Package leaflet: Information for the user

Kimoks
400 mg, film-coated tablets
moxifloxacin
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, ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

What Kimoks is and what it is used for
Important information before taking Kimoks
How to take Kimoks
Possible side effects
How to store Kimoks
Contents of the pack and other information

1. What Kimoks is and what it is used for

Kimoks contains the active substance moxifloxacin, which belongs to a group of antibiotics called fluoroquinolones. Moxifloxacin acts bactericidally against bacteria causing infections.
Moxifloxacin 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 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.
Pneumonia acquired outside the hospital (except severe cases).
Mild to moderate upper genital tract infections (pelvic inflammatory disease), including tubal infections and endometrial infections.

Moxifloxacin used alone is not sufficient for the treatment of these types of infections; therefore, your doctor should prescribe an additional antibacterial agent for the treatment of upper female genital tract infections (see section 2. "Important information before taking Kimoks", "Warnings and precautions", "Talk to your doctor before taking Kimoks").
If improvement has occurred during treatment of the following bacterial infections with moxifloxacin administered as an intravenous infusion, your doctor may also prescribe moxifloxacin tablets to complete the treatment course:

Community-acquired pneumonia,
Skin and soft tissue infections.

Moxifloxacin tablets should not be used to initiate treatment for any type of skin and soft tissue infection or for severe pneumonia.

2. Important information before taking Kimoks

When not to take Kimoks:

If the patient is allergic to moxifloxacin, other drugs in the quinolone group, or any of the other ingredients of this medicine (listed in section 6.).
If the patient is pregnant or breastfeeding.
If the patient has not reached 18 years of age.
If the patient has previously experienced tendon problems related to treatment with other quinolone antibiotics (see section “Warnings and precautions” and section 4. “Possible side effects”).
If the patient has congenital or acquired:
- any conditions associated with abnormal heart rhythm (visible on ECG – electrocardiogram)
- electrolyte imbalance (especially low blood potassium or magnesium levels)
- very slow heart rate (bradycardia)
- impaired heart function (heart failure)
- previously diagnosed heart rhythm disorders (arrhythmias)
If the patient is taking medicines that may cause specific changes in the ECG trace (see section “Kimoks and other medicines”). Moxifloxacin may cause changes in the ECG known as QT interval prolongation, which means delayed electrical conduction in the heart.
If the patient has severe liver disease or liver enzyme (aminotransferase) activity more than 5 times the upper limit of normal.

If the patient is unsure whether any of the above situations apply, they should consult
their doctor or pharmacist before using this medicine.
Warnings and precautions:
Before taking this medicine
Do not take antibacterial medicines containing fluoroquinolones or quinolones,
including Kimoks, if the patient has previously experienced any severe adverse
reaction while taking a quinolone or fluoroquinolone. In such a case, inform the doctor
as soon as possible.
Before starting treatment with Kimoks, discuss this with your doctor

Moxifloxacin may alter the heart's ECG trace, especially in women and elderly patients. If the patient is taking other medicines that reduce blood potassium levels, consult a doctor before starting Kimoks (see also section “When not to take Kimoks” and “Kimoks and other medicines”).
If the patient has ever experienced severe skin rash, skin peeling, blistering and/or oral mucosal ulceration after taking moxifloxacin.
If the patient has epilepsy or conditions that may cause seizures, consult a doctor before starting treatment with Kimoks.
If the patient has or has ever had mental health problems, consult a doctor before starting treatment with Kimoks.
If the patient has myasthenia gravis (a type of muscle weakness that may lead to paralysis in severe cases), taking Kimoks may worsen symptoms. If this occurs, consult a doctor immediately.
If the patient has been diagnosed with dilatation of a large blood vessel (aortic aneurysm or large peripheral artery).
If the patient has previously experienced aortic dissection (tearing of the aortic wall).
If the patient has been diagnosed with heart valve insufficiency.
If there is a family history of aortic aneurysm or aortic dissection, or congenital heart valve disease, or other risk factors or predisposing conditions (e.g. connective tissue disorders such as Marfan syndrome, 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, confirmed atherosclerosis, joint inflammation (arthritis), or endocarditis (heart infection)).
If the patient has diabetes, because moxifloxacin may cause changes in blood glucose levels.
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 is appropriate.
If the patient has a complicated upper genital tract infection (e.g. tubo-ovarian or pelvic abscess), the doctor may consider intravenous treatment necessary, as moxifloxacin may not be suitable.
For the treatment of mild to moderate upper genital tract infections, the doctor should prescribe an additional antibacterial medicine alongside Kimoks. If symptoms do not begin to improve within the first 3 days of treatment, the patient should consult the doctor.

While using this medicine

In case of sudden severe abdominal, back or chest pain, which may be symptoms of an aortic aneurysm or dissection, seek immediate emergency care. The risk of such events may be increased when taking systemic corticosteroids.
If sudden shortness of breath occurs, especially when lying down, or if ankle, foot or abdominal swelling is observed, or palpitations (sensation of rapid or irregular heartbeat) appear, consult a doctor immediately.
If palpitations or irregular heartbeat occur during treatment, contact a doctor immediately. The doctor may wish to perform an ECG to check heart rhythm.
The risk of cardiac dysfunction may increase with higher doses. Therefore, follow the prescribed dosage strictly.
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 dizziness upon standing. If these occur, stop taking Kimoks immediately and seek medical advice.
Moxifloxacin may cause rapid and severe hepatitis, which may lead to life-threatening liver failure (including death; see section 4. “Possible side effects”). Contact a doctor before continuing treatment if symptoms such as rapid deterioration in general condition and/or vomiting occur, associated with yellowing of the whites of the eyes, dark urine, itching, tendency to bleed, or brain dysfunction caused by liver disease (symptoms of impaired liver function or rapidly progressive and severe hepatitis).
Severe skin reactions Severe skin reactions have 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 or circular spots, often with central blisters on the trunk. Oral, throat, nasal, genital, or eye ulcers (red, swollen eyes) may also occur. These severe rashes are often preceded by fever and/or flu-like symptoms. These rashes may lead to extensive skin peeling, which may be life-threatening or fatal.
AGEP appears early in treatment as a red, scaly, widespread rash with subcutaneous nodules and blisters, accompanied by fever. The most common locations are skin folds, trunk, and upper limbs.
DRESS initially presents with flu-like symptoms and facial rash, followed by widespread rash with high fever. Blood tests show elevated liver enzymes and increased white blood cell count (eosinophilia), and enlarged lymph nodes. If severe rash or any of these skin symptoms occur, stop taking moxifloxacin and contact a doctor or seek medical advice immediately.
- Quinolone antibiotics, including moxifloxacin, may cause seizures. If they occur, stop taking Kimoks immediately and seek medical advice.
- Long-lasting, disabling and potentially irreversible serious adverse effects Antibacterial medicines containing fluoroquinolones/quinolones, including Kimoks, have been associated with very rare but serious adverse effects. Some of these were long-lasting (persisting for months or years), disabling, or potentially irreversible. These include: tendon, muscle and joint pain in 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 Kimoks, contact a doctor immediately before continuing treatment. The patient and doctor will decide whether to continue treatment, considering also antibiotics from other classes.
- Rarely, symptoms of nerve damage (neuropathy) such as pain, burning, tingling, numbness and/or weakness, particularly in feet and legs or hands and arms, may occur. In such a case, stop taking Kimoks and inform the doctor immediately to prevent potentially irreversible disease.
- Mental health problems may occur, even with first use of quinolone antibiotics, including Kimoks. In very rare cases, depression or mental health problems may lead to suicidal thoughts and self-harming behaviors, including suicide attempts (see section 4. “Possible side effects”). If such reactions occur, stop moxifloxacin immediately and consult a doctor.
- Diarrhea may occur during or after treatment with antibiotics, including Kimoks. If diarrhea is severe or prolonged, or if blood or mucus is present in the stool, stop taking moxifloxacin immediately and consult a doctor. In such cases, do not use medicines that inhibit or slow intestinal motility (peristalsis).
- Rarely, joint pain and swelling, tendon inflammation or tendon rupture may occur (see sections “When not to take Kimoks” and section 4. “Possible side effects”). The risk is increased in elderly patients (over 60 years), after organ transplantation, in patients with kidney problems or those receiving corticosteroids. Tendon inflammation and rupture may occur within the first 48 hours of treatment or even several months after stopping Kimoks. If early symptoms of tendon pain or inflammation (e.g. in the ankle, wrist, elbow, shoulder or knee) occur, stop taking Kimoks, contact a doctor, and rest the affected area. Avoid excessive physical exertion, as this may increase the risk of tendon rupture.
Elderly patients with kidney function disorders should drink adequate fluids during treatment with Kimoks, as dehydration may increase the risk of kidney failure.
If vision deteriorates or other visual disturbances occur, seek immediate advice from an ophthalmologist (see section “Driving and operating machinery” and section 4. “Possible side effects”).
Fluoroquinolone antibiotics may cause increased blood glucose levels above normal (hyperglycemia) or decreased blood glucose levels below normal (hypoglycemia), which in severe cases may lead to loss of consciousness (hypoglycemic coma) (see section 4. Possible side effects). In diabetic patients, careful monitoring of blood glucose levels is necessary.
Quinolone antibiotics may increase skin sensitivity to sunlight or UV radiation. During treatment with Kimoks, avoid prolonged sun exposure, intense sunlight, and use of tanning beds or other UV radiation sources (see section 4. “Possible side effects”).
The efficacy of moxifloxacin in treating severe burns, deep tissue infections, and diabetic foot infections with osteomyelitis (bone marrow infection) has not been established.

Children and adolescents
This medicine should not be used in children and adolescents under 18 years of age, as the efficacy and safety of its use have not been established in this age group (see section “When not to use Kimoks”).
Kimoks and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines planned for use.
When taking Kimoks, be aware that:
When Kimoks is used together with other medicines affecting heart function, the risk of heart rhythm disturbances increases. Therefore, do not take Kimoks simultaneously with the following medicines:

medicines belonging to the antiarrhythmic group (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), used to suppress abnormal heart rhythm,
antipsychotic medicines (e.g. phenothiazines, pimozide, sertindole, haloperidol, sulpiride), used to treat psychosis, especially schizophrenia and bipolar disorder,
tricyclic antidepressants,
certain antimicrobial medicines or those inhibiting microbial growth (e.g. saquinavir, sparfloxacin, intravenous erythromycin, pentamidine, antimalarials, especially halofantrine),
certain antihistamines (e.g. terfenadine, astemizole, mizolastine), used to treat allergy symptoms,
other medicines (e.g. cisapride, intravenous vinpocetine, bepridil, difemanil).
Inform the doctor if taking medicines that may reduce blood potassium levels (e.g. certain diuretics, certain laxatives and purgatives [in high doses], or glucocorticosteroids [anti-inflammatory medicines], amphotericin B) or slow heart rate, as this may increase the risk of serious heart rhythm disturbances while taking Kimoks.
Medicines containing magnesium or aluminium (such as antacids used for digestive disorders), medicines containing iron or zinc, medicines containing didanosine, and medicines containing sucralfate (used in gastrointestinal disorders) may

reduce the effectiveness of Kimoks. Therefore, a 6-hour interval should be maintained between
taking Kimoks and these medicines.

Concurrent administration of a medicine containing charcoal and moxifloxacin reduces the effectiveness of moxifloxacin. Therefore, simultaneous use of both medicines is not recommended.
If taking oral anticoagulants (e.g. warfarin) concurrently, the doctor may order blood clotting time tests.

Kimoks with food and drink
Kimoks can be taken independently of meals (including dairy meals).
Pregnancy, breastfeeding and effects on fertility
Do not use moxifloxacin during pregnancy or breastfeeding.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.
Animal studies did not show any effect on fertility during treatment with this medicine.
Driving and operating machinery
Moxifloxacin may cause dizziness, lightheadedness, sudden transient loss of vision, or brief fainting. If such symptoms occur, do not drive or operate machinery.
Kimoks contains the colouring agent sunset yellow FCF, which may cause allergic reactions.
The medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. the medicine is considered “sodium-free”.

3. How to take Kimoks

This medicine should always be taken exactly as directed by your doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.
The recommended dose for adults is one 400 mg coated tablet once daily.
Kimoks tablets are taken orally. The tablet should be swallowed whole (to mask its bitter taste) with a large amount of liquid. Kimoks may be taken regardless of meals. Try to take the tablet at approximately the same time each day.
The break line on the tablet is intended only to facilitate splitting for easier swallowing.
There is no need to adjust the dosage 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 the physician, the recommended duration of Kimoks treatment is:

Acute exacerbation of chronic obstructive pulmonary disease, including bronchitis: 5 to 10 days,
Lung infections, excluding pneumonia that developed during hospitalization: 10 days,
Acute sinusitis (acute bacterial sinusitis): 7 days,
Mild to moderately severe lower respiratory tract infections (pelvic inflammatory disease), including fallopian tube infections and endometrial mucosal infections: 14 days.

If moxifloxacin in coated tablets is used to complete a treatment course initiated with moxifloxacin infusion solution, the recommended treatment duration is:

Community-acquired pneumonia (pneumonia acquired outside the hospital): 7–14 days. In most patients with pneumonia, the switch to oral moxifloxacin coated 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 coated tablets occurred within 6 days.

It is important to complete the full course of treatment, even if symptoms improve after a few days. Premature discontinuation of Kimoks may result in incomplete eradication of the infection, possible relapse, worsening of the patient's condition, and development of bacterial resistance to Kimoks.
Do not exceed the recommended dose or prolong the duration of treatment (see section 2. "Important information before taking Kimoks", "Warnings and precautions").
Taking more Kimoks than recommended
If more than the prescribed number of tablets is taken in one day, seek immediate medical help. If possible, bring all remaining tablets, the medicine packaging, and this leaflet to show the doctor or pharmacist.
Missing a dose of Kimoks
If a patient forgets to take the tablet at the usual time, they should take it as soon as they remember, on the same day. If a dose is missed for one day, the patient should take the usual dose (one tablet) the next day. Do not take a double dose to make up for a missed dose.
If the patient is unsure what to do, they should consult their doctor or pharmacist.
Stopping Kimoks treatment
Premature discontinuation of the medicine may result in incomplete cure of the infection.
If it is necessary to stop treatment early, consult your doctor.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.

Listed below are the most serious adverse reactions observed during treatment with moxifloxacin.
If the patient experiences:

rapid heartbeat (uncommon adverse reaction),
sudden feeling of being unwell or yellowing of the whites of the eyes, dark urine, itching of the skin, tendency to bleed, or disturbances in thinking or insomnia (these may be signs and symptoms of fulminant hepatitis, which can lead to life-threatening liver failure) (very rare adverse reaction, fatalities have been reported),
severe skin rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis. These may appear as red, target-like or circular skin lesions, often with central blisters on the trunk, skin peeling, ulceration of the mouth, throat, nose, genital organs and eyes, and may be preceded by fever and flu-like symptoms (very rare adverse reaction, potentially life-threatening),
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 adverse reaction is unknown),
widespread rash, high fever, increased liver enzyme activity, blood abnormalities (eosinophilia), swollen lymph nodes and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome) (frequency of this adverse reaction is unknown),
syndrome related to disturbances in water excretion and low sodium concentration (syndrome of inappropriate antidiuretic hormone secretion) (very rare adverse reaction),
loss of consciousness due to significantly reduced blood glucose levels (hypoglycaemic coma) (very rare adverse reaction),
inflammation of blood vessels (symptoms may include red skin spots, usually on the lower legs, or joint pain) (very rare adverse reaction),
severe, rapidly generalizing allergic reaction, including very rarely life-threatening anaphylactic shock (e.g. difficulty breathing, sudden drop in blood pressure, rapid pulse) (uncommon adverse reaction),
swelling, including swelling of the airways (uncommon adverse reaction, potentially life-threatening),
seizures (uncommon adverse reaction),
nervous system-related problems such as pain, burning sensation, tingling, numbness, and (or) limb weakness (uncommon adverse reaction),
depression (which in very rare cases may lead to self-harm, including suicidal thoughts or suicide attempts) (uncommon adverse reaction),
loss of mental capacity (may lead to self-harm, including suicidal thoughts or suicide attempts) (very rare adverse reaction),
severe diarrhoea with blood and (or) mucus (antibiotic-associated colitis, including pseudomembranous colitis), which very rarely may progress to life-threatening complications (uncommon adverse reaction),
tendon pain and swelling (tendinitis) (uncommon adverse reaction) or tendon rupture (very rare adverse reaction),
muscle weakness, tenderness or pain, particularly accompanied by malaise, high fever and 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 adverse reaction is unknown),

stop taking Kimoks immediately and inform your doctor without delay,
as urgent medical assistance may be required.

Additionally, if the patient experiences:

transient loss of vision (very rare adverse reaction),
eye discomfort or pain, especially upon exposure to light (very rare adverse reaction),
seek immediate advice from an ophthalmologist.

If, during treatment with moxifloxacin, the patient develops a life-threatening irregular heartbeat (torsade de pointes) or cardiac arrest (very rare adverse reactions),
inform your doctor immediately about the use of moxifloxacin
and do not restart treatment with this medicine.

In very rare cases, worsening of myasthenia symptoms has been observed. In such a case,
consult your doctor immediately.

If the patient has diabetes and notices an increase or decrease in blood glucose levels (uncommon or very rare adverse reaction), inform the doctor immediately.

If an elderly patient with impaired kidney function develops reduced urine output, swelling of the legs, ankles or feet, fatigue, nausea, drowsiness, shortness of breath or confusion (these may be signs and symptoms of kidney failure, a rare adverse reaction),
consult a doctor immediately.

Listed below are other adverse reactions observed during treatment with moxifloxacin, categorized by frequency:

Common (may affect up to 1 in 10 patients)

nausea
diarrhoea
dizziness
stomach and abdominal pain
vomiting
headache
increased blood levels of certain liver enzymes (aminotransferases)
infections caused by resistant bacteria or fungi, e.g. fungal infections of the mouth or vagina
heart rhythm disturbances (visible on ECG) in patients with low blood potassium levels

Uncommon (may affect up to 1 in 100 patients)

rash
gastrointestinal discomfort (dyspepsia or heartburn)
altered taste sensation (in very rare cases, loss of taste)
sleep disturbances (mainly insomnia)
increased blood levels of certain liver enzymes (gamma-glutamyltransferase and (or) alkaline phosphatase)
low count of certain white blood cells (leukocytes, neutrophils)
constipation
itching
dizziness (sensation of spinning or falling)
drowsiness
flatulence
heart rhythm disturbances (visible on ECG)
liver function disorders (including increased blood levels of a liver enzyme - LDH)
reduced appetite and food intake
low white blood cell count
pain, such as back, chest, pelvic pain and limb pain
increased number of certain blood cells involved in blood clotting
excessive sweating
increased number of certain 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 levels of a digestive enzyme (amylase)
motor restlessness, agitation
tingling and (or) numbness
urticaria
blood vessel dilation
confusion and disorientation
reduced number of certain blood cells essential for blood clotting
visual disturbances (including double or blurred vision)
reduced blood clotting ability
increased blood lipid levels
low red blood cell count
muscle pain
allergic reactions
increased blood bilirubin levels
inflammation of the gastric mucosa
dehydration
severe heart rhythm disturbances
dry skin
angina pectoris (chest pain due to insufficient oxygen supply to the heart muscle)

Rare (may affect up to 1 in 1,000 patients)

muscle twitching
muscle cramps
hallucinations
high blood pressure
swelling (of hands, feet, ankles, lips, within the mouth or throat)
low blood pressure
kidney function disorders (including increased values in 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 sensory disturbances
unusual dreams
concentration difficulties
swallowing difficulties
changes in smell (including loss of smell)
balance disorders and poor motor coordination (due to dizziness)
partial or complete memory loss
hearing disturbances, including deafness (usually transient)
increased blood uric acid levels
emotional lability
speech disturbances
fainting
muscle weakness

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

reduced number of red blood cells, white blood cells and platelets (pancytopenia)
arthritis
abnormal heart rhythm
increased skin sensitivity
depersonalization (feeling of loss of self-identity)
increased blood coagulability
muscle stiffness
significant reduction in certain white blood cells (agranulocytosis)

Frequency unknown (frequency cannot be estimated from available data)

Increased sensitivity of the skin to sunlight or UV radiation (see also section 2. "Warnings and precautions").
Well-defined, erythematous lesions with or without blisters, appearing within hours after moxifloxacin administration, healing with post-inflammatory residual pigmentation; usually recurring in the same skin or mucosal site upon subsequent exposure to moxifloxacin.

Administration of quinolone and fluoroquinolone antibiotics, in some cases regardless of pre-existing risk factors, has very rarely led to long-term (lasting for months or years) or permanent adverse reactions, such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as pricking, tingling, tickling, burning, numbness or pain (neuropathy), fatigue, memory and concentration problems, mental health disorders (symptoms may include sleep disturbances, anxiety, panic attacks, depression and suicidal thoughts), as well as hearing, vision, taste and smell disturbances.

In patients receiving fluoroquinolones, cases of aortic aneurysm and dissection due to aortic wall dilation and weakening, which may result in rupture and lead to death, as well as cases of heart valve regurgitation, have been reported. See also section 2.

Additionally, during treatment with Kimoks, the following adverse reactions, very rarely reported with other quinolone antibiotics, may occur:

increased intracranial pressure (symptoms include headache, vision problems, including blurred vision, blind spots, double vision, vision loss)
increased blood sodium levels
increased blood calcium levels
a specific type of disease characterized by reduced number of red blood cells (haemolytic anaemia)

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions 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 4921 301
Fax: +48 22 4921 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Kimoks

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack after "EXP".
The expiry date refers to the last day of the stated month.
No special temperature storage conditions are required for this medicine.
Store in the original packaging to protect from light.
Medicines must 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 Kimoks contains

The active substance is moxifloxacin. Each coated tablet contains 400 mg of moxifloxacin (as moxifloxacin hydrochloride). The dimensions of each tablet are approximately 20 mm x 8 mm.
Other components are:
Tablet core: microcrystalline cellulose, pregelatinized corn 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, sunset yellow (E 110), lac.

What Kimoks looks like and contents of the pack
Kimoks is a pale orange, elongated, biconvex coated tablet with a score line on one side.
The coated tablets are packed in hard, opaque blisters made of OPA/Aluminum/PVC/Aluminum foil. Each blister contains 5 or 7 tablets. The cardboard carton contains either 1 blister with 5 tablets (5 tablets), or 1 blister with 7 tablets (7 tablets), or 2 blisters with 5 tablets each (10 tablets), and a package leaflet.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Importer
ALKALOID-INT d.o.o.
Šlandrova ulica 4
1231 Ljubljana - Črnuče
Slovenia
email: [email protected]

This medicinal product is authorised for marketing in the European Economic Area countries under the following names:
Bulgaria Kimoks 400 mg film-coated tablets
Кимокс 400 mg филмирани таблетки
Croatia Melvedok 400 mg filmom obložene tablete
Poland Kimoks
Romania Kimoks 400 mg comprimate filmate
Slovenia Kimoks 400 mg filmsko obložene tablete

Kimox