Floxitrat

Package Leaflet: Information for the Patient

Floxitrat, 400 mg, Film-Coated Tablets

Moxifloxacin

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• You should keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medication has been prescribed for your current condition only. 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 those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet:

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

1. What is Floxitrat and what is it used for

Floxitrat contains the active substance moxifloxacin, which is an antibiotic belonging to the fluoroquinolone group. Floxitrat kills bacteria that cause infections.
Floxitrat is used to treat patients aged 18 years and older with the following bacterial infections caused by bacteria susceptible to moxifloxacin. Floxitrat should only be used to treat these infections when other commonly used antibiotics cannot be used or have not been effective:
sinus infection, exacerbation of chronic bronchitis or community-acquired pneumonia (except severe cases);
mild to moderate upper genital tract infections, including fallopian tube and cervix infections.
Treatment with Floxitrat tablets alone is not sufficient for the treatment of upper genital tract infections, so your doctor will prescribe another antibiotic in addition (see section 2 "Important information before taking Floxitrat" and "Warnings and precautions").
If initial treatment with moxifloxacin infusion has been effective in treating the following bacterial infections, your doctor may prescribe Floxitrat tablets to complete the treatment course:
community-acquired pneumonia,
skin and soft tissue infections.
Floxitrat tablets should not be used for the initial treatment of any type of skin and soft tissue infection or for the treatment of severe pneumonia.

2. Important information before taking Floxitrat

If you have any doubts about the following situations, you should consult your doctor.

When Not to Take Floxitrat

if you are allergic to the active substance moxifloxacin, any other quinolone antibiotic, or any of the other ingredients of this medication (listed in section 6);
if you are pregnant or breastfeeding;
if you are under 18 years of age;
if you have had a disease or tendon disorders related to quinolone antibiotic treatment in the past (see also "Warnings and precautions" and section 4 "Possible side effects").
if you have or have had any of the following conditions or congenital conditions:

• any heart condition with abnormal heart rhythms (visible on an ECG, which records the heart's electrical activity),
• electrolyte imbalance in the blood (especially low potassium or magnesium levels),
• very slow heart rate (called "bradycardia"),
• heart muscle weakness (heart failure),
• past heart rhythm disorders or
• if you are taking other medications that affect the ECG (see "Floxitrat and other medications"). Floxitrat may cause changes in the ECG, such as prolonged QT interval (delayed electrical impulse conduction).

if you have severe liver disease or elevated liver enzymes (transaminases) more than 5 times the upper limit of normal.

Warnings and Precautions

Before taking this medication
Do not take fluoroquinolone or quinolone antibacterial medications, including Floxitrat, if you have experienced any severe side effects while taking quinolones or fluoroquinolones in the past. In such cases, inform your doctor as soon as possible.
Before taking Floxitrat, discuss this with your doctor.

• Floxitrat may change the heart rhythm recording on the ECG, especially in women or the elderly. If you are taking any medication that lowers potassium levels in the blood, consult your doctor before taking Floxitrat (see also "When not to take Floxitrat" and "Floxitrat and other medications").
• If you have epilepsyor other conditions that may cause seizures, consult your doctor before taking Floxitrat.
• If you have or have had psychiatric disorders, consult your doctor before taking Floxitrat.
• If you have myasthenia gravis(abnormal muscle fatigue leading to muscle weakness, and in severe cases, paralysis), Floxitrat may worsen the symptoms of the disease. If you suspect such symptoms, seek medical attention immediately.
• If you have been diagnosed with enlargement of a large blood vessel(aortic or large peripheral artery aneurysm).
• If you have had aortic dissection(tear in the aortic wall) in the past.
• If there have been cases of aortic aneurysm or dissectionin your family, or other risk factors or predisposing conditions (e.g., connective tissue diseases such as Marfan syndrome or vascular Ehlers-Danlos syndrome, or vascular diseases such as Takayasu arteritis, giant cell arteritis, Behcet's disease, hypertension, or confirmed atherosclerosis).
• If you or a family member has a rare congenital condition - glucose-6-phosphate dehydrogenase deficiency, inform your doctor, who will assess whether Floxitrat is suitable for you.
• If you have complicated upper genital tract infections(e.g., due to abscesses of the fallopian tubes and ovaries or in the pelvic area) and your doctor considers intravenous treatment necessary, taking Floxitrat tablets is not suitable for you.
• To treat mild to moderate upper genital tract infections, your doctor will prescribe another antibiotic in addition to Floxitrat tablets. If you do not feel better after 3 days of treatment, consult your doctor.
• If you have diabetes, as moxifloxacin may affect blood sugar levels.
• If you have ever experienced a severe skin rash or skin peeling after taking moxifloxacin.

During Treatment with Floxitrat

• If you experience heart palpitations or irregular heartbeat, inform your doctor immediately. Your doctor may recommend an ECG to check your heart rhythm.
• The risk of heart rhythm disordersmay increase with higher doses of the medication, so you should strictly follow the recommended dosage.
• There is a risk that you may experience a severe, sudden allergic reaction(anaphylactic reaction or anaphylactic shock), even after the first dose. Symptoms may include chest tightness, feeling dizzy, nausea, or fainting. Stop taking Floxitrat and seek medical attention immediately if you experience these symptoms.
• Floxitrat may cause rapid and severe liver inflammation, which can lead to life-threatening liver failure (including cases of death, see section 4 "Possible side effects"). If you experience sudden severe illness and/or vomiting, yellowing of the whites of the eyes, dark urine, itching, bleeding tendency, or signs of liver disease (liver dysfunction or severe liver inflammation), seek medical attention before taking the next dose of Floxitrat.
• During moxifloxacin treatment, 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 red spots with a target-like appearance or round spots, often with blisters on the torso. They may also be accompanied by ulcers in the mouth, throat, nose, genitals, and eyes, and may be preceded by fever and flu-like symptoms. The appearance of such severe skin rashes is often life-threatening and may lead to death.
• AGEP appears at the beginning of treatment as a red, scaly, generalized rash with bumps under the skin and blisters, accompanied by fever. The most common locations are mainly in skin folds, on the torso, and upper limbs. If you experience severe rash or any of these skin symptoms, stop taking moxifloxacin and contact your doctor or seek medical attention immediately.
• Quinolone antibiotics, including Floxitrat, may cause seizures. If this happens, stop taking Floxitrat and seek medical attention immediately.
• You may rarely experience nerve damage symptomssuch as pain, burning, tingling, numbness, and/or weakness, especially in the feet and legs or hands and arms. If this happens, stop taking Floxitrat and inform your doctor immediately.
• It is possible to experience psychiatric disorders, even if you are taking a quinolone antibiotic (including Floxitrat) for the first time. In very rare cases, depression or psychiatric disorders have led to suicidal thoughts and behaviors, including suicide attempts (see section 4 "Possible side effects").

If you experience any of these reactions, stop taking Floxitrat and seek medical attention immediately.

• During or after treatment with the antibiotic (including Floxitrat), you may experience diarrhea. If it becomes severe or persistent, contains blood or mucus, stop taking Floxitrat and seek medical attention immediately.Do not take medications that slow down bowel movements.
• Rarely, you may experience joint or tendon pain and swelling, or tendinitis or tendon rupture. The risk is increased in the elderly (over 60 years), after organ transplantation, in patients with kidney problems, or those taking corticosteroids. Tendinitis and tendon rupture can occur within the first 48 hours of treatment and up to several months after stopping Floxitrat. If you experience the first symptoms of pain or tendinitis (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking Floxitrat, contact your doctor, and rest the affected area.Avoid excessive strain, as it may increase the risk of tendon rupture.
• If you experience sudden severe abdominal, back, or chest pain, seek emergency medical attention immediately.
• If you are elderly and have kidney problems, you should drink plenty of fluids during treatment, as dehydration may increase the risk of kidney failure.
• If your vision worsens during Floxitrat treatment or you experience eye problems, seek immediate attention from an ophthalmologist(see "Driving and using machines" and section 4 "Possible side effects").
• Fluoroquinolone antibiotics may cause high blood sugar levels(hyperglycemia) or low blood sugar levels(hypoglycemia), which may rarely 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.
• Quinolone antibiotics may increase sensitivity of the skin to sunlight and UV radiation. During Floxitrat treatment, avoid prolonged exposure to sunlight or intense sunlight and do not use sunbeds or lamps that emit artificial ultraviolet radiation.
• The effectiveness of Floxitrat has not been established in the treatment of severe burns, deep tissue infections, or diabetic foot infections with bone and joint involvement (osteomyelitis).

Quinolone antibiotics may cause high blood sugar levels(hyperglycemia) or low blood sugar levels(hypoglycemia), which may rarely lead to loss of consciousness (hypoglycemic coma) in severe cases (see section 4 "Possible side effects"). This is important for patients with diabetes. Patients with diabetes are advised to carefully monitor their blood sugar levels.

Children and Adolescents

This medication should not be used in children and adolescents under 18 years of age, as its efficacy and safety in this age group have not been established (see "When not to take Floxitrat").

Floxitrat and Other Medications

Tell your doctor or pharmacist about all medications you are currently taking or plan to take.
When taking Floxitrat, keep in mind that:

• Taking Floxitrat with other medications that affect heart rhythmincreases the risk of heart rhythm disorders. Therefore, do not take the following medications while taking Floxitrat: anti-arrhythmic medications (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide); antipsychotic medications (e.g., phenothiazines, pimozide, sertindole, haloperidol, sultopride); tricyclic antidepressants; certain anti-infective medications (e.g., saquinavir, sparfloxacin, intravenous erythromycin, pentamidine, antimalarial medications, especially halofantrine); certain antihistamines (e.g., terfenadine, astemizole, mizolastine); other medications (e.g., cisapride, intravenous vincamine, bepridil, and difemanyl).
• Medications that lower potassium levels in the blood(e.g., certain diuretics, certain laxatives, and enemas [in large doses] or corticosteroids [anti-inflammatory medications], amphotericin B) may also increase the risk of severe heart rhythm disorders during Floxitrat treatment.
• Any medication containing magnesium or aluminum(e.g., antacids used to treat indigestion), iron, zinc, or didanosine, or any medication containing sucralfate(used to treat stomach disorders) may reduce the effectiveness of Floxitrat. Take Floxitrat 6 hours before or 6 hours after taking another medication.
• Taking activated charcoalat the same time as Floxitrat may reduce the effectiveness of Floxitrat. It is not recommended to take both medications at the same time.
• If you are taking oral anticoagulants(e.g., warfarin), your doctor may recommend monitoring your blood clotting time.

Floxitrat with Food and Drink

The medication can be taken with or without food (including dairy products) and at any time of the day.

Pregnancy, Breastfeeding, and Fertility

Do not takeFloxitrat during pregnancy or breastfeeding.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, consult your doctor or pharmacist before taking this medication.
Animal studies do not indicate that this medication affects fertility.

Driving and Using Machines

Floxitrat may cause dizziness or fainting, sudden transient loss of vision, and short-term fainting. If you experience these symptoms, do not drive or operate machinery.
This medication contains less than 1 mmol (23 mg) of sodium per dose, which means it is essentially "sodium-free".

3. How to Take Floxitrat

Always take this medication exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
The recommended dose for adults is one 400 mg film-coated tablet per day.
Floxitrat tablets are for oral use. Swallow the tablet whole (to avoid the bitter taste) with a large amount of water. You can take the medication with or without food, but take it at the same time every day.
The same dose can be taken by the elderly, patients with low body mass, or patients with kidney problems.
The duration of treatment depends on the type of infection. If your doctor does not recommend otherwise, the recommended treatment duration is:
exacerbation of chronic bronchitis: 5-10 days
community-acquired pneumonia (except hospital-acquired pneumonia): 10 days
acute bacterial sinusitis: 7 days
mild to moderate upper genital tract infections in women (pelvic inflammatory disease), including fallopian tube and cervix infections: 14 days
If Floxitrat tablets are used to complete the treatment course with moxifloxacin infusion, the recommended treatment duration is:
community-acquired pneumonia: 7-14 days
Most patients with pneumonia were switched to moxifloxacin tablets within 4 days.
skin and soft tissue infections: 7-21 days
Most patients with skin and soft tissue infections were switched to moxifloxacin tablets within 6 days.
It is essential to complete the full treatment course, even if you feel better after a few days of taking the medication. Stopping Floxitrat too early may result in the infection not being completely cured, and the infection may recur or worsen.
Bacteria that cause infections may develop resistance to Floxitrat.
Do not exceed the recommended dose or duration of treatment (see section 2 "Important information before taking Floxitrat", "Warnings and precautions").

Taking More Than the Recommended Dose of Floxitrat

If you take more than the prescribed dose of one tablet per day, seek medical attention immediately. Try to bring the remaining tablets, packaging, or this leaflet to show your doctor or pharmacist what you have taken.

Missing a Dose of Floxitrat

If you miss a dose, take it as soon as you remember on the same day. If you do not remember until the next day, take the scheduled dose for that day. Do not take a double dose to make up for the missed tablet.
If you are unsure what to do, consult your doctor or pharmacist.

Stopping Floxitrat Treatment

Stopping treatment too early may result in the infection not being completely cured. If you want to stop taking the tablets before completing the treatment course, consult your doctor.
If you have any further questions about taking this medication, consult your doctor or pharmacist.

4. Possible Side Effects

Like all medications, Floxitrat can cause side effects, although not everybody gets them.
The following are the most serious side effects observed during Floxitrat treatment. If you experience:

• abnormal heart rhythm (rare side effect),
• sudden severe illness or yellowing of the whites of the eyes, dark urine, itching, bleeding tendency, or liver dysfunction (may be signs of severe liver inflammation, which can lead to life-threatening liver failure [very rare side effect, which may be fatal]),
• severe skin rash, including Stevens-Johnson syndrome and toxic epidermal necrolysis. It may appear as red spots with a target-like appearance or round spots, often with blisters on the torso, and may be accompanied by ulcers in the mouth, throat, nose, genitals, and eyes, and may be preceded by fever and flu-like symptoms (very rare side effects, potentially life-threatening),
• red, scaly, generalized rash with bumps under the skin and blisters, accompanied by fever (acute generalized exanthematous pustulosis) (frequency of this side effect is unknown),
• syndrome associated with water imbalance and low sodium levels (SIADH) (very rare side effect),
• loss of consciousness due to significantly low blood sugar levels (hypoglycemic coma) (very rare side effect),
• blood vessel inflammation (may manifest as red spots on the skin, usually on the legs, or joint pain) (very rare side effect),
• severe, sudden allergic reaction, including very rare life-threatening anaphylactic shock (e.g., difficulty breathing, sudden drop in blood pressure, rapid heartbeat) (rare side effect),
• swelling, including swelling of the airways (rare side effect, potentially life-threatening),
• seizures (rare side effect),
• nerve damage symptoms, such as pain, burning, 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),
• psychiatric disorders (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 (antibiotic-associated colitis, including pseudomembranous colitis), which may rarely progress to life-threatening complications (rare side effects),
• tendon pain and swelling (tendinitis) (rare side effect) or tendon rupture (very rare side effect),
• weakness, tenderness, or pain in the muscles, especially if accompanied by feeling unwell, high fever, or dark urine. This may be due to abnormal muscle breakdown, which can be life-threatening and lead to kidney problems (a condition known as rhabdomyolysis) (frequency of this side effect is unknown). Stop taking Floxitrat and seek medical attention immediately, as you may need urgent medical attention.

In addition, if you experience:

• transient loss of vision (very rare side effect), seek immediate attention from an ophthalmologist.

If you experience life-threatening heart rhythm disorders (torsades de pointes) or cardiac arrest (very rare side effect) while taking Floxitrat, inform your doctor immediately and do not restart treatment with Floxitrat.

Floxitrat and Do Not Restart Treatment.

Very rarely, myasthenia gravis symptoms have worsened. If your myasthenia gravis symptoms worsen, seek medical attention immediately.
If you have diabetes and experience increased or decreased blood sugar levels (rare or very rare side effect), inform your doctor immediately.
If you are elderly and have kidney problems, and you experience decreased urine output, swelling of the feet, ankles, or hands, feeling tired, nausea, drowsiness, shortness of breath, or confusion (may be signs of kidney failure; rare side effect), seek medical attention immediately.
Other side effectsobserved during Floxitrat treatment are listed below by frequency:

Other Side Effects

Common(may affect up to 1 in 10 people)
infections caused by resistant bacteria or fungi, e.g., oral thrush (candidiasis) and vaginal thrush (vaginal candidiasis)
headache
dizziness
nausea
vomiting
stomach and abdominal pain
heart rhythm disorders (visible on ECG) in patients with low potassium levels in the blood
diarrhea
increased activity of certain liver enzymes (transaminases) in the blood
Uncommon(may affect up to 1 in 100 people)
rash
stomach upset (indigestion or heartburn)
taste disturbances (in very rare cases, loss of taste)
sleep disturbances (mainly insomnia)
increased activity of a certain liver enzyme (gamma-glutamyltransferase and/or alkaline phosphatase) in the blood
low white blood cell count (leukopenia, neutropenia)
constipation
itching
feeling dizzy (vertigo)
drowsiness
gas
heart rhythm disorders (visible on ECG)
liver dysfunction (including increased activity of a certain liver enzyme in the blood - LDH)
decreased appetite and food intake
low white blood cell count
pain (e.g., in the chest, back, pelvis, or limbs)
increased number of blood cells necessary for blood clotting
sweating
increased number of certain white blood cells (eosinophils)
anxiety
feeling unwell (mainly weakness or fatigue)
tremors
joint pain
heart palpitations
irregular heartbeat
breathing difficulties (including asthma)
increased activity of a digestive enzyme (amylase) in the blood
restlessness and/or agitation
tingling or numbness
hives
vasodilation
feeling confused or disoriented
decreased number of blood cells necessary for blood clotting
vision disturbances (including double vision 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
chest pain (angina pectoris)
Rare(may affect up to 1 in 1,000 people)
muscle tremors
muscle cramps
hallucinations
high blood pressure
swelling (of hands, feet, ankles, lips, mouth, or throat)
low blood pressure
kidney dysfunction (including increased results of certain kidney function tests, such as urea and creatinine levels)
liver inflammation
mouth inflammation
ringing in the ears (tinnitus)
jaundice (yellowing of the whites of the eyes or skin)
sensory disturbances
unusual dreams
concentration disturbances
swallowing difficulties
smell disturbances (including loss of smell)
balance and coordination disturbances (due to dizziness)
partial or complete memory loss
hearing disturbances, including deafness (usually temporary)
increased uric acid levels in the blood
emotional instability
speech disturbances
fainting
muscle weakness
Very Rare(may affect up to 1 in 10,000 people)
joint inflammation
abnormal heart rhythm
increased skin sensitivity
feeling of strangeness
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)
Frequency Not Known(frequency cannot be estimated from the available data)
loss of consciousness due to significantly low blood sugar levels (hypoglycemic coma). See section 2.
The following side effects have been reported very rarely during treatment with other quinolone antibiotics, but may also occur with Floxitrat:
increased sodium levels in the blood
increased calcium levels in the blood
a specific type of decreased red blood cell count (hemolytic anemia)
increased skin sensitivity to sunlight or ultraviolet radiation
Administration of quinolone and fluoroquinolone antibiotics has very rarely caused long-term (lasting for months or years) or permanent side effects, such as tendinitis, tendon rupture, joint pain, limb pain, walking difficulties, abnormal sensations (e.g., tingling, burning, numbness, or pain), neuropathy, depression, fatigue, sleep disturbances, memory disturbances, and hearing, vision, taste, and smell disturbances.

Reporting Side Effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. You can also report side effects directly to the Department of Drug Safety Monitoring, 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
You can also report side effects to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medication.

5. How to Store Floxitrat

Keep this medication out of the sight and reach of children.
There are no special storage instructions for this medication.
Shelf life after first opening the HDPE container: 1 year.
Do not use this medication after the expiry date stated on the carton, blister, or HDPE container after EXP. The expiry date refers to the last day of the month stated.
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the Pack and Other Information

What Floxitrat Contains

The active substance is moxifloxacin.
Each film-coated tablet contains 400 mg of moxifloxacin (as hydrochloride).
The other ingredients are: microcrystalline cellulose, maize starch, sodium carboxymethylcellulose (type A), colloidal anhydrous silica, magnesium stearate.
Coating: Sepifilm 003 (hypromellose, microcrystalline cellulose, magnesium stearate, type I), Sepisperse Dry 5023 (hypromellose, microcrystalline cellulose, titanium dioxide [E171], iron oxide red [E172]), Sepisperse Dry 5084 (hypromellose, microcrystalline cellulose, titanium dioxide [E171], carmine [E120]).

What Floxitrat Looks Like and Contents of the Pack

Floxitrat is a pink, capsule-shaped film-coated tablet, approximately 17.6 mm x 7.6 mm in size, with the symbol "400" embossed on one side.
Pack sizes:
blister packs containing 5, 7, 10, 14, and 20 film-coated tablets
HDPE containers containing 5, 7, and 10 film-coated tablets
Not all pack sizes and types may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria
Manufacturer
S.C. Sandoz S.R.L.
Str Livezeni nr. 7A
RO-540472 Târgu-Mureş, Romania
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany
Lek S.A.
ul. Domaniewska 50 C
02-672 Warsaw
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia
Lek Pharmaceuticals d.d.
Trimlini 2D
9220 Lendava, Slovenia

For More Information on This Medication and Its Names in EU Member States, Contact:

Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00
Date of Last Revision of the Leaflet:05/2020
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