Moxifloxacin Kern Pharma 400 mg film-coated tablets EFG: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Moxifloxacin Kern Pharma 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 must not be given to other people, even if they have the same symptoms as you, because it could harm them.
If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

What Moxifloxacin Kern Pharma is and what it is used for
What you need to know before taking Moxifloxacin Kern Pharma
How to take Moxifloxacin Kern Pharma
Possible side effects
How to store Moxifloxacin Kern Pharma
Contents of the pack and other information

1. What Moxifloxacino Kern Pharma is and what it is used for

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

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

It is important that you follow the instructions regarding dose, dosing interval, and duration of treatment as directed by your doctor.

Do not store or reuse this medicine. If you have any antibiotic left over after completing treatment, return it to the pharmacy for proper disposal. Do not dispose of medicines via wastewater or household waste.

Moxifloxacino Kern Pharma is indicated in patients aged 18 years and older for the treatment of bacterial infections when moxifloxacin is active against certain bacteria. Moxifloxacino Kern Pharma should only be used to treat such infections when commonly used antibiotics cannot be used or have not worked.

The treatable infections are: sinus infection, sudden worsening of long-term inflammation of the airways, or community-acquired pneumonia (except severe cases).

Mild to moderate upper female genital tract infections (pelvic inflammatory disease), including infection of the fallopian tubes and infection of the uterine mucous membrane. For these types of infections, Moxifloxacino Kern Pharma tablets alone are not sufficient as monotherapy; therefore, in addition to Moxifloxacino Kern Pharma, your doctor must prescribe another antibiotic for the treatment of mild to moderate upper female genital tract infections.

If the following conditions have shown improvement during initial treatment with Moxifloxacino Kern Pharma infusion solution, your doctor may prescribe Moxifloxacino Kern Pharma tablets to complete the treatment: community-acquired pneumonia, skin and soft tissue infections.

Moxifloxacino Kern Pharma tablets should not be used to initiate treatment of any type of skin and soft tissue infection or for severe lung infections.

2. What you need to know before taking Moxifloxacin Kern Pharma

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

Do not take Moxifloxacin Kern Pharma

If you are allergic (hypersensitive) to moxifloxacin or to other quinolones or to any of the other ingredients 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.
If you have a hereditary heart condition or have experienced a condition associated with abnormal heart rhythm (as observed on electrocardiogram), suffer from electrolyte imbalances (especially low levels of potassium or magnesium in the blood), have a very slow heart rate (bradycardia), have a weak heart (heart failure), have a history of heart rhythm disorders, or are taking other medications that cause changes in the electrocardiogram (ECG) (see section Other medicines and Moxifloxacin Kern Pharma). This is because moxifloxacin may cause changes in the ECG, such as QT interval prolongation, meaning delayed electrical conduction in the heart.
If you have severe liver disease or if your liver enzyme levels (transaminases) are increased to five times above the upper limit of normal.

Warnings and precautions

Before starting this medicine

Do not take antibacterial medicines containing fluoroquinolones or quinolones, including moxifloxacin, 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 Moxifloxacin Kern Pharma.

Seek immediate advice from an ophthalmologist if you experience any changes in vision or any eye problems.

Moxifloxacin may alter the heart ECG, especially if you are a woman or an elderly patient. If you are currently taking any medication that causes low blood potassium levels, consult your doctor before taking this medicine.
If you suffer from 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 this medicine is suitable for you.
If you have a complicated upper female genital tract infection (associated with tubo-ovarian or pelvic abscess) requiring intravenous treatment as determined by your doctor, treatment with moxifloxacin tablets is not appropriate.
For the treatment of a mild to moderate upper female genital tract infection, 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 have been diagnosed with an enlarged blood vessel or a "bulge" in a large blood vessel (aortic aneurysm or peripheral large vessel aneurysm).
If you have previously experienced an episode of aortic dissection (tear in the aortic wall).
If you have a family history of aortic dissection or aneurysm, congenital heart valve disease, or other predisposing risk factors or disorders (e.g., connective tissue disorders such as Marfan syndrome, Ehlers-Danlos syndrome, Turner syndrome, or Sjögren's syndrome (an autoimmune inflammatory disease), or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet's disease, hypertension, known atherosclerosis, rheumatoid arthritis (a joint disease), or endocarditis (a heart infection)).
If you have diabetes, as you may be at risk of blood sugar level changes with moxifloxacin.
If you have ever developed a severe skin rash, skin peeling, blisters, and/or mouth sores after taking moxifloxacin.
If you have been diagnosed with heart valve insufficiency (regurgitation of heart valves).

During treatment with this medicine:

If you experience palpitations or irregular heartbeats during treatment, inform your doctor immediately. Your doctor may perform an ECG to assess your heart rhythm.
The risk of heart problems may increase with higher doses. Therefore, you must follow 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 this medicine and contact your doctor immediately.
Moxifloxacin Kern Pharma 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 continuing treatment if you develop symptoms such as sudden malaise and/or malaise associated with yellowing of the whites of the eyes, dark urine, skin itching, bleeding tendency, or liver-induced brain disease (symptoms of reduced liver function or severe liver inflammation).
Quinolone antibiotics, including moxifloxacin, may cause seizures. If this occurs, treatment with this medicine must be stopped and you should contact your doctor immediately.
Severe, disabling, long-lasting, and potentially irreversible side effects. Antibacterial medicines containing fluoroquinolones or quinolones, including moxifloxacin, have been associated with very rare but serious adverse effects, some of which are 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 loss, severe fatigue, and serious sleep disorders.
If you experience sudden, severe abdominal, chest, or back pain, which may be symptoms of aortic dissection or aneurysm, seek emergency medical help immediately. The risk may be increased if you are receiving systemic corticosteroid treatment.
If you develop sudden shortness of breath, especially when lying down, or notice swelling in your ankles, feet, or abdomen, or experience palpitations (sensation of rapid or irregular heartbeat), inform your doctor immediately.

If you experience any of these adverse effects after taking Moxifloxacin Kern Pharma, 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.

Rarely, you may experience symptoms of nerve damage (neuropathy), such as pain, burning, tingling, numbness, and/or weakness, particularly in the feet and legs or hands and arms. If this occurs, stop taking Moxifloxacin Kern Pharma and inform your doctor immediately to prevent potentially irreversible complications.
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, treatment with this medicine must be stopped and you should inform your doctor immediately.
You may develop diarrhea during or after taking antibiotics, including moxifloxacin. If diarrhea is severe or persistent, or if you notice blood or mucus in your stool, stop taking this medicine immediately and consult your doctor. In such cases, do not take medications that stop or slow intestinal movement.
Rarely, joint pain and swelling, or tendon inflammation or rupture may occur. The risk is higher if you are elderly (over 60 years), have had 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 moxifloxacin. At the first sign of tendon pain or swelling (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking Moxifloxacin Kern Pharma, contact your doctor, and rest the affected area. Avoid unnecessary physical activity, as this may increase the risk of tendon rupture.
If you experience sudden, severe chest, abdominal, or back pain, go immediately to an emergency department.
If you are elderly and have kidney problems, take care to maintain adequate fluid intake, as dehydration may increase the risk of kidney failure.
If your vision worsens or you experience any other eye disturbances during treatment with this medicine, consult an ophthalmologist immediately (see sections 2 “Driving and use of machines” and 4 “Possible side effects”).
Fluoroquinolone antibiotics may increase your blood sugar levels above normal (hyperglycemia), or decrease your blood sugar levels below normal (hypoglycemia), which in severe cases may lead to loss of consciousness (hypoglycemic coma) (see section 4 “Possible side effects”). If you have diabetes, your blood sugar levels should be closely monitored.
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 treatment with this medicine (see section 4 “Possible side effects”).
The efficacy of moxifloxacin infusion solution has not been established in the treatment of severe burns, deep tissue infections, or diabetic foot infections with osteomyelitis (bone marrow infection).

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 the use of moxifloxacin.

SJS/TEN may initially appear on the trunk as red, target-like spots or circular patches, often with central blisters. Mouth, throat, nose, genital, and eye ulcers (red, swollen eyes) may also occur. 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 start of treatment as a widespread, red, scaly rash with bumps under the skin and blisters, accompanied by fever. The most common locations are 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 fever, 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 and adolescents under 18 years of age, as efficacy and safety have not been established in this age group (see section Do not take Moxifloxacin Kern Pharma).

Other medicines and Moxifloxacin Kern Pharma

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

With Moxifloxacin Kern Pharma, 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: antiarrhythmics (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), antipsychotics (e.g., phenothiazines, pimozide, sertindole, haloperidol, sultopride), tricyclic antidepressants, certain antimicrobials (e.g., saquinavir, sparfloxacin, intravenous erythromycin, pentamidine, antimalarials, particularly halofantrine), certain antihistamines (terfenadine, astemizole, mizolastine), and other drugs (e.g., cisapride, intravenous vincamine, bepridil, difemethilene).
While taking moxifloxacin, inform your doctor if you are taking other medicines that lower blood potassium levels or reduce heart rate, as they may increase the risk of serious heart rhythm disturbances.
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 tablets at least 6 hours before or after taking these medicines.
Taking medicinal activated charcoal orally at the same time as moxifloxacin tablets reduces their effect. Therefore, it is recommended not to take these medicines simultaneously.
If you are currently taking oral anticoagulants (e.g., warfarin), your doctor may need to monitor your blood clotting time.

Use of Moxifloxacin Kern Pharma with food and drinks

The effect of this medicine is not affected by food, including dairy products.

Pregnancy, breastfeeding, and fertility

Do not use this medicine during pregnancy or while 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 do not indicate that fertility could be affected by taking this medicine.

Driving and use of machines

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

Moxifloxacin Kern Pharma contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet, i.e., essentially "sodium-free".

3. How to take Moxifloxacino Kern Pharma

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

The recommended dose in adults is one 400 mg film-coated tablet, taken once daily.

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

Dose adjustment is not necessary in elderly patients, patients with low body weight, or patients with kidney problems.

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

Acute exacerbation of chronic bronchitis (acute exacerbation of chronic obstructive pulmonary disease, including bronchitis): 5–10 days.
Community-acquired lung infections (pneumonia), except in severe cases: 10 days.
Acute bacterial sinusitis: 7 days.
Mild to moderate upper female genital tract infections (pelvic inflammatory disease), including fallopian tube infection and infection of the uterine mucosa: 14 days.

When moxifloxacin is used to complete a treatment initiated with moxifloxacin intravenous solution, the recommended durations are:

Community-acquired pneumonia: 7–14 days.

Most patients with pneumonia were switched from intravenous to oral treatment after 4 days.

Skin and soft tissue infections: 7–21 days.

Most patients with skin and soft tissue infections were switched from intravenous to oral treatment 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.

Do not exceed the recommended dose or duration of treatment.

If you take more Moxifloxacino Kern Pharma than you should

If you take more than the recommended number of tablets per day, contact your doctor immediately and, if possible, bring the remaining medication, packaging, or this leaflet, and show your doctor or pharmacist what you have taken.

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

If you forget to take Moxifloxacino Kern Pharma

If you miss a dose, take the tablet as soon as you remember on the same day. If you do not take your tablet one day, take the normal dose (one tablet) the next day. Do not take two tablets to make up for the missed dose.

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

If you stop treatment with Moxifloxacino Kern Pharma

If you stop taking this medicine too early, your infection may not be completely cured, it may return, your condition may worsen, and it may lead to bacterial resistance to the antibiotic. Consult your doctor if you intend 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 following adverse effects have been observed during treatment with moxifloxacin. The assessment of adverse effects is based on the following frequency data:

Frequent: between 1 and 10 in every 100 patients.

Uncommon: between 1 and 10 in every 1,000 patients.

Rare: between 1 and 10 in every 10,000 patients.

Very rare: less than 1 in every 10,000 patients.

Not known: cannot be estimated from the available data.

Infections

Frequent: Infections caused by resistant bacteria or fungi, for example oral and vaginal infections caused by Candida.

Blood and lymphatic system disorders

Uncommon: Low red blood cell count, low white blood cell count, low levels of certain white blood cells (neutrophils), decrease or increase in certain blood cells necessary for blood clotting, increase in certain white blood cells (eosinophils), reduced blood clotting.

Very rare: Increased blood clotting, significant decrease in certain white blood cells (agranulocytosis), decrease in the number of red blood cells, white blood cells, and platelets (pancytopenia).

Endocrine disorders

Very rare: Syndrome associated with disturbances in water excretion and low sodium levels (SIADH).

Allergic reactions

Uncommon: Allergic reactions.

Rare: Severe, sudden, and generalized allergic reaction, including very rarely life-threatening shock (e.g., difficulty breathing, drop in blood pressure, rapid pulse), swelling (including potentially life-threatening swelling of the airways).

Alterations in laboratory tests

Uncommon: Increase in blood lipids (fats).

Rare: Increased blood glucose, increased blood uric acid.

Very rare: Loss of consciousness due to severe drop in blood sugar levels (hypoglycemic coma).

Psychiatric disorders

Uncommon: Anxiety, restlessness/agitation.

Rare: Emotional instability, depression (in very rare cases leading to self-harm, such as suicidal thoughts or suicide attempts), hallucinations.

Very rare: Depersonalization disorder (feeling detached from oneself), dementia (possibly leading to self-harm such as suicidal thoughts or suicide attempts).

Nervous system

Frequent: Headache, dizziness.

Uncommon: Tingling sensation (pins and needles) and/or numbness, altered taste (in very rare cases, loss of taste), confusion and disorientation, sleep disorders (predominantly insomnia), tremors, sensation of vertigo (feeling of spinning and falling), somnolence.

Rare: Skin sensation disorders, olfactory disturbances (including loss of smell), abnormal dreams, concentration difficulties, speech disturbances, total or partial memory loss, balance disorders and lack of coordination (due to dizziness).

Very rare: Increased skin sensitivity.

Eyes

Uncommon: Visual disturbances, including double and blurred vision.

Very rare: Transient loss of vision.

Ears

Rare: Tinnitus (ringing or noises in the ears), hearing impairments including deafness (usually reversible).

Cardiac system (see section 2 “What you need to know before starting to take Moxifloxacino Kern Pharma)

Frequent: Changes in heart rhythm (ECG) in patients with low blood potassium levels.

Uncommon: Changes in heart rhythm (ECG), palpitations, irregular and rapid heartbeat, serious heart rhythm disturbances, angina pectoris.

Rare: Abnormally rapid heartbeat, fainting.

Very rare: Heart rhythm disturbances, irregular heartbeat that may be life-threatening, cardiac arrest.

Vascular system

Uncommon: Dilation of blood vessels.

Rare: Hypertension, hypotension.

Respiratory system

Uncommon: Difficulty breathing, including asthmatic states.

Gastrointestinal system

Frequent: Nausea, vomiting, abdominal and stomach pain, diarrhea.

Uncommon: Decreased appetite and food intake, flatulence and constipation, gastric discomfort (indigestion/acid reflux), inflammation of the stomach (gastritis), increased levels of a digestive enzyme in blood (amylase).

Rare: Difficulty swallowing, mouth inflammation, severe diarrhea with blood and/or mucus (antibiotic-associated colitis, including pseudomembranous colitis), which in very rare circumstances may lead to life-threatening complications.

Liver

Frequent: Increased levels of certain liver enzymes in blood (transaminases).

Uncommon: Impaired liver function (including increased levels of a liver enzyme in blood, LDH), increased bilirubin in blood, increased levels of a liver enzyme in blood (gamma-glutamyl transferase and/or alkaline phosphatase).

Rare: Jaundice (yellowing of the whites of the eyes or skin), liver inflammation.

Very rare: Fulminant hepatitis with life-threatening liver failure (including fatal cases).

Skin

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

A red, scaly, widespread rash with bumps under the skin and blisters, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis) (the frequency of this adverse effect is “not known”).
Widespread rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes, and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome) (the frequency of this adverse effect is “not known”).

Uncommon: Itching, rash, urticaria, dry skin, skin lesions.

Very rare: Inflammation of blood vessels (signs may include red spots on the skin, usually on the legs, or effects such as joint pain).

Severe skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis. These may appear on the trunk as red target-like spots or circular lesions, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes, and may be preceded by fever and flu-like symptoms (potentially life-threatening).

Not known: Increased sensitivity of the skin to sunlight or UV radiation (see also section 2. Warnings and precautions).

Clearly defined erythematous patches with or without blisters appearing within hours after administration of moxifloxacin and disappearing with post-inflammatory hyperpigmentation; these often recur in the same area of skin or mucosa upon subsequent exposure to moxifloxacin.

Musculoskeletal system

Uncommon: Joint and muscle pain.

Rare: Tendon pain and inflammation (tendinitis), muscle cramps, muscle spasms, muscle weakness.

Very rare: Tendon rupture, joint inflammation, muscle stiffness, worsening of symptoms of myasthenia gravis.

Not known: Muscle weakness, tenderness or pain, particularly if accompanied by malaise, fever, or dark urine. These symptoms may be caused by abnormal muscle breakdown that can be life-threatening and lead to kidney problems (a condition called rhabdomyolysis).

Kidneys

Uncommon: Dehydration.

Rare: Kidney disorders (including increased results in kidney laboratory tests such as urea and creatinine), kidney failure.

General adverse effects

Uncommon: Malaise (mainly weakness or fatigue), pain in the back, limbs, pelvis, and chest, sweating.

Rare: Swelling (of hands, feet, ankles, lips, mouth, and throat).

Very rare cases of long-term (even months or years) or permanent adverse effects, such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as pricking, tingling, pins and needles, burning, numbness, or pain (neuropathy), fatigue, reduced memory and concentration, mental health effects (which may include sleep disorders, anxiety, panic attacks, depression, and suicidal ideation), as well as reduced hearing, vision, taste, and smell, have been associated with the use of quinolone and fluoroquinolone antibiotics, in some cases regardless of pre-existing risk factors.

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 levels of sodium and calcium in blood, reduced count of a certain type of red blood cells (hemolytic anemia), nervous system problems such as pain, burning, tingling, numbness, and/or weakness in the limbs.

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.

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 can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Moxifloxacin Kern Pharma

Keep this medicine out of sight and reach of children.

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

No special storage conditions are required.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Moxifloxacin Kern Pharma

The active substance is moxifloxacin. Each film-coated tablet contains 400 mg of moxifloxacin in the form of hydrochloride.
The other components (excipients) are: mannitol (E-421), silicon dioxide anhydrous (E-551), microcrystalline cellulose type 102 (E-460i), sodium carboxymethyl starch type A (from potato), hydroxypropylcellulose (E-463), magnesium stearate (E-470b) and talc. The tablets are coated with a mixture of talc (E-553b), partially hydrolyzed polyvinyl alcohol (E-1203), titanium dioxide (E-171), macrogol, yellow iron oxide (E-172) and red iron oxide (E-172).

Appearance of the product and contents of the pack

Film-coated pink, oblong, biconvex tablets.

Each standard pack contains aluminum/aluminum blisters of 5 or 7 film-coated tablets.

Each clinical pack contains aluminum/aluminum blisters of 100 film-coated tablets.

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer

Pharmathen Internacional S.A.

Industrial Park Sapes,

Rodopi Prefecture, Block N 5, 69300 Rodopi

Greece

Pharmaten S.A.

Dervenakion, 6 Pallini, 15351 Attiki

Greece

Date of the most recent revision of this leaflet: May 2025

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