Avelox 400 mg film-coated tablets

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
Moxifloxacin
Available from:
Bayer Limited
ATC code:
J01MA; J01MA14
INN (International Name):
Moxifloxacin
Dosage:
400 milligram(s)
Pharmaceutical form:
Film-coated tablet
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Fluoroquinolones; moxifloxacin
Authorization status:
Marketed
Authorization number:
PA1410/027/001
Authorization date:
1999-12-10

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Package leaflet: Information for the patient

Avelox 400 mg film-coated tablets

For use in adults.

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 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

What Avelox is and what it is used for

What you need to know before you take Avelox

How to take Avelox

Possible side effects

How to store Avelox

Contents of the pack and other information

1.

What Avelox is and what it is used for

Avelox contains the active substance moxifloxacin which belongs to a group of antibiotics called

fluoroquinolones. Avelox works by killing bacteria that cause infections.

Avelox is used in patients of 18 years and older for treating the following bacterial infections when caused

by bacteria against which moxifloxacin is active. Avelox should only be used to treat these infections when

usual antibiotics cannot be used or have not worked:

Infection of the sinuses, sudden worsening of long term inflammation of the airways or infection of the lungs

(pneumonia) acquired outside the hospital (except severe cases).

Mild to moderate infections of the female upper genital tract (pelvic inflammatory disease), including

infections of the fallopian tubes and infections of the uterus mucous membrane.

Avelox tablets are not sufficient for sole therapy of this kind of infections and therefore another antibiotic in

addition to Avelox 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 Avelox, Warnings and precautions,

Talk to your doctor before taking Avelox

If the following bacterial infections have shown improvement during initial treatment with Avelox solution

for infusion, Avelox 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.

Avelox 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.

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2.

What you need to know before you take Avelox

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

Do not take Avelox

If you are allergic to the active substance moxifloxacin, any other quinolone antibiotics or any of the

other ingredients of this medicine (listed in section 6).

If you are pregnant or breast-feeding.

If you are under 18 years of age.

If you have a history of tendon disease or disorder which was related to treatment with quinolone

antibiotics (see sections

Warnings and precautions

4. Possible side effects

If you 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, or you are taking other medicines that result

in abnormal ECG changes (see section

Other medicines and Avelox

This is because Avelox can cause changes on the ECG, that is a prolongation of the QT-interval i.e.

delayed conduction of electrical signals.

If you have a severe liver disease or increased liver enzymes (transaminases) higher than 5 times the

upper normal limit.

Warnings and precautions

Before taking this medicine

You should not take fluoroquinolone/quinolone antibacterial medicines, including Avelox, if you have

experienced any serious adverse reaction in the past when taking a quinolone or fluoroquinolone. In this

situation, you should inform your doctor as soon as possible.

Talk to your doctor before taking Avelox

Avelox can

change your heart’s ECG

, especially if you are female, or if you are elderly. If you are

currently taking any

medicine that decreases your blood potassium levels

, consult your doctor

before taking Avelox (see also sections

Do not take Avelox

Other medicines and Avelox

If you have ever developed

a severe skin rash or skin peeling, blistering and/or mouth sores

after

taking moxifloxacin.

If you suffer from

epilepsy

or a condition which makes you likely to have

convulsions

, consult your

doctor before taking Avelox.

If you have or have ever had any

mental health problems

, consult your doctor before taking Avelox.

If you suffer from

myasthenia gravis

taking Avelox may worsen the symptoms of your disease. If

you think you are affected consult your doctor immediately.

If you have been diagnosed with an

enlargement or “bulge” of a large blood vessel

(aortic aneurysm

or large vessel peripheral aneurysm).

If you have experienced a previous episode of

aortic dissection

(a tear in the aorta wall).

If you have a family history of

aortic aneurysm or aortic dissection

or other risk factors or

predisposing conditions (e.g. connective tissue disorders such as Marfan syndrome, or vascular Ehlers-

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Danlos syndrome, or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behcet´s

disease, high blood pressure, or known atherosclerosis).

If you are

diabetic

because you may experience a risk of

change in blood sugar levels

with

moxifloxacin

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 Avelox is suitable for you.

If you have a

complicated infection of the female upper genital tract

(e.g. associated with an

abscess of the fallopian tubes and ovaries or of the pelvis), for which your doctor considers an

intravenous treatment necessary, treatment with Avelox 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 Avelox. If there is no improvement in symptoms

after 3 days of treatment, please consult your doctor.

When taking Avelox

If you experience

palpitations or irregular heart beat

during the period of treatment, you should

inform your doctor immediately. He/she may wish to perform an ECG to measure your heart rhythm.

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 Avelox and seek

medical advice immediately.

Avelox may cause a

rapid and severe inflammation of the liver

which could lead to life-threatening

liver failure (including fatal cases, see section

4. Possible side effects

). 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).

Serious skin reactions

Serious skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute

generalised exanthematous pustulosis (AGEP) have been reported with the use of moxifloxacin.

SJS/TEN can appear initially as reddish target-like spots or circular patches often with central

blisters on the trunk. Also, ulcers of mouth, throat, nose, genitals and eyes (red and swollen

eyes) can occur. These serious skin rashes are often preceded by fever and/or flu-like symptoms.

The rashes may progress to widespread peeling of the skin and life-threatening complications or

be fatal.

AGEP appears at the initiation of treatment as a red, scaly widespread rash with bumps under

the skin and blisters accompanied by fever. The most common location: mainly localized on the

skin folds, trunk, and upper extremities.

If you develop a serious rash or another of these skin symptoms, stop taking moxifloxacin and contact

your doctor or seek medical attention immediately.

Quinolone antibiotics, including Avelox, may cause

convulsions

. If this happens, stop taking Avelox

and contact your doctor immediately.

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Prolonged, disabling and potentially irreversible serious side effects.

Fluoroquinolone/quinolone

antibacterial medicines, including Avelox, have been associated with very rare but serious side effects,

some of them being long lasting (continuing months or years), disabling or potentially irreversible.

This includes tendon, muscle and joint pain of the upper and lower limbs, difficulty in walking,

abnormal sensations such as pins and needles, tingling, tickling, numbness or burning (paraesthesia),

sensory disorders including impairment of vision, taste and smell, and hearing, depression, memory

impairment, severe fatigue, and severe sleep disorders.

If you experience any of these side effects after taking Avelox, contact your doctor immediately prior

to continuing treatment. You and your doctor will decide on continuing the treatment considering also

an antibiotic from another class.

You may rarely experience

symptoms of nerve damage (neuropathy)

such as pain, burning, tingling,

numbness and/or weakness especially in the feet and legs or hands and arms. If this happens, stop

taking Avelox and inform your doctor immediately in order to prevent the development of potentially

irreversible condition.

You may experience

mental health problems

even when taking quinolone antibiotics, including

Avelox, for the first time. In very rare cases depression or mental health problems have led to suicidal

thoughts and self-injurious behaviour such as suicide attempts (see section

4. Possible side effects

). If

you develop such reactions, stop taking Avelox and inform your doctor immediately.

You may develop

diarrhoea

whilst taking, or after taking, antibiotics including Avelox. If this

becomes severe or persistent or you notice that your stool contains blood or mucus you should stop

taking Avelox immediately and consult your doctor. In this situation, you should not take medicines

that stop or slow down bowel movement.

Pain and swelling in the joints and inflammation or rupture of tendons

may occur rarely (see

sections

Do not take Avelox

4. Possible side effects

). Your risk is increased if you are elderly

(above 60 years of age), have received an organ transplant, have kidney problems or if you are being

treated with corticosteroids. Inflammation and ruptures of tendons may occur within the first 48 hours

of treatment and even up to several months after stopping of Avelox therapy. At the first sign of pain

or inflammation of a tendon (for example in your ankle, wrist, elbow, shoulder or knee), stop taking

Avelox, contact your doctor and rest the painful area. Avoid any unnecessary exercise as this might

increase the risk of a tendon rupture.

If you feel

sudden, severe pain in your abdomen, chest or back

, go immediately to an emergency

room.

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 your eyes seem to be otherwise affected, consult an eye

specialist immediately (see sections

Driving and using machines

4. Possible side effects).

Fluoroquinolone antibiotics may cause an

increase of your blood sugar levels

above normal levels

(hyperglycemia), or

lowering of your blood sugar levels

below normal levels (hypoglycaemia),

potentially leading to loss of consciousness (hypoglycaemic coma) in severe cases (see section

4. Possible side effects

). If you suffer from diabetes, your blood sugar should be carefully monitored

.

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Quinolone antibiotics may make your

skin

become more

sensitive to sunlight or UV light

. You

should avoid prolonged exposure to sunlight or strong sunlight and should not use a sunbed or any

other UV lamp while taking Avelox.

The efficacy of 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 Avelox

Other medicines and Avelox

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines

besides Avelox.

For Avelox, be aware of the following:

If you are taking Avelox and other medicines that affect your heart there is an increased risk for

altering your heart rhythm. Therefore, do not take Avelox together with the following medicines:

Medicines that belong to the group of 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), and other medicines (e.g. cisapride, intravenous vincamine,

bepridil and diphemanil).

You must tell your doctor if you are taking other medicines that can lower your blood potassium levels

(e.g. some diuretics, some laxatives and enemas [high doses] or corticosteroids [anti-inflammatory

drugs], amphotericin B) or cause a slow heart rate because these can also increase the risk of serious

heart rhythm disturbances while taking Avelox.

Any medicine containing magnesium or aluminium such as antacids for indigestion, or any medicine

containing iron or zinc, medicine containing didanosine or medicine containing sucralfate to treat

gastrointestinal disorders can reduce the action of Avelox tablets. Therefore, take your Avelox tablet 6

hours before or after taking the other medicine.

Taking oral medicinal charcoal at the same time as Avelox tablets reduces the action of Avelox.

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.

Avelox with food and drink

The effect of Avelox is not influenced by food including dairy products.

Pregnancy, breast-feeding and fertility

Do not take Avelox if you are pregnant or breast-feeding.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your

doctor or pharmacist for advice before taking this medicine.

Animal studies do not indicate that your fertility will be impaired by taking this medicine.

Driving and using machines

Avelox may make you feel dizzy or light-headed, you may experience a sudden, transient loss of vision, or

you might faint for a short period. If you are affected in this way do not drive or operate machinery.

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Avelox contains lactose and sodium

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before

taking Avelox.

This medicine contains less than 1 millimole sodium (23 milligrams) per film-coated tablet, that is to say

essentially “sodium-free”.

3.

How to take Avelox

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or

pharmacist if you are not sure.

The recommended dose for adults is one 400 mg film-coated tablet once daily.

Avelox tablets are for oral use. Swallow the tablet as a whole (to mask the bitter taste) and with plenty of

liquid. You can take Avelox with or without food. It is recommended that you take the 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 Avelox film-coated tablets are:

Sudden worsening of chronic bronchitis (acute exacerbation of chronic obstructive pulmonary disease

including 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 Avelox film-coated tablets are used to complete a course of therapy started with Avelox solution for

infusion, the recommended durations of use are:

Infection of the lungs (pneumonia) acquired outside the hospital

7 - 14 days

Most patients with pneumonia were switched to oral treatment with Avelox 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 Avelox

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

2. What you need to

know before you take Avelox

Warnings and precautions

If you take more Avelox than you should

If you take more than the prescribed one tablet a day, 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.

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If you forget to take Avelox

If you forget to take your tablet you should take it as soon as you remember on the same day. If you do not

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 Avelox

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.

most serious side effects

observed during the treatment with Avelox are listed below:

If you notice

an abnormal fast heart rhythm (rare side effect)

that you suddenly start feeling unwell or notice yellowing of the whites of the eyes, dark urine, itching

of the skin, a tendency to bleed or disturbances of thought or wakefulness (these can be signs and

symptoms of fulminant inflammation of the liver potentially leading to life-threating liver failure (very

rare side effect, fatal cases have been observed))

serious skin rashes including Stevens-Johnson syndrome and toxic epidermal necrolysis. These can

appear as reddish target-like macules or circular patches often with central blisters on the trunk, skin

peeling, ulcers of mouth, throat, nose, genitals and eyes and can be preceded by fever and flu-like

symptoms (very rare side effects, potentially life-threatening).

a red, scaly widespread rash with bumps under the skin and blisters accompanied by fever at the

initiation of treatment (acute generalised exanthematous pustulosis) (frequency of this side effect is

“not known”)

syndrome associated with impaired water excretion and low levels of sodium (SIADH) (very rare side

effect)

loss of consciousness due to severe decrease in blood sugar levels (hypoglycaemic coma) (very rare

side effect)

inflammation of blood vessels (signs could be red spots on your skin, usually on your lower legs or

effects like joint pain) (very rare side effect)

a severe, sudden generalised allergic reaction incl. very rarely a life-threatening shock (e.g. difficulty

in breathing, drop of blood pressure, fast pulse) (rare side effect)

swelling incl. swelling of the airway (rare side effect, potentially life-threatening)

convulsions (rare side effect)

troubles associated with the nervous system such as pain, burning, tingling, numbness and/or

weakness in extremities (rare side effect)

depression (in very rare cases leading to self-harm, such as suicidal ideations/thoughts, or suicide

attempts) (rare side effect)

insanity (potentially leading to self-harm, such as suicidal ideations/thoughts, or suicide attempts)

(very rare side effect)

severe diarrhoea containing blood and/or mucus (antibiotic associated colitis incl. pseudomembranous

colitis), which in very rare circumstances, may develop into complications that are life-threatening

(rare side effects)

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pain and swelling of the tendons (tendonitis) (rare side effect) or a tendon rupture (very rare side

effect)

muscle weakness, tenderness or pain and particularly, if at the same time, you feel unwell, have a high

temperature or have dark urine. They may be caused by an abnormal muscle breakdown which can be

life threatening and lead to kidney problems (a condition called rhabdomyolysis) (frequency of this

side effect is “not known”).

stop taking Avelox and tell your doctor immediately

as you may need urgent medical advice.

In addition, if you notice

transient loss of vision (very rare side effect),

discomfort or pain to the eyes, especially due to light exposure (very rare to rare side effect)

contact an eye specialist immediately

If you have experienced life-threatening irregular heart beat (Torsade de Pointes) or stopping of heart beat

while taking Avelox (very rare side effects),

tell your treating doctor immediately that you have taken

Avelox and do not restart the treatment.

A worsening of the symptoms of myasthenia gravis has been observed in very rare cases. If this happens,

consult your doctor immediately

If you suffer from diabetes and you notice that your blood sugar is increased or decreased (rare or very rare

side effect),

inform your doctor immediately

If you are elderly with existing kidney problems and you notice decrease in urine output, swelling in your

legs, ankles or feet, fatigue, nausea, drowsiness, shortness of breath or confusion (these can be signs and

symptoms of kidney failure, a rare side effect),

consult your doctor immediately.

Other side effects

which have been observed during treatment with Avelox are listed below by how likely

they are:

Common

(may affect up to 1 in 10 people)

nausea

diarrhoea

dizziness

stomach and abdominal ache

vomiting

headache

increase of a special liver enzyme in the blood (transaminases)

infections caused by resistant bacteria or fungi e.g. oral and vaginal infections caused by Candida

change of the heart rhythm (ECG) in patients with low blood potassium level

Uncommon

(may affect up to 1 in 100 people)

rash

stomach upset (indigestion/heartburn)

changes in taste (in very rare cases loss of taste)

sleep problems (predominantly sleeplessness)

increase of a special liver enzyme in the blood (gamma-glutamyl-transferase and/or alkaline

phosphatase)

low number of special white blood cells (leukocytes, neutrophils)

constipation

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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

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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)

a drop in the number of red and white blood cells and platelets (pancytopenia)

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)

Very rare cases of long lasting (up to months or years) or permanent adverse drug reactions, such as tendon

inflammations, tendon rupture, joint pain, pain in the limbs, difficulty in walking, abnormal sensations such

as pins and needles, tingling, tickling, burning, numbness or pain (neuropathy), depression, fatigue, sleep

disorders, memory impairment, as well as impairment of hearing, vision, and taste and smell have been

associated with administration of quinolone and fluoroquinolone antibiotics, in some cases irrespective of

pre-existing risk factors.

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 Avelox: raised pressure in

the skull (symptoms include headache, visual problems including blurred vision, “blind” spots, double

vision, loss of vision), increased blood sodium levels, increased blood calcium levels, a special type of

reduced red blood cell count (haemolytic anaemia), increased sensitivity of the skin to sunlight or UV light.

Health Products Regulatory Authority

17 June 2020

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Page 1 of 15

Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Avelox 400 mg film-coated tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

1 film-coated tablet contains 400 mg moxifloxacin (as hydrochloride).

Excipient with known effect: The film-coated tablet contains 68mg lactose monohydrate (=66.56mg lactose) (see section 4.4)

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Film-coated tablet

Dull red film-coated tablet with an oblong, convex shape with facet, a dimension of 17 x 7 mm, and marked with “M400” on

one side and “BAYER” on the other side.

4 CLINICAL PARTICULARS

4.1 Therapeutic Indications

Avelox 400 mg film-coated tablets are indicated for the treatment of the following bacterial infections in patients of 18 years

and older caused by bacteria susceptible to moxifloxacin (see sections 4.4, 4.8 and 5.1).

In the following indications, Moxifloxacin should be used only when it is considered inappropriate to use other antibacterial

agents that are commonly recommended for the treatment of these infections:

- Acute bacterial sinusitis

- Acute exacerbation of chronic obstructive pulmonary disease including bronchitis

In the following indications, Moxifloxacin should be used only when it is considered inappropriate to use antibacterial agents

that are commonly recommended for the initial treatment of these infections or when these have failed:

- Community acquired pneumonia, except severe cases

- Mild to moderate pelvic inflammatory disease (i.e. infections of female upper genital tract, including

salpingitis and endometritis), without an associated tubo-ovarian or pelvic abscess. Avelox 400 mg

film-coated tablets are not recommended for use in monotherapy of mild to moderate pelvic inflammatory

disease but should be given in combination with another appropriate antibacterial agent (e.g. a cephalosporin)

due to increasing moxifloxacin resistance of Neisseria gonorrhoeae unless moxifloxacin-resistant Neisseria

gonorrhoeae can be excluded (see sections 4.4 and 5.1).

Avelox 400 mg film-coated tablets may also be used to complete a course of therapy in patients who have shown

improvement during initial treatment with intravenous moxifloxacin for the following indications:

- Community-acquired pneumonia

- Complicated skin and skin structure infections

Avelox 400 mg film-coated tablets should not be used to initiate therapy for any type of skin and skin structure

infection or in severe community-acquired pneumonia.

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

4.2 Posology and method of administration

Posology (adults)

The recommended dose is one 400 mg film-coated tablet once daily.

Renal/hepatic impairment

Health Products Regulatory Authority

17 June 2020

CRN009TCM

Page 2 of 15

No adjustment of dosage is required in patients with mild to severely impaired renal function or in patients on chronic dialysis

i.e. haemodialysis and continuous ambulatory peritoneal dialysis (see section 5.2 for more details).

There is insufficient data in patients with impaired liver function (see section 4.3).

Other special populations

No adjustment of dosage is required in the elderly and in patients with low bodyweight.

Paediatric population

Moxifloxacin is contraindicated in children and adolescents (< 18 years). Efficacy and safety of moxifloxacin in children and

adolescents have not been established (see section 4.3).

Method of administration

The film-coated tablet should be swallowed whole with sufficient liquid and may be taken independent of meals.

Duration of administration

Avelox 400 mg film-coated tablets should be used for the following treatment durations:

- Acute exacerbation of chronic obstructive pulmonary disease

including bronchitis 5 - 10 days

- Community acquired pneumonia 10 days

- Acute bacterial sinusitis 7 days

- Mild to moderate pelvic inflammatory disease 14 days

Avelox 400 mg film-coated tablets have been studied in clinical trials for up to 14 days treatment.

Sequential (intravenous followed by oral) therapy

In clinical studies with sequential therapy most patients switched from intravenous to oral therapy within 4 days

(community-acquired pneumonia) or 6 days (complicated skin and skin structure infections). The recommended total duration

of intravenous and oral treatment is 7 – 14 days for community-acquired pneumonia and 7 – 21 days for complicated skin and

skin structure infections.

The recommended dose (400 mg once daily) and duration of therapy for the indication being treated should not be exceeded.

4.3 Contraindications

- Hypersensitivity to moxifloxacin, other quinolones or to any of the excipients listed in section 6.1.

- Pregnancy and lactation (see section 4.6).

- Patients below 18 years of age.

- Patients with a history of tendon disease/disorder related to quinolone treatment.

Both in preclinical investigations and in humans, changes in cardiac electrophysiology have been observed following exposure

to moxifloxacin, in the form of QT prolongation. For reasons of drug safety, moxifloxacin is therefore contraindicated in

patients with:

- Congenital or documented acquired QT prolongation

- Electrolyte disturbances, particularly in uncorrected hypokalaemia

- Clinically relevant bradycardia

- Clinically relevant heart failure with reduced left-ventricular ejection fraction

- Previous history of symptomatic arrhythmias

Moxifloxacin should not be used concurrently with other drugs that prolong the QT interval (see also section 4.5).

Due to limited clinical data, moxifloxacin is also contraindicated in patients with impaired liver function (Child Pugh C) and in

patients with transaminases increase > 5fold ULN.

4.4 Special warnings and precautions for use

The use of moxifloxacin should be avoided in patients who have experienced serious adverse reactions in the past when using

quinolone or fluoroquinolone containing products (see section 4.8). Treatment of these patients with moxifloxacin should only

be initiated in the absence of alternative treatment options and after careful benefit/risk assessment (see also section 4.3).

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The benefit of moxifloxacin treatment especially in infections with a low degree of severity should be balanced with the

information contained in the warnings and precautions section.

Prolongation of QTc interval and potentially QTc-prolongation-related clinical conditions

Moxifloxacin has been shown to prolong the QTc interval on the electrocardiogram in some patients. In the analysis of ECGs

obtained in the clinical trial program, QTc prolongation with moxifloxacin was 6 msec ± 26 msec, 1.4% compared to baseline.

As women tend to have a longer baseline QTc interval compared with men, they may be more sensitive to QTc-prolonging

medications. Elderly patients may also be more susceptible to drug-associated effects on the QT interval.

Medication that can reduce potassium levels should be used with caution in patients receiving moxifloxacin (see also

sections 4.3 and 4.5).

Moxifloxacin should be used with caution in patients with ongoing proarrhythmic conditions (especially women and elderly

patients), such as acute myocardial ischaemia or QT prolongation as this may lead to an increased risk for ventricular

arrhythmias (incl. torsade de pointes) and cardiac arrest (see also section 4.3). The magnitude of QT prolongation may increase

with increasing concentrations of the drug. Therefore, the recommended dose should not be exceeded.

If signs of cardiac arrhythmia occur during treatment with moxifloxacin, treatment should be stopped and an ECG should be

performed.

Hypersensitivity/allergic reactions

Hypersensitivity and allergic reactions have been reported for fluoroquinolones including moxifloxacin after first administration.

Anaphylactic reactions can progress to a life-threatening shock, even after the first administration. In cases of clinical

manifestations of severe hypersensitivity reactions moxifloxacin should be discontinued and suitable treatment (e.g. treatment

for shock) initiated.

Severe liver disorders

Cases of fulminant hepatitis potentially leading to liver failure (including fatal cases) have been reported with moxifloxacin (see

section 4.8). Patients should be advised to contact their doctor prior to continuing treatment if signs and symptoms of

fulminant hepatic disease develop such as rapidly developing asthenia associated with jaundice, dark urine, bleeding tendency

or hepatic encephalopathy.

Liver function tests/investigations should be performed in cases where indications of liver dysfunction occur.

Severe cutaneous adverse reactions

Severe cutaneous adverse reactions (SCARs) including toxic epidermal necrolysis (TEN: also known as Lyell's syndrome),

Stevens Johnson syndrome (SJS) and Acute Generalised Exanthematous Pustulosis (AGEP), which could be life-threatening or

fatal, have been reported with moxifloxacin (see section 4.8). At the time of prescription, patients should be advised of the

signs and symptoms of severe skin reactions and be closely monitored. If signs and symptoms suggestive of these reactions

appear, moxifloxacin should be discontinued immediately, and an alternative treatment should be considered. If the patient

has developed a serious reaction such as SJS, TEN or AGEP with the use of moxifloxacin, treatment with moxifloxacin must not

be restarted in this patient at any time

Patients predisposed to seizures

Quinolones are known to trigger seizures. Use should be with caution in patients with CNS disorders or in the presence of

other risk factors which may predispose to seizures or lower the seizure threshold. In case of seizures, treatment with

moxifloxacin should be discontinued and appropriate measures instituted.

Prolonged, disabling and potentially irreversible serious adverse drug reactions

Very rare cases of prolonged (continuing months or years), disabling and potentially irreversible serious adverse drug reactions

affecting different, sometimes multiple, body systems (musculoskeletal, nervous, psychiatric and senses) have been reported in

patients receiving quinolones and fluoroquinolones irrespective of their age and pre-existing risk factors. Moxifloxacin should

be discontinued immediately at the first signs or symptoms of any serious adverse reaction and patients should be advised to

contact their prescriber for advice.

Peripheral neuropathy

Cases of sensory or sensorimotor polyneuropathy resulting in paraesthesia, hypaesthesia, dysaesthesia, or weakness have been

reported in patients receiving quinolones and fluoroquinolones. Patients under treatment with moxifloxacin should be advised

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to inform their doctor prior to continuing treatment if symptoms of neuropathy such as pain, burning, tingling, numbness, or

weakness develop in order to prevent the development of potentially irreversible condition (see section 4.8).

Psychiatric reactions

Psychiatric reactions may occur even after the first administration of quinolones, including moxifloxacin. In very rare cases

depression or psychotic reactions have progressed to suicidal thoughts and self-injurious behaviour such as suicide attempts

(see section 4.8). In the event that the patient develops these reactions, moxifloxacin should be discontinued and appropriate

measures instituted. Caution is recommended if moxifloxacin is to be used in psychotic patients or in patients with history of

psychiatric disease.

Antibiotic-associated diarrhoea incl. colitis

Antibiotic-associated diarrhoea (AAD) and antibiotic-associated colitis (AAC), including pseudomembranous colitis and

Clostridium difficile-associated diarrhoea, has been reported in association with the use of broad spectrum antibiotics including

moxifloxacin and may range in severity from mild diarrhoea to fatal colitis. Therefore it is important to consider this diagnosis

in patients who develop serious diarrhoea during or after the use of moxifloxacin. If AAD or AAC is suspected or confirmed,

ongoing treatment with antibacterial agents, including moxifloxacin, should be discontinued and adequate therapeutic

measures should be initiated immediately. Furthermore, appropriate infection control measures should be undertaken to

reduce the risk of transmission. Drugs inhibiting peristalsis are contraindicated in patients who develop serious diarrhoea.

Patients with myasthenia gravis

Moxifloxacin should be used with caution in patients with myasthenia gravis because the symptoms can be exacerbated.

Tendinitis and tendon rupture

Tendinitis and tendon rupture (especially but not limited to Achilles tendon), sometimes bilateral, may occur as early as within

48 hours of starting treatment with quinolones and fluoroquinolones and have been reported to occur even up to several

months after discontinuation of treatment (see sections 4.3 and 4.8). The risk of tendinitis and tendon rupture is increased in

older patients, patients with renal impairment, patients with solid organ transplants, and those treated concurrently with

corticosteroids. Therefore, concomitant use of corticosteroids should be avoided.

At the first sign of tendinitis (e.g. painful swelling, inflammation) the treatment with moxifloxacin should be discontinued and

alternative treatment should be considered. The affected limb(s) should be appropriately treated (e.g. immobilisation).

Corticosteroids should not be used if signs of tendinopathy occur.

Aortic aneurysm and dissection

Epidemiologic studies report an increased risk of aortic aneurysm and dissection after intake of fluoroquinolones, particularly in

the older population.

Therefore, fluoroquinolones should only be used after careful benefit-risk assessment and after consideration of other

therapeutic options in patients with positive family history of aneurysm disease, or in patients diagnosed with pre-existing

aortic aneurysm and/or aortic dissection, or in presence of other risk factors or conditions predisposing for aortic aneurysm

and dissection (e.g. Marfan syndrome, vascular Ehlers-Danlos syndrome, Takayasu arteritis, giant cell arteritis, Behcet´s disease,

hypertension, known atherosclerosis).

In case of sudden abdominal, chest or back pain, patients should be advised to immediately consult a physician in an

emergency department.

Patients with renal impairment

Elderly patients with renal disorders should use moxifloxacin with caution if they are unable to maintain adequate fluid intake,

because dehydration may increase the risk of renal failure.

Vision disorders

If vision becomes impaired or any effects on the eyes are experienced, an eye specialist should be consulted immediately (see

sections 4.7 and 4.8).

Dysglycemia

As with all fluoroquinolones, disturbances in blood glucose, including both hypoglycemia and hyperglycemia have been

reported with moxifloxacin (see section 4.8). In moxifloxacin-treated patients, dysglycemia occurred predominantly in elderly

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diabetic patients receiving concomitant treatment with an oral hypoglycemic agent (e.g. sulfonylurea) or with insulin. Cases of

hypoglycaemic coma have been reported. In diabetic patients, careful monitoring of blood glucose is recommended.

Prevention of photosensitivity reactions

Quinolones have been shown to cause photosensitivity reactions in patients. However, studies have shown that moxifloxacin

has a lower risk to induce photosensitivity. Nevertheless patients should be advised to avoid exposure to either UV irradiation

or extensive and/or strong sunlight during treatment with moxifloxacin.

Patients with glucose-6-phosphate dehydrogenase deficiency

Patients with a family history of or actual glucose-6-phosphate dehydrogenase deficiency are prone to haemolytic reactions

when treated with quinolones. Therefore, moxifloxacin should be used with caution in these patients.

Patients with pelvic inflammatory disease

For patients with complicated pelvic inflammatory disease (e.g. associated with a tubo-ovarian or pelvic abscess), for whom an

intravenous treatment is considered necessary, treatment with Avelox 400 mg film-coated tablets is not recommended.

Pelvic inflammatory disease may be caused by fluoroquinolone-resistant Neisseria gonorrhoeae. Therefore in such cases

empirical moxifloxacin should be co-administered with another appropriate antibiotic (e.g. a cephalosporin) unless

moxifloxacin-resistant Neisseria gonorrhoeae can be excluded. If clinical improvement is not achieved after 3 days of treatment,

the therapy should be reconsidered.

Patients with special cSSSI

Clinical efficacy of intravenous moxifloxacin in the treatment of severe burn infections, fasciitis and diabetic foot infections with

osteomyelitis has not been established.

Interference with biological tests

Moxifloxacin therapy may interfere with the Mycobacterium spp. culture test by suppression of mycobacterial growth causing

false negative results in samples taken from patients currently receiving moxifloxacin.

Patients with MRSA infections

Moxifloxacin is not recommended for the treatment of MRSA infections. In case of a suspected or confirmed infection due to

MRSA, treatment with an appropriate antibacterial agent should be started (see section 5.1).

Paediatric population

Due to adverse effects on the cartilage in juvenile animals (see section 5.3) the use of moxifloxacin in children and adolescents

< 18 years is contraindicated (see section 4.3).

Information about excipients

Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption

should not take this medicine.

This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially "sodium-free".

4.5 Interaction with other medicinal products and other forms of interactions

Interactions with medicinal products

An additive effect on QT interval prolongation of moxifloxacin and other medicinal products that may prolong the QTc interval

cannot be excluded. This might lead to an increased risk of ventricular arrhythmias, including torsade de pointes. Therefore,

co-administration of moxifloxacin with any of the following medicinal products is contraindicated (see also section 4.3):

- anti-arrhythmics class IA (e.g. quinidine, hydroquinidine, disopyramide)

- anti-arrhythmics class III (e.g. amiodarone, sotalol, dofetilide, ibutilide)

- antipsychotics (e.g. phenothiazines, pimozide, sertindole, haloperidol, sultopride)

- tricyclic antidepressive agents

- certain antimicrobial agents (saquinavir, sparfloxacin, erythromycin IV, pentamidine, antimalarials particularly halofantrine)

- certain antihistaminics (terfenadine, astemizole, mizolastine)

- others (cisapride, vincamine IV, bepridil, diphemanil).

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Moxifloxacin should be used with caution in patients who are taking medication that can reduce potassium levels (e.g. loop

and thiazide-type diuretics, laxatives and enemas [high doses], corticosteroids, amphotericin B) or medication that is associated

with clinically significant bradycardia.

An interval of about 6 hours should be left between administration of agents containing bivalent or trivalent cations (e.g.

antacids containing magnesium or aluminium, didanosine tablets, sucralfate and agents containing iron or zinc) and

administration of moxifloxacin.

Concomitant administration of charcoal with an oral dose of 400 mg moxifloxacin led to a pronounced prevention of drug

absorption and a reduced systemic availability of the drug by more than 80%. Therefore, the concomitant use of these two

drugs is not recommended (except for overdose cases, see also section 4.9).

After repeated dosing in healthy volunteers, moxifloxacin increased C

of digoxin by approximately 30% without affecting

AUC or trough levels. No precaution is required for use with digoxin.

In studies conducted in diabetic volunteers, concomitant administration of oral moxifloxacin with glibenclamide resulted in a

decrease of approximately 21% in the peak plasma concentrations of glibenclamide. The combination of glibenclamide and

moxifloxacin could theoretically result in a mild and transient hyperglycaemia. However, the observed pharmacokinetic

changes for glibenclamide did not result in changes of the pharmacodynamic parameters (blood glucose, insulin). Therefore no

clinically relevant interaction was observed between moxifloxacin and glibenclamide.

Changes in INR

A large number of cases showing an increase in oral anticoagulant activity have been reported in patients receiving

antibacterial agents, especially fluoroquinolones, macrolides, tetracyclines, cotrimoxazole and some cephalosporins. The

infectious and inflammatory conditions, age and general status of the patient appear to be risk factors. Under these

circumstances, it is difficult to evaluate whether the infection or the treatment caused the INR (international normalised ratio)

disorder. A precautionary measure would be to more frequently monitor the INR. If necessary, the oral anticoagulant dosage

should be adjusted as appropriate.

Clinical studies have shown no interactions following concomitant administration of moxifloxacin with: ranitidine, probenecid,

oral contraceptives, calcium supplements, morphine administered parenterally, theophylline, cyclosporine or itraconazole.

In vitro studies with human cytochrome P450 enzymes supported these findings. Considering these results a metabolic

interaction via cytochrome P450 enzymes is unlikely.

Interaction with food

Moxifloxacin has no clinically relevant interaction with food including dairy products.

4.6 Fertility, pregnancy and lactation

Pregnancy

The safety of moxifloxacin in human pregnancy has not been evaluated. Animal studies have shown reproductive toxicity (see

section 5.3). The potential risk for humans is unknown. Due to the experimental risk of damage by fluoroquinolones to the

weight-bearing cartilage of immature animals and reversible joint injuries described in children receiving some

fluoroquinolones, moxifloxacin must not be used in pregnant women (see section 4.3).

Breastfeeding

There is no data available in lactating or nursing women. Preclinical data indicate that small amounts of moxifloxacin are

secreted in milk. In the absence of human data and due to the experimental risk of damage by fluoroquinolones to the

weight-bearing cartilage of immature animals, breast-feeding is contraindicated during moxifloxacin therapy (see section 4.3).

Fertility

Animal studies do not indicate impairment of fertility (see section 5.3).

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4.7 Effects on ability to drive and use machines

No studies on the effects of moxifloxacin on the ability to drive and use machines have been performed. However,

fluoroquinolones including moxifloxacin may result in an impairment of the patient's ability to drive or operate machinery due

to CNS reactions (e.g. dizziness; acute, transient loss of vision, see section 4.8) or acute and short lasting loss of consciousness

(syncope, see section 4.8). Patients should be advised to see how they react to moxifloxacin before driving or operating

machinery.

4.8 Undesirable effects

Adverse reactions based on all clinical trials and derived from post-marketing reports with moxifloxacin 400 mg (oral and

sequential therapy) sorted by frequencies are listed below:

Apart from nausea and diarrhoea all adverse reactions were observed at frequencies below 3%.

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Frequencies are defined

- common (≥ 1/100 to < 1/10)

- uncommon (≥ 1/1,000 to < 1/100)

- rare (≥ 1/10,000 to < 1/1,000)

- very rare (< 1/10,000)

- not known (cannot be estimated from the available data)

System Organ

Class (MedDRA)

Common

Uncommon

Rare

Very Rare

Not known

Infections and

infestations

Superinfections due to

resistant bacteria or

fungi e.g. oral and

vaginal candidiasis

Blood and

lymphatic

system disorders

Anaemia

Leucopenia(s)

Neutropenia

Thrombocytopenia

Thrombocythemia

Blood eosinophilia

Prothrombin time

prolonged/INR

increased

Prothrombin level

increased/INR

decreased

Agranulocytosis

Pancytopenia

Immune system

disorders

Allergic reaction

(see section 4.4)

Anaphylaxis incl. very

rarely

life-threatening

shock (see section

4.4) Allergic

oedema/

angiooedema (incl.

laryngeal oedema,

potentially

life-threatening, see

section 4.4)

Endocrine

disorders

Syndrome of

inappropriate

antidiuretic

hormone

secretion (SIADH)

Metabolism and

nutrition

disorders

Hyperlipidemia

Hyperglycemia

Hyperuricemia

Hypoglycemia

Hypoglycaemic

coma

Psychiatric

disorders*

Anxiety reactions

Psychomotor

Emotional lability

Depression (in very

Depersonalization

Psychotic

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hyperactivity/

agitation

rare cases potentially

culminating in

self-injurious

behaviour, such as

suicidal ideations/

thoughts, or suicide

attempts, see section

4.4)

Hallucination

Delirium

reactions

(potentially

culminating in

self-injurious

behaviour, such

as suicidal

ideations/

thoughts, or

suicide attempts,

see section 4.4)

Nervous system

disorders*

Headache

Dizziness

Par- and

Dysaesthesia

Taste disorders

(incl. ageusia in

very rare cases)

Confusion and

disorientation

Sleep disorders

(predominantly

insomnia)

Tremor

Vertigo

Somnolence

Hypoaesthesia

Smell disorders (incl.

anosmia)

Abnormal dreams

Disturbed

coordination (incl.

gait disturbances,

esp. due to dizziness

or vertigo)

Seizures incl. grand

mal convulsions (see

section 4.4)

Disturbed attention

Speech disorders

Amnesia

Peripheral

neuropathy and

polyneuropathy

Hyperaesthesia

Eye disorders*

Visual

disturbances incl.

diplopia and

blurred vision

(especially in the

course of CNS

reactions, see

section 4.4)

Photophobia

Transient loss of

vision (especially

in the course of

CNS reactions,

see sections 4.4

and 4.7)

Uveitis and

bilateral acute iris

transillumination

(see section 4.4)

Ear and

labyrinth

disorders*

Tinnitus

Hearing impairment

incl. deafness

(usually reversible)

Cardiac

disorders

QT prolongation in

patients with

hypokalaemia (see

sections 4.3 and 4.4)

QT prolongation

(see section 4.4)

Palpitations

Tachycardia

Atrial fibrillation

Angina pectoris

Ventricular

tachyarrhythmias

Syncope (i.e., acute

and short lasting loss

of consciousness)

Unspecified

arrhythmias

Torsade de

Pointes (see

section 4.4)

Cardiac arrest

(see section 4.4)

Vascular

disorders

Vasodilatation

Hypertension

Hypotension

Vasculitis

Respiratory,

thoracic and

mediastinal

disorders

Dyspnea

(including

asthmatic

conditions)

Gastrointestinal

disorders

Nausea

Vomiting

Gastrointestinal and

abdominal pains

Decreased

appetite and food

intake

Constipation

Dysphagia

Stomatitis

Antibiotic associated

colitis (incl.

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Diarrhoea

Dyspepsia

Flatulence

Gastritis

Increased amylase

pseudomembranous

colitis, in very rare

cases associated with

life-threatening

complications, see

section 4.4)

Hepatobiliary

disorders

Increase in

transaminases

Hepatic

impairment (incl.

LDH increase)

Increased bilirubin

Increased

gamma-glutamyl-t

ransferase

Increase in blood

alkaline

phosphatase

Jaundice

Hepatitis

(predominantly

cholestatic)

Fulminant

hepatitis

potentially

leading to

life-threatening

liver failure (incl.

fatal cases, see

section 4.4)

Skin and

subcutaneous

tissue disorders

Pruritus

Rash

Urticaria

Dry skin

Bullous skin

reactions like

Stevens-Johnson

syndrome or

toxic epidermal

necrolysis

(potentially

life-threatening,

see section 4.4)

Acute

Generalised

Exanthematous

Pustulosis

(AGEP)

Musculoskeletal

and connective

tissue disorders*

Arthralgia

Myalgia

Tendonitis (see

section 4.4)

Muscle cramp

Muscle twitching

Muscle weakness

Tendon rupture

(see section 4.4)

Arthritis

Muscle rigidity

Exacerbation of

symptoms of

myasthenia gravis

(see section 4.4)

Rhabdomyolysis

Renal and

urinary

disorders

Dehydration

Renal impairment

(incl. increase in BUN

and creatinine)

Renal failure (see

section 4.4)

General

disorders and

administration

site conditions*

Feeling unwell

(predominantly

asthenia or

fatigue)

Painful conditions

(incl. pain in back,

chest, pelvic and

extremities)

Sweating

Oedema

*Very rare cases of prolonged (up to months or years), disabling and potentially irreversible serious drug reactions affecting

several, sometimes multiple, system organ classes and senses (including reactions such as tendonitis, tendon rupture,

arthralgia, pain in extremities, gait disturbance, neuropathies associated with paraesthesia, depression, fatigue, memory

impairment, sleep disorders, and impairment of hearing, vision, taste and smell) have been reported in association with the use

of quinolones and fluoroquinolones in some cases irrespective of pre-existing risk factors (see section 4.4).

There have been very rare cases of the following side effects reported following treatment with other fluoroquinolones, which

might possibly also occur during treatment with moxifloxacin: increased intracranial pressure (including pseudotumor cerebri),

hypernatraemia, hypercalcaemia, haemolytic anaemia, photosensitivity reactions (see section 4.4).

Reporting of suspected adverse reactions

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Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued

monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected

adverse reactions via HPRA Pharmacovigilance. Website: www.hpra.ie

4.9 Overdose

No specific countermeasures after accidental overdose are recommended. In the event of overdose, symptomatic treatment

should be implemented. ECG monitoring should be undertaken, because of the possibility of QT interval prolongation.

Concomitant administration of charcoal with a dose of 400 mg oral moxifloxacin will reduce systemic availability of the drug by

more than 80%. The use of charcoal early during absorption may be useful to prevent excessive increase in the systemic

exposure to moxifloxacin in cases of oral overdose.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Quinolone antibacterials, fluoroquinolones, ATC code: J01MA14

Mechanism of action

Moxifloxacin has in vitro activity against a wide range of Gram-positive and Gram-negative pathogens.

The bactericidal action of moxifloxacin results from the inhibition of both type II topoisomerases (DNA gyrase and

topoisomerase IV) required for bacterial DNA replication, transcription and repair. It appears that the C8-methoxy moiety

contributes to enhanced activity and lower selection of resistant mutants of Gram-positive bacteria compared to the C8-H

moiety. The presence of the bulky bicycloamine substituent at the C-7 position prevents active efflux, associated with the norA

or pmrA genes seen in certain Gram-positive bacteria.

Pharmacodynamic investigations have demonstrated that moxifloxacin exhibits a concentration dependent killing rate.

Minimum bactericidal concentrations (MBC) were found to be in the range of the minimum inhibitory concentrations (MIC).

Effect on the intestinal flora in humans

The following changes in the intestinal flora were seen in volunteers following oral administration of moxifloxacin: Escherichia

coli, Bacillus spp., Enterococcus spp., and Klebsiella spp. were reduced, as were the anaerobes Bacteroidesvulgatus,

Bifidobacterium spp., Eubacterium spp., and Peptostreptococcus spp.. For Bacteroides fragilis there was an increase. These

changes returned to normal within two weeks.

Mechanism of resistance

Resistance mechanisms that inactivate penicillins, cephalosporins, aminoglycosides, macrolides and tetracyclines do not

interfere with the antibacterial activity of moxifloxacin. Other resistance mechanisms such as permeation barriers (common in

Pseudomonas aeruginosa) and efflux mechanisms may also effect susceptibility to moxifloxacin.

In vitro resistance to moxifloxacin is acquired through a stepwise process by target site mutations in both type II

topoisomerases, DNA gyrase and topoisomerase IV. Moxifloxacin is a poor substrate for active efflux mechanisms in

Gram-positive organisms.

Cross-resistance is observed with other fluoroquinolones. However, as moxifloxacin inhibits both topoisomerase II and IV with

similar activity in some Gram-positive bacteria, such bacteria may be resistant to other quinolones, but susceptible to

moxifloxacin.

Breakpoints

EUCAST clinical MIC and disk diffusion breakpoints for moxifloxacin (01.01.2012):

Organism

Susceptible

Resistant

Staphylococcus spp.

≤ 0.5 mg/l

≥ 24 mm

> 1 mg/l

< 21 mm

S. pneumoniae

≤ 0.5 mg/l

≥ 22 mm

> 0.5 mg/l

< 22 mm

Streptococcus Groups A, B, C, G

≤ 0.5 mg/l

≥ 18 mm

> 1 mg/l

< 15 mm

H. influenzae

≤ 0.5 mg/l

≥ 25 mm

> 0.5 mg/l

< 25 mm

M. catarrhalis

≤ 0.5 mg/l

≥ 23 mm

> 0.5 mg/l

< 23 mm

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