MOXIFLOXACIN SANDOZ 400 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Moxifloxacino Sandoz 400 mg film-coated tablets EFG

Read the entire package leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this package 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 you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet1. What is Moxifloxacino Sandoz and what is it used for

1. What you need to know before you start taking Moxifloxacino Sandoz
2. How to take Moxifloxacino Sandoz
3. Possible side effects
4. Storage of Moxifloxacino Sandoz
5. Contents of the pack and further information

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

Moxifloxacino Sandoz contains moxifloxacino, an antibiotic that belongs to a group of antibiotics called fluoroquinolones. Moxifloxacino works by killing the bacteria that cause infections.

Moxifloxacino is indicated in patients 18 years and older for the treatment of the following bacterial infectionswhen caused by bacteria against which moxifloxacino is active. Moxifloxacino should only be used to treat these infections when usual antibiotics cannot be taken or do not have an effect:

Sinus infection, sudden worsening of long-term airway inflammation or community-acquired pneumonia (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 this type of infection, moxifloxacino tablets are not sufficient as the only treatment. Therefore, in addition to moxifloxacino tablets, your doctor must prescribe another antibiotic for the treatment of mild or moderate infections of the upper female genital tract (see section 2. What you need to know before you start taking Moxifloxacino Sandoz, Warnings and precautions, Consult your doctor before taking Moxifloxacino Sandoz).

If the following infections have shown improvement during initial treatment with moxifloxacino solution for infusion, your doctor may prescribe moxifloxacino tablets to complete the treatment course for:

• community-acquired pneumonia,
• skin and soft tissue infections.

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

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

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

Do not take Moxifloxacino Sandoz:

• if you are allergic to moxifloxacino, other quinolones, or any of the other components of this medication (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 precautions" and 4. "Possible adverse effects"),
• if you were born with, have, or have had
• any disease related to an abnormal heart rhythm (observed in ECG, electrical recording of the heart),
• you suffer from electrolyte imbalances in the blood (especially low levels of potassium or magnesium in the blood),
• you have a very slow heart rate (called "bradycardia"),
• you have a weak heart (heart failure),
• you have a history of heart rhythm disorders

or

• you are taking other medications that produce disorders in the ECG (see section "Other medications and Moxifloxacino Sandoz"). This is because moxifloxacino can cause changes in the ECG, such as a prolongation of the QT interval, i.e., a delay in the conduction of electrical signals in the heart.
• If you have a severe liver disease or increased levels of liver enzymes (transaminases) 5 times above the upper limit of normal.

Warnings and precautions

Before starting to take this medication

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

Consult your doctor before starting to take Moxifloxacino Sandoz:

• moxifloxacino may modify the ECG of the heart, especially if you are a woman or an elderly patient. If you are currently taking any medication that leads to a decrease in potassium levels in the blood, consult your doctor before taking moxifloxacino (see also sections "Do not take Moxifloxacino Sandoz" and "Other medications and Moxifloxacino Sandoz"),
• if you suffer from epilepsyor other conditions that may cause seizures, consult your doctor before taking moxifloxacino,
• if you have or have ever had any mental health problems, consult your doctor before taking moxifloxacino,
• if you have myasthenia gravis(abnormal muscle fatigue that leads to weakness and paralysis in severe cases), your symptoms may worsen if you take moxifloxacino. If you think this affects you, consult your doctor immediately,
• if you have been diagnosed with an enlargement or "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 dissection or aneurysms, 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, or Sjögren's syndrome (an autoimmune inflammatory disease), or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet's disease, hypertension, known atherosclerosis, rheumatoid arthritis (a joint disease), or endocarditis (a heart infection)),
• if you or a family member suffers from glucose-6-phosphate dehydrogenase deficiency(a rare hereditary disease), inform your doctor, who will indicate if 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 pelvis), for which your doctor considers intravenous treatment necessary, oral moxifloxacino 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 3 days of treatment you do not notice an improvement in symptoms, consult your doctor.
• if you are diabetic because you may experience a risk of change in blood sugar levels with moxifloxacino,
• if you have ever developed a severe skin rash or skin peelingand blisters and/or sores in the mouth after taking moxifloxacino.

During treatment with Moxifloxacino Sandoz

• if you notice palpitations or irregular heartbeatsduring the treatment period, you should inform your doctor immediately. He or she may perform an ECG to measure the heart rate,
• the risk of heart problemscan be increased with an increase in the dose. Therefore, you should take the recommended dose,
• in rare cases, you may suffer a severe allergic reaction(anaphylactic shock) even with the first dose, and develop the following symptoms: 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 inflammation, which can lead to life-threatening liver failure (including fatal cases, see section 4. "Possible adverse effects"). Consult your doctor before continuing treatmentwith more tabletsif you develop symptoms such as sudden 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),
• severe skin reactions have been reported with the use of moxifloxacino, 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).
• Stevens-Johnson syndrome/TEN may initially appear on the trunk as reddish grains in the shape of a target or circular 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 a generalized peeling of the skin and complications that can be life-threatening or fatal.
• AGEP appears at the beginning of treatment as a red, scaly, and generalized rash with bumps under the skin and blisters, accompanied by fever. The most common location: mainly localized in skin folds, trunk, and upper limbs.
• Drug reaction with eosinophilia and systemic symptoms (DRESS) appears initially with pseudo-flu-like symptoms and a rash on the face, later a widespread rash with high body temperature, increased 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.

• quinolone antibiotics, including moxifloxacino, may cause seizures. If this occurs, stop taking moxifloxacino and contact your doctor immediately,
• in rare cases, you may experience nerve damage symptomssuch as pain, burning, tingling, numbness, and/or weakness especially in feet and legs or hands and arms. If this occurs, 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 moxifloxacino. 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, treatment with moxifloxacino should be discontinued and your doctor informed immediately,
• you may develop diarrheaduring or after taking antibiotics, including moxifloxacino. If the diarrhea is severe or persistent, or if you notice blood or mucus in the stool, stop taking moxifloxacino immediatelyand consult your doctor. In these situations, do not take medications that interrupt or slow down intestinal movement,
• in rare cases, pain and swelling in the joints and tendon inflammation or rupturemay occur. 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 feel a sudden and severe pain in the abdomen, chest, or back, which can be symptoms of aortic dissection or aneurysm, go to the emergency room immediately. 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 are an elderly patient and have kidney problems, make sure you have sufficient fluid intake, as dehydration can increase the risk of kidney failure,
• if your vision worsens or if you have any other eye disordersduring treatment with moxifloxacino, consult an ophthalmologist immediately(see sections "Driving and using machines" and 4. "Possible adverse effects"),
• fluoroquinolone antibiotics may cause an increase in blood sugar levelsabove normal levels (hyperglycemia) or a decrease in blood sugar levelsbelow normal levels (hypoglycemia), which in severe cases can cause loss of consciousness (hypoglycemic coma) (see section 4. "Possible adverse effects"). If you have diabetes, your blood sugar levels should be carefully monitored.
• quinolone antibiotics may increase the sensitivity of the skin to sunlight or UV. You should avoid prolonged exposure to sunlight or direct sunlight and not use sunbeds or any type of UV lamp during the administration of moxifloxacino (see section 4. Possible adverse effects),
• the efficacy of moxifloxacino solution for infusion in the treatment of severe burns, deep tissue infections, and diabetic foot infections with osteomyelitis (bone marrow infections) has not been established.

Quinolones may cause an increase in blood sugar levelsabove normal levels (hyperglycemia) or a decrease in blood sugar levelsbelow normal levels, which in severe cases can cause loss of consciousness (hypoglycemic coma) (see section 4. "Possible adverse effects"). This is important for people with diabetes. If you have diabetes, your blood sugar levels should be carefully monitored.

Severe, disabling, long-lasting, and potentially irreversible adverse effects.

Antibacterial medications that contain fluoroquinolones or quinolones, including moxifloxacino, have been associated with very rare but severe 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 pinching, tingling, tingling, 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 continue treatment, also considering the use of an antibiotic from another class.

Children and adolescents

Do not administer this medication to children and adolescents under 18 years old, as its efficacy and safety have not been established for this age group (see section "Do not take Moxifloxacino Sandoz").

Other medications and Moxifloxacino Sandoz

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

With moxifloxacino, you should consider the following:

• if you are taking moxifloxacino and other medications 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 medications:
• medications 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,
• certain antimicrobials (e.g., saquinavir, sparfloxacin, erythromycin administered intravenously, pentamidine, antimalarials, particularly halofantrine),
• certain antihistamines (terfenadine, astemizole, mizolastine),
• other medications (e.g., cisapride, intravenous vincamine, bepridil, and difemanil),

• you should inform your doctor if you are taking other medications that may decrease potassium levels in the blood (e.g., diuretics, laxatives, and enemas [high doses] or corticosteroids [anti-inflammatory medications], amphotericin B) or cause a decrease in heart rate, as these may also increase the risk of severe heart rhythm disorders,
• any other medication that contains magnesium or aluminum(such as antacids for indigestion) or any medication that contains iron, zinc, or didanosineor medications that contain sucralfate(for treating gastrointestinal disorders) may reduce the action of moxifloxacino tablets. Therefore, take your moxifloxacino tablets 6 hours before or after taking other medications,
• taking oral activated charcoalat the same time as moxifloxacino tablets reduces the action of moxifloxacino. Therefore, it is recommended not to use these medications simultaneously,
• if you are currently taking medications to prevent blood clot formation(oral anticoagulants such as warfarin), your doctor may need to monitor your blood coagulation time.

Taking Moxifloxacino Sandoz with food and drinks

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

Pregnancy, breastfeeding, and fertility

Do not usemoxifloxacino if you are pregnant or 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 medication.

Animal studies do not indicate that fertility may be altered by taking this medication.

Driving and using machines

Moxifloxacino may cause dizziness or drowsiness or a brief fainting spell, and you may also experience a sudden transient loss of vision or faint during a short period. If you experience these symptoms, do not drive vehicles or operate machinery.

Moxifloxacino Sandoz contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per film-coated tablet; it is essentially "sodium-free".

3. How to Take Moxifloxacino Sandoz

Follow the administration instructions of 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 tablet once a day.

Moxifloxacino tablets are for oral administration. Take the tablet whole (to mask the bitter taste) and with plenty of liquid. Moxifloxacino 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 told you otherwise, the duration of treatment with moxifloxacino is as follows:

• sudden worsening of chronic bronchitis (acute exacerbation): 5 to 10 days,
• lung infections (pneumonias), except for those acquired in the hospital setting: 10 days.
• acute infections of the paranasal sinuses (acute bacterial sinusitis): 7 days,
• 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: 14 days.

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

• community-acquired lung infections (pneumonias): 7 to 14 days.

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

• skin and soft tissue infections: 7 to 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 stop treatment with moxifloxacino too soon, it may be that the infection is not completely cured, the infection may return, or your condition may worsen, and you may also develop bacterial resistance to moxifloxacino.

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

If you take more Moxifloxacino Sandoz than you should

If you take more than one of the recommended tablets per day, consult your doctor immediatelyand, if possible, take the remaining medication, packaging, or this leaflet and show it to your doctor or pharmacist what you have taken.

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

If you forget to take Moxifloxacino Sandoz

In case of forgetting a dose, you should take the tablet as soon as you rememberon 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 not sure what to do, consult your doctor or pharmacist.

If you stop treatment with Moxifloxacino Sandoz

If you stop taking this medication too soon, it may be that your infection is not 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),
• a sudden feeling of discomfort or notice a yellowish color of the whites of the eyes, dark urine, itching of the skin, tendency to bleed or disorders of thought or wakefulness (these can be signs and symptoms of a fulminant liver inflammation that can lead to potentially fatal liver failure (very rare cases with fatal outcomes have been observed)),
• severe skin rashes including Stevens-Johnson syndrome and toxic epidermal necrolysis. These can appear on the trunk as reddish spots in a target shape or circular spots often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes, and can be preceded by fever and symptoms similar to those of the flu (very rare side effects, with possible risk to life),
• a red, scaly, and generalized 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 "not known"),
• generalized rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), increased lymph node size, 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 "not known"),
• 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 (the signs can be 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, which can rarely lead to life-threatening shock (e.g., difficulty breathing, decreased blood pressure, rapid pulse) (rare side effect),
• swelling including possible swelling of the airways (rare side effect, which can be life-threatening),
• seizures (rare side effect),
• problems associated with the nervous system, such as pain, burning, tingling, numbness, and/or weakness in the limbs (rare side effect),
• depression (in very rare cases leading to self-harm, such as suicidal thoughts or attempts) (rare side effect),
• madness (which can potentially lead to self-harm, such as suicidal thoughts or attempts) (very rare side effect),
• severe diarrhea with blood and/or mucus (antibiotic-associated colitis, including pseudomembranous colitis), which in very rare circumstances can generate life-threatening complications (rare side effect),
• 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 discomfort, have a fever, or your urine is dark. These symptoms can be caused by abnormal muscle breakdown that can be life-threatening and cause kidney problems (a condition called rhabdomyolysis) (the frequency of this side effect is "not known").

Stop taking moxifloxacino and inform your doctor immediately, as you may need urgent medical attention.

Additionally, if you notice

• transient loss of vision (very rare side effect),

contact an ophthalmologist immediately.

If you have experienced life-threatening irregular heartbeats (Torsade de Pointes) or interruption of the heart rhythm while taking moxifloxacino (very rare side effects), inform your doctor immediately that you have taken moxifloxacino and do not restart treatment.

A worsening of myasthenia gravis symptoms has been observed in very rare cases. If this happens, consult your doctor immediately.

If you have diabetes and notice that your blood sugar level increases or decreases (rare or very rare side effects), consult your doctor immediately.

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

Other side effectsthat have been observed during treatment with moxifloxacino are listed below based on frequency:

Common, may affect up to 1 in 10 people:

• infections caused by resistant bacteria or fungi, such as oral and vaginal infections caused by Candida (thrush),
• headache,
• dizziness,
• discomfort (nausea),
• feeling sick (vomiting),
• abdominal and stomach pain,
• alterations in the electrocardiogram (ECG) in patients with low potassium levels in the blood,
• diarrhea,
• increase in liver enzyme levels in the blood (transaminases).

Uncommon, may affect up to 1 in 100 people:

• rash,
• stomach discomfort (indigestion/heartburn),
• changes in taste (in very rare cases, loss of taste),
• sleep problems (predominantly insomnia),
• increase in a liver enzyme in the blood (gamma-glutamyl-transferase and/or alkaline phosphatase),
• low levels of certain white blood cells (leukocytes, neutrophils),
• constipation,
• itching,
• feeling of dizziness (spinning or falling),
• drowsiness,
• gas,
• change in heart rhythm (ECG),
• alteration of liver function (including an increase in a special liver enzyme in the blood (LDH)),
• decreased appetite and food intake,
• low white blood cell count,
• pains in the back, chest, pelvis, and limbs,
• increase in blood cells necessary for blood clotting,
• sweating,
• increase in certain white blood cells (eosinophils),
• anxiety,
• feeling of discomfort (predominantly weakness or fatigue),
• tremors,
• joint pain,
• palpitations,
• irregular and rapid heart rhythm,
• difficulty breathing, including asthma conditions,
• increase in a digestive enzyme in the blood (amylase),
• restlessness/agitation,
• feeling of tingling (pinch) and/or numbness,
• skin hives
• vasodilation,
• confusion and disorientation,
• decrease in certain blood cells necessary for blood clotting,
• visual disturbances, including double vision and blurred vision,
• decrease in blood clotting,
• increase in blood lipids (fats),
• low red blood cell count,
• muscle pain,
• allergic reaction,
• increase in bilirubin in the blood,
• stomach inflammation,
• dehydration,
• severe heart rhythm disturbances,
• dry skin,
• chest pain.

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

• muscle spasms,
• muscle cramp,
• hallucination,
• high blood pressure,
• swelling (of the hands, feet, ankles, lips, mouth, throat),
• low blood pressure,
• kidney failure (including an increase in special kidney test results, such as urea and creatinine),
• liver inflammation,
• mouth inflammation,
• ringing/buzzing in the ears,
• jaundice (yellowish color of the whites of the eyes or skin),
• decreased skin sensation,
• abnormal dreams,
• altered concentration,
• difficulty swallowing,
• changes in smell (including loss of smell),
• balance and coordination disorders (due to dizziness),
• partial or total memory loss,
• hearing impairment, including deafness (generally reversible),
• increase in uric acid in the blood,
• emotional instability,
• difficulty speaking,
• fainting,
• muscle weakness.

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

• joint inflammation,
• abnormal heart rhythms,
• increased skin sensitivity,
• feeling of not being oneself,
• increase in blood clotting,
• muscle stiffness,
• significant decrease in certain white blood cells (agranulocytosis),
• decrease in the number of red and white blood cells and platelets (pancytopenia).

Not known(cannot be estimated from the available data),

• loss of consciousness due to a severe decrease in blood sugar levels (hypoglycemic coma). See section 2.
• increased skin sensitivity to sunlight or UV radiation (see also section 2, Warnings and precautions)
• erythematous patches clearly delimited with/without blisters that appear in the hours following the administration of moxifloxacino and disappear with residual post-inflammatory hyperpigmentation; they usually reappear in the same place on the skin or mucous membrane with subsequent exposure to moxifloxacino.

Additionally, very rare cases of the following side effects have been reported after treatment with other quinolone antibiotics, which could also occur during treatment with moxifloxacino:

• increase in sodium levels in the blood,
• increase in calcium levels in the blood,
• reduced count of a certain type of red blood cell (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, pain in the limbs, difficulty walking, abnormal sensations such as pinching, tingling, burning, numbness, or pain (neuropathy), fatigue, decreased memory and concentration, effects on mental health (which can include sleep disorders, anxiety, panic attacks, depression, and suicidal ideation), as well as 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 cardiac valve insufficiency in patients who have received fluoroquinolones. See also section 2.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear 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 Sandoz

Keep this medication out of sight and reach of children.

No special storage conditions are required.

HDPE bottle

Shelf life after first opening: 1 year.

Do not use this medication after the expiration date shown on the packaging, blister pack, and HDPE bottle after CAD/EX. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, 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 Sandoz

• The active ingredient is moxifloxacino.

Each film-coated tablet contains 400 mg of moxifloxacino (as hydrochloride).

• The other ingredients are: microcrystalline cellulose, cornstarch, sodium carboxymethylcellulose (type A) of potato, anhydrous colloidal silica, magnesium stearate, hypromellose, macrogol stearate (Type I), titanium dioxide, red iron oxide, carmine acid.

Appearance of the Product and Package Contents

Film-coated tablets of pink color in capsule shape marked with "400" on one side.

Dimensions: approximately 17.6 mm x 7.6 mm

Package sizes:

• blister packs containing 4, 5, 7, 10, 14, 20, 25, 50, 70, 80, and 100 film-coated tablets,
• HDPE bottles with screw caps containing 4, 5, 7, 10, 14, 25, 50, 70, 80, and 100 film-coated tablets.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

S.C. Sandoz, S.R.L.

Str. Livezeni nr. 7A

RO-540472 Targu-Mures

Romania

or

Salutas Pharma GmbH

Otto von Guericke Allee 1,

39179 Barleben

Germany

or

Lek S.A.

Ul. Domaniewska, 50 C

02-672 Warszawa

Poland

or

Lek Pharmaceuticals d.d.

Verovskova, 57

1526 Ljubljana

Slovenia

or

Lek Pharmaceuticals d.d.

Trimlini 2D,

9220 Lendava

Slovenia

Date of the last revision of this leaflet:March 2025

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