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MOXIFLOXACIN 400 MG FILM-COATED TABLETS

Active substance(s): MOXIFLOXACIN / MOXIFLOXACIN HYDROCHLORIDE / MOXIFLOXACIN / MOXIFLOXACIN HYDROCHLORIDE / MOXIFLOXACIN / MOXIFLOXACIN HYDROCHLORIDE

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TEVA UK Ref:

231-30-14473-B LEA MOXIFLOXACIN 400mg TAB TUK Dim’s Changed?:
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Moxifloxacin 400 mg Film-coated
Tablets
Package leaflet:
Information for the patient

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.
• 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.







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 their 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
“Warnings and precautions”)
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 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
2 “Warnings and Precautions” and
section 4)
• 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 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.
• 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 or pharmacist 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
section 2 “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-6-phosphate 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
heartbeat 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 life-threatening liver failure
(including fatal cases, see section 4). 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) 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). 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 2. “Do not
take Moxifloxacin” and 4)
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 2. “Driving and using
machines“ and 4)
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)
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
2 “Do not take Moxifloxacin”).
Other medicines and Moxifloxacin
Tell your doctor or pharmacist if you are
taking/using, have recently taken/used or
might take/use any other medicines.
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), 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 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
may faint for a short period. If you are
affected 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.

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Moxifloxacin tablets are 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 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
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 “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 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. The most serious side effects
observed during treatment with
moxifloxacin are listed below:
If you notice
Rare: may affect up to 1 in 1,000 people
• an abnormal fast heart rhythm
• a severe, sudden generalised allergic
reaction incl. very rarely a life-threatening
shock (e.g. difficulty in breathing, drop
of blood pressure, fast pulse)
• swelling incl. swelling of the airway
(potentially life-threatening)
• convulsions
• troubles associated with the nervous
system such as pain, burning, tingling,
numbness and/or weakness in
extremities
• depression (in very rare cases leading
to self-harm, such as suicidal
ideations/thoughts, or suicide attempts)
• 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
• pain and swelling of the tendons
(tendonitis)
Very rare: may affect up to 1 in 10,000
people
• 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
(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) (potentially
life-threatening)
• insanity (potentially leading to
self-harm, such as suicidal
ideations/thoughts, or suicide attempts)
• a tendon rupture
stop taking Moxifloxacin and tell your
doctor immediately as you may need
urgent medical advice.
In addition
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.
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 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.
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, pharmacist or nurse. 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 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 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), 100 (Hospital pack)
film-coated 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 01/2017.
PL 00289/1617

14473-B

Expand Transcript

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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