Moxifloxacine Teva 400 mg, filmomhulde tabletten

/.../ contains the active substance moxifloxacin which belongs to a group of antibiotics called fluoroquinolones. /.../ works by killing bacteria that cause infections.

/.../ is used in patients of 18 years and older for treating the following bacterial infections, when caused by bacteria against which moxifloxacin is active. /.../ 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 infectons of the fallopian tubes and infections of the uterus mucous membrane /.../ are not sufficient fore sole therapy of this kind of infections and therefore, another antibiotic in addition to /.../ 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 /.../”, “Warnings and precautions”, “Talk to your doctor before taking /.../ ”).

If the following bacterial infections have shown improvement during initial treatment with moxifloxacin solution for infusion, /.../ 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

/.../ 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.

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

Do not take /.../

• 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.

• If you have a history of tendon disease or disorder which was related to treatment with quinolone antibiotics (see section “Warnings and Precautions...” and section 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 certain abnormal ECG changes (see section 2 “Other medicines and /.../”).

This is because /.../ can cause changes on the ECG, that is a prolongation of the QT-interval i.e. delayed conduction of electrical signals.

• If you have a severe liver disease or increased liver enzymes (transaminases) higher than 5 times the upper normal limit.

Warnings and precautions

Talk to your doctor before taking /.../

• /.../ 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 /.../ (see also sections “Do not take” and “Other medicines and /.../”).
• If you suffer from epilepsy or a condition which makes you likely to have convulsions, consult your doctor before taking /.../.
• If you have or have ever had any mental health problems, consult your doctor before taking /.../.
• If you suffer from myasthenia gravis, taking /.../ may worsen the symptoms of your disease. If you think you are affected consult your doctor immediately.
• If you or any member of your family have glucose-6-phosphate dehydrogenase deficiency (a rare hereditary disease), inform your doctor, who will advise whether /.../ 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 /.../ 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 /.../. If there is no improvement in symptoms after 3 days of treatment, please consult your doctor.

When taking /.../

• 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, with the following symptoms: tightness in the chest, feeling dizzy, feeling sick or faint, or experience dizziness on standing. If so, stop taking /.../ and seek medical advice immediately.
• /.../ may cause a rapid and severe inflammation of the liver which could lead to life-threateningl 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 beeing 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).

• If you develop a skin reaction or blistering and/or peeling of the skin and/or mucosal reactions (see section 4 “Possible side effects”) contact your doctor immediately before you continue treatment.

• Quinolone antibiotics, including /.../ may cause convulsions. If this happens, stop taking /.../ 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 /.../.
• You may experience mental health problems even when taking quinolone antibiotics, including /.../, 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 /.../ and inform your doctor immediately.
• You may develop diarrhoea whilst taking, or after taking, antibiotics including /.../. If this becomes severe or persistent or you notice that your stool contains blood or mucus you should stop taking /.../ immediately and consult your doctor. In this situation, you should not take medicines that stop or slow down bowel movement.
• /.../ may cause pain and inflammation of your tendons, even within 48 hours of starting treatment and up to several months after discontinuing /.../ therapy. The risk of inflammation and rupture of tendons is increased if you are elderly or if you are currently being treated with corticosteroids. At the first sign of any pain or inflammation you should stop taking /.../, 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 2. “Do not take /.../” and 4. “Possible side effects”).
• 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 you have any other eye disturbances whilst taking /.../, 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 /.../.
• 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 /.../”).

Other medicines and /.../

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

For /.../ be aware of the following:

• If you are taking /.../ and other medicines that affect your heart there is an increased risk for altering your heart rhythm. Therefore, do not take /.../ 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 /.../.

• 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 /.../. Therefore, take your /.../ 6 hours before or after taking the other medicine.
• Taking oral medical charcoal at the same time as /.../ reduces the action of /.../. 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.

/…/ with food and drink

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

Pregnancy, breast-feeding and fertility

Do not take /.../ 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

/.../ 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.

Dosage

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.

/.../ tablets are for oral use. Swallow the tablets as a whole (to mask the bitter taste) and with plenty of liquid. You can take /.../ 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 /.../ film coated tablets are:

When /.../ film-coated tablets are used to complete a course of therapy started with moxifloxacin solution for infusion, the recommended durations of use are:

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 “What you need to know before you take /.../”, “Warnings and precautions”).

If you take more /…/ 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.

If you forget to take /…/

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 /.../

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.

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.

Common side effects (may affect up to 1 in 10 people):

• infections caused by resistant bacteria or fungi, e.g. oral and vaginal infections caused by Candida (thrush)
• headache, dizziness
• change of the heart rhythm (ECG) in patients with low blood potassium level
• nausea, vomiting, stomach and abdominal ache, diarrhoea
• increase of special liver enzymes in the blood (transaminases)

Uncommon side effects (may affect up to 1 in 100 people):

• Low red blood cell count, 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
• allergic reaction
• increased blood lipids (fats)
• anxiety, restlessness/agitation
• tingling sensation (pins and needles) and/or numbness, changes in taste (in very rare cases loss of taste), confusion and disorientation, sleep problems (predominately sleeplessness), shaking, sensation of dizziness (spinning or falling over), sleepiness

• visual disturbances incl. double and blurred vision
• change of the heart rhythm (ECG), palpitations, irregular and fast heart beat, severe heart rhythm abnormalities, angina pectoris
• widening of blood vessels
• difficulty in breathing incl. asthmatic conditions
• decreased appetite and food intake, wind and constipation, stomach upset (indigestion/heartburn), inflammation of the stomach, increase of a special digestive enzyme in the blood (amylase)
• impaired liver function (incl. increase of a special liver enzyme in the blood (LDH)), increase of bilirubin in the blood, increase of a special liver enzyme in the blood (gammaglutamyl- transferase and/or alkaline phosphatase)
• itching, rash, skin hives, dry skin
• joint pain, muscle pain
• dehydration
• feeling unwell (predominantly weakness or tiredness), aches and pains such as back, chest,

pelvic and extremities pains, sweating

Rare side effects (may affect up to 1 in 1,000 people):

• Severe, sudden generalised allergic reaction incl. very rarely life-threatening shock (e.g.

difficulty in breathing, drop of blood pressure, fast pulse), swelling (incl. potentially lifethreatening swelling of the airway)

• increased blood sugar, increased blood uric acid
• emotional instability, depression (in very rare cases leading to self-harm, such as suicidal ideations/thoughts, or suicide attempts), hallucination
• impairment of skin sensation, changes in smell (incl. loss of smell), abnormal dreams, balance disorder and poor co-ordination (due to dizziness), convulsions, disturbed concentration, impaired 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/noise in the ears, hearing impairment including deafness (usually reversible)
• abnormal fast heart rhythm, fainting
• high blood pressure, low blood pressure
• difficulty in swallowing, inflammation of the mouth, 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
• jaundice (yellowing of the whites of the eyes or skin), inflammation of the liver
• pain and swelling of the tendons (tendonitis), muscle cramp, muscle twitching, muscle weakness
• kidney impairment (incl. increase in special kidney laboratory test results like urea and creatinine), kidney failure
• swelling (of the hands, feet, ankles, lips, mouth, throat)

Very rare side effects (may affect up to 1 in 10,000 people):

• Increased blood clotting, significant decrease of special white blood cells (agranulocytosis)
• a feeling of self-detachment (not being yourself), insanity (potentially leading to self-harm, such as suicidal ideations/thoughts, or suicide attempts)
• increase of skin sensitivity
• transient loss of vision
• abnormal heart rhythms, life-threatening irregular heart beat, stopping of heart beat
• fulminant inflammation of the liver potentially leading to life-threatening liver failure (incl. fatal cases)
• alterations of 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 tendon, inflammation of joints, muscle rigidity, worsening of the symptoms of myasthenia gravis

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 /.../: 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 or nurse. This includes any possible side effects

not listed in this leaflet. You can also report side effects directly via the national reporting system listed in

Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister and the carton after EXP. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What /…/ contains

The active substance is moxifloxacin.

Each film-coated tablet contains 400 mg moxifloxacin (base).

The other ingredients are:

Tablet core: Microcrystalline cellulose, Croscarmellose sodium, Colloidal anhydrous silica, Magnesium stearate

Film-coating: Hypromellose, Macrogol 4000, Iron oxide red (E172), Titanium dioxide (E171)

What /…/ looks like and contents of the pack

/.../ are reddish to red, oblong, biconvex film-coated tablets. /.../ is available in packs of 5, 7, 10, 14 film-coated tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

[To be completed nationally]

This medicinal product is authorised in the Member States of the EEA under the following names:

Austria: Moxifloxacin ratiopharm 400 mg Filmtabletten Germany: Moxifloxacin-ratiopharm 400 mg Filmtabletten

Greece: Moxifloxacin Teva Pharma 400 mg Επικαλυμμένα με λεπτό υμένιο δισκία Luxemburg: Moxifloxacin-ratiopharm 400 mg Filmtabletten

Netherlands: Moxifloxacine Teva 400 mg, filmomhulde tabletten

Spain: Moxifloxacino ratiopharm 400 mg comprimidos recubiertos con película EFG

This leaflet was last approved in

{MM/YYYY}