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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 400 mg film-coated tablets.
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 you 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 moxifloxacin as the active substance 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 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 Mocifloxacin 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 , called
prolongation of the QT-interval, indicating 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 lifethreatening 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 2. Driving and using machines and 4. Possible side effects).
- Quinolone antibiotics may make your skin become more sensitive to sunlight or UV light. You should
avoid prolonged exposure to sunlight or strong sunlight and should not use a sunbed or any other UV lamp
while taking Moxifloxacin 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. saquinavir, sparfloxacin, intravenous erythromycin, pentamidine, antimalarials particularly halofantrine)
• some antihistamines (e.g. terfenadine, astemizole, mizolastine)
• other medicines (e.g. cisapride, intravenous vincamine, bepridil and diphemanil).
- You must tell your doctor if you are taking other medicines that can lower your blood potassium levels (e.g. some diuretics, some laxatives and enemas [high doses] or corticosteroids [anti-inflammatory
drugs], amphotericin B) or cause a slow heart rate because these can also increase the risk of serious heart
rhythm disturbances while taking moxifloxacin.
- Any medicine containing magnesium or aluminium (such as antacids for indigestion), iron, zinc or
didanosine or any medicine containing sucralfate (to treat stomach disorders) can reduce the action of
Moxifloxacin 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 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 at the doses
recommended by your doctor.
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.
Moxifloxacin tablets contains Sunset Yellow FCF
Moxifloxacin tablets contains Sunset Yellow FCF (E110) which is a coloring agent that may cause allergic reactions.
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:

Bozza no.: 4 / Recto Data: 09.06.16
Colore: Nero
Lineagrafica sa
Codice: Moxifloxacin 400 mg Formato: mm 130 x 480 6596 Gordola

- 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 (gamma-glutamyl-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).
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.
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, Povidone and
Magnesium stearate.
Film coating: Opadry II 85F23452: Macrogol 3350, Red Iron Oxide (E172), Sunset yellow FCF (E110),
Polyvinyl alcohol, Titanium dioxide (E171), Talc.
What Moxifloxacin tablets look like and contents of the pack
Each light orange coloured film coated tablet is capsule shaped, biconvex.
Moxifloxacin tablets are packaged in cartons containing alu/PVC-PVDC 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:
Rivopharm UK Ltd.
30th Floor, 40 Bank Street, Canary Wharf,
London E14 5NR,
UK
Manufacturer:
Laboratoires BTT
ZI de Krafft,
67150 Erstein,
France
Distributed by:
Creo Pharma Ltd
Felsted Business Centre
Felsted, Essex, CM6 3LY
This medicinal product is authorised in the Member States of the EEA under the following names
United Kingdom
Moxifloxacin 400 mg film-coated tablets
Germany
Moxifloxacin Holsten 400 mg Filmtabletten
Bulgaria
моксифлоксацин Rivopharm 400 mg филмирани таблетки
This leaflet was last revised in 06/2016

Bozza no.: 4 / Verso Data: 09.06.16
Colore: Nero
Lineagrafica sa
Codice: Moxifloxacin 400 mg Formato: mm 130 x 480 6596 Gordola

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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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