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AVELOX 400 MG FILM-COATED TABLETS

Active substance(s): MOXIFLOXACIN HYDROCHLORIDE

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DRAFT 2015-07-09 COLOUR PRESENTATION IS NOT BINDING

Package leaflet: Information for the patient

0

Avelox

®

400mg film-coated tablets
For use in adults
Moxifloxacin

Read all of this leaflet carefully
before you start taking this
medicine because it contains
important information for you.
Keep this leaflet. You may need to read it again.
If you have more questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass
it on to others. It may harm them, even if their signs of illness
are the same as yours.

0 Avelox

®

400mg film-coated tablets
Active substance: Moxifloxacin

82110887

Package leaflet: information for the user

If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this
leaflet. See section 4.

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.

2. What you need to know before
you take Avelox

Contact your doctor if you are not sure if you belong to a
patient group described below.

Do not take Avelox







What is in this leaflet:
1. What Avelox is and what it is used for
2. What you need to know before you take Avelox
3. How to take Avelox
4. Possible side effects
5. How to store Avelox
6. Contents of the pack and other information

1. What Avelox is and what it is
used for



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 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 Warnings and Precautions … and section 4.
Possible side effects).
If you were born with or have
• any condition with abnormal heart rhythm (seen
on ECG, electrical recording of the heart)
• a salt imbalance in the blood (especially low levels
of potassium or magnesium in the blood)
• a very slow heart rhythm (called ‘bradycardia’)
• a weak heart (heart failure)
• a history of abnormal heart rhythms
or
• if you are taking other medicines that result in
abnormal ECG changes (see section Other
medicines and Avelox). This is because
Avelox 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 increased liver
enzymes (transaminases) higher than 5 times the upper
normal limit.

Avelox contains the active substance moxifloxacin, which
belongs to a group of antibiotics called fluoroquinolones.
Avelox works by killing bacteria that cause infections.

Warnings and precautions

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 2. What you need to know before you take
Avelox, Warnings and precautions, Talk to your doctor
before taking Avelox).
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:



Talk to your doctor before taking
Avelox








Avelox 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 taking Avelox (see
also sections Do not take and Other medicines and
Avelox).
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 glucose6-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
















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. Therefore, the recommended
dosage should be followed.
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 a rapid 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-injurious 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 cause pain and inflammation of your
tendons, even within 48 hours of starting treatment
and up to several months after discontinuing Avelox
therapy. The risk of inflammation and rupture of
tendons is increased 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,

PMR 82110887 (69/04/MU/0201410427) Pantone: 280, 239






rest the affected limb(s) and consult your doctor
immediately. Avoid any unnecessary exercise, as
this might increase the risk of a tendon rupture (see
sections Do not take Avelox… and 4. Possible side
effects).
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 otherwise affected, consult an eye
specialist immediately (see sections Driving and using
machines and 4. Possible side effects).
Fluoroquinolone antibiotics may cause disturbances in
blood sugar, including both a decrease in blood sugar
below normal levels (hypoglycemia) and an increase
in blood sugar above normal levels (hyperglycemia). In
patients treated with Avelox, disturbances in blood sugar
occurred predominantly in elderly patients receiving
concomitant treatment with oral antidiabetic medicines
that lower blood sugar (e.g. sulfonylurea) or with insulin.
If you suffer from diabetes, your blood sugar should
be carefully 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 taking Avelox.
The efficacy of Avelox 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
Do not give this medicine 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 take
Avelox).




didanosine or any medicine containing
sucralfate (to treat stomach disorders)
June
can reduce the action of Avelox tablets.
2015
Take your Avelox tablet 6 hours before
REVISED
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.

Avelox with food and drink
Avelox can be taken with or without food (including dairy
products).

Pregnancy, breast-feeding and
fertility
Do not take Avelox 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 taking this medicine.
Animal studies do not indicate that your fertility will be
impaired by taking this 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.

Avelox contains lactose

Other medicines and Avelox

If you have been told by your doctor that you have an
intolerance to some sugars, speak to your doctor before
taking Avelox.

Tell your doctor or pharmacist about any other medicines
that you are taking, took recently or might take.

3. How to take Avelox

For Avelox, be aware of the following:
• If you are taking Avelox and other medicines that
affect your heart there is an increased risk for altering
your heart rhythm. Therefore, do not take Avelox
together with the following medicines:
• medicines that belong to the group of antiarrhythmics (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)
• 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 [high
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 taking Avelox.
• Any medicine containing magnesium or aluminium
(such as antacids for indigestion), iron, zinc or

Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
The recommended dose for adults is one 400mg filmcoated 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

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When Avelox film-coated tablets are used to complete a
course of therapy started with Avelox solution for infusion,
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 film-coated tablets within 4 days.
• Infections of the skin and soft tissue 7 -21 days
Most patients with infections of the skin and soft tissue
were switched to oral treatment with Avelox film-coated
tablets within 6 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 2. What you need to know
before you take Avelox, Warnings and precautions).

If you take more Avelox 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

 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
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 this medicine, ask
your doctor or pharmacist.

4. Possible Side Effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them. The most serious side
effects observed during treatment with Avelox 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))
• alterations of the skin and mucous membranes like
painful blisters in the mouth/nose or at the penis/
vagina (Stevens-Johnson syndrome or toxic epidermal
necrolysis) (very rare side effects, potentially life
threatening)



a severe, sudden generalised allergic reaction incl.
very rarely a life-threatening 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 life-threatening)
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) stop
taking Avelox 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),
contact an eye specialist immediately.
If you have experienced life-threatening irregular heart beat
(Torsade de Pointes) or stopping of heart beat while taking
Avelox (very rare side effects), tell your treating doctor
immediately that you have taken Avelox 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 Avelox 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
• 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 (gammaglutamyl-transferase 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 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)
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)









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.

Reporting of side effects

 If you get any side effects, talk to your doctor
or pharmacist. This includes any possible
side effects not listed in this leaflet. You can
also report side effects directly (see details
below). By reporting side effects, you can
help provide more information on the safety
of this medicine.

6. Contents of the pack and other
information

What Avelox contains




The active substance is moxifloxacin. Each filmcoated tablet contains 400 milligram moxifloxacin as
hydrochloride.
The other ingredients are:
Tablet core: Microcrystalline cellulose, Croscarmellose
sodium, Lactose monohydrate (see section Avelox
contains lactose) and Magnesium stearate.
Film coating: Hypromellose, Macrogol 4000, Ferric
oxide (E172) and Titanium dioxide (E171).

What Avelox looks like and contents
of the pack
Each dull red film-coated tablet with an oblong, convex
shape with facet and a dimension of 17 x 7 millimeter is
marked with “M400” on one side and “BAYER” on the other
side.
Avelox is packaged in cartons containing colourless or white
opaque polypropylene/aluminium blisters.
Avelox is available in commercial packs containing 5, 7, and
10 film-coated tablets, in hospital packs containing 25, 50 or
70 film-coated tablets and in hospital multipacks comprising
5 cartons, each containing 16 film-coated tablets, or 10
cartons, each containing 10 film-coated tablets.
Avelox is also available in a sample pack of 1 film-coated
tablet in a carton containing aluminium/aluminium blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and
Manufacturer

ADR Reporting

Marketing Authorisation holder: Bayer plc
Bayer House
Strawberry Hill
Newbury
Berkshire
RG14 1JA
United Kingdom

The Medicines Authority

Manufacturer:

United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

Malta

Post-Licensing Directorate
203 Level 3, Rue D’Argens
GŻR-1368 Gżira
Website: www.medicinesauthority.gov.mt
e-mail: postlicensing.medicinesauthority@gov.mt

5. How to store Avelox
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the
blister and on the carton. The expiry date refers to the last
day of that month.
Do not store above 25°C.
Store in the original package in order to protect from moisture.
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.

PMR 82110887 (69/04/MU/0201410427) Pantone: 280, 239

Bayer Pharma AG
D-51368 Leverkusen
Germany

This medicinal product is authorised
in the Member States of the EEA
under the following names:
Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Greece, Hungary, Ireland, Latvia, Lithuania,
Luxembourg, Malta, the Netherlands, Poland, Portugal, Slovak
Republic, Slovenia, Sweden, United Kingdom: Avelox
France: Izilox
Germany, Italy: Avalox
This leaflet was last revised in June 2015.
Product Licence Number : PL 00010/0291

U

280x546-16809_15923

DRAFT 2015-07-09 COLOUR PRESENTATION IS NOT BINDING

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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