MOXIFLOXACIN AUROVITAS 400 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Moxifloxacino Aurovitas 400 mg Film-Coated Tablets EFG

For Adult Use

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Package Leaflet Contents

1. What is Moxifloxacino Aurovitas and what is it used for
2. What you need to know before taking Moxifloxacino Aurovitas
3. How to take Moxifloxacino Aurovitas
4. Possible side effects
5. Storage of Moxifloxacino Aurovitas
6. Package Contents and Additional Information

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

Moxifloxacino Aurovitas contains the active ingredient moxifloxacino, which belongs to the group of antibiotics called fluoroquinolones. Moxifloxacino acts by eliminating bacteria that cause infections.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as the flu or common cold.

It is essential that you follow the instructions regarding dosage, administration interval, and treatment duration indicated by your doctor.

Do not store or reuse this medication. If you have any leftover antibiotic after completing treatment, return it to the pharmacy for proper disposal. Do not throw away medications down the drain or in the trash.

Moxifloxacino is indicated in patients 18 years and older for the treatment of the following bacterial infections when caused by bacteria susceptible to moxifloxacino. Moxifloxacino should only be used to treat these infections when usual antibiotics cannot be used or have not worked:

• Sinus infection,
• Sudden worsening of long-term airway inflammation or lung infection (pneumonia) acquired outside the hospital in the community (except severe cases),
• Mild or moderate infections of the upper female genital tract (pelvic inflammatory disease), including infection of the fallopian tubes and infection of the uterine mucous membrane.

For the latter type of infections, moxifloxacino is not sufficient as the sole treatment; therefore, in addition to moxifloxacino, your doctor will prescribe another antibiotic for the treatment of upper female genital tract infections (see section 2. What you need to know before taking Moxifloxacino Aurovitas, Warnings and Precautions, Consult your doctor before taking Moxifloxacino Aurovitas).

If the following diseases have shown improvement during initial treatment with moxifloxacino solution for infusion, your doctor may prescribe moxifloxacino tablets to complete the treatment: Community-acquired pneumonia, skin and soft tissue infections.

Moxifloxacino should not be used to initiate treatment for any type of skin and soft tissue infection or severe lung infections.

2. What you need to know before starting to take Moxifloxacino Aurovitas

Consult your doctor if you are not sure if you belong to one of the patient groups described below.

Do not take Moxifloxacino Aurovitas:

• If you are allergic to the active ingredient moxifloxacin, to other quinolones, or to any of the other components of this medicine (included in section 6).
• If you are pregnant or breastfeeding.
• If you are under 18 years old.
• If you have a history of tendon disorders or injuries related to treatment with quinolone antibiotics (see sections Warnings and precautionsand 4. Possible adverse effects).
• If you suffer from any inherited disease or have suffered from any disease related to an abnormal heart rhythm (observed in ECG, heart electrical record), suffer from electrolyte imbalances in the blood (especially low potassium or magnesium levels in the blood), have a very low heart rate (called “bradycardia”), have a weak heart (heart failure), have a history of heart rhythm disorders, or are taking other medications that cause ECG disorders (see section Other medicines and Moxifloxacino Aurovitas). This is because moxifloxacin can cause changes in the ECG, such as a prolongation of the QT interval, i.e., delayed conduction of electrical signals in the heart.
• If you have severe liver disease or elevated liver enzyme levels (transaminases) 5 times above the upper limit of normal.

Warnings and precautions

Before taking this medicine

• You must not take antibacterial medicines that contain fluoroquinolones or quinolones, including moxifloxacin, if you have experienced a severe adverse reaction previously when taking a quinolone or a fluoroquinolone. If this is the case, you should inform your doctor as soon as possible.

Consult your doctor or pharmacist before starting to take Moxifloxacino Aurovitas:

• If you are diabetic because you may experience a risk of change in blood sugar levels with moxifloxacin.
• If you have ever developed a severe skin rash or skin peeling, blisters, and/or sores in the mouth after taking moxifloxacin.
• Moxifloxacino may modify your heart's ECG, especially if you are a woman or an elderly patient. If you are currently taking any medication that lowers your blood potassium levels, consult your doctor before taking moxifloxacin (see also sections Do not take Moxifloxacino Aurovitasand Other medicines and Moxifloxacino Aurovitas).
• If you suffer from epilepsyor any other condition that may cause you to have seizures, consult your doctor before taking moxifloxacin.
• If you have or have ever had any mental health problems, consult your doctor before taking moxifloxacin.
• If you have myasthenia gravis, your symptoms may worsen if you take moxifloxacin. If you think this affects you, consult your doctor immediately.
• If you or a member of your family has a deficiency of glucose-6-phosphate dehydrogenase(a rare inherited disease), inform your doctor, who will indicate whether moxifloxacino is suitable for you.
• If you have a complicated infection of the upper female genital tract(associated with an abscess in the Fallopian tubes and ovary or pelvic area), for which your doctor considers intravenous treatment necessary, moxifloxacino treatment is not appropriate.
• For the treatment of a mild to moderate infection of the upper female genital tract, your doctor should prescribe another antibiotic along with moxifloxacino. If after three days of treatment you do not notice an improvement in symptoms, consult your doctor.
• If you have been diagnosed with an enlargement or a “lump” of a large blood vessel (aortic aneurysm or large peripheral vessel aneurysm).
• If you have suffered a previous episode of aortic dissection (tear in the aortic wall).
• If you have been diagnosed with heart valve insufficiency (regurgitation of the heart valves).
• If you have a family history of aortic aneurysm or aortic dissection, congenital heart valve disease, or other risk factors or predisposing disorders (e.g., connective tissue disorders such as Marfan syndrome or Ehlers-Danlos syndrome, Turner syndrome, or Sjögren's syndrome (an autoimmune inflammatory disease), or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet's disease, arterial hypertension, or atherosclerosis, rheumatoid arthritis (a joint disease), or endocarditis (a heart infection)).

During treatment with Moxifloxacino Aurovitas

• If you feel a strong and sudden pain in the abdomen, chest, or back, which can be symptoms of aortic dissection or aneurysm, go immediately to an emergency service. The risk may increase if you are receiving systemic corticosteroid treatment.
• If you start experiencing a sudden onset of shortness of breath, especially when lying down, or if you notice swelling in the ankles, feet, or abdomen, or the appearance of heart palpitations (feeling of rapid or irregular heartbeat), you should inform your doctor immediately.
• If you notice palpitations or irregular heartbeatsduring the treatment period, you should inform your doctor immediately. Your doctor may perform an ECG to measure your heart rate.
• The risk of heart problemsmay increase with an increase in dose. Therefore, you should take the recommended dose.
• In rare cases, you may experience a sudden severe allergic reaction(anaphylactic shock) even with the first dose and develop symptoms such as chest tightness, dizziness, nausea, or fainting, or feel dizzy when standing up. If you experience these symptoms, stop taking moxifloxacino and consult your doctor immediately.
• Moxifloxacino may cause a rapid and severe liver inflammationthat can lead to life-threatening liver failure (including fatal cases, see section 4. Possible adverse effects). Please consult your doctor before continuing treatment if you develop symptoms such as a sudden feeling of discomfort and/or discomfort associated with a yellowish color of the whites of the eyes, dark urine, skin itching, tendency to bleed, or brain disease induced by liver damage (symptoms of reduced liver function or severe liver inflammation).
• Fluoroquinolone antibiotics, including moxifloxacin, may cause seizures. If this occurs, stop treatment with moxifloxacino and contact your doctor immediately.
• In rare cases, you may experience nerve damage symptoms (neuropathy)such as pain, burning, tingling, numbness, and/or weakness, especially in the feet and legs or hands and arms. If this happens, stop taking moxifloxacino and inform your doctor immediately to prevent the development of a potentially irreversible disorder.
• You may experience mental health problemseven after the first administration of quinolone antibiotics, including moxifloxacin. In very rare cases, mental health problems and depression have evolved into suicidal thoughts and self-harming behaviors such as suicide attempts (see section 4. Possible adverse effects). If you develop these reactions, you should stop treatment with moxifloxacino and inform your doctor immediately.
• You may develop diarrheaduring or after taking antibiotics, including moxifloxacin. If the diarrhea is severe or persistent, or if you notice blood or mucus in the stool, stop taking moxifloxacino immediately and consult your doctor. In these situations, you should not take medications that interrupt or slow down bowel movements.
• In rare cases, pain and swelling may appear in the joints and tendon inflammation or rupture. The risk is higher if you are an elderly person (over 60 years old), have received an organ transplant, have kidney problems, or are being treated with corticosteroids. Tendon inflammation and rupture can occur within the first 48 hours of treatment and even several months after stopping treatment with moxifloxacino. At the first sign of pain or tendon inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking moxifloxacino, contact your doctor, and rest the affected area. Avoid any unnecessary exercise, as this could increase the risk of tendon rupture.
• If you are an elderly person and have kidney problems, be careful to drink enough fluids, as dehydration can increase the risk of kidney failure.
• If your vision worsens or if your eyes seem to be affected, consult an ophthalmologist immediately (see sections 2. Driving and using machinesand 4. Possible adverse effects).

Severe skin reactions

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

• SSJ/TEN may initially appear on the trunk as reddish target-like spots, often with central blisters. Ulcers may also appear in the mouth, throat, nose, genitals, and eyes (red and swollen eyes). These severe skin rashes are often preceded by fever and/or flu-like symptoms. The rashes can progress to widespread skin peeling and life-threatening or fatal complications.
• AGEP appears at the start of treatment as a red, scaly, and widespread rash with bumps under the skin and blisters, accompanied by fever. The most common location is mainly localized in skin folds, trunk, and upper limbs.
• Drug reaction with eosinophilia and systemic symptoms (DRESS) initially appears with flu-like symptoms and a rash on the face, later followed by a widespread rash with high body temperature, elevated liver enzyme levels in blood tests, and increased eosinophilia and lymph node enlargement.

If you develop a severe rash or any of these skin symptoms, stop taking moxifloxacino and contact your doctor or seek medical attention immediately.

• Fluoroquinolone antibiotics may cause an increase in your blood sugar levels above normal levels (hyperglycemia) or a decrease in your blood sugar levels below normal levels, which in severe cases can cause loss of consciousness (hypoglycemic coma) (see section 4). This is important for people with diabetes. If you have diabetes, your blood sugar levels should be carefully monitored.
• Quinolone antibiotics may increase the sensitivity of your skin to sunlight or UV. You should avoid prolonged exposure to sunlight or direct sunlight and should not use sunbeds or any type of UV lamp during treatment with moxifloxacino (see section 4. Possible adverse effects).

Moxifloxacino has not been shown to be effective in the treatment of severe burns, deep tissue infections, and diabetic foot infections with osteomyelitis (bone marrow infections).

Severe, long-lasting, and potentially irreversible adverse effects

Antibacterial medicines that contain fluoroquinolones or quinolones, including moxifloxacin, have been associated with very rare but serious adverse effects, some of which were long-lasting (persistent for months or years), disabling, or potentially irreversible. This includes pain in the tendons, muscles, and joints of the upper and lower limbs, difficulty walking, abnormal sensations such as pins and needles, tingling, prickling, numbness, or burning (paresthesia), sensory disorders such as decreased vision, taste, smell, and hearing, depression, decreased memory, intense fatigue, and severe sleep disorders.

If you experience any of these adverse effects after taking moxifloxacino, contact your doctor immediately before continuing treatment. You and your doctor will decide whether to continue or not, also considering the use of an antibiotic from another class.

Children and adolescents

Do not give this medicine to children and adolescents under 18 years old because the efficacy and safety have not been established for this age group (see section Do not take Moxifloxacino Aurovitas).

Other medicines and Moxifloxacino Aurovitas

Tell your doctor or pharmacist if you are taking, have recently taken, or might take another medicine.

When taking Moxifloxacino Aurovitas, consider the following:

• If you are taking moxifloxacino and other medicines that affect the heart, there is a greater risk that heart rhythm disorders may occur. Therefore, you should not take moxifloxacino at the same time as the following drugs: medicines that belong to the class of antiarrhythmics (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), antipsychotics (e.g., phenothiazines, pimozide, sertindole, haloperidol, sultopride), tricyclic antidepressants, some antimicrobials (e.g., saquinavir, sparfloxacin, intravenous erythromycin, pentamidine, antimalarials, particularly halofantrine), some antihistamines (terfenadine, astemizole, mizolastine), and other drugs (e.g., cisapride, intravenous vincamine, bepridil, and difemanil).
• While taking moxifloxacino, you should inform your doctor if you are taking other medicines that may lower your blood potassium levels (e.g., diuretics, laxatives, and enemas (high doses) or corticosteroids (anti-inflammatory medicines), amphotericin B) or cause a decrease in heart rate, as these may also increase the risk of serious heart rhythm disorders.
• Any other medicine that contains magnesium or aluminum, such as antacids for indigestion, or any medicine that contains iron or zinc, medicines that contain didanosine, or medicines that contain sucralfate for treating gastrointestinal disorders may reduce the effect of moxifloxacino tablets. Therefore, take your moxifloxacino tablets 6 hours before or after taking other medicines.
• Taking oral activated charcoal at the same time as moxifloxacino tablets reduces the effect of these tablets. Therefore, it is recommended not to use these medicines simultaneously.
• If you are currently taking oral anticoagulants (e.g., warfarin), your doctor may need to monitor your blood coagulation time.

Taking Moxifloxacino Aurovitas with food, drinks, and alcohol

The effect of moxifloxacino is not altered by food, including dairy products.

Pregnancy, breastfeeding, and fertility

Do not use moxifloxacino during pregnancy or if you are breastfeeding.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Animal studies do not indicate that your fertility may be affected by taking this medicine.

Driving and using machines

Moxifloxacino may cause dizziness or vertigo or a brief fainting spell; you may experience a sudden transient loss of vision. If you experience these symptoms, do not drive vehicles or operate machinery.

Moxifloxacino Aurovitas contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially “sodium-free”.

3. How to take Moxifloxacino Aurovitas

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose in adults is one 400 mg film-coated tablet, once a day.

Moxifloxacino tablets are for oral administration. Take the tablet whole without chewing (to mask the bitter taste) and with plenty of liquid. Moxifloxacino Aurovitas can be taken with or without food. It is recommended that you take the tablet at approximately the same time every day.

No dose adjustment is necessary in elderly patients, in patients with low body weight, or in patients with kidney problems.

The duration of treatment depends on the type of infection. Unless your doctor has indicated otherwise, the duration of treatment with moxifloxacino is as follows:

• Sudden worsening of chronic bronchitis (acute exacerbation of chronic bronchitis): 5 – 10 days.
• Lung infections (pneumonias) acquired in the community, except in severe cases: 10 days.
• Acute infections of the paranasal sinuses (bacterial sinusitis): 7 days.
• Mild or moderate upper female genital tract infections (pelvic inflammatory disease), including fallopian tube infection and uterine mucous membrane infection: 14 days.

When moxifloxacino tablets are used to complete a treatment started with moxifloxacino solution for infusion, the recommended durations are:

• Community-acquired lung infections (pneumonias): 7 – 14 days.

Most patients with pneumonia switched from intravenous to oral treatment after 4 days.

• Skin and soft tissue infections: 7 – 21 days.

Most patients with skin and soft tissue infections switched from intravenous to oral treatment after 6 days.

It is important that you complete the full treatment, even if you start to feel better after a few days. If you interrupt treatment too early, the infection may not be completely cured, the infection may return, or your condition may worsen, and you may also develop bacterial resistance to the antibiotic.

Do not exceed the recommended dose and treatment duration (see section 2. What you need to know before taking Moxifloxacino Aurovitas, Warnings and precautions).

If you take more Moxifloxacino Aurovitas than you should

If you take more than the prescribed daily tablet, consult your doctor immediately and, if possible, take the remaining medication, packaging, or this leaflet to show the doctor or pharmacist what you have taken.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount used.

If you forget to take Moxifloxacino Aurovitas

In case of forgetting a dose, you should take the tablet as soon as you remember it on the same day. If you do not take your tablet one day, take the normal dose (one tablet) the next day. Do not take a double dose to make up for forgotten doses.

If you are unsure of what to do, consult your doctor or pharmacist.

If you stop taking Moxifloxacino Aurovitas

If you stop taking this medication too early, your infection may not be completely cured. Consult your doctor if you intend to stop taking the tablets before completing the full treatment.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

The most serious side effectsobserved during treatment with moxifloxacino are listed below:

If you notice:

• An abnormally fast heart rate (rare side effect).
• You start to feel unwell or notice yellowing of the whites of the eyes, dark urine, skin itching, tendency to bleed, disorders of thought or insomnia (these can be signs or symptoms of life-threatening liver inflammation due to liver failure (very rare side effect, with reported fatal cases)).
• Severe skin rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis. These can appear on the trunk as red spots in a target shape or circular patches, often with blisters in the center, skin peeling, 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).
• A red, scaly, and widespread rash with bumps under the skin and blisters, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis) (the frequency of this side effect is "unknown").
• A generalized rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes, and involvement of other body organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome) (the frequency of this side effect is "unknown").
• Syndrome associated with alterations in water elimination and low sodium levels (SIADH) (very rare side effect).
• Loss of consciousness due to a severe decrease in blood sugar levels (hypoglycemic coma) (very rare side effect).
• Inflammation of blood vessels (signs may include red spots on the skin, usually on the legs, or effects such as joint pain) (very rare side effect).
• Severe allergic reaction, sudden and generalized, including very rarely life-threatening shock (e.g., difficulty breathing, decreased blood pressure, rapid pulse) (rare side effects).
• Swelling, including possible swelling of the airways (rare side effect, potentially life-threatening).
• Seizures (rare side effect).
• Nervous system problems, such as pain, burning, tingling, numbness, and/or weakness in the limbs (rare side effect).
• Depression (possibly leading to self-harm, such as suicidal thoughts or attempts) (rare side effect).
• Dementia (may potentially lead to self-harming behaviors, such as suicidal thoughts or attempts) (rare side effect).
• Severe diarrhea with blood and/or mucus (antibiotic-associated colitis, including pseudomembranous colitis), which in rare circumstances can lead to life-threatening complications (rare side effects).
• Pain and inflammation of the tendons (tendinitis) (rare side effect) or tendon rupture (very rare side effect).
• Muscle weakness, sensitivity, or pain, particularly if you also feel unwell, have a fever, or your urine is dark. These symptoms can be caused by abnormal muscle breakdown, which can be life-threatening and cause kidney problems (a condition called rhabdomyolysis) (the frequency of this side effect is "unknown").

Stop taking Moxifloxacino Aurovitas and inform your doctor immediatelyas you need urgent medical attention.

Additionally, if you notice

• Transient loss of vision (very rare side effect),
• discomfort or pain in the eyes, especially due to light exposure (very rare to rare side effect).

Contact an ophthalmologist immediately.

If you have experienced life-threatening irregular heart rate (Torsade de Pointes) or cardiac arrest while taking Moxifloxacino Aurovitas (very rare side effects), inform your treating doctor immediately that you have taken Moxifloxacino Aurovitas and do not resume treatment.

In rare cases, worsening of myasthenia gravis symptoms has been observed. If this occurs, consult your doctor immediately.

If you have diabetes and notice that your blood glucose levels are increased or decreased (rare or very rare side effect), inform your doctor immediately.

If you are an elderly patient with kidney problems and notice a decrease in urine production, swelling of the legs, ankles, or feet, fatigue, nausea, drowsiness, difficulty breathing, or confusion (these can be signs or symptoms of kidney failure, a rare side effect), consult your doctor immediately.

Other side effects observed during treatment with moxifloxacino are listed below according to their probability:

Frequent(may affect up to 1 in 10 people):

• Nausea.
• Diarrhea.
• Dizziness.
• Stomach and abdominal pain.
• Vomiting.
• Headache.
• Increased levels of certain liver enzymes in the blood (transaminases).
• Infections caused by resistant bacteria or fungi, e.g., oral and vaginal infections caused by Candida.
• Change in heart rhythm (ECG), in patients with low potassium levels in the blood.

Uncommon(may affect up to 1 in 100 people):

• Rash.
• Gastric discomfort (indigestion/acid reflux).
• Alteration of taste (in very rare cases, loss of taste).
• Sleep disorders (mainly insomnia).
• Increased levels of specific liver enzymes in the blood (gamma-glutamyltransferase and/or alkaline phosphatase).
• Low levels of certain white blood cells (leukocytes, neutrophils).
• Constipation.
• Itching.
• Feeling of dizziness (feeling that everything is spinning or falling).
• Drowsiness.
• Flatulence.
• Change in heart rhythm (ECG).
• Alteration of liver function (including increased levels of a liver enzyme in the blood (LDH)).
• Decreased appetite or food intake.
• Low white blood cell count.
• Back, chest, pelvis, and limb pain.
• Increased levels of certain blood cells necessary for blood coagulation.
• Sweating.
• Increased levels of certain white blood cells (eosinophils).
• Anxiety.
• Malaise (mainly weakness or fatigue).
• Agitation.
• Joint pain.
• Palpitations.
• Irregular or rapid heart rate.
• Breathing difficulties, including asthma.
• Increased levels of certain digestive enzymes in the blood (amylase).
• Restlessness/agitation.
• Feeling of tingling (pins and needles) and/or numbness.
• Hives.
• Dilation of blood vessels.
• Confusion and disorientation.
• Decrease in certain blood cells necessary for blood coagulation.
• Visual disturbances, including double vision and blurred vision.
• Decrease in blood coagulation.
• Increased blood lipid levels (fats).
• Low red blood cell count.
• Muscle pain.
• Allergic reactions.
• Increased bilirubin levels in the blood.
• Stomach inflammation.
• Dehydration.
• Severe heart rhythm disorders.
• Dry skin.
• Chest pain.

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

• Muscle cramp.
• Muscle spasm.
• Hallucinations.
• Hypertension.
• Swelling (of hands, feet, ankles, lips, mouth, throat).
• Hypotension.
• Kidney disorders (including increased laboratory test results for the kidneys, such as urea and creatinine).
• Liver inflammation.
• Mouth inflammation.
• Ringing or noise in the ears.
• Jaundice (yellowing of the whites of the eyes or skin).
• Disorder of skin sensation.
• Abnormal dreams.
• Concentration disorders.
• Difficulty swallowing.
• Alteration of smell (including loss of smell).
• Disorders of balance and lack of coordination (due to dizziness).
• Partial or total loss of memory.
• Hearing impairment, including deafness (usually reversible).
• Increased uric acid levels in the blood.
• Emotional instability.
• Speech disorders.
• Fainting.
• Muscle weakness.

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

• Joint inflammation.
• Abnormal heart rhythm.
• Increased skin sensitivity.
• Feeling of loss of personality (not being oneself).
• Increased blood coagulation.
• Muscle stiffness.
• Significant decrease in certain white blood cells (agranulocytosis).
• Decrease in the number of red and white blood cells and platelets (pancytopenia).

Frequency not known(cannot be estimated from available data)

• Increased skin sensitivity to sunlight or UV radiation (see also section 2, Warnings and precautions).
• Clearly defined erythematous patches with/without blisters that appear in the hours following moxifloxacino administration and disappear with residual post-inflammatory hyperpigmentation; they usually reappear in the same place on the skin or mucous membranes with subsequent exposure to moxifloxacino.

Additionally, very rare cases of the following side effects have been reported after treatment with other quinolone antibiotics and may also occur during treatment with moxifloxacino: increased intracranial pressure (symptoms include headache, visual problems such as blurred vision, blind spots, double vision, loss of vision), increased sodium and calcium levels in the blood, a special type of reduced red blood cell count (hemolytic anemia).

The administration of quinolone and fluoroquinolone antibiotics has been associated with very rare cases of long-lasting (even months or years) or permanent adverse reactions, such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as pins and needles, tingling, burning, numbness, or pain (neuropathy), fatigue, decreased memory and concentration, effects on mental health (which may include sleep disorders, anxiety, panic attacks, depression, and suicidal ideation), and decreased hearing, vision, taste, and smell, in some cases regardless of the presence of pre-existing risk factors.

Cases of increased size and weakening or tearing of the aortic wall (aneurysms and dissections) have been reported, which could lead to rupture and be fatal, and heart valve failure in patients who have received fluoroquinolones. See also section 2.

Reporting of side effects

If you experience any side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Moxifloxacino Aurovitas

Keep this medication out of sight and reach of children.

This medication does not require special storage conditions.

Do not use this medication after the expiration date stated on the carton after EXP. The expiration date is the last day of the month indicated.

Medications should not be disposed of via wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Moxifloxacino Aurovitas

• The active ingredient is moxifloxacino. Each film-coated tablet contains 436.32 mg of moxifloxacino hydrochloride, equivalent to 400 mg of moxifloxacino.
• Other ingredients are:

Tablet core: Microcrystalline cellulose, sodium carboxymethyl starch (type A) (derived from potato starch), povidone (K-30), and magnesium stearate.

Coating: Hypromellose, titanium dioxide (E-171), macrogol 4000, and red iron oxide (E-172).

Appearance of the product and package contents

Light pink, film-coated tablets, elongated in shape, marked with "E 18" on one side and smooth on the other.

Moxifloxacino film-coated tablets are available in blister packs.

Package sizes: 5, 7, 10, and 50 film-coated tablets.

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

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

Belgium: Moxifloxacin AB 400 mg film-coated tablets

Spain: Moxifloxacino Aurovitas 400 mg film-coated tablets EFG

Netherlands: Moxifloxacin Aurobindo 400 mg, film-coated tablets

Poland: Moxifloxacin Aurovitas

Portugal: Moxifloxacina Aurovitas

Czech Republic: Moxifloxacin Aurovitas 400 mg film-coated tablets

Date of the last revision of this leaflet: April 2025

Detailed information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es)