Moxifloxacin accord

Package leaflet: Information for the user

Moxifloxacin Accord, 400 mg, film-coated tablets
for use in adults
Moxifloxacinum
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 further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

1. What Moxifloxacin Accord is and what it is used for
2. What you need to know 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 Moxifloxacin Accord is and what it is used for

Moxifloxacin Accord contains the active substance moxifloxacin, which belongs to a group of antibiotics known as fluoroquinolones. Moxifloxacin Accord acts bactericidally against bacteria causing infections.

Moxifloxacin Accord is used in patients aged 18 years and older for the treatment of the following bacterial infections, provided they are caused by bacteria sensitive to moxifloxacin.
Moxifloxacin Accord may be used to treat these infections only when commonly prescribed antibiotics are not suitable or have proven ineffective.

• Sinusitis, acute exacerbation of chronic bronchitis, or pneumonia, when the infection was not acquired in hospital (except in severe cases).
• Mild to moderate upper genital tract infections (pelvic inflammatory disease), including infections of the fallopian tubes and endometritis.

Moxifloxacin Accord used alone is not sufficient for the treatment of these types of infections; therefore, your doctor should also prescribe an additional antibacterial agent for the treatment of upper female genital tract infections (see section 2. What you need to know before taking Moxifloxacin Accord, Warnings and precautions, Before you take Moxifloxacin Accord, talk to your doctor or pharmacist).

If improvement has occurred during treatment of the following bacterial infections with Moxifloxacin Accord infusion solution, your doctor may also prescribe Moxifloxacin Accord tablets to complete the treatment course:

• Community-acquired pneumonia
• Skin and soft tissue infections

Moxifloxacin Accord should not be used to initiate treatment for all types of skin and soft tissue infections or for severe lung infections.

2. Important information before using Moxifloxacin Accord

If the patient has any doubts as to whether they belong to any of the groups described below, they should contact their doctor.

When not to use Moxifloxacin Accord

• if the patient is allergic to the active substance – moxifloxacin, other drugs in the quinolone group, or any of the other ingredients of this medicine (see section 6);
• during pregnancy and breastfeeding;
• in patients under 18 years of age;
• if the patient has previously experienced tendon disorders associated with treatment with other quinolone drugs (see sections Warnings and precautions and 4. Possible side effects);
• if the patient has:
  o a congenital or acquired abnormal heart rhythm (visible on electrocardiogram (ECG));
  o electrolyte imbalance (especially low blood potassium or magnesium levels);
  o very slow heart rate (bradycardia);
  o impaired heart function (heart failure);
  o a history of heart rhythm disorders (arrhythmias); or
  o if the patient is taking medicines that may cause specific changes in the ECG (see section Other medicines and Moxifloxacin Accord). Moxifloxacin Accord may cause changes in the ECG called QT prolongation, which means delayed electrical conduction in the heart;
• if the patient has liver disease or liver enzyme (aminotransferase) levels more than 5 times above the upper limit of normal.

Warnings and precautions
Before taking Moxifloxacin Accord

• Do not take antibacterial medicines containing fluoroquinolones or quinolones, including Moxifloxacin Accord, if the patient has previously experienced any severe adverse reaction while taking a quinolone or fluoroquinolone. In such a case, the doctor should be informed immediately.

Consult your doctor before starting Moxifloxacin Accord

• Moxifloxacin Accord may alter the heart's ECG, especially in women and elderly patients. If the patient is taking other medicines that lower blood potassium levels, consult the doctor before taking Moxifloxacin Accord (see also sections When not to use Moxifloxacin Accord and Other medicines and Moxifloxacin Accord).

• If the patient has epilepsy or conditions that may provoke seizures, inform the doctor before taking Moxifloxacin Accord.

• If the patient has or has ever had mental health disorders, they should consult their doctor before taking Moxifloxacin Accord.

• If the patient has myasthenia gravis (muscle weakness), taking Moxifloxacin Accord may worsen symptoms. If this occurs, contact the 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 previously experienced aortic dissection (damage to the aortic wall).

• If the patient has heart valve insufficiency.

• If in the patient’s family there has been aortic aneurysm or aortic dissection, congenital heart valve disease, or other risk factors or predisposing 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, Behçet'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 glucose-6-phosphate dehydrogenase deficiency (a rare inherited disorder), inform the doctor, who will assess whether Moxifloxacin Accord is appropriate.

• If the patient has a complicated upper genital tract infection (e.g. when tubo-ovarian or pelvic abscess is present), the doctor may consider intravenous administration necessary, as treatment with Moxifloxacin Accord tablets is not suitable.

• For the treatment of mild to moderate upper genital tract infections, the doctor should prescribe an additional antibacterial agent alongside Moxifloxacin Accord. If symptoms do not start to improve within the first 3 days of treatment, the patient should contact their doctor.

• If the patient has diabetes, because moxifloxacin may carry a risk of blood glucose changes.

• If the patient has ever experienced severe skin rash, skin peeling, blistering, and/or oral mucosal ulceration after taking moxifloxacin.

While using Moxifloxacin Accord

• If palpitations or irregular heartbeat occur during treatment, inform the doctor immediately. The doctor may order an ECG to check heart rhythm.

• Risk of heart function disturbances may increase with higher doses. Therefore, it is recommended to follow the prescribed dosage.

• There is a small risk of severe, sudden allergic reaction (anaphylactic reaction or anaphylactic shock), even after the first dose, with symptoms such as: chest tightness, dizziness, nausea, or fainting and vertigo upon standing. If any of these occur, stop taking Moxifloxacin Accord immediately and seek medical advice.

• Moxifloxacin Accord may cause rapid and severe liver inflammation, which may lead to life-threatening liver failure (including fatal outcomes, see section 4. Possible side effects). If symptoms such as rapid worsening of general condition, yellowing of the whites of the eyes, dark urine, itchy skin, tendency to bleed, or disturbances in thinking or insomnia occur, contact the doctor before taking the next dose.

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

• SJS/TEN may initially appear as reddish target-like spots or circular lesions, often with blisters on the trunk. Oral, throat, nasal, genital, and ocular ulcers (red, swollen eyes) may also occur. The onset of such severe skin rashes is often preceded by fever and/or flu-like symptoms. These rashes may progress to widespread skin peeling, life-threatening complications, or death.

• AGEP rash typically appears early in treatment as a red, scaly, generalized rash with subcutaneous papules and blisters, accompanied by fever. Most commonly affected areas: primarily skin folds, trunk, and upper limbs. If severe rash or any of these skin symptoms occur, discontinue moxifloxacin and contact a doctor or seek immediate medical help.

• Quinolone antibiotics, including Moxifloxacin Accord, may cause seizures. If seizures occur, immediately discontinue Moxifloxacin Accord and contact the doctor.

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

• Psychiatric disorders may occur, even with first use of quinolone antibiotics, including Moxifloxacin Accord. In very rare cases, depression or psychiatric disorders may lead to suicidal thoughts and self-harming behaviors, including suicide attempts (see section 4. Possible side effects). If such reactions occur, immediately discontinue Moxifloxacin Accord and contact the treating doctor.

• Diarrhea may occur during or after treatment with antibiotics, including Moxifloxacin Accord. If diarrhea worsens or persists, or if blood or mucus is observed in the stool, immediately discontinue Moxifloxacin Accord and consult a doctor. In such cases, do not use drugs that inhibit or slow intestinal motility (peristalsis).

• Rarely, joint pain, swelling, tendon inflammation, or tendon rupture may occur. The risk is increased in elderly patients (over 60 years), organ transplant recipients, patients with kidney disorders, or those receiving corticosteroid treatment. Tendon inflammation and rupture may occur within the first 48 hours of treatment and even several months after stopping Moxifloxacin Accord. At the first sign of tendon pain or inflammation (e.g. in the ankle, wrist, elbow, shoulder, or knee), discontinue Moxifloxacin Accord, contact the doctor, and rest the affected area. Avoid excessive physical exertion, as this may increase the risk of tendon rupture.

• If sudden severe abdominal, back, or chest pain occurs, which may indicate aortic aneurysm or dissection, seek emergency medical attention immediately. The risk may be higher in patients receiving systemic corticosteroids.

• If sudden shortness of breath, especially when lying down, or swelling of the ankles, feet, or abdomen, or palpitations (sensation of rapid or irregular heartbeat) occur, contact the doctor immediately.

• Elderly patients with kidney function disorders should drink adequate fluids, as dehydration may increase the risk of kidney failure.

• If vision deteriorates or other visual disturbances occur during treatment with Moxifloxacin Accord, consult an ophthalmologist immediately (see section Driving and operating machinery and section 4. Possible side effects).

• Fluoroquinolone antibiotics may cause blood glucose levels to rise above normal (hyperglycemia) or fall below normal (hypoglycemia), which may in severe cases lead to loss of consciousness (hypoglycemic coma) (see section 4. Possible side effects). In diabetic patients, blood glucose levels should be closely monitored (see section 4. Possible side effects).

• Quinolone antibiotics may increase skin sensitivity to sunlight and UV radiation. During treatment with Moxifloxacin Accord, avoid prolonged sun exposure, intense sunlight, and using tanning beds or other UV radiation sources.

• The efficacy of Moxifloxacin Accord in treating severe burns, deep tissue infections, and diabetic foot infections with osteomyelitis (bone marrow infection) has not been established.

Long-term, disabling and potentially irreversible serious adverse effects
Antibacterial drugs containing fluoroquinolones/quinolones, including Moxifloxacin Accord, have been associated with very rare but serious adverse effects. Some of these are long-lasting (persisting for months or years), disabling, or potentially irreversible. These include: tendon, muscle, and joint pain in the upper and lower limbs, difficulty walking, abnormal sensations such as pricking, tingling, tickling, numbness, or burning (paresthesia), sensory disturbances including vision, taste, smell, and hearing disorders, depression, memory disturbances, severe fatigue, and severe sleep disturbances.
If any of these adverse effects occur after taking Moxifloxacin Accord, contact the doctor immediately before continuing treatment. The patient and doctor will decide whether to continue treatment, possibly considering antibiotics from another class.

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

Other medicines and Moxifloxacin Accord
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use.

When taking Moxifloxacin Accord, be aware of the following:

• The risk of heart rhythm disturbances increases when Moxifloxacin Accord is taken with other medicines affecting heart function. Therefore, do not take Moxifloxacin Accord simultaneously with the following medicines:
  o antiarrhythmic drugs (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide);
  o antipsychotics (e.g. phenothiazines, pimozide, sertindole, haloperidol, sulpiride);
  o tricyclic antidepressants;
  o certain antibacterial drugs (e.g. saquinavir, sparfloxacin, intravenous erythromycin, pentamidine, antimalarials, particularly halofantrine);
  o certain antihistamines (e.g. terfenadine, astemizole, mizolastine);
  o other medicines (e.g. cisapride, intravenous vincamine, bepridil, difemanil).
• Inform the doctor if the patient is taking other medicines that may reduce blood potassium levels [e.g. certain diuretics, certain laxatives and enemas (high doses), or corticosteroids (anti-inflammatory drugs), amphotericin B] or slow heart rate, as they may increase the risk of serious heart rhythm disturbances when used with Moxifloxacin Accord.
• All medicines containing magnesium or aluminium, such as antacids used for digestive disorders, and all medicines containing iron or zinc, didanosine, or sucralfate, used for 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 charcoal and Moxifloxacin Accord tablets reduces the effectiveness of Moxifloxacin Accord. Therefore, concomitant use of both medicines is not recommended.
• If taking oral anticoagulants (e.g. warfarin) concurrently, the doctor may order blood clotting time tests.

Moxifloxacin Accord with food and drink
Food, including dairy products, does not affect the action of Moxifloxacin Accord.

Pregnancy, breastfeeding and fertility
Do not use Moxifloxacin Accord during pregnancy or breastfeeding.
If the patient is pregnant, breastfeeding, suspects pregnancy, or plans to become pregnant, they should consult their doctor or pharmacist before using this medicine.
Animal studies have not shown any adverse effect of this medicine on fertility.

Driving and operating machinery
Moxifloxacin Accord may cause dizziness, vertigo, sudden transient loss of vision, or brief fainting. If such symptoms occur, do not drive or operate machinery.

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

3. How to use Moxifloxacin Accord

This medicine should always be taken according to the instructions given by your doctor or pharmacist. If you
are unsure, you should contact your doctor or pharmacist again.
The recommended dose for adults is 1 film-coated tablet 400 mg once daily.
Moxifloxacin Accord is taken orally. The tablet should be swallowed whole (to avoid the bitter taste) with a large amount of fluid. Moxifloxacin Accord may be taken
regardless of meals. It is recommended to take the tablet at the same time each day.
Dose adjustment is not necessary in elderly patients, patients with low body weight, or
patients with renal function disorders.
The duration of treatment depends on the type of infection. Unless otherwise directed by your doctor, the recommended treatment duration for Moxifloxacin Accord film-coated tablets is:

• for acute exacerbation of chronic bronchitis (acute exacerbation of chronic obstructive pulmonary disease, including bronchitis) – 5–10 days;
• for community-acquired pneumonia – 10 days;
• for acute bacterial sinusitis – 7 days;
• for mild to moderate infection of the upper genital tract (pelvic inflammatory disease), including fallopian tube infection and endometrial infection – 14 days.

The recommended total treatment duration for patients in whom Moxifloxacin Accord tablets are administered to complete treatment initiated with moxifloxacin infusion solution is as follows:

• community-acquired pneumonia – 7–14 days. In most patients with community-acquired pneumonia, the route of administration was switched 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 switched from intravenous to oral within 6 days.

It is important to complete the full course of treatment, even if you start feeling better after a few days.
If treatment is stopped too early, the infection may not be completely cured, it may recur or worsen, and bacteria may develop resistance to the antibiotic.
Do not exceed the recommended dose or prolong the treatment duration (see section 2. Important information before taking Moxifloxacin Accord, Warnings and precautions).
Taking more than the recommended dose of Moxifloxacin Accord
If you take more than one prescribed tablet per day, you should seek medical help immediately
and, if possible, bring any remaining tablets, the medicine packaging, and this patient information leaflet to show your doctor or pharmacist.
Missing a dose of Moxifloxacin Accord
If you forget to take your tablet at the usual time, you should take it as soon as you remember on the same day. If you miss a dose for one day, take your usual dose (one tablet) the next day. Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
Stopping treatment with Moxifloxacin Accord
If you stop taking the medicine too early, the infection may not be completely cured. If you need to stop treatment earlier than planned, speak to your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.

The most serious side effects observed during treatment with moxifloxacin are listed below.
If any of the following side effects occur:

• very fast or irregular heartbeat (uncommon side effect);
• rapid worsening of general condition, yellowing of the whites of the eyes, dark urine, itching, tendency to bleed, and disturbances in thinking or insomnia [these may be signs and symptoms of fulminant hepatitis which can lead to life-threatening liver failure, including fatal outcome (very rare side effect)];
• severe skin rash, including Stevens-Johnson syndrome and toxic epidermal necrolysis. This may appear as reddish, target-like spots or circular patches, often with blisters on the trunk, peeling skin, sores in the mouth, throat, nose, genital organs and eyes, and may be preceded by fever and flu-like symptoms (very rare side effects, potentially life-threatening);
• red, peeling generalized rash with subcutaneous nodules and blisters, initially accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis) (frequency of this adverse reaction is "unknown");
• syndrome of inappropriate antidiuretic hormone secretion (SIADH) (very rare side effect);
• loss of consciousness due to significantly low blood sugar levels (hypoglycaemic coma) (very rare side effect);
• inflammation of blood vessels (may present as red blister-like skin lesions, usually on the lower legs, or joint pain) (very rare side effect);
• severe, rapidly spreading allergic reaction, including very rarely life-threatening anaphylactic shock (e.g. breathing difficulties, drop in blood pressure, rapid pulse) (uncommon side effect);
• swelling, including swelling of the airways (uncommon side effect, potentially life-threatening);
• seizures (uncommon side effect);
• nervous system-related symptoms such as pain, burning sensation, tingling, numbness and/or weakness of limbs (uncommon side effect);
• depression (very rarely leading to self-harm, e.g. hallucinations or suicidal thoughts or suicide attempts) (uncommon side effect);
• psychiatric disturbances (which may lead to self-harm, e.g. hallucinations or suicidal thoughts or suicide attempts) (very rare side effect);
• severe diarrhoea with blood and/or mucus in stool (antibiotic-associated colitis, including pseudomembranous colitis), which very rarely may be associated with life-threatening complications (uncommon side effects);
• tendon pain and swelling (tendonitis) (uncommon side effect) or tendon rupture (very rare side effect);
• muscle weakness, tenderness or pain, especially if associated with 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 adverse reaction is "unknown"), you must stop taking Moxifloxacin Accord and contact your doctor immediately, as immediate medical attention may be required.

Additionally, if any of the following occur:

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

If the patient experiences life-threatening irregular heartbeat (torsade de pointes) or cardiac arrest while taking Moxifloxacin Accord (very rare side effect), you must immediately inform the treating physician that the patient is taking Moxifloxacin Accord and must not restart this treatment.

Very rarely, worsening of myasthenia symptoms has been observed. If the patient's myasthenia symptoms worsen, contact the doctor immediately.

If the patient with diabetes experiences increased or decreased blood glucose levels (uncommon or very rare side effect), you must immediately inform the doctor.

If an elderly patient with impaired kidney function develops reduced urine volume, swelling of the legs, ankles or feet, fatigue, nausea, drowsiness, shortness of breath or confusion (these may be signs and symptoms of kidney failure; uncommon side effect), seek medical advice immediately.

Other side effects observed during moxifloxacin treatment are listed below, according to their frequency:

Common (may affect less than 1 in 10 people)

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

Uncommon (may affect less than 1 in 100 people)

• rash
• stomach discomfort (dyspepsia or heartburn)
• taste disturbances (very rarely loss of taste)
• sleep disturbances (e.g. insomnia or drowsiness)
• increased blood activity of liver enzymes (gamma-glutamyltransferase and/or alkaline phosphatase)
• low number of certain white blood cells (leukocytes, neutrophils)
• constipation
• itching
• sensation of dizziness (spinning or tumbling)
• drowsiness
• flatulence
• heart rhythm disturbances (visible on ECG)
• liver function disorders, including increased blood LDH (liver enzyme) activity
• reduced appetite and food intake
• low number of white blood cells
• back, chest, pelvic and limb pain
• decreased or increased number of blood cells necessary for blood clotting
• sweating
• increased number of white blood cells (eosinophils)
• anxiety
• malaise (mainly weakness or fatigue)
• tremor
• joint pain
• palpitations
• irregular and rapid heartbeat
• breathing difficulties (including asthmatic conditions)
• increased blood activity of digestive enzyme (amylase)
• motor restlessness or agitation
• tingling and/or numbness
• urticaria
• blood vessel dilation
• confusion and disorientation
• decreased number of platelets necessary for blood clotting
• vision disturbances, including double or blurred vision
• reduced blood clotting ability
• increased blood lipid levels
• low number of red blood cells
• muscle pain
• allergic reaction
• increased blood bilirubin concentration
• inflammation of the stomach mucosa
• dehydration
• severe heart rhythm disturbances
• dry skin
• angina pectoris

Rare (may affect less than 1 in 1,000 people)

• muscle twitching
• 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
• inflammation of the oral mucosa
• ringing or noise in the ears
• jaundice (yellowing of the whites of the eyes or skin)
• skin sensation disturbances
• unusual dreams
• concentration difficulties
• swallowing difficulties
• changes in smell (including loss of smell)
• balance and coordination disturbances (due to dizziness)
• partial or complete memory loss
• hearing disturbances, including deafness (usually transient)
• increased blood uric acid levels
• speech disturbances
• fainting
• muscle weakness

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

• arthritis
• abnormal heart rhythm
• increased skin sensitivity
• depersonalization (feeling of loss of self-identity)
• increased blood clotting
• muscle stiffness
• significant decrease in certain white blood cells (agranulocytosis)
• decreased number of red and white blood cells and platelets (pancytopenia)

Additionally, the following side effects have very rarely occurred during treatment with Moxifloxacin Accord, as described with other quinolone antibiotics:

• increased intracranial pressure (symptoms include headache, vision problems, including blurred vision, blind spots, double vision, vision loss)
• increased blood sodium concentration
• increased blood calcium concentration
• excessive breakdown of red blood cells (haemolytic anaemia)
• increased skin sensitivity to sunlight and UV radiation

Very rare cases of long-term (lasting months or years) or permanent side effects of the drug, such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, sensory disturbances such as pricking and tingling, tingling, tickling, burning, numbness or pain (neuropathy), depression, fatigue, sleep disturbances, memory disturbances, as well as impairment of 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.

In patients receiving fluoroquinolones, cases of expansion and weakening of arterial walls or arterial rupture (aneurysm and dissection), which may result in rupture and lead to death, as well as cases of heart valve insufficiency, have been reported. See also section 2.

Reporting of side effects

If any side effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: +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.

By reporting side effects, more information on the safety of this medicine can be collected.

5. How to store Moxifloxacin Accord

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and the cardboard box
after EXP. The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicinal product.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such measures will help
protect the environment.

6. Contents of the pack and other information

What Moxifloxacin Accord contains

• The active substance is moxifloxacin. Each coated tablet contains 400 mg of moxifloxacin in the form of hydrochloride.
• The other ingredients are: tablet core: mannitol, colloidal anhydrous silica, microcrystalline cellulose type 102, sodium carboxymethyl starch (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 contents of the pack
Pink, elongated, biconvex coated tablets.
Moxifloxacin Accord coated tablets are packed in PA/Aluminium/PVC/Aluminium blisters in cardboard cartons.
Moxifloxacin Accord is available in pack sizes containing 5, 7, 10, 14 and 30 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Accord Healthcare Polska Sp. z o.o.
Taśmowa Street 7
02-677 Warsaw
Poland
Manufacturer
Pharmathen S.A.
Dervenakion 6, Pallini
15351 Attikis
Greece
This medicinal product is authorised in the European Economic Area countries under the following names: