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.
3. How to use Avelox
Avelox will always be given to you by a doctor or healthcare professional.
The recommended dose for adults is one bottle 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 using 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. What you need to know before you are administered Avelox, Warnings and precautions).
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 medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine 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:
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
Very rare: may affect up to 1 in 10,000 people
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, significant decrease of special white blood cells (agranulocytosis)
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
Uncommon: Anxiety, restlessness/agitation
Rare: Emotional instability, depression (in very rare cases leading to self-harm, such as suicidal ideations/thoughts, or suicide attempts), hallucination
Very rare: A feeling of self-detachment (not being yourself), insanity (potentially leading to self-harm, such as suicidal ideations/thoughts, or suicide attempts)
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, troubles associated with the nervous system such as pain, burning, tingling, numbness and/or weakness in extremities
Very rare: Increase of skin sensitivity
Uncommon: Visual disturbances incl. double and blurred vision
Very rare: Transient loss of vision
Rare: Ringing/noise in the ears, hearing impairment including deafness (usually reversible)
Cardiac System (see section 2. What you need to know before you are administered Avelox)
Common: Change of the heart rhythm (ECG) in patients with low blood potassium level
Uncommon: Change of the heart rhythm (ECG), palpitations, irregular and fast heart beat, severe heart rhythm abnormalities, angina pectoris
Rare: Abnormal fast heart rhythm, fainting
Very rare: Abnormal heart rhythms, life-threatening irregular heart beat, stopping of heart beat
Uncommon: Widening of blood vessels
Rare: High blood pressure, low blood pressure
Uncommon: Difficulty in breathing incl. asthmatic conditions
Common: Nausea, vomiting, stomach and abdominal ache, diarrhoea
Uncommon: Decreased appetite and food intake, 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
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
Very rare: Fulminant inflammation of the liver potentially leading to life-threatening liver failure (incl. fatal cases)
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, muscle weakness
Very rare: Rupture of tendon, inflammation of joints, muscle rigidity, worsening of the symptoms of myasthenia gravis
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)
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 rhythm, 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: 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.
If you get any side effects, talk to your doctor, pharmacist or nurse immediately to get advice before receiving the next dose. This includes any side effects not listed in this leaflet.