Moxifloxacin aurovitas

Package leaflet: Information for the user

Moxifloxacin Aurovitas, 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.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents:

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

1. What Moxifloxacin Aurovitas is and what it is used for

Moxifloxacin Aurovitas contains the active substance moxifloxacin, which belongs to a group of antibiotics called fluoroquinolones. Moxifloxacin Aurovitas acts bactericidally against bacteria causing infections.
Moxifloxacin Aurovitas 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. Moxifloxacin Aurovitas 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 endometrial infections.

Moxifloxacin Aurovitas used alone is not sufficient for the treatment of these types of infections; therefore, your doctor should also prescribe an additional antibacterial agent for the treatment of upper female genital tract infections (see section 2. Important information before taking Moxifloxacin Aurovitas, Warnings and precautions, Before starting treatment with Moxifloxacin Aurovitas, consult your doctor or pharmacist).
If improvement has occurred during treatment of the following bacterial infections with Moxifloxacin Aurovitas infusion solution, your doctor may also prescribe Moxifloxacin Aurovitas tablets to complete the treatment course: community-acquired pneumonia, skin and soft tissue infections. Moxifloxacin Aurovitas tablets 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 Moxifloxacin Aurovitas

If the patient has any doubts whether they belong to any of the groups described below, they should contact
their doctor.
When not to use Moxifloxacin Aurovitas

• If the patient is allergic to the active substance – moxifloxacin, other drugs in the quinolone group, or any of the other ingredients of this medicine (see section 6).
• During pregnancy and breastfeeding.
• In patients under 18 years of age.
• If the patient has previously experienced tendon disease related to treatment with other quinolone drugs (see sections Warnings and precautions and 4. Possible side effects).
• If the patient has: congenital or acquired abnormal heart rhythm (visible on electrocardiogram (ECG) – recording of the heart's electrical activity); electrolyte imbalance (especially low blood potassium or magnesium levels); very slow heart rate (bradycardia); impaired heart function (heart failure); previously diagnosed heart rhythm disorders (arrhythmias), or if the patient is taking medications that may cause specific changes in the ECG (see section Other medicines and Moxifloxacin Aurovitas). Moxifloxacin Aurovitas 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 liver disease or liver enzyme activity (aminotransferases) exceeding five times the upper limit of normal.

Warnings and precautions
Before taking this medicine
Do not take antibacterial medicines containing fluoroquinolone/quinolone, including
Moxifloxacin Aurovitas, if serious adverse reactions occurred previously during treatment with a quinolone or fluoroquinolone. In such a case, inform the doctor immediately.
Before starting treatment with Moxifloxacin Aurovitas, consult a doctor or
pharmacist.

• If the patient has diabetes, because during treatment with moxifloxacin there may be a risk of changes in blood glucose levels.
• If the patient has ever experienced severe skin rash, skin peeling, blistering, and/or oral ulceration after taking moxifloxacin.
• Moxifloxacin Aurovitas may alter the heart's ECG , especially in women and elderly patients. If the patient is taking other medicines that lower blood potassium levels, consult a doctor before starting Moxifloxacin Aurovitas (see also sections When not to use Moxifloxacin Aurovitas and Other medicines and Moxifloxacin Aurovitas).
• If the patient has epilepsy or conditions that may provoke seizures , inform the doctor before starting treatment with Moxifloxacin Aurovitas.
• If the patient has or has ever had mental health problems , consult a doctor before starting treatment with Moxifloxacin Aurovitas.
• If the patient has myasthenia gravis (muscle weakness) , taking Moxifloxacin Aurovitas may worsen symptoms. If this occurs, consult a doctor immediately.
• If the patient or anyone in their family has glucose-6-phosphate dehydrogenase deficiency (a rare inherited disorder), inform the doctor, who will assess whether Moxifloxacin Aurovitas is appropriate.
• If the patient has a complicated upper genital tract infection (e.g. with tubo-ovarian abscess or pelvic abscess), the doctor may consider intravenous administration necessary, as oral Moxifloxacin Aurovitas tablets are not suitable.
• For treatment of mild or moderate upper genital tract infections , the doctor should prescribe an additional antibacterial medicine alongside Moxifloxacin Aurovitas. If symptoms do not improve within the first 3 days of treatment, the patient should contact their doctor.
• If the patient has been diagnosed with enlargement or "bulging" of a large blood vessel (aortic aneurysm or large peripheral artery aneurysm).
• If the patient has previously experienced aortic dissection (tearing within the aortic wall).
• If the patient has heart valve regurgitation (valvular 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 disorders such as Takayasu arteritis, giant cell arteritis, Behçet's disease, high blood pressure, diagnosed atherosclerosis, rheumatoid arthritis [joint disease], or endocarditis [heart infection]).

While taking Moxifloxacin Aurovitas

• If the patient experiences sudden, severe abdominal, chest, or back pain, which may indicate aortic aneurysm or dissection, seek emergency medical help immediately. Risk may be increased if the patient is being treated with systemic corticosteroids.
• If the patient develops sudden shortness of breath, especially when lying flat in bed, or notices swelling of the ankles, feet, or abdomen, or new palpitations (feeling of rapid or irregular heartbeat), inform the doctor immediately.
• If palpitations or irregular heartbeat occur during treatment, inform the doctor immediately. The doctor may order an ECG to check heart rhythm.
• Risk of heart function disturbances may increase with higher doses. Therefore, it is recommended to follow 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 these occur, stop taking Moxifloxacin Aurovitas immediately and seek medical advice.
• Moxifloxacin Aurovitas may cause rapid-onset, severe hepatitis , which may lead to life-threatening liver failure (including fatal outcomes, see section 4. Possible side effects). If symptoms such as rapid worsening of general condition, yellowing of the whites of the eyes, dark urine, itchy skin, tendency to bleeding, or disturbances in thinking or insomnia occur, contact a doctor before taking the next dose.
• Antibiotics of the quinolone group, including Moxifloxacin Aurovitas, may cause seizures. If seizures occur, stop taking Moxifloxacin Aurovitas immediately and consult a doctor.
• If symptoms of nerve damage (neuropathy) occur, such as pain, burning, tingling, numbness, and/or weakness, especially in the feet and legs or hands and arms , stop taking Moxifloxacin Aurovitas immediately and contact a doctor to prevent potentially irreversible damage.
• Mental health problems may occur, even with first use of quinolone antibiotics, including Moxifloxacin Aurovitas. In very rare cases, depression or mental health 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 Moxifloxacin Aurovitas immediately and consult a doctor.
• Diarrhea may occur during or after treatment with antibiotics, including Moxifloxacin Aurovitas. If it worsens or persists, or if blood or mucus is seen in the stool, stop taking Moxifloxacin Aurovitas immediately and consult a doctor. In such cases, do not use medicines that inhibit or slow intestinal motility (peristalsis).
• Joint pain and swelling, as well as tendon inflammation or rupture, may rarely occur. Risk is higher if the patient is elderly (over 60 years), has had an organ transplant, has kidney problems, or is being treated with corticosteroids. Tendon inflammation and rupture may occur within the first 48 hours of treatment or even several months after stopping Moxifloxacin Aurovitas. At the first sign of tendon pain or inflammation (e.g. in the ankle, wrist, elbow, shoulder, or knee), stop taking Moxifloxacin Aurovitas, contact a doctor, and rest the affected area. Avoid unnecessary exercise, as this may increase the risk of tendon rupture.
• 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 Moxifloxacin Aurovitas, seek immediate advice from an ophthalmologist (see section Driving and operating machinery and section 4. Possible side effects).

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

• SJS/TEN may initially appear as reddish target-like spots or circular lesions, often with blisters on the trunk. Oral, throat, nasal, genital, and eye ulcers (red, swollen eyes) may also occur. Such severe rashes are often preceded by fever and/or flu-like symptoms.
• Rashes may progress to widespread skin peeling and life-threatening complications or lead to death. AGEP rash appears early in treatment as a red, peeling, generalized rash with subcutaneous nodules and blisters, accompanied by fever. Most commonly affected areas: skin folds, trunk, and upper limbs.
• In DRESS syndrome, flu-like symptoms and facial rash appear initially, followed by widespread rash with high fever, increased liver enzyme activity and white blood cell count (eosinophilia) in blood tests, and enlarged lymph nodes.

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

• Fluoroquinolone antibiotics may cause blood glucose levels to rise above normal (hyperglycemia) or fall below normal (hypoglycemia), which in severe cases may lead to loss of consciousness (hypoglycemic coma) (see section 4. Possible side effects). Diabetic patients should carefully monitor blood glucose levels.
• Quinolone antibiotics may increase skin sensitivity to sunlight and UV radiation. During treatment with Moxifloxacin Aurovitas, avoid prolonged sun exposure, strong sunlight, and using tanning beds or other UV radiation sources (see section 4. Possible side effects).

The efficacy of Moxifloxacin Aurovitas has not been established in the treatment of severe burns, deep tissue infections, or diabetic foot infections with osteomyelitis (bone marrow infection).
Long-term, disabling, and potentially irreversible adverse reactions
Fluoroquinolone/quinolone antibacterial agents, including Moxifloxacin Aurovitas, are associated with very rare but serious adverse reactions, some of which are long-lasting (lasting months or years), disabling, or potentially irreversible. These include tendon disorders, muscle and joint pain in upper and lower limbs, difficulty moving, sensory disturbances such as pricking and tingling, burning, tickling, numbness, or burning sensations (paresthesias), sensory perception disorders including vision, taste, smell, and hearing, depression, memory disturbances, severe fatigue, and severe sleep disturbances.
If any of these adverse reactions occur after taking Moxifloxacin Aurovitas, contact a doctor immediately before continuing treatment. Together with the doctor, decide whether to continue treatment, considering also antibiotics from another class.
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 use Moxifloxacin Aurovitas).
Other medicines and Moxifloxacin Aurovitas
Inform the doctor or pharmacist about all medicines currently used, recently used, or planned for use.
When taking Moxifloxacin Aurovitas, be aware of the following:

• Taking Moxifloxacin Aurovitas with other medicines affecting heart function increases the risk of heart rhythm disturbances. Therefore, do not take Moxifloxacin Aurovitas simultaneously with the following medicines: antiarrhythmic drugs (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), antipsychotics (e.g. phenothiazines, pimozide, sertindole, haloperidol, sulpiride), tricyclic antidepressants, certain antibacterial drugs (e.g. saquinavir, sparfloxacin, intravenous erythromycin, pentamidine, antimalarials, especially halofantrine), certain antihistamines (e.g. terfenadine, astemizole, mizolastine), and other medicines (e.g. cisapride, intravenous vincamine, bepridil, difemanil).
• Inform the doctor if the patient is 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 used with Moxifloxacin Aurovitas.
• All medicines containing magnesium or aluminium, such as antacids used for digestive disorders, and all medicines containing iron or zinc, medicines containing didanosine, and sucralfate-containing medicines used for gastrointestinal disorders, may reduce the effectiveness of Moxifloxacin Aurovitas tablets. Therefore, a 6-hour interval should be maintained between taking Moxifloxacin Aurovitas tablets and other medicines.
• Concomitant oral administration of activated charcoal and Moxifloxacin Aurovitas tablets reduces the effectiveness of Moxifloxacin Aurovitas. Therefore, simultaneous use of both medicines is not recommended.
• If taking oral anticoagulants (e.g. warfarin) concurrently, the doctor may order blood clotting time tests.

Moxifloxacin Aurovitas with food and drink
Food, including dairy products, does not affect the action of Moxifloxacin Aurovitas.
Pregnancy, breastfeeding, and fertility
Do not use Moxifloxacin Aurovitas during pregnancy or breastfeeding.
If the patient is pregnant, breastfeeding, suspects pregnancy, or plans to become pregnant, they should consult a doctor or pharmacist before using this medicine.
Animal studies have not shown any negative effect of this medicine on fertility.
Driving and operating machinery
Moxifloxacin Aurovitas may cause dizziness, vertigo, sudden transient loss of vision, or brief fainting. If such symptoms occur, do not drive or operate machinery.
Moxifloxacin Aurovitas contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".

3. How to use Moxifloxacin Aurovitas

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
The recommended dose for adults is 1 coated tablet of 400 mg once daily.
Moxifloxacin Aurovitas tablets are taken orally. The tablet should be swallowed whole (to mask the bitter taste) with a large amount of fluid. Moxifloxacin Aurovitas can 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 function disorders.
The duration of treatment depends on the type of infection. Unless otherwise directed by a physician, the recommended duration of treatment with Moxifloxacin Aurovitas coated tablets is:

• Acute exacerbation of chronic bronchitis (exacerbation of chronic bronchitis): 5 to 10 days
• Pneumonia acquired outside the hospital, excluding severe cases: 10 days
• Acute sinus infections (acute bacterial sinusitis): 7 days
• Mild to moderate upper genital tract infections (pelvic inflammatory disease), including fallopian tube infection and endometrial infection: 0 days

Below is the recommended total duration of treatment in patients in whom Moxifloxacin Aurovitas tablets are administered to complete treatment initiated with moxifloxacin infusion solution.

• Lung infection (pneumonia) acquired outside the hospital: 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. Premature discontinuation of the medicine may result in incomplete eradication of the infection, recurrence of the disease, worsening of symptoms, or development of bacterial resistance to antibiotics.
Do not exceed the recommended dose or prolong the duration of treatment (see section 2. Information important before using Moxifloxacin Aurovitas, Warnings and precautions).
Taking more Moxifloxacin Aurovitas than prescribed
If more than the prescribed number of tablets has been taken in one day, seek immediate medical advice. If possible, bring any remaining tablets, the medicine packaging, and this patient information leaflet to show the doctor or pharmacist.
If you forget to take Moxifloxacin Aurovitas
If a dose is missed at the usual time, take it as soon as remembered on the same day. If the dose is missed for an entire 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 further questions about the use of this medicine, consult your doctor or pharmacist.
Stopping Moxifloxacin Aurovitas
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 fast heartbeat (uncommon adverse reaction),
• rapid worsening of 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 may lead to life-threatening liver failure, including fatal outcome (very rare adverse reactions)],
• severe skin rash, including Stevens-Johnson syndrome and toxic epidermal necrolysis. It may appear as reddish, target-like spots or
  circular lesions, often with blisters on the trunk, peeling skin, oral, throat, nasal, genital or ocular ulcers, 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 at the start of treatment (acute generalized exanthematous pustulosis) (frequency of this adverse reaction: "frequency not known"),
• widespread rash, high fever, elevated liver enzymes, 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 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 (hypoglycemic coma) (very rare adverse reaction),
• vasculitis (may present as red blisters on the skin, usually on the calves, or joint pain) (very rare adverse reaction),
• severe, rapidly generalized allergic reaction, including very rarely life-threatening anaphylactic shock (e.g. difficulty breathing, 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),
• neurological problems such as pain, burning sensation, tingling, numbness and/or weakness of limbs (uncommon adverse reaction),
• depression (very rarely leading to self-harm, e.g. hallucinations or suicidal thoughts or suicide attempts) (uncommon adverse reaction),
• psychiatric disorders (which may lead to self-harm, e.g. hallucinations or suicidal thoughts or suicide attempts) (very rare adverse reaction),
• severe diarrhea 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 should stop taking Moxifloxacin Aurovitas immediately and contact your doctor without delay,
as immediate medical help 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 should contact an ophthalmologist immediately.
If the patient develops a life-threatening irregular heartbeat (torsade de pointes) or
cardiac arrest while taking Moxifloxacin Aurovitas (very rare adverse reaction),
contact the treating physician immediately, inform them that the patient is taking Moxifloxacin Aurovitas, and do not restart treatment.
Exacerbation of myasthenia symptoms has been very rarely observed. If the patient's myasthenia symptoms worsen, consult a doctor immediately.
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 output, 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), consult a doctor immediately.
Other adverse reactions observed during moxifloxacin treatment are listed below,
according to their frequency of occurrence:
Common (may affect up to 1 in 10 people)

• nausea
• diarrhea
• dizziness
• stomach and abdominal pain
• vomiting
• headache
• increased activity of certain liver enzymes (aminotransferases) in blood
• infections caused by resistant bacteria or fungi, e.g. oral infections (thrush) 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
• gastrointestinal discomfort (dyspepsia or heartburn)
• taste disturbances (very rarely loss of taste)
• sleep disturbances (e.g. insomnia or drowsiness)
• increased blood levels of: gamma-glutamyltransferase and/or alkaline phosphatase (liver enzymes)
• low white blood cell count, neutrophils (certain white blood cells)
• constipation
• itching
• sensation of dizziness (spinning or falling)
• drowsiness
• flatulence
• heart rhythm disturbances (visible on ECG)
• liver function disorders, including increased LDH (liver enzyme) activity in blood
• decreased appetite and food intake
• low white blood cell count
• back, chest, pelvic pain and limb pain
• decreased or increased number of blood cells necessary for blood clotting
• sweating
• increased eosinophil count (type of white blood cells)
• 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)
• restlessness, agitation
• tingling and/or numbness
• urticaria
• blood vessel dilation
• confusion and disorientation
• decreased platelet count necessary for blood clotting
• vision disturbances (including double or blurred vision)
• reduced blood clotting
• increased blood fat levels
• low red blood cell count
• muscle pain
• allergic reaction
• increased bilirubin levels in blood
• gastric mucosal inflammation
• 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)
• skin sensation disturbances
• unusual dreams
• concentration difficulties
• swallowing difficulties
• changes in smell (including loss of smell)
• balance and coordination disturbances (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)

Frequency not known (frequency cannot be estimated from available data)

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

Additionally, the following adverse reactions have very rarely occurred during treatment with Moxifloxacin Aurovitas, and have been described after treatment with other quinolone antibiotics: 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, increased breakdown of red blood cells (hemolytic anemia).
Very rare cases of long-term (lasting months or years) or permanent adverse reactions to the drug, such as tendinitis, tendon rupture, joint pain, limb pain, difficulty moving, sensory disturbances such as pricking and tingling, burning, tickling, stinging, numbness or pain (neuropathy), fatigue, memory and concentration problems, effects on mental health (which may include sleep disturbances, anxiety, panic attacks, depression and suicidal thoughts), as well as hearing, vision, taste and smell disturbances have been associated with administration of quinolones and fluoroquinolone antibiotics, in some cases regardless of pre-existing risk factors.
In patients receiving fluoroquinolones, cases of aortic wall dilation and weakening, as well as aortic dissection (aneurysms and dissections), which may rupture and cause death, and cases of heart valve regurgitation 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 Aurovitas

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

6. Contents of the package and other information

What Moxifloxacin Aurovitas contains

• The active substance is moxifloxacin. Each coated tablet contains 436.32 mg of moxifloxacin hydrochloride, equivalent to 400 mg of moxifloxacin.
• The other ingredients are:
  Tablet core: microcrystalline cellulose (PH 101), sodium carboxymethyl starch (type A), povidone K30, microcrystalline cellulose (PH 102), magnesium stearate
  Coating: hypromellose 6cp, titanium dioxide (E 171), macrogol 4000, iron oxide red (E 172)

What Moxifloxacin Aurovitas looks like and contents of the pack
Coated tablet.
Matte, red, elongated coated tablet with the imprint "E 18" on one side and smooth on the other.
The coated tablets are packed in blisters made of PVC/PVDC/Aluminium and placed in cardboard boxes containing 5, 7, 10 or 50 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
Sokratesa 13D, lokal 27
01-909 Warsaw
e-mail: [email protected]
Manufacturer/Importer:
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
This medicinal product is authorised in the European Economic Area countries under the following names:
Belgium: Moxifloxacin AB 400 mg filmomhulde tabletten
Czech Republic: Moxifloxacin Aurovitas 400 mg potahované tablety
Netherlands: Moxifloxican Aurobindo 400 mg, filmomhulde tabletten
Poland: Moxifloxacin Aurovitas
Portugal: Moxifloxacina Aurovitas
Spain: Moxifloxacino Aurovitas 400 mg comprimidos recubiertos con película EFG