Moxifloxacin Aurovitas 400 mg film-coated tablets EFG: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Moxifloxacin Aurovitas 400 mg film-coated tablets EFG

For use in adults

Read all of this 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 adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

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

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

It is important to follow your doctor's instructions regarding dose, dosing interval, and duration of treatment.

Do not keep or reuse this medicine. If you have any antibiotic left over after completing treatment, return it to the pharmacy for proper disposal. Medicines should not be disposed of via wastewater or household waste.

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

Sinus infection,
Acute exacerbation of chronic bronchitis or community-acquired pneumonia (except severe cases),
Mild to moderate female upper genital tract infections (pelvic inflammatory disease), including infection of the Fallopian tubes and infection of the uterine mucous membrane.

For this last type of infection, moxifloxacin alone is not sufficient treatment; therefore, in addition to moxifloxacin, your doctor must prescribe another antibiotic for the treatment of female upper genital tract infections (see section 2. What you need to know before taking Moxifloxacino Aurovitas, Warnings and precautions, Consult your doctor before taking Moxifloxacino Aurovitas).

If the following conditions have improved during initial treatment with moxifloxacin solution for infusion, your doctor may prescribe moxifloxacin tablets to complete the treatment course: Community-acquired pneumonia, skin and soft tissue infections.

Moxifloxacin should not be used to initiate treatment of any type of skin and soft tissue infection or in severe lung infections.

2. What you need to know before starting to take Moxifloxacino Aurovitas

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

Do not take Moxifloxacino Aurovitas:

If you are allergic to the active substance moxifloxacin, to other quinolones, 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 damage related to treatment with quinolone antibiotics (see sections Warnings and precautions and 4. Possible side effects).
If you have a hereditary condition or have suffered from a disease associated with abnormal heart rhythm (observed on ECG, the electrical recording of the heart), have electrolyte imbalances in the blood (especially low levels of potassium or magnesium in the blood), have a very slow heart rate (called “bradycardia”), have a weak heart (heart failure), have a history of heart rhythm disturbances, or are taking other medications that cause ECG abnormalities (see section Other medicines and Moxifloxacino Aurovitas). 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 more than 5 times the upper limit of normal.

Warnings and precautions

Before taking this medicine

You must not take antibacterial medicines containing fluoroquinolones or quinolones, including moxifloxacino, if you have previously experienced a serious adverse reaction when taking 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 Aurovitas:

If you have diabetes, as 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.
Moxifloxacin may alter your heart's ECG, especially if you are female or elderly. If you are currently taking any medication that lowers your blood potassium levels, consult your doctor before taking moxifloxacin (see also sections Do not take Moxifloxacino Aurovitas and Other medicines and Moxifloxacino Aurovitas).
If you have epilepsy or another 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, 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 (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 infection, your doctor should prescribe another antibiotic in addition to moxifloxacin. If you do not notice an improvement in symptoms after three days of treatment, consult your doctor.
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 (regurgitation of heart valves).
If you have a family history of aortic aneurysm or aortic dissection, congenital heart valve disease, or other predisposing risk factors or disorders (e.g., connective tissue disorders such as Marfan syndrome or Ehlers-Danlos syndrome, Turner syndrome, or Sjögren’s syndrome (an inflammatory autoimmune disease), or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet’s disease, known hypertension or atherosclerosis, rheumatoid arthritis (a joint disease), or endocarditis (a heart infection)).

During treatment with Moxifloxacino Aurovitas

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 department. The risk may be increased if you are receiving systemic corticosteroid treatment.
If you develop sudden onset of shortness of breath, especially when lying down, or notice swelling in your ankles, feet, or abdomen, or the onset of palpitations (a sensation of rapid or irregular heartbeat), inform your doctor immediately.
If you notice 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, the recommended dose should be taken.
Rarely, you may experience a sudden, severe allergic reaction (anaphylactic reaction or shock), even with the first dose, and develop the following symptoms: 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 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, 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 moxifloxacin treatment and contact your doctor immediately.
Rarely, you may experience symptoms of nerve damage (neuropathy) such as pain, burning, tingling, numbness, and/or weakness, especially in the feet and legs or hands and arms. If this happens, stop taking moxifloxacin 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 diarrhea is severe or persistent, or if you notice blood or mucus in your stool, stop taking moxifloxacin immediately and consult your doctor. In these situations, do not take medicines 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 inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking moxifloxacin, contact your doctor, and rest the affected area. Avoid unnecessary exercise, as this may increase the risk of tendon rupture.
If you are elderly and have kidney problems, be careful to maintain adequate fluid intake, as dehydration may increase the risk of kidney failure.
If your vision worsens or your eyes appear affected, consult an ophthalmologist immediately (see sections 2. Driving and use of machines and 4. Possible side effects).

Serious skin reactions

Serious 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, 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 enzyme levels 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.

Fluoroquinolone antibiotics may cause an increase in blood sugar levels above normal (hyperglycemia), or a decrease in blood sugar levels below normal, which in severe cases may lead to loss of consciousness (hypoglycemic coma) (see section 4). This is particularly important for people with diabetes. If you have diabetes, your blood sugar levels should be carefully 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 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).

Serious, disabling, long-lasting, and potentially irreversible adverse effects

Antibacterial medicines containing fluoroquinolones or quinolones, including moxifloxacin, 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 loss, severe fatigue, and serious sleep disorders.

If you experience any of these adverse effects after taking moxifloxacin, contact your doctor immediately before continuing treatment. You and your doctor will decide whether to continue treatment, considering also the use of an antibiotic from another class.

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 Moxifloxacino Aurovitas).

Other medicines and Moxifloxacino Aurovitas

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

With Moxifloxacino Aurovitas, 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, you must not take moxifloxacin at the same time as the following drugs: medicines belonging to the class of antiarrhythmics (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), antipsychotics (e.g., phenothiazines, pimozide, sertindole, haloperidol, sultopride), tricyclic antidepressants, some antimicrobials (e.g., saquinavir, sparfloxacin, intravenous erythromycin, pentamidine, antimalarials, particularly halofantrine), some antihistamines (terfenadine, astemizole, mizolastine), and other drugs (e.g., cisapride, intravenous vincamine, bepridil, and difemethil).
While taking moxifloxacin, inform your doctor if you are taking other medicines that may lower blood potassium levels (e.g., diuretics, laxatives and enemas (high doses), or corticosteroids (anti-inflammatory medicines), amphotericin B) or cause a decrease in heart rate, as these may also increase the risk of serious heart rhythm disturbances.
Any other medicine containing magnesium or aluminium, 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 6 hours before or after taking other medicines.
Oral medicinal activated charcoal taken 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.

Taking Moxifloxacino Aurovitas with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

Do not use moxifloxacin 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 or vertigo or brief fainting spells, and you may experience a sudden, temporary loss of vision. If you experience these symptoms, do not drive or operate machinery.

Moxifloxacino Aurovitas 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 Aurovitas

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

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

Moxifloxacino tablets are for oral administration. Swallow the tablet whole without chewing (to mask the bitter taste) and with plenty of fluid. Moxifloxacino Aurovitas 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 required in elderly patients, patients with low body weight, or patients with kidney problems.

The duration of treatment depends on the type of infection. Unless otherwise directed by your doctor, the treatment duration with moxifloxacino is as follows:

Acute exacerbation of chronic bronchitis: 5 – 10 days.
Community-acquired pneumonia (lung infections), except in severe cases: 10 days.
Acute bacterial sinusitis (acute bacterial infection of the paranasal sinuses): 7 days.
Mild to moderate upper genital tract infections in women (pelvic inflammatory disease), including infection of the Fallopian tubes and infection of the uterine mucosal membrane: 14 days.

When moxifloxacino tablets are used to complete a treatment initiated with moxifloxacino perfusion solution, the recommended durations are:

Community-acquired pneumonia (lung infections): 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. If you stop treatment too early, the infection may not be completely cured, the infection may return or your condition may worsen, and antibiotic resistance may develop.

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

If you take more Moxifloxacino Aurovitas than you should

If you take more than the prescribed daily dose, contact your doctor immediately and, if possible, bring the remaining medication, packaging, or this leaflet to show your doctor or pharmacist 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 number 91 562 04 20, indicating the medicine and the amount used.

If you forget to take Moxifloxacino Aurovitas

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 a double dose to make up for a missed dose.

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

If you stop taking Moxifloxacino Aurovitas

If you stop taking this medicine too early, your infection may not be completely cured. 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 most serious adverse effects observed during treatment with moxifloxacin are listed below:

If you notice:

Abnormally fast heartbeat (rare adverse effect).
You start feeling unwell or notice yellowing of the whites of your eyes, dark urine, skin itching, tendency to bleed, disturbances in thinking, or insomnia (these may be signs or symptoms of fulminant liver inflammation with life-threatening risk due to 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, throat, nose, genital, and eye ulcers, 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 organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug-induced 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).
Severe, sudden, and generalized allergic reaction, very rarely including life-threatening shock (e.g., difficulty breathing, drop in blood pressure, rapid pulse) (rare adverse effects).
Swelling, including possible swelling of the airways (rare adverse effect, potentially life-threatening).
Seizures (rare adverse effect).
Nervous system-related problems such as pain, burning, tingling, numbness, and/or weakness in the limbs (rare adverse effect).
Depression (possibly leading to self-harm, such as suicidal thoughts/ideation or suicide attempts) (rare adverse effect).
Dementia (potentially leading to self-harming behaviors such as suicidal thoughts/ideation or suicide attempts) (rare adverse effect).
Severe diarrhea with blood and/or mucus (antibiotic-associated colitis, including pseudomembranous colitis), which in rare circumstances may lead to life-threatening complications (rare adverse effects).
Tendon pain and inflammation (tendinitis) (rare adverse effect) or tendon rupture (very rare adverse effect).
Muscle weakness, tenderness, or pain, particularly if you also feel unwell, have a fever, or your urine is dark. These symptoms may be caused by abnormal muscle breakdown that can be life-threatening and lead to kidney problems (a condition called rhabdomyolysis) (frequency of this adverse effect is "not known").

Stop taking Moxifloxacino Aurovitas and inform 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 (very rare to rare adverse effect),

Contact an ophthalmologist immediately.

If you have experienced life-threatening irregular heartbeats (Torsade de Pointes) or cardiac arrest while taking Moxifloxacino Aurovitas (very rare adverse effects), inform your treating physician immediately that you have taken Moxifloxacino Aurovitas and do not restart treatment.

In rare cases, worsening of symptoms of myasthenia gravis has been observed. If this occurs, consult your doctor immediately.

If you have diabetes and notice increased or decreased blood glucose levels (rare or very rare adverse effect), inform your doctor immediately.

If you are an elderly patient with kidney problems and notice reduced urine output, swelling of the legs, ankles, or feet, fatigue, nausea, drowsiness, breathing difficulties, or confusion (these may be signs or symptoms of kidney failure, a rare adverse effect), consult your doctor immediately.

Other adverse effects observed during treatment with moxifloxacin are listed below according to their likelihood:

Common (may affect up to 1 in 10 people):

Nausea.
Diarrhea.
Dizziness.
Stomach and abdominal pain.
Vomiting.
Headache.
Increased levels of certain liver enzymes in the blood (transaminases).
Infections caused by resistant bacteria or fungi, e.g., oral and vaginal infections caused by Candida.
Changes in heart rhythm (ECG), in patients with low blood potassium levels.

Uncommon (may affect up to 1 in 100 people):

Rash.
Gastric discomfort (indigestion/heartburn).
Taste disturbance (in very rare cases, loss of taste).
Sleep disorders (mainly insomnia).
Increase in specific liver enzymes in blood (gamma-glutamyltransferase and/or alkaline phosphatase).
Low levels of certain white blood cells (leukocytes, neutrophils).
Constipation.
Itching.
Sensation of vertigo (feeling that everything is spinning or about to fall).
Drowsiness.
Flatulence.
Changes in heart rhythm (ECG).
Impaired liver function (including increased levels of a liver enzyme in blood (LDH)).
Decreased appetite or food intake.
Low white blood cell count.
Back, chest, pelvic, and limb pain.
Increase in certain blood cells necessary for blood clotting.
Sweating.
Increase in certain white blood cells (eosinophils).
Anxiety.
Malaise (mainly weakness or fatigue).
Restlessness/agitation.
Joint pain.
Palpitations.
Irregular or rapid heartbeat.
Breathing difficulty including asthmatic states.
Increase in certain digestive enzymes in blood (amylase).
Restlessness/agitation.
Tingling sensation (pins and needles) and/or numbness.
Urticaria (hives).
Dilation of blood vessels.
Confusion and disorientation.
Decrease in certain blood cells necessary for blood clotting.
Vision disorders, including double and blurred vision.
Decreased blood coagulation.
Increased blood lipids (fats).
Low red blood cell count.
Muscle pain.
Allergic reactions.
Increased bilirubin in blood.
Inflammation of the stomach.
Dehydration.
Severe disturbances in heart rhythm.
Dry skin.
Angina pectoris.

Rare (may affect up to 1 in 1,000 people):

Muscle cramps.
Muscle spasms.
Hallucinations.
Hypertension.
Swelling (of hands, feet, ankles, lips, mouth, throat).
Hypotension.
Kidney abnormalities (including increased laboratory test results for kidney function, such as urea and creatinine).
Liver inflammation.
Mouth inflammation.
Tinnitus (ringing or 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).
Partial or complete memory loss.
Hearing impairment including deafness (usually reversible).
Increased uric acid in blood.
Emotional instability.
Speech disturbances.
Fainting.
Muscle weakness.

Very rare (may affect up to 1 in 10,000 people):

Joint inflammation.
Abnormal heart rhythm.
Increased skin sensitivity to light.
Feeling of loss of personality (not being oneself).
Increased blood coagulation.
Muscle stiffness.
Significant decrease in certain white blood cells (agranulocytosis).
Decrease in the number of 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 location upon subsequent exposure to moxifloxacin.

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 pressure in the skull (symptoms include headache, visual problems such as blurred vision, "blind spots," double vision, vision loss), increased levels of sodium and calcium in blood, a specific type of reduced red blood cell count (hemolytic anemia).

Administration of antibiotics containing quinolones and fluoroquinolones has been associated with very rare cases of long-term (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, 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), and reduced hearing, vision, taste, and smell, in some cases even in the absence 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 who received fluoroquinolones. See also section 2.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can 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 Aurovitas

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

This medicine does not require any special storage conditions.

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

Medicines should not be disposed of via wastewater drains 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 Moxifloxacino Aurovitas

The active substance is moxifloxacin. Each film-coated tablet contains 436.32 mg of moxifloxacin hydrochloride, equivalent to 400 mg of moxifloxacin.
The other components are:

Tablet core: Microcrystalline cellulose, sodium carboxymethyl starch (type A) (derived from potato starch), povidone (K-30) and magnesium stearate.

Coating: Hypromellose, titanium dioxide (E-171), macrogol 4000 and red iron oxide (E-172).

Appearance of the product and contents of the pack

Pale red, elongated film-coated tablets marked with "E 18" on one side and smooth on the other.

Moxifloxacino film-coated tablets are available in blister packs.

Pack sizes: 5, 7, 10 and 50 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

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

Belgium: Moxifloxacin AB 400 mg filmomhulde tabletten

Spain: Moxifloxacino Aurovitas 400 mg film-coated tablets EFG

Netherlands: Moxifloxican Aurobindo 400 mg, filmomhulde tabletten

Poland: Moxifloxacin Aurovitas

Portugal: Moxifloxacina Aurovitas

Czech Republic: Moxifloxacin Aurovitas 400 mg potahované tablety

Date of the most recent review of this leaflet: April 2025

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es)