MOXIFLOXACIN 400 MG FILM-COATED TABLETS

Active substance: MOXIFLOXACIN HYDROCHLORIDE

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Package leaflet: Information for the user

Moxifloxacin 400 mg film-coated tablets.
Adults
Active substance: Moxifloxacin

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. 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 tablets are and what they
are used for
2. What you need to know before you take
Moxifloxacin tablets
3. How to take Moxifloxacin tablets
4. Possible side effects
5. How to store Moxifloxacin tablets
6. Contents of the pack and other information

1. What Moxifloxacin tablets are and what
they are used for

Moxifloxacin tablets contain the active substance
moxifloxacin, which belongs to a group of
antibiotics called fluoroquinolones. Moxifloxacin
tablets work by killing bacteria that cause infections.
Moxifloxacin tablets 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 tablets 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 tablets are not sufficient on their own
for treating this kind of infection. Therefore,
another antibiotic in addition to Moxifloxacin
tablets should be prescribed by your doctor for the
treatment of infections of the female upper genital
tract (see section 2.What you need to know before
you take Moxifloxacin tablets, Warnings and
precautions, Talk to your doctor before taking
Moxifloxacin tablets).
If the following bacterial infections have shown
improvement during initial treatment with a
solution of Moxifloxacin 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 tablets

Contact your doctor if you are not sure if you
belong to a patient group described below.
Do not take Moxifloxacin tablets
- 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. Further information).
- 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
tablets). This is because Moxifloxacin
tablets 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
tablets
- Moxifloxacin tablets 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
tablets (see also sections Do not take and
Other medicines and Moxifloxacin tablets).
- If you suffer from epilepsy or a condition which
makes you likely to have convulsions talk to
your doctor before taking Moxifloxacin tablets.
- If you have or have ever had any mental health
problems, consult your doctor before taking
Moxifloxacin tablets.
- 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
tablets is suitable for you.
- If you suffer from myasthenia gravis
(abnormal muscle fatigue leading to weakness
and in serious cases paralysis), taking
Moxifloxacin tablets may worsen the symptoms
of your disease. If you think you are affected
consult your doctor immediately.
- 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 tablets. If there is
no improvement in symptoms after 3 days of
treatment, please consult your doctor.
When taking Moxifloxacin tablets
- 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 tablets and seek medical advice
immediately.
- Moxifloxacin tablets 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 Moxifloxacin
tablets, may cause convulsions. If this happens,
stop taking Moxifloxacin tablets 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 tablets.
- You may experience mental health problems
even when taking quinolone antibiotics,
including Moxifloxacin tablets, 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 tablets and inform your doctor
immediately.
- You may develop diarrhoea whilst or after
taking antibiotics including Moxifloxacin
tablets. If this becomes severe or persistent or
you notice that your stool contains blood or
mucus you should stop taking Moxifloxacin
tablets immediately and consult your doctor.
You should not take medicines that stop or slow
down bowel movement.
• Moxifloxacin tablets may cause pain and
inflammation of your tendons, even within 48
hours of starting treatment and up to several
months after discontinuing Moxifloxacin tablets
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 tablets, 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
tablets...and 4. Possible side effects).
- If you are elderly and have kidney problems
make sure that you drink plenty whilst taking
Moxifloxacin tablets. 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 tablets, consult an eye specialist
immediately (see sections 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 tablets.
- The efficacy of Moxifloxacin tablets 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 tablets).
Other medicines and Moxifloxacin tablets
Tell your doctor or pharmacist about any other
medicines that you are taking, took recently or
might take.
For Moxifloxacin tablets be aware of the following:
- If you are taking Moxifloxacin tablets and other
medicines that affect your heart there is an
increased risk for altering your heart rhythm.
Therefore, do not take Moxifloxacin tablets
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. sparfloxacin,
saquinavir,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 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 tablets. 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 tablets with food and drink
Moxifloxacin tablets can be taken with or without
food (including dairy products).

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

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 tablets are for oral use. Swallow the
tablet whole (to mask the bitter taste) and with
plenty of liquid. You can take Moxifloxacin tablets
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 tablets 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 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 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 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 tablets 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 tablets.
The recommended dose and duration of treatment
should not be exceeded (see section 2. What you
need to know before you take Moxifloxacin
tablets, Warnings and precautions).
If you take more Moxifloxacin tablets 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 tablets
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 tablets
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
following side effects have been observed during
treatment with Moxifloxacin tablets.
The frequency of possible side effects listed below
is defined using the following convention:
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
Cardiac System (see section 2. What you need to
know before you take Moxifloxacin tablets)
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 side effects:
• Infections 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 ache
• Diarrhoea
• Increase of a special liver enzyme in the blood
(transaminases)
Uncommon side effects:
• Allergic reaction
• 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)
• Problems 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 (gammaglutamyl-transferase 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 side effects:
• Severe, sudden 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)
• Severe diarrhoea containing blood and/or
mucus (antibiotic associated colitis including
pseudomembranous colitis), which very rarely,
may develop into complications that are
life-threatening
• 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, oedema)
Very rare side effects:
• 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 tablets:
• 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 get any side effects , talk to your doctor or
pharmacist. This includes any side effects not listed
in this leaflet.

5. How to store Moxifloxacin tablets

Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date stated
on the blister and carton. The expiry date refers to
the last day of the month.
Store in the original package in order to protect
from moisture.
Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These
measures will help protect the environment.

6. Contents of the pack and other information
What Moxifloxacin tablets contain
- The active substance is moxifloxacin. Each
film-coated tablet contains 400mg moxifloxacin
as hydrochloride.
- The other ingredients are:
Tablet core: Microcrystalline cellulose,
Croscarmellose sodium, Copovidone
Pregelatinised starch, Talc, Silica colloidal
anhydrous and Magnesium stearate.
Film coating: Opadry II 85F18422: Macrogol 3350,
Red Iron Oxide (E172), Polyvinyl alcohol,
Titanium dioxide (E171), Talc.
What Moxifloxacin tablets look like and
contents of the pack
Each pale red coloured film coated tablet is capsule
shaped and embossed with “400” on one side.
Moxifloxacin tablets are packaged in cartons
containing aluminium/aluminium blister.
They are available in commercial packs of 5, 7, and
10 film-coated tablets and in hospital packs of 25,
50, 70, 80, or 100 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
DOUBLE-E PHARMA LTD. 7th Floor,
Hume House, Ballsbridge, Dublin 4, Ireland
Manufacturer:
Laboratoires BTT, ZI de Krafft, 67150 Erstein,
France
Distributed by:
Creo Pharma Ltd, Felsted Business Centre, Felsted,
Essex CM6 3LY, UK
This leaflet was last revised in 06/2013

CRE-MOX-PIL-044_05
20/06/2013

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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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