Skip to Content

MOXIFLOXACIN 400MG FILM-COATED TABLETS

Active substance(s): MOXIFLOXACIN HYDROCHLORIDE / MOXIFLOXACIN HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
Rivopharm

Package Information Leaflet

UK/H/4905/01/DC

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.
- If you get any side effects, talk to you doctor or pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.
What is in this leaflet:
1. What Moxifloxacin 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 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)
- If you are pregnant or are breast-feeding.
- If you are under 18 years of age.
Moxifloxacin 400 mg film-coated tablets

ver 08/0517

Page 1 of 9

Rivopharm

Package Information Leaflet

UK/H/4905/01/DC

- 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.
Moxifloxacin 400 mg film-coated tablets

ver 08/0517

Page 2 of 9

Rivopharm

Package Information Leaflet

UK/H/4905/01/DC

- 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 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, 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).
- Fluoroquinolone antibiotics may cause disturbances in blood sugar, including both a decrease in blood
sugar below normal levels (hypoglycemia) and an increase in blood sugar above normal levels
(hyperglycemia). In patients treated with Moxifloxacin tablets, disturbances in blood sugar occurred
predominantly in elderly patients receiving concomitant treatment with oral antidiabetic medicines that
lower blood sugar (e. g. sulfonylurea) or with insulin. If you suffer from diabetes, your blood sugar should
be carefully monitored (see section 4. 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 if you are taking, have recently taken or might take any other medicines.
- 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).

Moxifloxacin 400 mg film-coated tablets

ver 08/0517

Page 3 of 9

Rivopharm

Package Information Leaflet

UK/H/4905/01/DC

- 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 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:
- 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.
Moxifloxacin 400 mg film-coated tablets

ver 08/0517

Page 4 of 9

Rivopharm

Package Information Leaflet

- Infections of the skin and soft tissue

UK/H/4905/01/DC

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 most
serious side effects observed during treatment with Moxifloxacin tablets are listed below:
If you notice any of the following stop taking Moxifloxacin tablets and tell your doctor immediately as
you may need urgent medical advice.
Rare (may affect up to 1 in 1,000 people)









an abnormal fast heart rhythm
a severe, sudden generalised allergic reaction incl. very rarely a life-threatening shock (e.g. difficulty in
breathing, drop of blood pressure, fast pulse, swelling incl. swelling of the airway) (potentially lifethreatening)
convulsions
troubles associated with the nervous system such as pain, burning, tingling, numbness and/or weakness
in extremities
depression (in very rare cases leading to self-harm, such as suicidal ideations/thoughts, or suicide
attempts)
severe diarrhoea containing blood and/or mucus (antibiotic associated colitis incl. pseudomembranous
colitis), which in very rare circumstances, may develop into complications that are life-threatening
pain and swelling of the tendons (tendonitis)
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) consult your doctor immediately.

Very rare (may affect up to 1 in 10,000 people)
Moxifloxacin 400 mg film-coated tablets

ver 08/0517

Page 5 of 9

Rivopharm











Package Information Leaflet

UK/H/4905/01/DC

that you suddenly start feeling unwell or notice yellowing of the whites of the eyes, dark urine, itching
of the skin, a tendency to bleed or disturbances of thought or wakefulness (these can be signs and
symptoms of fulminant inflammation of the liver potentially leading to life-threating liver failure fatal
cases have been observed)
alterations of the skin and mucous membranes like painful blisters in the mouth/nose or at the penis/
vagina (Stevens-Johnson syndrome or toxic epidermal necrolysis) (potentially life threatening)
Inflammation of blood vessels (signs could be red spots on your skin, usually on your lower
legs or effects like joint pain)
insanity (potentially leading to self-harm, such as suicidal ideations/thoughts, or suicide attempts)
a tendon rupture
transient loss of vision contact an eye specialist immediately
If you have experienced life-threatening irregular heart beat (Torsade de Pointes) or stopping of heart
beat while taking Moxifloxacin tablets, tell your treating doctor immediately that you have taken
Moxifloxacin tablets and do not restart the treatment.
A worsening of the symptoms of myasthenia gravis. If this happens, consult your doctor immediately.

In addition, if you notice:
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.
Other side effects which have been observed during treatment with Moxifloxacin tablets 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
• 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
Moxifloxacin 400 mg film-coated tablets

ver 08/0517

Page 6 of 9

Rivopharm





























Package Information Leaflet

UK/H/4905/01/DC

increased specialised white blood cells (eosinophils)
anxiety
feeling unwell (predominantly weakness or tiredness)
shaking
joint pain
palpitations
irregular and fast heart beat
difficulty in breathing incl. asthmatic conditions
increase of a special digestive enzyme in the blood (amylase)
restlessness / agitation
tingling sensation (pins and needles) and/or numbness
skin hives
widening of blood vessels
confusion and disorientation
decrease of special blood cells necessary for blood clotting
visual disturbances incl. double and blurred vision
decreased blood clotting
increased blood lipids (fats)
low red blood cell count
muscle pain
allergic reaction
increase of bilirubin in the blood
inflammation of the stomach
dehydration
severe heart rhythm abnormalities
dry skin
angina pectoris

Rare (may affect up to 1 in 1,000 people)
• muscle twitching
• muscle cramp
• hallucination
• high blood pressure
• swelling (of the hands, feet, ankles, lips, mouth, throat)
• low blood pressure
• kidney impairment (incl. increase in special kidney laboratory test results like urea and creatinine)
• inflammation of the liver
• inflammation of the mouth
• ringing/noise in the ears
• jaundice (yellowing of the whites of the eyes or skin)
• impairment of skin sensation
• abnormal dreams
• disturbed concentration
• difficulty in swallowing
• changes in smell (incl. loss of smell)
• balance disorder and poor co-ordination (due to dizziness)
• partial or total loss of memory
• hearing impairment including deafness (usually reversible)
• increased blood uric acid
• emotional instability
• impaired speech
• fainting
• muscle weakness

Very rare (may affect up to 1 in 10,000 people)
Moxifloxacin 400 mg film-coated tablets

ver 08/0517

Page 7 of 9

Rivopharm









Package Information Leaflet

UK/H/4905/01/DC

inflammation of joints
abnormal heart rhythms
increase of skin sensitivity
a feeling of self-detachment (not being yourself)
increased blood clotting
muscle rigidity
significant decrease of special white blood cells (agranulocytosis)

Also, there have been very rare cases of the following side effects reported following treatment with other
quinolone antibiotics, which might possibly also occur during treatment with Moxifloxacin 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.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed
in this leaflet. You can also report side effects directly via the national reporting system Yellow Card
Scheme, website: www.mhra.gov.uk/yellowcard. By reporting side effects, you can help provide more
information on the safety of this medicine.

5.

How to store Moxifloxacin 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.
Moxifloxacin 400 mg film-coated tablets

ver 08/0517

Page 8 of 9

Rivopharm

Package Information Leaflet

UK/H/4905/01/DC

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

This medicinal product is authorised in the Member States of the EEA under the following names
United Kingdom
Germany
Bulgaria

Moxifloxacin 400 mg film-coated tablets
Moxifloxacin Holsten 400 mg Filmtabletten
моксифлоксацин Rivopharm 400 mg филмирани таблетки

This leaflet was last revised in 05/2017

Moxifloxacin 400 mg film-coated tablets

ver 08/0517

Page 9 of 9

Expand view ⇕

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.

Hide