Moxistad 400 mg. 5 tablets
Moxistad contains the active substance moxifloxacin, which belongs to the group of antibiotics called fluoroquinolones. Moxostat acts by killing bacteria causing infections.
Moxostat 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.
Moxostat 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
Moxostat 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
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 Moxostat 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 are breast-feeding, think you may be pregnant or plan to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Animal studies do not indicate that your fertility will be reduced by using this medicine.
Driving and using machines
Moxista may make you feel dizzy and dizzy, may suddenly, temporarily lose sight, or you may lose consciousness for a short time. If you have such complaints, do not drive or operate machinery.
3. How to take Moxistad
Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose for adults is one film-coated tablet 400 mg once a day. Moxostat tablets are for oral use. The tablet is taken whole (to mask the bitter taste) with a lot of fluid. You may take Moxistad with and without food. It is recommended that you take the tablets at the same time each day.
No dose adjustment is necessary in elderly patients, low-body patients, or patients with kidney problems.
The duration of treatment depends on the type of infection. Unless otherwise prescribed by your doctor, Moxistad should be taken with the following duration:
Sudden worsening of chronic bronchitis (exacerbation of chronic bronchitis) 5-10 days
Infection of the lungs (pneumonia) acquired outside the hospital except for severe cases 10 days
Acute sinus infection (acute bacterial sinusitis) 7 days
Mild to moderate sexually transmitted infections (pelvic inflammatory disease), including infections of the fallopian tube and the lining of the uterus 14 days
Infections of the skin and skin structures 7-21 days
When Moxostat 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 and skin infections undergo oral treatment with Moxostat film-coated tablets
Disturbed balance and poor coordination (due to dizziness)
Partial or complete memory loss
Ringing or ringing in the ears, hearing impairment, including deafness (usually reversible)
Abnormally fast heartbeat
Loss of consciousness
High blood pressure, low blood pressure
Inflammation of the mouth
Muscle cramps or muscle cramps Pain and swelling of tendons (tendinitis)
Kidney damage (including increased levels of special laboratory tests such as urea and creatinine), kidney failure such as pain, burning, tingling, numbness and / or weakness in the limbs
Very rare: may affect up to 1 in 10,000 patients
Abnormal heart rhythm, life-threatening cardiac arrest, heart failure (cardiac arrest) (see section 2. What you need to know before you take Moxistad)
Fully inflammatory liver inflammation potentially leading to life-threatening liver failure (including fatal cases)
Changes in the skin and mucous membranes (painful blisters in the mouth / nose or in the penis / vagina), potentially life-threatening (Stevens-Johnson syndrome, toxic epidermal necrolysis)
Inflammation of the blood vessels (signs may be red spots on the skin, usually in the lower leg or painful joint effect).
Increased blood clotting, significant decrease in the number of certain blood cells (agranulocytosis)
A sense of separation from yourself (not yourself)
Madness (potentially leading to self-harm, such as intentions / thoughts of suicide or attempted suicide)
Transient loss of vision
More sensitive skin
Worsening of the symptoms of myasthenia gravis (abnormal muscle fatigue leading to muscle weakness and cases of paralysis)
In addition, there have been very rare instances of the following effects in treatment with other hypolipidemic antibiotics that may also occur with Moxistad:
increased levels of sodium in the blood
increased levels of calcium in the blood
a special type of red blood cell count (hemolytic anemia)
muscle reactions with muscle cell damage, increased skin sensitivity to sunlight or UV rays.
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.