Ciprofloxacin , solution for infusion U15730/D GB, font size: Arial 7,5pt, colour: Panton Black U, correction 6, size: 630 x 148 mm, Katarzyna St^pniewska, 23.09.2015

3.    Do not re-use an antibiotic without medical prescription, even if you want to treat a similar illness.

4.    Never give your anti biotic to another person; maybe it is not adapted to her/his illness.

5.    After completion of treatment, return all unused drugs to your chemist's shop to ensure they will be disposed of correctly

The following information is intended for healthcare professionals only:

Ciprofloxacin should be administered by intravenous infusion. For children, the infusion duration is 60 minutes. In adult patients, infusion time is 60 minutes for 400 mg Ciprofloxacin and 30 minutes for 200 mg Ciprofloxacin. Slow infusion into a large vein will minimise patient discomfort and reduce the risk of venous irritation. The infusion solution can be infused either directly or after mixing with other compatible infusion solutions.

Unless compatibility with other infusion solutions/drugs has been confirmed, the infusion solution must always be administered separately. The visual signs of incompatibility are e.g. precipitation, clouding, and discolouration.

Incompatibility appears with all infusion solutions/drugs that are physically or chemically unstable at the pH of the solution (e.g. penicillin, heparin solutions), especially in combination with solutions adjusted to an alkaline pH (pH of the ciprofloxacin infusion solutions: (4.0 -4.9).

After intravenous initiation of treatment, the treatment can be continued orally as well.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ciprofloxacin 100 mg/50 ml, solution for infusion

Ciprofloxacin 200 mg/100 ml, solution for infusion

Ciprofloxacin 400 mg/200 ml, solution for infusion

Ciprofloxacin (as hydrogen sulphate)

Read all of this leaflet carefully before you are given this medicine because it contains important information for you.

•    Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, pharmacist, nurse or healthcare professional.

•    If you get any side effects talk to your doctor, pharmacist, nurse or healthcare professional. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What Ciprofloxacin is and what it is used for

2.    What you need to know before you are given Ciprofloxacin

3.    Howto use Ciprofloxacin

4.    Possible side effects

5.    How to store Ciprofloxacin

6.    Contents of the pack and other information

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FRESENIUS

KABI

1. What Ciprofloxacin is and what it is used for

Ciprofloxacin contains the active substance ciprofloxacin. Ciprofloxacin is an antibiotic belonging to the fluoroquinolone family. Ciprofloxacin works by killing bacteria that cause infections. It only works with specific strains of bacteria.

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U15730/D GB

Adults

Ciprofloxacin is used in adults to treat the following bacterial infections:

•    respiratory tract infections

•    long lasting or recurring ear or sinus infections

•    urinaiy tract infections

•    infections of the testicles

•    genital organ infections in women

•    gastro-intestinal tract infections and intra-abdominal infections

•    skin and soft tissue infections

•    bone and joint infections

•    to treat infections in patients with a very low white blood cell count (neutropaenia)

•    to prevent infections in patients with a very low white blood cell count (neutropaenia)

•    anthrax inhalation exposure

If you have a severe infection or one that is caused by more than one type of bacterium, you may be given additional antibiotic treatment in addition to Ciprofloxacin.

Children and adolescents

Ciprofloxacin is used in children and adolescents, under specialist medical supervision, to treat the following bacterial infections:

•    lung and bronchial infections in children and adolescents suffering from cystic fibrosis

•    complicated urinary tract infections, including infections that have reached the kidneys (pyelonephritis)

•    anthrax inhalation exposure

Ciprofloxacin may also be used to treat other specific severe infections in children and adolescents when your doctor considers this necessary.

2. What you need to know before you are given Ciprofloxacin

You must NOT be given Ciprofloxacin if you are:

•    allergic to ciprofloxacin, to other quinolone drugs or to any of the other ingredients of this medicine (listed in section 6).

•    taking tizanidine (see Section 2: Other medicines and Ciprofloxacin)

Warnings and precautions

Before you are given Ciprofloxacin talk to your doctor, pharmacist, nurse or healthcare personnel:

•    if you have ever had kidney problems because your treatment may need to be adjusted

•    if you sufferfrom epilepsy or other neurological conditions

•    if you have a history of tendon problems during previous treatment with antibiotics such as Ciprofloxacin

•    if you have myasthenia gravis (a type of muscle weakness)

•    if you have heart problems.

Caution should betaken when using this kind of medicine, if you were bom with or have family history of prolonged QT interval (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 heart attack (myocardial infarction), you are female or elderly or you are taking other medicines that result in abnormal ECG changes (see section 2: Other medicines and Ciprofloxacin).

While under treatment with Ciprofloxacin

Tell your doctor immediately, if any of the following occurs during treatment with Ciprofloxacin. Your doctor will decide whether treatment with Ciprofloxacin needs to be stopped.

•    Severe, sudden allergic reaction (an anaphylactic reaction/shock, angio-oedema). Even with the first dose, there is a rare chance that you may experience a severe allergic reaction with the following symptoms: tightness in the chest, feeling dizzy, feeling sick or faint, or experience dizziness on standing. If this happens, tell your doctor immediately since the administration of Ciprofloxacin will have to be stopped.

•    Pain and swelling in the joints, and tendinitis may occur occasionally, particularly if you are elderly and are also being treated with corticosteroids. At the first sign of any pain or inflammation Ciprofloxacin will have to be stopped, rest the painful area. Avoid any unnecessary exercise as this might increase the risk of a tendon rupture.

•    If you suffer from epilepsy or other neurological conditions such as cerebral ischemia or stroke, you may experience side effects associated with the central nervous system. If this happens, stop taking Ciprofloxacin and contact your doctor immediately.

•    You may experience psychiatric reactions after first administration of ciprofloxacin. If you suffer from depression or psychosis, your symptoms may become worse under treatment with Ciprofloxacin. If this happens, stop taking Ciprofloxacin and contact your doctor immediately.

•    You may experience symptoms of neuropathy such as pain, burning, tingling, numbness and/or weakness. If this happens, stop taking Ciprofloxacin and contact your doctor immediately.

•    Diarrhoea may develop while you are on antibiotics, including Ciprofloxacin, or even several weeks after you have stopped using them. If it becomes severe or persistent or you notice that your stool contains blood or mucus tell your doctor immediately. Ciprofloxacin treatment will have to be stopped immediately, as this can be life-threatening. Do not take medicines that stop or slow down bowel movements.

•    Tell the doctor or laboratory staff that you are taking Ciprofloxacin if you have to provide a blood or urine sample.

•    If you suffer from kidney problems, tell the doctor because your dose may need to be adjusted.

•    Ciprofloxacin may cause liverdamage. Ifyou notice any symptoms such as loss of appetite, jaundice (yellowing of the skin), dark urine, itching, or tenderness of the stomach, Ciprofloxacin must be stopped immediately.

•    Ciprofloxacin may cause a reduction in the number of white blood cells and your resistance to infection may be decreased. Ifyou experience an infection with symptoms such as fever and serious deterioration of your general condition, or fever with local infection symptoms such as sore throat/pharynx/mouth or urinary problems you should see your doctor immediately. A blood test will be taken to check possible reduction of white blood cells (agranulocytosis). It is important to inform your doctor about your medicine.

•    Tell your doctor if you or a member of your family is known to have a deficiency in glucose-6-phosphate dehydrogenase (G6PD), since you may experience a risk of anemia with ciprofloxacin.

•    Your skin becomes more sensitive to sunlight or ultraviolet (UV) light under treatment with Ciprofloxacin. Avoid exposure to strong sunlight or artificial UV light such as sunbeds.

•    If your eyesight becomes impaired or if your eyes seem to be otherwise affected, consult an eye specialist immediately.

Other medicines and Ciprofloxacin

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

Do not use Ciprofloxacin together with tizanidine, because this may cause side effects such as low blood pressure and sleepiness (see Section 2: "You must not be given Ciprofloxacin").

The following medicines are known to interact with Ciprofloxacin in your body. Using Ciprofloxacin together with these medicines can influence the therapeutic effect of these medicines. It can also increase the probability of experiencing side effects such as low blood pressure and sleepiness (see Section 2).

Tell your doctor ifyou are taking:

•    Vitamin K antagonists (e.g. warfarin acenocoumarol, phenprocoumon orfluindionef orotheroral anti-coagulants (to thin the blood)

•    probenecid (for gout)

•    methotrexate (for certain types of cancer, psoriasis, rheumatoid arthritis)

•    theophylline (for breathing problems)

•    tizanidine (for muscle spasticity in multiple sclerosis)

•    olanzapine (an antipsychotic)

•    clozapine (an antipsychotic)

•    ropinirole (for Parkinson's disease)

•    phenytoin(forepilepsy)

•    metoclopramide (for nausea and vomiting)

•    Omeprazole (for stomach ulcers)

•    cyclosporin (for skin conditions, rheumatoid arthritis and in organ transplantation)

•    other medicines that can alter your heart rhythm: medicines that belong to the group of anti- arrhythmics (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some antimicrobials (that belong to the group of macrolides), some antipsychotics.

Ciprofloxacin may increase the levels of the following medicines in your blood:

•    pentoxifylline (forcirculatory disorders)

•    caffeine

•    Glibenclamide (for diabetes)

•    duloxetine (for depression, diabetic nerve damage or incontinence)

•    lidocaine (for heart conditions or anesthetic use)

•    sildenafil (e.g. forerectile dysfunction)

•    agomelatine

•    zolpidem

Ciprofloxacin with food and drink

Food and drink does not affect yourtreatment with Ciprofloxacin. Pregnancy and 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.

It is preferable to avoid the use of Ciprofloxacin during pregnancy. Do not take Ciprofloxacin during breastfeeding because ciprofloxacin is excreted in breast milkand can be harmful for your child

Driving and using machines

Ciprofloxacin may make you feel less alert. Some neurological adverse events can occur. Therefore, make sure you know how you react to

Ciprofloxacin before driving a vehicle or operating machinery. If in doubt, talk to your doctor.

Ciprofloxacin contains sodium

If you are on a low-sodium diet, take into account that 100 ml of Ciprofloxacin contain 15.1 mmol (=347 mg) sodium.

3. Howto use Ciprofloxacin

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Your doctor will explain to you exactly how much Ciprofloxacin you will be given as well as how often and for how long. This will depend on the type of infection you have and how bad it is.

Tell your doctor if you suffer from kidney problems because your dose may need to be adjusted.

Treatment usually lasts between 5 and 21 days, but may be longer for severe infections.

Your doctor will give you each dose by slow infusion through a vein into your bloodstream. For children, the infusion duration is 60 minutes. In adult patients, infusion time is 60 minutes for 400 mg Ciprofloxacin and 30 minutes for 200 mg Ciprofloxacin. Administering the infusion slowly helps prevent immediate side effects occurring.

Remembertodrinkplenty of fluids while you are taking Ciprofloxacin.

If you receive more Ciprofloxacin than you should

In case you have received more Ciprofloxacin than you should you may experience e.g. dizziness, tremor, headache, tiredness, abdominal discomfort or confusion.

Please tell your doctor or nurse if you experience any of these symptoms.

If a dose of Ciprofloxacin is forgotten

You will not be given a double dose to make up for a forgotten dose.

If you stop your course of Ciprofloxacin

• It is important that you finish 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 and the symptoms of the infection may return or get worse. You might also develop resistance to the antibiotic.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist, nurse or other healthcare professional.

4. Possible side effects

Like all medicines, Ciprofloxacin can cause side effects, although not

everybody gets them.

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

•    nausea, diarrhoea, vomiting

•    joint pains in children

•    local reaction at the injection site, rash

•    temporary increased amounts of substances in the blood (transaminases)

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

•    fungal superinfections

•    a high concentration of eosinophils, a type of white blood cell, increased or decreased amounts of a blood doting factor (thrombocytes)

•    loss of appetite (anorexia)

•    hyperactivity, agitation, confusion, disorientation, hallucinations

•    headache, dizziness, sleeping problems, taste disorders, pins and needles, unusual sensitivity to stimuli of the senses, seizures (see Section 2: Warnings and precautions), giddiness

•    eyesight problems

•    loss of hearing

•    rapid heartbeat (tachycardia)

•    expansion of the blood vessels (vasodilation), low blood pressure

•    abdominal pain, digestive problems such as stomach upset (indigestion/ heartburn), wind

•    liver disorders, increased amounts of one substance in the blood (bilirubin), jaundice (cholestatic icterus)

•    itching, hives

•    joint pain in adults

•    poorkidneyfunction, kidneyfailure

•    pains in your muscles and bones, feeling unwell (asthenia), fever, fluid retention

•    increase in blood alkaline phosphatase (a certain substance in the blood)

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

•    inflammation of the bowel (colitis) linked to antibiotic use (can be fatal in rare cases) (see Section 2: Warnings and precautions)

•    changes to the blood count (leukopenia, leukocytosis, neutropenia, anaemia), a drop in the number of red and white blood cells and platelets (pancytopenia), which may be fatal, bonemarrow depression which may also be fatal (see Section 2: Warnings and precautions)

allergic reaction, allergic swelling (oedema), rapid swelling of the skin and mucous membranes (angiooedema) increased blood sugar (hyperglycemia)

anxiety reaction, strange dreams, depression, mental disturbances (psychotic reactions) (see Section 2: Warnings and precautions) decreased skin sensitivity, tremor, migraine, disorder of sense of smell (olfactory disorders) tinnitus, impaired hearing

fainting, inflammation of the blood vessel (vasculitis) shortness of breath including asthmatic symptoms pancreatitis

hepatitis, death of liver cells (liver necrosis) very rarely leading to life-

threatening liver failure with possibly fatal outcome

sensitivity to light (see Section 2: Warnings and precautions), small,

pin- point bleeding under the skin (petechiae)

muscle pain, inflammation of the joints, increased muscle tone,

cramping, tendon rupture especially of the large tendon at the back of

the ankle (Achilles tendon) (see Section 2: Warnings and precautions)

blood or crystals in the urine (see Section 2: Warnings and precautions)

urinary tract inflammation

excessive sweating

increased levels of the enzyme amylase

Very rare side effects (may affect uptol in 10,000 people):

•    a special type of reduced red blood cell count (haemolytic anaemia); a dangerous drop in a type of white blood cells (agranulocytosis) which can be fatal

•    severe allergic reaction (anaphylactic reaction, anaphylactic shock, serum sickness) which can be fatal (see Section 2: Warnings and precautions)

•    disturbed coordination, unsteady walk (gait disturbance), pressure on the brain (intracranial pressure)

•    colour change distortions

•    various skin eruptions or rashes (e.g. the potentially fatal Stevens-Johnson syndrome or toxic epidermal necrolysis)

•    muscle weakness, tendon inflammation, worsening of the symptoms of myasthenia gravis (see Section 2: Warnings and precautions)

Not known (frequency cannot be estimated from the available data)

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

•    a rare severe skin rash, caused mostly by drugs (acute generalised exanthematous pustulosis -AGEP)

•    Abnormal fast heart rhythm, life-threatening irregular heart rhythm, alteration of the heart rhythm (called 'prolongation of QT interval', seen on ECG, electrical activity of the heart)

•    Feeling highly excited (mania) or feeling great optimism and overactivity (hypomania)

•    Serious hypersensitivity reaction called DRESS (Drug Reaction with Eosinophilia and Systemic Symptoms)

•    International normalised ration increased (in patients with Vitamin K antagonists)

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, nurse or healthcare professional. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly for the UK via the Yellow Card Scheme: 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 Ciprofloxacin

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 packaging after “Exp”. The expiry date refers to the last day of that month.

•    Do not refrigerate or freeze.

•    Store the infusion bag in the overpouch until it is used in order to protect from light.

•    Store the infusion bottle in the outer carton until it is used in order to protect from light.

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

6.    Contents of the packand further information What Ciprofloxacin contains

•    The active substance is ciprofloxacin (as hydrogen sulphate)

•    The other ingredients are sodium chloride, sulphuric acid, sodium hydroxide for pH adjustment, water for injections

What Ciprofloxacin looks like and contents of the pack

Ciprofloxacin is a sterile, clear and colourless solution.

Ciprofloxacin is contained in a dear flexible polyolefine bag with aluminium overpouch (Excel bags and Fneeflex bags) or in a polyethylene botUe (KabiPac).

50 ml solution contains 100 mg ciprofloxacin.

100 ml solution contains 200 mg ciprofloxacin.

200 ml solution contains 400 mg ciprofloxacin.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Fresenius Kabi Limited,

Cestrian Court, Eastgate Way Manor Park, Runcorn Cheshire, WA7 1NT UK

Manufacturer:

Fresenius Kabi Norge AS Postboks430, N-1753 Halden Norway

Fresenius Kabi Polska Sp. z o.o.

Wytwomia Plynow Infuzyjnych ul. Sienkiewicza 25,99-300 Kutno Poland

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

AT: Ciprofloxacin 100 mg/50 ml, -200 mg/100 ml, -400 mg/200 ml Infusionslosung

BE: Ciprofloxacin Fresenius Kabi 200 mg/100 ml, -400 mg/200 ml solution pour perfusion/ Infusionslosung/ oplossing voor intraveneuze infusie

CY: Ciprofloxacin 100 mg/50 ml, -200 mg/100 ml, -400 mg/200 ml SidAupa yia £yxuar|

CZ: Ciprofloxacin 100 mg/50 ml, -200 mg/100 ml, -400 mg/200 ml infuzni roztok

DE: Ciprofloxacin 100 mg/50 ml, -200 mg/100 ml, 400 mg/200 ml Infusionslosung

DK: Ciprofloxacin Fresenius Kabi 2 mg/ml infusionsvseske

EL: Ciprofloxacin 100 mg/50 ml, -200 mg/100 ml, -400 mg/200 ml 5idAupa yia £yxuar|

ES: Ciprofloxacin 2 mg/ml solucidn para perfusidn

FI: Ciprofloxacin Fresenius Kabi 2 mg/ml infuusioneste, liuos

HU: Ciprofloxacin 200 mg/100 ml, -400 mg/200 ml oldatos infuzio

IT: Ciprofloxacin 100 mg/50 ml, -200 mg/100 ml, -400 mg/200 ml soluzione per infusione

NL: Ciprofloxacin 100 mg/50 ml, -200 mg/100 ml, -400 mg/200 ml oplossing voor infusie

PL: Ciprofloxacin 100 mg/50 ml, -200 mg/100 ml, -400 mg/200 ml roztwor do infuzji

PT: Ciprofloxacin 100 mg/50 ml, -200 mg/100 ml, -400 mg/200 ml Solugao para perfusao

SE: Ciprofloxacin Fresenius Kabi 2 mg/ml infusionsvatska, losning

SK: Ciprofloxacin 100 mg/50 ml, -200 mg/100 ml, -400 mg/200 ml infuzny intravenozny roztok

UK: Ciprofloxacin 100 mg/50 ml, -200 mg/100 ml, -400 mg/200 ml solution for infusion

This leaflet was last revised in September 2015

Advice/medical education

Antibiotics are used to cure bacterial infections. They are ineffective against viral infections.

If your doctor has prescribed antibiotics, you need them precisely for your current illness.

Despite antibiotics, some bacteria may survive or grow. This phenomenon is called resistance: some anti biotic treatments become ineffective.

Misuse of antibiotics increases resistance. You may even help bacteria become resistant and therefore delay your cure or decrease antibiotic efficacy if you do not respect appropriate:

•    dosage

•    schedules

•    duration of treatment

Consequently, to preserve the efficacy of this drug:

1.    Use antibiotics only when prescribed.

2.    Strictly follow the prescription.