Properties
What is it?
Read the instructions carefully before using the medicine, as it contains important information for you. Keep these instructions; you may need to read them again. If you have any questions, 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 they have the same symptoms as you. If you notice any side effects or experience effects not listed in the instructions, tell your doctor or pharmacist. See section 4. The instructions for use contain: 1. What Moxifloxacin is and what it is used for? 2. Information before using Moxifloxacin 3. How to use Moxifloxacin 4. Possible side effects 5. Storage conditions for Moxifloxacin 6. Package contents and additional information. 1. What Moxifloxacin is and what it is used for? Moxifloxacin contains the active substance moxifloxacin, which belongs to a group of antibiotics called fluoroquinolones. The mechanism of action of the medicine is that Moxifloxacin kills the bacteria causing the infection. Moxifloxacin is used in patients aged 18 years and over to treat bacterial infections caused by bacteria sensitive to moxifloxacin. Moxifloxacin is used to treat the following infections where other antibiotics are not suitable or ineffective: sinusitis, exacerbations of chronic respiratory diseases and pneumonia, when treatment is not carried out in a hospital (except for severe cases); mild to moderate infections of the upper genital organs (pelvic inflammatory disease), fallopian tubes, or endometrium. Moxifloxacin is not used alone to treat these types of infections. Therefore, your doctor should also consider the use of other antibacterial agents when treating upper genital tract infections in women (see section 2 "Special precautions and warnings" - consult your doctor or pharmacist for recommendations). If improvement is observed during the treatment of the following infections with moxifloxacin infusion solution, your doctor may also prescribe Moxifloxacin film-coated tablets to complete the treatment: respiratory tract infections (pneumonia) not requiring hospital treatment, skin and soft tissue infections. Moxifloxacin should not be used at the beginning of treatment for any type of skin and soft tissue infection or for severe lung infections. 2. Information before using Moxifloxacin If you are unsure about anything, consult your doctor. Do not use Moxifloxacin if: you are allergic to moxifloxacin or other quinolone antibiotics or any of the other ingredients of this medicine (listed in section 6). during pregnancy and breastfeeding. in patients under 18 years of age. if you have a history of joint problems during treatment with quinolone antibiotics (see section 2 "Information before using quinolones", "Warnings and precautions"). if you have congenital or acquired conditions: - any condition related to heart rhythm disorders (ECG abnormalities, impaired heart activity) - electrolyte imbalance (especially low levels of potassium and magnesium in the blood) - slow heart rate (bradycardia) - heart failure - arrhythmia (rhythm disorder) or - if you are taking medications that may cause ECG changes (see section 2 "Information before using Moxifloxacin", "Using Moxifloxacin with other medicines"). Moxifloxacin may also cause ECG changes and prolongation of the QT interval, indicating a disorder of cardiac conduction. - if you have severe liver disorders or elevated liver enzyme levels (transaminases) more than 5 times the normal level. Warnings and precautions Before using Moxifloxacin, consult your doctor or pharmacist. - Moxifloxacin may cause changes in the heart's ECG, especially in women and the elderly. If you have low potassium levels in your blood, you should consult your doctor before using Moxifloxacin (see section 2 "Information before using Moxifloxacin" and "Using Moxifloxacin with other medicines"). - If you have epilepsy or conditions that may lead to seizures, you should consult your doctor before using Moxifloxacin. - If you have a history of any mental disorders, you should consult your doctor before using Moxifloxacin. - If you have myasthenia gravis (muscle weakness), Moxifloxacin may cause or worsen the symptoms of the disease. In such cases, you should seek immediate medical attention. - If you or a close relative has or has had glucose-6-phosphate dehydrogenase deficiency (a rare congenital disease), you should inform your doctor. Your doctor will assess the situation and decide on the correct use of Moxifloxacin. - If you have upper genital tract infections (e.g., fallopian tube, ovarian, or pelvic abscess), your doctor may decide to administer moxifloxacin intravenously, as Moxifloxacin tablets are not used in this case. - For the treatment of mild to moderate upper genital tract infections, your doctor will also prescribe other antibacterial agents along with Moxifloxacin. If symptoms do not improve after the first 3 days of treatment, you should consult your doctor. During treatment with Moxifloxacin: - If you experience palpitations or irregular heartbeat during treatment, you should seek immediate medical attention. Your doctor may order an ECG to check your heart rate. - The risk of cardiac abnormalities may increase with increasing dosage. Therefore, it is essential to maintain the correct dosage. - There is a high risk of severe, sudden allergic reactions (anaphylactic reactions and anaphylactic shock), including after the first dose, accompanied by symptoms such as chest tightness, dizziness, feeling faint or collapsing, and orthostatic hypotension. If such effects occur, you should stop taking Moxifloxacin and consult your doctor. - Moxifloxacin can cause a severe form of liver inflammation, which can lead to life-threatening liver failure (including fatal outcomes, see section 4 "Possible side effects"). Consult your doctor if you experience symptoms such as sudden worsening of mood and/or health condition, manifested by symptoms such as yellowing of the eyes, darkening of urine, itching, tendency to bleed, and liver disorders (symptoms of impaired liver function and inflammation). - If you notice changes and ulcers on your skin and/or peeling of the skin or ulceration of the mucous membranes (see section 4 "Possible side effects"), you should consult your doctor immediately before taking the next dose. - Quinolone antibiotics, including Moxifloxacin, can cause seizures. In case of seizures, you should stop taking Moxifloxacin and consult your doctor. - If you experience neuropathic symptoms such as pain, burning, tingling, numbness, or weakness, you should seek immediate medical attention before taking the next dose. - Mental health problems may occur, even with the use of first-generation quinolone antibiotics, as well as with Moxifloxacin. In very rare cases, depression and anorexia may occur, which can lead to suicidal thoughts and self-harm attempts. (See section 4 "Possible side effects"). If such symptoms occur, you should stop taking the medicine immediately and consult your doctor. - Diarrhea may develop during and after the use of Moxifloxacin. If diarrhea persists for a long time or if you notice bloody stools, you should stop using Moxifloxacin and consult your doctor. In such cases, you should use antidiarrheal and intestinal motility regulating agents. - Moxifloxacin can sometimes cause tendon pain and inflammation, including within 48 hours of starting treatment and lasting for several months after completing treatment. The risk of tendon inflammation and rupture is high in the elderly and in patients treated concurrently with corticosteroids. At the first sign of pain or inflammation, you should stop using Moxifloxacin and consult your doctor. Damaged tendons should be rested, and physical exertion should be avoided to prevent tendon rupture (see section 2 "Information before using Moxifloxacin" and section Children and adolescents This medicine should not be used in children and adolescents under 18 years of age, as the efficacy and safety of the preparation in this age group have not been confirmed (see section 2 "Information before using Moxifloxacin" and "Do not use Moxifloxacin"). Using Moxifloxacin with other medicines Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription. When using Moxifloxacin, consider: if you are taking heart medications along with Moxifloxacin, as the risk of arrhythmia may increase. Therefore, Moxifloxacin should not be used with the following medicines: - Medicines belonging to the group of antiarrhythmics (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide) - Antipsychotics (e.g., phenothiazine, pimozide, sertindole, haloperidol, sulpiride) - Tricyclic antidepressants - Certain anti-infective agents (e.g., saquinavir, sparfloxacin, intravenous erythromycin, pentamidine, antimalarials, especially halofantrine). - Certain antihistamines (e.g., terfenadine, astemizole, mizolastine) - Other medicines (e.g., cisapride, intravenous vancomycin, bepridil, and difemantil). Tell your doctor if you are taking medications that may cause a decrease in blood potassium levels (e.g., certain diuretics, laxatives (in high doses), or glucocorticoids (anti-inflammatory agents, amphotericin B)) or medications for arrhythmia, as the risk of serious cardiac arrhythmias may increase when using Moxifloxacin. Medicines containing magnesium or aluminum (e.g., antacids used for indigestion), medicines containing iron or zinc, didanosine, or medicines containing sucralfate (used for gastrointestinal treatment) may reduce the effectiveness of Moxifloxacin. Therefore, a 6-hour interval should be maintained between the administration of these preparations. Simultaneous administration of Moxifloxacin and medicines containing carbohydrates weakens the action of Moxifloxacin. Therefore, these two preparations cannot be used simultaneously. If you are taking oral anticoagulants (e.g., warfarin), your doctor should perform tests to monitor blood clotting time. Using Moxifloxacin with food and drinks Moxifloxacin 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, or suspect you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medicine. Animal studies have not revealed any effects of moxifloxacin on fertility. Effects on the ability to drive and operate machinery Moxifloxacin may cause dizziness, sudden loss of vision, therefore, you should not drive or operate machinery during treatment. 3. How to use Moxifloxacin Always use this medicine exactly as prescribed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist. The recommended dose for adults is 1 film-coated tablet of Moxifloxacin 400mg once daily. The tablet should be swallowed whole (to mask the bitter taste) with a large amount of water. Moxifloxacin can be taken with or without food. It is recommended to take the medicine at the same time each day. No dose adjustment is required in the elderly, patients with low body weight, or patients with impaired kidney function. The duration of treatment depends on the type of infection. Unless your doctor has instructed otherwise, it is recommended to take Moxifloxacin for the following durations: – Acute exacerbation of chronic obstructive pulmonary disease (chronic bronchitis): 5 to 10 days. – Lung infection, pneumonia, unless treatment is carried out in a hospital: 10 days. – Acute sinusitis (exacerbation of bacterial sinusitis): 7 days. – Mild and moderate infections of the upper genital tract (pelvic inflammatory disease), including inflammation of the fallopian tubes or endometrium: 14 days. If Moxifloxacin tablets are used as additional treatment after moxifloxacin infusion solution, the duration of use is: – For non-hospital treatment of lung infections, 7-14 days. In most patients, after treatment for pneumonia, moxifloxacin tablets were used for an additional 4 days. – Skin and soft tissue infections: 7-21 days. In most patients, after treatment for skin and soft tissue infections, film-coated tablets were used for 6 days after switching to oral tablets. It is important to complete the course of treatment, even if you feel better. Stopping the medication prematurely can lead to a relapse of the infection and resistance to Moxifloxacin, and worsening of the condition. Do not exceed the recommended dose and duration of treatment (see section 2 "Information before using Moxifloxacin", "Warnings and precautions"). Overdose If you accidentally take more than one tablet of Moxifloxacin per day, you should seek immediate medical attention. Take the remaining tablets or the medicine packaging with you to show your doctor or pharmacist, making it easier for them to take safety measures. If you miss a dose If you accidentally forget to take a tablet, take it as soon as you remember on the same day. The next day, continue taking the tablet as usual. Do not take a double dose to compensate for a missed dose. If you have any uncertainties, consult your doctor or pharmacist. If you want to stop taking Moxifloxacin If you stop treatment prematurely, the infection may not be completely cured and may relapse. If you wish to stop treatment, you should consult your doctor. If you have any questions about this medicine, ask your doctor or pharmacist. 4. Possible side effects Like all medicines, this medicine can cause side effects, although not everyone gets them. The following side effects have been observed with the use of moxifloxacin. Common side effects (occur in more than 1 in 10 patients): – Infections caused by bacteria resistant to the preparation or fungal infections, e.g., thrush and vaginal candidiasis – Headache – Dizziness – Arrhythmia (ECG) in patients with low blood potassium levels (see section 2, "Information before using Moxifloxacin"). – Vomiting – Nausea – Stomach and abdominal pain – Diarrhea – Increased levels of certain liver enzymes (transaminases). Uncommon side effects (occur in more than 1 in 100 patients): – Allergic reactions – Reduction in the number of red blood cells (anemia) – Reduction in the number of white blood cells – Reduction in the number of certain white blood cells (neutrophils) – Reduction or increase in the number of certain blood cells required for blood clotting – Increase in the number of certain white blood cells (eosinophils) – Reduced blood clotting – Increased levels of fats in the blood – Feeling of fear and anxiety, irritability or agitation – Tingling and numbness – Taste disturbances (very rarely loss of taste) – Confusion and disorientation – Sleep problems (insomnia or drowsiness) – Tremor – Dizziness (feeling of falling) – Vision problems (double or blurred vision) – Arrhythmia (on ECG), palpitations, irregular or rapid heartbeat, reduced heart rate, chest pain (angina) (see section 2 "Information before using Moxifloxacin") – Vasodilation (flushing) – Breathing problems (asthmatic symptoms) – Loss or increase in appetite – Constipation – Gastrointestinal symptoms (indigestion or heartburn) – Gastritis – Increased levels of digestive enzymes in the blood (amylase) – Liver dysfunction (including increased activity of liver enzymes such as LDH in the blood: increased bilirubin and liver enzymes in the blood - gamma-glutamyltranspeptidase and/or alkaline phosphatase). – Itching, rash, dry skin – Joint pain, muscle pain – Dehydration – Malaise (feeling weak, tired), back pain, chest pain, pain in the back and limbs – Excessive sweating Rare side effects (expected in more than 1 in 1000 patients): – Severe, sudden allergic reactions, including life-threatening shock (e.g., difficulty breathing, sharp drop in blood pressure, rapid heartbeat), swelling (including life-threatening swelling of the airways). – Severe diarrhea with blood, which may be life-threatening (antibiotic-associated colitis, including pseudomembranous colitis) - Jaundice (yellowing of the eyes and skin), liver inflammation - Tendon pain and swelling (tendinitis) - Increased blood sugar levels - Increased blood uric acid levels - Emotional lability - Depression (very rarely can lead to a tendency for self-harm and suicidal behavior) - Hallucinations - Skin sensitivity - Olfactory disorders (including loss) - Abnormal dreams - Movement and coordination disorders (due to dizziness) - Seizures - Concentration disorders - Speech disorders - Partial or complete memory loss - Nervous system disorders, such as pain, burning, tingling, numbness, or weakness in the limbs. - Ringing and noise in the ears, hearing loss up to deafness (temporary) - Arrhythmia, seizures (see section 2 "Information before using Moxifloxacin") - High or low blood pressure - Difficulty swallowing - Inflammation of the oral mucosa - Muscle spasms and tremors - Muscle weakness - Kidney problems (including increased kidney function indicators such as urea and creatinine), kidney failure - Swelling (hands, feet, lips, or throat) Very rare side effects (occur in more than 1 in 10,000 patients): – Severe hepatitis, which may be life-threatening (including fatal outcomes), kidney failure – Changes in skin and mucous membranes (painful blisters in the mouth/nose or on the genitals), potentially life-threatening (Stevens-Johnson syndrome, toxic epidermal necrolysis) – Tendon rupture – Increased blood clotting, reduced number of white blood cells (agranulocytosis) – Personality disorders – Mental disorders (which may lead to self-harm or suicide attempts) – Transient vision impairment – Increased skin sensitivity – Heart rhythm disorders with life-threatening increase in heart rate (see section 2 "Information before using Moxifloxacin"). – Arthritis – Muscle stiffness – Worsening of myasthenia gravis (muscle weakness, in severe cases paralysis) The following side effects have been observed very rarely with other quinolone antibiotics, which may also occur with Moxifloxacin: - Increased sodium levels in the blood - Increased calcium levels in the blood - Reduction in the number of red blood cells (hemolytic anemia) - Muscle cell disorders - Increased skin sensitivity to light or ultraviolet rays. Information about side effects If you notice any side effects, including effects not described in the instructions for use, tell your doctor or pharmacist. 5. Storage conditions for Moxifloxacin Keep out of reach of children. Do not use after the expiry date indicated on the packaging. The expiry date refers to the last day of that month. The batch number is indicated on the packaging. Store in the original packaging to protect from moisture. No special storage conditions are required. Do not dispose of the medicine in drains or household waste. Ask your pharmacist about its disposal. These measures will help protect the environment. 6. Package contents and additional information What Moxifloxacin contains: – The active substance is moxifloxacin. Each film-coated tablet contains 400mg of moxifloxacin (in the form of moxifloxacin hydrochloride). – The excipients are microcrystalline cellulose, croscarmellose sodium, magnesium stearate in the tablet core and hypromellose 6MPa.s, macrogol 4000, titanium dioxide (E171) and red iron oxide (E172) in the tablet coating.
