Moxifloxacin msn

Package leaflet: Information for the user

Moxifloxacin MSN, 400 mg, film-coated tablets
For use in adults.
Moxifloxacinum
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• Please consult your doctor or pharmacist if you have any further questions.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm other people even if their symptoms are the same as yours.
• If any side effects worsen or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents:

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

1. What Moxifloxacin MSN is and what it is used for
Moxifloxacin MSN contains the active substance moxifloxacin, which belongs to a group of
antibiotics called fluoroquinolones. Moxifloxacin MSN acts bactericidally against bacteria causing
infections.
Moxifloxacin MSN is used in patients aged 18 years and older to treat the following bacterial
infections caused by bacteria susceptible to moxifloxacin. Moxifloxacin MSN may be used to treat
these infections only when commonly used antibiotics are not suitable or have been ineffective.

• Acute bacterial sinusitis, acute exacerbation of chronic bronchitis, or community-acquired pneumonia (except severe cases).
• Mild to moderate infections of the upper female genital tract (pelvic inflammatory disease), including infections of the fallopian tubes and endometritis.

Moxifloxacin MSN alone is not sufficient to treat these types of infections; therefore, your doctor should prescribe an additional antibacterial agent for treating infections of the upper female genital tract (see section 2. Important information before taking Moxifloxacin MSN, Warnings and precautions, Talk to your doctor or pharmacist before taking Moxifloxacin MSN).

If improvement occurs during intravenous infusion treatment with Moxifloxacin MSN for the following bacterial infections, your doctor may also prescribe Moxifloxacin MSN tablets to complete the treatment course: community-acquired pneumonia, skin and soft tissue infections. Moxifloxacin MSN tablets should not be used to initiate treatment for all types of skin and soft tissue infections or for severe lung infections.

2. What you need to know before taking Moxifloxacin MSN

If you are unsure whether you belong to any of the groups described below, please consult your doctor.

When not to take Moxifloxacin MSN

• If you are allergic to the active substance moxifloxacin, to other quinolone antibiotics, or to any of the other ingredients of this medicine (listed in section 6).
• During pregnancy or breastfeeding.
• In patients under 18 years of age.
• If you have previously experienced tendon disorders associated with treatment with other quinolone antibiotics (see section Warnings and precautions and section 4. Possible side effects).
• If you have:
  • congenital or acquired abnormal heart rhythm (visible on electrocardiogram (ECG) as an abnormality in the electrical activity of the heart);
  • electrolyte imbalance (especially low blood potassium or magnesium levels);
  • very slow heart rate (bradycardia);
  • heart failure;
  • a history of heart rhythm disorders (arrhythmias); or
  • if you are taking medicines that may cause specific changes in the ECG (see section Moxifloxacin MSN and other medicines). Moxifloxacin MSN may cause changes in the ECG known as QT interval prolongation, which indicates delayed electrical conduction in the heart.
• If you have liver disease or if liver enzyme activity (aminotransferases) exceeds five times the upper limit of normal.

Warnings and precautions
Before taking the medicine
Do not take antibacterial agents containing fluoroquinolone/quinolone, including Moxifloxacin MSN, if you have previously experienced any serious adverse reactions while taking a quinolone or fluoroquinolone. In such a case, inform your doctor immediately.
Talk to your doctor before starting treatment with Moxifloxacin MSN.

• Moxifloxacin MSN may alter the heart's ECG , particularly in women and elderly patients. If you are taking medicines that lower blood potassium levels, consult your doctor before starting Moxifloxacin MSN (see also sections When not to take Moxifloxacin MSN and Moxifloxacin MSN and other medicines).
• If you have ever experienced severe skin rash , skin peeling, blistering, and/or oral mucosal ulceration after taking moxifloxacin.
• If you have epilepsy or conditions that may cause seizures, inform your doctor before starting Moxifloxacin MSN.
• If you have or have ever had mental health problems , consult your doctor before starting Moxifloxacin MSN.
• If you have myasthenia gravis (muscle weakness leading to fatigue and, in severe cases, paralysis), taking Moxifloxacin MSN may worsen symptoms. If this occurs, consult your doctor immediately.
• If you have been diagnosed with dilation or "bulging" of a large blood vessel (aortic aneurysm or peripheral aneurysm of a large vessel).
• If you have previously experienced an episode of aortic dissection (tearing of the aortic wall).
• If you have been diagnosed with heart valve insufficiency (valvular regurgitation).
• If there is a family history of aortic aneurysm or aortic dissection, congenital heart valve defect, 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 disorders such as Takayasu arteritis, giant cell arteritis, Behçet's disease, high blood pressure, diagnosed atherosclerosis, rheumatoid arthritis [joint disease], or endocarditis [heart infection]).
• If you have diabetes , because treatment with moxifloxacin may carry a risk of blood glucose fluctuations .
• If you or anyone in your family has glucose-6-phosphate dehydrogenase deficiency (a rare inherited disorder), inform your doctor, who will assess whether Moxifloxacin MSN is appropriate for you.
• If you have a complicated upper genital tract infection (e.g. if a tubo-ovarian or pelvic abscess is present), your doctor may consider intravenous treatment necessary, as oral Moxifloxacin MSN tablets are not suitable.
• For the treatment of mild to moderate upper genital tract infections , your doctor should prescribe, in addition to Moxifloxacin MSN, another antibacterial agent. If symptoms do not begin to improve within the first 3 days of treatment, you should contact your doctor.

While taking Moxifloxacin MSN

• If you experience palpitations or irregular heartbeat during treatment, inform your doctor immediately. Your doctor may order an ECG to check your heart rhythm.
• The risk of cardiac dysfunction may increase with higher doses. Therefore, it is recommended to adhere strictly to the prescribed 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, nausea or fainting, and vertigo upon standing. If any of these occur, stop taking Moxifloxacin MSN immediately and seek medical advice.
• Moxifloxacin MSN may cause severe, rapidly progressing hepatitis , which may lead to life-threatening liver failure (including fatal outcomes, see section 4. Possible side effects). If you experience symptoms such as rapid deterioration in general condition, yellowing of the whites of the eyes, dark urine, skin itching, tendency to bleed, or disturbances in thinking or insomnia, contact your doctor before taking the next dose.
• Severe skin reactions Severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP), 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, pharyngeal, nasal, genital, and ocular mucosal ulcers (red, swollen eyes) may also occur. These severe rashes are often preceded by fever and/or flu-like symptoms. Such rashes may progress to widespread skin peeling and life-threatening complications or death.
  • AGEP rash appears early in treatment as a red, scaly, generalized rash with subcutaneous nodules and blisters, accompanied by fever. Most commonly affected areas: skin folds, trunk, and upper limbs.

If a severe rash or any of these skin symptoms occur, stop taking moxifloxacin and contact your doctor or seek immediate medical help.

• Antibiotics of the quinolone group, including Moxifloxacin MSN, may cause seizures . If seizures occur, stop taking Moxifloxacin MSN immediately and consult your doctor.

• Long-term, disabling, and potentially irreversible serious adverse reactions Fluoroquinolone and quinolone antibiotics, including Moxifloxacin MSN, have been associated with very rare but serious adverse reactions, some of which are long-lasting (lasting months or years), cause disability, or are potentially irreversible. These include tendon, muscle, and joint pain in the upper and lower limbs, difficulty walking, sensory disturbances such as pricking and tingling, numbness, tickling, or burning sensations (paresthesias), sensory disturbances including impaired vision, taste, smell, and hearing, depression, memory disturbances, severe fatigue, and severe sleep disturbances. If any of these adverse reactions occur after taking Moxifloxacin MSN, contact your doctor immediately before continuing treatment. Your doctor will decide whether to continue treatment after consultation with you, possibly considering switching to an antibiotic from another class.

• Rarely, symptoms of nerve damage (neuropathy) may occur, such as pain, burning, tingling, numbness, and/or weakness, particularly in the feet and legs or hands and arms. Stop taking Moxifloxacin MSN and contact your doctor immediately to avoid potentially irreversible conditions.

• Psychiatric disorders may occur, even with first-time use of quinolone antibiotics, including Moxifloxacin MSN. In very rare cases, depression or psychiatric disorders may lead to suicidal thoughts and self-harming behaviors, including suicide attempts (see section 4. Possible side effects). If you experience such reactions, stop taking Moxifloxacin MSN immediately and consult your doctor.

• Diarrhea may occur during or after treatment with antibiotics, including Moxifloxacin MSN. If diarrhea worsens or persists, or if blood or mucus is present in the stool, stop taking Moxifloxacin MSN immediately and consult your doctor . Do not use medications that inhibit or slow intestinal motility (peristalsis).

• Pain, swelling, joint inflammation, and tendon inflammation or rupture may occur rarely (see section When not to take Moxifloxacin MSN and section 4. Possible side effects). Risk is increased if you are elderly (over 60 years), have had an organ transplant, have kidney problems, or are being treated with corticosteroids. Tendon pain and inflammation may occur within 48 hours of starting treatment and up to several months after stopping Moxifloxacin MSN. If you experience early symptoms of tendon pain or inflammation (e.g. in the knee, wrist, elbow, shoulder, or ankle), stop taking Moxifloxacin MSN, consult your doctor, and rest the affected limb. Avoid unnecessary exercise, as it may increase the risk of tendon rupture.

• If you experience sudden, severe abdominal, chest, or back pain , which may indicate an aortic aneurysm or dissection, seek emergency medical attention immediately. Risk may be increased if you are being treated with systemic corticosteroids.

• If you develop sudden shortness of breath, especially when lying flat, notice swelling in your ankles, feet, or abdomen, or experience new palpitations (sensation of rapid or irregular heartbeat), inform your doctor immediately.

• Elderly patients with renal impairment should drink plenty of fluids while taking Moxifloxacin MSN, as dehydration may increase the risk of kidney failure.

• If your vision deteriorates or you experience other eye-related symptoms during treatment with Moxifloxacin MSN, consult an ophthalmologist immediately (see section Driving and using machines and section 4. Possible side effects).

• Fluoroquinolone antibiotics may cause elevated blood glucose levels (hyperglycemia) or reduced blood glucose levels (hypoglycemia), which in severe cases may lead to loss of consciousness (hypoglycemic coma) (see section 4. Possible side effects). This is particularly important for diabetic patients. Diabetic patients should carefully monitor their blood glucose levels.

• Quinolone antibiotics may increase skin sensitivity to sunlight and UV radiation. During treatment with Moxifloxacin MSN, avoid prolonged sun exposure, intense sunlight, and using sunbeds or other UV sources.

• The efficacy of Moxifloxacin MSN has not been established in the treatment of severe burns, deep tissue infections, or diabetic foot infections with osteomyelitis (bone infection).

Children and adolescents
This medicine should not be used in children and adolescents under 18 years of age, as efficacy and safety have not been established in 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, have recently taken, or plan to take.

When taking Moxifloxacin MSN, be aware of the following:

• The risk of heart rhythm disturbances increases when Moxifloxacin MSN is taken with other medicines affecting heart function . Therefore, do not take Moxifloxacin MSN together with the following medicines:
  • antiarrhythmic drugs (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide),
  • antipsychotic drugs (e.g. phenothiazines, pimozide, sertindole, haloperidol, sulpiride),
  • tricyclic antidepressants,
  • certain antibacterial agents (e.g. saquinavir, sparfloxacin, intravenous erythromycin, pentamidine, antimalarials, particularly halofantrine),
  • certain antihistamines (e.g. terfenadine, astemizole, mizolastine),
  • other medicines (e.g. cisapride, intravenous vincamine, bepridil, difemanil).
• Inform your doctor if you are taking other medicines that may reduce blood potassium levels [e.g. certain diuretics, certain laxatives and enemas (high doses), or corticosteroids (anti-inflammatory drugs), amphotericin B] or slow heart rate, as they may increase the risk of serious heart rhythm disturbances when taken with Moxifloxacin MSN.
• All medicines containing magnesium or aluminium , such as antacids used for digestive disorders, and all medicines containing iron or zinc , medicines containing didanosine , and medicines containing sucralfate used for gastrointestinal disorders may reduce the effectiveness of Moxifloxacin MSN tablets. Therefore, a 6-hour interval should be maintained between taking Moxifloxacin MSN tablets and other medicines.
• Concomitant oral administration of activated charcoal and Moxifloxacin MSN tablets reduces the effectiveness of Moxifloxacin MSN. Therefore, simultaneous use of both medicines is not recommended.
• If you are taking oral anticoagulants (e.g. warfarin), your doctor may order blood clotting time tests.

Moxifloxacin MSN with food and drink
Moxifloxacin MSN may be taken with or without food (including dairy products).

Pregnancy, breastfeeding, and fertility
Do not take Moxifloxacin MSN during pregnancy or breastfeeding.
If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.
Animal studies have not shown any negative effects of this medicine on fertility.

Driving and using machines
Moxifloxacin MSN may cause dizziness, lightheadedness, sudden transient loss of vision, or brief fainting. If you experience any of these symptoms, do not drive or operate machinery.

Moxifloxacin MSN contains lactose
If your doctor has previously diagnosed you with an intolerance to certain sugars, consult your doctor before starting treatment with Moxifloxacin MSN.

Moxifloxacin MSN contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, meaning it is considered "sodium-free".

3. How to use Moxifloxacin MSN

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

• Acute exacerbation of chronic bronchitis (acute worsening of chronic obstructive pulmonary disease, including bronchitis): 5 to 10 days
• Community-acquired pneumonia, excluding 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

Below is the recommended total treatment duration for patients in whom Moxifloxacin MSN tablets
are used to complete treatment initiated with Moxifloxacin MSN infusion solution.

• Community-acquired pneumonia: 7–14 days
• In most patients with community-acquired pneumonia, the route of administration was switched from intravenous to oral within 4 days.
• Skin and soft tissue infections: 7–21 days
• In most patients with skin and soft tissue infections, the route of administration was switched from intravenous to oral within 6 days.

It is important to complete the full course of treatment, even if symptoms improve after a few
days. Stopping the medicine too early may result in the infection not being completely cured,
may lead to recurrence or worsening of symptoms, and may promote the development of bacterial
resistance to Moxifloxacin MSN.
Do not exceed the recommended dose or prolong the treatment duration (see section 2. Important
information before using Moxifloxacin MSN, Warnings and precautions).
Taking more Moxifloxacin MSN than recommended
If more than the prescribed number of tablets is taken in one day, seek medical help immediately.
If possible, bring any remaining tablets, the packaging, and this patient information leaflet to
show the doctor or pharmacist.
Missing a dose of Moxifloxacin MSN
If a dose is missed at the usual time, the patient should take it as soon as possible 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 Moxifloxacin MSN treatment
If treatment is stopped too early, the infection may not be completely cured. If it is necessary
to discontinue treatment 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 reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The most serious adverse reactions observed during treatment with moxifloxacin are listed below.
If any of the following adverse reactions occur:

• abnormally rapid heartbeat (uncommon adverse reaction),
• rapid deterioration in general condition, yellowing of the whites of the eyes, dark urine, skin itching, 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 reaction)],
• severe skin rash, including Stevens-Johnson syndrome and toxic epidermal necrolysis. This may appear as reddish, target-like spots or circular patches, often with blisters on the trunk, peeling skin, and sores in the mouth, throat, nose, genital organs, and eyes, and may be preceded by fever and flu-like symptoms (very rare adverse reactions, potentially life-threatening),
• red, peeling, generalized rash with subcutaneous nodules and blisters, initially accompanied by fever during treatment (acute generalized exanthematous pustulosis) (frequency of this adverse reaction: "frequency not known"),
• syndrome related to impaired water excretion and low sodium levels (SIADH) (very rare adverse reaction),
• loss of consciousness due to significantly low blood sugar levels (hypoglycaemic coma) (very rare adverse reaction),
• inflammation of blood vessels (may present as red blisters on the skin, usually on the calves, or joint pain) (very rare adverse reaction),
• severe, rapidly spreading allergic reaction, including very rarely life-threatening shock (e.g. breathing difficulties, drop in blood pressure, rapid pulse) (uncommon adverse reaction),
• swelling, including swelling of the airways (uncommon adverse reaction, potentially life-threatening),
• seizures (uncommon adverse reaction),
• nervous system-related problems such as pain, burning sensation, tingling, numbness, and/or weakness in limbs (uncommon adverse reaction),
• depression (rarely leading to self-harm, e.g. hallucinations, suicidal thoughts, or suicide attempts) (uncommon adverse reaction),
• psychiatric disorders (may lead to self-harm, e.g. hallucinations, suicidal thoughts, or suicide attempts) (very rare adverse reaction),
• severe diarrhoea with blood and/or mucus in stool (antibiotic-associated colitis, including pseudomembranous colitis), which very rarely may be associated with life-threatening complications (uncommon adverse reactions),
• tendon pain and swelling (tendinitis) (uncommon adverse reaction) or tendon rupture (very rare adverse reaction),
• 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 reaction: "frequency not known"). You must stop taking Moxifloxacin MSN and contact your doctor immediately, as urgent medical care may be required.

Additionally, if any of the following occur:

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

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

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

Uncommon (may affect up to 1 in 100 people)

• rash,
• stomach discomfort (dyspepsia or heartburn),
• taste disturbances (very rarely loss of taste),
• sleep disturbances (mainly insomnia),
• increased blood levels of: gamma-glutamyl transferase and/or alkaline phosphatase (liver enzymes),
• low white blood cell count, low neutrophil count (a type of white blood cell),
• constipation,
• itching,
• sensation of dizziness (spinning or tumbling),
• drowsiness,
• flatulence,
• heart rhythm disturbances (visible on ECG),
• liver function abnormalities, including increased blood LDH activity (liver enzyme),
• reduced appetite and food intake,
• low white blood cell count,
• back, chest, pelvic and limb pain,
• decreased or increased number of blood cells necessary for blood clotting,
• sweating,
• increased eosinophil count (a type of white blood cell),
• anxiety,
• malaise (mainly weakness or fatigue),
• tremor,
• joint pain,
• palpitations,
• irregular and rapid heartbeat,
• breathing difficulties (including asthmatic conditions),
• increased blood amylase activity (digestive enzyme),
• motor restlessness or agitation,
• tingling and/or numbness,
• urticaria,
• blood vessel dilation,
• confusion and disorientation,
• reduced platelet count necessary for blood clotting,
• visual disturbances (including double or blurred vision),
• reduced blood clotting,
• increased blood fat levels,
• low red blood cell count,
• muscle pain,
• allergic reaction,
• increased blood bilirubin levels,
• inflammation of the stomach mucosa,
• dehydration,
• severe heart rhythm disturbances,
• dry skin,
• angina pectoris.

Rare (may affect up to 1 in 1,000 people)

• muscle twitching,
• muscle cramps,
• hallucinations,
• high blood pressure,
• swelling (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),
• hepatitis,
• inflammation of the oral mucosa,
• ringing or noise in the ears,
• jaundice (yellowing of the whites of the eyes or skin),
• disturbances in skin sensation,
• unusual dreams,
• difficulty concentrating,
• swallowing difficulties,
• changes in smell (including loss of smell),
• disturbances in balance and 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 (may affect up to 1 in 10,000 people)

• arthritis,
• abnormal heart rhythm,
• increased skin sensitivity,
• depersonalization (feeling of loss of self-identity),
• increased blood clotting,
• muscle stiffness,
• significant decrease in certain white blood cells (agranulocytosis),
• decreased number of red and white blood cells and platelets (pancytopenia).

Very rare cases of long-term (lasting months or years) or permanent adverse reactions to the medicine, such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, sensory disturbances such as pricking and tingling, tingling, tickling, burning, numbness or pain (neuropathy), depression, fatigue, sleep disturbances, memory disturbances, as well as impaired hearing, vision, taste and smell, have been associated with the use of quinolone and fluoroquinolone antibiotics, in some cases regardless of pre-existing risk factors.
Additionally, very rare cases of the following adverse reactions reported after treatment with other quinolone antibiotics may also occur during treatment with Moxifloxacin MSN:

• 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 certain type of disease characterized by reduced number of red blood cells (hemolytic anaemia),
• increased skin sensitivity to sunlight or UV radiation.

In patients receiving fluoroquinolones, cases of aortic aneurysm and dissection (enlargement and weakening of the aortic wall or rupture of the aortic wall), which may rupture and lead to death, as well as cardiac valve insufficiency, have been reported. See also section 2.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Moxifloxacin MSN

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and the carton. The expiry date refers to the last day of the stated month.
No special storage instructions are required for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

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

What Moxifloxacin MSN looks like and contents of the pack
Matte, red, capsule-shaped coated tablet (length 17 ± 0.1 mm, width 7 ± 0.1 mm, thickness 6 ± 0.2 mm) with the imprint “M” on one side and “400” on the other side.
Moxifloxacin MSN is packed in PVC/PVDC/Aluminium blisters in cardboard boxes.
Moxifloxacin MSN is available in packs containing 5, 7, 10 or 14 coated tablets.

Marketing Authorisation 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 medicinal product is authorised in the following European Economic Area countries 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