MOLOXIN 400 mg. 5 tablets
Moloxin contains the active ingredient moxifloxacin, which belongs to a group of antibiotics called fluoroquinolones. Moloxin works by killing bacteria that cause infections.
Moloxin be used in patients 18 years of age and older for the treatment of bacterial infections when caused by bacteria against which moxifloxacin is effective. Moloxin should be used to treat these infections when antibiotics are commonly recommended can not be used or where the treatment with them has failed:
Sinus infections, sudden worsening of long-term inflammation of the airways or infection of the lungs (pneumonia) acquired outside the hospital (except severe cases);
Mild to moderate infections of the female genital tract (pelvic inflammatory disease), including infections of the fallopian tubes and the lining of the uterus.
Moloxin tablets are not sufficient for self-treatment of such infections. In addition Moloxin tablets your doctor should prescribe another antibiotic to treat infections of the upper part of the female reproductive system (see section 2 What you should know before taking Moloxin, Warnings and precautions Talk to your doctor before taking Moloxin ).
If these bacterial infections have shown improvement during initial treatment with Moloxin infusion, Moloxin tablets can also be prescribed by your doctor to complete the course of treatment: infection of the lungs (pneumonia) acquired outside the hospital, skin infections and soft tissues.
Moloxin tablets should not be used for initiation of therapy for each type of infections, skin and soft tissue, or in severe infections in the lungs.
2. What you need to know before taking Moloxin
Contact your doctor if you are not sure whether you belong to a group of patients described below.
Do not take Moloxin:
If you are allergic to moxifloxacin, other quinolone antibiotics or any of the other ingredients of this medicine (listed in section 6);
If you are pregnant or breast-feeding;
If you are under 18 years of age;
If you have had problems in the past tendons related to treatment with quinolone antibiotics (see Warnings and Precautions and section 4. Possible side effects);
If you have a congenital disease or:
a condition associated with an abnormal heart rhythm (registered on ECG, electrical recording of the heart);
suffer from salt imbalance in the blood (especially low levels of potassium or magnesium in the blood);
you have a very slow heart rhythm (called 'bradycardia');
have a weak heart (heart failure);
you have previously had an abnormal heart rhythm;
if you are taking other drugs that may lead to abnormal ECG changes (see section 2 What you should know before taking Moloxin, Other medicines and Moloxin). Moloxin possible reason for changes in ECG, namely the extension of the QT-interval, ie delaying the conduction of electrical signals;
If you suffer from severe liver disease or have elevated liver enzymes (transaminases) more than 5 times the upper normal limit.
Warnings and Precautions
Talk to your doctor or pharmacist before taking Moloxin:
Moloxin can change your heart's ECG, especially in women or the elderly. If you are currently taking any medications that lower potassium levels in the blood, tell your doctor before taking Moloxin (see also section 2. What you need to know before you take Moloxin, Moloxin not take other drugs and Moloxin);
If you suffer from epilepsy or a disease that makes you likely to have convulsions, consult your doctor before taking Moloxin;
If you have or have ever had mental health problems, consult your doctor before taking Moloxin;
If you suffer from myasthenia gravis (abnormal muscle fatigue leading to weakness and in severe cases, paralysis), the adoption of Moloxin may worsen the symptoms of your illness. If you think this applies to you, consult your doctor immediately;
If you or someone in your family have glucose-6-phosphate dehydrogenase (a rare hereditary disease), inform your doctor who will advise you whether Moloxin is suitable for you;
If you have a complicated infection of the female reproductive system (eg. Associated with an abscess of the fallopian tubes and ovaries or of the pelvis), for which your doctor considers that an intravenous treatment necessary, treatment with Moloxin tablets is not appropriate;
For the treatment of mild to moderate infections of the female reproductive system, your doctor should prescribe another antibiotic in addition to Moloxin.
Please consult your doctor if 3 days after initiation of treatment there is no improvement in symptoms.
When taking Moloxin
If you get palpitations or irregular heart beat during the period of treatment, you should immediately notify your doctor. He / she may decide you do an ECG to measure your heart rate;
The risk of heart problems may increase with increasing dose. Therefore, the recommended dose should be respected;
There is a rare opportunity to experience a severe, sudden allergic reaction (anaphylactic reaction / shock) even with the first dose. Symptoms include chest tightness, dizziness, nausea or light-headedness or dizziness when standing up. If so, stop taking Moloxin and seek medical advice immediately;
Moloxin may cause a rapid and severe inflammation of the liver that can lead to life-threatening liver failure (including fatal cases, see section 4 Possible side effects). Please tell your doctor before you continue the treatment if you develop signs such as rapid deterioration and / or general malaise with yellowing of the whites of the eyes, dark urine, itching of the skin, a tendency to bleed or liver induced brain damage (symptoms of reduced liver activity or rapid and severe inflammation of the liver);
If a skin reaction or blistering and / or peeling of the skin and / or mucosal reactions (see section 4 Possible side effects), tell your doctor before you continue treatment;
Quinolone antibiotics, including Moloxin can cause seizures. If this happens, stop taking the medicine and contact your doctor immediately;
You may experience symptoms of neuropathy such as pain, burning, tingling, numbness and / or weakness. If this happens, tell your doctor before you continue treatment with Moloxin;
It is possible to occur mental problems even after the first administration of quinolone antibiotics, including Moloxin. In very rare cases, depression or mental problems progressed to suicidal thoughts and self-injury, such as attempted suicide (see section 4 Possible side effects). If you develop such reactions Moloxin stop treatment and inform your doctor immediately;
You may get diarrhea during or after treatment with antibiotics, including Moloxin. If it becomes severe or persistent or you notice that your stool contains blood or mucus you should stop taking Moloxin and consult your doctor. You should not take medicines that stop or slow down bowel movement;
Moloxin can cause pain and inflammation of your tendons, even within 48 hours of treatment and up to several months after discontinuation of Moloxin. The risk of inflammation and rupture of tendons is increased if you are elderly or being treated with corticosteroids. At the first sign of any pain or inflammation you should stop taking Moloxin, rest the affected (s) limb (s) at rest and inform Bashiya doctor. Avoid any unnecessary exercise, as this may increase the risk of tendon rupture (see points 2 What you should know before you start taking Moloxin, not take Moloxin, 4 Possible side effects);
If you are elderly and have kidney problems, be sure to drink enough fluids while being treated with Moloxin. If you are dehydrated, this can increase the risk of renal failure;
If your eyesight becomes impaired or have any other eye disturbances whilst taking Moloxin immediately consult an eye specialist (see. 3 How to take Moloxin, Driving and using machines and 4 Possible side effects);
Quinolone antibiotics may make your skin more sensitive to sunlight or UV rays. You should avoid prolonged exposure to sunlight or strong sunlight and should not be exposed to light in a sunbed or any other UV lamp while taking Moloxin;
Efficacy of moxifloxacin in the treatment of severe burns, deep tissue infections and diabetic foot infections with osteomyelitis (infections of the bone marrow) it is established.
Children and adolescents
This medicine should not be given to children and adolescents under 18 years since safety and efficacy have not been established in this age group (see point 2 What you should know before taking Moloxin, not take Moloxin).
Other medicines and Moloxin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
For Moloxin should know the following:
If Moloxin taking other medicines that affect your heart there is an increased risk of changes in your heartbeat. Therefore, do not take Moloxin together with the following medicines:
Medicines that belong to the group of antiarrhythmic agents (eg. Quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide);
Antipsychotics (eg. Phenothiazine, pimozide, sertindole, haloperidol, sultopride);
Some antimicrobial agents (eg. Saquinavir, sparfloxacin, intravenous erythromycin, pentamidine, antimalarials preparations, particularly halofantrine);
Some antihistamines (eg. Terfenadine, astemizole, mizolastine);
Other drugs (eg. Cisapride, intravenous vincamine, bepridil and diphemanil);
You should tell your doctor if you take other medicines that can lower potassium levels in the blood (eg. Some diuretics, some laxatives or enemas [high doses] or corticosteroids [NSAIDs], amphotericin B) or cause slow heart rhythm as they can also increase the risk of serious heart rhythm disturbances while taking Moloxin;
Medicines containing magnesium or aluminum (such as antacids for stomach disorders), or medicines containing iron, zinc or didavozin or medicines containing sucralfate (used to treat gastrointestinal disorders) may reduce the effects of Moloxin tablets. Take Moloxin tablets six hours before or after taking the other medicine;
Coadministration of Moloxin tablets and charcoal reduces the action of Moloxin. Therefore, concomitant use of these drugs is not recommended;
If you are currently taking medicines to thin the blood (oral anticoagulants, eg. Warfarin) may be necessary for your doctor to monitor coagulation times.
Moloxin with food and drink
Moloxin can be taken with or without food (including dairy products).
Pregnancy, lactation and fertility
Moloxin not take if you are pregnant or breast-feeding.
If you are pregnant or breast-feeding, think you may be pregnant or planning to become pregnant, ask your doctor or pharmacist before taking this medicine. Studies in animals have shown that fertility will be reduced by taking this medicine.
Driving and using machines
Moloxin can make you feel dizzy or light-headed, you may experience sudden blackouts or for a short time can otmalee. If you are affected, do not drive or operate machinery.
3. How to take Moloxin
Always take this medicine exactly as prescribed by your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist.
The recommended adult dose is one tablet of 400 mg once daily.
Moloxin tablets are for oral use. Swallow the tablet whole (to mask the bitter taste) and with sufficient fluid. You can take Moloxin with or without food. Try to take the tablet at approximately the same time each day.
The same dose can be taken by elderly patients, patients with a low bodyweight or in patients with kidney problems.
The time it will take depends on your Moloxin infection. Unless your doctor tells you otherwise, your treatment will be as follows:
Sudden worsening (acute exacerbation) of chronic bronchitis: 5-10 days;
Infection of the lungs (pneumonia), with the exception of hospital-acquired pneumonia: 10 days;
Acute infection of the sinuses (acute bacterial sinusitis): 7 days;
Mild to moderate infections of the female genital tract (pelvic inflammatory disease), including infection of the fallopian tubes and infection of the lining of the uterus: 14 days.
When Moloxin tablets used to complete the course of treatment, start with Moloxin infusion, the recommended duration of use is:
Infection of the lungs (pneumonia) acquired outside the hospital: 7-14 days;
Most patients with pneumonia were switched to oral treatment with Moloxin tablets within 4 days
Infections of skin and soft tissue: 7-21 days.
Most patients with infections of the skin and soft tissues are converted to oral therapy Moloxin tablets within 6 days.
It is important to complete the course of treatment, even if you begin to feel better after a few days. If you stop taking Moloxin too early your infection may not be completely cured and return or your condition may get worse. It is possible that the bacteria causing your infection to develop resistance to Moloxin.
The recommended dose and duration of treatment should not be exceeded (see point 2 What you should know before taking Moloxin, Warnings and Precautions).
If you take more dose Moloxin
If you take more than the prescribed one tablet a day, seek medical help immediately. Try to take any remaining tablets, the packaging or this leaflet with you to show the doctor or pharmacist what you have taken.
If you forget to take Moloxin
If you forget to take a tablet, you should take it as soon as you remember the same day. If you do not remember and do not take your tablet during the day, take your normal dose (one tablet) on the next day. Do not take a double dose to make up the missed dose.
If you are not sure what to do, consult your doctor or pharmacist.
If you stop taking Moloxin
If you stop taking this medicine too soon, your infection may not be completely cured. Consult your doctor if you should stop taking before the end of the treatment course.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The following adverse reactions have been observed during treatment with moxifloxacin.
Common (may affect up to 1 in 10 patients):
Infections caused by resistant bacteria or fungi eg. oral and vaginal infections caused by Candida (thrush);
Changes in heart rate (ECG) in patients with low levels of potassium in the blood (see section 2. What you need to know before taking Moloxin);
Feeling sick (nausea);
Stomach and abdominal pain;
Increase of certain liver enzymes in the blood (transaminases).
Uncommon (may affect up to 1 in 100 patients):
Reduced number of red blood cells (anemia);
Reduced number of white blood cells;
Low numbers of special white blood cells (neutrophils);
Decrease or increase of special blood cells necessary for blood clotting;
Increased specialized white blood cells (eosinophils);
Decreased blood clotting;
Elevated blood lipids (fats);
Anxiety, restlessness or agitation;
Tingling (pins and needles) and / or numbness;
Changes in taste (in very rare cases loss of taste);
Confusion and disorientation;
Sleep disorder (eg. Insomnia or drowsiness);
Feeling of dizziness (vertigo or loss of consciousness);
Vision problems (including double or blurred vision);
Changes in heart rate (ECG), palpitations, irregular and fast heart beat, severe heart rhythm disorders, chest pain (angina) (see section 2. What you need to know before taking Moloxin);
Dilation of blood vessels (sudden redness);
Difficulty breathing (incl. Asthmatic conditions);
Reduced appetite and food intake;
Flatulence and constipation;
Stomach upset (indigestion or heartburn);
Inflammation of the stomach;