Prospect: information for the patient

Moxifloxacino Sandoz 400 mg film-coated tablets EFG

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any questions, consult your doctor or pharmacist.

-This medicine has been prescribed only for you, and you should not give it to otherseven if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

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

3.How to take Moxifloxacino Sandoz

4.Possible side effects

5.Storage of Moxifloxacino Sandoz

6.Contents of the pack and additional information

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

Moxifloxacino is indicated for patients 18 years of age and older for the treatment of the followingbacterial infectionswhen caused by bacteria against which moxifloxacino is active. Moxifloxacino should be used only to treat these infections when usual antibiotics cannot be taken or are ineffective:

Acute exacerbation of chronic inflammation of the airways or sinusitis, or community-acquired pneumonia (except severe cases).

Mild to moderate upper genital tract infections in females (inflammatory pelvic disease), including salpingitis and endometritis.

For this type of infection, moxifloxacino tablets are not sufficient as a single treatment. Therefore, in addition to moxifloxacino tablets, your doctor should prescribe another antibiotic for the treatment of mild to moderate upper genital tract infections (see section 2. What you need to know before 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 infusion solution, your doctor may prescribe moxifloxacino tablets to complete the treatment course of:

• 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 pneumonia.

Consult your doctor if you are unsure if you belong to any of the patient groups described below.

Do not take Moxifloxacino Sandoz:

• if you are allergic to moxifloxacino, other quinolonas or any of the other components of this medication (including in section 6),
• if you are pregnant or breastfeeding,
• if you are under 18 years old,
• if you have a history of tendon damage or lesions related to antibiotic quinolone treatment (see sections “Warnings and precautions” and 4. “Possible side effects”),
• if you were born with, have or had
• any disease related to an abnormal heart rhythm (observed on ECG, heart electrical recording),
• if you have electrolyte imbalances in the blood (especially low levels of potassium or magnesium in the blood),
• if you have a very slow heart rate (called “bradycardia”),
• if you have a weak heart (heart failure),
• if you have a history of heart rhythm disturbances

or

• if you are taking other medications that cause ECG disturbances (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

Do not take fluoroquinolone or quinolone antibacterial medications, including moxifloxacino, if you have had a severe reaction to a quinolone or fluoroquinolone in the past. If this is the case, inform your doctor as soon as possible.

Consult your doctor before starting to take Moxifloxacino Sandoz:

• moxifloxacino maymodify the ECG of the heart, especially if you are a woman or an elderly patient. If you are currently taking any medication that causes a decrease in blood potassium levels, consult your doctor before taking moxifloxacino (see also sections “Do not take Moxifloxacino Sandoz” and “Other medications and Moxifloxacino Sandoz”),
• if you suffer fromepilepsyor another condition that may causeseizures, consult your doctor before taking moxifloxacino,
• if you have or have ever had anymental health problems, consult your doctor before taking moxifloxacino,
• if you havemyasthenia 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 alarge blood vessel aneurysmor a “bulge” of a large blood vessel(aortic aneurysm or a large peripheral blood vessel aneurysm),
• if you have had a previous episode ofaortic dissection(tear in the aorta wall),
• if you have been diagnosed with heart valve insufficiency,
• if you have a family history ofaortic dissection or aneurysm, congenital heart valve diseaseor 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 fromglucose-6-phosphate dehydrogenase deficiency(a rare hereditary disease), inform your doctor, who will indicate whether moxifloxacino is suitable for you,
• if you have acomplicated upper genital tract infection in women(associated with a fallopian tube and ovarian abscess or pelvic abscess), for which your doctor considers intravenous treatment, oral moxifloxacino is not suitable,
• for the treatment of amild to moderate upper genital tract infection in women, your doctor must prescribe another antibiotic in combination with moxifloxacino. If you do not notice an improvement in symptoms after 3 days of treatment, consult your doctor.
• if you are diabetic because you may experience a risk of changes in blood sugar levels with moxifloxacino,
• if you have ever developed a severe skin rash or skin peeling, blisters and/or mouth sores after taking moxifloxacino.

During treatment with Moxifloxacino Sandoz

• if you noticepalpitations or irregular heartbeatsduring the treatment period, you must inform your doctor immediately. Your doctor may perform an ECG to measure your heart rate,
• therisk of heart problemsmay increase with increasing doses. Therefore, the recommended dose should be taken,
• in rare cases, you may experience asevere allergic reactioneven with the first dose, and develop the following symptoms: chest tightness, dizziness, nausea or fainting, or feeling dizzy when standing up.In case of these symptoms, discontinue moxifloxacino administration and consult your doctor immediately,
• moxifloxacino may cause arapid and severe inflammation of the liver, which may lead to liver insufficiency that puts your life at risk (including fatal cases, see section 4. “Possible side effects”).Consult your doctor before continuing treatmentwith more tabletsif you develop symptoms such as sudden discomfort and/or discomfort associated with yellowing of the whites of the eyes, dark urine, itching, bleeding tendency or liver damage-induced cerebral disease,
• severe skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN), generalized acute pustular psoriasis (GAP) have been reported with the use of moxifloxacino, and drug reaction with eosinophilia and systemic symptoms (DRESS or drug hypersensitivity syndrome).
• SSJ/TEN may initially appear on the trunk as red, target-shaped spots or circular patches often with central blisters. They may also appear as ulcers in the mouth, throat, nose, genitals and eyes (red and swollen eyes). These severe skin reactions often precede fever and/or flu-like symptoms. The reactions may progress to generalized skin peeling and complications that may put your life at risk or be fatal.
• GAP appears at the beginning of treatment as a red, scaly and generalized rash with subcutaneous nodules and blisters accompanied by fever. The most common location: mainly localized in skin folds, trunk and upper limbs.
• DRESS initially appears with flu-like symptoms and a rash on the face, followed by a widespread rash with high body temperature, increased levels of liver enzymes in blood tests and increased levels of a type of white blood cell (eosinophilia) and enlarged lymph nodes.

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

• antibiotics quinolones, including moxifloxacino, may causeseizures. If this occurs, stop taking moxifloxacino and contact your doctor immediately,
• in rare cases, you may experiencenerve damage symptoms (neuropathy)such as pain, burning, tingling, numbness and/or weaknessespecially 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 experiencemental 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-harm behaviors such as attempted suicide (see section 4. “Possible side effects”). If you develop these reactions, treatment with moxifloxacino should be interrupted and your doctor should be informed immediately,
• you may developdiarrheaduring or after taking antibiotics, including moxifloxacino. If diarrhea is severe or persistent, or if you notice blood or mucus in your stool,stop taking moxifloxacino immediatelyand consult your doctor. In these situations, you should not take medications that slow down or stop intestinal movement,
• in rare cases, you may experiencejoint pain and swelling, inflammation or tendon 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 taking corticosteroids. Tendon inflammation and rupture can occur in the first 48 hours of treatment and even several months after stopping moxifloxacino treatment. At the first sign of tendon pain or inflammation (e.g., in the ankle, wrist, elbow, shoulder or knee), stop taking moxifloxacino, contact your doctor and keep the painful area at rest. Avoid any unnecessary exercise, as this may increase the risk of tendon rupture,
• if you experience asudden and intense pain in the abdomen, chest or back, which may be symptoms of aortic dissection or aneurysm, go to the emergency room immediately. You may be at higher risk if you are receiving systemic corticosteroids,
• if you start experiencing a sudden appearance of shortness of breath, especially when lying down, or if you notice swelling in your ankles, feet or abdomen or palpitations (sensation of rapid or irregular heartbeat), inform your doctor immediately,
• if you are an elderly person and havekidney problems, ensure that your fluid intake is sufficient, as dehydration may increase the risk of kidney insufficiency,
• if your vision worsens or if you experience any othereye problemsduring moxifloxacino treatment,consult an ophthalmologist immediately(see sections “Driving and operating machinery” and 4. “Possible side effects” ),
• 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 may cause a loss of consciousness (hypoglycemic coma) (see section 4.Possible side effects). If you have diabetes, your blood sugar levels should be carefully controlled.
• quinolone antibiotics may increase your skin's sensitivity to sunlight or UV light. You should avoid prolonged exposure to sunlight or direct sunlight and not use sunbeds or any type of UV lamp during moxifloxacino administration, (see section 4. Possible side 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 your blood sugar levels above normal levels (hyperglycemia) or a decrease in your blood sugar levels below normal levels, which in severe cases may cause a loss of consciousness (hypoglycemic coma) (see section4, Possible side effects). This is important for people with diabetes. If you have diabetes, your blood sugar levels should be carefully controlled.

Severe, prolonged and potentially irreversible incapacitating effects.

Fluoroquinolone or quinolone antibacterial medications, including moxifloxacino, have been associated with rare but severe adverse effects, some of which were of long duration (persistent for months or years), incapacitating or potentially irreversible. This includes pain in tendons, muscles and joints of the upper and lower limbs, difficulty walking, abnormal sensations such as pinpricks, 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 with the treatment, also considering the use of an antibiotic of another class.

Children and adolescents

Do not administer this medication to children and adolescents under 18 years old because 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 takenrecentlyor may need to take any other medication.

When taking moxifloxacino, you should be aware of the following:

• if you are taking moxifloxacino andother medications that affect the heart, there is a higher risk of heart rhythm disturbances. Therefore, do not take moxifloxacino at the same time as the following medications:
• antiarrhythmic medications (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide),
• antipsychotics (e.g., phenothiazines, pimozide, sertindole, haloperidol, sulpiride),
• tricyclic antidepressants,
• some antimicrobials (e.g., saquinavir, sparfloxacin, erythromycin administered intravenously, pentamidine, antimalarials, particularly halofantrine),
• some antihistamines (terfenadine, astemizole, mizolastine),
• other medications (e.g., cisapride, vincamine intravenously, bepridil and difemanil),

• inform your doctor if you are taking other medications that may decrease blood potassium levels (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 disturbances,
• any other medication that contains magnesium or aluminum(such as antacids for indigestion) or any medication that containsiron, zincordidanosineor medications that containsucralfate(for treating gastrointestinal disorders) may reduce the action of moxifloxacino tablets. Therefore, take your moxifloxacino tablets 6 hours before or after taking other medications,
• the oral administration ofactivated charcoalmedicinal at 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 takingblood thinners(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 intend to become pregnant, consultyour doctor or pharmacist before using this medication.

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

Driving and operating machinery

Moxifloxacino may cause dizziness or drowsiness or a brief loss of consciousness, you may also experience a sudden and temporary loss of vision, or you may faint for a short time. 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 coated tablet; it is essentially “sodium-free”.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist.This medication should be taken exactly as directed by your doctor or pharmacist.If you are unsure, 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 approximately at 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:

• Acute exacerbation of chronic bronchitis: 5 to 10 days,
• Pulmonary infections (pneumonias), except for hospital-acquired pneumonias: 10 days.
• Acute bacterial sinusitis: 7 days,
• Mild to moderate upper genital tract infections in females (pelvic inflammatory disease), including fallopian tube infection and uterine mucosal membrane infection: 14 days.

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

• Community-acquired pulmonary infections (pneumonias): 7 to 14 days.

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

• Soft tissue and skin infections: 7 to 21 days.

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

It is essential to complete the treatment, even if you start feeling better after a few days. If you interrupt the treatment with moxifloxacino too soon, the infection may not be completely cured, the infection may recur, or your condition may worsen, and it may also lead to bacterial resistance to moxifloxacino.

Do not exceed the recommended dose and duration of treatment (see section2. What you need to know before starting to take 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, bring the remaining medication, the packaging, or this leaflet to show your 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 ingested.

If you forget to take Moxifloxacino Sandoz

In case of forgotten doseyou should take the tablet as soon as you remember iton the same day. If you miss a dose, take the normal dose (one tablet) the next day. Do not take a double dose to compensate for the missed doses.

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

If you interrupt the treatment with Moxifloxacino Sandoz

If you interrupt the treatment with this medication too soon, your infection may not be completely cured. Consult your doctor if you plan to stop taking the tablets before completing the treatment.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Themost serious side effectsobserved during treatment with moxifloxacino are listed below:

If you notice

• an abnormally fast heart rate (rare side effect),
• sudden feeling of discomfort or notice a yellowish color of the white of the eyes, dark urine, skin itching, tendency to bleed or disturbances in thought or vigilance (these may be signs and symptoms of a fulminant liver inflammation that can lead to potentially fatal liver insufficiency (very rare secondary cases have been observed)),
• severe skin eruptions including Stevens-Johnson syndrome and toxic epidermal necrolysis. These may appear on the trunk as red macules in the shape of a target or circular patches often with blisters in the center, skin peeling, mouth, throat, nose, genital, and eye ulcers and may be preceded by fever and flu-like symptoms (very rare side effects, with possible life-threatening risk),
• a red, scaly, and generalized rash with bumps under the skin and blisters accompanied by fever at the beginning of treatment (acute generalized pustular psoriasis) (the frequency of this side effect is "unknown"),
• generalized rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), lymph node enlargement, and involvement of other body organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug-induced hypersensitivity syndrome) (the frequency of this side effect is “unknown”),
• syndrome associated with water loss and low sodium levels (SIADH) (very rare side effect),
• loss of consciousness due to severe decrease in blood sugar levels (hypoglycemic coma) (very rare side effect),
• inflammation of blood vessels (the signs may be red patches on the skin, usually on the legs or effects such as joint pain),
• severe allergic reaction, sudden, and generalized, which can cause life-threatening shock in very rare cases (e.g., difficulty breathing, low blood pressure, rapid pulse),
• swelling including possible respiratory tract swelling (rare side effect that 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 that lead to self-harm, such as suicidal thoughts or attempts),
• madness (which can potentially lead to self-harm, such as suicidal thoughts or attempts),
• severe diarrhea with blood and/or mucus (antibiotic-associated colitis, including pseudomembranous colitis), which in very rare cases can cause life-threatening complications (rare side effect),
• tendon pain and inflammation (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 may 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 "unknown").

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 irregular heartbeats that put your life at risk (Torsade de Pointes) or interruption of 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 levels increase or decrease (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 may be signs and symptoms of kidney insufficiency. rare side effect),consult your doctor immediately..

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

Frequent, may affect up to 1 in 10 people:

• infections caused by resistant bacteria or fungi such as oral infections and vaginal infections caused by Candida (thrush),
• headache,
• dizziness,
• unwellness (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 blood levels of a liver enzyme (transaminases).

Rare, may affect up to1 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 count of certain white blood cells (leukocytes, neutrophils),
• constipation,
• itching,
• feeling of dizziness (giró or fall),
• drowsiness,
• gas,
• change in heart rhythm (ECG),
• liver function alteration (including increase of a special liver enzyme in the blood (LDH),
• decreased appetite and food intake,
• low count of white blood cells,
• back, chest, pelvis, and limb pain,
• increase in blood cells necessary for blood coagulation,
• sweating,
• increase in certain white blood cells (eosinophils),
• anxiety,
• feeling of unwellness (predominantly weakness or fatigue),
• shaking,
• 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 pins and needles and/or numbness,
• skin hives
• enlargement 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,
• increase in blood fats (lipids),
• low count of red blood cells,
• muscle pain,
• allergic reaction,
• increase in bilirubin in the blood,
• stomach inflammation,
• dehydration,
• severe abnormalities in heart rhythm,
• dry skin,
• angina pectoris.

Rare, may affect up to1 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 insufficiency (including increased special laboratory test results of the kidneys, such as urea and creatinine),
• liver inflammation,
• mouth inflammation,
• ringing in the ears,
• jaundice (yellowish color of the white of the eyes or skin),
• skin sensation deterioration,
• abnormal dreams,
• concentration alteration,
• difficulty swallowing,
• changes in sense of smell (including loss of smell),
• balance and coordination disorder (due to dizziness),
• partial or total loss of memory,
• auditory deterioration, including deafness (usually reversible),
• increase in uric acid in the blood,
• emotional instability,
• difficulty speaking,
• syncope,
• muscle weakness.

Very rare, may affect up to1 in 10,000 people:

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

Unknown(cannot be estimated from available data),

• loss of consciousness due to severe decrease in blood sugar levels (hypoglycemic coma). See section 2.
• increase in skin sensitivity to sunlight or UV radiation (see also section 2, Warnings and precautions)
• clearly demarcated 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 skin or mucosa location with subsequent exposure to moxifloxacino.

Additionally, very rare cases of the following side effects have been reported after treatment with other quinolone antibiotics, which may 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 cells (hemolytic anemia).

The administration of quinolone and fluoroquinolone antibiotics has been associated with very rare cases of long-lasting or permanent adverse reactions (even months or years after treatment), such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as pins and needles, numbness, tingling, burning, or pain (neuropathy), depression, fatigue, sleep disorders, decreased memory, 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 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 prospectus. You can also report them directly through theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the 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 appearing on the packaging, blister pack and HDPE bottle after CAD/EX. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Moxifloxacino Sandoz

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

Appearance of the product and content of the container

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

Dimensions: approximately 17.6 mm x 7.6 mm

Container sizes:

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

Only some container sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing

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

Last review date of this leaflet:June 2024

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