Avalox contains the active substance moxifloxacin which belongs to a group
of antibiotics called fluoroquinolones. Avalox works by killing bacteria
that cause infections if they are caused by bacteria that are susceptible to
moxifloxacin.
Avalox 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

Contact your doctor if you are not sure if you belong to a patient group
described below.
Do not use Avalox
▸ If you are allergic to the active substance moxifloxacin, any other
quinolone antibiotics or 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 a history of tendon disease or disorder which was related
to treatment with quinolone antibiotics (see sections Warnings and
precautions and 4. Possible side effects).
▸ If you were born with or have had any condition with abnormal heart
rhythm (seen on ECG, electrical recording of the heart), have salt
imbalance in the blood (especially low level of potassium or magnesium
in the blood), have a very slow heart rhythm (called ‘bradycardia’), have
a weak heart (heart failure), have a history of abnormal heart rhythms,
or you are taking other medicines that result in abnormal ECG changes
(see section Other medicines and Avalox). This is because Avalox can
cause changes on the ECG, that is a prolongation of the QT-interval i.e.
delayed conduction of electrical signals.
▸ If you have a severe liver disease or liver enzymes (transaminases) that
are higher than 5 times the upper normal limit.
Warnings and precautions
Before taking this medicine
You should not take fluoroquinolone/quinolone antibacterial medicines,
including Avalox, if you have experienced any serious adverse reaction in
the past when taking a quinolone or fluoroquinolone. In this situation, you
should inform your doctor as soon as possible.
Talk to your doctor before Avalox is administered for the first time
Avalox can change your heart’s ECG, especially if you are female, or if you
are elderly. If you are currently taking any medicine that decreases your
blood potassium levels, consult your doctor before Avalox is administered
(see also sections Do not use Avalox and Other medicines and Avalox).
▸ If you have ever developed a severe skin rash or skin peeling, blistering
and/or mouth sores after taking moxifloxacin.
▸ If you suffer from epilepsy or a condition which makes you likely to have
convulsions, tell your doctor before Avalox is administered.
▸If you have or have ever had any mental health problems, consult your
doctor before Avalox is administered.
▸ If you suffer from myasthenia gravis using Avalox may worsen the
symptoms of your disease. If you think you are affected consult your doctor
immediately.
▸ If you have been diagnosed with an enlargement or “bulge” of a large
blood vessel (aortic aneurysm or large vessel peripheral aneurysm).
v If you have experienced a previous episode of aortic dissection (a tear in
the aorta wall).
v If you have been diagnosed with leaking heart valves (heart valve
regurgitation).
v If you have a family history of aortic aneurysm or aortic dissection
or congenital heart valve disease, or other risk factors or predisposing
conditions (e.g. connective tissue disorders such as Marfan syndrome
or Ehlers-Danlos syndrome, Turner syndrome, Sjögren’s syndrome [an
inflammatory autoimmune disease], or vascular disorders such as Takayasu
arteritis, giant cell arteritis, Behçet's disease, high blood pressure, or known
atherosclerosis, rheumatoid arthritis [a disease of the joints] or endocarditis
[an infection of the heart]).
▸ If you are diabetic because you may experience a risk of change in blood
sugar levels with moxifloxacin.
▸ 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 Avalox is suitable for you.
▸ Avalox should be given intravenously (in the vein) only, and should not be
administered into an artery.
When using Avalox
▸ If you experience palpitations or irregular heart beat during the
period of treatment, you should inform your doctor immediately. He/she
may wish to perform an ECG to measure your heart rhythm.
▸ The risk of heart problems may increase with increase of the dose and
the speed of the perfusion into your vein.
▸ 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 Avalox solution for infusion has to be
discontinued immediately.
▸ Avalox 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.
▸Serious skin reactions
Serious skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis,
and acute generalised exanthematous
pustulosis (AGEP) have been reported with the use of moxifloxacin.
o SJS/TEN can appear initially as reddish targetlike spots or circular patches often with
central blisters on the trunk. Also, ulcers of
mouth, throat, nose, genitals and eyes (red and swollen eyes) can occur. These serious
skin rashes are often preceded by fever
and/or flu-like symptoms. The rashes may progress to widespread peeling of the skin
and life-threatening complications or be fatal.
o AGEP appears at the initiation of treatment as a red, scaly widespread rash with bumps
under the skin and blisters accompanied by
fever. The most common location: mainly localized on the skin folds, trunk, and upper
extremities.
If you develop a serious rash or another of these skin symptoms, stop taking moxifloxacin
and contact your doctor or seek medical attention immediately..
▸ Quinolone antibiotics, including Avalox, may cause convulsions. If this
happens, treatment with Avalox has to be discontinued.
▸ Prolonged, disabling and potentially irreversible serious side
effects. Fluoroquinolone/quinolone antibacterial medicines, including
Avalox, have been associated with very rare but serious side effects,
some of them being long lasting (continuing months or years), disabling
or potentially irreversible. This includes tendon, muscle and joint pain
of the upper and lower limbs, difficulty in walking, abnormal sensations
such as pins and needles, tingling, tickling, numbness or burning
(paraesthesia), sensory disorders including impairment of vision, taste
and smell, and hearing, depression, memory impairment, severe fatigue,
and severe sleep disorders.
If you experience any of these side effects after taking Avalox, contact
your doctor immediately prior to continuing treatment. You and your
doctor will decide on continuing the treatment considering also an
antibiotic from another class.
▸ You may rarely experience symptoms of nerve damage (neuropathy)
such as pain, burning, tingling, numbness and/or weakness especially
in the feet and legs or hands and arms. If this happens, stop taking
Avalox and inform your doctor immediately in order to prevent the
development of potentially irreversible condition.
▸ You may experience mental health problems even when taking
quinolone antibiotics, including Avalox, for the first time. In very
rare cases depression or mental health problems have led to suicidal
thoughts and self-injurious behaviour such as suicide attempts (see

section 4. Possible side effects). If you develop such reactions, treatment
with Avalox has to be discontinued.
▸ You may develop diarrhoea whilst taking, or after taking, antibiotics
including Avalox. If this becomes severe or persistent or you notice
that your stool contains blood or mucus you should stop using Avalox
immediately and consult your doctor. In this situation, you should not
take medicines that stop or slow down bowel movement.
▸ Pain and swelling in the joints and inflammation or rupture of
tendons may occur rarely (see sections Do not use Avalox and 4.
Possible side effects). Your risk is increased if you are elderly (above 60
years of age), have received an organ transplant, have kidney problems
or if you are being treated with corticosteroids. Inflammation and
ruptures of tendons may occur within the first 48 hours of treatment
and even up to several months after stopping of Avalox therapy. At
the first sign of pain or inflammation of a tendon (for example in your
ankle, wrist, elbow, shoulder or knee), stop taking Avalox, contact your
doctor and rest the painful area. Avoid any unnecessary exercise as this
might increase the risk of a tendon rupture.
▸If you feel sudden, severe pain in your abdomen, chest or back, which can be
symptoms of aortic aneurysm and dissection,
go immediately to an emergency room. Your risk may be increased if you are being treated
with systemic corticosteroids.

▸If you start experiencing a rapid onset of shortness of breath, especially when you lie
down flat in your bed, or you notice swelling of your ankles, feet or abdomen, or a new
onset of heart palpitations (sensation of rapid or irregular heartbeat), you should inform a
doctor immediately.
▸ 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.
▸ If your eyesight becomes impaired or if your eyes seem to be otherwise
affected, consult an eye specialist immediately (see sections Driving and
using machines and 4. Possible side effects).
▸ Fluoroquinolone antibiotics may cause an increase of your blood sugar levels above
normal levels (hyperglycemia), or lowering of your blood sugar levels below normal levels
(hypoglycaemia), potentially leading to loss of consciousness (hypoglycaemic coma) in
severe cases (see section 4. Possible side effects). If you suffer from diabetes, your
blood sugar should be carefully monitoredcarefully monitored (see section 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 using Avalox.
▸ There is limited experience on use of sequential intravenous/oral Avalox
for the treatment of infection of the lungs (pneumonia) acquired outside
the hospital.
▸ The efficacy of Avalox in the treatment of severe burns, infections of
deep tissue and diabetic foot infections with osteomyelitis (infections of
the bone marrow) has not been established.
Children and adolescents
This medicine must not be administered to children and adolescents under
the age of 18 because efficacy and safety have not been established for this
age group (see section Do not use Avalox).
Other medicines and Avalox
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines besides Avalox.
For Avalox, be aware of the following:
▸ If you are using Avalox and other medicines that affect your heart
there is an increased risk for altering your heart rhythm. Therefore, do
not use Avalox together with the following medicines: Medicines that
belong to the group of anti-arrhythmics (e.g. quinidine, hydroquinidine,
disopyramide, amiodarone, sotalol, dofetilide, ibutilide), antipsychotics
(e.g. phenothiazines, pimozide, sertindole, haloperidol, sultopride),
tricyclic antidepressants, some antimicrobials (e.g. saquinavir,
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).
▸ You must tell your doctor if you are taking other medicines that can
lower your blood potassium levels (e.g. some diuretics, some laxatives
and enemas [large doses] or corticosteroids [anti-inflammatory drugs],
amphotericin B) or cause a slow heart rate because these can also

increase the risk of serious heart rhythm disturbances while using
Avalox.
▸ If you are currently taking oral anti-coagulants (e.g. warfarin), it may be
necessary for your doctor to monitor your blood clotting times.
Avalox with food and drink
The effect of Avalox is not influenced by food including dairy products.
Pregnancy, breast-feeding and fertility
Do not use Avalox if you are pregnant or breast-feeding.
If you are pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby, ask your doctor or pharmacist for advice before
using this medicine.
Animal studies do not indicate that your fertility will be impaired by using
this medicine.
Driving and using machines
Avalox may make you feel dizzy or light-headed, you may experience a
sudden, transient loss of vision, or you might faint for a short period. If you
are affected in this way do not drive or operate machinery.
Avalox contains sodium
This medicine contains 787 milligrams (approximately 34 millimoles)
sodium (main component of cooking/table salt) in each bottle with
250 milliliter solution for infusion. This is equivalent to 39.35% of the
recommended maximum daily dietary intake of sodium for an adult.

Avalox will always be given to you by a doctor or healthcare professional.
The recommended dose for adults is one bottle once daily.
Avalox 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 Avalox. In
some cases your doctor may start your treatment with Avalox solution for
infusion and then continue your treatment with Avalox 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
Avalox 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 Avalox,
Warnings and precautions).
If you receive more Avalox than you should
If you are concerned that you may have been received too much Avalox,
contact your doctor immediately.
If you miss a dose of Avalox
If you are concerned that you may have missed a dose of Avalox, contact
your doctor immediately.
If you stop using Avalox
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 Avalox solution for infusion or Avalox 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.

Like all medicines, this medicine can cause side effects, although not everybody
gets them.
The most serious side effects observed during the treatment with Avalox are
listed below:
If you notice
▸ an abnormal fast heart rhythm (rare side effect)
▸ that you suddenly start feeling 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 (these can be signs and symptoms of fulminant
inflammation of the liver potentially leading to life-threating liver failure
(very rare side effect, fatal cases have been observed))
▸ serious skin rashes including Stevens-Johnson syndrome and toxic
epidermal necrolysis. These can appear as reddish target-like macules or
circular patches often with central blisters on the trunk, skin peeling, ulcers
of mouth, throat, nose, genitals and eyes and can be preceded by fever and
flu-like symptoms (very rare side effects, potentially life-threatening).
▸ a red, scaly widespread rash with bumps under the skin and blisters
accompanied by fever at the initiation of treatment (acute generalised
exanthematous pustulosis) (frequency of this side effect is “not known”)
▸ syndrome associated with impaired water excretion and low levels of
sodium (SIADH) (very rare side effect)
▸loss of consciousness due to severe decrease in blood sugar levels
(hypoglycaemic coma) (very rare side effect)
▸ inflammation of blood vessels (signs could be red spots on your skin,
usually on your lower legs or effects like joint pain) (very rare side effect)
▸ a severe, sudden generalised allergic reaction incl. very rarely a lifethreatening
shock (e.g. difficulty in breathing, drop of blood pressure, fast
pulse) (rare side effect)
▸ swelling incl. swelling of the airway (rare side effect, potentially lifethreatening)
▸ convulsions (rare side effect)
▸ troubles associated with the nervous system such as pain, burning, tingling,
numbness and/or weakness in extremities (rare side effect)
▸ depression (in very rare cases leading to self-harm, such as suicidal
ideations/thoughts, or suicide attempts) (rare side effect)
▸ insanity (potentially leading to self-harm, such as suicidal ideations/
thoughts, or suicide attempts) (very rare side effect)
▸ 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 (rare side effects)
▸ pain and swelling of the tendons (tendonitis) (rare side effect) or a tendon
rupture (very rare side effect)
▸ muscle weakness, tenderness or pain and particularly, if at the same time,
you feel unwell, have a high temperature or have dark urine. They may be
caused by an abnormal muscle breakdown which can be life threatening
and lead to kidney problems (a condition called rhabdomyolysis) (frequency
of this side effect is “not known”).
stop taking Avalox and tell your doctor immediately as you may need
urgent medical advice.
In addition, if you notice
▸ transient loss of vision (very rare side effect),
▸ discomfort or pain to the eyes, especially due to light exposure (very rare to
rare side effect)
contact an eye specialist immediately.
If you have experienced life-threatening irregular heart beat (Torsade de
Pointes) or stopping of heart beat while taking Avalox (very rare side effects),
tell your treating doctor immediately that you have taken Avalox and do
not restart the treatment.
A worsening of the symptoms of myasthenia gravis has been observed in very
rare cases. If this happens, consult your doctor immediately.
If you suffer from diabetes and you notice that your blood sugar is increased or
decreased (rare or very rare side effect), inform your doctor immediately.
If you are elderly with existing kidney problems and you notice decrease in
urine output, swelling in your legs, ankles or feet, fatigue, nausea, drowsiness,
shortness of breath or confusion (these can be signs and symptoms of kidney
failure, a rare side effect), consult your doctor immediately.
Other side effects which have been observed during treatment with Avalox are
listed below by how likely they are:
Common (may affect up to 1 in 10 people)
▸ nausea
▸ diarrhoea
▸ dizziness
▸ stomach and abdominal ache
▸ vomiting
▸ headache
▸increase of a special liver enzyme in the blood (transaminases)
▸infections caused by resistant bacteria or fungi e.g. oral and vaginal
infections caused by Candida
▸ pain or inflammation at injection site
▸ change of the heart rhythm (ECG) in patients with low blood potassium
level
Uncommon (may affect up to 1 in 100 people)
▸ rash
▸ stomach upset (indigestion/heartburn)
▸ changes in taste (in very rare cases loss of taste)
▸ sleep problems (predominantly sleeplessness)
▸ increase of a special liver enzyme in the blood (gamma-glutamyltransferase
and/or alkaline phosphatase)
▸ low number of special white blood cells (leukocytes, neutrophils)
▸ constipation
▸ itching
▸ sensation of dizziness (spinning or falling over)
▸ sleepiness
▸ wind
▸ change of the heart rhythm (ECG)
▸ impaired liver function (incl. increase of a special liver enzyme in the blood
(LDH))
▸ decreased appetite and food intake
▸ low white blood cells count
▸aches and pains such as back, chest, pelvic and extremities pains
▸ increase of special blood cells necessary for blood clotting
▸ sweating
▸ increased specialised white blood cells (eosinophils)
▸anxiety
▸ feeling unwell (predominantly weakness or tiredness)
▸ shaking
▸ joint pain
▸palpitations
▸ irregular and fast heart beat
▸ difficulty in breathing incl. asthmatic conditions
▸ increase of a special digestive enzyme in the blood (amylase)
▸ restlessness / agitation
▸ tingling sensation (pins and needles) and/or numbness
▸skin hives
▸ widening of blood vessels
▸confusion and disorientation
▸ decrease of special blood cells necessary for blood clotting
▸ visual disturbances incl. double and blurred vision
▸ decreased blood clotting
▸ increased blood lipids (fats)
▸low red blood cell count
▸ muscle pain
▸ allergic reaction
▸ increase of bilirubin in the blood
▸ inflammation of a vein
▸ inflammation of the stomach
▸ dehydration
▸ severe heart rhythm abnormalities
▸ dry skin
▸ angina pectoris
Rare (may affect up to 1 in 1,000 people)
▸muscle twitching
▸ muscle cramp
▸ hallucination
▸high blood pressure
▸ swelling (of the hands, feet, ankles, lips, mouth, throat)
▸ low blood pressure
▸ kidney impairment (incl. increase in special kidney laboratory test results
like urea and creatinine)
▸ inflammation of the liver
▸ inflammation of the mouth
▸ ringing/noise in the ears
▸ jaundice (yellowing of the whites of the eyes or skin)
▸ impairment of skin sensation
▸ abnormal dreams
▸ disturbed concentration
▸ difficulty in swallowing
▸ changes in smell (incl. loss of smell)
▸ balance disorder and poor co-ordination (due to dizziness)
▸ partial or total loss of memory
▸ hearing impairment including deafness (usually reversible)
▸ increased blood uric acid
▸ emotional instability
▸ impaired speech
▸ fainting
▸muscle weakness
Very rare (may affect up to 1 in 10,000 people)
▸ a drop in the number of red and white blood cells and platelets
(pancytopenia)
▸ inflammation of joints
▸ abnormal heart rhythms
▸ increase of skin sensitivity
▸ a feeling of self-detachment (not being yourself)
▸increased blood clotting
▸ muscle rigidity
▸ significant decrease of special white blood cells (agranulocytosis)
Very rare cases of long lasting (up to months or years) or permanent adverse
drug reactions, such as tendon inflammations, tendon rupture, joint pain,
pain in the limbs, difficulty in walking, abnormal sensations such as pins and
needles, tingling, tickling, burning, numbness or pain (neuropathy), depression,
fatigue, sleep disorders, memory impairment, as well as impairment of hearing,
vision, and taste and smell have been associated with administration of
quinolone and fluoroquinolone antibiotics, in some cases irrespective of preexisting
risk factors.
Cases of an enlargement and weakening of the aortic wall or a tear in the aortic
wall (aneurysms and dissections), which may rupture and may be fatal, and of
leaking heart valves have been reported in patients receiving fluoroquinolones
(see also section 2, Warnings and precautions).
The following symptoms have been observed more frequently in patients
treated intravenously:
Common (may affect up to 1 in 10 people)
▸Increase of a special liver enzyme in the blood (gamma-glutamyltransferase)
Uncommon (may affect up to 1 in 100 people)
▸ severe diarrhoea containing blood and/or mucus (antibiotic associated
colitis) which in very rare circumstances, may develop into complications
that are life-threatening
▸ abnormal fast heart rhythm
▸ hallucination
▸ low blood pressure
▸kidney impairment (incl. increase in special kidney laboratory test results
like urea and creatinine)
▸ kidney failure
▸ swelling (of the hands, feet, ankles, lips, mouth, throat)
▸ convulsions
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 Avalox: raised pressure in the skull
(symptoms include headache, visual problems including blurred vision, “blind”
spots, double vision, loss of vision), increased blood sodium levels, increased
blood calcium levels, a special type of reduced red blood cell count (haemolytic
anaemia), increased sensitivity of the skin to sunlight or UV light.
To report any side effect(s):
The National Pharmacovigilance and Drug Safety Centre (NPC).
Fax: + 966 - 11 - 205 - 7662.
Call NPC at +966 - 11 - 2038222,
Ext.: 2317 - 2356 - 2340.
Reporting hotline: 19999.
E-mail: npc.drug@sfda.gov.sa.
Website: www.sfda.gov.sa/npc

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label
of the bottle and on the carton. The expiry date refers to the last day of that
month.
Do not store below 15°C.
Do not store above 30°C.

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 this medicine if you notice any visible particulate matter or if the
solution is cloudy.
Do not throw away any medicines via wastewater or household waste. Ask
your pharmacist how to throw away medicines you no longer use. These
measures will help protect the environment.