Uncommon(may affect up to 1 in 100 people)

• rash,
• stomach upset (indigestion or heartburn),
• taste disturbances (very rarely, loss of taste),
• sleep disturbances (mainly insomnia),
• increased activity of gamma-glutamyltransferase and/or alkaline phosphatase in the blood (liver enzymes),
• low white blood cell count (leukopenia), low neutrophil count (a type of white blood cell),
• constipation,
• itching,
• feeling of dizziness (spinning or tilting),
• drowsiness,
• wind,
• heart rhythm disorders (visible on ECG),
• liver function disorders, including increased LDH activity in the blood (liver enzyme),
• decreased appetite and food intake,
• low white blood cell count,
• back pain, chest pain, pelvic pain, and limb pain,
• decreased or increased blood clotting factor count,
• sweating,
• increased eosinophil count (a type of white blood cell),
• anxiety,
• general malaise (mainly weakness or fatigue),
• tremors,
• joint pain,
• heart palpitations,
• irregular and rapid heartbeat,
• breathing difficulties (including asthma),
• increased amylase activity in the blood (digestive enzyme),
• restlessness or agitation,
• tingling and/or numbness,
• hives,
• vasodilation,
• confusion and disorientation,
• low platelet count (thrombocytopenia),
• visual disturbances (including double or blurred vision),
• bleeding disorders,
• 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 affect up to 1 in 1,000 people)

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

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

• joint inflammation,
• 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),
• decrease in the number of red and white blood cells and platelets (pancytopenia).

Very rare cases of long-term (lasting months or years) or irreversible side effects of fluoroquinolone and quinolone antibiotics, including Moxifloxacin MSN, such as tendonitis, tendon rupture, joint pain, limb pain, walking difficulties, sensory disturbances such as tingling and numbness, neuropathy, depression, fatigue, sleep disturbances, memory impairment, as well as hearing, vision, taste, and smell impairment, have been reported, sometimes regardless of pre-existing risk factors.
Additionally, very rare cases of the following side effects have been reported with other quinolone antibiotics, which may also occur with Moxifloxacin MSN:

• increased intracranial pressure (symptoms include headache, vision problems, including blurred vision, "blind" spots, double vision, loss of vision),
• increased sodium levels in the blood,
• increased calcium levels in the blood,
• a certain type of disease in which there is a decreased number of red blood cells (hemolytic anemia),
• increased skin sensitivity to sunlight or UV radiation.

Patients taking fluoroquinolones have reported cases of aortic aneurysm or aortic dissection (a tear in the aortic wall) and aortic valve problems, which can rupture and lead to death, as well as leaky heart valves. See also section 2.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Moxifloxacin MSN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton. The expiry date refers to the last day of the month.
There are no special storage precautions for this medicine.
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. Package contents and other information

What Moxifloxacin MSN contains

The active substance is moxifloxacin.
Each film-coated tablet contains 400 mg of moxifloxacin in the form of moxifloxacin hydrochloride.
The other ingredients are:
Tablet core:
Lactose monohydrate, povidone K29/32, lactose anhydrous, croscarmellose sodium, colloidal silica anhydrous, magnesium stearate.
Tablet coating:
Opadry Brown 03B86891: hypromellose 6 mPas, titanium dioxide (E 171), macrogol 400, iron oxide red (E 172).

What Moxifloxacin MSN looks like and contents of the pack

Matte, red film-coated tablet with a capsule shape (length 17 ± 0.1 mm, width 7 ± 0.1 mm, and thickness 6 ± 0.2 mm) and embossed with "M" on one side and "400" on the other side.
Moxifloxacin MSN is packaged in PVC/PVDC/Aluminum blisters in a cardboard box.
Moxifloxacin MSN is available in packs containing 5, 7, 10, or 14 film-coated tablets.

Marketing authorization holder:

Vivanta Generics s.r.o.
Třtinová 260/1, Čakovice
196 00 Prague 9
Czech Republic
tel.: (+48) 699 711 147

Importer:

Pharmadox Healthcare Limited
KW20A, Kordin Industrial Park
Paola, PLA3000
Malta

This medicine is authorized in the Member States of the European Economic Area under the following names:

Czech Republic:

Moxifloxacin MSN
Hungary:

Moxifloxacin MSN 400 mg filmtabletta
Netherlands:

Moxifloxacine MSN 400 mg filmomhulde tabletten
Poland:

Moxifloxacin MSN
Romania:

Moxifloxacina Vivanta 400 mg comprimate filmate
Slovakia:

Moxifloxacin MSN

Date of last revision of the leaflet: 07/2023