MOXIFLOXACIN TEVAGEN 400 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Moxifloxacino Tevagen 400 mg film-coated tablets EFG

For use 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 Tevagen and what is it used for
2. What you need to know before taking Moxifloxacino Tevagen
3. How to take Moxifloxacino Tevagen
4. Possible side effects
5. Storage of Moxifloxacino Tevagen
6. Contents of the pack and further information

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

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

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

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

For this type of infection, Moxifloxacino Tevagen is not sufficient as the only treatment; therefore, in addition to Moxifloxacino Tevagen, your doctor will prescribe another antibiotic for the treatment of upper female genital tract infections (see section 2 "Warnings and Precautions").

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

• Lung infection (pneumonia) acquired outside the hospital
• Skin and soft tissue infections

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

2. What you need to know before taking Moxifloxacino Tevagen

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

Do not take Moxifloxacino Tevagen

• if you are allergic to moxifloxacino, other quinolone antibiotics, or any of the other components of this medication (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 injuries related to treatment with quinolone antibiotics (see section 2 "Warnings and precautions" and section 4).
• if you were born with or have suffered from

any disease related to an abnormal heart rhythm (observed in ECG, electrical recording of the heart), has electrolyte imbalances in the blood (especially low potassium or magnesium levels in the blood), has a very slow heart rate (called "bradycardia"), has a weak heart (heart failure), has a history of rhythm disorders or is taking other medications that produce abnormal ECG disorders (see section 2 "Other medications and Moxifloxacino Tevagen").

This is because Moxifloxacino Tevagen 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 severe liver disease or elevated liver enzymes (transaminases) 5 times above the upper limit of normal.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Moxifloxacino Tevagen

• Moxifloxacino Tevagen may modify the heart's ECG, 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 Tevagen (see also section 2 "Do not take Moxifloxacino Tevagen" and "Other medications and Moxifloxacino Tevagen").
• If you suffer from epilepsyor another condition that may cause seizures, consult your doctor before taking Moxifloxacino Tevagen.
• If you have or have ever had any mental health problems, consult your doctor before taking Moxifloxacino Tevagen.
• If you have myasthenia gravis, your symptoms may worsen if you take Moxifloxacino Tevagen. If you think this affects you, inform your doctor immediately.
• If you have been diagnosed with an enlargement or "lump" of a large blood vessel(aortic aneurysm or large peripheral vessel aneurysm).
• If you have suffered a previous episode of aortic dissection(tear in the aortic wall).
• If you have been diagnosed with heart valve insufficiency(regurgitation of the heart valves)
• If you have a family history of aortic aneurysm or aortic dissection, congenital heart valve disease, or other risk factors or predisposing conditions (e.g., connective tissue disorders such as Marfan syndrome, Ehlers-Danlos vascular syndrome, Turner syndrome, or Sjögren's syndrome (an autoimmune inflammatory disease), or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet's disease, arterial hypertension, or atherosclerosis), or rheumatoid arthritis (a joint disease) or endocarditis (a heart infection).
• If you or a family member has glucose-6-phosphate dehydrogenase deficiency(a rare hereditary disease), inform your doctor, and they will indicate if Moxifloxacino Tevagen 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 ovaries or in the pelvis), for which your doctor considers intravenous treatment necessary, Moxifloxacino Tevagen 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 Tevagen. If you do not notice an improvement in symptoms after three days of treatment, consult your doctor.
• 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 rash or skin peeling, blisters, and/or sores in the mouth after taking moxifloxacino.

Before starting to take this medication

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

During treatment with this medication

• If you notice palpitations or irregular heartbeatsduring the treatment period, you must inform your doctor immediately. They 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.
• If you feel a strong and sudden 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 your ankles, feet, or abdomen, or the appearance of heart palpitations (feeling of rapid or irregular heartbeat), you must inform your doctor immediately.

• In rare cases, you may suffer a sudden severe allergic reaction(anaphylactic shock) even with the first dose and develop the following symptoms: chest tightness, feeling of dizziness, feeling of nausea, or fainting or feeling dizzy when standing. If you experience these symptoms, stop taking Moxifloxacino Tevagen and consult your doctor immediately.
• Moxifloxacino Tevagen may cause a rapid and severe liver inflammation, which can lead to potentially life-threatening liver failure (including fatal cases, see section 4). Please consult your doctor before continuing treatment if you develop symptoms such as a sudden feeling of discomfort and/or nausea associated with a yellowish color of the whites of the eyes, dark urine, skin itching, tendency to bleed, or brain disease induced by liver damage (symptoms of reduced liver function or rapid and severe liver inflammation).
• Quinolone antibiotics, including Moxifloxacino Tevagen, may cause seizures. If this occurs, stop taking Moxifloxacino Tevagen and contact your doctor immediately.
• In rare cases, 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 happens, stop taking Moxifloxacino Tevagen 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 Tevagen. 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). If you develop these reactions, stop taking Moxifloxacino Tevagen and inform your doctor immediately.
• You may have diarrheaduring or after taking antibiotics, including Moxifloxacino Tevagen. If it becomes intense or persistent or you notice that your stools contain blood or mucus, you must stop taking Moxifloxacino Tevagen immediately and consult your doctor.In these situations, do not take medications that inhibit or slow down intestinal movement.
• In rare cases, pain and swelling in the joints and tendon inflammation or rupturemay occur. The risk is higher if you are an elderly person (over 60 years old), have received an organ transplant, have kidney problems, or are being treated with corticosteroids. Tendon inflammation and rupture can occur within the first 48 hours of treatment and even several months after stopping treatment with Moxifloxacino Tevagen. At the first sign of pain or tendon inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking Moxifloxacino Tevagen, 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 strong and sudden pain in the abdomen, chest, or back, go to the emergency room immediately.
• If you are elderly and have kidney problems, be careful to drink enough fluids, as dehydration can increase the risk of kidney failure.
• If your vision worsens or your eyes seem to be affected in any other way, consult an eye doctor immediately(see sections 2 "Driving and using machines" and 4).
• Antibiotics like fluoroquinolones may cause an increase in your blood sugar levels above normal levels (hyperglycemia) or a decrease in your blood sugar levels below normal levels (hypoglycemia), which in severe cases can lead to loss of consciousness (hypoglycemic coma) (see section 4. Possible adverse effects). If you have diabetes, your blood sugar levels must be carefully controlled.
• Quinolone antibiotics may increase skin sensitivity to sunlight or UV. You should avoid prolonged exposure to sunlight or direct sunlight and not use sunbeds or any type of UV lamp during treatment with Moxifloxacino Tevagen.
• 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 skin reactions

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

• Stevens-Johnson syndrome/TEN may initially appear on the trunk as reddish targets 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 widespread skin peeling and complications that can be life-threatening or fatal.
• AGEP appears at the start of treatment as a red, scaly, and generalized rash with bumps under the skin and blisters accompanied by fever. The most common location is mainly localized in skin folds, trunk, and upper limbs.

The drug reaction with eosinophilia and systemic symptoms (DRESS) initially appears with 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 eosinophils (a type of white blood cell) and enlarged lymph nodes. If you develop a severe rash or any of these skin symptoms, stop taking moxifloxacino and contact your doctor or seek medical attention immediately.

Severe, long-lasting, and potentially irreversible adverse effects

Antibacterial medications containing fluoroquinolones or quinolones, including Moxifloxacino Tevagen, 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, prickling, numbness, or burning (paresthesia), sensory disorders such as decreased vision, taste, smell, and hearing, depression, decreased memory, intense fatigue, and severe sleep disorders.

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

Children and adolescents

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

Using Moxifloxacino Tevagen with other medications

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

With Moxifloxacino Tevagen, you should consider the following:

• If you are taking Moxifloxacino Tevagen and other medications that affect the heart, there is a greater risk of heart rhythm disorders. Therefore, do not take Moxifloxacino Tevagen at the same time as the following medications:

• medications belonging to the class of antiarrhythmics (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide),
• antipsychotics (e.g., phenothiazines, pimozide, sertindole, haloperidol, sultopride),
• tricyclic antidepressants,
• some antimicrobial agents (e.g., saquinavir, sparfloxacin, erythromycin intravenous, pentamidine, antimalarials, particularly halofantrine),
• some antihistamines (e.g., terfenadine, astemizole, mizolastine),
• and other medications (e.g., cisapride, vincamine intravenous, bepridil, and difemanil).

• You must inform your doctor if you are taking other medications that may decrease potassium levels in the blood (e.g., some diuretics, some laxatives, enemas [high doses], or corticosteroids [anti-inflammatory medications], amphotericin B) or medications that may cause a decrease in heart rate, as these may also increase the risk of severe heart rhythm disorders while taking Moxifloxacino Tevagen.
• Any medication containing magnesium or aluminum, such as antacids for indigestion, or any medication containing iron or zinc, medications containing didanosine, or medications containing sucralfatefor gastrointestinal disorders may reduce the action of Moxifloxacino Tevagen. Therefore, take your Moxifloxacino Tevagen tablets 6 hours before or after taking other medications.
• Taking any medication containing activated charcoalorally at the same time as Moxifloxacino Tevagen reduces the action of Moxifloxacino Tevagen. Therefore, it is recommended not to use these medications simultaneously.
• If you are currently taking oral anticoagulants(e.g., warfarin), your doctor may need to monitor your blood coagulation time.

Taking Moxifloxacino Tevagen with food and drinks

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

Pregnancy, breastfeeding, and fertility

Do not use Moxifloxacino Tevagen if you are pregnant or breastfeeding.

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

Animal studies have not indicated that fertility is impaired with the use of this medication.

Driving and using machines

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

Moxifloxacino Tevagen contains sodium

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

3. How to take Moxifloxacino Tevagen

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

Dosage

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

Method of administration

Moxifloxacino Tevagen tablets are for oral use. Take the tablet whole (to mask the bitter taste) and with plenty of liquid.

You can take Moxifloxacino Tevagen 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 indicated otherwise, the duration of treatment with Moxifloxacino Tevagen is as follows:

• Sudden worsening of chronic bronchitis (acute exacerbation): 5 – 10 days
• Lung infections (pneumonia) acquired in the community, except in severe cases: 10 days
• Acute infections of the paranasal sinuses (acute bacterial sinusitis): 7 days
• 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: 14 days.

When Moxifloxacino Tevagen film-coated tablets are used to complete a treatment initiated with moxifloxacino solution for infusion, the recommended treatment durations are:

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

Do not exceed the recommended dose and treatment duration (see section 2 "Warnings and precautions").

If you take moreMoxifloxacinoTevagen than you should

If you take more than one of the recommended 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 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 Tevagen

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

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

If you interrupt treatment with Moxifloxacino Tevagen

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

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not all people experience them. During treatment with moxifloxacino, more serious side effectshave been observed, which are detailed below:

If you notice:

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

• an abnormally fast heart rate
• a sudden, severe, generalized allergic reaction, including, very rarely, life-threatening shock (e.g., difficulty breathing, decreased blood pressure, rapid pulse)
• inflammation, including inflammation of the airways (potentially life-threatening)
• seizures
• nervous system problems such as pain, burning, tingling, numbness, and/or weakness in the limbs
• depression (in very rare cases leading to self-harm, such as suicidal thoughts or attempts)
• severe diarrhea containing blood and/or mucus (colitis, including antibiotic-associated pseudomembranous colitis), which in very rare circumstances can lead to life-threatening complications
• pain and inflammation of the tendons (tendinitis)

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

• sudden onset of feeling unwell or noticing yellowing of the whites of the eyes, dark urine, itching of the skin, tendency to bleed, or disorders of thought or wakefulness (these can be signs and symptoms of fulminant liver inflammation that can lead to life-threatening liver failure (fatal cases have been observed)
• severe skin eruptions, 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, potentially life-threatening side effects) syndrome associated with alterations in water elimination and low sodium levels (SIADH) (very rare side effect)
• loss of consciousness due to a severe decrease in blood sugar levels (hypoglycemic coma) (very rare side effect)
• inflammation of blood vessels (the signs can be reddish spots on the skin, normally on the lower legs or effects such as joint pain)
• dementia (can lead to self-harm, such as suicidal thoughts or intentions)
• tendon rupture
• a reddish, scaly, and generalized eruption with bumps under the skin and blisters accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis) (the frequency of this side effect is "unknown")
• a generalized eruption, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), enlargement of the lymph nodes, and affection of other body organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome) (the frequency of this side effect is "unknown")
• 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 "unknown")

Stop taking Moxifloxacino Tevagen and consult your doctor immediatelyas you may need urgent medical attention.

Additionally, if you notice

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

• eye discomfort or pain, especially due to light exposure (very rare to rare side effect),

contact an ophthalmologist immediately.

If you have experienced potentially life-threatening irregular heartbeats (Torsade de Pointes) or interruption of the heartbeat while taking Moxifloxacino Tevagen (very rare side effects), inform your doctor immediately that you are taking Moxifloxacino Tevagen and do not start treatment again.

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

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

If you are an elderly patient with existing kidney problems and notice a decrease in urine production, swelling of your 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 effectshave been observed during treatment with moxifloxacino, which are detailed below according to their probability:

Frequent: may affect up to 1 in 10 patients

• nausea
• diarrhea
• dizziness
• abdominal and stomach pain
• vomiting
• headache
• increase in certain liver enzymes in the blood (transaminases)
• infections caused by resistant bacteria or fungi, such as 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 patients

• skin rash
• stomach discomfort (indigestion/acid reflux)
• changes in taste (in very rare cases, loss of taste)
• sleep disorders (predominantly insomnia)
• increase in certain liver enzymes in the blood (gamma-glutamyl-transferase and/or alkaline phosphatase)
• low number of certain white blood cells (leukocytes, neutrophils)
• constipation
• itching
• feeling of dizziness (feeling of rotation or falling)
• drowsiness
• gas
• change in heart rhythm (ECG)
• liver function disorders (including increased liver enzymes in the blood (LDH))
• decreased appetite and food intake
• low white blood cell count
• pains and discomfort in the back, chest, pelvis, and limbs
• increase in certain blood cells necessary for blood coagulation
• sweating
• increase in certain specialized white blood cells (eosinophilia)
• anxiety
• feeling of discomfort (predominantly weakness or fatigue)
• tremor
• joint pain
• palpitations
• irregular and rapid heartbeat
• difficulty breathing, including asthma
• increase in certain digestive enzymes in the blood (amylase)
• restlessness/agitation
• feeling of tingling and/or numbness
• urticaria on the skin
• vasodilation
• confusion and disorientation
• decrease in certain blood cells necessary for blood coagulation
• visual disturbances, including double or blurred vision
• decrease in blood coagulation
• increase in blood lipids (fats)
• low red blood cell count
• muscle pain
• allergic reaction
• increase in bilirubin in the blood
• stomach inflammation
• dehydration
• severe heart rhythm disorders
• dry skin
• angina pectoris

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

• muscle spasms
• muscle cramps
• hallucinations
• high blood pressure
• inflammation (of the hands, feet, ankles, lips, mouth, throat)
• low blood pressure
• kidney disorders (including increased laboratory test results for kidney function, such as urea and creatinine)
• liver inflammation
• mouth inflammation
• ringing/noise in the ears
• jaundice (yellowing of the whites of the eyes or skin)
• disorder of skin sensitivity
• abnormal dreams
• concentration problems
• difficulty swallowing
• changes in smell (including decreased sense of smell)
• disorder of balance and poor coordination (due to dizziness)
• partial or total memory loss
• hearing disorders, including deafness (usually reversible)
• increase in blood uric acid
• emotional instability
• speech disorders
• fainting
• muscle weakness

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

• joint inflammation
• abnormal heart rhythm
• increased skin sensitivity
• feeling of loss of personality (feeling of not being oneself)
• increased blood coagulation
• muscle stiffness
• significant decrease in certain white blood cells (agranulocytosis)
• decrease in the number of red blood cells and platelets (pancytopenia)

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

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

Additionally, very rare cases of the following side effects have been reported after treatment with other quinolone antibiotics and may also occur during treatment with Moxifloxacino Tevagen:

• increase in intracranial pressure (symptoms include headache, visual problems such as blurred vision, blind spots, double vision, loss of vision)

• 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 (even months or years) or permanent adverse reactions, such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as pinching, tingling, burning, numbness, or pain (neuropathy), fatigue, decreased memory and concentration, effects on mental health (including sleep disorders, anxiety, panic attacks, depression, and suicidal ideation), as well as decreased hearing, vision, taste, and smell, in some cases regardless of the presence of pre-existing risk factors.

Cases of increased size and weakening or tearing of the aortic wall (aneurysms and dissections) have been reported, which could lead to rupture and be fatal, as well as heart valve insufficiency 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 medication.

5. Conservation of Moxifloxacino Tevagen

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date that appears on the blister pack and carton after "EXP" or "CAD". The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Container Contents and Additional Information

Composition of Moxifloxacino Tevagen

The active ingredient is moxifloxacin.

Each film-coated tablet contains 400 mg of moxifloxacin.

The other components are:

Tablet core: Microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate

Film coating: Hypromellose, Macrogol 4000, red iron oxide (E172) and titanium dioxide (E171).

Appearance of Moxifloxacino Tevagen and Container Contents

Moxifloxacino Tevagen film-coated tablets are slightly pink, elongated, and biconvex. The tablets are approximately 17 mm in length and 7.5 mm in width.

Moxifloxacino Tevagen is available in packs of 5, 7, 10, 14, 25, (5x5), 70 (7x10), 80 (16x5), 100 (10x10), 100 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/ Anabel Segura, 11. Edificio Albatros B, 1ª Planta.

28108 Alcobendas (Madrid)

Spain

Manufacturer:

Merckle GmbH

Ludwig-Merckle-Straße 3, 89143 Blaubeuren

Germany

Or

TEVA Pharmaceutical Works Private Limited Company

Pallagi út 13, 4042 Debrecen

Hungary

Or

TEVA UK Ltd

Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG

United Kingdom

Or

Pharmachemie B.V.

Swensweg 5, 2031 GA Haarlem

Netherlands

Or

Teva Operations Poland Sp.z.o.o

ul. Mogilska 80, 31-546, Krakow

Poland

This pharmaceutical product is authorized in the EEA Member States under the following names:

Germany: Moxifloxacin AbZ 400 mg Filmtabletten

Belgium: Moxifloxacine Teva

Denmark: Moxiva

Spain: Moxifloxacino Tevagen 400 mg film-coated tablets EFG

Hungary: Moxifloxacin-ratiopharm 400 mg filmtabletta

Italy: Moxifloxacina Teva 400 mg Compresse rivestite con film

United Kingdom: Moxifloxacin 400 mg Film-coated Tablets

Date of the Last Revision of this Leaflet:April 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/

You can access detailed and updated information about this medicinal product by scanning the QR code included in the packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/76633/P_76633.html