Avelox. 400 mg. 5 tablets
Avelox. 400 mg. 5 tablets
What is AVELOX 400 mg film-coated tablets and what it is used?
AVELOX 400 mg film-coated tablets containing a broad-spectrum antibiotic , which means that it kills a wide range of pathogenic microorganisms . Moxifloxacin, the active substance of AVELOX 400 mg film-coated tablets belongs to the quinolone group.
AVELOX 400 mg tablets are used to treat bacterial infections of the following ( with the proviso that they are caused by organisms sensitive to moxifloxacin):
• exacerbation of chronic bronchitis
• Acquired Pneumonia
• Acute sinusitis ( inflammation in the paranasal sinuses ) and infections of the skin and soft tissues .
2 . What you should know before taking AVELOX 400 mg tablets ?
You should not use A VELOX 400 mg film-coated tablets:
if you are allergic to moxifloxacin, other quinolones or any other ingredients , if you have a history of inflammation or tendon damage after treatment with these active substances ( quinolones )
if you have a congenital or any condition with certain abnormal electrocardiogram (ECG , QT interval) if you suffer from salt disorders, especially if you have low concentrations of K + in your blood ( hypokalemia )
if you have a clinically significant bradycardia (slow heart rate) , if your doctor has diagnosed clinically relevant heart failure with reduced left ventricular ejection fraction ( weak heart ) if you have a history of symptomatic cardiac arrhythmias . A VELOX 400 mg film-coated tablets should not be used with other drugs that cause certain ECG abnormalities ( QT prolongation ) .
if you have impaired liver function (Child-Pugh class C) or elevated transaminases > 5 times the upper normal limit .
Pregnant women , nursing mothers , children and adolescents should not take A VELOX 400 mg film-coated tablets.
Particular attention is necessary when used AVELOX400 mg film-coated tablets in the following cases :
if you have ever had seizures , you should consult your doctor before taking A VELOX 400 mg film-coated tablets
if you have a visual impairment or damage to your eyes , you should consult an ophthalmologist immediately .
Inflammation and torn ligaments may occur during therapy with quinolones , including moxifloxacin ( drug AVELOX 400 mg film-coated tablets) , especially in elderly patients or patients receiving concomitant therapy with anti-inflammatory drugs (corticosteroids ) . At the first signs of pain or inflammation should stop taking AVELOX 400 mg film-coated tablets to place limb and consult your doctor immediately regarding further treatment .
Moxifloxacin causes certain abnormal electrocardiogram ( ECG) known as prolongation of the QT interval in some patients.
Although the effect is not very pronounced , A VELOX 400 mg film-coated tablets should be used with caution if you are taking other medicines that can reduce potassium level in the blood. Patients at increased risk of arrhythmia (eg, acute myocardial ischemia ) should be careful when taking Avelox. Prolongation of the QT interval may increase the risk of certain types of cardiac arrhythmias ( ventricular arrhythmia , including torsades de pointes). Since the degree of prolongation of the QT interval is increased in proportion to the dosage recommended dose must not be exceeded. Consult your doctor if you have doubts. If symptoms of cardiac arrhythmia occur during treatment with A VELOX stop treatment and consult your doctor. If you have impaired liver , talk to your doctor to do a test .
Broad-spectrum antibiotics , including moxifloxacin can cause severe diarrhea ( pseudomembranous colitis) . In this situation must be taken immediately appropriate therapeutic measures . In case of severe diarrhea occurring during or after the use of antibiotics , please consult your doctor immediately . Do not take medications that suppress gastric motility .
If you or a member of your family is established glucose- b -phosphate dehodrogenazen deficiency ( congenital or acquired metabolic disorder ) , please tell your doctor before taking AVELOX 400 mg film-coated tablets.
In contrast to other quinolones , moxifloxacin not pose a significant risk of inducing in photosensitivity assay. However, during treatment with AVELOX 400 mg film-coated tablets , you TRYAVNA avoid UV irradiation ( alpine sun, solarium ) and not exposed to excessive and / or strong sunlight .
Hypersensitivity reactions or allergic reactions (e.g., skin rash ) may occur after the first administration of the quinolone . In extremely rare cases can be severe Cutting rapid allergic reactions ranging to life- threatening shock. In these cases the use of moxifloxacin should immediately be stopped immediately and should start treatment ( eg treatment for shock) .
You should always consult your doctor or pharmacist before taking the medication.
Do not take AVELOX 400 mg tablets if you are pregnant . breastfeeding
You should always consult your doctor or pharmacist before taking the medication.
Do not take A VELOX 400 mg tablets if you are pregnant . Driving and using machines
If you are sleepy after taking A VELOX 400 mg film-coated tablets , avoid driving or operating machinery.
Important information for certain other ingredients in AVELOX 400 mg film-coated tablets:
AVELOX 400 mg film-coated tablets contain lactose. Therefore, you should not take this medication without consulting your doctor know if you have glucose intolerance .
Interactions with other drugs
Please tell your doctor or pharmacist if you are taking / using other medicines or have taken / used other drugs recently , even if these are drugs without prescription.
Please note the following when you are taking other medicines:
• A VELOX can affect heart rate (QT interval) . This effect can be increased in case of concomitant administration of the following drugs : Class 1 antiarrhythmics (eg quinidine, hydroquinidine , disopyramide ) and class III ( eg amiodarone , sotalol , dofetilide , ibutilide ) antiarrhythmics (medicines to treat cardiac arrhythmias ) , neuroleptics ( medicines for the treatment of psychiatric disorders , such as phenothiazine, pimozide, sertindole , haloperidol, sultopride ) , tricyclic antidepressants, anti- set ( sparfloxacin , intravenous erythromycin, pentamidine, antimalarials , particularly halofantrine ) , certain drugs used to treat allergic symptoms ( terfenadine, astemizole, mizolastine ) and others ( cisapride , a medicine used to stimulate peristalsis , intravenous vincamine , bepredil , diphemanil ) . Moxifloxacin should therefore not be used in conjunction with these products.
• A range from about 6 hours must elapse between taking drugs that contain certain metals ( divalent or trivalent cations ) and taking AVELOX 400 mg film-coated tablets. This includes antacids containing magnesium or aluminum (medicines used to prevent hyperacidity of the stomach) , certain anti-viral tablets containing didanosine, sucralfate medicines containing iron or zinc.
• Co-administration of AVELOX 400 mg film-coated tablets and charcoal significantly reduced the absorption of moxifloxacin in the body. Therefore, concomitant use of these two products is not recommended.
• In studies conducted in healthy subjects , concomitant administration of AVELOX 400 mg film-coated tablets with digoxin (a medicine used to treat heart failure) results in an approximately 30% increase in peak plasma concentrations of digoxin. No special precautions for concomitant A VELOX and digoxin.
• In studies conducted in patients with diabetes , concomitant administration of AVELOX 400 mg film-coated tablets with glibenclamide ( a medicine used to treat diabetes) resulted in a 21 % decrease in peak plasma concentrations of glibenclamide. Blood glucose and insulin levels were not affected.
• Increased anticoagulant effect was reported in a large number of cases in which the patients were treated with both antibiotics and anticoagulants. However, it is reported clinically significant interaction of moxifloxacin and warfarin ( anticoagulant) . The values of coagulation parameters can be monitored more frequently and as a precaution anticoagulant dosage is adjusted as necessary.
No interactions when AVELOX 400 mg film-coated tablets are taken with medicines containing the following drugs : ranitidine (used to treat peptic ulcers) , probenecid (used to reduce serum uric acid) , oral contraceptives (tablet birth control ) , calcium supplements , morphine ( a narcotic analgesic ) , theophylline (used to treat asthma) or itraconazole (used for the treatment of fungal infections) .
When taking AVELOX 400 mg film-coated tablets with food and drink
The effects of AVELOX 400 mg film-coated tablets are not affected by food , including dairy products.
3 . How should I take AVELOX 400 mg tablets ?
A VELOX 400 mg film-coated tablets are always taken in accordance with the instructions of your doctor. Please consult your doctor or pharmacist if you are not sure how to take this medicine.
A VELOX 400 mg film-coated tablets should be taken orally . Unless prescribed otherwise by your doctor , the usual dose is: Adults take 1 tablet . AVELOX 400 mg tablets once daily.
No need dose adjustment in elderly patients , patients with low body weight, patients with mild to moderate renal impairment or patients on dialysis.
No data available for use in patients with impaired hepatic function.
Please consult your doctor or pharmacist if you have the impression that the effects of AVELOX 400 mg film-coated tablets are very strong or very weak.
Film-coated tablets are swallowed whole with plenty of fluid. You should not take A VELOX 400 mg film-coated tablets with food .
Unless prescribed otherwise by your doctor AVELOX 400 mg tablets should be taken with the following duration :
• pulmonary inflammation of the lower tract ( bronchitis ): 5 to 10 days
• pneumonia ( community acquired ) : 10 days
• Acute sinusitis (inflammation of the paranasal sinuses ) 7 days
» Skin infections 7 days
You must complete the full course of treatment with AVELOX 400 mg film-coated tablets , as the infection may not be completely cured.
If you take a large amount of AVELOX 400 mg film-coated tablets , we suggest :
The recommended dose of 400 mg once daily should not be exceeded. If you have accidentally taken more than one tablet a day , you should continue your treatment the next day, as prescribed . Co-administration of activated charcoal and 400 mg moxifloxacin reduces the bioavailability of moxifloxacin with more than 80%. Early administration of activated charcoal may be useful in order to prevent very high levels of moxifloxacin in the blood, if an overdose is taken moxifloxacin tablets.
If you forget to take A VELOX 400 mg film-coated tablets:
You should take your next tablet immediately and continue your treatment with one tablet a day.
Do not take a double dose to correct missed a single dose. The effects of discontinuation of A VELOX 400 mg film-coated tablets: If taking AVELOX 400 mg tablets stop your symptoms may worsen . Please consult your doctor if you should stop taking A VELOX 400 mg film-coated tablets before the end of the treatment course .
4 . What side effects are possible?
Like all drugs , AVELOX 400 mg tablets can have side effects .
Hyperglycemia ( elevated blood sugar) , hyperlipidemia ( elevated lipid levels ), increased prothrombin levels / decreased INR ( specific coagulation parameters) , jaundice ( jaundice caused primarily by obstruction of bile) in connection with altered liver function, elevated levels of specific liver enzyme (LDH), elevated levels of creatinine and urea .
Based on clinical experience with AVELOX400 mg film-coated tablets so far , it is not possible to give a definitive assessment of the possible side effects after taking AVELOX. Isolated cases of the following adverse reactions have been reported during treatment with other fluoroquinolones and they can also occur during treatment with AVELOX400 mg film-coated tablets: Transient loss of vision, balance problems including ataxia ( affecting the ability to perform movements ) hypernatriemia (increased levels of sodium in the blood ) , hypercalcemia (increased levels of calcium in the blood) , neutropenia (a reduced number of particular types of white blood cells) , hemolysis (excessive degradation of red blood cells) .
Tell your doctor or pharmacist if you observe any side effects not listed in this leaflet for the patient.
5 . How should I store AVELOX tablets ?
Keep out of reach of children.
Store at a temperature not higher than 25 ° C. The tablets can be stored in their original packaging .
The film-coated tablets can be stored in the original container next to their use.
The shelf life of this product is printed on the label on the packaging and
on blister strips .
Do not use after expiry date .
Active substance : moxifloxacin hydrochloride
1 tablet contains 400 mg moxifloxacin in the form of 436,8 mg moxifloxacin hydrochloride as a pharmaceutically active substance.
List of excipients
Krospomeloza sodium, lactose monohydrate, magnesium stearate , microcrystalline cellulose , hypromellose , macrogol 4000 , titanium dioxide (E 171 ) and iron oxide (E 172).
AVELOX400 mg film-coated tablets are available in packs containing 5, 7 or 10 tablets and hospital packs.
The film-coated tablets are pale red and marked with " M400 " on one side and "Bayer" on the other strana.Filmiranite tablets are packaged in polypropylene / blister strips and come in cardboard boxes.
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