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MOXIFLOXACIN 400 MG FILM-COATED TABLETS

Active substance(s): MOXIFLOXACIN / MOXIFLOXACIN HYDROCHLORIDE

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TEVA UK Ref:

231-30-14473-A LEA MOXIFLOXACIN 400mg TAB TUK
MOXIFLOXACIN 400 mg
FILM-COATED TABLETS
PACKAGE LEAFLET:
INFORMATION FOR THE PATIENT/USER

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 any further 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. Do not
re-use this medicine without medical
prescription, even if you want to treat a
similar illness.
• If you get any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in 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 of
18 years and older 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 for sole therapy of these
kinds of infections and 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)
• are pregnant or are breast-feeding
• are under 18 years of age
• have a history of tendon disease or
disorder which was related to treatment
with quinolone antibiotics (see section
“Warnings and Precautions” and
section 4. “Possible side effects”)
• were born with or have had any
condition with abnormal heart rhythm
(seen on ECG, electrical recording of the
heart)
• have salt imbalance in the blood
(especially low level of potassium or
magnesium in the blood)
• have a very slow heart rhythm (called
“bradycardia”)
• have a weak heart (heart failure)
• have a history of abnormal heart rhythms
• are taking other medicines that result in
certain abnormal ECG changes (see
section 2 “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
• 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, consult 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,
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-6-phosphate dehydrogenase
deficiency (a rare hereditary disease),
inform 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, with the
following symptoms: tightness in the
chest, feeling dizzy, feeling sick or faint,
or experience dizziness on standing. If so,
stop taking Moxifloxacin and seek
medical advice immediately
• Moxifloxacin may cause a rapid and
severe inflammation of the liver which













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28 March 2014

could lead to life-threatening liver failure
(including fatal cases, see section 4
“Possible side effects”). Please contact
your doctor before you continue the
treatment if you develop signs such as
rapidly feeling unwell and/or being sick
associated with 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)
if you develop a skin reaction or
blistering and/or 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 taking,
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. In this situation, 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
currently being treated with
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 2. “Do
not take Moxifloxacin” and 4. “Possible
side effects”)
if you are elderly with existing kidney
problems take care that your fluid intake
is sufficient because dehydration may
increase the risk of kidney failure
if your eyesight becomes impaired or if
you have any other eye disturbances
whilst taking Moxifloxacin, consult an
eye specialist immediately (see sections
2. “Driving and using machines“ and 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 solution for
infusion 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 if you:”).
Other medicines and Moxifloxacin
Tell your doctor or pharmacist if you are
taking, have recently taken or might take
any other medicines besides Moxifloxacin.
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
anti-arrhythmics (e.g. quinidine,
hydroquinidine, disopyramide,
amiodarone, sotalol, dofetilide,
ibutilide)
• antipsychotics (e.g. phenothiazines,
pimozide, sertindole, haloperidol,
sultopride)
• tricyclic antidepressants
• some antimicrobials (e.g. saquinavir,
sparfloxacin, intravenous erythromycin,
pentamidine, antimalarials particularly
halofantrine)
• some antihistamines (e.g. terfenadine,
astemizole, mizolastine)
• 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, or any medicine containing
iron or zinc, medicine containing
didanosine or medicine containing
sucralfate to treat gastrointestinal
disorders can reduce the action of
Moxifloxacin. Therefore, take your
Moxifloxacin 6 hours before or after
taking the other medicine
• taking oral medical charcoal at the same
time as Moxifloxacin reduces the action
of Moxifloxacin. Therefore it is
recommended that these medicines are
not used together
• if you are currently taking oral
anti-coagulants (e.g. warfarin), it may be
necessary for your doctor to monitor
your blood clotting times.
Moxifloxacin with food and drink
The effect of Moxifloxacin is not influenced
by food including dairy products.
Pregnancy, breast-feeding and fertility
Do not take Moxifloxacin 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
Moxifloxacin may make you feel dizzy or
light headed, you may experience a
sudden, transient loss of vision, or you
might faint for a short period. If you are
affected in this way do not drive or operate
machinery.

3

How to take Moxifloxacin

Dosage
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
400 mg film-coated tablet once daily.
Moxifloxacin tablets are for oral use.
Swallow the tablets as a whole (to mask
the bitter taste) and with plenty of liquid.
You can take Moxifloxacin with or without
food. It is recommended that you take the

TEVA UK Ref:

231-30-14473-A LEA MOXIFLOXACIN 400mg TAB TUK
tablet at approximately the same time each
day.
No adjustment of the dose is required in
elderly patients, patients with a low
bodyweight or in patients with kidney
problems.
The duration of treatment depends upon
the type of infection. Unless otherwise
indicated by your doctor the recommended
durations of use of Moxifloxacin
Film-coated Tablets are:
• sudden worsening of chronic bronchitis
(acute exacerbation of chronic bronchitis)
5 - 10 days
• infection of the lungs (pneumonia)
acquired outside the hospital, except
severe cases 10 days
• 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 Film-coated Tablets are
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 film-coated tablets within
4 days
• infections of the skin and soft tissue
7 - 21 days.
Most patients with infections of the skin
and soft tissue were switched to oral
treatment with moxifloxacin film-coated
tablets within 6 days.
It is important that you complete the
course of treatment, even if you begin to
feel better after a few days. If you stop
taking this medicine too soon your
infection may not be completely cured, the
infection may return or your condition may
get worse and you may also create a
bacterial resistance to the antibiotic.
The recommended dose and duration of
treatment should not be exceeded (see
section “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, seek medical advice
immediately and, if possible, 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 take your tablet on
one 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, consult
your doctor or pharmacist.
If you stop taking Moxifloxacin
If you stop taking this medicine too soon
your infection may not be completely
cured. Consult your doctor if you wish to
stop taking your tablets before the end of
the course of treatment.
If you have any further questions on the
use of 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.
If you experience any of the following, stop
taking this medicine immediately and seek
urgent medical advice.
Uncommon side effects (may affect up to 1
in 100 people):
• change of the heart rhythm (ECG),
palpitations, irregular and fast heart beat,
severe heart rhythm abnormalities,
angina pectoris
• difficulty in breathing including asthmatic
conditions.
Rare side effects (may affect up to 1 in
1,000 people):
• severe, sudden generalised allergic
reaction including very rarely
life-threatening shock (e.g. difficulty in
breathing, drop of blood pressure, fast
pulse), swelling (including potentially
life-threatening swelling of the airway)
• depression (in very rare cases leading to
self-harm, such as suicidal
ideations/thoughts, or suicide attempts)
• difficulty in swallowing, inflammation of
the mouth, severe diarrhoea containing
blood and/or mucus (antibiotic
associated colitis including
pseudomembranous colitis), which in
very rare circumstances, may develop
into complications that are
life-threatening
• swelling (of the hands, feet, ankles, lips,
mouth, throat).






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28 March 2014

(LDH), increase of bilirubin in the blood,
increase of a special liver enzyme in the
blood (gammaglutamyl-transferase
and/or alkaline phosphatase)
itching, rash, skin hives, dry skin
joint pain, muscle pain
dehydration
feeling unwell (predominantly weakness
or tiredness), aches and pains such as
back, chest, pelvic and extremities pains,
sweating.

Rare side effects (may affect up to 1 in
1,000 people):
• increased blood sugar, increased blood
uric acid
• emotional instability, hallucination
• impairment of skin sensation, changes in
smell (including loss of smell), abnormal
dreams, balance disorder and poor
co-ordination (due to dizziness),
convulsions, disturbed concentration,
impaired speech, partial or total loss of
memory, troubles associated with the
nervous system such as pain, burning,
tingling, numbness and/or weakness in
extremities
• ringing/noise in the ears, hearing
impairment including deafness (usually
reversible)
• abnormal fast heart rhythm, fainting
• high blood pressure, low blood pressure
• jaundice (yellowing of the whites of the
eyes or skin), inflammation of the liver
• pain and swelling of the tendons
(tendonitis), muscle cramp, muscle
twitching, muscle weakness
• kidney impairment (including increase in
special kidney laboratory test results like
urea and creatinine), kidney failure.
Very rare side effects (may affect up to 1 in
10,000 people):
• a feeling of self-detachment (not being
yourself)
• increase of skin sensitivity
• transient loss of vision
• rupture of tendon, inflammation of joints,
muscle rigidity, worsening of the
symptoms of myasthenia gravis.
Furthermore, there have been very rare
cases of the following side effects reported
following treatment with other quinolone
antibiotics, which might possibly also
occur during treatment with 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 this medicine out of the sight and
reach of children.
Do not use this medicine after the expiry
date which is stated on the blister and the
carton after EXP. The expiry date refers to
the last day of that month.
This medicinal product does not require
any special storage conditions.
Do not throw away any medicines via
wastewater. 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 substance is moxifloxacin.
Each film-coated tablet contains 400 mg
moxifloxacin (base).
The other ingredients are:
Tablet core: Microcrystalline cellulose,
Croscarmellose sodium, Colloidal
anhydrous silica, Magnesium stearate.
Film-coating: Hypromellose, Macrogol
4000, Iron oxide red (E172), Titanium
dioxide (E171).
What Moxifloxacin looks like and contents
of the pack
Moxifloxacin are light pink, oblong,
biconvex film-coated tablets.
Moxifloxacin is available in packs of 5, 7,
10, 14, 25 (5x5), 50 (5x10), 70 (7x10), 80
(16x5), 100 (10x10) tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
TEVA UK Limited, Eastbourne, BN22 9AG,
UK.
Manufacturer
TEVA Pharmaceutical Works Private
Limited Company, Pallagi út 13, 4042
Debrecen, Hungary.
This leaflet was last revised in 03/2014
PL 00289/1617

Very rare side effects (may affect up to 1 in
10,000 people):
• increased blood clotting, significant
decrease of special white blood cells
(agranulocytosis)
• fulminant inflammation of the liver
potentially leading to life-threatening
liver failure (including fatal cases)
• alterations of the skin and mucous
membranes (painful blisters in the
mouth/nose or at the penis/vagina),
potentially life-threatening
(Stevens-Johnson-Syndrome, toxic
epidermal necrolysis)
• insanity (potentially leading to self-harm,
such as suicidal ideations/thoughts, or
suicide attempts)
• abnormal heart rhythms, life-threatening
irregular heart beat, stopping of heart beat.
The following side effects have also been
observed during treatment with
moxifloxacin.
Common side effects (may affect up to 1 in
10 people):
• infections caused by resistant bacteria or
fungi, e.g. oral and vaginal infections
caused by Candida (thrush)
• headache, dizziness
• change of the heart rhythm (ECG) in
patients with low blood potassium level
• nausea, vomiting, stomach and
abdominal ache, diarrhoea
• increase of special liver enzymes in the
blood (transaminases).
Uncommon side effects (may affect up to 1
in 100 people):
• low red blood cell count, low white blood
cell count, low numbers of special white
blood cells (neutrophils), decrease or
increase of special blood cells necessary
for blood clotting, increased specialised
white blood cells (eosinophils),
decreased blood clotting
• allergic reaction
• increased blood lipids (fats)
• anxiety, restlessness/agitation
• tingling sensation (pins and needles)
and/or numbness, changes in taste (in
very rare cases loss of taste), confusion
and disorientation, sleep problems
(predominately sleeplessness), shaking,
sensation of dizziness (spinning or falling
over), sleepiness
• visual disturbances including double and
blurred vision
• widening of blood vessels
• decreased appetite and food intake, wind
and constipation, stomach upset
(indigestion/heartburn), inflammation of
the stomach, increase of a special
digestive enzyme in the blood (amylase)
• impaired liver function including increase
of a special liver enzyme in the blood

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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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