Moxifloxacin Krka 400 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Package Leaflet: Information for the Patient

Moxifloxacino Krka 400 mg Film-coated Tablets EFG

Read the entire leaflet carefully before you start taking this medicine, 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 should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet Contents

1. What Moxifloxacino Krka is and what it is used for
2. What you need to know before taking Moxifloxacino Krka
3. How to take Moxifloxacino Krka
4. Possible adverse effects
5. How to store Moxifloxacino Krka
6. Contents of the pack and other information

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

Moxifloxacino Krka contains moxifloxacin as the active substance, which belongs to a group of antibiotics called fluoroquinolones. Moxifloxacin works by killing bacteria that cause infections.

Moxifloxacin is indicated in patients aged 18 years or older for the treatment of the following bacterial infections when caused by bacteria known to be susceptible to moxifloxacin. Moxifloxacin should only be used to treat such infections when commonly recommended antibiotics cannot be used or have not been effective:

• Sinus infection, acute exacerbation of chronic bronchitis, or community-acquired pneumonia (excluding severe cases).

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

For these types of infections, treatment with moxifloxacin alone is not sufficient; therefore, in addition to moxifloxacin, your doctor must prescribe another antibiotic for the treatment of infections of the female upper genital tract (see section 2. What you need to know before taking Moxifloxacino Krka, Warnings and Precautions, Consult your doctor before starting Moxifloxacino).

If the following bacterial infections have shown improvement during initial treatment with moxifloxacin in perfusion solution, your doctor may prescribe moxifloxacin tablets to complete the treatment course: community-acquired pneumonia, skin and soft tissue infections.

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

2. What you need to know before taking Moxifloxacino Krka

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

Do not take Moxifloxacino Krka

• If you are allergic to moxifloxacin, to other quinolone antibiotics, or to any of the other components of this medicine (listed in section 6).
• If you are pregnant or breastfeeding.
• If you are under 18 years of age.
• If you have a history of tendon disorders or tendon injuries related to treatment with quinolone antibiotics (see "Warnings and Precautions" in this section; and section 4: "Possible side effects").
• If you were born with or suffer from:
• any condition associated with abnormal heart rhythm (as seen on ECG, the electrical recording of the heart);
• imbalances in blood electrolytes (especially low levels of potassium or magnesium in the blood);
• a very slow heart rate (called "bradycardia");
• a weakened heart (heart failure);
• a history of heart rhythm disturbances; or
• you are taking other medicines that cause changes in the ECG (see "Other medicines and Moxifloxacino Krka" in this section). This is because moxifloxacin may cause changes in the ECG, such as QT interval prolongation, meaning a delay in the electrical conduction in the heart.
• If you have severe liver disease or if your liver enzyme levels (transaminases) increase to 5 times above the upper limit of normal.

Warnings and precautions

Before starting to take this medicine

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

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

• Moxifloxacin may alter your heart's ECG, especially if you are female or elderly. If you are currently taking any medication that causes low blood potassium levels, consult your doctor before taking moxifloxacin (see "Do not take Moxifloxacino Krka" and "Other medicines and Moxifloxacino Krka" in this section).

  • If you have been diagnosed with an enlargement or "bulge" in a large blood vessel (aortic aneurysm or peripheral large vessel aneurysm).

• If you have previously experienced an episode of aortic dissection (a tear in the wall of the aorta).

  • If you have been diagnosed with heart valve insufficiency (heart valve regurgitation).

• If you have a family history of aortic 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 vascular Ehlers-Danlos syndrome, Turner syndrome, or Sjögren's syndrome (an autoimmune inflammatory disease), or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behcet's disease, known hypertension or atherosclerosis, rheumatoid arthritis (a joint disease), or endocarditis (a heart infection)).

• If you have epilepsy or any other condition that may cause seizures, consult your doctor before taking moxifloxacin.

• If you have or have ever had any mental health problems, consult your doctor before taking moxifloxacin.

• If you have myasthenia gravis (abnormal muscle fatigue leading to weakness and, in severe cases, paralysis), your symptoms may worsen if you take moxifloxacin. If you think this applies to you, consult your doctor immediately.

• If you or a family member has glucose-6-phosphate dehydrogenase deficiency (a rare inherited disorder), inform your doctor, who will determine whether moxifloxacin is suitable for you.

• If you have a complicated upper female genital tract infection (e.g., associated with a tubo-ovarian or pelvic abscess), for which your doctor considers intravenous treatment necessary, moxifloxacin treatment is not appropriate.

• For the treatment of mild to moderate upper female genital tract infections, your doctor should prescribe another antibiotic in addition to moxifloxacin. If you do not notice symptom improvement within three days of treatment, consult your doctor.

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

During treatment with Moxifloxacino Krka

• If you notice palpitations or irregular heartbeat during treatment, inform your doctor immediately. Your doctor may perform an ECG to monitor your heart rhythm.
• The risk of heart problems may increase with higher doses. Therefore, you must take the recommended dose.
• Rarely, you may experience a sudden, severe allergic reaction (anaphylactic reaction or shock), even after the first dose, with symptoms such as chest tightness, dizziness, nausea, fainting, or vertigo when standing. If these symptoms occur, stop taking moxifloxacin and contact your doctor immediately.
• Moxifloxacin may cause rapid and severe liver inflammation, which may lead to life-threatening liver failure (including fatal cases; see section 4: "Possible side effects"). Please consult your doctor before taking any further tablets if you develop symptoms such as sudden malaise and/or malaise associated with yellowing of the whites of the eyes, dark urine, skin itching, tendency to bleed, or brain disease caused by liver damage (symptoms of reduced liver function or severe liver inflammation).
• Quinolone antibiotics, including moxifloxacin, may cause seizures. If this occurs, stop treatment with moxifloxacin and contact your doctor immediately.
  • Severe, disabling, long-lasting, and potentially irreversible adverse effects.

Antibacterial medicines containing fluoroquinolones or quinolones, including Moxifloxacino Krka, have been associated with very rare but serious adverse effects, some of which were long-lasting (persisting for months or years), disabling, or potentially irreversible. These include tendon, muscle, and joint pain in the upper and lower limbs, difficulty walking, abnormal sensations such as pricking, tingling, pins and needles, numbness, or burning (paresthesia), sensory disturbances such as reduced vision, taste, smell, or hearing, depression, memory impairment, severe fatigue, and serious sleep disorders.

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 treatment, possibly considering the use of an antibiotic from 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 in the hands and arms. If this occurs, stop taking Moxifloxacino Krka and inform your doctor immediately to prevent potentially irreversible damage.

• You may experience mental health problems even after the first dose of quinolone antibiotics, including moxifloxacin. In very rare cases, mental health problems and depression have progressed to suicidal thoughts and self-harming behaviors such as suicide attempts (see section 4: "Possible side effects"). If you develop these reactions, stop treatment with moxifloxacin and inform your doctor immediately.

• You may develop diarrhea during or after taking antibiotics, including moxifloxacin. If the diarrhea is severe or persistent, or if you notice blood or mucus in your stools, stop taking moxifloxacin immediately and consult your doctor. In such cases, do not take medications that stop or slow intestinal movement.

  • Rarely, joint pain and swelling, and tendon inflammation or rupture may occur. The risk is higher if you are elderly (over 60 years), have received an organ transplant, have kidney problems, or are taking corticosteroids. Tendon inflammation and rupture may occur within the first 48 hours of treatment or even several months after stopping Moxifloxacino Krka. At the first sign of tendon pain or 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 unnecessary physical activity, as this may 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 experience sudden, severe pain in the abdomen, chest, or back, which may be symptoms of aortic dissection or aneurysm, go immediately to an emergency room. The risk may be increased if you are receiving systemic corticosteroid treatment.

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

• Fluoroquinolone antibiotics may cause blood sugar levels to rise above normal (hyperglycemia) or fall below normal (hypoglycemia), potentially leading to loss of consciousness (hypoglycemic coma) in severe cases (see section 4: Possible side effects). If you have diabetes, your blood sugar levels should be carefully monitored.

If you are elderly and have kidney problems, ensure adequate fluid intake during treatment with moxifloxacin, as dehydration may increase the risk of kidney failure.

• If your vision worsens or you experience any other eye disturbances during treatment with moxifloxacin, consult an ophthalmologist immediately (see "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 skin sensitivity to sunlight or UV light. You should avoid prolonged exposure to sunlight or direct sunlight and must not use sunbeds or any type of UV lamp during moxifloxacin treatment (see section 4. Possible side effects).
• The efficacy of moxifloxacin has not been established in the treatment of severe burns, deep tissue infections, or diabetic foot infections with osteomyelitis (bone marrow infections).

Severe skin reactions

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

• SJS/TEN may initially appear on the trunk as reddish, target-like spots or circular patches, often with central blisters. Ulcers may also develop in the mouth, throat, nose, genitals, and eyes (red, swollen eyes). These severe skin rashes are often preceded by fever and/or flu-like symptoms. The rashes may progress to widespread skin peeling and life-threatening or fatal complications.
• AGEP appears at the beginning of treatment as a widespread, red, scaly rash with bumps under the skin and blisters, accompanied by fever. The most common locations: mainly in skin folds, trunk, and upper limbs.
• Drug reaction with eosinophilia and systemic symptoms (DRESS) initially presents with flu-like symptoms and a facial rash, followed by a widespread rash, high body temperature, elevated liver enzymes in blood tests, increased levels of a type of white blood cell (eosinophilia), and enlarged lymph nodes.

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

Children and adolescents

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

Other medicines and Moxifloxacino Krka

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

With moxifloxacin, consider the following:

• If you are taking moxifloxacin and other medicines that affect the heart, there is an increased risk of heart rhythm disturbances. Therefore, do not take moxifloxacin at the same time as the following medicines:
• medicines belonging to the antiarrhythmic class (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide);
• antipsychotics (e.g., phenothiazines, pimozide, sertindole, haloperidol, sultopride);
• tricyclic antidepressants;
• some antimicrobial agents (e.g., saquinavir, sparfloxacin, intravenous erythromycin, pentamidine, antimalarials — particularly halofantrine —);
• some antihistamines (e.g., terfenadine, astemizole, mizolastine);
• other medicines (e.g., cisapride, intravenous vincamine, bepridil, difemethil).
• Inform your doctor if you are taking other medicines that may reduce potassium levels in the blood (e.g., certain diuretics, some laxatives, enemas [at high doses], corticosteroids [anti-inflammatory drugs], amphotericin B) or medicines that may reduce heart rate, as these may also increase the risk of serious heart rhythm disturbances while taking moxifloxacin.
• Any medicine containing magnesium or aluminum (such as antacids for indigestion), or any medicine containing iron or zinc, medicines containing didanosine, or medicines containing sucralfate (used to treat gastrointestinal disorders) may reduce the effect of moxifloxacin tablets. Therefore, take your moxifloxacin tablet 6 hours before or after taking the other medicine.
• Taking any medicine containing activated charcoal at the same time as moxifloxacin reduces the effect of moxifloxacin. Therefore, it is recommended not to use these medicines simultaneously.
• If you are currently taking blood-thinning medicines (oral anticoagulants such as warfarin), your doctor may need to monitor your blood clotting time.

Use of Moxifloxacino Krka with food and drinks

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

Pregnancy, breastfeeding, and fertility

Do not take moxifloxacin if you are pregnant or breastfeeding.

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

Animal studies have not indicated that fertility may be affected by this medicine.

Driving and use of machines

Moxifloxacin may make you feel dizzy or lightheaded, and you may experience sudden, temporary vision loss or brief fainting. If affected, do not drive or operate machinery.

Moxifloxacino Krka contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; hence, it is essentially "sodium-free".

3. How to take Moxifloxacino Krka

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

Moxifloxacin tablets are for oral use. Swallow the tablet whole (to mask the bitter taste) with plenty of liquid. You may take moxifloxacin with or without food. It is recommended that you take the tablet at approximately the same time each day.

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

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

• Acute exacerbation of chronic bronchitis: 5–10 days.
• Lung infections (pneumonia), except pneumonia acquired during hospital stay: 10 days.
• Acute bacterial sinusitis: 7 days.
• Mild to moderate upper female genital tract infections (pelvic inflammatory disease), including infection of the fallopian tubes and infection of the uterine mucous membrane: 14 days.

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

• Community-acquired pneumonia: 7–14 days.

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

• Skin and soft tissue infections: 7–21 days.

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

It is important that you complete the full course of treatment, even if you start to feel better after a few days. If you stop taking moxifloxacin too soon, the infection may not be completely cured, and the infection may return or your condition may worsen. It may also lead to bacterial resistance to moxifloxacin.

Do not exceed the recommended dose or duration of treatment (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 the prescribed number of tablets per day, contact your doctor immediately. If possible, take the remaining tablets, the packaging, or this leaflet with you and show it to your doctor or pharmacist to indicate what you have taken.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Moxifloxacino Krka

If you forget to take a tablet, take it as soon as you remember on the same day. If you do not remember until the next day, take your normal dose (one tablet) the following day. Do not take a double dose to make up for the forgotten dose.

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

If you stop taking Moxifloxacino Krka

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

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

4. Possible adverse effects

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

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

If you notice:

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

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

Additionally, if you notice:

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

contact an ophthalmologist immediately.

If you have experienced potentially life-threatening irregular heartbeats (Torsades de Pointes) or interruption of heart rhythm while taking moxifloxacin (very rare adverse effects), inform your doctor immediately that you have taken moxifloxacin and do not restart treatment.

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

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

If you are elderly, have kidney problems, and notice reduced urine output, swelling in legs, ankles, or feet, fatigue, nausea, drowsiness, shortness of breath, or confusion (these may be signs and symptoms of kidney failure, a rare adverse effect), contact your doctor immediately.

The following other adverse effects have been observed during treatment with moxifloxacin, categorized by frequency:

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

• nausea
• diarrhea
• dizziness
• stomach and abdominal pain
• vomiting
• headache
• increased levels of 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 blood potassium levels

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

• rash
• gastric discomfort (indigestion/acid reflux)
• altered taste (in very rare cases, loss of taste)
• sleep disorders (mainly insomnia)
• increased levels of a liver enzyme in blood (gamma-glutamyltransferase and/or alkaline phosphatase)
• low levels of certain white blood cells (leukocytes, neutrophils)
• constipation
• itching
• sensation of vertigo (spinning or falling)
• drowsiness
• flatulence
• change in heart rhythm (ECG)
• impaired liver function (including increased levels of a liver enzyme in blood, LDH)
• decreased appetite and food intake
• low white blood cell count
• back, chest, pelvic, and limb pain
• increase in certain blood cells necessary for blood clotting
• sweating
• increased levels of certain white blood cells (eosinophils)
• anxiety
• malaise (mainly weakness or fatigue)
• tremors
• joint pain
• palpitations
• irregular and rapid heartbeat
• breathing difficulty, including asthmatic states
• increased levels of a digestive enzyme in blood (amylase)
• restlessness/agitation
• tingling and/or numbness sensation
• skin hives
• dilation of blood vessels
• confusion and disorientation
• decrease in blood cells necessary for blood clotting
• visual disturbances, such as double vision and blurred vision
• decreased blood clotting
• increased blood lipids (fats)
• low red blood cell count
• muscle pain
• allergic reactions
• increased bilirubin in blood
• stomach inflammation
• dehydration
• severe disturbances in heart rhythm
• dry skin
• angina pectoris

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

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

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

• joint inflammation
• irregular heart rate
• increased skin sensitivity
• feeling of depersonalization (not feeling like oneself)
• increased blood clotting
• muscle stiffness
• significant decrease in a type of white blood cells (agranulocytosis)
• decrease in red blood cells, white blood cells, and platelets (pancytopenia)

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

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

The administration of antibiotics containing quinolones and fluoroquinolones has been associated with very rare cases of long-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 pricking, tingling, crawling, burning, numbness, or pain (neuropathy), fatigue, reduced memory and concentration, effects on mental health (which may include sleep disorders, anxiety, panic attacks, depression, and suicidal thoughts), as well as reduced hearing, vision, taste, and smell, in some cases regardless of the presence of pre-existing risk factors.

Cases of enlargement and weakening or tearing of the aortic wall (aneurysms and dissections), which could lead to rupture and potentially be fatal, and heart valve insufficiency have been reported in patients receiving fluoroquinolones. See also section 2.

Additionally, very rare cases of the following adverse effects, described after treatment with other quinolone antibiotics, may possibly also occur during treatment with moxifloxacin:

• increased intracranial pressure (symptoms include headache, visual disturbances such as blurred vision, "blind spots", double vision, vision loss)
• increased blood sodium levels
• increased blood calcium levels
• reduced count of certain red blood cells (hemolytic anemia)

Reporting of adverse effects

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

5. Storage of Moxifloxacin Krka

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Store in the original packaging to protect it from moisture.

This medicine does not require any special storage temperature.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of MoxifloxacinoKrka

• The active substance is moxifloxacin. Each film-coated tablet contains moxifloxacin hydrochloride equivalent to 400 mg of moxifloxacin.
• 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 “Moxifloxacino Krka contains sodium”.

Appearance of the product and contents of the pack

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 boxes containing 5, 7, 10, 14, 25, 28, 30, 50, 70, 80, 100 or 120 tablets in blister packs.

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 further information regarding this medicinal product from 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 the most recent review of this leaflet: February 2025

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