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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Moxifloxacino Stada 400 mg film-coated tablets EFG

For use in adults only

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; do not give it to other people, even if they have the same symptoms as you, because it could 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

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

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

Moxifloxacino Stada contains moxifloxacin as the active substance, 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 that you follow the instructions regarding dose, dosing interval, and duration of treatment as given by your doctor.

Do not store or reuse this medicine. If you have any antibiotic left after completing your treatment, return it to the pharmacy for proper disposal. Medicines must 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 such infections when commonly used antibiotics cannot be used or have not worked:

Sinus infection, sudden worsening of long-term inflammation of the airways, or lung infection (pneumonia) acquired outside the hospital in the community (except severe cases).
Mild or moderate infections of the upper female genital tract (pelvic inflammatory disease), including infection of the fallopian tubes and infection of the uterine mucous membrane. For this type of infection, moxifloxacin tablets alone are not sufficient as monotherapy; therefore, in addition to moxifloxacin, your doctor must prescribe another antibiotic (see section 2. What you need to know before taking Moxifloxacino Stada, Warnings and precautions, Consult your doctor or pharmacist before taking Moxifloxacino Stada).

If the following conditions have shown improvement during initial treatment with moxifloxacin infusion solution, your doctor may prescribe moxifloxacin tablets to complete the treatment:

Lung infection (pneumonia) acquired outside the hospital, skin and soft tissue infections.

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

2. What you need to know before taking Moxifloxacino Stada

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

DO NOT take Moxifloxacino Stada

If you are allergic to moxifloxacin, 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 (see section 2. Warnings and precautions and section 4. Possible side effects).
If you were born with or suffer from:
any condition characterized by abnormal heart rhythm (seen on ECG, the electrical recording of the heart)
imbalances in blood salts (especially low levels of potassium or magnesium in the blood)
a very slow heart rate (called "bradycardia")
a weak heart (heart failure)
a history of heart rhythm disturbances (arrhythmias)

you are taking other medicines that cause disturbances in the ECG (see section "Other medicines and Moxifloxacino Stada"). 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

Talk to your doctor or pharmacist before taking Moxifloxacino Stada.

Moxifloxacin may alter the heart's ECG, especially if you are female or elderly. If you are currently taking any medication that causes low potassium levels in the blood, consult your doctor before taking moxifloxacin (see also sections Do not take Moxifloxacino Stada and Other medicines and Moxifloxacino Stada).
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 (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 infection of the upper female genital tract (e.g., associated with a tubo-ovarian or pelvic abscess), for which your doctor considers intravenous treatment necessary, treatment with moxifloxacin tablets is not appropriate.
For the treatment of a mild to moderate infection of the upper female genital tract, your doctor should prescribe another antibiotic in addition to moxifloxacin. If you do not notice improvement in symptoms after three days of treatment, consult your doctor.
If you have been diagnosed with an enlargement or "bulging" of a large blood vessel (aortic aneurysm or peripheral aneurysm of a large vessel).
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 dissection or aneurysm, congenital heart valve disease, or other risk factors or predisposing conditions (e.g., connective tissue disorders such as Marfan syndrome, 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, hypertension, known atherosclerosis, rheumatoid arthritis (a joint disease), or endocarditis (a heart infection)).
You should 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.
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.

If you experience sudden, severe pain in the abdomen, chest, or back, go immediately to the emergency department.

During treatment with Moxifloxacino Stada

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 after the first dose. Symptoms may include chest tightness, dizziness, nausea, fainting, or vertigo upon standing. If these symptoms occur, stop taking moxifloxacin and consult your doctor immediately.
Moxifloxacin may cause rapid and severe liver inflammation, which could lead to life-threatening liver failure (including fatal cases, see section 4. Possible side effects). If you suddenly feel unwell and/or feel discomfort, develop yellowing of the whites of the eyes, dark urine, skin itching, a tendency to bleed, or brain disease caused by liver damage (symptoms of reduced liver function or severe liver inflammation), please consult your doctor before continuing treatment.
Quinolone antibiotics, including moxifloxacin, may cause seizures. If this occurs, treatment with moxifloxacin should be stopped and you should 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, including 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 swelling (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 experience sudden, severe pain in the abdomen, chest, or back, which may be symptoms of aortic dissection or aneurysm, go immediately to the emergency department. The risk may be increased if you are receiving systemic corticosteroid treatment.
If you begin to experience sudden 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 are elderly and have kidney problems, ensure you drink plenty of fluids while taking moxifloxacin. Dehydration may increase the risk of kidney failure.
If your vision worsens or if your eyes appear to be affected in any other way, consult an ophthalmologist immediately (see sections 2. Driving and use of machines and 4. Possible side effects).
Quinolone antibiotics may cause an increase in your blood sugar levels above normal (hyperglycemia), or a decrease 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 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 infusion solution has not been established for the treatment of severe burns, deep tissue infections, or diabetic foot infections with osteomyelitis (bone marrow infections).
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 side 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 decline, severe fatigue, and serious sleep disorders.

If you experience any of these side effects after taking moxifloxacin, 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.

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-shaped spots or circular lesions, 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 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 rash on the face, followed by a widespread rash, high body temperature, increased 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.

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 Stada).

Other medicines and Moxifloxacino Stada

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, you should not take moxifloxacin at the same time as the following drugs:
medicines belonging to the antiarrhythmic group (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 (e.g., terfenadine, astemizole, mizolastine)
other medicines (e.g., cisapride, intravenous vincamine, bepridil, and difemethilene)
Inform your doctor if you are taking other medicines that may reduce potassium levels in the blood (e.g., certain 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 while taking moxifloxacin.
Any other medicine containing magnesium or aluminum (such as antacids for indigestion), iron, zinc, or didanosine, or any medicine containing sucralfate (used to treat gastrointestinal disorders) may reduce the effect of moxifloxacin. Take your moxifloxacin tablets 6 hours before or after taking other medicines.
Taking medicinal activated charcoal orally at the same time as moxifloxacin reduces its effect. Therefore, simultaneous use of these medicines is not recommended.
If you are currently taking medicines to thin the blood (oral anticoagulants such as warfarin), your doctor may need to monitor your blood clotting time.

Use of Moxifloxacino Stada with food and drinks

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

Pregnancy, breastfeeding, and fertility

Do not use 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 do not indicate that your 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, temporary loss of vision. If you experience these symptoms, do not drive or operate machinery.

Moxifloxacino Stada contains sodium

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

3. How to take Moxifloxacino Stada

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 once daily.

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

Method of administration

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

Duration of treatment

The length of time you will take moxifloxacin depends on your infection. Unless your doctor has instructed otherwise, your treatment will be as follows:

for sudden worsening (acute exacerbation) of chronic bronchitis: 5–10 days
for lung infections (pneumonia), except for pneumonia that begins during a hospital stay: 10 days
for acute infections of the paranasal sinuses (acute bacterial sinusitis): 7 days
for mild to moderate female upper genital tract infections (pelvic inflammatory disease), including fallopian tube infection and infection of the uterine mucous membrane: 14 days

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

Community-acquired pneumonia (pneumonia acquired outside the hospital): 7–14 days

Most patients with pneumonia were switched to oral treatment with moxifloxacin film-coated tablets within 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 within 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 and could return or worsen. The bacteria causing your infection may become resistant to moxifloxacin.

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

If you take more Moxifloxacino Stada than you should

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

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

If you forget to take Moxifloxacino Stada

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 next scheduled dose (one tablet) at the usual time. 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 taking Moxifloxacino Stada

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 will experience them. The most serious adverse effects observed during treatment with moxifloxacin are listed below:

If you experience

an abnormally fast heartbeat (rare side effect)
sudden feeling unwell or notice yellowing of the whites of the eyes, dark urine, itching of the skin, tendency to bleed, or disturbances in thinking or consciousness (these may be signs and symptoms of fulminant liver inflammation that can lead to life-threatening 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 spots or circular lesions, 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 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 disturbances in water excretion and low sodium levels (SIADH) (very rare adverse effect)
loss of consciousness due to a severe drop in 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)
a severe, sudden generalized allergic reaction, very rarely including life-threatening shock (e.g., difficulty breathing, drop in blood pressure, rapid pulse) (rare adverse effect)
swelling including swelling of the airways (rare adverse effect, potentially fatal)
seizures (rare adverse effect)
nervous system-related problems such as pain, burning, tingling, numbness, and/or weakness in the limbs (rare adverse effect)
depression (in very rare cases leading to self-harm, such as suicidal thoughts or suicide attempts) (rare adverse effect)
psychosis (which may potentially lead to self-harm, such as suicidal thoughts or suicide attempts) (very rare adverse effect)
severe diarrhea containing blood and/or mucus (antibiotic-associated colitis, including pseudomembranous colitis), which in very rare cases may lead to life-threatening complications (rare adverse effect)
tendon pain and swelling (tendinitis) (rare adverse effect) or tendon rupture (very rare adverse effect)
muscle weakness, sensitivity, or pain, particularly if you also feel unwell, have a fever, or your urine is dark. These symptoms may be caused by abnormal muscle breakdown that can be life-threatening and lead to kidney problems (a condition called rhabdomyolysis) (frequency of this adverse effect is "not known")

stop taking Moxifloxacino Stada and contact your doctor immediately, as you may require urgent medical attention.

Additionally, if you experience

temporary loss of vision (very rare adverse effect),

contact an ophthalmologist immediately.

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

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

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

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

Other adverse effects observed during treatment with moxifloxacin are listed below by frequency:

Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

rash
stomach discomfort (indigestion/heartburn)
taste disturbances (in very rare cases, loss of taste)
sleep problems (predominantly insomnia)
increase in a specific liver enzyme in the blood (gamma-glutamyl transferase and/or alkaline phosphatase)
low count of specific white blood cells (leukocytes, neutrophils)
constipation
itching
sensation of dizziness (spinning or falling)
drowsiness
flatulence
change in heart rhythm (ECG)
impaired liver function (including increase in a specific liver enzyme in the blood (LDH))
decreased appetite and food intake
low white blood cell count
back, chest, pelvic, and limb pain
increased levels of specific blood cells needed for blood clotting
sweating
increased count of specialized white blood cells (eosinophils)
anxiety
feeling unwell (predominantly weakness or fatigue)
tremors
joint pain
palpitations
irregular and rapid heartbeat
difficulty breathing including asthmatic conditions
increase in a specific digestive enzyme in the blood (amylase)
restlessness/agitation
tingling sensation (pins and needles) and/or numbness
hives on the skin
dilation of blood vessels
confusion and disorientation
decrease in specific blood cells needed for blood clotting
visual disturbances including double and blurred vision
reduced blood clotting
increased blood lipids (fats)
low red blood cell count
muscle pain
allergic reaction
increased bilirubin in the blood
inflammation of the stomach
dehydration
severe heart rhythm abnormalities
dry skin
angina pectoris

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

muscle spasms
muscle cramps
hallucinations
high blood pressure
swelling (of hands, feet, ankles, lips, mouth, throat)
low blood pressure
kidney failure (including increased results of special kidney laboratory tests such as urea and creatinine)
liver inflammation
mouth inflammation
ringing or noise in the ears
jaundice (yellowing of the whites of the eyes or skin)
deterioration of skin sensation
abnormal dreams
disturbed concentration
difficulty swallowing
smell disturbances (including loss of smell)
balance disorder and poor coordination (due to dizziness)
partial or complete memory loss
hearing impairment, including deafness (usually reversible)
increased uric acid in the blood
emotional instability
difficulty speaking
fainting
muscle weakness

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

joint inflammation
abnormal heart rhythms
increased skin sensitivity
feeling of detachment (not being yourself)
increased blood clotting
muscle stiffness
significant decrease in specific white blood cells (agranulocytosis)
decrease in red blood cells, white blood cells, and platelets (pancytopenia)

Frequency not known (cannot be estimated from available data)

syndrome associated with impaired water excretion and low sodium levels (SIADH)
loss of consciousness due to a severe drop in blood sugar levels (hypoglycemic coma). See section 2.
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 typically recur in the same skin or mucosal site 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 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 a specific type of red blood cells (hemolytic anemia)

The 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, effects on mental health (which may include sleep disorders, anxiety, panic attacks, depression, and suicidal ideation), and decreased 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 who have received 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 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 Stada

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

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

Store in the original packaging to protect it from moisture.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their packaging at the SIGRE Point in your pharmacy. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Moxifloxacino Stada

The active substance is moxifloxacin.

One film-coated tablet contains 400 mg of moxifloxacin, equivalent to 436.80 mg of moxifloxacin hydrochloride.

The other components are:

Tablet core:

Microcrystalline cellulose
Povidone K-30
Sodium croscarmellose
Colloidal anhydrous silica
Magnesium stearate

Coating film:

Hypromellose
Propylene glycol
Titanium dioxide (E171)
Talc
Iron oxide red (E172)

Appearance of the medicinal product and contents of the container

Moxifloxacino Stada 400 mg are pink, film-coated, oblong, biconvex tablets, approximately 17.6 mm long and 6.9 mm wide.

Moxifloxacino Stada 400 mg film-coated tablets are packaged in boxes containing Al/PVC/PVdC blisters. Package sizes: 5, 7, 10, 14, 15 and 20 film-coated tablets or 5x1, 7x1, 10x1, 14x1, 15x1, 20x1 film-coated tablets (unit dose).

Only certain package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.
Frederic Mompou, 5
08960 Sant Just Desvern (Barcelona)
Spain
[email protected]

Manufacturer

STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany

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

Germany: Moxifloxacin Stada 400 mg Filmtabletten
Belgium: Moxifloxacine EG 400 mg filmomhulde tabletten
Finland: Moxifloxacin Stada 400 mg tabletti, kalvopäällysteinen
Slovenia: Moksifloksacin Stada 400 mg filmsko obložene tablete
Spain: Moxifloxacino Stada 400 mg comprimidos recubiertos con película EFG
Luxembourg: Moxifloxacine EG 400 mg, comprimés pelliculés
Portugal: Moxifloxacina Ciclum 400 mg comprimidos revestidos por película

Date of the most recent review of this leaflet: January 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/