Skip to Content

AVELOX 400MG FILM-COATED TABLETS

Active substance(s): MOXIFLOXACIN

View full screen / Print PDF » Download PDF ⇩
Transcript
S0587-5-RM-PIL-18.09.2015



PACKAGE LEAFLET:
INFORMATION FOR THE USER




®

Avelox 400mg film-coated tablets



(moxifloxacin hydrochloride)

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.

Your medicine is available by the above name, but
will be referred to as Avelox throughout the
remainder of this leaflet.

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 Warnings and precautions
Talk to your doctor before taking Avelox
not pass it on to others. It may harm them, even if
 Avelox can change your heart’s ECG, especially
their signs of illness are the same as yours.
if you are female, or if you are elderly. If you are
 If you get any side effects, talk to your doctor or
currently taking any medicine that decreases your
pharmacist. This includes any possible side effects
blood potassium levels, consult your doctor before
not listed in this leaflet. See section 4.
taking Avelox (see also sections Do not take and
What is in this leaflet:
Other medicines and Avelox).
1. What Avelox is and what it is used for
 If you suffer from epilepsy or a condition which
2. What you need to know before you take
makes you likely to have convulsions talk to your
Avelox
doctor before taking Avelox.
3. How to take Avelox
 If you have or have ever had any mental health
4. Possible side effects
problems, consult your doctor before taking
5. How to store Avelox
Avelox.
6. Contents of the pack and other information
 If you suffer from myasthenia gravis (abnormal
muscle fatigue leading to weakness and in serious
1. What Avelox is and what it is used for
cases paralysis), taking Avelox may worsen the
Avelox contains the active substance moxifloxacin,
symptoms of your disease. If you think you are
which belongs to a group of antibiotics called
affected consult your doctor immediately.
fluoroquinolones. Avelox works by killing bacteria that
 If you or any member of your family have glucosecause infections.
6-phosphate dehydrogenase deficiency (a rare
Avelox is used in patients aged 18 years and above
hereditary disease), tell your doctor, who will
for treating the following bacterial infections when
advise whether Avelox is suitable for you.
 If you have a complicated infection of the female
caused by bacteria against which moxifloxacin is
upper genital tract (e.g. associated with an
active. Avelox should only be used to treat these
infections when usual antibiotics cannot be used or
abscess of the fallopian tubes and ovaries or of the
have not worked:
pelvis), for which your doctor considers an
intravenous treatment necessary, treatment with
Infection of the sinuses, sudden worsening of long
Avelox tablets is not appropriate.
term inflammation of the airways or infection of the
 For the treatment of mild to moderate infections
lungs (pneumonia) acquired outside the hospital
of the female upper genital tract your doctor
(except severe cases).
should prescribe another antibiotic in addition to
Avelox. If there is no improvement in symptoms
Mild to moderate infections of the female upper
after 3 days of treatment, please consult your
genital tract (pelvic inflammatory disease), including
doctor.
infections of the fallopian tubes and infections of the
uterus mucous membrane.













When taking Avelox

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:
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








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)







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 lifethreatening 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, 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).

Other medicines and Avelox
Tell your doctor or pharmacist about any other
medicines that you are taking, took recently or might
take.
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 [antiinflammatory 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 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.

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

3.

How to take Avelox

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
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.

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)
If you have any further questions about this medicine,  changes in taste (in very rare cases loss of taste)
 sleep problems (predominantly sleeplessness)
ask your doctor or pharmacist.
 increase of a special liver enzyme in the blood
4. Possible Side Effects
(gammaglutamyl-transferase and/or alkaline
Like all medicines, this medicine can cause side
phosphatase)
effects, although not everybody gets them. The most  low number of special white blood cells
serious side effects observed during treatment with
(leukocytes, neutrophils)
Avelox are listed below:
 constipation
 itching
If you notice
 sensation of dizziness (spinning or falling over)
 an abnormal fast heart rhythm (rare side effect)
 sleepiness
 that you suddenly start feeling unwell or notice
 wind
yellowing of the whites of the eyes, dark urine,
 change of the heart rhythm (ECG)
itching of the skin, a tendency to bleed or
 impaired liver function (incl. increase of a special
disturbances of thought or wakefulness (these can
liver enzyme in the blood (LDH))
be signs and symptoms of fulminant inflammation
 decreased appetite and food intake
of the liver potentially leading to life-threating liver
 low white blood cells count
failure (very rare side effect, fatal cases have been
 aches and pains such as back, chest, pelvic and
observed))
extremities pains
 alterations of the skin and mucous membranes like
 increase of special blood cells necessary for blood
painful blisters in the mouth/nose or at the penis/
clotting
vagina (Stevens-Johnson syndrome or toxic
 sweating
epidermal necrolysis) (very rare side effects,
 increased specialised white blood cells
potentially life threatening)
(eosinophils)
 a severe, sudden generalised allergic reaction incl.
 anxiety
very rarely a life-threatening shock (e.g. difficulty in
 feeling unwell (predominantly weakness or
breathing, drop of blood pressure, fast pulse) (rare
tiredness)
side effect)
 shaking
 swelling incl. swelling of the airway (rare side
 joint pain
effect, potentially life-threatening)
 palpitations
 convulsions (rare side effect)
 irregular and fast heart beat
 troubles associated with the nervous system such
 difficulty in breathing incl. asthmatic conditions
as pain, burning, tingling, numbness and/or
 increase of a special digestive enzyme in the blood
weakness in extremities (rare side effect)
(amylase)
 depression (in very rare cases leading to self-harm,
 restlessness / agitation
such as suicidal ideations/thoughts, or suicide
 tingling sensation (pins and needles) and/or
attempts) (rare side effect)
numbness
 insanity (potentially leading to self-harm, such as
 skin hives
suicidal ideations/thoughts, or suicide attempts)
 widening of blood vessels
(very rare side effect)
 confusion and disorientation
 severe diarrhoea containing blood and/or mucus
 decrease of special blood cells necessary for blood
(antibiotic associated colitis incl.
clotting
pseudomembranous colitis), which in very rare
 visual disturbances incl. double and blurred vision
circumstances, may develop into complications that
 decreased blood clotting
are life-threatening (rare side effects)
 increased blood lipids (fats)
 pain and swelling of the tendons (tendonitis) (rare
 low red blood cell count
side effect) or a tendon rupture (very rare side
 muscle pain
effect) stop taking Avelox and tell your doctor
 allergic reaction
immediately as you may need urgent medical
 increase of bilirubin in the blood
advice.
 inflammation of the stomach
 dehydration
In addition, if you notice
 severe heart rhythm abnormalities
 transient loss of vision (very rare side effect),
 dry skin
contact an eye specialist immediately.
 angina pectoris
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.

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

5.

How to store Avelox

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated
on the blister and carton. The expiry date refers to the
last day of the 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.
If your medicine becomes discoloured or shows any
signs of deterioration, you should seek the advice of
your pharmacist.

6.

Contents of the pack and other
information

What Avelox contains
The active substance is moxifloxacin.
Each tablet contains 400mg moxifloxacin (as
hydrochloride).
The other ingredients are:
Tablet core: Microcrystalline cellulose, croscarmellose
sodium, lactose monohydrate (see section 2 - Avelox
contains lactose) and magnesium stearate.
Film coating: iron oxide (E172), hypromellose 15cps,
macrogol 4000 and titanium dioxide (E171).

What Avelox looks like and contents of the
pack
Dull red film-coated tablet with an oblong, convex
shape with facet and a dimension of 17mm x 7mm,
and marked with “M400” on one side and “BAYER” on
the other side.
Avelox are available in blister pack of 5 tablets.
Manufacturer:
Bayer Pharma AG
D-51368 Leverkusen, Germany.
Procured from within the EU and repackaged by:
Amimed Direct Ltd, Hendon, London, NW9 6AQ.
Product Licence Holder: Sam Pharma Ltd, Unit 20
Garrick Industrial Estate, Irving Way, Hendon,
London, NW9 6AQ.
PL 33902/0587
POM
Leaflet revision date: 18/09/2015
Avelox® is a registered trademark of Bayer
Intellectual Property GmbH.
S0587-5-RM-PIL-18.09.2015

Expand view ⇕

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.

Hide