Moxifloxacin Aurovitas

Leaflet accompanying the packaging: information for the user

Moxifloxacin Aurovitas, 400 mg, film-coated tablets

for adult use only
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 any 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 the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

Moxifloxacin Aurovitas contains the active substance moxifloxacin, which belongs to a group of antibiotics called fluoroquinolones. Moxifloxacin Aurovitas has a bactericidal effect on bacteria that cause infections.
Moxifloxacin Aurovitas is used in adult patients (18 years and older) to treat the following bacterial infections, if they are caused by bacteria susceptible to moxifloxacin. Moxifloxacin Aurovitas 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 pneumonia, when the infection did not occur in the hospital (except for severe cases).
• Mild or moderate upper genital tract infections (pelvic inflammatory disease), including salpingitis and endometritis.

Moxifloxacin Aurovitas used alone is not sufficient to treat this type of infection, so the doctor should prescribe an additional antibacterial medicine to treat upper genital tract infections (see section 2. Important information before taking Moxifloxacin Aurovitas, Warnings and precautions, Before starting treatment with Moxifloxacin Aurovitas, consult a doctor or pharmacist).
If there is an improvement in the treatment of the following bacterial infections due to the administration of Moxifloxacin Aurovitas solution for infusion, the doctor may also prescribe Moxifloxacin Aurovitas tablets to complete the treatment: community-acquired pneumonia, skin and soft tissue infections. Moxifloxacin Aurovitas tablets should not be used to start treatment for any type of skin and soft tissue infection or in severe pneumonia.

2. Important information before taking Moxifloxacin Aurovitas

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

When not to take Moxifloxacin Aurovitas

• In case of hypersensitivity to the active substance - moxifloxacin, other quinolone drugs, or any of the other ingredients of the medicine (see section 6).
• During pregnancy and breastfeeding.
• In patients under 18 years of age.
• If the patient has a history of tendon disease related to treatment with other quinolone drugs (see sections Warnings and precautionsand 4. Possible side effects).
• If the patient has: congenital or acquired abnormal heart rhythm (visible in the electrocardiogram (ECG) - a record 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; a history of heart rhythm disorders (arrhythmias) or if the patient is taking medications that may cause specific changes in the ECG recording (see section Other medicines and Moxifloxacin Aurovitas). Moxifloxacin Aurovitas may cause changes in the ECG recording, called QT interval prolongation, which means delayed conduction of electrical signals in the heart.
• If the patient has liver disease or liver enzyme activity (aminotransferases) exceeding 5 times the upper limit of normal.

Warnings and precautions

Before taking this medicine

Do not take antibacterial medicines containing fluoroquinolones, including Moxifloxacin Aurovitas, if serious side effects have occurred in the past while taking a quinolone or fluoroquinolone. In such a situation, the doctor should be informed as soon as possible.

Before starting treatment with Moxifloxacin Aurovitas, consult a doctor or pharmacist.

• If the patient has diabetes, as moxifloxacin may cause a risk of changing blood sugar levels.
• If the patient has ever experienced a severe skin rash or peeling of the skin, blistering, and (or) ulceration of the oral cavity after taking moxifloxacin.
• Moxifloxacin Aurovitas may change the ECG recording of the heart, especially in women and the elderly. In the case of concomitant use of medications that lower potassium levels in the blood, before starting treatment with Moxifloxacin Aurovitas, consult a doctor (see also sections When not to take Moxifloxacin Aurovitasand Other medicines and Moxifloxacin Aurovitas).
• If the patient has epilepsyor conditions that may cause seizures, they should inform their doctor before starting treatment with Moxifloxacin Aurovitas.
• If the patient has or has had mental health problems, they should consult their doctor before starting treatment with Moxifloxacin Aurovitas.
• If the patient has myasthenia gravis (muscle weakness), taking Moxifloxacin Aurovitas may lead to worsening of the disease symptoms. If this happens, the patient should consult their doctor immediately.
• If the patient or anyone in their family has glucose-6-phosphate dehydrogenase deficiency(a rare inherited disease), they should inform their doctor, who will assess whether Moxifloxacin Aurovitas 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 it necessary to administer the medicine intravenously, as taking Moxifloxacin Aurovitas in tablet form is not appropriate.
• In order to treat mild or moderate upper genital tract infections, the doctor should prescribe an additional antibacterial medicine to the patient, in addition to Moxifloxacin Aurovitas. If the symptoms do not start to improve within the first 3 days of treatment, the patient should consult their doctor.
• If the patient has been diagnosed with an aneurysm or "bulging" of a large blood vessel (aortic aneurysm or peripheral artery aneurysm).
• If the patient has had a previous case of aortic dissection (the appearance of a free space in the aortic wall).
• If the patient has been diagnosed with valve regurgitation (valve insufficiency).
• If the patient has a history of aortic aneurysm or aortic dissection, or congenital heart valve disease, or other risk factors, or conditions predisposing to them (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, or diagnosed atherosclerosis, rheumatoid arthritis [joint disease] or endocarditis [heart infection]).

During treatment with Moxifloxacin Aurovitas

• If the patient feels a sudden, severe abdominal, chest, or back pain, which may be a sign of an aortic aneurysm and dissection, they should go to the emergency room 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 flat in bed, or notices swelling of the ankles, feet, or abdomen, or new palpitations (feeling of rapid or irregular heartbeat), they should inform their doctor immediately.
• If the patient experiences palpitations or irregular heartbeatduring treatment, they should inform their doctor immediately. The doctor may order an ECG test to check the heart rhythm.
• The risk of heart problemsmay increase with increasing doses. Therefore, it is recommended to follow the prescribed dosage of the medicine.
• There is a small risk of a severe, sudden allergic reaction(anaphylactic reaction or anaphylactic shock) even after the first dose of the medicine, with symptoms such as chest tightness, dizziness, nausea, or fainting, and a feeling of spinning when standing up. In case of their occurrence, the patient should stop taking the medicine immediately.

Moxifloxacin Aurovitas and consult a doctor.

• Moxifloxacin Aurovitas may cause liver inflammation with a rapid and severe course, which can lead to life-threatening liver failure (including fatal outcomes, 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 disorders of thinking or insomnia occur, the patient should contact their doctor before taking the next dose.
• Antibiotics from the quinolone group, including Moxifloxacin Aurovitas, may cause seizures. In case of seizures, the patient should stop taking Moxifloxacin Aurovitas immediately and consult their doctor.
• If nerve damage symptoms (neuropathy)occur, such as pain, burning sensation, tingling, numbness, and (or) weakness, especially in the feet and legs or hands and arms, the patient should stop taking Moxifloxacin Aurovitas immediately and consult their doctor to prevent the development of a potentially irreversible condition.
• Mental health problemsmay occur, even with the first use of quinolone antibiotics, including Moxifloxacin Aurovitas. In very rare cases, depression or mental health problems can lead to suicidal thoughts and self-destructive behaviors, such as suicide attempts (see section 4. Possible side effects). If the patient experiences such reactions, they should stop taking Moxifloxacin Aurovitas immediately and consult their doctor.
• During or after treatment with antibiotics, including Moxifloxacin Aurovitas, diarrheamay occur. If it worsens or lasts for a longer period, or if blood or mucus is found in the stool, the patient should stop taking Moxifloxacin Aurovitas immediately and consult their doctor. In such a situation, the patient should not take medications that slow down or stop intestinal movement (peristalsis).
• Pain and swelling of the joints, as well as inflammation or rupture of the tendons, may rarely occur. The risk is higher if the patient is elderly (over 60 years old), has had an organ transplant, has kidney problems, or is being treated with corticosteroids. Tendon inflammation and ruptures can occur within the first 48 hours of treatment, and even several months after stopping treatment with Moxifloxacin Aurovitas. At the first signs of pain or tendon inflammation (e.g., in the ankle, wrist, elbow, arm, or knee), the patient should stop taking Moxifloxacin Aurovitas, consult their doctor, and rest the affected area. The patient should avoid unnecessary exercise, as it may increase the risk of tendon rupture.
• Elderly patients with kidney problemsshould drink an adequate amount of fluids, as dehydration can increase the risk of kidney failure.
• If the patient's vision worsens or other vision problemsoccur during treatment with Moxifloxacin Aurovitas, they should seek the advice of an ophthalmologist (see also section Driving and using machinesand section 4. Possible side effects).

Severe skin reactions

During treatment with moxifloxacin, severe skin reactions have been reported, 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 syndromes may initially appear as red spots with a target-like appearance or round spots, often with blisters on the torso. They may also cause ulcers in the mouth, throat, nose, genitals, and eyes (red and swollen eyes). The occurrence of such severe skin rashes is often preceded by fever and (or) flu-like symptoms.
• The rash may transform into generalized peeling of the skin and life-threatening complications or lead to death. AGEP rash appears at the beginning of treatment in the form of a red, peeling, generalized rash with nodules under the skin and blisters, accompanied by fever. The most common location: localized mainly in skin folds, torso, and upper limbs.
• In DRESS syndrome, initial symptoms include flu-like symptoms and a rash on the face, followed by a widespread rash with high fever, elevated liver enzymes, and eosinophilia, as well as swollen lymph nodes.

In case of a severe rash or any of these skin symptoms, the patient should stop taking moxifloxacin and consult their doctor or seek immediate medical attention.

• Fluoroquinolone antibiotics may cause an increase in blood sugar levels above normal (hyperglycemia) or a decrease in blood sugar levels to below normal (hypoglycemia), which may potentially lead to loss of consciousness (hypoglycemic coma) in severe cases (see section 4. Possible side effects). In diabetic patients, blood sugar levels should be closely monitored.
• Quinolone antibiotics may increase sensitivity of the skin to sunlight and UV radiation. During treatment with Moxifloxacin Aurovitas, the patient should avoid prolonged exposure to sunlight, strong sunlight, and use of sunbeds or other sources of UV radiation (see section 4. Possible side effects).

The efficacy of Moxifloxacin Aurovitas has not been established in the treatment of severe burns, deep tissue infections, and diabetic foot infections with osteomyelitis (bone infection).
Long-term, disabling, and potentially irreversible serious side effects
Fluoroquinolone/quinolone antibacterial medicines, including Moxifloxacin Aurovitas, are associated with very rare but serious side effects, some of which are long-term (lasting months or years), disabling, or potentially irreversible. These include tendon, muscle, and joint pain, difficulty moving, sensory disturbances, such as tingling and numbness, burning, prickling, itching, and (or) pain (paresthesia), sensory disturbances, including vision, taste, and smell disorders, depression, memory disorders, severe fatigue, and severe sleep disorders.
In case of any of these side effects after taking Moxifloxacin Aurovitas, the patient should contact their doctor directly to decide on continuing treatment, also considering an antibiotic from another class.

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 Aurovitas).

Other medicines and Moxifloxacin Aurovitas

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

• When taking Moxifloxacin Aurovitas with other medicines that affect heart function, the risk of heart rhythm disorders increases. Therefore, Moxifloxacin Aurovitas should not be taken simultaneously with the following medicines: antiarrhythmic medicines (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), antipsychotic medicines (e.g., phenothiazines, pimozide, sertindole, haloperidol, sultopride), tricyclic antidepressants, certain antibacterial medicines (e.g., saquinavir, sparfloxacin, intravenous erythromycin, pentamidine, antimalarial medicines, especially halofantrine), certain antihistamines (e.g., terfenadine, astemizole, mizolastine), and other medicines (e.g., cisapride, intravenous vincamine, bepridil, and difemanil).
• The patient should inform their doctor if they are taking other medicines that may lower potassium levels in the blood (e.g., certain diuretics, certain laxatives, and enemas [large doses] or corticosteroids [anti-inflammatory medicines], amphotericin B), as they may increase the risk of serious heart rhythm disorders when taking Moxifloxacin Aurovitas.
• All medicines containing magnesium or aluminum, such as antacids used in digestive disorders, and all medicines containing iron or zinc, medicines containing didanosine, and sucralfate used in the treatment of 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, it is not recommended to take both medicines simultaneously.
• In case of concomitant use of oral anticoagulant medicines (e.g., warfarin), the doctor may order blood coagulation tests.

Moxifloxacin Aurovitas with food and drink

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

Pregnancy, breastfeeding, and fertility

Moxifloxacin Aurovitas should not be taken during pregnancy and breastfeeding.
If the patient is pregnant, breastfeeding, suspects they are pregnant, or plans to become pregnant, they should consult their doctor or pharmacist before taking this medicine.
Animal studies do not show a negative effect of this medicine on fertility.

Driving and using machines

Moxifloxacin Aurovitas may cause dizziness and a feeling of fainting, sudden, transient loss of vision, or may cause a short-term fainting spell. In case of such symptoms, the patient should not drive vehicles or operate any machines.

Moxifloxacin Aurovitas contains sodium

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

3. How to take Moxifloxacin Aurovitas

This medicine should always be taken as directed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist again.
The recommended dose for adults is 1 film-coated tablet of 400 mg once a day.
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 with or without food. It is recommended to take the tablet at the same time every day.
There is no need to adjust the dose in elderly patients, those with low body weight, or those with kidney problems.
The duration of treatment depends on the type of infection. Unless the doctor has prescribed otherwise, the recommended duration of treatment with Moxifloxacin Aurovitas film-coated tablets is:

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

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

• community-acquired pneumonia 7-14 days Most patients with community-acquired pneumonia had their 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 their route of administration changed from intravenous to oral within 6 days.

It is essential to complete the full treatment cycle, even if the patient feels better after a few days. If the patient stops taking the medicine too early, the infection may not be completely cured, the disease may recur, or the patient's condition may worsen, and the bacteria may develop resistance to the antibiotic.
Do not exceed the recommended dose or prolong treatment (see section 2. Important information before taking Moxifloxacin Aurovitas, Warnings and precautions).

Taking a higher dose of Moxifloxacin Aurovitas than recommended

In case of taking more than one prescribed tablet per day, the patient should seek medical help immediately and, if possible, take all remaining tablets, packaging, and this leaflet to show the doctor or pharmacist.

Missing a dose of Moxifloxacin Aurovitas

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

Stopping treatment with Moxifloxacin Aurovitas

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

4. Possible side effects

Like all medicines, Moxifloxacin Aurovitas can cause side effects, although not everybody gets them.
The most serious side effectsobserved during treatment with moxifloxacin are presented below.

• abnormal heart rhythm (rare side effect),
• rapid deterioration of well-being, yellowing of the whites of the eyes, dark urine, itching of the skin, tendency to bleed, and disorders of thinking or insomnia [these may be signs of fulminant hepatitis that can lead to life-threatening liver failure, including fatal outcomes (very rare side effects)],
• 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),

In case of any of the above side effects, the patient should stop taking Moxifloxacin Aurovitas and seek medical help immediately.
Additionally, in case of:

• transient loss of vision (very rare side effect),
• discomfort or eye pain, especially due to exposure to light (very rare or rare side effect),

the patient should seek the advice of an ophthalmologist immediately.
If the patient experiences a life-threatening irregular heartbeat ( torsade de pointes) or cardiac arrest while taking Moxifloxacin Aurovitas(very rare side effect), they should inform their doctor that they are taking Moxifloxacin Aurovitas and not resume treatment.
Very rarely, worsening of myasthenia symptoms has been observed. If the patient's myasthenia symptoms worsen, they should consult their doctor immediately.
If the patient with diabetes experiences an increase or decrease in blood sugar levels (rare or very rare side effect), they should tell their doctor.
If the patient, who is elderly with kidney problems, experiences a decrease in urine output, swelling of the feet, ankles, or hands, fatigue, nausea, drowsiness, shortness of breath, or confusion (these may be signs of kidney failure; rare side effect), they should consult their doctor 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 activity of certain liver enzymes (aminotransferases) in the blood
• infections caused by resistant bacteria or fungi, e.g., oral thrush (candidiasis) and vaginal candidiasis (thrush)
• heart rhythm disorders (visible in ECG) in patients with low potassium levels in the blood

Uncommon (may affect up to 1 in 100 people)

• rash
• gastrointestinal disorders (indigestion or heartburn)
• taste disorders (very rarely, loss of taste)
• sleep disorders (e.g., insomnia or drowsiness)
• increased activity of: gamma-glutamyltransferase and (or) alkaline phosphatase (liver enzymes) in the blood
• low white blood cell count, neutrophils (a type of white blood cell)
• constipation
• itching
• feeling of dizziness (spinning or tilting)
• drowsiness
• wind
• heart rhythm disorders (visible in ECG)
• liver function disorders, including increased activity of LDH (liver enzyme) in the blood
• decreased appetite and food intake
• low white blood cell count
• back pain, chest pain, pelvic pain, and limb pain
• decreased or increased number of blood cells necessary for blood clotting
• sweating
• increased number of eosinophils (a type of white blood cell)
• anxiety
• malaise (mainly weakness or fatigue)
• tremors
• joint pain
• palpitations
• irregular and rapid heartbeat
• breathing difficulties (including asthma-like conditions)
• increased activity of amylase (a digestive enzyme) in the blood
• restlessness, agitation
• tingling and (or) numbness
• hives
• vasodilation
• confusion and disorientation
• decreased number of platelets necessary for blood clotting
• vision disorders (including double or blurred vision)
• decreased blood clotting
• increased levels of fats in the blood
• low red blood cell count
• muscle pain
• allergic reaction
• 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 twitching
• muscle cramps
• hallucinations
• high blood pressure
• edema (swelling of hands, feet, ankles, lips, mouth, or throat)
• low blood pressure
• kidney function disorders (including increased results of certain kidney function tests, such as urea and creatinine levels)
• hepatitis
• stomatitis
• ringing or noise in the ears
• jaundice (yellowing of the whites of the eyes or skin)
• skin sensation disorders
• unusual dreams
• concentration disorders
• difficulty swallowing
• smell disorders (including loss of smell)
• balance and coordination disorders (due to dizziness)
• partial or complete loss of memory
• hearing disorders, including deafness (usually temporary)
• increased sodium levels in the blood
• emotional instability
• speech disorders
• 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 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)

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

• Increased sensitivity of the skin to sunlight or UV radiation (see also section 2, Warnings and precautions).
• Acute, sharply demarcated, red, blistering patches, which appear within a few hours of moxifloxacin administration and heal with post-inflammatory hyperpigmentation; these usually recur in the same area of skin or mucous membrane after re-exposure to moxifloxacin.

In addition, during treatment with Moxifloxacin Aurovitas, the following very rare side effects have been reported, which have also been observed with other quinolone antibiotics: 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, and increased breakdown of red blood cells (hemolytic anemia).
Very rare cases of long-term (lasting months or years) or permanent side effects of the medicine, such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty moving, sensory disturbances, such as tingling and numbness, burning, prickling, itching, and (or) pain (neuropathy), fatigue, memory and concentration disorders, and effects on mental health (which may include sleep disorders, anxiety, panic attacks, depression, and suicidal thoughts), as well as hearing, vision, taste, and smell disorders, have been associated with the administration of quinolone and fluoroquinolone antibiotics, in some cases regardless of pre-existing risk factors.
In patients taking fluoroquinolones, cases of aortic dilatation and aortic aneurysm, as well as aortic dissection (tear in the aortic wall), which can rupture and cause death, have been reported, as well as cases of aortic valve regurgitation. See also section 2.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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, more information can be collected on the safety of the medicine.

5. How to store Moxifloxacin Aurovitas

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

6. Contents of the pack and other information

What Moxifloxacin Aurovitas contains

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

What Moxifloxacin Aurovitas looks like and contents of the pack

Film-coated tablet.
Matte, red, oblong film-coated tablet with the inscription "E 18" on one side and smooth on the other side.
The film-coated tablets are packaged in PVC/PVDC/Aluminum blisters in cardboard boxes of 5, 7, 10, or 50 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.
ul. 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 authorized for sale in the Member States of the European

Economic Area under the following names:

Belgium:
Moxifloxacin AB 400 mg film-coated tablets
Czech Republic:
Moxifloxacin Aurovitas 400 mg coated tablets
Netherlands:
Moxifloxacin Aurobindo 400 mg, film-coated tablets
Poland:
Moxifloxacin Aurovitas
Portugal:
Moxifloxacina Aurovitas
Spain:
Moxifloxacino Aurovitas 400 mg film-coated tablets EFG

Date of last update of the leaflet: 04.2025