Leaflet: information for the patient

Moxifloxacino Krka 400mg film-coated tablets

Read this leaflet carefully before you start taking thismedicine,because it contains important information for you.

• Keep this leaflet, as 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 must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Moxifloxacino Krka contains moxifloxacino as the active ingredient, which belongs to the group of antibiotics known as fluoroquinolonas. Moxifloxacino acts by eliminating bacteria that cause infections.

Moxifloxacino is indicated for patients 18 years of age or older for the treatment of the following bacterial infections when caused by bacteria where moxifloxacino is active. Moxifloxacino should only be used to treat these infections when usual antibiotics cannot be used or have not been effective:

Paranasal sinus infection, sudden worsening of chronic inflammation of the airways, or pneumonia acquired outside the hospital (except for severe cases).

Mild to moderate infections of the upper female genital tract (inflammatory pelvic disease), including fallopian tube infection and uterine mucous membrane infection.

For this type of infection, a single treatment with moxifloxacino is not sufficient, so your doctor will also prescribe another antibiotic for the treatment of upper female genital tract infections (see section 2. "What you need to know before starting to take Moxifloxacino Krka, Warnings and Precautions, Consult your doctor before starting to take Moxifloxacino").

If the following bacterial infections have shown improvement during the initial treatment with moxifloxacino in solution for infusion, your doctor may prescribe moxifloxacino in tablets to complete the treatment: pneumonia acquired outside the hospital, skin and soft tissue infections.

Moxifloxacino 400 mg tablets should not be used as initial treatment for any type of skin and soft tissue infection or for severe lung infections.

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

Do not take Moxifloxacino Krka

-If you are allergic to moxifloxacino, other quinolone antibiotics, or any of the other components of this medication (including those listed in section 6).

-If you are pregnant or breastfeeding.

-If you are under 18 years old.

-If you have a history of tendon damage or lesions related to antibiotic treatment (see“Warnings and Precautions” in this section;and section 4: “Possible side effects”).

-If you were born with or have:

-any disease related to an abnormal heart rhythm (observed on ECG, heart electrical recording);

-electrolyte imbalances in the blood (especially low levels of potassium or magnesium in the blood);

-very low heart rate (denominated “bradycardia”);

-weak heart (heart failure);

-history of heart rhythm disturbances or

-are taking other medications that cause ECG disturbances (see “Other medications and Moxifloxacino Krka” in this section). 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 severe liver disease or increased levels of liver enzymes (transaminases) 5 times above the upper limit of normal.

Warnings and precautions

Before starting to take this medication

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

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

-Moxifloxacino maymodify your heart's ECG, especially if you are a woman or an elderly patient. If you are currently taking any medication that causes a decrease in blood potassium levels, consult your doctor before taking moxifloxacino (see “Do not take Moxifloxacino Krka” and “Other medications and Moxifloxacino Krka” in this section).

• If you have been diagnosed with a large blood vessel aneurysm or peripheral aneurysm of a large vessel.

-If you have had a previous episode of aortic dissection (a tear in the aorta wall).

• If you have been diagnosed with heart valve insufficiency (regurgitation of 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 or Ehlers-Danlos vascular 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, or atherosclerosis known, rheumatoid arthritis (a joint disease) or endocarditis (a heart infection)).

-If you suffer fromepilepsyor another condition that may causeseizures, consult your doctor before taking moxifloxacino.

-If you have or have had anymental health problems, consult your doctor before taking moxifloxacino.

-If you havemyasthenia gravis(abnormal muscle fatigue leading to weakness and, in severe cases, paralysis) your symptoms may worsen if you take moxifloxacino. If you think this affects you, consult your doctor immediately.

-If you or a family member hasglucose-6-phosphate dehydrogenase deficiency(a rare hereditary disease), inform your doctor and they will tell you if moxifloxacino is suitable for you.

-If you have acomplicated upper genital tract infection in women(e.g., associated with a Fallopian tube and ovarian abscess or pelvic abscess), for which your doctor considers intravenous treatment, oral treatment with moxifloxacino is not appropriate.

-For the treatment ofmild to moderate upper genital tract infections in women, your doctor should prescribe another antibiotic in addition to moxifloxacino. If you do not notice an improvement in symptoms after three days of treatment, consult your doctor.

• If you are diabetic because you may experience a risk of changes in blood sugar levels with moxifloxacino.
• If you have ever developed a severe skin rash or skin peeling, blisters, and/or mouth sores after taking moxifloxacino.

During treatment with Moxifloxacino Krka

-If you noticepalpitations or irregular heartbeatsduring the treatment period, you must inform your doctor immediately. They may perform an ECG to measure your heart rate.

-Therisk of heart problemsmay increase with increasing doses. Therefore, the recommended dose should be taken.

-In rare cases, you may experience asevere allergic reaction(anaphylactic reaction), even with the first dose, and develop the following symptoms: chest tightness, dizziness, nausea, or fainting, or feeling dizzy when standing.Immediately stop taking moxifloxacino and consult your doctor.

-Moxifloxacino may cause arapid and severe inflammation of the liver, which may lead to liver failure that puts your life at risk (including fatal cases, see section 4: “Possible side effects”). Please consult your doctor before taking any other tablets if you develop symptoms such as sudden discomfort and/or discomfort associated with yellowing of the white of the eyes, dark urine, itching, bleeding tendency, or liver damage-induced cerebral damage (symptoms of reduced liver function or severe liver inflammation).

-Quinolone antibiotics, including moxifloxacino, may causeseizures. If this occurs, the treatment with moxifloxacino should be interrupted and you should contact your doctor immediately.

• Severe, prolonged, and potentially irreversible incapacitating effects.

Fluoroquinolone or quinolone antibiotics, including Moxifloxacino Krka, have been associated with rare but severe adverse effects, some of which were persistent for months or years, incapacitating, or potentially irreversible. This includes tendon pain, muscle and joint pain in the upper and lower limbs, difficulty walking, abnormal sensations such as pinching, tingling, numbness, or burning (paresthesia), sensory disturbances such as decreased vision, taste, smell, and hearing, depression, decreased memory, intense fatigue, and severe sleep disturbances.

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

-You may rarely experiencenervous system damage symptoms(neuropathy) such as pain, burning, tingling, numbness, and/or weakness, especially in the feet and legs, or in the hands and arms. If this happens, stop taking Moxifloxacino Krka and inform your doctor immediately to prevent the development of a potentially irreversible disease.

-You may experiencemental health problemseven after the first administration of quinolone antibiotics, including moxifloxacino. In rare cases, mental health problems and depression have evolved into suicidal thoughts and self-harm behaviors such as attempted suicide (see section 4: “Possible side effects”). If you develop these reactions, treatment with moxifloxacino should be interrupted and you should inform your doctor immediately.

-You may developdiarrheaduring or after taking antibiotics, including moxifloxacino. If the diarrhea is severe or persistent, or if you notice blood or mucus in the stool,immediately stop taking moxifloxacino and consult your doctor. In these situations, you should not take medications that slow down or stop intestinal movement.

• In rare casesyou may experience pain and swelling in the joints and inflammation or rupture of tendons. The risk is higher if you are an elderly person (over 60 years old), have received an organ transplant, have kidney problems, or are taking corticosteroids. Tendon inflammation and rupture can occur in the first 48 hours of treatment and even several months after stopping treatment with Moxifloxacino Krka.At the first sign of tendon pain or inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), immediately stop taking Moxifloxacino Krka, consult your doctor immediately, and rest the affected area. Avoid any unnecessary exercise, as this may increase the risk of tendon rupture (see section 2: “What you need to know before starting to take Moxifloxacino Krka”, subsection “Do not take Moxifloxacino”; and section 4: “Possible side effects”).

• If you experience asevere and sudden pain in the abdomen, chest, or back, which may be symptoms of aortic dissection or aneurysm, go to the emergency room immediately. The risk may increase if you are receiving systemic corticosteroids.

• If you start experiencing a sudden onset of shortness of breath, especially when lying down, or if you notice swelling in the ankles, feet, or abdomen, or palpitations (sensation of rapid or irregular heartbeat), you must inform your doctor immediately.

-Fluoroquinolone antibiotics may causean increase in blood sugar levelsabove normal levels (hyperglycemia), ordecreased blood sugar levelsbelow normal levels (hypoglycemia)that may lead to loss of consciousness (hypoglycemic coma) in severe cases (see section 4: Possible side effects). If you are diabetic, your blood sugar levels should be carefully controlled.

If you are an elderly person and havekidney problems, make sure your fluid intake is sufficient during treatment with moxifloxacino, as dehydration may increase the risk of kidney failure.

-If your vision worsens, or if you experience any othereye problemsduring treatment with moxifloxacino, consult an ophthalmologist immediately (see “Driving and use of machines” in this section; section 3: “How to take Moxifloxacino Krka”; and section 4: “Possible side effects”).

-Quinolone antibiotics may increase thesensitivity of the skin to sunlight or UV. You should avoid prolonged exposure to sunlight or direct sunlight and not use sunbeds or any type of UV lamp during moxifloxacino administration (see section 4. Possible side effects).

-The efficacy of moxifloxacino 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 (NET), generalized acute pustular psoriasis (PEGA), and drug reaction with eosinophilia and systemic symptoms (DRESS or hypersensitivity syndrome) have been reported with the use of moxifloxacino.

• SSJ/NET may initially appear on the trunk as red, ring-shaped spots or circular patches often with central blisters. They may also appear as ulcers in the mouth, throat, nose, genitals, and eyes (red and swollen eyes). These severe skin eruptions often come with fever and/or flu-like symptoms. The eruptions may progress to widespread skin peeling and complications that may put your life at risk or be fatal.
• PEGA appears at the beginning of treatment as a red, scaly, and generalized rash with subcutaneous nodules and blisters accompanied by fever. The most common location: mainly localized in skin folds, trunk, and upper limbs.
• DRESS initially appears with flu-like symptoms and a rash on the face, followed by a widespread rash with high body temperature, increased liver enzymes in blood tests, and increased eosinophils, and enlarged lymph nodes.

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

Children and adolescents

Do not administer this medication to children or adolescents under 18 years old, as its safety and efficacy have not been established in this age group (see subsection “Do not take Moxifloxacino Krka” in this section).

Other medications and Moxifloxacino Krka

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

With moxifloxacino, you should be aware of the following:

-If you are taking moxifloxacino and other medications that affect the heart, there is a higher risk of severe heart rhythm disturbances. Therefore, do not take moxifloxacino at the same time as the following medications:

-antiarrhythmic medications (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide);

-antipsychotics (e.g., phenothiazines, pimozide, sertindole, haloperidol, sultopride);

-tricyclic antidepressants;

-some antimicrobial agents (e.g., saquinavir, sparfloxacino, intravenous erythromycin, pentamidine, antimalarials —particularly halofantrine—);

-some antihistamines (e.g., terfenadine, astemizole, mizolastine);

-other medications (e.g., cisapride, intravenous vincamine, bepridil, difemanil).

-You should inform your doctor if you are taking other medications that may decrease blood potassium levels (e.g., some diuretics, some laxatives, enemas [at high doses], corticosteroids [anti-inflammatory drugs], amphotericin B) or medications that may cause a decrease in heart rate, as these may also increase the risk of severe heart rhythm disturbances while taking moxifloxacino.

-Anymedication containing magnesium or aluminum(such as antacids for indigestion), or any medication containingiron or zinc, medications containing didanosine, or medications containingsucralfate(for treating gastrointestinal disorders) may reduce the action of moxifloxacino tablets. Therefore, take your moxifloxacino tablet 6 hours before or after taking the other medication.

-The simultaneous use of any medication containingactivated charcoalreduces the action of moxifloxacino. Therefore, it is recommended not to use these medications simultaneously.

-If you are currently taking anticoagulant medications (oral anticoagulants such as warfarin), your doctor may need to monitor your blood clotting time.

Use of Moxifloxacino Krka with food and drinks

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

Pregnancy, lactation, and fertility

Do not take moxifloxacino if you are pregnant or breastfeeding.

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

The studies in animals have not indicated that your fertility may be affected by taking this medication.

Driving and use of machines

Moxifloxacino may make you feel dizzy or experience a sudden loss of vision or brief fainting. If you are affected, do not drive vehicles or operate machinery.

Moxifloxacino Krka contains sodium

This medication contains less than 1 mmolof sodium (23 mg) per tablet; it is essentially “sodium-free”.

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

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

Moxifloxacino tablets are for oral use. Take the tablet whole (to mask the bitter taste) and with plenty of liquid. You can take moxifloxacino 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 with Moxifloxacino depends on the type of infection. Unless your doctor has told you otherwise, your treatment will be as follows:

-Acute exacerbation of chronic bronchitis: 5–10 days.

-Pulmonary infections (pneumonia), except for pneumonia that begins during hospital stay: 10 days.

-Acute bacterial sinusitis: 7 days.

-Mild to moderate upper genital tract infections in females (pelvic inflammatory disease), including fallopian tube infection and uterine mucous membrane infection: 14 days

When moxifloxacino in film-coated tablets is used to complete a treatment initiated with moxifloxacino in infusion solution, the recommended durations of use are:

-Pulmonary infections (pneumonia) acquired outside the hospital:7–14 days.

Most patients with pneumonia were switched to oral treatment with moxifloxacino in 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 essential to complete the treatment, even if you start feeling better after a few days. If you stop taking moxifloxacinotoo soon, the infection may not be completely cured, and the infection may recur or your condition may worsen. You may also develop bacterial resistance to moxifloxacino.

Do not exceed the recommended dose and duration of treatment (seesection 2.What you need to know before starting to take Moxifloxacino Krka, Warnings and precautions).

If you take more Moxifloxacino Krka than you should

If you take more than one of the prescribed tablets a day,contact your doctor immediately. If possible, bring the remaining tablets, the packaging, or this leaflet to the doctor or pharmacist and show them what you have taken.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, phone:915620420, indicating the medication and the amount used.

If you forgot to take Moxifloxacino Krka

If you forgot to take a tablet,take it as soon as you remember on the same day.If you do not remember to take it on the same day, take your regular dose (one tablet) the next day. Do not take a double dose to compensate for the missed dose.

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

If you interrupt the treatment with Moxifloxacino Krka

If you interrupt the treatment with this medication too soon, 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.

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

The most serious side effects observed during treatment with moxifloxacino are listed below:

If you notice:

• an abnormally fast heart rate (rare side effect)
• a sudden feeling of discomfort or notice a yellowish discoloration of the white of the eyes, dark urine, skin itching, tendency to bleed or alterations in thought or vigilance (may be signs and symptoms of fulminant liver inflammation that can potentially lead to fatal liver failure (very rare side effect, fatal cases have been observed)
• severe skin eruptions including Stevens-Johnson syndrome and toxic epidermal necrolysis. These may appear on the trunk as red macules in the shape of a target or circular patches often with blisters in the center, skin peeling, mouth, throat, nose, genital and eye ulcers and may be preceded by fever and flu-like symptoms (very rare side effects, potentially life-threatening)
• a red, scaly, and generalized rash with bumps under the skin and blisters accompanied by fever at the beginning of treatment (acute generalized pustular psoriasis) (the frequency of this side effect is "unknown")
• generalized rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), lymph node enlargement and involvement of other body organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug-induced hypersensitivity syndrome) (the frequency of this side effect is “unknown”)
• syndrome associated with water loss and low sodium levels (SIADH) (very rare side effect)
• loss of consciousness due to severe low blood sugar levels (hypoglycemic coma) (very rare side effect)
• inflammation of blood vessels (the signs may be red patches on the skin, usually on the legs, or effects such as joint pain; very rare side effect)
• severe and sudden allergic reaction, including very rarely life-threatening shock (e.g. difficulty breathing, low blood pressure, rapid pulse) (rare side effect)
• swelling, including respiratory tract swelling (rare side effect, potentially life-threatening)
• seizures (rare side effect)
• problems associated with the nervous system, such as pain, burning, tingling, numbness, and/or weakness in the limbs (rare side effect)
• depression (in rare cases, it has evolved into self-harm, suicidal thoughts or attempts (rare side effect)
• madness (which can lead to self-harming behaviors, such as suicidal thoughts or attempts; very rare side effect)
• severe diarrhea with blood and/or mucus (antibiotic-associated colitis, including pseudomembranous colitis) that, in rare cases, can lead to life-threatening complications (rare side effect)
• tendon pain and inflammation (tendinitis; rare side effect) or tendon rupture (very rare side effect)
• muscle weakness, sensitivity, or pain, particularly if you also feel unwell, have a fever, or your urine is dark. These symptoms may be caused by abnormal muscle breakdown that can be life-threatening and lead to kidney problems (a condition called rhabdomyolysis) (frequency of this side effect is "unknown")

Stop taking Moxifloxacino Krka and contact your doctor immediately, as you may need urgent medical help.

Additionally, if you notice:

• transient loss of vision (very rare side effect)
• eye discomfort or pain, especially due to light exposure (side effect from very rare to rare)

Contact an ophthalmologist immediately.

If you have experienced potentially fatal irregular heartbeats (Torsades de Pointes) or a heart stoppage while taking moxifloxacino (very rare side effects),inform your doctor immediately that you have been taking moxifloxacino and do not restart treatment.

It has been observed that, in rare cases, symptoms of myasthenia gravis may worsen. If this occurs,consult your doctor immediately.

If you have diabetes and notice that your blood sugar levels increase or decrease (rare or very rare side effect),inform your doctor immediately.

If you are elderly, have kidney problems, and observe a decrease in urine production, swelling in the legs, ankles, or feet, fatigue, nausea, drowsiness, shortness of breath, or confusion (these may be signs and symptoms of kidney insufficiency, a rare side effect),consult your doctor immediately.

The following side effects have been observed during treatment with moxifloxacino according to their frequency:

Frequent side effects (may affect up to 1 in 10 patients):

• nausea
• diarrhea
• dizziness
• abdominal and stomach pain
• vomiting
• headache (cephalalgia)
• increase in certain liver enzymes in the blood (transaminases)
• bacterial or fungal infections, e.g. oral and vaginal candidiasis
• change in heart rhythm (ECG) in patients with low potassium levels in the blood

Rare side effects (may affect up to 1 in 100 patients):

• skin rash
• gastrointestinal discomfort (indigestion/heartburn)
• alteration of taste (in rare cases, loss of taste)
• sleep disturbances (predominantly insomnia)
• increase in a liver enzyme in the blood (gamma-glutamyltransferase and/or alkaline phosphatase)
• low levels of certain white blood cells (leukocytes, neutrophils)
• constipation
• itching
• vertigo (feeling of spinning or falling)
• drowsiness
• flatulence
• change in heart rhythm (ECG)
• liver function alteration (including increase in a liver enzyme in the blood, LDH)
• decreased appetite and food intake
• low white blood cell count
• back, chest, pelvis, and limb pain
• increase in certain blood cells necessary for blood coagulation
• sweating
• increase in certain white blood cells (eosinophils)
• anxiety
• uncomfortable feeling (mainly weakness or fatigue)
• tremors
• joint pain
• palpitations
• irregular and rapid heart rate
• difficulty breathing, including asthma-like states
• increase in a digestive enzyme in the blood (amylase)
• restlessness/agitation
• tingling and/or numbness sensation
• skin rashes
• vasodilation
• confusion and disorientation
• decrease in blood cells necessary for blood coagulation
• eye disorders, such as double vision and blurred vision
• decreased blood coagulation
• increase in blood fats (lipids)
• low red blood cell count
• muscle pain
• allergic reactions
• increase in bilirubin in the blood
• stomach inflammation
• dehydration
• severe alteration of heart rhythm
• dry skin
• angina pectoris

Rare side effects (may affect up to 1 in 1,000 patients):

• muscle cramps
• muscle contractures
• hallucinations
• increased blood pressure
• swelling (of hands, feet, ankles, lips, mouth, and throat)
• decreased blood pressure
• kidney function alterations (including increase in laboratory test results for the kidneys, such as urea and creatinine)
• liver inflammation
• mouth inflammation
• tinnitus (ringing in the ears)
• jaundice (yellowish discoloration of the white of the eyes or skin)
• skin sensation disorders
• abnormal dreams
• concentration disorders
• difficulty swallowing
• alteration of sense of smell (including loss of smell)
• balance and coordination disorders (due to dizziness)
• total or partial loss of memory
• hearing loss (usually reversible)
• increase in uric acid in the blood
• emotional instability
• speech alteration
• syncope
• muscle weakness

Very rare side effects (may affect up to 1 in 10,000 patients):

• joint inflammation
• irregular heart rhythm;
• increased skin sensitivity
• feeling of depersonalization (not being oneself)
• increase in blood coagulation
• muscle stiffness
• significant decrease in a type of white blood cell (agranulocytosis)
• decrease in the number of red and white blood cells and platelets (pancytopenia)

Frequency unknown (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/without blisters that appear in the hours following moxifloxacino administration and disappear with residual post-inflammatory hyperpigmentation; they usually reappear in the same skin or mucosal area with subsequent exposure to moxifloxacino

The administration of quinolone and fluoroquinolone antibiotics has been associated with very rare cases of long-lasting or permanent adverse reactions (even months or years) such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as pinpricks, tingling, numbness, burning, or pain (neuropathy), depression, fatigue, sleep disorders, decreased memory, and decreased hearing, vision, taste, and smell, in some cases regardless of the presence of pre-existing risk factors.

Cases of increased size and weakening or tearing of the aortic wall (aneurysms and dissections) that could lead to rupture and be fatal, and heart valve insufficiency in patients who have received fluoroquinolones have been reported. See also section 2.

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

• increased intracranial pressure (symptoms include headache, visual disturbances such as blurred vision, blind spots, double vision, loss of vision);
• increased sodium levels in the blood;
• increased calcium levels in the blood;
• low red blood cell count (hemolytic anemia);

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use: https://www.notificaram.es/. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from moisture.

This medication does not require any special storage temperature.

Medications should not be disposed of through drains or trash. Deposit the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of MoxifloxacineKrka

-The active ingredient is moxifloxacine. Each film-coated tablet contains hydrochloride of moxifloxacine corresponding to 400 mg of moxifloxacine.

-The other components are microcrystalline cellulose, sodium croscarmellose and magnesium stearate in the tablet core and hypromellose 6 mPa·s, macrogol 4000, titanium dioxide (E171) and iron oxide red (E172) in the film coating. See section 2 “Moxifloxacine Krka contains sodium”.

Appearance of the product and contents of the package

The film-coated tablets are dark pink, biconvex, capsule-shaped; with dimensions: length 15.9 mm – 16.6 mm, and thickness 5.8 mm – 7.0 mm.

Moxifloxacine Krka 400 mg film-coated tablets EFG are available in packs of 5, 7, 10, 14, 25, 28, 30, 50, 70, 80, 100 or 120 film-coated tablets in blisters.

Only some package sizes may be marketed.

Marketing Authorization Holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Responsible for manufacturing

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

KRKA-FARMA d.o.o., DPC Jastrebarsko, Cvetkovic bb, 10450 Jastrebarsko, Croatia

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

KRKA Farmacéutica, S.L., C/ Anabel Segura 10, Pta. Baja, Oficina 1, 28108 Alcobendas, Madrid, Spain.

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

Last revision date of this leaflet: June 2024

For further information about this medicinal product, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).