Due to regulatory changes, the content of the following Patient Information Leaflet may vary from the one found in your medicine pack. Please compare the 'Leaflet prepared/revised date' towards the end of the leaflet to establish if there have been any changes.
If you have any doubts or queries about your medication, please contact your doctor or pharmacist.
Avelox 400mg/250ml solution for infusion
Active ingredient: Moxifloxacin
Read all of this leaflet carefully before you start using this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
- 1. What Avelox is and what it is used for
- 2. Before you use Avelox
- 3. How to use Avelox
- 4. Possible side effects
- 5. How to store Avelox
- 6. Further information
What Avelox Is And What It Is Used For
Avelox contains moxifloxacin as the active ingredient which belongs to a group of antibiotics called fluoroquinolones. Avelox works by killing bacteria that cause infections if they are caused by bacteria that are susceptible to moxifloxacin.
Avelox is used in adults for treating the following bacterial infections:
- Infection of the lungs (pneumonia) acquired outside the hospital
- Infections of the skin and soft tissue
Before You Use Avelox
Contact your doctor if you are not sure if you belong to a patient group described below.
Do not use Avelox
- If you are allergic (hypersensitive) to the active ingredient moxifloxacin, any other quinolone antibiotics or any of the other ingredients (see section 6. Further information) of Avelox.
- If you are pregnant or breast-feeding.
- If you are a child or an adolescent still growing.
- If you have a history of tendon disease or disorder which was related to treatment with quinolone antibiotics (see sections Take special care ... and 4. Possible side effects).
- If you were born with or have had any condition with certain abnormal electrocardiogram (ECG, electrical recording of the heart) changes.
- If you have salt imbalance in the blood, especially low concentrations of potassium in the blood (hypokalaemia) which are currently not corrected by treatment.
- If you have a very slow heart rate (bradycardia).
- If you have a weak heart (heart failure).
- If you have a history of abnormal heart rhythms (arrhythmias).
- If you are taking other medicines that result in certain abnormal ECG changes (see section Taking other medicines).
- If you have a severe liver disease or liver enzymes (transaminases) that are higher than 5 times the upper normal limit.
Take special care with Avelox
Before using Avelox for the first time
- Avelox can temporarily change your heart’s ECG, which can very rarely lead to life-threatening disturbances of the heart rhythm. If you are female or elderly, you may be more sensitive to ECG changes. If the blood supply to your heart muscle is impaired, consult your doctor before you are given Avelox because this can increase the risk of heart rhythm disturbances.
- If you are currently taking any medicine that decreases your blood potassium levels, consult your doctor before taking Avelox because this can increase the risk of heart rhythm disturbances.
- If you experience palpitations or irregular heart beat during the period of treatment, you should stop taking Avelox and inform your doctor immediately.
- If you suffer from epilepsy or a condition which makes you likely to have convulsions, tell your doctor before taking Avelox.
- If you suffer from myasthenia gravis using 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), inform your doctor, who will advise whether Avelox is suitable for you.
When using Avelox
- The risk of cardiac abnormalities may increase with the dose and the speed of the infusion into your vein.
- Avelox should be given intravenously (in the vein) only, and should not be administered into an artery.
- There is a rare chance that you may experience a severe, sudden allergic reaction (an anaphylactic reaction/shock) even with the first dose, with symptoms that may include tightness in the chest, feeling dizzy, feeling sick or faint, or experience dizziness on standing. If this happens treatment with Avelox solution for infusion has to be discontinued 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). Please contact your doctor before you continue the treatment if you suddenly start to feel unwell or notice yellowing of the whites of the eyes, dark urine, itching of the skin, a tendency to bleed or disturbances of thought or wakefulness.
- If you develop a skin reaction or blistering and/or peeling of the skin and/or mucosal reactions (see section 4. Possible side effects) contact your doctor immediately before you continue the treatment.
- You may develop diarrhoea whilst taking, 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. In this situation, you should not take medicines that stop or slow down bowel movement.
- If you are elderly with existing kidney problems take care that your fluid intake is sufficient because dehydration may increase the risk of kidney failure
- Avelox may occasionally cause pain and inflammation of your tendons, particularly if you are elderly or if you are currently being treated with corticosteroids. At the first sign of any pain or inflammation you should stop taking Avelox, rest the affected limb and consult your doctor immediately.
- If your eyesight becomes impaired or if you have any other eye disturbances whilst taking Avelox, consult an eye specialist immediately.
- 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.
- There is limited experience on use of sequential intravenous/oral Avelox for the treatment of infection of the lungs (pneumonia) acquired outside the hospital.
- The efficacy of Avelox in the treatment of severe burns, infections of deep tissue, major purulent ulcers (abscesses) and diabetic foot infections with osteomyelitis (infections of the bone marrow) has not been established.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines besides Avelox, including medicines obtained without a prescription.
For Avelox be aware of the following:
- If you are taking other medicines that affect your heart during treatment with Avelox there is an increased risk for altering your heart rhythm. Therefore, do not take the following medicines during treatment with Avelox: Medicines that belong to the group of anti-arrhythmics (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), neuroleptics (e.g. phenothiazines, pimozide, sertindole, haloperidol, sultopride), tricyclic antidepressants, some antimicrobials (e.g. sparfloxacin, intravenous erythromycin, pentamidine, antimalarials particularly halofantrine), some antihistamines (e.g. terfenadine, astemizole, mizolastine), and other medicines (e.g. cisapride, intravenous vincamine, bepridil and diphemanil).
- Special care is needed if you are taking other medicines that can lower your blood potassium levels or cause a slow heart rate because these can also increase the risk of serious heart rhythm disturbances while taking Avelox.
- If you are currently taking oral anti-coagulants (e.g. warfarin), it may be necessary for your doctor to monitor your blood clotting times.
Using Avelox with food and drink
The effect of Avelox is not influenced by 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 or you might faint for a short period. If you are affected in this way do not drive or operate machinery.
Important information about some of the ingredients of Avelox
This medicinal product contains 787mg (approximately 34mmol) sodium per dose. If you are on a controlled-salt diet, please inform your doctor immediately.
How To Use Avelox
Avelox will always be given to you by a doctor or healthcare professional.
The usual dose for adults is one bottle bag once daily.
Avelox is for intravenous use. Your doctor should ensure that the infusion is given at a constant flow over 60 minutes.
No adjustment of the dose is required in elderly patients, patients with a low bodyweight or in patients with kidney problems.
Your doctor will decide on the duration of your treatment with Avelox. In some cases your doctor may start your treatment with Avelox solution for infusion and then continue your treatment with Avelox tablets.
The duration of treatment depends upon the type of infection, and how well you respond to treatment but the recommended durations of use are:
- Infection of the lungs (pneumonia) acquired outside the hospital 7 - 14 days
Most patients with pneumonia were switched to oral treatment with Avelox tablets within 4 days.
- Infections of the skin and soft tissue 7 - 21 days
For patients with complicated skin and skin structure infections the mean duration of intravenous treatment was approximately 6 days and the average overall duration of treatment (infusion followed by tablets) was 13 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 this medicine too soon your infection may not be completely cured, the infection may return or your condition may get worse, and you may also create a bacterial resistance to the antibiotic.
The recommended dose and duration of treatment should not be exceeded (see section 2. Before you use Avelox..., Take special care ...).
If you receive more Avelox than you should
If you are concerned that you may have received too much Avelox, contact your doctor immediately.
If you miss a dose of Avelox
If you are concerned that you may have missed a dose of Avelox, contact your doctor immediately.
If you stop using Avelox
If the treatment with this medicine is stopped too soon your infection may not be completely cured. Consult your doctor if you wish to stop the treatment with Avelox solution for infusion or Avelox tablets before the end of the course of treatment.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible Side Effects
Like all medicines, Avelox can cause side effects, although not everybody gets them.
The following side effects have been observed during treatment with Avelox. The frequency of possible side effects listed below is defined using the following convention:
Very common: affects more than 1 user in 10
Common: affects 1 to 10 users in 100
Uncommon: affects 1 to 10 users in 1,000
Rare: affects 1 to 10 users in 10,000
Very rare: affects less than 1 user in 10,000
Not known: frequency cannot be estimated from the available data
Infections
Common: Infections caused by resistant bacteria or fungi e.g. oral and vaginal infections caused by Candida
Blood and Lymph System
Uncommon: Low red blood cell count, 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
Very rare: Increased blood clotting
Allergic Reactions
Uncommon: Allergic reaction
Rare: Severe, sudden generalised allergic reaction incl. very rarely life-threatening shock (e.g. difficulty in breathing, drop of blood pressure, fast pulse), swelling (incl. potentially life-threatening swelling of the airway)
Changes in Laboratory Test Results
Uncommon: Increased blood lipids (fats)
Rare: Increased blood sugar, increased blood uric acid
Psychiatric Effects
Uncommon: Anxiety, restlessness/agitation
Rare: Emotional instability, depression (in very rare cases leading to self-harm), hallucination
Very rare: A feeling of self-detachment (not being yourself), insanity (potentially leading to self-harm)
Nervous System
Common: Headache, dizziness
Uncommon: Tingling sensation (pins and needles) and/or numbness, changes in taste (in very rare cases loss of taste), confusion and disorientation, sleep problems (predominantly sleeplessness), shaking, sensation of dizziness (spinning or falling over), sleepiness
Rare: Impairment of skin sensation, changes in smell (incl. loss of smell), abnormal dreams, balance disorder and poor co-ordination (due to dizziness), convulsions, disturbed concentration, impaired speech, partial or total loss of memory
Very rare: Increase of skin sensitivity
Eye
Uncommon: Visual disturbances incl. double and blurred vision
Ear
Rare: Ringing/noise in the ears
Cardiovascular System
Common: Distinct alteration of the electrical activity of the heart (ECG) in patients with decreased blood potassium
Uncommon: Distinct alteration of the electrical activity of the heart (ECG), palpitations, irregular and fast heart beat, severe cardiac rhythm abnormalities, angina pectoris, flushing
Rare: Abnormal fast heart rate, fainting, high blood pressure, low blood pressure
Very rare: Unspecific abnormal heart rhythms, irregular heart beat (Torsade de Pointes), stopping of heart beat (see section 2. Before you use Avelox....)
Respiratory System
Uncommon: Difficulty in breathing incl. asthmatic conditions
Gastrointestinal System
Common: Nausea, vomiting, stomach and abdominal ache, diarrhoea
Uncommon: Loss of appetite, wind and constipation, stomach upset (indigestion/heartburn), inflammation of the stomach, increase of a special digestive enzyme in the blood (amylase)
Rare: Difficulty in swallowing, inflammation of the mouth, severe diarrhoea containing blood and/or mucus (antibiotic associated colitis incl. pseudomembranous colitis), which in very rare circumstances, may develop into complications that are life-threatening
Liver
Common: Increase of a special liver enzyme in the blood (transaminases)
Uncommon: Impaired liver function (incl. 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)
Rare: Jaundice (yellowing of the whites of the eyes or skin), inflammation of the liver
Very rare: Fulminant inflammation of the liver potentially leading to life-threatening liver failure (incl. fatal cases)
Skin
Uncommon: Itching, rash, skin hives, dry skin
Very rare: Alterations of 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)
Muscular and Joint System
Uncommon: Joint pain, muscle pain
Rare: Pain and swelling of the tendons (tendonitis), muscle cramp, muscle twitching
Very rare: Rupture of tendon, inflammation of joints, muscle rigidity, worsening of the symptoms of myasthenia gravis
Kidney
Uncommon: Dehydration
Rare: Kidney impairment (incl. increase in special kidney laboratory test results like urea and creatinine), kidney failure
General Side Effects
Uncommon: Feeling unwell (predominantly weakness or tiredness), aches and pains such as back, chest, pelvic and extremities pains, sweating
Rare: Swelling (of the hands, feet, ankles, lips, mouth, throat)
Infusion site
Common: Pain or inflammation at injection site
Uncommon: Inflammation of a vein
The following symptoms have been observed more frequently in patients treated intravenously:
Common: Increase of a special liver enzyme in the blood (gamma-glutamyl-transferase)
Uncommon: Abnormal fast heart rate, low blood pressure, swelling (of the hands, feet, ankles, lips, mouth, throat), severe diarrhoea containing blood and/or mucus (antibiotic associated colitis) which in very rare circumstances, may develop into complications that are life-threatening, convulsions, hallucination, kidney impairment (incl. increase in special kidney laboratory test results like urea and creatinine), kidney failure
Furthermore, 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: transient loss of vision, increased blood sodium levels, increased blood calcium levels, increased breakdown of red blood cells, muscle reactions with muscle cell damage, increased sensitivity of the skin to sunlight or UV light.
If you feel you are suffering from a side effect, especially if any of the side effects gets 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
Keep out of the reach and sight of children.
Do not use Avelox after the expiry date which is stated on the label on the bottle bag and carton.
Do not refrigerate or freeze.
Use immediately after first opening and/or dilution.
This product is for single use only. Any unused solution should be discarded.
At cool storage temperatures precipitation may occur, which will re-dissolve at room temperature.
Do not use if you notice any visible particulate matter or if the solution is cloudy.
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 contains
- The active substance is moxifloxacin. Each bottle bag contains 400mg moxifloxacin (as hydrochloride). 1 ml contains 1.6 mg moxifloxacin (as hydrochloride).
- The other ingredients are sodium chloride, hydrochloric acid (for pH-adjustment), sodium hydroxide (for pH-adjustment) and water for injections
What Avelox looks like and contents of the pack
Avelox is a clear, yellow solution for infusion.
Avelox is packaged in cartons containing a 250ml glass bottle with a chlorobutyl rubber stopper. Packs of 1 and 5 bottles.
Avelox is packaged in cartons containing 250ml polyolefine bags with polypropylene port sealed in aluminium foil overwrap. Packs of 5 and 12 bags.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing authorisation holder:
Berkshire
Manufacturer:
This medicinal product is authorised in the Member States of the EEA under the following names:
Austria: Avelox
Belgium: Avelox
Cyprus: Avelox
Czech Republic: Avelox
Denmark: Avelox
Estonia: Avelox
Finland: Avelox
France: Izilox
Germany: Avalox
Greece: Avelox
Hungary: Avelox
Ireland: Avelox
Italy: Avalox
Latvia: Avelox
Lithuania: Avelox
Luxembourg: Avelox
Malta: Avalox
The Netherlands: Avelox
Poland: Avelox
Portugal: Avelox
Slovak Republic: Avelox
Slovenia: Avelox
Spain: Muzolil
Sweden: Avelox
United Kingdom: Avelox
This leaflet was last approved in November 2009.
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