PACKAGE LEAFLET

Package leaflet: Information for the user

Moxifloxacin 400 mg/250 ml solution for infusion

Moxifloxacin

What is in this leaflet

1.    What Moxifloxacin is and what it is used for

2.    What you need to know before you use Moxifloxacin

3.    How to use Moxifloxacin

4.    Possible side effects

5.    How to store Moxifloxacin

6.    Contents of the pack and other information

1.    What Moxifloxacin is and what it is used for

Moxifloxacin contains the active substance moxifloxacin which belongs to a group of antibiotics called fluoroquinolones. Moxifloxacin works by killing bacteria that cause infections if they are caused by bacteria that are susceptible (sensitive) to moxifloxacin.

Moxifloxacin is used in adults for treating the following bacterial infections:

-    Infection of the lungs (pneumonia) acquired outside the hospital

-    Infections of the skin and soft tissue Moxifloxacin is only used to treat these infections when usual antibiotics cannot be used or have not worked.

2.    What you need to know before you use Moxifloxacin

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

Do not use Moxifloxacin

•    If you are allergic to 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 and 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);

•    If you have salt imbalance in the blood (especially low level of potassium or magnesium in the blood);

•    If you 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 Moxifloxacin). This is because Moxifloxacin can cause changes on the ECG, that is a prolongation of the QT-interval, that is a delayed conduction of electrical signals.

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

Warnings and precautions

Talk to your doctor before Moxifloxacin is

administered to you for the first time. It is

important you know that:

•    Moxifloxacin 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 Moxifloxacin is administered to you (also see sections Do not use Moxifloxacin and Other medicines and Moxifloxacin).

•    If you suffer from epilepsy or a condition which makes you likely to have convulsions, tell your doctor before Moxifloxacin is administered to you.

•    If you have or have ever had any mental health problems, consult your doctor before Moxifloxacin is administered to you.

•    If you suffer from myasthenia gravis (rare disease leading to muscle weakness) because using Moxifloxacin 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 Moxifloxacin is suitable for you.

•    Moxifloxacin should be given intravenously (in the vein) only, and should not be administered into an artery.

Treatment with Moxifloxacin should be

stopped immediately in the following cases:

•    There is a rare chance that you may experience a severe, sudden allergic reaction (an

anaphylactic reaction/shock) even with the first dose. Tell your doctor if you experience symptoms that may include tightness in the chest, feeling dizzy, feeling sick or faint, or experience dizziness on standing.

•    Moxifloxacin 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 suddenly start to feel 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.

•    Quinolone antibiotics, including Moxifloxacin, may cause convulsions. If this happens, treatment with Moxifloxacin has to be discontinued.

•    You may experience mental health problems

even when taking quinolone antibiotics, including Moxifloxacin, 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, treatment with Moxifloxacin has to be discontinued.

•    Moxifloxacin may cause pain and inflammation of your tendons, even within 48 hours of starting treatment and up to several months after discontinuing Moxifloxacin 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 using Moxifloxacin, 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 use Moxifloxacin and 4. Possible side effects).

During treatment with Moxifloxacin you

should inform your doctor immediately:

•    If you experience palpitations or irregular heart beat during the period of treatment. He/she may wish to perform an ECG to measure your heart rhythm.

•    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 the treatment.

• Yo u m a y e x p e r i e n c e s y m p t o m s o f neuropathy such as pain, burning, tingling, numbness and/or weakness. If this happens, inform your doctor immediately prior to continuing treatment with Moxifloxacin.

•    You may develop diarrhoea whilst taking, or after taking, antibiotics including Moxifloxacin. If this becomes severe or persistent or you notice that your stool contains blood or mucus you should stop using Moxifloxacin immediately and consult your doctor. In this situation, you should not take medicines that stop or slow down bowel movement.

•    If your eyesight becomes impaired or if you have any other eye disturbances whilst using Moxifloxacin, consult an eye specialist immediately (see sections Driving and using machines and 4. Possible side effects).

When using Moxifloxacin you should be aware that:

•    The risk of heart problems may increase with increase of the dose and the speed of the perfusion into your vein.

•    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.

•    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 using Moxifloxacin.

•    There is limited experience on use of sequential intravenous/oral Moxifloxacin for the treatment of infection of the lungs (pneumonia) acquired outside the hospital.

•    The efficacy of Moxifloxacin 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

This medicine must not be administered 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 use Moxifloxacin).

Other medicines and Moxifloxacin

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

When receiving treatment with Moxifloxacin be aware of the following

If you are using Moxifloxacin together with other medicines that affect your heart there is an increased risk for altering your heart rhythm. Therefore, do not use Moxifloxacin together with the following medicines:

•    Medicines that belong to the group of anti-arrhythmics (such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide);

•    Antipsychotics (such as phenothiazines, pimozide, sertindole, haloperidol, sultopride);

•    Tricyclic antidepressants, some antimicrobials (such as saquinavir, sparfloxacin, intravenous erythromycin, pentamidine, antimalarials particularly halofantrine);

•    Some antihistamines (such as terfenadine, astemizole, mizolastine);

•    Other medicines such as cisapride, intravenous vincamine, bepridil and diphemanil.

You must tell your doctor:

•    if you are taking other medicines that can lower your blood potassium levels (for instance some diuretics, some laxatives and enemas [large doses] or corticosteroids [antiinflammatory medicines], amphotericin B);

•    if you are taking other medicines that can cause a slow heart rate because these can also increase the risk of serious heart rhythm disturbances while using Moxifloxacin;

•    if you are currently taking oral anticoagulants (for instance warfarin); it may be necessary for your doctor to monitor your blood clotting times.

Moxifloxacin with food, drink and alcohol

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

You should not drink alcohol while using Moxifloxacin.

Pregnancy, breast-feeding and fertility

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 using this medicine.

Do not use Moxifloxacin if you are pregnant or breast-feeding.

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

Driving and using machines

Moxifloxacin may make you feel dizzy or lightheaded, you may experience a sudden, brief (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.

Moxifloxacin contains sodium

This medicinal product contains 1206 mg (approximately 54 mmol) sodium per dose. If you are on a controlled-salt diet, please inform your doctor immediately.

3. How to use Moxifloxacin

Moxifloxacin will always be given to you by a doctor or healthcare professional.

The recommended dose for adults is 1 bottle once daily.

Moxifloxacin is for intravenous (into a vein) use. Your doctor should ensure that the infusion is given at a constant flow over 60 minutes.

No adjustment of the dose is required in elderly patients, patients with a low bodyweight or in patients with kidney problems.

Duration of treatment

Your doctor will decide on the duration of your treatment with Moxifloxacin. In some cases your doctor may start your treatment with Moxifloxacin solution for infusion and then continue your treatment with respective tablets.

The duration of treatment depends upon the type of infection, and how well you respond to treatment but 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 using 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.

If you receive more Moxifloxacin than you should

If you are concerned that you may have received more Moxifloxacin than prescribed, contact your doctor immediately.

antibiotics, which might possibly also occur during treatment with Moxifloxacin:

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

•    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 immediately to get advice before receiving the next dose. This includes any side effects not listed in this leaflet. By reporting side effects you can help provide more information on the safety of this medicine.

For UK - You can report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

For Ireland - Reports may be made by following the links to the online reporting option accessible from the IMB homepage, or by completing the downloadable report form also accessible from the IMB website, which may be completed manually and submitted to the IMB via freepost, to the following address: FREEPOST

Pharmacovigilance Section Irish Medicines Board Kevin O’Malley House Earlsfort Centre Earlsfort Terrace Dublin 2

Tel: +353 1 6764971 Fax: +353 1 6762517 Website: www.imb.ie(http://www.imb.ie) e-mail: imbpharmacovigilance@imb.ie

5.    How to store Moxifloxacin

Since this product will be administered by medical proffesionals they will be responsible for the correct storage of the product both before and during its use, as well as for the correct disposal.

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 label on the bottle and carton after EXP. The expiry date refers to the last day of the month.

Do not refrigerate or freeze. Keep the bottle in the outer carton in order to protect from light.

This product is for single use only. Any unused solution should be discarded.

At cool storage temperatures precipitation may occur, which will re-dissolve at room temperature.

Do not use this medicine if you notice any visible particulate matter or if the solution is cloudy.

Your doctor or the hospital staff will normally store Moxifloxacin and they are responsible for the quality of the product when it has been opened and if it is not used immediately. They are also responsible for disposing of any unused Moxifloxacin correctly.

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 contains

•    The active substance is moxifloxacin. Each 250 ml bottle contains 400 mg moxifloxacin (as hydrochloride). Each ml contains 1.6 mg moxifloxacin (as hydrochloride).

•    The other ingredients are sodium acetate-trihydrate, sulphuric acid (for pH-adjustment), sodium sulfate, anhydrous and water for injections (see section Moxifloxacin contains sodium).

What Moxifloxacin looks like and contents of the pack

Moxifloxacin is a clear, yellow solution for infusion.

Moxifloxacin is packaged in cartons containing 250 ml low-density polyethylene bottles (KabiPac) with a chlorobutyl or bromobutyl rubber stopper. Packs contain 1, 10, 20, 25 or 40 bottles.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Fresenius Kabi Limited Cestrian Court, Eastgate Way,

Manor Park, Runcorn,

Cheshire, UK WA7 1NT

Manufacturer

Fresenius Kabi Polska Sp. z.o.o Sienkiewica 25,

99-300 Kutno Poland

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

Country	Trade Name
Austria	Moxifloxacin Kabi 400 mg/250 ml Infusionslosung
Belgium	Moxifloxacine Fresenius Kabi 400 mg/250 ml oplossing voor infusie
Bulgaria	MoKC^l$.^OKca^^lH Ka6n 400 mg/250 ml MH$y3MOHeH pa3TBop
Czech Republic	Moxifloxacin Kabi 400 mg/250 ml infuzni roztok
Denmark	Moxifloxacin Fresenius Kabi
Germany	Moxifloxacin Kabi 400 mg/250 ml Infusionslosung
Finland	Moxifloxacin Fresenius Kabi 400 mg/250 ml infuusioneste, liuos
Hungary	Moxifloxacin Kabi 400 mg/250 ml oldatos infuzio
Ireland	Moxifloxacin 400 mg/250 ml solution for infusion
Italy	Moxifloxacina Kabi
Luxembourg	Moxifloxacin Kabi 400 mg/250 ml Infusionslosung
Netherlands	Moxifloxacine Fresenius Kabi 400 mg/250ml oplossing voor infusie
Poland	Moxifloxacin Kabi
Romania	Moxifloxacina Kabi 400 mg/250 ml solute perfuzabila
Slovakia	Moxifloxacin Kabi 400 mg/250 ml infuzny roztok
Slovenia	Moksifloksacin Kabi 400 mg/250 ml raztopina za infundiranje
Spain	Moxifloxacin Fresenius Kabi 400 mg/250 ml, solucion para perfusion
Sweden losning	Moxifloxacin Fresenius Kabi 400 mg/250 ml, infusionsvatska,
United Kingdom	Moxifloxacin 400 mg/250 ml solution for infusion

This leaflet was last revised Nov 2013

Moxifloxacin should not be co-infused with other drugs.

The following solutions are incompatible with Moxifloxacin:

Sodium chloride 10% and 20% solutions, Sodium bicarbonate 4.2% and 8.4% solutions.

FRESENIUS KABI

Package leaflet: Information for the user

Moxifloxacin 400 mg/250 ml solution for infusion

Moxifloxacin

What is in this leaflet

1.    What Moxifloxacin is and what it is used for

2.    What you need to know before you use Moxifloxacin

3.    How to use Moxifloxacin

4.    Possible side effects

5.    How to store Moxifloxacin

6.    Contents of the pack and other information

1. What Moxifloxacin is and what it is used for

Moxifloxacin contains the active substance moxifloxacin which belongs to a group of antibiotics called fluoroquinolones. Moxifloxacin works by killing bacteria that cause infections if they are caused by bacteria that are susceptible (sensitive) to moxifloxacin.

Moxifloxacin is used in adults for treating the following bacterial infections:

-    Infection of the lungs (pneumonia) acquired outside the hospital

-    Infections of the skin and soft tissue

Moxifloxacin is only used to treat these infections when usual antibiotics cannot be used or have not worked.

2. What you need to know before you are administered Moxifloxacin

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

If you are allergic to 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 and 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);

If you have salt imbalance in the blood (especially low level of potassium or magnesium in the blood);

If you 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 Moxifloxacin). This is because Moxifloxacin can cause changes on the ECG, that is a prolongation of the QT-interval, that is a delayed conduction of electrical signals.

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

Warnings and precautions

Talk to your doctor before Moxifloxacin is administered to you for the first time. It is important you

know that:

•    Moxifloxacin 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 Moxifloxacin is administered to you (also see sections Do not use Moxifloxacin and Other medicines and Moxifloxacin).

•    If you suffer from epilepsy or a condition which makes you likely to have convulsions, tell your doctor before Moxifloxacin is administered to you.

•    If you have or have ever had any mental health problems, consult your doctor before Moxifloxacin is administered to you.

•    If you suffer from myasthenia gravis (rare disease leading to muscle weakness) because using Moxifloxacin 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 Moxifloxacin is suitable for you.

•    Moxifloxacin should be given intravenously (in the vein) only, and should not be administered into an artery.

Treatment with Moxifloxacin should be stopped immediately in the following cases:

•    There is a rare chance that you may experience a severe, sudden allergic reaction (an anaphylactic reaction/shock) even with the first dose. Tell your doctor if you experience symptoms that may include tightness in the chest, feeling dizzy, feeling sick or faint, or experience dizziness on standing.

•    Moxifloxacin 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 suddenly start to feel 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.

•    Quinolone antibiotics, including Moxifloxacin, may cause convulsions. If this happens, treatment with Moxifloxacin has to be discontinued.

•    You may experience mental health problems even when taking quinolone antibiotics, including Moxifloxacin, 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, treatment with Moxifloxacin has to be discontinued.

•    Moxifloxacin may cause pain and inflammation of your tendons, even within 48 hours of starting treatment and up to several months after discontinuing Moxifloxacin 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 using Moxifloxacin, 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 use Moxifloxacin and 4. Possible side effects).

During treatment with Moxifloxacin you should inform your doctor immediately:

•    If you experience palpitations or irregular heart beat during the period of treatment. He/she may wish to perform an ECG to measure your heart rhythm.

•    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 the treatment.

•    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.

•    You may develop diarrhoea whilst taking, or after taking, antibiotics including Moxifloxacin. If this becomes severe or persistent or you notice that your stool contains blood or mucus you should stop using Moxifloxacin immediately and consult your doctor. In this situation, you should not take medicines that stop or slow down bowel movement.

•    If your eyesight becomes impaired or if you have any other eye disturbances whilst using Moxifloxacin, consult an eye specialist immediately (see sections Driving and using machines and 4. Possible side effects).

hen using Moxifloxacin you should be aware that:

The risk of heart problems may increase with increase of the dose and the speed of the perfusion into your vein.

•    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.

•    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 using Moxifloxacin.

•    There is limited experience on use of sequential intravenous/oral Moxifloxacin for the treatment of infection of the lungs (pneumonia) acquired outside the hospital.

•    The efficacy of Moxifloxacin 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

This medicine must not be administered 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 use Moxifloxacih).

Other medicines and Moxifloxacin

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

When receiving treatment with Moxifloxacin be aware of the following

If you are using Moxifloxacin together with other medicines that affect your heart there is an increased risk for altering your heart rhythm. Therefore, do not use Moxifloxacin together with the following medicines:

•    Medicines that belong to the group of anti-arrhythmics (such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide);

•    Antipsychotics (such as phenothiazines, pimozide, sertindole, haloperidol, sultopride);

•    Tricyclic antidepressants, some antimicrobials (such as saquinavir, sparfloxacin, intravenous erythromycin, pentamidine, antimalarials particularly halofantrine);

•    Some antihistamines (such as terfenadine, astemizole, mizolastine);

•    Other medicines such as cisapride, intravenous vincamine, bepridil and diphemanil.

You must tell your doctor:

•    if you are taking other medicines that can lower your blood potassium levels (for instance some diuretics, some laxatives and enemas [large doses] or corticosteroids [anti-inflammatory medicines], amphotericin B);

•    if you are taking other medicines that can cause a slow heart rate because these can also increase the risk of serious heart rhythm disturbances while using Moxifloxacin;

•    if you are currently taking oral anti-coagulants (for instance warfarin); it may be necessary for your doctor to monitor your blood clotting times.

Moxifloxacin with food, drink and alcohol

The effect of Moxifloxacin is not influenced by food, including dietary products.

You should not drink alcohol while using Moxifloxacin.

Pregnancy, breast-feeding and fertility

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 using this medicine.

Do not use Moxifloxacin if you are pregnant or breast-feeding.

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

Driving and using machines

Moxifloxacin may make you feel dizzy or light-headed, you may experience a sudden, brief (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.

Moxifloxacin contains sodium

This medicinal product contains 1206 mg (approximately 54 mmol) sodium per dose. If you are on a controlled-salt diet, please inform your doctor immediately.

3. How to use Moxifloxacin

Moxifloxacin will always be given to you by a doctor or healthcare professional. The recommended dose for adults is 1 bag once daily.

Moxifloxacin is for intravenous (into a vein) use. Your doctor should ensure that the infusion is given at a constant flow over 60 minutes.

No adjustment of the dose is required in elderly patients, patients with a low bodyweight or in patients with kidney problems.

Duration of treatment

Your doctor will decide on the duration of your treatment with Moxifloxacin. In some cases your doctor may start your treatment with Moxifloxacin solution for infusion and then continue your treatment with respective tablets.

The duration of treatment depends upon the type of infection, and how well you respond to treatment but 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 using 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.

If you receive more Moxifloxacin than you should

If you are concerned that you may have received more Moxifloxacin than prescribed, contact your doctor immediately.

If you miss a dose of Moxifloxacin

If you are concerned that you may have missed a dose of Moxifloxacin, contact your doctor immediately.

If you stop using Moxifloxacin

If your treatment with this medicine is stopped too soon your infection may not be completely cured. Consult your doctor if you wish to stop your treatment with Moxifloxacin before the end of your 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.

Tell your doctor immediately and treatment should be stopped if you experience the side

effects listed below, because they may be life-threatening:

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

•    Severe, sudden generalised allergic reaction including very rarely life-threatening shock (for instance difficulty in breathing, drop of blood pressure, fast pulse), swelling (including potentially life-threatening swelling of the airway).

•    Depression (in very rare cases leading to self-harm, such as suicidal thoughts or suicide attempts).

•    Severe diarrhoea containing blood and/or mucus (antibiotic associated colitis including pseudomembranous colitis), which in very rare circumstances, may develop into complications that are life-threatening.

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

•    A feeling of self-detachment (not being yourself), insanity (potentially leading to self-harm, such as suicidal thoughts or suicide attempts).

•    Life-threatening irregular heartbeat, stopping of heartbeat.

•    Fulminant (dangerous) inflammation of the liver potentially leading to life-threatening liver failure (including fatal cases);

•    Alterations of the skin and mucous membranes (painful blisters in the mouth or nose or at the penis or vagina), potentially life-threatening (Stevens-Johnson-Syndrome, toxic epidermal necrolysis).

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, for instance, oral and vaginal infections caused by Candida;

•    Headache, dizziness;

•    Change of the heart rhythm (as seen on the ECG) in patients with low blood potassium level (see section 2. What you need to know before you are using Moxlfloxaclhi;

•    Nausea, vomiting, stomach and abdominal ache, diarrhoea;

•    Increase of a special liver enzyme in the blood (transaminases);

•    Pain or inflammation at injection site.

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 (thrombocytes), 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 (mainly sleeplessness), shaking, sensation of dizziness (spinning or falling over), sleepiness;

•    Visual disturbances including double and blurred vision;

•    Change of the heart rhythm (as seen on the ECG), palpitations, irregular and fast heartbeat, severe heart rhythm abnormalities, angina pectoris (chest pain);

•    Widening of blood vessels;

•    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);

• Impaired liver function (including increase of a special liver enzyme in the blood (LDH), increase of bilirubin in the blood, increase of a special liver enzyme in the blood (gammaglutamyl-transferase and/or alkaline phosphatase);

•    Itching, rash, skin hives, dry skin;

•    Joint pain, muscle pain;

•    Dehydration;

•    Feeling unwell (predominantly weakness or tiredness), aches and pains such as back, chest, pelvic and extremities pains, sweating;

•    Inflammation of a vein.

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

•    Increased blood sugar, increased blood uric acid;

•    Emotional instability, hallucination;

•    Impairment of skin sensation, changes in smell (including loss of smell), abnormal dreams, balance disorder and poor coordination (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 or noise in the ears, hearing impairment including deafness (usually reversible);

•    Fainting;

•    High blood pressure, low blood pressure;

•    Difficulty in swallowing, inflammation of the mouth;

•    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 (including 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);

•    Increase of skin sensitivity;

•    Transient loss of vision;

•    Abnormal heart rhythms;

•    Rupture of tendon, inflammation of joints, muscle rigidity, worsening of the symptoms of myasthenia gravis.

The following symptoms have been observed more frequently in patients treated intravenously:

Common (may affect up to 1 in 10 users)

•    Increase of a special liver enzyme in the blood (gamma-glutamyl-transferase).

Uncommon (may affect up to 1 in 100 users)

•    Abnormally fast heart rhythm;

•    Low blood pressure;

•    Swelling (of the hands, feet, ankles, lips, mouth, throat);

•    Severe diarrhoea containing blood and/or mucus (antibiotic associated colitis) which in very rare circumstances, may develop into complications that are life-threatening;

•    Convulsions;

•    Hallucination;

•    Kidney impairment (including increase in special kidney laboratory test results like urea and creatinine), kidney failure.

The following side effects have been reported following treatment with other quinolone antibiotics, which might possibly also occur during treatment with Moxifloxacin:

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

•    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 immediately to get advice before receiving the next dose. This includes any side effects not listed in this leaflet. By reporting side effects you can help provide more information on the safety of this medicine.

For UK - You can report side effects directly via the Yellow Card Scheme at: www.mhra.aov.uk/ vellowcard

For Ireland - Reports may be made by following the links to the online reporting option accessible from the IMB homepage, or by completing the downloadable report form also accessible from the IMB website, which may be completed manually and submitted to the IMB via freepost, to the following address:

FREEPOST

Pharmacovigilance Section Irish Medicines Board Kevin O’Malley House Earlsfort Centre Earlsfort Terrace Dublin 2

Tel: +353 1 6764971 Fax: +353 1 6762517

Website: www.imb.ie(http://www.imb.ie) e-mail: imbDharmacoviailance@imb.ie

5. How to store Moxifloxacin

Since this product will be administered by medical professionals they will be responsible for the correct storage of the product both before and during its use, as well as for the correct disposal.

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 label on the bag and carton after EXP. The expiry date refers to the last day of the month.

MockupJeaflet_common_english_draft6.indd 2

Do not refrigerate or freeze.

This product is for single use only. Any unused solution should be discarded.

At cool storage temperatures precipitation may occur, which will re-dissolve at room temperature.

Do not use this medicine if you notice any visible particulate matter or if the solution is cloudy.

Your doctor or the hospital staff will normally store Moxifloxacin and they are responsible for the quality of the product when it has been opened and if it is not used immediately. They are also responsible for disposing of any unused Moxifloxacin correctly.

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 contains

•    The active substance is moxifloxacin. Each 250 ml bag contains 400 mg moxifloxacin (as hydrochloride). Each ml contains 1.6 mg moxifloxacin (as hydrochloride).

•    The other ingredients are sodium acetate-trihydrate, sulfuric acid (for pH-adjustment), sodium sulfate, anhydrous and water for injections (see section Moxifloxacin contains sodium).

What Moxifloxacin looks like and contents of the pack

Moxifloxacin is a clear, yellow solution for infusion.

Moxifloxacin is packaged in cartons containing 250 ml Polyolefine bags (free/fex) with an administration port (infusion port) and addition port (injection port) consisting of a polypropylene housing and an aluminium over pouch. Packs contain 1,10,20, 25 or 40 bags.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Fresenius Kabi Limited Cestrian Court, Eastgate Way,

Manor Park, Runcorn,

Cheshire, UK WA71NT

Manufacturer

Fresenius Kabi Norge AS Svinesundsveien 80,

1789 Berg 0stfold Norway

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

The following information is intended for medical or healthcare professionals only:

Moxifloxacin can be administered via a T-tube together with the following solutions:

Water for injections, sodium chloride 0.9%, glucose 5% /10%, Ringer’s solution, compound sodium lactate solution (Hartmann’s solution, Ringer-lactate solution).

Moxifloxacin should not be co-infused with other drugs.

The following solutions are incompatible with Moxifloxacin:

Sodium chloride 10% and 20% solutions,

Sodium bicarbonate 4.2% and 8.4% solutions.