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PACKAGE LEAFLET: INFORMATION FOR THE USER

Ciprofloxacin 2mg/ml Solution for Infusion

(Ciprofloxacin 100mg/50ml, 200mg/100ml and 400mg/200ml)

Read all of this leaflet carefully before you are given this medicine.

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

•    If you have any further questions, ask your doctor or pharmacist.

•    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

| 1. WHAT CIPROFLOXACIN INFUSION IS AND WHAT IT IS USED FOR |

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

Adults

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

•    respiratory tract infections

•    long lasting or recurring ear or sinus infections

•    urinary 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 (neutropenia)

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

•    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 Infusion.

Children and adolescents

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

2. BEFORE YOU ARE GIVEN CIPROFLOXACIN INFUSION

doctor immediately since the administration of Ciprofloxacin Infusion 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 Infusion 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 Infusion 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 Infusion. If this happens, stop taking Ciprofloxacin Infusion 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 Infusion and contact your doctor immediately.

•    Diarrhoea may develop while you are on antibiotics, including Ciprofloxacin Infusion 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 Infusion 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 Infusion if you have to provide a blood or urine sample.

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

•    Ciprofloxacin Infusion may cause a reduction in the number of white blood cells and your resistance to infection may be decreased. If you 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 anaemia with ciprofloxacin.

•    Your skin becomes more sensitive to sunlight or ultraviolet (UV) light under treatment with Ciprofloxacin Infusion. 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.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Do not use Ciprofloxacin Infusion 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 Infusion if you are...')

The following medicines are known to interact with Ciprofloxacin Infusion in your body. Using Ciprofloxacin Infusion together with these medicines can influence the therapeutic effect of these medicines. It can also increase the probability of experiencing side effects.

You must tell your doctor if you are taking:

•    other medicines that can alter your heart rhythm i.e. 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

•    warfarin or other oral 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)

•    clozapine (an antipsychotic)

•    ropinirole (for Parkinson’s disease)

•    phenytoin (for epilepsy).

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

•    pentoxifylline (for circulatory disorders)

•    caffeine

Taking Ciprofloxacin Infusion with food and drink

Food and drink does not affect your treatment with Ciprofloxacin Infusion.

Pregnancy and breast-feeding

It is preferable to avoid the use of Ciprofloxacin Infusion during pregnancy. Tell your doctor if you are planning to get pregnant.

Do not take Ciprofloxacin Infusion during breast feeding because ciprofloxacin is excreted in breast milk and can be harmful for your child.

The following information is intended for medical or healthcare professionals only

Ciprofloxacin Infusion should be administered by intravenous infusion. For children, the infusion duration is 60 minutes. In adult patients, the infusion time is 60 minutes for 400 mg Ciprofloxacin Infusion and 30 minutes for 200 mg Ciprofloxacin Infusion. 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. penicillins, heparin solutions), especially in combination with solutions adjusted to an alkaline pH (pH of the ciprofloxacin infusion solutions: 3.5 - 4.6).

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

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Driving and using machines

Ciprofloxacin Infusion may make you feel less alert. Some neurological adverse events can occur. Therefore, make sure you know how you react to Ciprofloxacin Infusion before driving a vehicle or operating machinery. If in doubt, talk to your doctor.

Important information about some of the ingredients of Ciprofloxacin Infusion

This medicine contains 5.5g glucose per 100ml of infusion solution. This should be taken into account in patients with diabetes mellitus.

Your doctor will explain to you exactly how much Ciprofloxacin Infusion 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 the infusion time is 60 minutes for 400 mg Ciprofloxacin Infusion and 30 minutes for 200 mg Ciprofloxacin Infusion. Administering the infusion slowly helps prevent immediate side effects occurring.

Remember to drink plenty of fluids while you are taking Ciprofloxacin Infusion.

If you stop your course of Ciprofloxacin Infusion

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 more questions about the use of this product, ask your doctor or pharmacist.

| 4. POSSIBLE SIDE EFFECTS | ³

rupture - especially of the large tendon at the back of the ankle (Achilles tendon) (see Section 2: Take special care with Ciprofloxacin Infusion)

•    blood or crystals in the urine (see Section 2: Take special care with Ciprofloxacin Infusion), urinary tract inflammation

•    excessive sweating

•    abnormal levels of a clotting factor (prothromibin) increased levels of the enzyme amylase

Very rare side effects (less than 1 in every 10,000 people are likely to get these):

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

•    severe allergic reaction (anaphylactic reaction, anaphylactic shock, serum sickness) which can be fatal (see Section 2: Take special care with Ciprofloxacin Infusion)

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

•    visual colour 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: Take special care with Ciprofloxacin Infusion)

Frequency not known (cannot be estimated from the available data)

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

•    heart problems: abnormal fast heart rhythm, life-threatening irregular heart rhythm, alteration of heart rhythm (called ‘prolongation of QT interval’, seen on ECG, electrical activity of the heart)

Reporting of side effects If you get any side effects, talk to your doctor, pharmacist

or nurse. This includes any possible side effects not listed in this leaflet. You can also

report side effects directly via the Yellow Card Scheme at: 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 INFUSION |

Store in the original package. Do not refrigerate or freeze.

Keep out of the reach and sight of children.

Do not use Ciprofloxacin Infusion after the expiry date which is stated on the carton after "EXP": The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. These measures will help to protect the environment.

| 6. FURTHER INFORMATION |

What Ciprofloxacin Infusion contains

The active ingredient is ciprofloxacin (as ciprofloxacin lactate).

The other ingredients are lactic acid solution, glucose monohydrate and water for injection.

What Ciprofloxacin Infusion looks like and contents of the pack

Solution for infusion.

Ciprofloxacin Infusion is available in 50ml, 100ml or 200ml PVC bags. The 50ml bag contains 100mg Ciprofloxacin, the 100ml bag contains 200mg Ciprofloxacin and the 200ml bag contains 400mg Ciprofloxacin.

Marketing Authorisation Holder

Villerton Invest SA,

40, Avenue Monterey L-2163 Luxembourg

Manufacturer

S.C. Infomed Fluids S.r.l.

Str. Theodor Pallady nr. 50, Sector 3,

Bucarest - Romania

This leaflet was last revised in January 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 antibiotic 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 medicine:

1    - Use antibiotics only when prescribed.

2    - Strictly follow the prescription.

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

similar illness.

4    - Never give your antibiotic to another person; it may not be suitable for 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

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1

You must not be given Ciprofloxacin Infusion if you are:

•    allergic (hypersensitive) to the active substance, to other quinolone drugs or to any of the other ingredients of Ciprofloxacin Infusion (see section 6)

•    taking tizanidine (see Section 2: Taking other medicines)

Take special care with Ciprofloxacin Infusion

Before you are given Ciprofloxacin Infusion, tell your doctor if you:

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

•    suffer from epilepsy or other neurological conditions

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

•    have myasthenia gravis (a type of muscle weakness)

Heart problems:

Caution should be taken when using this kind of medicine if you:

•    were born with or have a family history of prolonged QT interval (seen on ECG, electrical recording of the heart)

•    have salt imbalance in the blood (especially low levels 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)

•    are female or elderly

•    are taking other medicines that result in abnormal ECG changes (see ‘Taking other medicines’)

2

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

gets them.

If any of the side effects gets serious, or if you notice any side effects not listed in this

leaflet, tell your doctor or pharmacist.

Common side effects (between 1 and 10 in every 100 people are likely to get these):

•    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 (between 1 and 10 in every 1,000 people are likely to get these):

•    fungal superinfections

•    a high concentration of eosinophils, a type of white blood cell, increased or decreased amounts of a blood cloting 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: Take special care with Ciprofloxacin Infusion), 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

•    poor kidney function, kidney failure

•    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 (between 1 and 10 in every 10,000 people are likely to get these):

•    inflammation of the bowel (colitis) linked to antibiotic use (can be fatal in rare cases) (see Section 2: Take special care with Ciprofloxacin Infusion)

•    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, bone-marrow depression which may also be fatal (see Section 2: Take special care with Ciprofloxacin Infusion)

•    allergic reaction, allergic swelling (oedema), rapid swelling of the skin and mucous membranes (angiooedema), severe allergic reaction (anaphylactic shock) which can be life-threatening (see Section 2: Take special care with Ciprofloxacin Infusion

3

   increased blood sugar (hyperglycaemia)

•    anxiety reaction, strange dreams, depression, mental disturbances (psychotic reactions) (see Section 2: Take special care with Ciprofloxacin Infusion

•    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

•    sensitivity to light (see Section 2: Take special care with Ciprofloxacin Infusion), small, pin-point bleeding under the skin (petechiae)

•    muscle pain, inflammation of the joints, increased muscle tone, cramping, tendon