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AVELOX 400MG TABLETS

Active substance(s): MOXIFLOXACIN HYDROCHLORIDE

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Package leaflet: Information for the patient
®

Avelox 400mg Tablets
(moxifloxacin hydrochloride)

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.
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.
The name of your medicine is Avelox 400mg Tablets but
will be referred to as Avelox throughout this leaflet.
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
Avelox contains the active substance moxifloxacin, which
belongs to a group of antibiotics called fluoroquinolones.
Avelox works by killing bacteria that cause infections.
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 is not sufficient on it’s own for treating this kind of
infection. Therefore, another antibiotic in addition to Avelox
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 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 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)
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.

Warnings and precautions
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 glucose- 6phosphate 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 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, 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 [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
didanosine or any medicine containing sucralfate (to
treat stomach disorders) can reduce the action of
Avelox. Take your Avelox 6 hours before or after taking
the other medicine.
Taking any medicine containing charcoal at the same
time as Avelox 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
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
film-coated tablet once daily.
Avelox is 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 is 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 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 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 via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects, you can help provide more
information on the safety of this medicine.

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

6. Contents of the pack and other information
What Avelox contains
The active ingredient is moxifloxacin hydrochloride.
Each tablet contains 400mg moxifloxacin
(as hydrochloride).
The other ingredients are:
Tablet core: microcrystalline cellulose, croscarmellose
sodium, lactose monohydrate and magnesium stearate.
Film coating: hypromellose, macrogol 4000, yellow ferric
oxide (E172) and titanium dioxide (E171).

What Avelox looks like and contents of the pack
Avelox is dull red film-coated tablet with an oblong, convex
shape with facet, marked ‘M400’ on one side and ‘BAYER’
on the reverse.
Avelox is available in blister packs containing 5 film-coated
tablets.
Manufactured by: Bayer Pharma AG, D-51368
Leverkusen – Germany.
Procured from within the EU and repackaged by the
Product Licence holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
Avelox® 400mg Tablets,
PL No: 18799/2419

POM

Leaflet date: 12.10.2015
®
Avelox is registered trademark of Bayer Corporation.

Package leaflet: Information for the patient
®

Avelox 400mg Tablets
(moxifloxacin hydrochloride)

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.
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.
The name of your medicine is Avelox 400mg Tablets but
will be referred to as Avelox throughout this leaflet.
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
Avelox contains the active substance moxifloxacin, which
belongs to a group of antibiotics called fluoroquinolones.
Avelox works by killing bacteria that cause infections.
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 is not sufficient on it’s own for treating this kind of
infection. Therefore, another antibiotic in addition to Avelox
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 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 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)
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.

Warnings and precautions
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 glucose- 6phosphate 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 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, 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 [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
didanosine or any medicine containing sucralfate (to
treat stomach disorders) can reduce the action of
Avelox. Take your Avelox 6 hours before or after taking
the other medicine.
Taking any medicine containing charcoal at the same
time as Avelox 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
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
film-coated tablet once daily.
Avelox is 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 is 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 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 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 via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects, you can help provide more
information on the safety of this medicine.

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

6. Contents of the pack and other information
What Avelox contains
The active ingredient is moxifloxacin hydrochloride.
Each tablet contains 400mg moxifloxacin
(as hydrochloride).
The other ingredients are:
Tablet core: microcrystalline cellulose, croscarmellose
sodium, lactose monohydrate and magnesium stearate.
Film coating: hypromellose, macrogol 4000, yellow ferric
oxide (E172) and titanium dioxide (E171).

What Avelox looks like and contents of the pack
Avelox is dull red film-coated tablet with an oblong, convex
shape with facet, marked ‘M400’ on one side and ‘BAYER’
on the reverse.
Avelox is available in blister packs containing 5 film-coated
tablets.
Manufactured by: Bayer Pharma AG, D-51368
Leverkusen – Germany.
Procured from within the EU and repackaged by the
Product Licence holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
Avelox® 400mg Tablets,
PL No: 18799/2419

POM

Leaflet date: 12.10.2015
®
Avelox is registered trademark of Bayer Corporation.

Package leaflet: Information for the patient

Moxifloxacin 400mg Tablets
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.
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.
The name of your medicine is Moxifloxacin 400mg Tablets
but will be referred to as Moxifloxacin throughout this
leaflet.
What is in this leaflet:
1. What Moxifloxacin is and what it is used for
2. What you need to know before you take
Moxifloxacin
3. How to take Moxifloxacin
4. Possible side effects
5. How to store Moxifloxacin
6. Contents of the pack and other information

1. What Moxifloxacin is and what it is used for
Moxifloxacin contains the active substance moxifloxacin,
which belongs to a group of antibiotics called
fluoroquinolones. Moxifloxacin works by killing bacteria
that cause infections.
Moxifloxacin is used in patients aged 18 years and above
for treating the following bacterial infections when caused
by bacteria against which moxifloxacin is active.
Moxifloxacin 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.
Moxifloxacin is not sufficient on it’s own for treating this
kind of infection. Therefore, another antibiotic in addition to
Moxifloxacin 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
Moxifloxacin’, ‘Warnings and precautions’, Talk to
your doctor before taking Moxifloxacin).
If the following bacterial infections have shown
improvement during initial treatment with Moxifloxacin
solution for infusion, Moxifloxacin 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.
Moxifloxacin 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
Moxifloxacin

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

Do not take Moxifloxacin
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 Moxifloxacin’). This is because
Moxifloxacin 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.

Warnings and precautions
Talk to your doctor before taking Moxifloxacin
Moxifloxacin 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
Moxifloxacin (see also sections ‘Do not take’ and ‘Other
medicines and Moxifloxacin’).
If you suffer from epilepsy or a condition which makes
you likely to have convulsions talk to your doctor before
taking Moxifloxacin.
If you have or have ever had any mental health
problems, consult your doctor before taking
Moxifloxacin.
If you suffer from myasthenia gravis (abnormal muscle
fatigue leading to weakness and in serious cases
paralysis), taking Moxifloxacin 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- 6phosphate dehydrogenase deficiency (a rare
hereditary disease), tell your doctor, who will advise
whether Moxifloxacin 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 Moxifloxacin 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 Moxifloxacin. If there is
no improvement in symptoms after 3 days of treatment,
please consult your doctor.

When taking Moxifloxacin
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 Moxifloxacin and seek medical advice
immediately.
Moxifloxacin 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 Moxifloxacin, may cause
convulsions. If this happens, stop taking Moxifloxacin
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 Moxifloxacin.
You may experience mental health problems even
when taking quinolone antibiotics, including
Moxifloxacin, 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 Moxifloxacin and inform your
doctor immediately.
You may develop diarrhoea whilst or after taking
antibiotics including Moxifloxacin. If this becomes severe
or persistent or you notice that your stool contains blood
or mucus you should stop taking Moxifloxacin
immediately and consult your doctor. You should not
take medicines that stop or slow down bowel movement.
Moxifloxacin may cause pain and inflammation of your
tendons, even within 48 hours of starting treatment and
up to several months after discontinuing Moxifloxacin
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 Moxifloxacin, 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 Moxifloxacin…’ and 4. ‘Possible side
effects’).
If you are elderly and have kidney problems make sure
that you drink plenty whilst taking Moxifloxacin. 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 Moxifloxacin, 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 Moxifloxacin.
The efficacy of Moxifloxacin 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 Moxifloxacin’).

Other medicines and Moxifloxacin
Tell your doctor or pharmacist about any other medicines
that you are taking, took recently or might take.
For Moxifloxacin, be aware of the following:
If you are taking Moxifloxacin and other medicines that
affect your heart there is an increased risk for altering
your heart rhythm. Therefore, do not take Moxifloxacin
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 Moxifloxacin.
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
Moxifloxacin. Take your Moxifloxacin 6 hours before or
after taking the other medicine.
Taking any medicine containing charcoal at the same
time as Moxifloxacin reduces the action of Moxifloxacin.
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.

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

Pregnancy, breast-feeding and fertility
Do not take Moxifloxacin 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
Moxifloxacin 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.

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

3. How to take Moxifloxacin
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
film-coated tablet once daily.
Moxifloxacin is for oral use. Swallow the tablet whole (to
mask the bitter taste) and with plenty of liquid. You can
take Moxifloxacin 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 Moxifloxacin 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 Moxifloxacin is used to complete a course of
therapy started with Moxifloxacin 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 Moxifloxacin 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 Moxifloxacin 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 Moxifloxacin 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 Moxifloxacin.
The recommended dose and duration of treatment
should not be exceeded (see section 2. ‘What you need
to know before you take Moxifloxacin’, ‘Warnings
and precautions’)

If you take more Moxifloxacin 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 Moxifloxacin
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 Moxifloxacin
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 Moxifloxacin
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 Moxifloxacin 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 Moxifloxacin (very rare side effects), tell your
treating doctor immediately that you have taken
Moxifloxacin 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 Moxifloxacin 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 Moxifloxacin:
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 via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects, you can help provide more
information on the safety of this medicine.

5. How to store Moxifloxacin
Keep out of the sight and reach of children.
Do not store above 25°C.
Store in the original package in order to protect from
moisture.
Do not use tablets after the expiry date which is stated on
the blister and carton label after ‘Exp’. The expiry date
refers to the last day of that month.
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.

6. Contents of the pack and other information
What Moxifloxacin contains
The active ingredient is moxifloxacin hydrochloride.
Each tablet contains 400mg moxifloxacin
(as hydrochloride).
The other ingredients are:
Tablet core: microcrystalline cellulose, croscarmellose
sodium, lactose monohydrate and magnesium stearate.
Film coating: hypromellose, macrogol 4000, yellow ferric
oxide (E172) and titanium dioxide (E171).

What Moxifloxacin looks like and contents of the
pack
Moxifloxacin is dull red film-coated tablet with an oblong,
convex shape with facet, marked ‘M400’ on one side and
‘BAYER’ on the reverse.
Moxifloxacin is available in blister packs containing 5 filmcoated tablets.
Manufactured by: Bayer Pharma AG, D-51368
Leverkusen – Germany.
Procured from within the EU and repackaged by the
Product Licence holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK. POM
Moxifloxacin 400mg Tablets, PL 18799/2419
Leaflet date: 12.10.2015

Package leaflet: Information for the patient

Moxifloxacin 400mg Tablets
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.
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.
The name of your medicine is Moxifloxacin 400mg Tablets
but will be referred to as Moxifloxacin throughout this
leaflet.
What is in this leaflet:
1. What Moxifloxacin is and what it is used for
2. What you need to know before you take
Moxifloxacin
3. How to take Moxifloxacin
4. Possible side effects
5. How to store Moxifloxacin
6. Contents of the pack and other information

1. What Moxifloxacin is and what it is used for
Moxifloxacin contains the active substance moxifloxacin,
which belongs to a group of antibiotics called
fluoroquinolones. Moxifloxacin works by killing bacteria
that cause infections.
Moxifloxacin is used in patients aged 18 years and above
for treating the following bacterial infections when caused
by bacteria against which moxifloxacin is active.
Moxifloxacin 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.
Moxifloxacin is not sufficient on it’s own for treating this
kind of infection. Therefore, another antibiotic in addition to
Moxifloxacin 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
Moxifloxacin’, ‘Warnings and precautions’, Talk to
your doctor before taking Moxifloxacin).
If the following bacterial infections have shown
improvement during initial treatment with Moxifloxacin
solution for infusion, Moxifloxacin 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.
Moxifloxacin 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
Moxifloxacin

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

Do not take Moxifloxacin
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 Moxifloxacin’). This is because
Moxifloxacin 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.

Warnings and precautions
Talk to your doctor before taking Moxifloxacin
Moxifloxacin 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
Moxifloxacin (see also sections ‘Do not take’ and ‘Other
medicines and Moxifloxacin’).
If you suffer from epilepsy or a condition which makes
you likely to have convulsions talk to your doctor before
taking Moxifloxacin.
If you have or have ever had any mental health
problems, consult your doctor before taking
Moxifloxacin.
If you suffer from myasthenia gravis (abnormal muscle
fatigue leading to weakness and in serious cases
paralysis), taking Moxifloxacin 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- 6phosphate dehydrogenase deficiency (a rare
hereditary disease), tell your doctor, who will advise
whether Moxifloxacin 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 Moxifloxacin 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 Moxifloxacin. If there is
no improvement in symptoms after 3 days of treatment,
please consult your doctor.

When taking Moxifloxacin
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 Moxifloxacin and seek medical advice
immediately.
Moxifloxacin 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 Moxifloxacin, may cause
convulsions. If this happens, stop taking Moxifloxacin
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 Moxifloxacin.
You may experience mental health problems even
when taking quinolone antibiotics, including
Moxifloxacin, 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 Moxifloxacin and inform your
doctor immediately.
You may develop diarrhoea whilst or after taking
antibiotics including Moxifloxacin. If this becomes severe
or persistent or you notice that your stool contains blood
or mucus you should stop taking Moxifloxacin
immediately and consult your doctor. You should not
take medicines that stop or slow down bowel movement.
Moxifloxacin may cause pain and inflammation of your
tendons, even within 48 hours of starting treatment and
up to several months after discontinuing Moxifloxacin
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 Moxifloxacin, 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 Moxifloxacin…’ and 4. ‘Possible side
effects’).
If you are elderly and have kidney problems make sure
that you drink plenty whilst taking Moxifloxacin. 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 Moxifloxacin, 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 Moxifloxacin.
The efficacy of Moxifloxacin 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 Moxifloxacin’).

Other medicines and Moxifloxacin
Tell your doctor or pharmacist about any other medicines
that you are taking, took recently or might take.
For Moxifloxacin, be aware of the following:
If you are taking Moxifloxacin and other medicines that
affect your heart there is an increased risk for altering
your heart rhythm. Therefore, do not take Moxifloxacin
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 Moxifloxacin.
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
Moxifloxacin. Take your Moxifloxacin 6 hours before or
after taking the other medicine.
Taking any medicine containing charcoal at the same
time as Moxifloxacin reduces the action of Moxifloxacin.
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.

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

Pregnancy, breast-feeding and fertility
Do not take Moxifloxacin 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
Moxifloxacin 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.

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

3. How to take Moxifloxacin
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
film-coated tablet once daily.
Moxifloxacin is for oral use. Swallow the tablet whole (to
mask the bitter taste) and with plenty of liquid. You can
take Moxifloxacin 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 Moxifloxacin 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 Moxifloxacin is used to complete a course of
therapy started with Moxifloxacin 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 Moxifloxacin 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 Moxifloxacin 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 Moxifloxacin 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 Moxifloxacin.
The recommended dose and duration of treatment
should not be exceeded (see section 2. ‘What you need
to know before you take Moxifloxacin’, ‘Warnings
and precautions’)

If you take more Moxifloxacin 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 Moxifloxacin
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 Moxifloxacin
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 Moxifloxacin
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 Moxifloxacin 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 Moxifloxacin (very rare side effects), tell your
treating doctor immediately that you have taken
Moxifloxacin 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 Moxifloxacin 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 Moxifloxacin:
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 via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects, you can help provide more
information on the safety of this medicine.

5. How to store Moxifloxacin
Keep out of the sight and reach of children.
Do not store above 25°C.
Store in the original package in order to protect from
moisture.
Do not use tablets after the expiry date which is stated on
the blister and carton label after ‘Exp’. The expiry date
refers to the last day of that month.
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.

6. Contents of the pack and other information
What Moxifloxacin contains
The active ingredient is moxifloxacin hydrochloride.
Each tablet contains 400mg moxifloxacin
(as hydrochloride).
The other ingredients are:
Tablet core: microcrystalline cellulose, croscarmellose
sodium, lactose monohydrate and magnesium stearate.
Film coating: hypromellose, macrogol 4000, yellow ferric
oxide (E172) and titanium dioxide (E171).

What Moxifloxacin looks like and contents of the
pack
Moxifloxacin is dull red film-coated tablet with an oblong,
convex shape with facet, marked ‘M400’ on one side and
‘BAYER’ on the reverse.
Moxifloxacin is available in blister packs containing 5 filmcoated tablets.
Manufactured by: Bayer Pharma AG, D-51368
Leverkusen – Germany.
Procured from within the EU and repackaged by the
Product Licence holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK. POM
Moxifloxacin 400mg Tablets, PL 18799/2419
Leaflet date: 12.10.2015

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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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