is an antibiotic from the quinolone family, the fluoroquinolone group. The active substance is ofloxacin. It works by killing bacteria that cause infections. It is active only against certain strains of bacteria.
Indication
OXIFLOXACIN ZENTIVA is indicated for the treatment of the following bacterial infections:
· some urinary tract infections (bladder and kidney infections),
· some infections of the genital tract in men and women (for example: gonorrhea, a sexually transmitted disease),
· some bone and joint infections,
· some respiratory tract infections,
· some sinus infections,
· some skin infections,
· when infected with anthrax.
Contraindications and precautions
· if you take corticosteroid medications for a long time, as they can increase the risk of tendinitis and tendon rupture while using OXIFLOXACIN ZENTIVA 200 mg, notched, film-coated tablets.
· if you have an intense sports activity,
· and/or if you have already had tendinitis.
Never take OXIFLOXACIN ZENTIVA 200 mg, film-coated tablets:
· If you are allergic to ofloxacin, other quinolones, or any of the other ingredients of this medicine listed in section 6. Signs of an allergic reaction may include rash, difficulty breathing or swallowing, swelling of the lips, face, throat, or tongue. ;
· if you suffer from epilepsy;
· if you have already had problems with tendons when taking antibiotics of the same family as OFLOXAKIN ZENTIVA 200 mg, film-coated tablets. The tendon connects the muscle to the skeleton;
· If you are a child or teenager (see "Warnings and Precautions");
· If you are pregnant or breastfeeding.
Warnings and precautions
Talk to your doctor or pharmacist before taking OFLOXAKIN ZENTIVA 200 mg, film-coated tablets.
In children and adolescents
OXIFLOXACIN ZENTIVA 200 mg, film-coated tablets, can be used in children aged 6 years and older (this age barrier is due to the dosage form, given that taking any tablets is not recommended for older children under 6 years of age, since they can lead to improper administration) and in adolescents, in exceptional cases, under under the supervision of a specialist, for the treatment of some severe bacterial infections that cannot be cured with other antibiotics.
Before taking OFLOXAKIN ZENTIVA 200 mg film-coated tablets with a risk:
You should not take fluoroquinolones/quinolone antibiotics, including ofloxacin, if you have experienced serious side effects when taking quinolones or fluoroquinolones in the past. In this case, you should inform your doctor as soon as possible.
Tell your doctor or pharmacist if:
· you are taking corticosteroids (see the section "Other medicines" and OFLOXAKIN ZENTIVA 200 mg, film-coated tablets);
· you have already had tendinitis;
· You have already had kidney problems, as treatment adaptation may be required;
· you have had a transplant;
· you have liver problems;
· Do you have neurological problems, including seizures, or psychiatric problems;
· you suffer from myasthenia gravis (a rare disease that causes muscle weakness), because this medicine can worsen your condition;
· you have heart problems: it is recommended to be careful when taking a medication such as ofloxacin if you were born or have a family history of QT prolongation (observed on an ECG, electrical recording of the heart), or if you have an electrolyte imbalance (especially low concentrations of potassium or magnesium in the blood), very slow heart rhythm (bradycardia), weak heart (heart failure), history of seizures, heart attack (myocardial infarction), or if you have a woman or an elderly person, or if you are taking medication, which may cause certain abnormal changes on the ECG (see the section "Other medications and OXIFLOXACIN ZENTIVA 200 mg, film-coated tablets");
· you have been diagnosed with an enlargement or "bulge" of a large blood vessel (aortic aneurysm or peripheral large vessel aneurysm);
· have you ever had an episode of aortic dissection (rupture of the aortic wall) before;
· if you have been diagnosed with heart valve insufficiency (valvular regurgitation
· cordial);
- you have a family history of aortic aneurysm, aortic dissection, or congenital heart valve defect, or you have other risk factors or predisposing conditions (for example, connective tissue diseases such as Marfan syndrome or Ehlers-Danlos vascular disease, Turner syndrome, Sjogren syndrome [an inflammatory autoimmune disease] or vascular diseases such as such as Takayasu arteritis, giant cell arteritis (or Horton's disease), Behcet's disease, high blood pressure or known atherosclerosyou have a family history of aortic aneurysm, aortic dissection, or congenital heart valve defect, or you have other risk factors or predisposing conditions (for example, connective tissue diseases such as Marfan syndrome or Ehlers-Danlos vascular disease, Turner syndrome, Sjogren syndrome [an inflammatory autoimmune disease] or vascular diseases such as such as Takayasu arteritis, giant cell arteritis (or Horton's disease), Behcet's disease, high blood pressure or known atherosclerosis, rheumatoid arthritis [joint disease] or endocarditis [heart infection]).
· you suffer from diabetes to the extent that you are taking concomitant antidiabetic treatment (oral or by injection of insulin) due to an increase or decrease in glycemia (blood sugar levels), in particular, patients have already experienced hypoglycemic comas treated with antidiabetic agents;
· You or a member of your family is deficient in glucose-6-phosphate dehydrogenase, bec· You or a member of your family is deficient in glucose-6-phosphate dehydrogenase, because when taking this medicine you may be at risk of serious blood problems (destruction of red blood cells).
The use of this drug is not recommended for patients with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome (rare hereditary diseases).
When taking OXIFLOXACIN ZENTIVA 200 mg, the film-coated tablet has clogged edges:
Stop taking OXIFLOXACIN ZENTIVA 200 mg, film-coated tablets, and seek medical attention immediately if you notice any of the following serious side effects - you may need urgent medical attention:
· Severe and sudden allergic reaction (anaphylactic reaction/shock). From the first dose, there is a risk of a severe allergic reaction, which may manifest itself in the following symptoms: chest tightness, dizziness, nausea or fai· Severe and sudden allergic reaction (anaphylactic reaction/shock). From the first dose, there is a risk of a severe allergic reaction, which may manifest itself in the following symptoms: chest tightness, dizziness, nausea or fainting, as well as dizziness when getting up. If these symptoms occur, stop taking OFLOXAKIN ZENTIVA 200 mg, notched, film-coated tablets, as your life may be at risk, and consult a doctor immediately.
· The appearance of blisters with peeling of the skin, especially around the mouth, eyes or genitals, which can quickly spread throughout the body and endanger your life (Stevens-Johnson syndrome, Lyell syndrome) (see section 4. "What are the possible side effects?"). Tell your doctor immediately if you experience reactions on the skin or mucous membranes.
· Decrease in blood sugar (blood sugar level). This decrease was more often reported in the elderly, usually in diabetics. Low blood sugar levels can lead to coma (hypoglycemic coma). Other antibacterial treatment should be considered.
· Serious, long-lasting, disabling and potentially irreversible side effects.
Fluoroquinolone/quinolone antibacterial drugs, including this drug, cause very rare but serious side effects, some of which may be persistent (lasting months or years), disabling or potentially irreversible. These include pain in the tendons, muscles and joints of the upper and lower extremities, difficulty walking, abnormal sensations such as tingling, tThese include pain in the tendons, muscles and joints of the upper and lower extremities, difficulty walking, abnormal sensations such as tingling, tingling, tickling, numbness or burning sensation (paresthesia), sensory disorders including visual, taste, smell and hearing disorders, depression, memory disorders, severe fatigue and severe sleep disorders.
If you experience any of these side effects after taking this medicine, contact your doctor immediately before continuing treatment. You and your doctor will decide whether to continue treatment, taking into account the possibility of using an antibiotic from another family.
· In rare cases, joint pain and swelling may occur, as well as inflammation or rupture of tendons. The risk is higher if you are an elderly · In rare cases, joint pain and swelling may occur, as well as inflammation or rupture of tendons. The risk is higher if you are an elderly person (over 60 years old), if you have had an organ transplant, if you have kidney problems or if you take corticosteroids. Inflammation and tendon tears may occur during the first 48 hours of treatment and up to several months after discontinuation of treatment with ofloxacin. At the first signs of pain or inflammation of the tendon (for example, in the ankle, wrist, elbow, shoulder oAt the first signs of pain or inflammation of the tendon (for example, in the ankle, wrist, elbow, shoulder or knee), stop taking the drug, consult a doctor and stop taking the affected limb at rest. Avoid unnecessary strain, as this can increase the risk of tendon rupture. Be careful when resuming walking if you have been bedridden for several days due to the risk of tendon rupture. Antibiotics from the quinolone family, one of which is OXIFLOXACIN ZENTIVA 200 mg, film-coated tablets, should no longer be prescribed to you.
In particular, the risk of joint inflammation in children should be carefully monitored. If a child develops joint pain during treatment with ofloxacin, it must be interrupted and the affected joint placed at rest. Inform your doctor immediately, and a specialist's consultation is required.
· If you suffer from epilepsy, you should not take this medicine. If you have another neurological condition, neurological side effects (seizures) may occur. If they occur, stop taking OXIFLOXACINAZENTIVE 200 mg, film-coated tablets, and consult a doctor immediately.
· When using ofloxacin Zentiva 200 mg, film-coated tablets, mental reactio
Dosage
In adults
The usual dose is 400 mg / day in 2 doses (1 tablet of 200 mg in the morning and evening).
In some bronchial infections, the dose is 400 mg / day once or 2 tablets of 200 mg once.
In some cases, your doctor may prescribe a higher dosage depending on the severity of the infection.
The dosage can be adapted for people with renal insufficiency or for people with liver failure.
As part of exceptional treatment in children and adolescents (the dose is calculated depending on the child's body weight)
As an indication, the dose is from 10 to 15 mg / kg / day in two doses, not exceeding 400 mg / day in two doses.
Method and route of administration
The oral way.
The tablets are swallowed with a small amount of water.
The tablets should be taken on an empty stomach or with meals. Do not take OXIFLOXACIN ZENTIVA 200 mg, film-coated tablets, simultaneously with antacid drugs (see the section "Other medicines" and OXIFLOXACIN ZENTIVA, 200 mg, film-coated tablets).
Frequency of administration
1-2 doses per day.
If your doctor recommended that you take OXIFLOXACIN ZENTIVA 200 mg, film-coated tablets, once a day, it is best to take them in the morning.
Duration of treatment
To be effective, this antibiotic must be used regularly in prescribed doses and for as long as the doctor advises.
The disappearance of fever or any other symptoms does not mean that you are completely cured. Any feeling of fatigue is not related to antibiotic treatment, but to the infection itself. Reducing or suspending treatment will not affect this feeling and will delay your recovery.