Kimoks

Leaflet accompanying the packaging: Information for the user

Kimoks

400 mg, film-coated tablets

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

1. What is Kimoks and what is it used for

Kimoks contains the active substance moxifloxacin, which belongs to a group of antibiotics called fluoroquinolones. Moxifloxacin has a bactericidal effect on bacteria that cause infections.
Moxifloxacin is used in patients aged 18 and older to treat the following bacterial infections, if they are caused by bacteria that are sensitive to moxifloxacin.
Moxifloxacin 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 obstructive pulmonary disease.
• Pneumonia, when the infection did not occur in the hospital (except for severe cases).
• Mild or moderately severe upper genital tract infections (pelvic inflammatory disease), including infections of the fallopian tubes and infections of the uterine mucosa.

Moxifloxacin 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 Kimoks", "Warnings and precautions", "Before starting Kimoks, discuss this with your doctor").
If an improvement occurs during the treatment of the following bacterial infections due to the administration of moxifloxacin in the form of an infusion solution, the doctor may also prescribe moxifloxacin in the form of tablets to complete the treatment:

• community-acquired pneumonia (pneumonia),
• skin and soft tissue infections.

Moxifloxacin in the form of tablets should not be used to start treating any type of skin and soft tissue infection or in severe pneumonia.

2. Important information before taking Kimoks

When not to take Kimoks:

• If the patient is allergic to moxifloxacin, other quinolone drugs, or any of the other ingredients of this medicine (listed in section 6).
• If the patient is pregnant or breastfeeding.
• If the patient is under 18 years old.
• If the patient has had tendon problems in the past related to treatment with other quinolone drugs (see section "Warnings and precautions" and section 4. "Possible side effects").
• If the patient has congenital or acquired:
• any conditions related to irregular heart rhythm (visible in the ECG - a record of the heart's electrical activity)
• electrolyte imbalance disorders (especially decreased potassium or magnesium levels in the blood)
• very slow heart rate (bradycardia)
• heart failure
• past rhythm disorders (arrhythmias)
• If the patient is taking medicines that may cause specific changes in the ECG (see section "Kimoks and other medicines"). Moxifloxacin may cause changes in the ECG, called QT interval prolongation, which means a delay in the conduction of electrical signals in the heart.
• If the patient has severe liver disease or liver enzyme activity (aminotransferases) that exceeds 5 times the upper limit of normal.

If the patient is unsure whether any of the above situations apply to them, they should consult a doctor or pharmacist before taking this medicine.

Warnings and precautions:

Before taking this medicine

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

Before starting Kimoks, discuss this with your doctor

• Moxifloxacin may change the ECG of the heart, especially in women and the elderly. If you are taking medicines that lower potassium levels in the blood, you should consult your doctor before starting Kimoks (see also section "When not to take Kimoks" and section "Kimoks and other medicines").
• If you have ever had a severe skin rash or peeling, blisters, and (or) ulcersafter taking moxifloxacin.
• In case of epilepsyor conditions that may cause seizures, you should consult your doctor before starting Kimoks.
• If you have or have had mental health problems, you should consult your doctor before starting Kimoks.
• If you have myasthenia gravis(a type of muscle weakness, which can lead to paralysis in severe cases), taking Kimoks may worsen the symptoms of the disease. If this happens, you should consult your doctor 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 you have been diagnosed with heart valve problems.
• If there have been cases of aortic aneurysm or dissectionin your family, or other risk factors or conditions that predispose to it (e.g., Marfan syndrome or Ehlers-Danlos syndrome, Turner syndrome, Sjögren's syndrome (an autoimmune inflammatory disease), or vascular diseases such as Takayasu arteritis, giant cell arteritis, Behçet's disease, hypertension, or proven atherosclerosis, arthritis (joint disease), or endocarditis (heart infection)).
• If you have diabetes, as moxifloxacin may increase the risk of changes in blood sugar levels.
• In case of glucose-6-phosphate dehydrogenase deficiency(a rare inherited disease), you should inform your doctor, who will assess whether moxifloxacin is a suitable medicine for you.
• If you have a complicated upper genital tract infection(e.g., tubo-ovarian abscess, ovarian or pelvic abscess), your doctor may consider it necessary to administer the medicine intravenously, as moxifloxacin is not suitable.
• In order to treat mild to moderate upper genital tract infections, your doctor should prescribe an additional antibacterial medicine to you, in addition to Kimoks. If symptoms do not improve within the first 3 days of treatment, you should consult your doctor.

While taking this medicine

• In case of sudden severe abdominal, back, or chest pain, which may be a sign of an aortic aneurysm or dissection, you should immediately go to the emergency department. The risk of these changes may be increased in patients taking 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), you should immediately consult your doctor.
• If you experience palpitations or irregular heartbeatduring treatment, you should immediately contact your doctor. Your doctor may want to perform an ECG to check your heart rhythm.
• The risk of heart rhythm disordersmay increase with increasing doses. Therefore, you should follow the recommended dosage of the medicine.
• There is a small risk of severe, sudden allergic reactions(anaphylactic reaction or anaphylactic shock) even after the first dose of the medicine, with symptoms such as chest tightness, dizziness, nausea, or fainting and dizziness when standing up.

In case of their occurrence, you should immediately stop taking Kimoks and consult your doctor.

• Moxifloxacin may cause severe liver inflammation, which can lead to life-threatening liver failure (including death, see section 4. "Possible side effects"). You should contact your doctor before continuing treatmentif you experience symptoms such as rapid deterioration of your condition and (or) vomiting, associated with yellowing of the whites of the eyes, dark urine, itching, tendency to bleed, and liver-related disorders of brain function (symptoms of impaired liver function or rapidly progressing and severe liver inflammation).
• Severe skin reactionshave been reported during moxifloxacin treatment, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), acute generalized exanthematous pustulosis (AGEP), and drug reaction with eosinophilia and systemic symptoms (DRESS).
• SJS or TEN may initially appear as red, target-like patches or circular patches, often with central blisters on the torso, skin peeling, oral, throat, nasal, genital, and eye ulcers (red and swollen eyes). These severe skin rashes are often preceded by fever and (or) flu-like symptoms. These rashes can lead to widespread skin peeling, which can be life-threatening or fatal.
• AGEP appears at the beginning of treatment as a red, peeling, widespread rash with nodules under the skin and blisters, accompanied by fever. The most common location is mainly in skin folds, on the torso, and upper limbs.
• In DRESS syndrome, flu-like symptoms and a rash on the face initially occur, followed by a widespread rash with high body temperature, elevated liver enzymes, and elevated white blood cell count (eosinophilia), and swollen lymph nodes. If a severe rash or other skin symptoms occur, you should stop taking moxifloxacin and immediately consult your doctor or seek medical attention.
• Quinolone antibiotics, including moxifloxacin, may cause seizures. If they occur, you should immediately stop taking Kimoks and consult your doctor.
• Long-lasting, disabling, and potentially irreversible severe side effectsFluoroquinolone/quinolone antibacterial medicines, including Kimoks, have been associated with very rare but severe side effects. Some of them have been long-lasting (lasting for months or years), disabling, or potentially irreversible. These include: tendon, muscle, and joint pain in the upper and lower limbs, walking difficulties, abnormal sensations such as tingling, burning, prickling, numbness, or pain (paresthesia), sensory disturbances, including vision, taste, and smell and hearing disorders, depression, memory disorders, severe fatigue, and severe sleep disorders. If you experience any of these side effects after taking Kimoks, you should immediately consult your doctor before continuing treatment. You and your doctor will decide whether to continue treatment, also considering antibiotics from another group.
• Rarely, nerve damagesymptoms may occur, such as pain, burning, tingling, numbness, or weakness, especially in the feet and legs or hands and arms. In such a case, you should stop taking Kimoks and immediately inform your doctor to prevent the development of potentially irreversible disease.
• Mental health problemsmay occur, even with the first use of quinolone antibiotics, including Kimoks. In very rare cases, depression or mental health problems may lead to suicidal thoughts and self-aggressive behaviors, such as suicide attempts (see section 4. "Possible side effects"). If you experience such reactions, you should immediately stop taking moxifloxacin and consult your doctor.
• Diarrheamay occur during or after the end of treatment with antibiotics, including Kimoks. If you experience severe or prolonged diarrhea or blood or mucus in your stool, you should immediately stop taking moxifloxacin and consult your doctor. In such a situation, you should not take medicines that slow down or stop bowel movements (peristalsis).
• Rarely, joint or tendon pain and inflammation or tendon rupturemay occur (see sections "When not to take Kimoks" and section 4. "Possible side effects"). The risk is increased in the elderly (over 60 years), after organ transplantation, in patients with kidney problems, or those taking corticosteroids. Tendon inflammation and rupture can occur within the first 48 hours of treatment and even up to several months after stopping Kimoks. When the first symptoms of tendon pain or inflammation occur (e.g., in the ankle, wrist, elbow, shoulder, or knee), you should stop taking Kimoks, consult your doctor, and rest the affected area. You should avoid excessive strain, as it may increase the risk of tendon rupture.

Patients with advanced age and kidney function disorders should drink an adequate amount of fluids while taking Kimoks, as dehydration may increase the risk of kidney failure.

• If vision worsensor other vision disturbances occur, you should immediately consult an ophthalmologist (see section "Driving and using machines" and section 4. "Possible side effects").
• Fluoroquinolone antibiotics may cause increased blood sugar levelsabove normal (hyperglycemia) or decreased blood sugar levelsbelow normal (hypoglycemia), which can lead to loss of consciousness (hypoglycemic coma) in severe cases (see section 4. Possible side effects). In diabetic patients, it is necessary to carefully monitor blood sugar levels.
• Quinolone antibiotics may increase sensitivity of the skin to sunlight or UV radiation. During Kimoks treatment, you should avoid prolonged sun exposure, strong sunlight, and use of sunbeds or other sources of UV radiation (see section 4. "Possible side effects").
• The efficacy of moxifloxacin has not been established in the treatment of severe burns, deep tissue infections, and diabetic foot infections with bone involvement (bone infection).

Children and adolescents

This medicine 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 section "When not to take Kimoks").

Kimoks and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
When taking Kimoks, you should be aware that:

• Quinolone antibiotics, including moxifloxacin, may increase the risk of heart rhythm disorders when taken with other medicines that affect heart function. Therefore, you should not take Kimoks with the following medicines:
• medicines belonging to the group of antiarrhythmic drugs (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), used to suppress irregular heart rhythm,
• antipsychotic medicines (e.g., phenothiazines, pimozide, sertindole, haloperidol, sultopride), used to treat psychosis, especially in schizophrenia and bipolar disorder,
• tricyclic antidepressants,
• certain antibacterial medicines (e.g., saquinavir, sparfloxacin, intravenous erythromycin, pentamidine, antimalarial medicines, especially halofantrine),
• certain antihistamine medicines (e.g., terfenadine, astemizole, mizolastine), used to treat allergy symptoms,
• other medicines (e.g., cisapride, intravenous vincamine, bepridil, and difemanil).
• You should inform your doctor about taking medicines that may lower potassium levels in the blood (e.g., certain diuretics, certain laxatives, and enemas [in large doses] or glucocorticoids [anti-inflammatory medicines]), as this may increase the risk of serious heart rhythm disorders during Kimoks treatment.
• Medicines containing magnesium or aluminum(such as antacids, used to treat digestive disorders), medicines containing ironor zinc, medicines containing didanosine, and medicines containing sucralfate(used to treat gastrointestinal disorders) may reduce the effectiveness of Kimoks. Therefore, you should maintain a 6-hour interval between taking Kimoks and these medicines.

Concomitant administration of a medicine containing charcoaland moxifloxacin reduces the effectiveness of moxifloxacin. 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), your doctor may order blood coagulation tests.

Kimoks with food and drink

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

Pregnancy, breastfeeding, and fertility

Moxifloxacin should not be used during pregnancy and breastfeeding.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, you should consult your doctor or pharmacist before taking this medicine.
Animal studies have not shown any effect on fertility during moxifloxacin treatment.

Driving and using machines

Moxifloxacin may cause dizziness and dizziness, sudden transient loss of vision, or short-term fainting. If you experience such symptoms, you should not drive vehicles or operate machinery.
Kimoks contains the orange dye, which may cause allergic reactions.
The medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means the medicine is considered "sodium-free".

3. How to take Kimoks

This medicine should always be taken exactly as prescribed by your doctor or pharmacist. In case of doubts, you should consult your doctor or pharmacist.
The recommended dose for adults is one 400 mg film-coated tablet once a day.
Kimoks tablets are taken orally. The tablet should be swallowed whole (to mask the bitter taste) with a large amount of fluid. Kimoks can be taken with or without food (including dairy products). You should try to take the tablet at approximately the same time every day.
The dividing line on the tablet is only to facilitate breaking the tablet to make it easier to swallow.
There is no need to adjust the dose in elderly patients, those with low body weight, or those with kidney function disorders.
The duration of treatment depends on the type of infection.
Unless your doctor has prescribed otherwise, the recommended treatment duration with Kimoks is:

• acute exacerbation of chronic obstructive pulmonary disease, including bronchitis: 5 to 10 days,
• pneumonia, except for hospital-acquired pneumonia: 10 days,
• acute bacterial sinusitis: 7 days,
• mild or moderate upper genital tract infections (pelvic inflammatory disease), including infections of the fallopian tubes and infections of the uterine mucosa: 14 days.

If moxifloxacin in the form of tablets is used to complete a treatment cycle with moxifloxacin in the form of an infusion solution, the recommended treatment duration is:

• community-acquired pneumonia: 7-14 days. In most patients with pneumonia, the switch to oral moxifloxacin tablets occurred within 4 days.
• skin and soft tissue infections: 7-21 days. In most patients with skin and soft tissue infections, the switch to oral moxifloxacin tablets occurred within 6 days.

It is essential to complete the full treatment cycle, even if you feel better after a few days. If you stop taking Kimoks too early, the infection may not be completely cured, the disease may recur, or your condition may worsen, and the bacteria may develop resistance to Kimoks.
You should not exceed the recommended dose or prolong the treatment duration (see section 2. "Important information before taking Kimoks", "Warnings and precautions").

Taking a higher dose of Kimoks than recommended

If you have taken more than one prescribed tablet per day, you should immediately seek medical attention and, if possible, take all remaining tablets, packaging, and this leaflet to show your doctor or pharmacist.

Missing a dose of Kimoks

If you forget to take a tablet at the usual time, you should take it as soon as you remember that day. If you miss a dose one day, you should take your usual dose (one tablet) the next day. You should not take a double dose to make up for the missed dose.
If you are unsure what to do, you should consult your doctor or pharmacist.

Stopping Kimoks treatment

If you stop taking the medicine too early, the infection may not be completely cured.
If you need to stop treatment early, you should consult your doctor.
If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following are the most serious side effectsobserved during moxifloxacin treatment:
If you experience:

• abnormal heart rhythm (rare side effect),
• sudden worsening of your condition or yellowing of the whites of the eyes, dark urine, itching, tendency to bleed, or liver-related disorders of brain function (symptoms of fulminant liver inflammation, which can lead to life-threatening liver failure) (very rare side effect, including deaths),
• severe skin rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis. They can appear as red, target-like patches or circular patches, often with central blisters on the torso, skin peeling, oral, throat, nasal, genital, and eye ulcers, and may be preceded by fever and flu-like symptoms (very rare side effect, potentially life-threatening),
• a red, peeling, widespread rash with nodules under the skin and blisters, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis) (frequency of this side effect is unknown),
• widespread rash, high body temperature, elevated liver enzymes, and elevated white blood cell count (eosinophilia), and swollen lymph nodes (drug reaction with eosinophilia and systemic symptoms, also known as DRESS) (frequency of this side effect is unknown),
• syndrome associated with water excretion disorders and low sodium levels (syndrome of inappropriate antidiuretic hormone secretion) (very rare side effect),
• loss of consciousness due to significantly decreased blood sugar levels (hypoglycemic coma) (very rare side effect),
• vasculitis (symptoms may include red spots on the skin, usually on the lower legs, or effects such as joint pain) (very rare side effect),
• severe, potentially life-threatening allergic reactions, including very rare 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),
• nervous system problems, such as pain, burning, tingling, numbness, or weakness (rare side effect),
• depression (which in very rare cases may lead to self-harm, such as suicidal thoughts or attempts) (rare side effect),
• confusion (which may lead to self-harm, such as suicidal thoughts or attempts) (very rare side effect),
• severe diarrhea with blood and (or) mucus (antibiotic-associated colitis, including pseudomembranous colitis), which can very rarely lead to life-threatening complications (rare side effect),
• tendon pain and swelling (tendinitis) (rare side effect) or tendon rupture (very rare side effect),
• muscle weakness, tenderness, or pain, especially with accompanying poor condition, high body temperature, and dark urine. This may be due to abnormal muscle breakdown, which can be life-threatening and lead to kidney problems (a condition called rhabdomyolysis) (frequency of this side effect is unknown).

You should stop taking Kimoks and immediately inform your doctor, as urgent medical attention may be necessary.
In addition, if you experience:

• transient loss of vision (very rare side effect),
• discomfort or eye pain, especially when exposed to light (very rare side effect), you should immediately consult an ophthalmologist.

If you experience a life-threatening irregular heartbeat (torsades de pointes) or cardiac arrest (very rare side effects) while taking moxifloxacin, you should immediately inform your doctor about taking moxifloxacin and not start this treatment again.
In very rare cases, worsening of myasthenia gravis symptoms has been observed. In such a situation, you should immediately consult your doctor.
If you have diabetes and notice that your blood sugar levels have increased or decreased (rare or very rare side effect), you should immediately inform your doctor.
If you are an elderly patient with kidney function disorders and experience decreased urine output, swelling of the feet, ankles, or hands, fatigue, nausea, drowsiness, shortness of breath, or confusion (which may be symptoms of kidney failure, a rare side effect), you should immediately consult your doctor.
The following are other side effectsthat have been observed during moxifloxacin treatment, listed in order of frequency:

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

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

Uncommon(may affect up to 1 in 100 people treated)

• rash
• gastrointestinal disorders (indigestion or heartburn)
• changes in taste (in very rare cases, loss of taste)
• sleep disorders (mainly insomnia)
• increased blood levels of certain liver enzymes (gamma-glutamyltransferase and (or) alkaline phosphatase)
• low white blood cell count (leukopenia, neutropenia)
• constipation
• itching
• dizziness (feeling of spinning or falling)
• drowsiness
• wind
• heart rhythm disorders (visible in the ECG)
• liver function disorders (including increased blood levels of a certain liver enzyme - LDH)
• decreased appetite and food intake
• low white blood cell count
• pains, such as back pain, chest pain, pelvic pain, and limb pain
• increased count of certain blood cells necessary for blood clotting
• increased sweating
• increased count of certain white blood cells (eosinophils)
• restlessness
• malaise (mainly weakness or fatigue)
• tremors
• joint pain
• palpitations
• irregular and rapid heartbeat
• breathing difficulties (including asthma)
• increased blood levels of a digestive enzyme (amylase)
• restlessness, agitation
• tingling or numbness
• hives
• vasodilation
• confusion and disorientation
• decreased count of certain blood cells necessary for blood clotting
• vision disturbances (including double or blurred vision)
• decreased blood clotting
• increased blood fat levels
• low red blood cell count
• muscle pain
• allergic reactions
• increased blood bilirubin levels
• gastritis
• dehydration
• severe heart rhythm disorders
• dry skin
• angina pectoris (chest pain caused by insufficient oxygen supply to the heart muscle)

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

• muscle twitching
• muscle cramps
• hallucinations
• high blood pressure
• swelling (of hands, feet, ankles, or face, or in the mouth or throat)
• low blood pressure
• kidney function disorders (including increased values of certain kidney function tests, such as urea and creatinine)
• liver inflammation
• oral mucositis
• 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 changes (including loss of smell)
• balance and coordination disorders (due to dizziness)
• partial or complete memory loss
• hearing disorders, including deafness (usually temporary)
• increased blood uric acid levels
• emotional instability
• speech disorders
• fainting
• muscle weakness

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

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

Frequency not known(frequency cannot be estimated from the available data)

• Increased skin sensitivity to sunlight or UV radiation (see also section 2. "Warnings and precautions").
• Acute, sharply defined, red, target-like patches with blisters or without blisters, which appear within a few hours of moxifloxacin administration and heal with post-inflammatory hyperpigmentation; usually recur in the same area of skin or mucous membrane after re-exposure to moxifloxacin.

Administration of quinolone and fluoroquinolone antibiotics has very rarely caused long-lasting (lasting for months or years) or permanent side effects, such as tendon inflammation, tendon rupture, joint pain, limb pain, walking difficulties, abnormal sensations (e.g., tingling, burning, prickling, numbness, or pain), nerve damage, fatigue, memory and concentration disorders, and mental health problems (symptoms may include sleep disorders, anxiety, panic attacks, depression, and suicidal thoughts) and hearing, vision, taste, and smell disorders.
In patients taking fluoroquinolones, cases of aortic aneurysm or dissection (a tear in the aortic wall) have been reported, which can be fatal, as well as cases of heart valve problems. See also section 2.
Additionally, during Kimoks treatment, the following side effects have been reported very rarely, which are also described with other quinolone antibiotics:

• increased intracranial pressure (symptoms include headache, vision problems, including blurred vision, "blind" spots, double vision, loss of vision)
• increased blood sodium levels
• increased blood calcium levels
• a specific type of red blood cell disorder (hemolytic anemia)

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Kimoks

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "EXP".
The expiry date refers to the last day of the month stated.
There are no special storage temperature requirements for this medicine.
Store in the original packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. You should ask your 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 Kimoks contains

• The active substance of the medicine is moxifloxacin. Each film-coated tablet contains 400 mg of moxifloxacin (as moxifloxacin hydrochloride). The dimensions of each tablet are approximately 20 mm x 8 mm.
• The other ingredients are: Tablet core: microcrystalline cellulose, maize starch, low-substituted hydroxypropylcellulose, sodium lauryl sulfate, sodium stearyl fumarate. Tablet coating: Opadry II orange 85 F 230039: polyvinyl alcohol, titanium dioxide (E 171), macrogol 4000, talc, orange yellow S (E 110), lake.

What Kimoks looks like and what the pack contains

Kimoks is a prolonged, convex on both sides, pale orange film-coated tablet with a dividing line on one side.
The film-coated tablets are packed in hard, non-transparent blisters made of OPA/Aluminium/PVC/Aluminium foil. Each blister contains 5 or 7 tablets. The cardboard box with prints contains 1 blister with 5 tablets (5 tablets) or 1 blister with 7 tablets (7 tablets) or 2 blisters with 5 tablets (10 tablets) and a leaflet.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

ALKALOID-INT d.o.o.
Šlandrova ulica 4
1231 Ljubljana - Črnuče
Slovenia
email: info@alkaloid.si

This medicinal product is authorised in the Member States of the European

Economic Area under the following names:

Bulgaria
Kimoks 400 mg film-coated tablets
Кимокс 400 mg филмирани таблетки
Croatia
Melvedok 400 mg film-coated tablets
Poland
Kimoks
Romania
Kimoks 400 mg film-coated tablets
Slovenia
Kimoks 400 mg film-coated tablets
Date of last leaflet update:02/2025