Moxifloxacin Accord

Leaflet attached to the packaging: information for the user

Moxifloxacin Accord, 400 mg, film-coated tablets

for use in adults
Moxifloxacin

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Moxifloxacin Accord and what is it used for
• 2. Important information before taking Moxifloxacin Accord
• 3. How to take Moxifloxacin Accord
• 4. Possible side effects
• 5. How to store Moxifloxacin Accord
• 6. Contents of the pack and other information

1. What is Moxifloxacin Accord and what is it used for

Moxifloxacin Accord contains the active substance moxifloxacin, which belongs to a group of
antibiotics called fluoroquinolones. Moxifloxacin Accord works bactericidally on bacteria
causing infections.
Moxifloxacin Accord is used in patients aged 18 and over to treat the following bacterial infections, if they are caused by bacteria sensitive to moxifloxacin.
Moxifloxacin Accord can only be used to treat these infections if the use of commonly administered antibiotics is not possible or if they have been ineffective.
Sinusitis, acute exacerbation of chronic bronchitis or pneumonia, if the infection did not occur in the hospital (except for severe cases).
Mild or moderate upper genital tract infections (pelvic inflammatory disease) including infections of the fallopian tubes and infection of the uterine lining.
Moxifloxacin Accord used alone is not sufficient to treat this type of infection, so the doctor should prescribe an additional antibacterial medicine to treat upper genital tract infections (see section 2. Important information before taking Moxifloxacin Accord, Warnings and precautions, Before taking Moxifloxacin Accord
and consult a doctor or pharmacist).
If improvement occurs during treatment of the following bacterial infections due to intravenous administration of Moxifloxacin Accord solution, the doctor may also prescribe Moxifloxacin Accord tablets to complete the treatment: community-acquired pneumonia, skin and soft tissue infections.
Moxifloxacin Accord should not be used to initiate treatment for any type of skin and soft tissue infection or in severe pneumonia.

2. Important information before taking Moxifloxacin Accord

If the patient has any doubts about which group they belong to, they should contact their doctor.

When not to take Moxifloxacin Accord

• if the patient is allergic to the active substance - moxifloxacin, other quinolone drugs or any of the other ingredients of the medicine (see section 6);
• during pregnancy and breastfeeding;
• in patients under 18 years of age;
• if the patient has a history of tendon disease related to treatment with other quinolone drugs (see sections Warnings and precautions and 4. Possible side effects);
• if the patient has: o congenital or acquired irregular heart rhythm (visible in the electrocardiogram (ECG) - a record of the heart's electrical activity); o electrolyte imbalance (especially low potassium or magnesium levels in the blood); o very slow heart rate (bradycardia); o heart failure; o a history of heart rhythm disorders (arrhythmias) or if the patient is taking medicines that can cause specific changes in the ECG (see section Other medicines and Moxifloxacin Accord). Moxifloxacin Accord may cause changes in the ECG, called QT interval prolongation, which means delayed conduction of electrical signals in the heart;
• if the patient has liver disease or liver enzyme activity (aminotransferases) exceeding 5 times the upper limit of normal.

Warnings and precautions

Before taking Moxifloxacin Accord

• You should not take antibacterial medicines containing fluoroquinolones or quinolones, including Moxifloxacin Accord, if you have ever had a severe side effect while taking a quinolone or fluoroquinolone. In such a situation, you should inform your doctor as soon as possible.

You should consult your doctor before starting to take Moxifloxacin

Accord

• Moxifloxacin Accord may change the heart's ECG, especially in women and the elderly. When taking medicines that lower potassium levels in the blood, you should consult your doctor before taking Moxifloxacin Accord (see also sections When not to take Moxifloxacin Accord and Other medicines and Moxifloxacin Accord).
• If the patient has epilepsyor conditions that may cause seizures, they should inform their doctor before taking Moxifloxacin Accord.
• If the patient has or has had mental health problems, they should consult their doctor before taking Moxifloxacin Accord.
• If the patient has myasthenia gravis (muscle weakness), taking Moxifloxacin Accord may exacerbate the symptoms of the disease. If this happens, the patient should contact their doctor immediately.
• If the patient has been diagnosed with enlargement or "bulging" of a large blood vessel(aortic aneurysm or large peripheral artery aneurysm).
• If the patient has had aortic dissection(damage to the aortic wall).
• If the patient has been diagnosed with heart valve regurgitation.
• If there is a history of aortic aneurysm or aortic dissectionin the patient's family, or congenital heart valve disease, or other risk factors or conditions (e.g. connective tissue disorders such as Marfan syndrome or Ehlers-Danlos syndrome, Turner syndrome, Sjögren's syndrome [an autoimmune inflammatory disease] or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behcet's disease, high blood pressure or diagnosed atherosclerosis, rheumatoid arthritis [joint disease] or endocarditis [heart infection]).

If the patient or someone in their family has a deficiency of glucose-6-phosphate dehydrogenase (a rare inherited disease), they should inform their doctor, who will assess whether Moxifloxacin Accord is a suitable medicine.

• If the patient has a complicated upper genital tract infection(e.g. when there is an abscess of the fallopian tube, ovary or in the pelvis), the doctor may consider it necessary to administer the medicine intravenously, as taking Moxifloxacin Accord tablets is not appropriate.
• In order to treat mild or moderate upper genital tract infections, the doctor should prescribe an additional antibacterial medicine to the patient, in addition to Moxifloxacin Accord. If the symptoms do not start to improve within the first 3 days of treatment, the patient should consult their doctor.
• If the patient has diabetes, as moxifloxacin may increase the risk of changes in blood sugar levels.
• If the patient has ever had a severe skin rash or peeling of the skin after taking moxifloxacin, with blisters and/or ulcers of the mouth.

During treatment with Moxifloxacin Accord

• If palpitations or irregular heartbeatoccur during treatment, the patient should immediately inform their doctor. The doctor may order an ECG to check the heart rhythm.
• The risk of heart problemsmay increase with increasing doses. Therefore, it is recommended to follow the recommended dosage of the medicine.
• There is a small risk of a severe, sudden allergic reaction(anaphylactic reaction or anaphylactic shock) even after the first dose of the medicine, with symptoms such as chest tightness, dizziness, nausea or fainting and a feeling of spinning when standing up. If these symptoms occur, the patient should stop taking Moxifloxacin Accord and seek medical attention immediately.
• Moxifloxacin Accord may cause liver inflammation with a rapid and severe course, which can lead to life-threatening liver failure (including fatal cases, see section 4. Possible side effects). If symptoms such as rapid deterioration of well-being, yellowing of the whites of the eyes, dark urine, itching of the skin, tendency to bleed and disorders of thinking or insomnia occur, the patient should contact their doctor before taking the next dose.
• Severe skin reactions: During treatment with moxifloxacin, severe skin reactions have been reported, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and acute generalized exanthematous pustulosis (AGEP).
• SJS/TEN may initially appear as reddish spots resembling a target, or round spots, often with blisters on the torso. They can also cause ulcers in the mouth, throat, nose, genitals and eyes (red and swollen eyes). The occurrence of such severe skin rashes is often preceded by fever and/or flu-like symptoms. Rashes can transform into generalized skin peeling and life-threatening complications or lead to death.
• AGEP appears at the beginning of treatment in the form of a red, peeling, generalized rash with nodules under the skin and blisters, accompanied by fever. The most common location: mainly localized to skin folds, torso and upper limbs. If a severe rash or any of these skin symptoms occur, the patient should stop taking moxifloxacin and consult their doctor or seek medical attention immediately.
• Antibiotics from the quinolone group, including Moxifloxacin Accord, may cause seizures. If seizures occur, the patient should stop taking Moxifloxacin Accord and consult their doctor.

If nerve damage symptoms (neuropathy)occur, such as pain, burning sensation, tingling, numbness and/or weakness, especially in the feet and legs or hands and arms, the patient should immediately contact their doctor before taking the next dose.

• Mental health problems may occur, even with the first use of quinolone antibiotics, including Moxifloxacin Accord. In very rare cases, depression or mental health problems can lead to suicidal thoughts and self-destructive behaviors, such as suicide attempts (see section 4. Possible side effects). If the patient experiences such reactions, they should stop taking Moxifloxacin Accord and immediately inform their attending doctor.
• During or after treatment with antibiotics, including Moxifloxacin Accord, diarrheamay occur. If it worsens or lasts for a long time, or if blood or mucus appears in the stool, the patient should stop taking Moxifloxacin Accord and consult their doctor. In such a situation, the patient should not take medicines that slow down or stop bowel movements (peristalsis).
• Rarely, pain and swelling of the joints and tendons, or tendon inflammation or rupture may occur. The risk is increased in the elderly (over 60 years), after organ transplantation, in cases of kidney problems or treatment with corticosteroids. Tendon inflammation and rupture can occur within 48 hours of starting treatment and even several months after stopping Moxifloxacin Accord. When the first symptoms of pain or tendon inflammation occur (e.g. in the ankle, wrist, elbow, shoulder or knee), the patient should stop taking Moxifloxacin Accord, consult their doctor and rest the affected area. The patient should avoid excessive strain, as it may increase the risk of tendon rupture.
• In case of sudden severe abdominal, back or chest pain, which may be a sign of an aortic aneurysm or aortic dissection, the patient should immediately go to the emergency room. The risk of these changes may be higher in patients treated with systemic corticosteroids.
• In case of sudden shortness of breath, especially when lying down, or swelling of the ankles, feet or abdomen, or palpitations (feeling of rapid or irregular heartbeat), the patient should immediately consult their doctor.
• Elderly patients with kidney problemsshould drink an adequate amount of fluids, as dehydration can increase the risk of kidney failure.
• If the patient's vision worsens or other vision problemsoccur during treatment with Moxifloxacin Accord, they should immediately consult an ophthalmologist (see section Driving and using machinesand section 4. Possible side effects).
• Fluoroquinolone antibiotics may increase blood sugar levels to above normal (hyperglycemia) or decrease blood sugar levels to below normal (hypoglycemia), which can potentially lead to loss of consciousness (hypoglycemic coma) in severe cases (see section 4. Possible side effects). Patients with diabetes should carefully monitor their blood sugar levels (see section 4. Possible side effects) .
• Fluoroquinolone antibiotics may increase sensitivity of the skin to sunlight and UV radiation. During treatment with Moxifloxacin Accord, the patient should avoid prolonged exposure to sunlight, strong sunlight and use of sunbeds or other sources of UV radiation.
• The efficacy of Moxifloxacin Accord has not been established in the treatment of severe burns, deep tissue infections and diabetic foot infections with osteomyelitis (bone infection).

Long-term, debilitating and potentially irreversible severe side effects
Fluoroquinolone/quinolone antibacterial medicines, including Moxifloxacin Accord, have been associated with very rare but severe side effects. Some of them were long-term (lasting for months or years), debilitating or potentially irreversible.
These include: tendon pain, muscle and joint pain in the upper and lower limbs, difficulty walking, abnormal sensations, such as tingling, burning, tingling, itching, numbness or burning (paresthesia), sensory disturbances, including vision, taste and smell and hearing disturbances, depression, memory disorders, severe fatigue and severe sleep disorders.
If the patient experiences any of these side effects after taking Moxifloxacin Accord, they should immediately contact their doctor before continuing treatment. The patient and doctor will decide whether to continue treatment, also considering antibiotics from another group.

Children and adolescents

This medicine should not be used in children and adolescents under 18 years of age, as the efficacy and safety of use for this age group have not been established (see section When not to take Moxifloxacin Accord).

Other medicines and Moxifloxacin Accord

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
When taking Moxifloxacin Accord, the patient should be aware of the following:

• When taking Moxifloxacin Accord with other medicines that affect heart function, the risk of heart rhythm disorders increases. Therefore, Moxifloxacin Accord should not be taken at the same time as the following medicines: o medicines belonging to the group of anti-arrhythmic medicines (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide); o antipsychotic medicines (e.g. phenothiazines, pimozide, sertindole, haloperidol, sultopride); o tricyclic antidepressant medicines; o certain antibacterial medicines (e.g. saquinavir, sparfloxacin, intravenous erythromycin, pentamidine, antimalarial medicines, especially halofantrine); o certain antihistamine medicines (e.g. terfenadine, astemizole, mizolastine); o other medicines (e.g. cisapride, intravenous vincamine, bepridil and difemanil).
• The patient should inform their doctor if they are taking other medicines that can lower potassium levels in the blood [e.g. certain diuretics, certain laxatives and enemas (large doses) or corticosteroids (anti-inflammatory medicines), amphotericin B] or slow down the heart rate, as they may increase the risk of serious heart rhythm disorders when taking Moxifloxacin Accord.
• All medicines containing magnesium or aluminum, such as antacids used to treat digestive disorders, and all medicines containing iron or zinc, medicines containing didanosineand medicines containing sucralfateused to treat gastrointestinal disorders, may reduce the effectiveness of Moxifloxacin Accord. Therefore, a 6-hour interval should be maintained between taking Moxifloxacin Accord tablets and other medicines.
• Concomitant oral administration of activated charcoaland Moxifloxacin Accord tablets reduces the effectiveness of Moxifloxacin Accord. Therefore, it is not recommended to take both medicines at the same time.
• In case of concomitant use of oral anticoagulant medicines(e.g. warfarin), the doctor may order blood coagulation tests.

Moxifloxacin Accord with food and drink

Food, including dairy products, does not affect the action of Moxifloxacin Accord.

Pregnancy, breastfeeding and fertility

Moxifloxacin Accord should not be taken during pregnancy and breastfeeding.
If the patient is pregnant, breastfeeding, suspects they are pregnant or plans to become pregnant, they should consult their doctor or pharmacist before taking this medicine.
Animal studies do not show a negative effect of this medicine on fertility.

Driving and using machines

Moxifloxacin Accord may cause dizziness and dizziness, sudden transient loss of vision or may cause short-term fainting. If such symptoms occur, the patient should not drive vehicles or operate machines.

Moxifloxacin Accord contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. the medicine is considered "sodium-free".

3. How to take Moxifloxacin Accord

This medicine should always be taken as directed by the doctor or pharmacist. In case of doubts, the patient should contact their doctor or pharmacist again.
The recommended dose for adults is 1 film-coated tablet of 400 mg once a day.
Moxifloxacin Accord is taken orally. The tablet should be swallowed whole (to avoid the bitter taste), with a large amount of liquid. Moxifloxacin Accord can be taken with or without food. It is recommended to take the tablet at the same time of day.
There is no need to adjust the dose in elderly patients, those with low body weight, or patients with kidney problems.
The duration of treatment depends on the type of infection. Unless the doctor has prescribed otherwise, the recommended duration of treatment with Moxifloxacin Accord film-coated tablets is:

• in acute exacerbation of chronic bronchitis (acute exacerbation of chronic obstructive pulmonary disease, including bronchitis) - 5-10 days;
• in pneumonia, if the infection did not occur in the hospital - 10 days;
• in acute bacterial sinusitis - 7 days;
• in mild or moderate upper genital tract infections (pelvic inflammatory disease), including infections of the fallopian tubes and infection of the uterine lining - 14 days.

The following are the recommended total treatment durations for patients for whom Moxifloxacin Accord film-coated tablets are administered to complete treatment started with moxifloxacin intravenous solution:

• community-acquired pneumonia - 7-14 days. In most patients with community-acquired pneumonia, the route of administration was changed from intravenous to oral within 4 days;
• skin and soft tissue infections - 7-21 days. In most patients with skin and soft tissue infections, the route of administration was changed from intravenous to oral within 6 days.

It is essential to complete the full treatment cycle, even if the patient's condition improves after a few days. If the patient stops taking the medicine too early, the infection may not be completely cured, the disease may recur or worsen, and the bacteria may develop resistance to the antibiotic.
The patient should not exceed the recommended dose or prolong the treatment period (see section 2. Important information before taking Moxifloxacin Accord, Warnings and precautions).

Taking a higher dose of Moxifloxacin Accord than recommended

If the patient takes more than one prescribed tablet per day, they should immediately seek medical attentionand, if possible, take all remaining tablets, packaging and this leaflet to show their doctor or pharmacist.

Missing a dose of Moxifloxacin Accord

If the patient forgets to take a tablet at the usual time, they should take it as soon as they remember that day. If the patient misses a dose one day, they should take the usual dose (one tablet) the next day. The patient should not take a double dose to make up for the missed dose.
In case of doubts about taking the medicine, the patient should consult their doctor or pharmacist.

Stopping treatment with Moxifloxacin Accord

If the patient stops taking the medicine too early, the infection may not be completely cured. If the patient needs to stop treatment early, they should discuss it with their doctor.
In case of further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Moxifloxacin Accord can cause side effects, although not everybody gets them.
The most serious side effectsobserved during treatment with moxifloxacin are presented below.

• abnormal heart rhythm (rare side effect);
• rapid deterioration of well-being, yellowing of the whites of the eyes, dark urine, itching of the skin, tendency to bleed and disorders of thinking or insomnia [these may be symptoms of fulminant hepatitis that can lead to life-threatening liver failure, including fatal cases (very rare side effect)];
• severe skin rash, including Stevens-Johnson syndrome and toxic epidermal necrolysis. It may appear as reddish spots resembling a target or round spots, often with blisters on the torso, peeling skin, ulcers in the mouth, throat, nose, genitals and eyes, and may be preceded by fever and flu-like symptoms. Rashes can transform into generalized skin peeling and life-threatening complications or lead to death (very rare side effects, potentially life-threatening);
• red, peeling, generalized rash with nodules under the skin and blisters, which is accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis) (frequency of this side effect is "unknown");
• syndrome associated with water retention and low sodium levels (SIADH) (very rare side effect);
• loss of consciousness due to significantly decreased blood sugar levels (hypoglycemic coma) (very rare side effect);
• vasculitis (may manifest as red spots on the skin, usually on the lower legs, or joint pain) (very rare side effect);
• severe, life-threatening allergic reaction, including very rare anaphylactic shock (e.g. difficulty breathing, low blood pressure, rapid heartbeat) (rare side effect);
• swelling, including swelling of the airways (rare side effect, potentially life-threatening);
• seizures (rare side effect);
• nerve problems, such as pain, burning sensation, tingling, numbness and/or weakness (rare side effect);
• depression (very rarely leading to self-harm, e.g. suicidal thoughts or behaviors or suicide attempts) (rare side effect);
• mental problems (may lead to self-harm, e.g. suicidal thoughts or behaviors or suicide attempts) (very rare side effect);
• severe diarrhea with blood and/or mucus in the stool (antibiotic-associated colitis, including pseudomembranous colitis), which can very rarely be associated with life-threatening complications (rare side effects);
• tendon pain and swelling (tendinitis) (rare side effect) or tendon rupture (very rare side effect);
• weakness, tenderness or muscle pain, especially if accompanied by malaise, high fever or dark urine. This may be due to abnormal breakdown of muscle tissue, which can be life-threatening and lead to kidney problems (a condition known as rhabdomyolysis) (frequency of this side effect is "unknown") the patient should stop taking Moxifloxacin Accord and immediately inform their doctor, as immediate medical attention may be necessary.

Additionally, if the following occur:

• transient loss of vision (very rare side effect),
• decrease in the number of red and white blood cells and platelets (pancytopenia), the patient should immediately contact an ophthalmologist.

If the patient experiences a life-threatening irregular heartbeat ( torsade de pointes) or cardiac arrest while taking Moxifloxacin Accord(very rare side effect), they should immediately inform their attending doctor that they are taking Moxifloxacin Accord and not resume this treatment.
Very rarely, worsening of myasthenia symptoms has been observed. If the patient's myasthenia symptoms worsen, they should immediately contact their doctor
If the patient with diabetes experiences an increase or decrease in blood sugar levels (rare or very rare side effect), they should immediately inform their doctor.
If the elderly patient with kidney problems experiences a decrease in urine output, swelling of the feet, ankles or abdomen, fatigue, nausea, drowsiness or shortness of breath (these may be symptoms of kidney failure; rare side effect), they should immediately consult their doctor.
Other side effectsobserved during treatment with moxifloxacin are presented below, according to their frequency:

Common (may occur in less than 1 in 10 people)

• nausea
• diarrhea
• dizziness
• stomach and abdominal pain
• vomiting
• headache
• increased activity of liver enzymes in the blood (aminotransferases)
• infections caused by resistant bacteria or fungi, e.g. oral thrush and vaginal thrush caused by yeast
• heart rhythm disorders (visible in ECG) in patients with low potassium levels in the blood

Uncommon (may occur in less than 1 in 100 people)

• rash
• stomach problems (indigestion or heartburn)
• taste disorders (very rarely loss of taste)
• sleep disorders (e.g. insomnia or drowsiness)
• increased activity of liver enzymes in the blood (gamma-glutamyltransferase

and/or alkaline phosphatase)

• low levels of certain white blood cells (leukocytes, neutrophils)
• constipation
• itching
• feeling of dizziness (spinning or tilting)
• drowsiness
• wind
• heart rhythm disorders (visible in ECG)
• liver function disorders, including increased LDH (liver enzyme) activity in the blood
• decreased appetite and food intake
• low white blood cell count
• back, chest, pelvic and limb pain
• decrease or increase in the number of blood cells necessary for blood clotting
• sweating
• increased white blood cell count (eosinophils)
• anxiety
• malaise (mainly weakness or fatigue),
• tremors
• joint pain
• palpitations
• irregular and rapid heartbeat
• breathing difficulties (including asthma)
• increased activity of the digestive enzyme (amylase) in the blood
• restlessness or agitation
• tingling and/or numbness
• hives,
• vasodilation
• confusion and disorientation
• decrease in the number of platelets necessary for blood clotting
• vision problems, including double or blurred vision
• decreased blood clotting
• increased levels of fats in the blood
• low red blood cell count
• muscle pain
• allergic reaction
• increased bilirubin levels in the blood
• gastritis
• dehydration
• severe heart rhythm disorders
• dry skin
• angina pectoris

Rare (may occur in less than 1 in 1000 people)

• muscle tremors
• muscle cramps
• hallucinations
• high blood pressure
• swelling (hands, feet, ankles, lips, mouth or throat)
• low blood pressure
• kidney function disorders (including increased results of certain kidney function tests, such as urea and creatinine levels)
• hepatitis
• stomatitis
• ringing or noise in the ears,
• jaundice (yellowing of the whites of the eyes or skin),
• skin sensation disorders
• unusual dreams
• concentration disorders
• swallowing difficulties
• smell disorders (including loss of smell)
• balance and coordination disorders (due to dizziness)
• partial or complete memory loss
• hearing disorders, including hearing loss (usually temporary)
• increased uric acid levels in the blood
• speech disorders
• fainting
• muscle weakness

Very rare (may occur in less than 1 in 10,000 people)

• arthritis
• abnormal heart rhythm
• increased skin sensitivity
• depersonalization (feeling of loss of one's own identity)
• increased blood clotting
• muscle stiffness
• significant decrease in the number of certain white blood cells (agranulocytosis)
• decrease in the number of red and white blood cells and platelets (pancytopenia)

In addition, during treatment with Moxifloxacin Accord, the following very rare side effects have been reported, which have also been described with other quinolone antibiotics:

• increased intracranial pressure (symptoms include headache, vision problems, including blurred vision, "blind" spots, double vision, loss of vision)
• increased sodium levels in the blood
• increased calcium levels in the blood
• increased breakdown of red blood cells (hemolytic anemia)
• increased sensitivity of the skin to sunlight and UV radiation

Very rare cases of long-term (lasting for months or years) or permanent side effects of the medicine, such as tendonitis, tendon rupture, joint pain, limb pain, difficulty walking, sensory disturbances, such as tingling and numbness, neuropathy, depression, fatigue, sleep disorders, memory disorders, as well as hearing, vision, taste and smell disturbances, have been associated with the use of quinolone and fluoroquinolone antibiotics, including Moxifloxacin Accord. In some cases, these were independent of pre-existing risk factors.
Patient reports have shown cases of aortic aneurysm or aortic dissection (aortic rupture) and aortic valve regurgitation in patients taking fluoroquinolones. See also section 2.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Jerozolimskie Avenue 181C, 02-222 Warsaw
phone: +48 22 49 21 301, fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Moxifloxacin Accord

The medicine should be stored out of sight and reach of children.
The medicine should not be taken after the expiry date stated on the blister pack and carton after EXP. The expiry date refers to the last day of the month.
There are no special precautions for the storage of the medicinal product.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Moxifloxacin Accord contains

• The active substance of the medicine is moxifloxacin. Each film-coated tablet contains 400 mg of moxifloxacin, in the form of hydrochloride.
• The other ingredients are: tablet core: mannitol, anhydrous colloidal silica, microcrystalline cellulose type 102, sodium carboxymethylcellulose (type A), hydroxypropylcellulose, magnesium stearate, talc; coating: polyvinyl alcohol, titanium dioxide (E 171), macrogol 4000, talc, yellow iron oxide (E 172), red iron oxide (E 172).

What Moxifloxacin Accord looks like and what the pack contains

Pink, oblong, biconvex film-coated tablets.
Moxifloxacin Accord film-coated tablets are packaged in PA/Aluminum/PVC/Aluminum blisters in a cardboard box.
Moxifloxacin Accord is available in packs containing 5, 7, 10, 14 and 30 tablets.
Not all pack sizes may be available in the market.

Marketing authorization holder

Accord Healthcare Polska Sp. z o.o.
Taśmowa 7 Street
02-677 Warsaw

Manufacturer

Pharmathen S.A.
Dervenakion 6, Pallini
15351 Attikis
Greece

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

Date of last revision of the leaflet: November 2020