MOXIFLOXACIN KRKA 400 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Moxifloxacino Krka 400mg film-coated tablets EFG

Read the entire package leaflet carefullybefore starting to take thismedication,as it contains important informationfor 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 Krka and what is it used for
2. What you need to know before taking Moxifloxacino Krka
3. How to take Moxifloxacino Krka
4. Possible side effects
5. Storage of Moxifloxacino Krka
6. Package contents and additional information

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

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

Moxifloxacino is indicated in patients 18 years 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 such 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 to moderate upper female genital tract infections (pelvic inflammatory disease), including fallopian tube infection and uterine mucous membrane infection.

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

If the following bacterial infections have shown improvement during initial treatment with moxifloxacino in solution for infusion, your doctor may prescribe moxifloxacino in tablets to complete the treatment: community-acquired pneumonia, 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 severe pneumonia.

2. What you need to know before taking Moxifloxacino Krka

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

Do not take Moxifloxacino Krka

• If you are allergic to moxifloxacin, 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 old.
• If you have a history of tendon disorders or injuries related to treatment with quinolone antibiotics (see "Warnings and Precautions" in this section; and section 4: "Possible side effects").
• If you were born with or suffer from:
• any disease related to an abnormal heart rhythm (observed in ECG, heart electrical record);
• electrolyte imbalances in the blood (especially low potassium or magnesium levels in the blood);
• a very slow heart rate (called "bradycardia");
• a weak heart (heart failure);
• you have a history of heart rhythm disorders or
• you are taking other medications that cause ECG disorders (see "Other medications and Moxifloxacino Krka" in this section). This is because moxifloxacin 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 liver enzyme levels (transaminases) 5 times above the upper limit of normal.

Warnings and precautions

Before starting to take this medication

You should not take antibacterial medications that contain fluoroquinolones or quinolones, including Moxifloxacino Krka, if you have had a severe adverse reaction in the past when taking a quinolone or a fluoroquinolone. If this is your case, you should inform your doctor as soon as possible.

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

• Moxifloxacino may modify your 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 moxifloxacin (see "Do not take Moxifloxacino Krka" and "Other medications and Moxifloxacino Krka" in this section).
  • 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 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 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, arterial hypertension, or known atherosclerosis, rheumatoid arthritis (a joint disease), or endocarditis (a heart infection)).
• If you suffer from epilepsy or 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 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 has glucose-6-phosphate dehydrogenase deficiency (a rare hereditary disease), inform your doctor, and they will indicate if moxifloxacino is suitable for you.
• If you have a complicated upper female genital tract infection (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 treatment is not appropriate.
• For the treatment of mild to moderate upper female genital tract infections, your doctor should prescribe another antibiotic along with 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 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.

During treatment with Moxifloxacino Krka

• If you notice palpitations or irregular heartbeats during the treatment period, you should inform your doctor immediately. They may perform an ECG to measure your heart rate.
• The risk of heart problems may 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 reaction or shock), even with the first dose, and develop the following symptoms: chest tightness, dizziness, nausea, or fainting, or feel dizzy when standing up. If these symptoms occur, stop taking moxifloxacino and consult your doctor immediately.
• Moxifloxacino may cause rapid and severe liver inflammation, which can lead to life-threatening liver failure (including fatal cases, see section 4: "Possible side effects"). Please consult your doctor before taking any more tablets if you develop symptoms such as sudden discomfort and/or discomfort 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 severe liver inflammation).
• The quinolone antibiotics, including moxifloxacino, may cause seizures. If this occurs, treatment with moxifloxacino should be discontinued, and you should contact your doctor immediately.
  • Severe, disabling, long-lasting, and potentially irreversible side effects.

The antibacterial medications that contain fluoroquinolones or quinolones, including Moxifloxacino Krka, have been associated with very rare but severe side 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 side effects after taking Moxifloxacino Krka, 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.

• You may rarely 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 Krka and inform your doctor immediately to prevent the development of a potentially irreversible disease.
• You may experience mental health problems, even 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 side effects"). If you develop these reactions, you should discontinue treatment with moxifloxacino and inform your doctor immediately.
• You may develop diarrhea during or after taking antibiotics, including moxifloxacino. If the diarrhea is severe or persistent, or if you notice blood or mucus in the 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 Krka. At the first sign of pain or tendon inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking Moxifloxacino Krka immediately, consult your doctor immediately, and rest the affected area. Avoid any unnecessary exercise, as this can increase the risk of tendon rupture (see section 2: "What you need to know before taking Moxifloxacino Krka", subsection "Do not take Moxifloxacino Krka"; and section 4: "Possible side effects").

• If you feel severe 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 experiencing sudden 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.

• Fluoroquinolone antibiotics may cause an increase in blood sugar levels above normal levels (hyperglycemia) or a decrease in blood sugar levels below normal levels (hypoglycemia), which can potentially lead to loss of consciousness (hypoglycemic coma) in severe cases (see section 4: Possible side effects). If you have diabetes, your blood sugar level should be carefully controlled.

If you are elderly and have kidney problems, make sure you drink enough fluids during treatment with moxifloxacino, as dehydration can increase the risk of kidney failure.

• If your vision worsens or if you have any other eye disorders during treatment with moxifloxacino, consult an ophthalmologist immediately (see "Driving and using machines" in this section; section 3: "How to take Moxifloxacino Krka"; and section 4: "Possible side effects").
• 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 moxifloxacino administration (see section 4. Possible side effects).
• The efficacy of moxifloxacino has not been established in the treatment of severe burns, deep tissue infections, and diabetic foot infections with osteomyelitis (bone marrow infections).

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.

• SSJ/TEN 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 widespread skin peeling and life-threatening complications.
• 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 is 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 followed by a widespread rash 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 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

Tell your doctor or pharmacist if you are taking, have recently taken, or might 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, do not take moxifloxacino at the same time as the following medications:
• medications that belong to the class of antiarrhythmics (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide);
• antipsychotics (e.g., phenothiazines, pimozide, sertindole, haloperidol, sultoprida);
• tricyclic antidepressants;
• certain antimicrobial agents (e.g., saquinavir, sparfloxacin, intravenous erythromycin, pentamidine, antimalarials — particularly halofantrine —);
• certain 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 potassium levels in the blood (e.g., certain diuretics, certain laxatives, enemas [at high doses], corticosteroids [anti-inflammatory medications], amphotericin B) or medications that may cause a decrease in heart rate, as these can also increase the risk of severe heart rhythm disorders while taking moxifloxacino.
• Any medication that contains magnesium or aluminum (such as antacids for indigestion), or any medication that contains iron or zinc, medications that contain didanosine, or medications that contain sucralfate (for gastrointestinal disorders) may reduce the effect of moxifloxacino tablets. Therefore, take your moxifloxacino tablet 6 hours before or after taking the other medication.
• Taking any medication that contains activated charcoal at 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.

Using Moxifloxacino Krka with food and drinks

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

Pregnancy, breastfeeding, and fertility

Do not take moxifloxacino if you are pregnant or breastfeeding.

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

Animal studies have not indicated that your fertility may be affected by taking this medication.

Driving and using machines

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

Moxifloxacino Krka contains sodium

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

3. How to take Moxifloxacino Krka

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 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 at approximately 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 indicated otherwise, your treatment will be as follows:

• Sudden worsening of chronic bronchitis (acute exacerbation): 5-10 days.
• Lung infections (pneumonia), except for pneumonia that starts during hospital stay: 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 film-coated tablets are used to complete a treatment started with moxifloxacino infusion solution, 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 stop taking moxifloxacino too soon, the infection may not be completely cured, and the infection may return or your condition may worsen. You may also develop bacterial resistance to moxifloxacino.

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

If you take more Moxifloxacino Krka than you should

If you take more than one of the prescribed tablets per day, contact your doctor immediately. If possible, take the remaining tablets, packaging, or this leaflet and show them 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 used.

If you forget to take Moxifloxacino Krka

If you forget to take a tablet, you should 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 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 Krka

If you interrupt 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.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

The most serious side effectsobserved 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 color of the whites of the eyes, dark urine, skin itching, tendency to bleed, or alterations in thought or wakefulness (these can be signs and symptoms of a severe liver inflammation that can potentially lead to fatal liver failure (very rare side effect, with reported fatal cases)
• 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 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 red spots on the skin, usually on the legs, or effects such as joint pain; very rare side effect)
• severe allergic reaction, sudden and generalized, including very rarely life-threatening shock (e.g., difficulty breathing, decreased 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, it has evolved into self-harm, suicidal ideas/thoughts, or suicide attempts (rare side effect)
• madness (which can lead to self-harming behaviors, such as suicidal ideas/thoughts or attempts; very rare side effect)
• severe diarrhea with blood and/or mucus (antibiotic-associated colitis, including pseudomembranous colitis) that, in very rare circumstances, 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 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 Krka and contact your doctor immediately, as you may need urgent medical attention.

Additionally, if you notice:

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

contact an ophthalmologist immediately.

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

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

If you have diabetes and notice that your blood sugar level increases or decreases (rare or very rare side effect), tell 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 can be signs and symptoms of kidney failure, a rare side effect), consult your doctor immediately.

The following other side effectshave been observed during treatment with moxifloxacino, according to their frequency:

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

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

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

• rash
• gastric discomfort (indigestion/acid reflux)
• alteration of taste (in very rare cases, loss of taste)
• sleep disorders (predominantly insomnia)
• increase in a liver enzyme in blood (gamma-glutamyltransferase and/or alkaline phosphatase)
• low levels of certain white blood cells (leukocytes, neutrophils)
• constipation
• itching
• feeling of vertigo (that everything is spinning or that you are going to fall)
• drowsiness
• flatulence
• change in heart rhythm (ECG)
• alteration of liver function (including increase in liver enzyme in blood, LDH)
• decrease in appetite and food intake
• low white blood cell count
• back, chest, pelvis, and limb pain
• increase in certain blood cells necessary for blood clotting
• sweating
• increase in certain white blood cells (eosinophils)
• anxiety
• discomfort (mainly weakness or fatigue)
• tremors
• joint pain
• palpitations
• irregular and rapid heartbeat
• breathing difficulties, including asthmatic conditions
• increase in a digestive enzyme in the blood (amylase)
• restlessness/agitation
• feeling of tingling and/or numbness
• skin rash
• dilation of blood vessels
• confusion and disorientation
• decrease in blood cells necessary for blood clotting
• vision disorders, such as double vision and blurred vision
• decrease in blood clotting
• increase in blood lipids (fats)
• low red blood cell count
• muscle pain
• allergic reactions
• increase in bilirubin in blood
• stomach inflammation
• dehydration
• severe heart rhythm disorders
• dry skin
• angina pectoris

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

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

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

• joint inflammation
• irregular heart rate;
• increase in skin sensitivity
• feeling of depersonalization (not being oneself)
• increase in blood clotting
• 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 not known (cannot be estimated from available data)

• increase in 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 moxifloxacino administration 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

The administration of antibiotics containing quinolones and fluoroquinolones 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 (which can include sleep disorders, anxiety, panic attacks, depression, and suicidal thoughts), as well as decreased hearing, vision, taste, and smell, in some cases regardless of the presence of pre-existing risk factors.

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

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:

• 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 blood
• increase in calcium levels in blood
• reduced count of certain red blood cells (hemolytic anemia).

Reporting of side effects

If you experience any side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed 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 Krka

Keep this medication out 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 thrown away through wastewater or household waste. Deposit the packaging and medications you no longer need in the SIGRE collection point at the pharmacy. 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 Krka

• The active ingredient is moxifloxacino. Each film-coated tablet contains moxifloxacino hydrochloride equivalent to 400 mg of moxifloxacino.
• The other ingredients are microcrystalline cellulose, sodium croscarmellose, and magnesium stearate in the tablet core, and hypromellose 6 mPa·s, macrogol 4000, titanium dioxide (E171), and red iron oxide (E172) in the film coating. See section 2 “Moxifloxacino Krka contains sodium”.

Appearance of the product and container contents

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.

Moxifloxacino 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 tablets contained in blisters.

Only some pack sizes may be marketed.

Marketing authorization holder

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

Manufacturer

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

You can request more information about this medicinal product by contacting 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 under the following names:

Date of last revision of this leaflet: February 2025

Detailed 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/).