Package Insert: Patient Information

Moxifloxacino Stada 400 mg Film-Coated Tablets EFG

For use in adults only

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Moxifloxacino Stada contains moxifloxacino as the active ingredient, which belongs to the group of antibiotics known as fluoroquinolones. Moxifloxacino acts by eliminating bacteria that cause infections.

Moxifloxacino is indicated for patients 18 years of age and older for the treatment of the following bacterial infections when caused by bacteria, when moxifloxacino is active against these bacteria. Moxifloxacino should only be used to treat these infections when usual antibiotics cannot be used or have not worked:

Paranasal sinus infection, sudden worsening of chronic inflammation of the airways or community-acquired pneumonia (except severe cases).

Mild to moderate upper genital tract infections in females (inflammatory pelvic disease), including fallopian tube infection and uterine mucous membrane infection. For this type of infection, moxifloxacino tablets are not sufficient as a single treatment, so your doctor will also prescribe another antibiotic for the treatment of mild to moderate upper genital tract infections (see section2.What you need to know before starting to take Moxifloxacino Stada, Advertencias and precautions, Consult your doctor or pharmacist before starting to take Moxifloxacino Stada).

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

Community-acquired pneumonia, skin and soft tissue infections.

Moxifloxacino should not be used to initiate treatment for any type of skin and soft tissue infection or severe pneumonia.

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

Do not take Moxifloxacino Stada

• If you are allergic to moxifloxacino, other quinolonas or any of the other components of this medication (listed in section 6).
• If you are pregnant or breastfeeding.
• If you are under 18 years old.
• If you have a history of tendon alterations or injuries related to antibiotic quinolone treatment (see sections2. Warnings and precautionsand section4. Possible side effects).
• If you have been born with or have:

• any disease characterized by abnormal heart rhythm (observed on ECG, heart electrical recording)
• electrolyte imbalances in the blood (especially low levels of potassium or magnesium in the blood)
• a very slow heart rhythm (called “bradycardia”)
• a weak heart (heart failure)
• a history of heart rhythm alterations (arrhythmias)

or

• are taking other medications that cause ECG disturbances (see section “Other medications and Moxifloxacino Stada”). This is because moxifloxacino can cause changes in the ECG, such as a prolongation of the QT interval, i.e., a delay in the conduction of electrical signals in the heart.

• if you have a severe liver disease or increased levels of liver enzymes (transaminases) 5 times above the upper limit of normal.

Warnings and precautions

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

• Moxifloxacino may modify the ECG of the heart, especially if you are a woman or an elderly patient. If you are currently taking any medication that causes a decrease in blood potassium levels, consult your doctor before taking moxifloxacino(see also sectionsDo not take Moxifloxacino Stada and Other medications and Moxafloxacino Stada)
• If you suffer fromepilepsyor any other condition that may causeconvulsions, consult your doctor before taking moxifloxacino.
• If you have or have ever had anymental health problems, consult your doctor before taking moxifloxacino.
• If you havemyasthenia gravis(abnormal muscle fatigue that causes weakness and in severe cases paralysis), your symptoms may worsen if you take moxifloxacino. If you think this affects you, consult your doctor immediately.
• If you or a family member hasglucose-6-phosphate dehydrogenase deficiency(a rare hereditary disease), inform your doctor, who will indicate if moxifloxacino is suitable for you.
• Ifyou have acomplicated upper genital tract infection in women(for example, associated with a fallopian tube and ovarian abscess or pelvic abscess), for which your doctor considers intravenous treatment, oral treatment with moxifloxacino is not appropriate.
• For the treatment of a mild to moderate upper genital tract infection in women, your doctor must prescribe another antibiotic in combination with moxifloxacino. If you do not notice an improvement in symptoms after three days of treatment, consult your doctor.
• If you have been diagnosed with an aortic aneurysm or peripheral aneurysm of a large vessel.
• If you have had a previous episode of aortic dissection (a tear in the aortic wall).
• If you have been diagnosed with heart valve insufficiency (valve regurgitation).
• If you have a family history of aortic dissection or aneurysm, congenital heart valve disease or other risk factors or conditions (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)).
• Do not take fluoroquinolone or quinolone-containing antibacterial medications, including moxifloxacino, if you have had a severe reaction to a quinolone or fluoroquinolone in the past. If this is your case, inform your doctor as soon as possible.
• If you arediabeticbecause you may experience a risk of changes in blood sugar levels with moxifloxacino.
• If you have ever developed asevere skin rashorskin peeling, blisters and/or mouth sores after taking moxifloxacino.

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

During treatment with Moxifloxacino Stada

• Ifyou noticepalpitations orthattheheartbeats areirregularduring the treatment period, you must inform your doctor immediately. He or she may perform an ECG to measure heart rhythm.
• Therisk of heart problemsmay increase with increasing doses. Therefore, the recommended dose should be taken.
• Inrareoccasions,you maysufferasuddensevereallergic reactionevenwiththefirstdose. The symptoms may be: chest tightness, dizziness, nausea or fainting, or feeling dizzy when standing.Immediately stop taking moxifloxacino and consult your doctor.
• Moxifloxacino may cause arapid and severe inflammation of the liver, which may lead to liver failure that puts your life at risk (including fatal cases, see section4. Possible side effects). If you suddenly feel unwell and/or feel discomfort and have yellowing of the whites of the eyes, dark urine, itching, bleeding tendency or liver damage-induced cerebral damage, please consult your doctor before continuing treatment.
• Quinolone antibiotics, including moxifloxacino, may causeconvulsions. If this occurs, the treatment with moxifloxacino must be stopped and you must contact your doctor immediately.
• In rare cases, you may experiencenerve damage symptoms(neuropathy) such as pain, burning, tingling, numbness and/or weakness, especially in the feet and legs or hands and arms. If this happens, stop taking moxifloxacino and inform your doctor immediately to prevent the development of a potentially irreversible disorder.
• You mayexperiencemental health problemsevenafterthefirstdoseofantibiotics. In very rare cases, mental health problems and depression have evolved into suicidal thoughts and self-harm behaviors such as attempted suicide (see section4. Possible side effects). If you develop these reactions, you must stop taking moxifloxacino and inform your doctor immediately.
• You may developdiarrheaduring or after taking antibiotics, including moxifloxacino. If the diarrhea is severe or persistent, or if you notice blood or mucus in the stool,immediately stop taking moxifloxacino and consult your doctor. In these situations, you should not take medications that slow down or stop intestinal movement.
• In rare cases, you may experiencejoint pain and swelling, inflammation or tendon rupture. The risk is higher if you are an elderly person (over 60 years old), have received an organ transplant, have kidney problems or are taking corticosteroids. Tendon inflammation and rupture can occur within the first 48 hours of treatment and even several months after stopping moxifloxacino treatment. If you experience any signs of tendon pain or inflammation (e.g., in the ankle, wrist, elbow, shoulder or knee), stop taking moxifloxacino,contact your doctorand keep the affected area at rest. Avoid any unnecessary exercise, as this may increase the risk of tendon rupture.
• If you experience sudden, intense pain in the abdomen, chest or back, which may be symptoms of aortic dissection or aneurysm, go to the emergency room immediately. You may be at increased risk if you are taking corticosteroids systemically.
• If you start experiencing sudden shortness of breath, especially when lying down, or if you notice swelling in the ankles, feet or abdomen or palpitations (sensation of rapid or irregular heartbeat), you must inform your doctor immediately.
• If you are an elderly person and havekidney problems, make sure to drink plenty of water while taking moxifloxacino. If you become dehydrated, you may increase the risk of kidney failure.
• If yourvision worsensor if your eyes appear to be affected in any other way,consult an ophthalmologist immediately(see sections2. Driving and operating machineryand4. Possible side effects).
• Fluoroquinolone antibiotics may cause an increase in your blood sugar levels above normal levels (hyperglycemia), or a decrease in your blood sugar levels below normal levels (hypoglycemia), which in severe cases may cause a loss of consciousness (hypoglycemic coma) (see section 4. Possible side effects). If you have diabetes, your blood sugar levels must be carefully controlled.
• Quinolone antibiotics may increase thesensitivity of the skin to sunlight or UV. You should avoid prolonged exposure to sunlight or direct sunlight and not use sunbeds or any type of UV lamp during moxifloxacino treatment (see section 4. Possible side effects).
• The efficacy of moxifloxacino solution for infusion in the treatment of severe burns, deep tissue infections and diabetic foot infections with osteomyelitis (bone marrow infections) has not been established.
• Severe, incapacitating, prolonged and potentially irreversible effects

Fluoroquinolone or quinolone-containing antibacterial medications, including moxifloxacino, have been associated with rare but severe adverse effects, some of which have been of long duration (persistent for months or years), incapacitating or potentially irreversible. This includes tendon pain, muscle and joint pain in the upper and lower extremities, difficulty walking, abnormal sensations such as pinpricks, tingling, numbness or burning (paresthesia), sensory disorders such as decreased vision, taste, smell and hearing, depression, decreased memory, intense fatigue and severe sleep disorders.

If you experience any of these adverse effects after taking moxifloxacino, contact your doctor immediately before continuing treatment. You and your doctor will decide whether to continue or not with the treatment, also considering the use of an antibiotic of another class.

Severe skin reactions

Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN), generalized acute pustular psoriasis (GAP) and drug reaction with eosinophilia and systemic symptoms (DRESS or hypersensitivity syndrome) have been reported with the use of moxifloxacino.

•SSJ/TEN may initially appear on the trunk as red, ring-shaped spots or circular patches often with central blisters. They may also appear in the mouth, throat, nose, genitals and eyes (red and swollen eyes). These severe skin eruptions often precede fever and/or flu-like symptoms. The eruptions may progress to widespread skin peeling and complications that may put your life at risk or be fatal.

•GAP appears at the beginning of treatment as a red, scaly and generalized rash with subcutaneous nodules and blisters accompanied by fever. The most common location: mainly localized in skin folds, trunk and upper limbs.

•DRESS initially appears with flu-like symptoms and a rash on the face, followed by a widespread rash with high body temperature, increased liver enzymes in blood tests and increased levels of a type of white blood cell (eosinophilia) and enlarged lymph nodes.

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

Children and adolescents

Do not give this medication to children and adolescents under 18 years old because its efficacy and safety have not been established (see sectionDo not take Moxifloxacino Stada).

Other medications and Moxifloxacino Stada

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

With moxifloxacino, you should be aware of the following:

• If you are taking moxifloxacino and othermedications that affect the heart, there is a higher risk of abnormal heart rhythm. Therefore, do not take moxifloxacino at the same time as the following medications:

• antiarrhythmic medications (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 medications(e.g., cisapride, vincamine intravenous, bepridil and difemanil)

• You should inform your doctor if you are taking other medications that may decrease blood potassium levels (e.g., some diuretics, laxatives and enemas [high doses] or corticosteroids [anti-inflammatory medications], amphotericin B) or cause a decrease in heart rate, as these may also increase the risk of severe heart rhythm disturbances while taking moxifloxacino.
• Any othermedication containing magnesium or aluminum(such as antacids for indigestion),iron, zinc or didanosineorany medication containingsucralfate (for treating gastrointestinal disorders)may reduce the action of moxifloxacino. Take your moxifloxacino tablets 6 hours before or after taking other medications.
• Theoral administration of activated charcoalat the same time as moxifloxacino reduces the action of moxifloxacino. Therefore, it is recommended not to use these medications simultaneously.
• If you are currently takingblood thinners(oral anticoagulants such as warfarin), your doctor may need to control your blood clotting time.

Use of Moxifloxacino Stada with food and drinks

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

Pregnancy, lactation and fertility

Do not use moxifloxacino if you are pregnant or breastfeeding.

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

The animal studies do not indicate that your fertility may be altered by taking this medication.

Driving and operating machinery

Moxifloxacino may cause dizziness or vertigo or a brief loss of consciousness, you may experience sudden loss of vision. If you experience these symptoms, do not drive vehicles or operate machinery.

Moxifloxacino Stada contains sodium

This medication contains less than 23 mg of sodium (1mmol) per coated tablet; it is essentially “sodium-free”.

Follow exactly the administration instructions of this medication indicated 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 a day.

No dose adjustment is necessary in elderly patients, in patients with low body weight, or in patients with kidney problems.

Administration Form

Moxifloxacino tablets are for oral administration. Take the tablet whole without chewing (to mask the bitter taste) and with plenty of liquid. Moxifloxacino can be taken with or without food. Try to take the tablet approximately at the same time every day.

Treatment Duration

The time during which you will take moxifloxacino depends on your infection. Unless your doctor has told you otherwise, your treatment will be the following:

• for sudden worsening (acute exacerbation) of chronic bronchitis: 5-10 days
• for lung infections (pneumonia)except pneumonia that begins during a hospital stay: 10 days
• For acute bacterial sinusitis: 7 days
• Mild or moderate upper genital tract infections in females (pelvic inflammatory disease), including fallopian tube infection and uterine mucous membrane infection: 14 days

When moxifloxacino tablets are used to complete a treatment cycle initiated with moxifloxacino solution for infusion, the recommended durations of use are:

•Lung infections (pneumonia) acquired outside the hospital: 7-14 days

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

•Soft tissue and skin infections: 7-21 days

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

It is essential to complete the treatment, even if you start feeling better after a few days. If you interrupt the treatment too soon, the infection may not be completely cured, and the infection may recur or your condition may worsen. The bacteria causing your infection may become resistant to moxifloxacino.

Do not exceed the recommended dose and treatment duration (see section2. What you need to know before starting to take Moxifloxacino Stada, Warnings and Precautions).

If you take more Moxifloxacino Stada than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service. Phone: 91 562 04 20 indicating the medication and the amount used.

If you forgot to take Moxifloxacino Stada

In case of forgetting a tabletyou should take it as soon as you remember on the same day.If you do not remember to take your tablet on the same day, take the usual dose (one tablet) the next day. Do not take two tablets to compensate for the missed dose.

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

If you interrupt the treatment with Moxifloxacino Stada

If you interrupt the treatment too soon, your infection may not be completely cured. Consult your doctor if you plan to stop taking the tablets before completing the treatment.

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

Like all medications, this medication may cause side effects, although not everyone will experience them. The most serious side effects observed during treatment with moxifloxacine are listed below:

If you feel

• syndrome associated with alterations in water excretion and low sodium levels (SIADH) (very rare side effect)
• loss of consciousness due to a severe decrease in blood sugar levels (hypoglycemic coma) (very rare side effect)
• inflammation of blood vessels (the signs may be red patches on the skin, usually on the legs or effects such as joint pain)

•a severe and sudden generalized allergic reaction, including very rarely a life-threatening shock (e.g., difficulty breathing, low blood pressure, rapid pulse) (rare side effect)

•swelling, including swelling of the airways (rare side effect, potentially fatal)

•seizures (rare side effect)

•problems associated with the nervous system, such as pain, burning, tingling, numbness, and/or weakness in the limbs (rare side effect)

•depression (in very rare cases that lead to self-harm, such as suicidal thoughts or attempts) (rare side effect)

•madness (which may potentially lead to self-harm, such as suicidal thoughts or attempts) (very rare side 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 side effects)

•tendon pain and swelling (tendinitis) (rare side effect) or tendon rupture (very rare side effect)

•muscle weakness, sensitivity, or pain, particularly if you also feel unwell, have a fever, or your urine is dark. These symptoms may be caused by abnormal muscle breakdown that may put your life at risk and lead to kidney problems (a condition called rhabdomyolysis) (the frequency of this side effect is "unknown")

Stop taking Moxifloxacino Stada and inform your doctor immediately,as you may need urgent medical attention.

Additionally, if you feel

•transient loss of vision (very rare side effect),

contact an ophthalmologist immediately.

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

A worsening of myasthenia gravis symptoms has been observed in very rare cases. If this happens,consult your doctor immediately.

If you have diabetes and notice that your blood sugar levels increase or decrease (rare or very rare side effects),inform your doctor immediately.

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

Other side effectsthat have been observed during treatment with moxifloxacine are listed below according to their frequency:

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

•nausea

•diarrhea

•dizziness

•stomach and abdominal pain

•vomiting

•headache

•increase in a special liver enzyme in the blood (transaminases)

•bacterial or fungal infections, e.g., oral and vaginal infections caused by Candida

•change in heart rhythm (ECG) in patients with low potassium levels in the blood

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

•rash

•indigestion/heartburn

•changes in taste (in very rare cases, loss of taste)

•sleep problems (predominantly insomnia)

•increase in a special liver enzyme in the blood (gamma-glutamyltransferase and/or alkaline phosphatase)

•low count of special white blood cells (leukocytes, neutrophils)

•constipation

•itching

•dizziness (feeling of spinning or falling)

•drowsiness

•wind

•change in heart rhythm (ECG)

•liver function alteration (including increase in a special liver enzyme in the blood (LDH))

•decreased appetite and food intake

•low count of white blood cells

•back, chest, pelvic, and limb pain

•increase in special blood cells necessary for blood clotting

•sweating

•increase in eosinophils

•anxiety

•feeling of discomfort (predominantly weakness or fatigue)

•tremors

•joint pain

•palpitations

•irregular and rapid heart rhythm

•difficulty breathing, including asthma-like conditions

•increase in a special digestive enzyme in the blood (amylase)

•restlessness/agitation

•tingling and/or numbness

•hives on the skin

•vasodilation

•confusion and disorientation

•decrease in special blood cells necessary for blood clotting

•visual disturbances, including double vision and blurred vision

•decreased blood clotting

•increase in blood lipids (fats)

•low count of red blood cells

•muscle pain

•allergic reaction

•increase in bilirubin in the blood

•gastritis

•dehydration

•severe abnormalities in heart rhythm

•dry skin

•angina pectoris

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

•muscle spasms

•muscle cramps

•hallucinations

•high blood pressure

•swelling (of the hands, feet, ankles, lips, mouth, throat)

•low blood pressure

•kidney insufficiency (including increased results of special kidney function tests, such as urea and creatinine)

•liver inflammation

•mouth inflammation

•tinnitus (ringing in the ears)

•jaundice (yellowish discoloration of the white of the eyes or skin)

•skin sensation deterioration

•abnormal dreams

•concentration disturbance

•difficulty swallowing

•olfactory changes (including loss of smell)

•balance and coordination disorders (due to dizziness)

•partial or total memory loss

•hearing loss, including deafness (usually reversible)

•increase in uric acid in the blood

•emotional instability

•difficulty speaking

•syncope

•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)

•increase in blood clotting

•muscle stiffness

•significant decrease in special white blood cells (agranulocytosis)

•decrease in the number of red and white blood cells and platelets (pancytopenia)

Frequency unknown(cannot be estimated from available data)

•syndrome associated with alteration of water excretion and low sodium levels (SIADH)

•loss of consciousness due to a severe decrease in blood sugar levels (hypoglycemic coma). See section 2.

•increase in skin sensitivity to sunlight or UV radiation (see also section 2, Warnings and precautions)

•clearly demarcated erythematous patches with/without blisters that appear in the hours following moxifloxacine administration and disappear with residual post-inflammatory hyperpigmentation; they usually reappear in the same skin or mucosal area with subsequent exposure to moxifloxacine

In addition, very rare cases of the following side effects have been reported, described after treatment with other quinolone antibiotics and may also occur during treatment with moxifloxacine:

• Increased intracranial pressure (symptoms include headache, visual disturbances such as blurred vision, "blind spots," double vision, loss of vision)
• Increased sodium levels in the blood
• Increased calcium levels in the blood
• Reduced count of a specific type of red blood cells (hemolytic anemia)

The administration of quinolone and fluoroquinolone antibiotics has been associated with very rare cases of long-lasting or permanent adverse reactions (including months or years), such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as pinpricks, tingling, itching, burning, numbness, or pain (neuropathy), depression, fatigue, sleep disorders, decreased memory, and decreased hearing, vision, taste, and smell, in some cases regardless of the presence of pre-existing risk factors.

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

Reporting of adverse reactions:

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse reactions, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the box and on the blister pack after CAD. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from moisture.

Medications should not be disposed of through drains or in the trash. Deposit the containers and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Moxifloxacino Stada Composition

• The active ingredient is moxifloxacino.

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

• The other components are:

Tablet core:

Microcrystalline cellulose

Povidone K-30

Sodium croscarmellose

Anhydrous colloidal silica

Magnesium stearate

Film coating::

Hydroxypropyl methylcellulose

Propylene glycol

Titanium dioxide (E171)

Talc

Iron oxide red (E172)

Appearance of the product and contents of the package

Moxifloxacino Stada 400 mg are pink, oblong, biconvex film-coated tablets, approximately 17.6 mm in length and 6.9 mm in width.

Moxifloxacino Stada 400 mg film-coated tablets are packaged in aluminum/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 (single-dose).

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible 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 with the following names:

Germany:Moxifloxacin Stada 400 mg Filmtabletten

Belgium:Moxifloxacine EG 400 mg filmomhulde tabletten

Finland:Moxifloxacin Stada400 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 Ciclum400 mg comprimidos revestidos porpelícula

Last review date of this leaflet: April 2024

For detailed and updated information on this medicinal product, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/