MOXIFLOXACIN STADA 400 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Moxifloxacino Stada 400 mg film-coated tablets EFG

For use only in adults

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

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

Contents of the Package Leaflet

1. What is Moxifloxacino Stada and what is it used for
2. What you need to know before taking Moxifloxacino Stada
3. How to take Moxifloxacino Stada
4. Possible side effects
5. Storage of Moxifloxacino Stada
6. Package contents and additional information

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

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

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

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

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

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

Sinus infection, sudden worsening of long-term airway inflammation or community-acquired pneumonia (except severe cases).

Mild or moderate upper female genital tract infections (pelvic inflammatory disease), including fallopian tube infection and uterine mucous membrane infection. For this type of infection, moxifloxacino tablets are not sufficient as sole treatment; therefore, your doctor will also prescribe another antibiotic for the treatment of mild or moderate upper female genital tract infections (see section 2. What you need to know before taking Moxifloxacino Stada, Warnings and precautions,Consult your doctor or pharmacist before taking Moxifloxacino Stada).

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

Community-acquired pneumonia, skin and soft tissue infections.

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

2. What you need to know before you start taking Moxifloxacino Stada

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

DO NOT take Moxifloxacino Stada

• 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 section 2. Warnings and precautionsand section 4. Possible adverse effects)
• If you were born with or suffer from:

• any disease characterized by an abnormal heart rhythm (observed in ECG, electrical record 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")
• a weak heart (heart failure)
• a history of heart rhythm disorders (arrhythmias)

or

• you are taking other medications that produce disorders in the ECG (see section "Other medications and Moxifloxacino Stada"). 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

Consult your doctor or pharmacist before starting to take Moxifloxacino Stada.

• 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 Stada and Other medications and Moxifloxacino Stada)
• If you suffer from epilepsyor another condition 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 produces weakness and in severe cases paralysis), the symptoms of your disease may worsen if you take moxifloxacino. If you think this affects you, consult your doctor immediately.
• If you or a family member has 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(e.g., associated with an abscess in the fallopian tubes and ovary or pelvis), for which your doctor considers intravenous treatment necessary, treatment with moxifloxacino tablets is not appropriate.
• For the treatment of a mild to moderate infection of the upper female genital tract, your doctor must prescribe another antibiotic along with moxifloxacino. If after three days of treatment you do not notice an improvement in symptoms, consult your doctor.
• If you have been diagnosed with an enlargement or "bulge" of a large blood vessel (aortic aneurysm or peripheral aneurysm of a large vessel).
• If you have experienced a previous episode of aortic dissection (a tear in the aortic wall).
• If you have been diagnosed with a heart valve disorder (regurgitation of the heart valves).
• If you have a family history of aortic dissections 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)).
• You should not take antibacterial medications that contain fluoroquinolones or quinolones, including moxifloxacino, if you have experienced any severe adverse reaction in the past when taking a quinolone or fluoroquinolone. If this is the case, you should inform your doctor as soon as possible.
• If you are diabeticbecause you may experience a risk of change in blood sugar levels with moxifloxacino.
• If you have ever developed a severe skin rashor skin peeling, blisters, and/or sores in the mouthafter taking moxifloxacino.

If you feel a sudden and severe pain in the abdomen, chest, or back, go to the emergency room immediately.

During treatment with Moxifloxacino Stada

• If you notice palpitations orthatyourheartbeats areirregularduring the treatment period, you should inform your doctor immediately. Your doctor may perform an ECG to measure your heart rate.
• The risk of heart problemsmay increase with an increase in dose. Therefore, you should take the recommended dose.
• In rare cases, you may suffer a sudden severe allergic reaction(anaphylactic shock) even with the first dose. The symptoms may be: chest tightness, dizziness, nausea, or fainting, or feeling 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). If you suddenly feel unwell and/or feel discomfort and have a yellowish color in the whites of your eyes, dark urine, skin itching, tendency to bleed, or brain disease induced by liver damage (symptoms of reduced liver function or severe liver inflammation), please consult your doctor beforecontinuing treatment.
• Quinolone antibiotics, including moxifloxacino, may cause seizures. If this occurs, treatment with moxifloxacino should be discontinued, and you should contact your doctor immediately.
• In rare cases, you may experience nerve damage symptoms(neuropathy) such as pain, burning, tingling, numbness, and/or weakness, especially in the feet and legs or hands and arms. If this happens, stop taking moxifloxacino and inform your doctor immediately to prevent the development of a potentially irreversible disorder.
• You may experience mental health problemseven after the first administration of quinolone antibiotics, including 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, you should discontinue treatment with moxifloxacino and inform your doctor 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 your stool, stop taking moxifloxacino immediately and consult your doctor. In these situations, you should not take medications that interrupt or slow down intestinal movement.
• In rare cases, pain and swelling in the joints and inflammation or rupture of the tendonsmay 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 discontinuing 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 to experience 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 elderly and have kidney problems, make sure to drink plenty of water while taking moxifloxacino. If you become dehydrated, you may increase the risk of kidney failure.
• If your vision worsensor if your eyes seem to be affected in any other way, consult an ophthalmologist immediately(see sections 2. Driving and using machinesand 4. Possible adverse effects).
• Quinolone antibiotics may cause an increase in your blood sugar level above normal levels (hyperglycemia) or a decrease in your blood sugar level below 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 level should be carefully controlled.
• Quinolone antibiotics may increase the sensitivity of the skin to sunlight or UV. You should avoid prolonged exposure to sunlight or direct sunlight and should not use sunbeds or any type of UV lamp during 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.
• Severe, 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 the treatment, also considering the use of an antibiotic of another class.

Severe skin reactions

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

• SSJ/NET may initially appear on the trunk as reddish grains in a target shape 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 appears 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.

Children and adolescents

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

Other medications and Moxifloxacino Stada

Tell your doctor or pharmacist if you are taking, have recently taken, or may 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 group of antiarrhythmics (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide)
• antipsychotics (e.g., phenothiazines, pimozide, sertindole, haloperidol, sultopride)
• tricyclic antidepressants
• some antimicrobials (e.g., saquinavir, sparfloxacin, erythromycin intravenously, pentamidine, antimalarials, particularly halofantrine)
• some antihistamines (e.g., terfenadine, astemizole, mizolastine)
• other medications (e.g., cisapride, vincamine intravenously, bepridil, and difemanil)

• You should inform your doctor if you are taking other medications that may decrease potassium levels in the blood (e.g., some 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 while taking moxifloxacino.
• Any other medication that contains magnesium or aluminum(such as antacids for indigestion), iron, zinc, or didanosine, or any medication that contains sucralfate (for gastrointestinal disorders)may reduce the effect of moxifloxacino. Take your moxifloxacino tablets 6 hours before or after taking other medications.
• Taking oral activated charcoalat the same time as moxifloxacino reduces the effect of moxifloxacino. Therefore, it is recommended not to use these medications simultaneously.
• If you are currently taking blood-thinning medications(oral anticoagulants such as warfarin), your doctor may need to monitor your blood coagulation time.

Use of Moxifloxacino Stada with food and beverages

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

Pregnancy, breastfeeding, and fertility

Do not use moxifloxacino 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 your fertility may be altered by taking this medication.

Driving and using machines

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

Moxifloxacino Stada contains sodium

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

3. How to take Moxifloxacino Stada

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

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

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

Method of administration

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

Duration of treatment

The length of time you will take moxifloxacino depends on your infection. Unless your doctor has told you otherwise, your treatment will be as follows:

• for sudden worsening (acute exacerbation) of chronic bronchitis: 5-10 days
• for lung infections (pneumonia) except for pneumonia that starts during a hospital stay: 10 days
• for 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 tablets are used to complete a treatment cycle started with moxifloxacino solution for infusion, the recommended durations of use are:

• lung infection (pneumonia) acquired outside the hospital: 7-14 days

Most patients with pneumonia were switched to oral treatment with moxifloxacino film-coated tablets in 4 days.

• skin and soft tissue infections: 7-21 days

Most patients with skin and soft tissue infections were switched to oral treatment with moxifloxacino film-coated tablets in 6 days.

It is important to take the complete treatment, even if you start to feel better after a few days. If you interrupt the treatment too early, the infection may not be completely cured, and the infection may return or your condition may worsen. The bacteria that cause your infection may become resistant to moxifloxacino.

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

If you take more Moxifloxacino Stada than you should

If you take more than one of the recommended tablets per day, consult your doctor immediately. Try tobring the remaining medication, packaging, or leaflet to show the doctor or pharmacist what you have taken.

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

If you forget to take Moxifloxacino Stada

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

If you are not sure what to do, consult your doctor or pharmacist.

If you stop taking Moxifloxacino Stada

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The most serious side effectsobserved during treatment with moxifloxacino are listed below:

If you feel

• an abnormal fast heart rhythm (rare side effect)
• that you suddenly start to feel unwell or notice a yellowish color of the whites of the eyes, dark urine, itching of the skin, tendency to bleed, or alterations in thought or wakefulness (these can be signs and symptoms of a severe liver inflammation that can lead to life-threatening liver failure)
• 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 patches often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes, and can be preceded by fever and flu-like symptoms (very rare side effects, potentially life-threatening)
• a red, scaly, and widespread rash with bumps under the skin and blisters accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis) (the frequency of this side effect is "not known")
• a widespread rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes, and involvement of other body organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome) (the frequency of this side effect is "not known")

• syndrome associated with altered 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)
• a severe and sudden generalized allergic reaction, including very rarely a life-threatening shock (e.g., difficulty breathing, low blood pressure, rapid pulse) (rare side effect)
• swelling, including swelling of the airways (rare side effect, potentially fatal)
• 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 that contains blood and/or mucus (antibiotic-associated colitis, including pseudomembranous colitis), which in very rare circumstances can lead to life-threatening complications (rare side effects)
• pain and swelling of the tendons (tendinitis) (rare side effect) or tendon rupture (very rare side effect)
• muscle weakness, sensitivity, or pain, particularly if you also feel unwell, have a fever, or your urine is dark. These symptoms can be caused by abnormal muscle breakdown 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 Stada and inform your doctor immediately,as you may need urgent medical attention.

Additionally, if you feel

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

contact an ophthalmologist immediately.

If you have experienced a life-threatening irregular heartbeat (Torsade de Pointes) or interruption of heartbeats while taking moxifloxacino (very rare side effects), inform your treating 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), inform your doctor immediately.

If you are an elderly patient with existing 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, a rare side effect), consult your doctor immediately.

Other side effectsthat have been observed during treatment with moxifloxacino are listed below according to their frequency:

Common (may affect up to 1 in 10 people)

• nausea
• diarrhea
• dizziness
• stomach and abdominal pain
• vomiting
• headache
• increase in a special liver enzyme in the blood (transaminases)
• infections caused by resistant bacteria or fungi, e.g., oral and vaginal infections caused by Candida
• change in heart rhythm (ECG) in patients with low potassium levels in the blood

Uncommon (may affect up to 1 in 100 people)

• rash
• stomach discomfort (indigestion/heartburn)
• changes in taste (in very rare cases, loss of taste)
• sleep problems (predominantly insomnia)
• increase in a special liver enzyme in the blood (gamma-glutamyl-transferase and/or alkaline phosphatase)
• low levels of special white blood cells (leukocytes, neutrophils)
• constipation
• itching
• feeling of dizziness (spinning or falling)
• drowsiness
• wind
• change in heart rhythm (ECG)
• liver function alteration (including increase in a special liver enzyme in the blood (LDH))
• decreased appetite and food intake
• low white blood cell count
• pain in the back, chest, pelvis, and limbs
• increase in special blood cells necessary for blood clotting
• sweating
• increase in specialized 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 special digestive enzyme in the blood (amylase)
• restlessness/agitation
• feeling of tingling (tingling) and/or numbness
• hives on the skin
• vasodilation
• confusion and disorientation
• decrease in special 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
• gastritis
• dehydration
• severe heart rhythm abnormalities
• dry skin
• angina pectoris

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

• muscle spasms
• muscle cramps
• hallucinations
• high blood pressure
• swelling (of the hands, feet, ankles, lips, mouth, throat)
• low blood pressure
• kidney failure (including increased results of special kidney laboratory tests, 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)
• worsening of skin sensation
• abnormal dreams
• disturbed concentration
• difficulty swallowing
• changes in smell (including loss of smell)
• balance and coordination disorders (due to dizziness)
• partial or total loss of memory
• hearing impairment, including deafness (generally reversible)
• increase in blood uric acid levels
• 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 detachment (not being yourself)
• increase in blood clotting
• muscle stiffness
• significant decrease in special white blood cells (agranulocytosis)
• decrease in the number of red and white blood cells and platelets (pancytopenia)

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

• syndrome associated with altered water elimination and low sodium levels (SIADH)
• 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 and may also occur during treatment with moxifloxacino:

• Increased pressure in the skull (symptoms include headache, visual problems such as blurred vision, blind spots, double vision, loss of vision)
• Increased sodium levels in the blood
• Increased 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), 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 cardiac valve failure in patients who have received fluoroquinolones. See also section 2.

Reporting of side effects

If you experience any side effect, consult your doctor or pharmacist, even if it is a possible side effect 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 medicine.

5. Conservation of Moxifloxacino Stada

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date that appears on the box and on the blister after CAD. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from moisture.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines that you no longer need in the SIGRE Point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This way, you will help protect the environment.

6. Container Content and Additional Information

Composition of Moxifloxacino Stada

• The active ingredient is moxifloxacin.

A film-coated tablet contains 400 mg of moxifloxacin equivalent to 436.80 mg of moxifloxacin hydrochloride.

• The other components are:

Core of the tablet:

Microcrystalline cellulose

Povidone K-30

Croscarmellose sodium

Anhydrous colloidal silica

Magnesium stearate

Coating film:

Hypromellose

Propylene glycol

Titanium dioxide (E171)

Talc

Red iron oxide (E172)

Appearance of the product and container content

Moxifloxacino Stada 400 mg are film-coated tablets of pink color, oblong, biconvex, approximately 17.6 mm long and 6.9 mm wide.

Moxifloxacino Stada 400 mg film-coated tablets are packaged in boxes containing aluminum/PVC/PVdC blisters. Package sizes: 5, 7, 10, 14, 15, and 20 film-coated tablets or 5x1, 7x1, 10x1, 14x1, 15x1, 20x1 film-coated tablets (unit dose).

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratory STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

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

Germany: Moxifloxacin Stada 400 mg Filmtabletten

Belgium: Moxifloxacine EG 400 mg filmomhulde tabletten

Finland: Moxifloxacin Stada 400 mg tabletti, kalvopäällysteinen

Slovenia: Moksifloksacin Stada 400 mg filmsko obložene tablete

Spain: Moxifloxacino Stada 400 mg comprimidos recubiertos con película EFG

Luxembourg: Moxifloxacine EG 400 mg, comprimés pelliculés

Portugal: Moxifloxacina Ciclum 400 mg comprimidos revestidos por película

Date of the last revision of this prospectus: January 2025

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