Moxifloxacin Sandoz 400 mg film-coated tablets EFG: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Moxifloxacino Sandoz 400 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only, and you should not give it to other people even if they have the same symptoms as you, because it could harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are

adverse effects not listed in this leaflet. See section 4.

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

What you need to know before taking Moxifloxacino Sandoz
How to take Moxifloxacino Sandoz
Possible side effects
How to store Moxifloxacino Sandoz
Contents of the pack and other information

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

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

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

It is important to follow your doctor's instructions regarding dosage, dosing interval, and duration of treatment.

Do not store or reuse this medicine. If you have any antibiotic left after completing the treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of via wastewater or household waste.

Moxifloxacin is indicated in patients aged 18 years and older for the treatment of the following bacterial infections when caused by bacteria to which moxifloxacin is active. Moxifloxacin should only be used to treat these infections when commonly used antibiotics cannot be taken or are ineffective:

Sinus infection, sudden worsening of long-term airway inflammation, or community-acquired pneumonia (except severe cases).
Mild to 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 these types of infections, moxifloxacin tablets alone are not sufficient as sole therapy. Therefore, in addition to moxifloxacin tablets, your doctor must prescribe another antibiotic for the treatment of mild to moderate upper female genital tract infections (see section 2. What you need to know before taking Moxifloxacin Sandoz, Warnings and precautions, Consult your doctor before taking Moxifloxacin Sandoz).

If either of the following infections has shown improvement during initial treatment with moxifloxacin infusion solution, your doctor may prescribe moxifloxacin tablets to complete the course of treatment:

Community-acquired lung infection (pneumonia),
Skin and soft tissue infections.

Moxifloxacin tablets should not be used to initiate treatment of skin and soft tissue infections or of severe lung infections.

2. What you need to know before taking Moxifloxacino Sandoz

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

Do not take Moxifloxacino Sandoz:

if you are allergic to the active substance moxifloxacin, to other quinolones, or to any of the other ingredients of this medicine (listed in section 6),
if you are pregnant or breastfeeding,
if you are under 18 years of age,
if you have a history of tendon disorders or tendon injuries related to treatment with quinolone antibiotics (see sections “Warnings and precautions” and 4. “Possible side effects”),
if you were born with, have, or have had
any condition associated with abnormal heart rhythm (as seen on ECG, the electrical recording of the heart),
electrolyte imbalances in the blood (especially low levels of potassium or magnesium in the blood),
a very slow heart rate (called “bradycardia”),
heart failure,
a history of heart rhythm disorders,

you are taking other medicines that cause ECG abnormalities (see section “Other medicines and Moxifloxacino Sandoz”). This is because moxifloxacin may cause changes in the ECG, such as QT interval prolongation, which means delayed electrical conduction in the heart.
If you have severe liver disease or if liver enzyme levels (transaminases) increase to 5 times above the upper limit of normal.

Warnings and precautions

Before starting this medicine

Do not take antibacterial medicines containing fluoroquinolones or quinolones, including moxifloxacin, if you have previously experienced a serious adverse reaction to a quinolone or fluoroquinolone. If this applies to you, inform your doctor as soon as possible.

Talk to your doctor before taking Moxifloxacino Sandoz:

moxifloxacin may alter the heart ECG, especially if you are a woman or an elderly patient. If you are currently taking any medication that causes low potassium levels in the blood, consult your doctor before taking moxifloxacin (see also sections “Do not take Moxifloxacino Sandoz” and “Other medicines and Moxifloxacino Sandoz”),
if you have ever developed a severe skin rash, skin peeling, blisters and/or mouth sores after taking moxifloxacin,
if you have epilepsy or any other condition that may cause 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 (abnormal muscle fatigue leading to weakness and, in severe cases, paralysis), your symptoms may worsen if you take moxifloxacin. If you think this applies to you, consult your doctor immediately,
if you have been diagnosed with enlargement or a “bulge” in a large blood vessel (aortic aneurysm or peripheral large vessel aneurysm),
if you have previously experienced aortic dissection (a tear in the wall of the aorta),
if you have been diagnosed with heart valve insufficiency (heart valve regurgitation),
if you have a family history of aortic dissection or aortic aneurysm, 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, Behcet’s disease, hypertension, known atherosclerosis, rheumatoid arthritis (a joint disease), or endocarditis (a heart infection)),
If you are diabetic, because you may be at risk of changes in blood sugar levels with moxifloxacin,
if you or a family member has glucose-6-phosphate dehydrogenase deficiency (a rare inherited condition), inform your doctor, who will determine whether moxifloxacin is suitable for you,
if you have a complicated upper female genital tract infection (associated with a tubo-ovarian or pelvic abscess), for which your doctor considers intravenous treatment necessary, treatment with moxifloxacin tablets is not appropriate,
for the treatment of a mild to moderate upper female genital tract infection, your doctor should prescribe another antibiotic in addition to moxifloxacin. If you do not notice improvement in symptoms after 3 days of treatment, consult your doctor.

During treatment with Moxifloxacino Sandoz

if you experience palpitations or irregular heartbeat during treatment, you must inform your doctor immediately. They may perform an ECG to monitor your heart rhythm,
the risk of heart problems may increase with higher doses. Therefore, the recommended dose should be taken,
rarely, you may experience a sudden, severe allergic reaction (anaphylactic reaction or shock), even after the first dose, with symptoms such as chest tightness, dizziness, nausea, fainting, or vertigo upon standing. If these symptoms occur, stop taking moxifloxacin and consult your doctor immediately,
moxifloxacin may cause rapid and severe liver inflammation, which may lead to life-threatening liver failure (including fatal cases, see section 4. “Possible side effects”). Consult your doctor before continuing treatment if you develop symptoms such as sudden malaise and/or malaise associated with yellowing of the whites of the eyes, dark urine, skin itching, tendency to bleed, or brain disease caused by liver damage (symptoms of reduced liver function or severe liver inflammation),
serious skin reactions have been reported with moxifloxacin use, including Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN), acute generalized exanthematous pustulosis (AGEP), and drug reaction with eosinophilia and systemic symptoms (DRESS syndrome or drug hypersensitivity syndrome).
SJS/TEN may initially appear on the trunk as red, target-like spots or circular patches, often with central blisters. Ulcers may also develop in the mouth, throat, nose, genitals, and eyes (red, swollen eyes). These severe skin rashes are often preceded by fever and/or flu-like symptoms. The rashes may progress to widespread skin peeling and complications that can be life-threatening or fatal.
AGEP appears at the beginning of treatment as a widespread, red, scaly rash with bumps under the skin and blisters, accompanied by fever. The most common locations: mainly in skin folds, trunk, and upper limbs.
Drug reaction with eosinophilia and systemic symptoms (DRESS) initially presents with flu-like symptoms and a facial rash, later progressing to a widespread rash, high fever, elevated liver enzymes in blood tests, increased levels of a type of white blood cell (eosinophilia), and enlarged lymph nodes.

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

quinolone antibiotics, including moxifloxacin, may cause seizures. If this occurs, stop taking moxifloxacin and contact your doctor immediately,
Serious, prolonged, disabling, and potentially irreversible adverse reactions

Fluoroquinolone/quinolone antibacterial medicines, including moxifloxacin, have been associated with very rare but serious adverse effects, some of which are long-lasting (may persist for months or years), disabling, or potentially irreversible. These include pain in tendons, muscles, and joints of the upper and lower limbs, difficulty walking, abnormal sensations such as pricking, tingling, pins and needles, numbness, or burning (paresthesia), sensory disturbances such as changes in vision, taste, smell, and hearing, depression, memory impairment, severe fatigue, and serious sleep disorders.

If you experience any of these adverse effects after taking moxifloxacin, contact your doctor immediately before continuing treatment. You and your doctor will decide whether to continue treatment, considering also the possibility of using an antibiotic from another class.

rarely, you may experience symptoms of nerve damage (neuropathy) such as pain, burning, tingling, numbness, and/or weakness, especially in the feet and legs or hands and arms. If this occurs, stop taking moxifloxacin and inform your doctor immediately to prevent the development of a potentially irreversible disorder,
you may experience mental health problems even after the first dose of quinolone antibiotics, including moxifloxacin. In very rare cases, mental health problems and depression have progressed to suicidal thoughts and self-harming behaviors such as suicide attempts (see section 4. “Possible side effects”). If you develop these reactions, treatment with moxifloxacin must be stopped and you must inform your doctor immediately,
you may develop diarrhea during or after taking antibiotics, including moxifloxacin. If diarrhea is severe or persistent, or if you notice blood or mucus in your stool, stop taking moxifloxacin immediately and consult your doctor. In these situations, do not take medicines that stop or slow intestinal movement,
rarely, joint pain and swelling, and tendon inflammation or rupture may occur. The risk is higher if you are elderly (over 60 years), have received an organ transplant, have kidney problems, or are taking corticosteroids. Tendon inflammation and rupture may occur within the first 48 hours of treatment or even several months after stopping moxifloxacin. At the first sign of tendon pain or swelling (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking moxifloxacin, contact your doctor, and rest the affected area. Avoid unnecessary physical activity, as this may increase the risk of tendon rupture,
if you experience sudden, severe abdominal, chest, or back pain, which may be symptoms of aortic dissection or aneurysm, go immediately to the emergency department. The risk may increase if you are receiving systemic corticosteroid treatment,
if you suddenly develop shortness of breath, especially when lying down, or notice swelling in your ankles, feet, or abdomen, or the onset of palpitations (sensation of rapid or irregular heartbeat), inform your doctor immediately,
if you are elderly and have kidney problems, ensure adequate fluid intake, as dehydration may increase the risk of kidney failure,
if your vision worsens or you experience any other eye disturbances during treatment with moxifloxacin, consult an ophthalmologist immediately (see sections “Driving and use of machines” and 4. “Possible side effects”),
fluoroquinolone antibiotics may cause elevated blood sugar levels (hyperglycemia) or decreased blood sugar levels (hypoglycemia), which in severe cases may lead to loss of consciousness (hypoglycemic coma) (see section 4. “Possible side effects”). If you have diabetes, your blood sugar levels should be carefully monitored.
quinolone antibiotics may increase skin sensitivity to sunlight or UV light. You should avoid prolonged exposure to sunlight or direct sunlight and must not use sunbeds or any type of UV lamp during moxifloxacin treatment (see section 4. “Possible side effects”),
the efficacy of moxifloxacin infusion solution has not been established in the treatment of severe burns, deep tissue infections, or diabetic foot infections with osteomyelitis (bone marrow infection).

Children and adolescents

Do not give this medicine to children and adolescents under 18 years of age, as efficacy and safety have not been established in this age group (see section “Do not take Moxifloxacino Sandoz”).

Other medicines and Moxifloxacino Sandoz

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

With moxifloxacin, consider the following:

if you are taking moxifloxacin and other medicines that affect the heart, there is an increased risk of heart rhythm disturbances. Therefore, do not take moxifloxacin at the same time as the following medicines:
medicines belonging to the antiarrhythmic class (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, intravenous erythromycin, pentamidine, antimalarials, particularly halofantrine),
some antihistamines (terfenadine, astemizole, mizolastine),
other medicines (e.g., cisapride, intravenous vincamine, bepridil, and difemethil),
inform your doctor if you are taking other medicines that may reduce potassium levels in the blood (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 disturbances,
any other medicine containing magnesium or aluminium (such as antacids for indigestion) or any medicine containing iron, zinc, didanosine, or medicines containing sucralfate (used to treat gastrointestinal disorders) may reduce the effect of moxifloxacin tablets. Therefore, take your moxifloxacin tablets 6 hours before or after taking other medicines,
taking medicinal activated charcoal orally at the same time as moxifloxacin tablets reduces the effect of moxifloxacin. Therefore, it is recommended not to use these medicines simultaneously,
if you are currently taking medicines to prevent blood clots (oral anticoagulants such as warfarin), your doctor may need to monitor your blood clotting time.

Taking Moxifloxacino Sandoz with food and drinks

Moxifloxacin may be taken with or without food (including dairy products).

Pregnancy, breastfeeding, and fertility

Do not use moxifloxacin 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 medicine.

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

Driving and use of machines

Moxifloxacin may cause dizziness, lightheadedness, or brief fainting. You may also experience sudden transient loss of vision or short-term fainting. If you experience these symptoms, do not drive or operate machinery.

Moxifloxacino Sandoz contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; therefore, it is essentially “sodium-free”.

3. How to take Moxifloxacino Sandoz

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose in adults is one 400 mg tablet once daily.

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

There is no need to adjust the dose in elderly patients, patients with low body weight, or patients with kidney problems.

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

Acute exacerbation of chronic bronchitis: 5 to 10 days (acute exacerbation of chronic obstructive pulmonary disease, including bronchitis),
Community-acquired lung infections (pneumonia), except in severe cases: 10 days,
Acute bacterial sinus infections (acute bacterial sinusitis): 7 days,
Mild to moderate female upper genital tract infections (pelvic inflammatory disease), including fallopian tube infection and infection of the uterine mucous membrane: 14 days.

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

Community-acquired lung infections (pneumonia): 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 course of treatment, even if you start to feel better after a few days. If you stop moxifloxacino treatment too early, the infection may not be completely cured, it may return or worsen, and bacterial resistance to moxifloxacino may develop.

Do not exceed the recommended dose or treatment duration (see section 2. 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 the recommended number of tablets per day, contact your doctor immediately and, if possible, bring the remaining medication, packaging, or this leaflet, and show it to your doctor or pharmacist to indicate what you have taken.

You may also call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and amount ingested.

If you forget to take Moxifloxacino Sandoz

If you forget to take a dose, take the tablet as soon as you remember on the same day. If you miss a dose for 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 what to do, consult your doctor or pharmacist.

If you stop taking Moxifloxacino Sandoz

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

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

4. Possible adverse effects

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

The most serious adverse effects observed during treatment with moxifloxacin are listed below:

If you notice

abnormally fast heartbeat (rare adverse effect),
sudden feeling of unwellness or notice yellowing of the whites of the eyes, dark urine, skin itching, tendency to bleed, or disturbances in thinking or alertness (these may be signs and symptoms of fulminant liver inflammation that can lead to potentially life-threatening liver failure (very rare fatal cases have been observed)),
severe skin rashes including Stevens-Johnson syndrome and toxic epidermal necrolysis. These may appear on the trunk as red, target-like rashes or circular lesions, often with blisters in the center, skin peeling, mouth ulcers, and sores in the throat, nose, genitals, and eyes, and may be preceded by fever and flu-like symptoms (very rare adverse effects, potentially life-threatening),
a widespread red, scaly rash with bumps under the skin and blisters accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis) (frequency of this adverse effect is "not known"),
widespread rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes, and involvement of other body organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome) (frequency of this adverse effect is "not known"),
syndrome associated with impaired water excretion and low sodium levels (SIADH) (very rare adverse effect),
loss of consciousness due to severe drop in blood sugar levels (hypoglycemic coma) (very rare adverse effect),
inflammation of blood vessels (signs may include red skin spots, usually on the legs, or symptoms such as joint pain) (very rare adverse effect),
sudden, severe generalized allergic reaction, which may very rarely cause life-threatening shock (e.g., difficulty breathing, drop in blood pressure, rapid pulse) (rare adverse effect),
swelling, including possible swelling of the airways (rare adverse effect, potentially life-threatening),
seizures (rare adverse effect),
nervous system problems such as pain, burning, tingling, numbness, and/or weakness in the limbs (rare adverse effect),
depression (in very rare cases leading to self-harm, such as suicidal thoughts or suicide attempts) (rare adverse effect),
psychosis (potentially leading to self-harm, such as suicidal thoughts or suicide attempts) (very rare adverse effect),
severe diarrhea with blood and/or mucus (antibiotic-associated colitis, including pseudomembranous colitis), which in very rare circumstances may lead to life-threatening complications (rare adverse effect),
tendon pain and inflammation (tendinitis) (rare adverse effect) or tendon rupture (very rare adverse effect),
muscle weakness, tenderness, or pain, particularly if you also feel unwell, have fever, or dark urine. These symptoms may be caused by abnormal muscle breakdown that can be life-threatening and lead to kidney problems (a condition called rhabdomyolysis) (frequency of this adverse effect is "not known").

Stop taking moxifloxacin and contact your doctor immediately, as you may require urgent medical attention.

Additionally, if you notice

temporary loss of vision (very rare adverse effect),
eye discomfort or pain, especially due to light exposure (very rare to rare adverse effect),

contact an ophthalmologist immediately.

If you have experienced life-threatening irregular heartbeats (Torsade de Pointes) or cardiac arrest while taking moxifloxacin (very rare adverse effects), inform your doctor immediately that you have taken moxifloxacin and do not restart treatment.

Worsening of myasthenia gravis symptoms has been observed in very rare cases. If this occurs, contact your doctor immediately.

If you have diabetes and notice your blood sugar levels increasing or decreasing (rare or very rare adverse effects), contact your doctor immediately.

If you are an elderly patient with kidney problems and notice reduced urine output, swelling in the legs, ankles, or feet, fatigue, nausea, drowsiness, breathing difficulties, or confusion (these may be signs and symptoms of kidney failure, rare adverse effect), contact your doctor immediately.

Other adverse effects observed during treatment with moxifloxacin are listed below by frequency:

Frequent, may affect up to 1 in 10 people:

nausea
diarrhea
dizziness
stomach and abdominal pain
vomiting
headache
increase in specific liver enzymes in blood (transaminases)
infections caused by resistant bacteria or fungi, such as oral and vaginal Candida infections
electrocardiogram (ECG) changes in patients with low blood potassium levels

Uncommon, may affect up to 1 in 100 people:

rash
stomach discomfort (indigestion/heartburn)
taste disturbances (in very rare cases, loss of taste)
sleep problems (predominantly insomnia)
increase in liver enzymes in blood (gamma-glutamyl transferase and/or alkaline phosphatase)
low levels of certain white blood cells (leukocytes, neutrophils)
constipation
itching
sensation of dizziness (spinning or falling)
somnolence
flatulence
change in heart rhythm (ECG)
impaired liver function (including increase in a specific liver enzyme in blood (LDH))
decreased appetite and food intake
low white blood cell count
back, chest, pelvic, and limb pain
increased blood cells necessary for blood clotting
sweating
increase in certain white blood cells (eosinophils)
anxiety
feeling unwell (predominantly weakness or fatigue)
tremors
joint pain
palpitations
irregular and rapid heartbeat
breathing difficulties including asthmatic conditions
increase in digestive enzyme in blood (amylase)
restlessness/agitation
tingling sensation (pins and needles) and/or numbness
hives
blood vessel dilation
confusion and disorientation
decrease in certain blood cells necessary for blood clotting
visual disturbances including double and blurred vision
reduced blood clotting
increased blood lipids (fats)
low red blood cell count
muscle pain
allergic reaction
increased bilirubin in blood
stomach inflammation
dehydration
severe heart rhythm abnormalities
dry skin
angina

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

muscle spasms
muscle cramp
hallucination
high blood pressure
swelling (of hands, feet, ankles, lips, mouth, throat)
low blood pressure
kidney failure (including increased results in special kidney laboratory tests 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)
impaired skin sensation
abnormal dreams
altered concentration
difficulty swallowing
changes in smell (including loss of smell)
balance disorder and poor coordination (due to dizziness)
partial or complete memory loss
hearing impairment, including deafness (usually reversible)
increased uric acid in blood
emotional instability
difficulty speaking
fainting
muscle weakness

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

decrease in red blood cells, white blood cells, and platelets (pancytopenia)
joint inflammation
abnormal heart rhythms
increased skin sensitivity
feeling of detachment from oneself
increased blood clotting
muscle stiffness
significant decrease in certain white blood cells (agranulocytosis)

Not known (cannot be estimated from available data):

increased skin sensitivity to sunlight or UV radiation (see also section 2, Warnings and precautions)
clearly demarcated erythematous patches with or without blisters appearing within hours after administration of moxifloxacin and disappearing with residual post-inflammatory hyperpigmentation; these typically recur in the same skin or mucosal site upon subsequent exposure to moxifloxacin.

The administration of antibiotics containing quinolones and fluoroquinolones has been associated with very rare cases of long-term (even months or years) or permanent adverse reactions, such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as pricking, tingling, pins and needles, burning, numbness, or pain (neuropathy), fatigue, memory and concentration impairment, effects on mental health (which may 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 enlargement and weakening or tearing of the aortic wall (aneurysms and dissections), which could lead to rupture and potentially be fatal, and heart valve insufficiency have been reported in patients receiving fluoroquinolones. See also section 2, "Warnings and precautions."

Additionally, very rare cases of the following adverse reactions have been reported after treatment with other quinolone antibiotics, which may also occur during treatment with moxifloxacin:

Increased intracranial pressure (symptoms include headache, visual disturbances such as blurred vision, scotomas, double vision, or vision loss),
Increased blood sodium levels,
Increased blood calcium levels,
A specific type of decreased red blood cell count (hemolytic anemia).

Reporting of adverse effects

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

5. Storage of Moxifloxacin Sandoz

Keep this medicine 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 medicine after the expiry date stated on the packaging, blister, and HDPE bottle after CAD/EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the container and other information

Composition of Moxifloxacino Sandoz

The active substance is moxifloxacin.

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

The other components are: microcrystalline cellulose, corn starch, sodium carboxymethyl starch (type A) from potato, colloidal anhydrous silica, magnesium stearate, hypromellose, polyethylene glycol stearate (Type I), titanium dioxide (E-171), iron oxide red (E-172), carmine acid (E-120).

Appearance of the product and contents of the container

Film-coated, capsule-shaped, pink tablets marked with "400" on one side.

Dimensions: approximately 17.6 mm x 7.6 mm

Pack sizes:

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

Only some pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Parque Norte Business Park

Roble Building

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Novartis Pharmaceuticals S.R.L

Str. Livezeni nr. 7A

RO-540472 Targu-Mures

Romania

Salutas Pharma GmbH

Otto von Guericke Allee 1,

39179 Barleben

Germany

Lek S.A.

Ul. Domaniewska, 50 C

02-672 Warszawa

Poland

Lek Pharmaceuticals d.d.

Verovskova, 57

1526 Ljubljana

Slovenia

Lek Pharmaceuticals d.d.

Trimlini 2D,

9220 Lendava

Slovenia

Date of the most recent review of this leaflet: December 2025.

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