Moxistad 400 mg. 7 tablets
Moxistad contains the active substance moxifloxacin, which belongs to the group of antibiotics called fluoroquinolones. Moxistad acts by killing bacteria causing infections.
Moxistad should be used to treat certain bacterial infections where it is effective. Moxostat should be used to treat such infections where antibiotics that are usually recommended can not be used or when treatment with them has failed:
Sinus infections, sudden worsening of long-term inflammation of the respiratory tract or lung infection (pneumonia) acquired outside the hospital (except in severe cases).
Mild to moderate sexually transmitted infections (pelvic inflammatory disease) including infections of the fallopian tube and the lining of the uterus.
Moxistad tablets are not enough to treat this type of infection alone and your doctor should therefore prescribe another antibiotic in addition to Moxistad tablets for the treatment of infections of the upper genital tract of the female genital tract (see section 2. What you should know before take Moxistad Warnings and precautions Talk to your doctor before taking Moxistad.
If the following bacterial infections have shown improvement during the initial treatment with moxifloxacin solution for infusion, Moxostat tablets may also be prescribed by your doctor for completing the course of treatment:
Infection of the lungs (pneumonia) acquired outside the hospital, skin infections and skin structures.
Moxostat tablets should not be used to initiate therapy for any type of skin and skin infection or in severe cases of lung infections.
2. What you need to know before you take Moxistad
Ask your doctor if you are not sure whether you fall into any of the following groups of patients.
Do not take Moxistad
If you are allergic to the active substance moxifloxacin, to other quinolone antibiotics or to 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 previously had inflammation or damage to the tendons associated with treatment with quinolone antibiotics (see section Warnings and precautions and section 4 Possible side effects).
If you have a congenital or documented condition associated with a heart rhythm disorder (visible on ECG, an electrical heart rate record), you suffer from salt imbalance in the blood (especially low levels of potassium or magnesium in the blood), have a slow heartbeat (called ' bradycardia '), have a weak heart (heart failure), have a history of heart rhythm or other medicines that can cause ECG changes (see Other Medicines and Moxistad). Moxostat may be the cause of ECG changes, namely prolongation of the QT interval, ie. delays in conduction of electrical signals.
If you suffer from severe liver disease or elevated liver enzymes (transaminases) more than 5 times the upper normal range.
Warnings and precautions
Talk to your doctor before taking Moxistad
Moxistad may change your ECG, especially in women or in the elderly. If you are currently taking any medicines that lower your blood potassium levels, tell your doctor before taking Moxostat (see also section "Do not take Moxistad" and Other medicines and Moxistad)
If you suffer from epilepsy or from a condition that causes you to have seizures, talk to your doctor before taking Moxistad.
If you have or have ever had any mental problems, talk to your doctor before taking Moxistad.
If you suffer from myasthenia gravis, taking Moxistad may worsen the symptoms of your illness. If you think this applies to you, talk to your doctor immediately.
If you or someone in your family have a deficiency of glucose-6-phosphate dehydrogenase (a rare inherited disorder), tell your doctor who will advise you if Moxistad is appropriate for you.
If you have a complicated infection of the upper genital tract of the female genital tract (eg associated with the abscess of the fallopian tube and the ovary or pelvis), which your doctor considers intravenous treatment to be necessary, treatment with Moxistad tablets is not appropriate.
For the treatment of mild to moderate infections of the upper genital tract of the female reproductive system. Your doctor should prescribe another antibiotic in addition to Moxistad. Please consult your doctor if there is no improvement in symptoms within 3 days after starting treatment.
When you are taking Moxistad
If you get heartburn or irregular heartbeat during treatment, you should tell your doctor immediately. He / she may ask you to make an ECG or measure you
You may experience symptoms of nervous system disorder (neuropathy) such as pain, burning, tingling, numbness and / or weakness, especially on the fingers and toes. If this happens, tell your doctor immediately before proceeding with Moxistad.
Psychic problems may occur even after the first use of quinolone antibiotics, including Moxistad. However, very rare cases of depression or mental problems can lead to suicidal thoughts or self-injuring behavior such as suicide attempts (see section 4. Possible side effects). But if you develop such reactions stop taking Moxistad and tell your doctor immediately.
You may experience diarrhea during or after treatment with antibiotics, including Moxostat. If it becomes severe or persistent, or you notice that your stools contain blood or mucus, you should stop taking Moxistad immediately and consult your doctor. In this situation, you should not take any medicine that stops or slows down the bowels.
Mockstadt may sometimes cause pain and inflammation in your tendons, even within 48 hours of starting treatment and up to several months after discontinuation of Moxistad treatment. The risk of tendon inflammation and rupture is increased if you are elderly or are taking corticosteroids. At the first signs of some pain or inflammation, you should stop taking Moxistad, leave the affected limb (s) at rest and tell your doctor immediately. Avoid unnecessary stress as this may increase the risk of tendon rupture (see Do not take Moxistar and 4. Possible side effects).
If you are elderly with existing kidney problems, take care to take enough fluids because dehydration can increase the risk of kidney failure.
If your vision is damaged or if you have other eye disorders after taking Moxistad, consult a specialist eye specialist immediately (see Driving and using machines and 4. Possible side effects).
Quinolone antibiotics can make your skin more sensitive to sunlight or UV rays. You should avoid prolonged exposure to sunlight or strong sunlight and do not expose yourself to sunlight or any other UV light while taking Moxistad.
The efficacy of moxifloxacin solution for infusion in the treatment of severe burns, deep tissue infections and diabetic foot infections with osteomyelitis (bone marrow infection) has not been established.
Other Drugs and Moxistad
Tell your doctor or pharmacist if you are taking, have recently taken or might take any medicines other than Moxistad.
For Moxistad you should know the following:
If you are taking Moxostat and other medicines that affect your heart, there is an increased risk of changing your heartbeat. Therefore, do not take Moxostat with the following medicines:
medicines that belong to the group of antiarrhythmics (eg quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetipid, ibutilide),
antipsychotics (eg phenothiazines, pimozide, sertindole, haloperidol, sulpodride)
some antimicrobial products (eg saquinavir, sparfloxacid, intravenous erythromycin, pentamidine, antimalarials, especially halofantrine)
some antihistamines (eg terfenadine, astemizole, mizolastine)
other medicines (eg cisapride, intravenous vincamine, bepridil and difenmanyl).
You should tell your doctor if you are taking other medicines that can lower blood potassium levels (eg some diuretics, some laxatives and enemas (high doses) or corticosteroids (anti-inflammatory medicines) or cause heart rhythm and they may also increase the risk of serious heart rhythm disturbances while taking Moxistad.
Medicines containing magnesium or aluminum such as antacids for stomach upsets or medicines containing iron or zinc, medicaments containing didanosine or medicines containing sucralfate for the treatment of gastrointestinal disorders may reduce the effect of Moxistad tablets. Therefore, take Moxostat tablets 6 hours before or after taking the other medicine.
Concomitant oral administration of Moxistad and activated charcoal reduces the effect of Moxistad. Concomitant use of these two products is therefore not recommended.
If you are currently taking oral anticoagulants (eg warfarin), your doctor may need to monitor your coagulation time.
Mockstock with food and beverages
The effect of Moxistad is not affected by food intake, including dairy products.
Pregnancy, breastfeeding and fertility
Do not take Moxistad if you are pregnant or breast-feeding.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine
When Moxistad film-coated tablets are used to complete the course of treatment initiated with moxifloxacin infusion solution, the recommended duration of use is:
Infection of the lungs (pneumonia) acquired outside the hospital - 7-14 days
Most patients with pneumonia undergo oral treatment with Moxostat film-coated tablets within 4 days.
Most patients with skin infections and skin structures undergo oral treatment with Moxistad film-coated tablets within 6 days.
It is important to complete the course of treatment even if you begin to feel better in a few days. If you stop taking this medicine too soon your infection may not be fully cured, it may return or your condition may get worse and you may also develop antibiotic resistance.
The recommended dose and duration of treatment should not be exceeded (see section 2. What you need to know before taking Moxostat, "Warnings and Precautions").
If you take more Moxistad than you should
If you take more than one tablet a day, seek immediate medical attention and, if possible, take the tablets, their pack or this leaflet with you to show them to your doctor or pharmacist.
If you forget to take Moxistad
If you forget to take a tablet, you should take it as soon as you remember the same day. If you do not take the tablet within the day, take the usual dose (one tablet) the next day. Do not take a double dose to make up for the missed dose. If you are not sure what to do, talk to your doctor or pharmacist.
If you stop taking Moxistad
If you stop taking this medicine early, your infection may not be fully cured. Talk to your doctor if you want to stop treatment before the end of treatment.
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 everyone gets them.
The following side effects have been reported with Moxistad. The evaluation of adverse reactions is based on the following frequency data:
Common: may affect up to 1 in 10 patients
Infections caused by resistant bacteria or fungi, e.g. oral and vaginal infections caused by Candida
Change of heart rate (ECG) in patients with low levels of potassium in the blood
Gastric and abdominal pain
Elevation of certain liver enzymes in the blood (transaminases)
Uncommon: may affect up to 1 in 100 patients
Change in heart rhythm (ECG), palpitations, irregular heartbeat, severe heart rhythm disturbances, angina
Reduced red blood cell count (anemia) decrease white blood cell count
Reduced number of specialized white blood cells (neutrophils)
Decrease or increase of special blood cells required for blood clotting
Enhanced specialized white blood cells (eosinophils)
Delayed blood clotting Elevated blood lipids (fats)
Anxiety, anxiety / excitement
Tingling (needles) and / or stiffness
Changes in taste (in very rare cases loss of taste)
Confusion and disorientation
Impaired sleep (mostly insomnia)
Feeling dizzy (dizziness or loss of consciousness) drowsiness
Visual disturbance including double and blurred vision
Chest pain (tightness)
Expansion of blood vessels
Difficulty breathing, incl. asthmatic conditions
Loss of appetite
Gastric disorder (indigestion or heartburn)
Inflammation of the stomach
Elevated blood levels of certain enzymes responsible for digestion (amylase)
Impaired hepatic function (including elevation of certain liver enzymes in the blood LDH) Blood bilirubin increased, increased specific liver enzymes in the blood (gamma-glutamyltransferase and / or alkaline phosphatase)
Itching, rash, urticaria, dry skin
Joint pain, muscle pain
Total malaise (mostly weakness or fatigue) »back, chest, pelvic and extremity pain
Rare: may affect up to 1 in 1,000 patients
Severe, sudden generalized allergic reaction incl. very rarely life-threatening shock (eg difficulty in breathing, drop in blood pressure, accelerated heart beat), edema (including potentially life-threatening airway edema)
Severe diarrhea associated with blood and / or mucus (associated with antibiotic colitis, including pseudomembranous colitis), which very rarely can lead to life-threatening complications
Jaundice (yellowing of white eyes or skin), inflammation of the liver
Increased blood sugar
Increased blood uric acid
Depression (in very rare cases leading to self-harm, such as intentions / thoughts of suicide or attempted suicide)
How to Store Moxistad
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the blister and carton. The expiry date refers to the last day of that month.
Store in the original package in order to protect from moisture.
Do not dispose of medicines in the sewage system or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
6. Package Contents and Additional Information
What Moxistad contains
The active substance is moxifloxacin.
The other ingredients (excipients) are:
Tablet core: Microcrystalline cellulose, Povidone K 30, Croscarmellose sodium, Silica, colloidal anhydrous, Magnesium stearate.
Filming coating: Hypromellose, Propylene glycol, Titanium dioxide (E171), Talc, Iron oxide, red (E172).
What Moxistad looks like and what the package contains
Pink, oblong, biconvex tablets approximately 17.6 mm long and approximately 6.9 mm wide.
Blisters of PVC / PVDC / Al-foil
Pack sizes of 5, 7, 10, 25, 50 tablets.
Not all pack sizes may be marketed.