Avelox (Moxifloxacin) 400mg film-coated tablets
What Avelox tablets are and what they are used for
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Avelox contains moxifloxacin as the active ingredient which belongs to a group of antibiotics called fluoroquinolones. Avelox works by killing bacteria that cause infections.
Avelox is used in patients aged 18 years and above for treating the following bacterial infections when caused by bacteria against which moxifloxacin is active. Avelox should only be used to treat these infections when usual antibiotics cannot be used or have not worked:
- Infection of the sinuses, 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 upper genital tract (pelvic inflammatory disease), including infections of the fallopian tubes and infections of the uterus mucous membrane.
Avelox tablets are not sufficient on their own for treating this kind of infection. Therefore, another antibiotic in addition to Avelox tablets should be prescribed by your doctor for the treatment of infections of the female upper genital tract (see section Before taking Avelox tablets).
If the following bacterial infections have shown improvement during initial treatment with Avelox solution for infusion, Avelox tablets may also be prescribed by your doctor to complete the course of therapy: Infection of the lungs (pneumonia) acquired outside the hospital, infections of the skin and soft tissue. Avelox tablets should not be used to initiate therapy for any type of infections of the skin and soft tissue or in severe infections of the lungs.
Before you take Avelox tablets
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Contact your doctor if you are not sure if you belong to a patient group described below.
Do not take Avelox tablets
- If you are allergic (hypersensitive) to the active ingredient moxifloxacin, any other quinolone antibiotics or any of the other ingredients. The ingredients are listed in section 6 Further information.
- If you are pregnant or are breast-feeding.
- If you are under 18 years of age.
- If you have previously had problems with your tendons related to treatment with quinolone antibiotics
- (see section Take special care … and section 4 Possible side effects).
- If you were born with or have any condition with certain abnormal electrocardiogram (ECG, electrical recording of the heart) changes
- a salt imbalance in the blood, especially low concentrations of potassium in the blood (hypokalaemia) which are currently not corrected by treatment
- a very slow heart rate (bradycardia)
- a weak heart (heart failure)
- a history of abnormal heart rhythms (arrhythmias) or
- if you are taking other medicines that result in certain abnormal ECG changes (see section Taking other medicines). This is because Avelox can cause a certain change on the ECG
- If you have a severe liver disease or increased liver enzymes (transaminases) higher than 5 times the upper normal limit.
Before taking Avelox tablets
Avelox can change your heart’s ECG, especially if you are female or elderly. If you are taking any medicine that decreases your blood potassium levels talk to your doctor before taking Avelox. If you experience palpitations or an irregular heartbeat during treatment, you should tell your doctor immediately. He/she may wish to perform an ECG to measure your heart rhythm.
If you suffer from epilepsy or a condition which makes you likely to have convulsions talk to your doctor before taking Avelox.
If you have or have ever had any mental health problems, consult your doctor before taking Avelox.
If you suffer from myasthenia gravis (abnormal muscle fatigue leading to weakness and in serious cases paralysis), taking Avelox may worsen the symptoms of your disease. If you think you are affected consult your doctor immediately.
If you or any member of your family have glucose-6-phosphate dehydrogenase deficiency (a rare hereditary disease), tell your doctor, who will advise whether Avelox is suitable for you.
If you have a complicated infection of the female upper genital tract (e.g. associated with an abscess of the fallopian tubes and ovaries or of the pelvis), for which your doctor considers an intravenous treatment necessary, treatment with Avelox tablets is not appropriate.
For the treatment of mild to moderate infections of the female upper genital tract your doctor should prescribe another antibiotic in addition to Avelox. If there is no improvement in symptoms after 3 days of treatment, please consult your doctor.
When taking Avelox tablets
The risk of heart problems may increase with higher doses, therefore, you should keep to the prescribed dose.
There is a rare chance that you may experience a severe, sudden allergic reaction (an anaphylactic reaction/shock) even with the first dose. Symptoms include tightness in the chest, feeling dizzy, feeling sick or faint, or dizziness when standing up. If so, stop taking Avelox and seek medical advice immediately.
Avelox may cause a rapid and severe inflammation of the liver which could lead to life-threatening
liver failure (including fatal cases, see section 4 Possible side effects). If you suddenly feel unwell and/or are being sick and also have yellowing of the whites of the eyes, dark urine, itching of the skin,a tendency to bleed or liver induced disease of the brain (symptoms of a reduced liver function or arapid and severe inflammation of the liver) please contact your doctor before taking any more tablets.
If you develop a skin reaction or blistering / peeling of the skin and/or mucosal reactions (see section 4 Possible side effects) contact your doctor immediately before you continue treatment.
Quinolone antibiotics, including Avelox, may cause convulsions. If this happens, stop taking Avelox and contact your doctor immediately.
You may experience symptoms of neuropathy such as pain, burning, tingling, numbness and/or weakness. If this happens, inform your doctor immediately prior to continuing treatment with Avelox.
You may experience mental health problems even when taking quinolone antibiotics, including Avelox, for the first time. In very rare cases depression or mental health problems have led to suicidal thoughts and self-endangering behaviour such as suicide attempts (see section 4. Possible side effects). If you develop such reactions, stop taking Avelox and inform your doctor immediately.
You may develop diarrhoea whilst or after taking antibiotics including Avelox. If this becomes severe or persistent or you notice that your stool contains blood or mucus you should stop taking Avelox immediately and consult your doctor. You should not take medicines that stop or slow down bowel movement.
Avelox may occasionally cause pain and inflammation of your tendons, particularly if you are elderly or if you are also taking corticosteroids. At the first sign of any pain or inflammation you should stop taking Avelox, rest the affected limb and consult your doctor immediately. Avoid any unnecessary exercise, as this might increase the risk of a tendon rupture. Inflammation and ruptures of tendons may occur even up to several months after discontinuing Avelox therapy.
If you are elderly and have kidney problems make sure that you drink plenty whilst taking Avelox.
If you get dehydrated this may increase the risk of kidney failure.
If your eyesight becomes impaired or if your eyes seem to be affected whilst taking Avelox, consult an eye specialist immediately (see sections 2. Driving and using machines and 4. Possible side effects).
Quinolone antibiotics may make your skin become more sensitive to sunlight or UV light. You should avoid prolonged exposure to sunlight or strong sunlight and should not use a sunbed or any other UV lamp while taking Avelox.
Taking other medicines
Tell your doctor or pharmacist about any other medicines that you are taking or took recently. This includes medicines bought without a prescription.
For Avelox be aware of the following:
Do not take Avelox with the following medicines as there is an increased risk that your heartbeat may be altered:
- medicines that affect your heart rate or rhythm (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide)
- medicines used to treat severe mental disorders (e.g. phenothiazines, pimozide, sertindole, haloperidol, sultopride)
- tricyclic antidepressants
- other drugs used to treat infections (e.g. sparfloxacin, intravenous erythromycin, pentamidine, antimalarials particularly halofantrine)
- some antihistamines (e.g. terfenadine, astemizole, mizolastine)
- other medicines (e.g. cisapride, intravenous vincamine, bepridil and diphemanil).
- Any medicine containing magnesium or aluminium (such as antacids for indigestion), iron, zinc or didanosine
- or any medicine containing sucralfate (to treat stomach disorders) can reduce the action of Avelox tablets. Take your Avelox tablet 6 hours before or after taking the other medicine. Taking any medicine containing charcoal at the same time as Avelox tablets reduces the action of Avelox. It is recommended that these medicines are not used together.
If you are currently taking drugs to thin your blood (oral anti-coagulants such as warfarin), it may be necessary for your doctor to monitor your blood clotting time.
Taking Avelox tablets with food and drink
Avelox can be taken with or without food (including dairy products).
Pregnancy and breast-feeding
Do not take Avelox if you are pregnant or breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Avelox may make you feel dizzy or light-headed, you may experience a sudden, transient loss of vision, or you may faint for a short period. If you are affected do not drive or operate machinery.
Important information about some of the ingredients of Avelox tablets
Avelox tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, speak to your doctor before taking Avelox.
How to take Avelox tablets
When you buy cheap Moxifloxacin you must know how to use it
Always take Avelox exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure how to take Avelox.
The usual dose for adults is one 400mg film-coated tablet once daily.
Avelox tablets are for oral use. Swallow the tablet whole (to mask the bitter taste) and with plenty of liquid. You can take Avelox 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 you will take Avelox for depends on your infection. Unless your doctor tells you otherwise, your treatment will be as follows:
- for sudden worsening (acute exacerbation) of chronic bronchitis – 5-10 days
- for infection of the lungs (pneumonia) except for pneumonia which starts during a stay in hospital – 10 days
- for acute infection of the sinuses (acute bacterial sinusitis) – 7 days
Mild to moderate infections of the female upper genital tract (pelvic inflammatory disease), including infection of the fallopian tubes and infection of the uterus mucous membrane 14 days
It is important that you complete the course of treatment even if you begin to feel better after a few days. If you stop taking Avelox too soon your infection may not be completely cured and the infection may return or your condition may get worse. The bacteria causing your infection may become resistant to Avelox.
The recommended dose and duration of treatment should not be exceeded (see section Take special care).
If you take more Avelox tablets than you should
If you take more than the prescribed one tablet a day, get 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 Avelox tablets
If you forget to take your tablet you should take it as soon as you remember on the same day. If you do not remember on the same day, take your normal dose (one tablet) on the next day. Do not take a double dose to make up for a forgotten dose.
If you are unsure about what to do ask your doctor or pharmacist.
If you stop taking Avelox tablets
If you stop taking this medicine too soon your infection may not be completely cured. Talk to your doctor if you wish to stop taking your tablets before the end of the course of treatment.
If you have any further questions about Avelox, ask your doctor or pharmacist.
Possible side effects
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Like all medicines, Avelox can cause side effects, although not everybody gets them. The following side effects have been observed during treatment with Avelox.
Common side effects (between 1 and 10 in every 100 people are likely to get these):
- Infections caused by resistant bacteria or fungi, e.g. oral and vaginal infections caused by Candida (thrush)
- Headache
- Dizziness
- Changes in the electrical activity of the heart (ECG) in patients with less potassium in the blood
- Feeling sick (nausea)
- Being sick (vomiting)
- Stomach ache
- Diarrhoea
- Increase of a special liver enzyme in the blood (transaminases)
Uncommon side effects (between 1 and 10 in every 1000 people are likely to get these):
- Allergic reaction
- Changes in the electrical activity of the heart (ECG), palpitations, irregular and fast heartbeat, severe heart rhythm problems
- Low red blood cell count (anaemia)
- Low white blood cells count
- Low numbers of special white blood cells (neutrophils)
- Decrease or increase of special blood cells necessary for blood clotting
- Increased specialised white blood cells (eosinophils)
- Decreased blood clotting
- Increased blood lipids (fats)
- Feeling anxious, restless, or agitated
- Tingling sensation (pins and needles) and/or numbness
- Changes in taste (in very rare cases loss of taste)
- Feeling confused and disorientated
- Sleep problems (e.g. sleeplessness or sleepiness)
- Shaking
- Sensation of dizziness (spinning or falling over)
- Problems with vision (including double or blurred vision)
- Chest pain (angina)
- Widening of the blood vessels (flushing)
- Difficulty in breathing (including asthmatic conditions)
- Loss of appetite
- Wind and constipation
- Stomach upset (indigestion or heartburn)
- Inflammation of the stomach
- Increase of a special digestive enzyme in the blood (amylase)
- Problems with liver function (including increase of a special liver enzyme in the blood (LDH)), increase of bilirubin in the blood, increase of a special liver enzyme in the blood (gamma-glutamyl-transferase and/or alkaline phosphatase)
- Itching, rash, skin hives, dry skin
- Joint pain, muscle pain
- Dehydration
- Feeling unwell (usually weakness or tiredness), aches and pains such as back, chest, pelvic pains and pains in the extremities
- Sweating.
- Rare side effects (between 1 and 10 in every 10,000 people are likely to get these):
- Severe, sudden allergic reaction including very rarely life-threatening shock (e.g. difficulty in breathing, drop of blood pressure, fast pulse), swelling (including potentially life-threatening swelling of the airway)
- Severe diarrhoea containing blood and/or mucus (antibiotic associated colitis including pseudomembranous colitis), which very rarely, may develop into complications that are life-threatening
- Jaundice (yellowing of the whites of the eyes or skin), inflammation of the liver
- Pain and swelling of the tendons (tendonitis)
- Increased blood sugar
- Increased blood uric acid
- Feeling particularly emotional
- Depression (which in very rare cases may lead to self-harm, such as suicidal ideations/thoughts, or suicide attempts)
- Hallucination
- Problems with skin sensations
- Changes in smell (including loss of smell)
- Unusual dreams
- Problems with balance and co-ordination (due to dizziness)
- Convulsions
- Disturbed concentration
- Problems with speech
- Partial or total loss of memory
- Ringing or noise in the ears, hearing impairment including deafness (usually reversible)
- Faster heart rate than normal
- Fainting
- High or low blood pressure
- Difficulty in swallowing
- Inflammation of the mouth
- Muscle cramps or twitching
- Muscle weakness
- Kidney problems (including an increase in special kidney laboratory test results like urea and creatinine), kidney failure
- Swelling (of the hands, feet, ankles, lips, mouth or throat).
Very rare side effects (between 1 and 10 in every 100,000 people are likely to get these):
- Abnormal heart rhythms, irregular heartbeat (Torsade de Pointes), stopping of heart (cardiac arrest) (see section 2 Before you take Avelox)
- Severe inflammation of the liver potentially leading to life-threatening liver failure (including fatal cases)
- Changes to the skin and mucous membranes (painful blisters in the mouth/nose or at the penis/vagina), potentially life-threatening (Stevens-Johnson-Syndrome, toxic epidermal necrolysis)
- Rupture of tendons
- Increased blood clotting, significant decrease of special white blood cells (agranulocytosis)
- A feeling of self-detachment (not being yourself)
- Feeling mentally unwell (potentially leading to self-harm, such as suicidal ideations/thoughts, or suicide attempts)
- Transient loss of vision
- Skin feeling more sensitive
- Inflammation of joints
- Muscles feeling stiff
- Worsening of the symptoms of myasthenia gravis (abnormal muscle fatigue leading to weakness and in serious cases paralysis)
- Also, there have been very rare cases of the following side effects reported following treatment with other quinolone antibiotics, which might possibly also occur during treatment with Avelox:
- Increased blood sodium levels
- Increased blood calcium levels
- A special type of reduced red blood cell count (haemolytic anaemia)
- Muscle reactions with muscle cell damage
- Increased sensitivity of the skin to sunlight or UV light.
- Troubles associated with the nervous system such as pain, burning, tingling, numbness and/or weakness in extremities
If you feel you are suffering from a side effect, especially if any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist immediately to get advice before taking the next dose.
How to store Avelox tablets
Before purchase Moxifloxacin, you must read how to store
Keep out of the reach and sight of children.
Do not use Avelox tablets after the expiry date stated on the blister and carton.
Do not store above 25°C.
Store in the original package in order to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Further information
What Avelox tablets contain
The active substance is moxifioxacin. Each film-coated tablet contains 400mg moxifloxacin as hydrochloride.
The other ingredients are:
Tablet core: Microcrystalline cellulose, Croscarmellose sodium, Lactose monohydrate and Magnesiu stearate.
Film coating: Hypromellose, Macrogol 4000, Ferric oxide (El72) and Titanium dioxide (El71).
What Avelox tablets look like and contents of the pack
Each dull red, film-coated tablet is marked with “M400” on one side and “BAYER” on the reverse.
Avelox tablets are packaged in cartons containing colourless or white opaque polypropylene/aluminium blisters.
They are available in commercial packs of 5, 7, and 10 film-coated tablets and in hospital packs of 25, 50,70, 80, or 100 film-coated tablets.
Aluminium/aluminium blisters, sample pack of 1 film-coated tablet in a carton.
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| Dosage forms of Moxifloxacin: | |||
|---|---|---|---|
| Avelox abc pack 400 mg tablet | Avelox 400 mg tablet | Vigamox 0.5% eye drops | Vigamox 0.5% Solution 3ml Bottle |
| Avelox iv 400 mg/250 ml | |||
Synonyms of Moxifloxacin:
BAY 12-8039, Moxifloxacin, Moxifloxacin HCl, Moxifloxacin Hydrochloride
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Therapeutic classes of Moxifloxacin:
Anti-Bacterial Agents, Anti-Infective Agents, Quinolones
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