Moxifloxacin Aurobindo

Patient Information Leaflet: Information for the User

Moxifloxacina Aurobindo 400 mg film-coated tablets

Generic medicine
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. 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 be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this patient information leaflet

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

1. What Moxifloxacina Aurobindo is and what it is used for

Moxifloxacina Aurobindo contains moxifloxacin as the active substance, which belongs to a group of antibiotics called fluoroquinolones. Moxifloxacina Aurobindo works by killing the bacteria that cause infections.
Moxifloxacina Aurobindo is used in patients aged 18 years and older for the treatment of the following bacterial infections when caused by bacteria sensitive to moxifloxacin. Moxifloxacina Aurobindo should only be used to treat these infections when common antibiotics cannot be used or have not worked:

• Sinus infections.
• Acute exacerbation of chronic obstructive pulmonary disease (COPD, including bronchitis) or community-acquired pneumonia (except severe cases).
• Mild to moderate infections of the upper female genital tract (pelvic inflammatory disease), including infections of the Fallopian tubes and endometrial mucosa. Moxifloxacina Aurobindo tablets alone are not sufficient for the treatment of these types of infections. Therefore, your doctor must prescribe an additional antibiotic together with Moxifloxacina Aurobindo for the treatment of upper female genital tract infections ( see section 2 . *What you need to know before taking Moxifloxacina Aurobindo, Warnings and precautions, Talk to your doctor before taking Moxifloxacina Aurobindo ). If the following bacterial infections have shown improvement during initial treatment with moxifloxacin infusion solution, your doctor may prescribe Moxifloxacina Aurobindo tablets to complete the course of therapy: community-acquired pneumonia, skin and soft tissue infections. Moxifloxacina Aurobindo tablets must not be used as initial therapy for any type of skin and soft tissue infection or for severe lung infections.

2. What you should know before taking Moxifloxacina Aurobindo

Contact your doctor if you are unsure whether you belong to the group of patients described below.
Do not take Moxifloxacina Aurobindo

• If you are allergic to the active substance moxifloxacin, to any other quinolone antibiotic, 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 previously experienced tendon problems related to treatment with quinolone antibiotics (see section Warnings and precautions and section 4. Possible side effects).
• If you were born with or have:
  • any condition causing abnormal heart rhythm (detected by ECG, electrical recording of the heart),
  • an electrolyte imbalance in the blood (particularly low levels of potassium or magnesium in the blood),
  • very slow heart rate (called "bradycardia"),
  • weak heart (heart failure),
  • a history of abnormal heart rhythm,
  • or if you are taking other medicines that cause abnormal changes in the ECG (see section Other medicines and Moxifloxacina Aurobindo).
    This is because Moxifloxacina Aurobindo can cause a specific change in the ECG, namely QT interval prolongation, which means delayed electrical conduction.
• If you have severe liver disease or elevated liver enzymes (transaminases) more than 5 times above the upper normal limit.

Warnings and precautions
Before taking this medicine
You must not take antibacterial medicines containing fluoroquinolones/quinolones, including Moxifloxacina Aurobindo, if you have previously experienced any serious adverse reaction during treatment with a quinolone or fluoroquinolone. In such a case, inform your doctor as soon as possible.
Talk to your doctor before taking Moxifloxacina Aurobindo

• If you are diabetic, as moxifloxacin may cause changes in blood sugar levels.
• If you have ever developed a severe skin rash, skin peeling, blisters, and/or mouth sores after taking moxifloxacin.
• Moxifloxacina Aurobindo can alter your cardiac ECG, particularly if you are female or elderly. If you are currently taking any medicine that reduces potassium levels in the blood, consult your doctor before taking Moxifloxacina Aurobindo (see also sections Do not take Moxifloxacina Aurobindo and Other medicines and Moxifloxacina Aurobindo).
• If you suffer from epilepsy or a condition that makes you prone to seizures, consult your doctor before taking Moxifloxacina Aurobindo.
• If you have or have had any mental health problems, consult your doctor before taking Moxifloxacina Aurobindo.
• If you suffer from myasthenia gravis (abnormal muscle fatigue leading to weakness and, in severe cases, paralysis), taking Moxifloxacina Aurobindo may worsen the symptoms. If you suspect you have this condition, contact your doctor immediately.
• If you or any member of your family has glucose-6-phosphate dehydrogenase deficiency (an inherited disorder), inform your doctor, who will advise whether Moxifloxacina Aurobindo is suitable for you.
• If you have a complicated upper female genital tract infection (e.g., associated with tubo-ovarian or pelvic abscess), for which your doctor considers intravenous treatment necessary, treatment with Moxifloxacina Aurobindo tablets is not adequate.
• For the treatment of mild to moderate upper female genital tract infections, your doctor must prescribe another antibiotic in addition to Moxifloxacina Aurobindo. If there is no improvement in symptoms after 3 days of treatment, you must consult your doctor.
• If you have been diagnosed with enlargement or "bulging" of a large blood vessel (aortic aneurysm or peripheral aneurysm of a large blood vessel).
• If you have previously experienced episodes of aortic dissection (a tear in the wall of the aorta).
• If you have a family history of aortic aneurysm, aortic dissection, or other risk factors or predisposing conditions (e.g., connective tissue disorders such as Marfan syndrome, vascular Ehlers-Danlos syndrome, or if you have vascular diseases such as Takayasu arteritis, giant cell arteritis, Behcet's syndrome, known high blood pressure, or atherosclerosis).

If you experience sudden abdominal, chest, or back pain, go immediately to the emergency room.
During treatment with Moxifloxacina Aurobindo

• If you experience palpitations or irregular heartbeat during treatment, inform your doctor immediately. Your doctor may want to perform an ECG to assess your heart rhythm.
• The risk of heart problems may increase with higher doses. Therefore, you must follow the recommended dosage instructions.
• There is a rare possibility that you may experience a sudden, severe allergic reaction (an anaphylactic reaction/shock), even with the first dose. Symptoms include: chest tightness, dizziness, nausea or fainting, or dizziness upon standing. In this case, stop taking Moxifloxacina Aurobindo and consult your doctor immediately.
• Moxifloxacina Aurobindo may cause rapid and severe liver inflammation, which can lead to life-threatening liver failure (including fatal cases, see section 4. Possible side effects). If you suddenly feel unwell and/or generally unwell and also have yellowing of the whites of the eyes, dark urine, skin itching, a tendency to bleed, or liver-induced brain disease (symptoms of reduced liver function or rapid and severe liver inflammation), contact your doctor before taking further tablets.
• Quinolone antibiotics, including Moxifloxacina Aurobindo, may cause seizures. If this occurs, stop taking Moxifloxacina Aurobindo and contact your doctor immediately.
• Rarely, symptoms of nerve damage (neuropathy) such as pain, burning, tingling, numbness, and/or weakness, particularly in the feet and legs or hands and arms, may occur. In such cases, stop treatment with Moxifloxacina Aurobindo and inform your doctor immediately to prevent permanent nerve damage.
• You may experience mental health problems even when taking quinolone antibiotics, including Moxifloxacina Aurobindo, for the first time. In very rare cases, depression or mental health problems may lead to suicidal thoughts and self-harming behaviors such as suicide attempts (see section 4. Possible side effects). If you develop such reactions, stop taking Moxifloxacina Aurobindo and inform your doctor immediately.
• You may develop diarrhea during or after taking antibiotics, including Moxifloxacina Aurobindo. If it becomes severe or persistent, or if you notice blood or mucus in your stools, stop taking Moxifloxacina Aurobindo immediately and consult a doctor. In this situation, do not take medicines that block or slow intestinal movement.
• Rarely, joint pain and swelling, tendon inflammation, or tendon rupture may occur (see sections Do not take Moxifloxacina Aurobindo and 4. Possible side effects). 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 and up to several months after stopping Moxifloxacina Aurobindo. At the first sign of tendon pain or inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop treatment with Moxifloxacina Aurobindo, consult your doctor, and rest the affected area. Avoid unnecessary movements, as the risk of tendon rupture may increase.
• If you are elderly and have kidney problems, ensure you drink plenty of fluids while taking Moxifloxacina Aurobindo. Dehydration may increase the risk of kidney failure.
• If you notice vision impairment or any other eye-related side effects, consult an ophthalmologist immediately (see sections 2. Driving and use of machines and 4. Possible side effects).

Severe skin reactions
Serious skin reactions have been reported with moxifloxacin, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP).

• SJS/TEN may initially appear as reddish spots or circular patches, often with central blisters, on the trunk. Mouth, throat, nose, genital, and eye ulcers (red, swollen eyes) may also occur. These severe rashes are often preceded by fever and/or flu-like symptoms. The rashes may progress to widespread skin peeling and life-threatening complications or may be fatal.
• AGEP appears at the beginning of treatment as a red, scaly rash with bumps under the skin and blisters accompanied by fever. The most common locations are skin folds, trunk, and upper limbs. If you develop a severe skin rash or other skin-related symptoms, stop taking moxifloxacin and contact your doctor or seek immediate medical help.
• Fluoroquinolone antibiotics may increase your blood sugar levels above normal (hyperglycemia) or decrease them below normal, potentially causing unconsciousness (hypoglycemic coma) in severe cases (see section 4). This is particularly important for people with diabetes. If you have diabetes, your blood sugar levels must be closely monitored.
• Quinolone antibiotics may make your skin more sensitive to sunlight or UV rays. You should avoid prolonged exposure to sunlight or very strong sunlight and must not use sunbeds or any other UV lamps while taking Moxifloxacina Aurobindo.

The efficacy of Moxifloxacina Aurobindo in treating severe burns, deep tissue infections, and diabetic foot infections with osteomyelitis (bone marrow infection) has not been demonstrated.
Serious, prolonged, disabling, and potentially irreversible side effects
Fluoroquinolone/quinolone antibacterial medicines, including Moxifloxacina Aurobindo, have been associated with very rare but serious side effects, some of which may be prolonged (lasting months or years), disabling, or irreversible. These include tendon, muscle, and joint pain in arms and legs, difficulty walking, abnormal sensations such as pricking, tingling, tickling, numbness, or burning (paresthesia), sensory organ disturbances such as changes in vision, taste, smell, and hearing, depression, memory impairment, severe fatigue, and severe sleep disturbances.
If you experience any of these side effects after taking Moxifloxacina Aurobindo, consult your doctor immediately before continuing treatment. Your doctor will decide together with you whether to continue treatment and may consider using an antibiotic from another class.
Children and adolescents
Do not administer 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 Moxifloxacina Aurobindo).
Other medicines and Moxifloxacina Aurobindo
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine in addition to Moxifloxacina Aurobindo.
For Moxifloxacina Aurobindo, you should be aware of the following:

• If you are taking Moxifloxacina Aurobindo and other medicines that affect the heart, there is an increased risk of heart rhythm disturbances. Therefore, do not take Moxifloxacina Aurobindo together with the following medicines:

  • medicines belonging to the antiarrhythmic group (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide),
  • antipsychotics (e.g., phenothiazines, pimozide, sertindole, haloperidol, sulpiride),
  • 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 difemanil).

• You must inform your doctor if you are taking other medicines that may reduce potassium levels in the blood (e.g., certain diuretics, laxatives and enemas [at high doses], or corticosteroids [anti-inflammatory medicines], amphotericin B) or slow heart rate, as these may also increase the risk of serious heart rhythm disturbances while taking Moxifloxacina Aurobindo.

• Any medicine containing magnesium or aluminum, such as antacids for indigestion, iron or zinc, or didanosine, or any medicine containing sucralfate (for gastrointestinal disorders) may reduce the effect of Moxifloxacina Aurobindo tablets. Take your Moxifloxacina Aurobindo tablets 6 hours before or after taking other medicines.

• Taking any medicine containing charcoal together with Moxifloxacina Aurobindo tablets reduces the effect of Moxifloxacina Aurobindo. It is recommended that these medicines not be used together.

• If you are currently taking medicines to thin the blood (oral anticoagulants such as warfarin), your doctor may need to monitor your blood clotting times.

Moxifloxacina Aurobindo with food and drinks
Moxifloxacina Aurobindo may be taken with or without food (including dairy products).
Pregnancy and breastfeeding
Do not take Moxifloxacina Aurobindo if you are pregnant or breastfeeding.
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Animal studies have not indicated that fertility would be impaired by this medicine.
Driving and use of machines
Moxifloxacina Aurobindo may cause dizziness or drowsiness, sudden and transient vision loss, or fainting for a short period. If you experience these effects, do not drive or operate machinery.
Moxifloxacina Aurobindo contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., it is essentially 'sodium-free'.

3. How to take Moxifloxacina Aurobindo

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose for adults is one 400 mg film-coated tablet once daily.
Moxifloxacina Aurobindo tablets are for oral use. Swallow the tablet whole (to mask its bitter taste) with plenty of liquid. You may take Moxifloxacina Aurobindo with or without food. Try to take the tablet at approximately the same time each day.
The same dose may be used in elderly patients, patients with low body weight, or patients with kidney problems.
The length of time you need to take Moxifloxacina Aurobindo depends on the type of infection you have. Unless otherwise advised by your doctor, the duration of treatment will be as follows:

• Acute exacerbation of chronic obstructive bronchopulmonary disease, including bronchitis: 5–10 days.
• Lung infection (pneumonia), except for pneumonia acquired during hospital stay: 10 days.
• Acute bacterial sinusitis (sinus infection): 7 days.
• Mild to moderate female upper genital tract infections (pelvic inflammatory disease), including fallopian tube infection and infection of the uterine mucosa: 14 days. When Moxifloxacina Aurobindo film-coated tablets are used to complete a course of therapy initially started with moxifloxacin infusion solution, the recommended doses are:
• Community-acquired pneumonia (pneumonia contracted outside the hospital): 7–14 days. Most patients with pneumonia are switched to oral treatment with Moxifloxacina Aurobindo film-coated tablets within 4 days.
• Skin and soft tissue infections: 7–21 days. Most patients with skin and soft tissue infections are switched to oral treatment with Moxifloxacina Aurobindo 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 taking the medicine too early, your infection may not be completely cured, and it may return or your condition may worsen. The bacteria causing your infection may become resistant
to Moxifloxacina Aurobindo.
The recommended dose and duration of treatment must not be exceeded (see section 2. What you need to know before taking Moxifloxacina Aurobindo, Warnings and precautions).
If you take more Moxifloxacina Aurobindo than you should
If you take more than one tablet per day as prescribed, contact your doctor immediately and, if possible, bring the remaining tablets, the packaging, or the leaflet to show the doctor or pharmacist what you have taken.
If you forget to take Moxifloxacina Aurobindo
If you forget to take your tablet, take it as soon as you remember on the same day. If you do not remember until the next day, take your usual dose (one tablet) on the following day. Do not take a double dose to make up for the forgotten dose.
If you have any doubts about what to do, ask your doctor or pharmacist.
If you stop taking Moxifloxacina Aurobindo
Do not stop taking this medicine too early, as your infection may not be fully cured. Consult your doctor if you wish to stop taking the tablets before the end of the treatment.
If you have any questions about the use of this product, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

The most serious side effects observed during treatment with Moxifloxacina Aurobindo are listed below:
If you notice:

• abnormally fast heartbeat (uncommon side effect);
• a sudden feeling of illness or notice yellowing of the whites of the eyes, dark urine, skin itching, tendency to bleed, or disturbances in cognitive function or insomnia (these may be signs and symptoms of fulminant hepatitis which can lead to potentially fatal liver failure) (very rare side effect; fatal cases have been reported);
• severe skin rashes including Stevens-Johnson syndrome and toxic epidermal necrolysis. These may appear as reddish spots or circular lesions, often with central blisters on the trunk, skin peeling, mouth, throat, nose, genital or eye ulcers, and may be preceded by fever and flu-like symptoms (very rare side effects, potentially fatal);
• 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 side effect is “not known”);
• syndrome associated with reduced water excretion and low sodium levels (SIADH) (very rare side effect);
• loss of consciousness due to severe drop in blood sugar levels (hypoglycaemic coma) (very rare side effect);
• inflammation of blood vessels (signs may include red spots on the skin, usually on the lower legs, or symptoms such as joint pain) (very rare side effects);
• a severe, sudden and generalized allergic reaction, very rarely including potentially fatal shock (e.g. difficulty breathing, drop in blood pressure, rapid heartbeat) (uncommon side effect);
• swelling, including swelling of the airways (uncommon side effect, potentially fatal);
• seizures (uncommon side effect);
• nervous system disorders such as pain, burning, tingling, numbness and/or weakness in the extremities (uncommon side effect);
• depression (which in very rare cases may lead to self-harming behaviour, such as suicidal ideation/suicidal thoughts, or suicide attempts) (uncommon side effect);
• psychosis (which may lead to self-harming behaviour, such as suicidal ideation/suicidal thoughts, or suicide attempts) (very rare side effect);
• severe diarrhoea with blood and/or mucus (antibiotic-associated colitis, including pseudomembranous colitis), which in very rare circumstances may progress to potentially fatal complications (uncommon side effects);
• tendon pain and swelling (tendinitis) (uncommon side effect) or tendon rupture (very rare side effect);
• muscle weakness, tenderness or pain, particularly accompanied by feeling unwell, high temperature or dark urine. These may be caused by abnormal muscle damage which can be life-threatening and lead to kidney problems (a condition called rhabdomyolysis) (frequency of this side effect is “not known”);

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

Additionally, if you notice:

• temporary loss of vision (very rare side effect), seek immediate advice from an ophthalmologist. If you have experienced a potentially fatal irregular heart rhythm (torsades de pointes) or cardiac arrest while taking Moxifloxacina Aurobindo (very rare side effects), inform your doctor immediately that you have taken Moxifloxacina Aurobindo and do not restart treatment. In very rare cases, worsening of symptoms of myasthenia gravis has been observed. If this occurs, seek immediate medical advice. If you have diabetes and notice your blood sugar levels rising or falling (uncommon or very rare side effect), inform your doctor immediately. If you are elderly and already have kidney problems and notice reduced urine output, swelling in the legs, ankles or feet, fatigue, nausea, drowsiness, shortness of breath or confusion (these may be signs of kidney failure, a rare side effect), seek immediate medical advice.

Other side effects observed during treatment with Moxifloxacina Aurobindo are listed below according to their likelihood of occurrence:

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

• nausea
• diarrhoea
• dizziness
• stomach upset and abdominal pain
• vomiting
• headache
• increase in a specific liver enzyme in the blood (transaminases)
• infections caused by resistant bacteria or fungi, such as oral or 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)

• skin rash
• stomach disorders (indigestion/heartburn)
• altered sense of taste (in very rare cases, loss of taste)
• sleep disturbances (mainly insomnia)
• increase in a specific liver enzyme in the blood (gamma-glutamyl transferase and/or alkaline phosphatase)
• decrease in certain white blood cells in the blood (leukocytes, neutrophils)
• constipation
• itching
• sensation of dizziness (feeling of spinning or falling)
• drowsiness
• flatulence
• change in heart rhythm (ECG)
• impaired liver function (including increase in a specific liver enzyme in the blood (LDH))
• reduced appetite and food intake
• low number of white blood cells in the blood
• pain, such as back, chest, pelvic or limb pain
• increase in blood cells specialized in clotting
• sweating
• increase in specific white blood cells (eosinophils)
• anxiety
• feeling unwell (mainly weakness or fatigue)
• tremor
• joint pain
• palpitations
• irregular and rapid heartbeat
• breathing difficulties including asthmatic conditions
• increase in a specific digestive enzyme in the blood (amylase)
• restlessness/agitation
• tingling sensation (prickling and stinging) and/or numbness
• urticaria
• dilation of blood vessels
• confusion and disorientation
• decrease in blood cells specialized in clotting
• visual disturbances including diplopia (double vision) and blurred vision
• reduced blood clotting
• increase in blood lipids (fats)
• decrease in red blood cells
• muscle pain
• allergic reaction
• increased bilirubin in the blood
• inflammation of the stomach
• 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 (swelling of hands, feet, ankles, lips, mouth, throat)
• low blood pressure
• impaired kidney function (including increased laboratory markers of kidney function such as urea and creatinine)
• liver inflammation
• mouth inflammation
• ringing or noises in the ears
• jaundice (yellowing of the whites of the eyes or skin)
• impaired skin sensitivity
• unusual dreams
• concentration difficulties
• difficulty swallowing
• disturbances in smell (including loss of smell)
• balance disorders 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 in speaking
• fainting
• muscle weakness

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

• joint inflammation
• heart rhythm abnormalities
• increased skin sensitivity
• depersonalization (feeling of not being oneself)
• increased blood clotting
• muscle stiffness
• significant reduction in specialized white blood cells (agranulocytosis)
• decrease in red blood cells, white blood cells and platelets (pancytopenia)

Additionally, very rare cases of the following side effects have been reported following treatment with other quinolone antibiotics, which may also occur during treatment with Moxifloxacina Aurobindo:
increased pressure in the skull (symptoms include headache, visual disturbances including blurred vision, blind spots, double vision, vision loss), increased levels of sodium in the blood, increased levels of calcium in the blood, a specific type of decrease in red blood cells (haemolytic anaemia), increased skin sensitivity to sunlight or UV light.

Very rare cases of prolonged (lasting months or years) or permanent adverse drug reactions such as tendon inflammation, tendon rupture, joint pain, arm or leg pain, difficulty walking, abnormal sensations such as tingling, prickling, stinging, burning, numbness or pain (neuropathy), depression, fatigue, sleep disturbances, memory impairment and changes in hearing, vision, taste and smell have been associated with the use of quinolone and fluoroquinolone antibiotics, in some cases regardless of pre-existing risk factors.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Moxifloxacin Aurobindo

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 packaging after EXP. The expiry date refers to the last day of the month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Moxifloxacina Aurobindo Contains

• 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 starch glycolate (type A), povidone (K-30), magnesium stearate.
  Film coating: hypromellose, titanium dioxide (E171), macrogol 4000, and red iron oxide (E172).

Description of the Appearance of Moxifloxacina Aurobindo and Contents of the Package
Film-coated tablet
Opaque red, modified capsule-shaped, film-coated tablet, marked with "E 18" on one side and smooth on the other.
Moxifloxacina Aurobindo film-coated tablets are available in the following pack sizes:
PVC/PVdC – Aluminium blisters:
Moxifloxacin 400 mg tablets: 1, 5, 7, 10, 14, 25, 50, 70, 80 and 100 tablets
HDPE bottles with polypropylene closure:
Moxifloxacin 400 mg tablets: 30 and 1000 tablets
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder
Aurobindo Pharma (Italia) s.r.l.
Via San Giuseppe, 102
21047 Saronno (VA)
Italy

Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far,
Birzebbugia, BBG 3000.
Malta

Milpharm Limited
Ares, Odyssey Business Park, West End Road,
South Ruislip HA4 6QD.
United Kingdom

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
France: Moxifloxacine Arrow 400 mg, comprimé pelliculé
Germany: Moxifloxacin Aurobindo 400 mg filmtabletten
Italy: Moxifloxacina Aurobindo 400 mg compresse rivestite con film
Portugal: Moxifloxacina Aurobindo
Romania: Moxifloxacin Aurobindo 400 mg, comprimate filmate
Spain: Moxifloxacino Aurobindo 400 mg comprimidos recubiertos con película