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MOXIFLOXACIN 400MG FILM-COATED TABLETS

Active substance(s): MOXIFLOXACIN HYDROCHLORIDE

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Package leaflet: Information for the user

Moxifloxacin 400mg Film-coated 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 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 18 years of age
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
• 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’).
If the following bacterial infections have shown
improvement during initial treatment with
Moxifloxacin solution for infusion, Moxifloxacin
tablets may also be prescribed by your doctor to
complete the course of therapy:
• Infection of the lungs (pneumonia) acquired
outside the hospital,
• Infections of the skin and soft tissue.
Moxifloxacin tablets should not be used to initiate
therapy for any type of infections of the skin and
soft tissue or in severe infections of the lungs.

2 What you need to know before you take

Moxifloxacin

Do not take Moxifloxacin

• I f 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 breast-feeding.
• If you are younger than 18 years of age.
• If you have previously had problems with your
tendons related to treatment with quinolone
antibiotics (see ‘Warnings and Precautions’ and
section ‘4. Possible side effects’).
• If you have a severe liver disease or increased
liver enzymes (transaminases) higher than 5
times the upper normal limit.
• If you were born with or have any condition with
abnormal heart rhythm (seen on ECG, electrical
recording of the heart).
• If you have a salt imbalance in the blood
(especially low levels of potassium or magnesium
in the blood).
• If you have a very slow heart rhythm (called
‘bradycardia’).
• If you have a weak heart (heart failure).
• If you have a history of abnormal heart rhythms.
• If you are taking other medicines that result in
abnormal ECG changes (see ‘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.

Warnings and precautions
Talk to your doctor or pharmacist or nurse
before taking Moxifloxacin

• M
 oxifloxacin 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.
• If you suffer from epilepsy or a condition which
makes you likely to have convulsions, tell 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 tablets is not appropriate.
• For the treatment of mild to moderate
infections of the female upper genital
tract your doctor should prescribe another
antibiotic in addition to Moxifloxacin. If there
is no improvement in symptoms after 3 days of
treatment, please consult your doctor.
When taking Moxifloxacin
Be aware of this important information while taking
this medicine:
• 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.
continued top of next column

• T he 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 .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
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 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 ‘Do not take
Moxifloxacin’ and section ‘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 affected whilst taking
Moxifloxacin, consult an eye specialist
immediately (see ‘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 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 if you are taking,
have recently taken or might take other medicines.
In particular, when taking 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 (antiinflammatory 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 tablets.
Take your Moxifloxacin tablet 6 hours before or
after taking the other medicine.
• Taking any medicine containing charcoal at the
same time as Moxifloxacin tablets reduces the
action of Moxifloxacin. It is recommended that
these medicines are not used together.
• If you are currently taking medicines 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 may 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 breastfeeding, 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.

continued over page

Moxifloxacin 400mg tablet leaflet - UK

colours/plates:
1. Black

item no:

AAAG2846

dimensions:

print proof no:

3

pharmacode:

origination date: 25.11.13
approved for print/date

min pt size:

170 x 600

2.
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9, 10, 11

5.
6.

originated by:

DR

revision date:

28.11.13

Technical Approval

revised by:

DR

date sent:

supplier:

Pharmathen

technically app. date: 26.11.13

25.11.13

Non Printing Colours
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Driving and using machines

Moxifloxacin may make you feel dizzy or lightheaded, 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
Always take this medicine exactly as your doctor 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 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 length of 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) acquired
outside the hospital except severe cases 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 ‘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. 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 before your
prescription is finished 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
following side effects have been observed during
treatment with Moxifloxacin. The frequency of
possible side effects listed below is defined using
the following convention:
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
Very rare: may affect up to 1 in 10,000 people
Not known: frequency cannot be estimated from
the available data
Cardiac System (see 2.‘What you need to know
before you take Moxifloxacin’)
Common: Change of the heart rhythm (ECG) in
patients with low blood potassium level
Uncommon: Change of the heart rhythm (ECG),
palpitations, irregular and fast heartbeat, severe
heart rhythm abnormalities, chest pain (angina
pectoris)
Rare: Abnormal fast heart rhythm, fainting
Very rare: Abnormal heart rhythms, life-threatening
irregular heartbeat, stopping of heartbeat

Common

• I nfections caused by resistant bacteria or fungi,
e.g. oral and vaginal infections caused by
Candida (thrush)
• Headache
• Dizziness
• Feeling sick (nausea)
• Being sick (vomiting)
• Stomach and abdominal ache
• Diarrhoea
• Increase of a special liver enzyme in the blood
(transaminases)

Uncommon
























 llergic reaction
A
Low red blood cell count (anaemia)
Low white blood cells 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
Increased blood lipids (fats)
Feeling anxious, restless, or agitated
Tingling sensation (pins and needles) and/or
numbness
Changes in taste (in very rare cases loss of taste)
Feeling confused and disorientated
Sleep problems (e.g. sleeplessness or sleepiness)
Shaking
Sensation of dizziness (spinning or falling over)
Problems with vision (including double or
blurred vision)
Widening of the blood vessels (flushing)
Difficulty in breathing (including asthmatic
conditions)
Decreased appetite and food intake
Wind and constipation
Stomach upset (indigestion or heartburn)
Inflammation of the stomach
Increase of a special digestive enzyme in the
blood (amylase)

continued top of next column

• P
 roblems with liver function (including
increase of a special liver enzyme in the blood
(LDH)), increase of bilirubin in the blood,
increase of a special liver enzyme in the blood
(gamma-glutamyltransferase and/or alkaline
phosphatase)
• Itching, rash, skin hives, dry skin
• Joint pain, muscle pain
• Dehydration
• Feeling unwell (usually weakness or tiredness),
aches and pains such as back, chest, pelvic pains
and pains in the extremities
• Sweating.

Rare

• S evere, sudden allergic reaction including very
rarely life-threatening shock (e.g. difficulty
inbreathing, drop of blood pressure, fast pulse),
swelling (including potentially life-threatening
swelling of the airway)
• Severe diarrhoea containing blood and/or
mucus (antibiotic associated colitis including
pseudomembranous colitis), which very rarely,
may develop into complications that are
lifethreatening
• Jaundice (yellowing of the whites of the eyes or
skin), inflammation of the liver
• Pain and swelling of the tendons (tendonitis)
• Increased blood sugar
• Increased blood uric acid
• Feeling particularly emotional
• Depression (which in very rare cases may lead to
self-harm, such as suicidal ideations/thoughts, or
suicide attempts)
• Hallucination
• Problems with skin sensations
• Changes in smell (including loss of smell)
• Unusual dreams
• Problems with balance and co-ordination (due to
dizziness)
• Convulsions
• Disturbed concentration
• Problems with 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 or noise in the ears, hearing impairment
including deafness (usually reversible)
• High or low blood pressure
• Difficulty in swallowing
• Inflammation of the mouth
• Muscle cramps or twitching
• Muscle weakness
• Kidney problems (including an increase in
special kidney laboratory test results like urea
and creatinine), kidney failure
• Swelling (of the hands, feet, ankles, lips, mouth
or throat).
Very rare
• Severe inflammation of the liver potentially
leading to life-threatening liver failure (including
fatal cases)
• Changes to 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)
• Rupture of tendons
• Increased blood clotting, significant decrease of
special white blood cells (agranulocytosis)
• A feeling of self-detachment (not being yourself )
• Feeling mentally unwell (potentially leading to
self-harm, such as suicidal ideations/thoughts, or
suicide attempts)
• Transient loss of vision
• Skin feeling more sensitive
• Inflammation of joints
• Muscles feeling stiff
• Worsening of the symptoms of myasthenia
gravis (abnormal muscle fatigue leading to
weakness and in serious cases paralysis)
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.

If you feel you are suffering from a side
effect, especially if any of the side effects
get serious, or if you notice any side effects
not listed in this leaflet, please tell your
doctor or pharmacist immediately to get
advice before taking the next dose.
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 Yellow Card Scheme Website:
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.
Store in the original package in order to protect
from moisture.
Do not use Moxifloxacin film-coated tablets after
the expiry date {EXP} stated on the pack and blister.
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

• T he active substance is moxifloxacin. Each filmcoated tablet contains 400mg moxifloxacin,
corresponding to 436.37 mg moxifloxacin
hydrochloride.
• The other ingredients are:
Tablet core: Cellulose microcrystalline, Mannitol
(E421), Silica Colloidal anhydrous, Sodium Starch
Glycolate (Type A), Hydroxypropyl Cellulose, Talc
and Magnesium stearate.
Film coating: Polyvinyl alcohol part hydrolyzed
(E1203), Titanium dioxide (E171) Macrogol 3350/
PEG (E1521), Talc (E553b), Iron oxide yellow
(E172), Iron oxide red (E172)

What Moxifloxacin tablets looks like and
contents of the pack

Each tablet is presented as pink oblong biconvex
film coated tablet with a diameter 19.4 x 7.8 mm
and thickness 5.8 mm.
Moxifloxacin tablets are packaged in cartons
containing Aluminium/Aluminium blisters.
Marketing Authorisation Holder
Actavis Group PTC ehf. , Reykjavíkurvegi 76-78,
220 Hafnarfjörður, Iceland
Manufacturer
Pharmathen S.A, 6, Dervenakion str., 153 51,
Pallini Attiki, Greece
This leaflet was last revised in November 2013.

If you would like a
leaflet with larger
text, please contact
01271 385257.
AAAG2846

Moxifloxacin 400mg tablet leaflet - UK

colours/plates:
1. Black

item no:

AAAG2846

dimensions:

print proof no:

3

pharmacode:

origination date: 25.11.13
approved for print/date

min pt size:

170 x 600

2.
3.
4.

9, 10, 11

5.
6.

originated by:

DR

revision date:

28.11.13

Technical Approval

revised by:

DR

date sent:

supplier:

Pharmathen

technically app. date: 26.11.13

25.11.13

Non Printing Colours
1.
2.
3.

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