CIPROFLOXACIN 400MG/200ML SOLUTION FOR INFUSION

Active substance: CIPROFLOXACIN

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Warnings and Precautions

V003/A UK

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ciprofloxacin 400 mg/200 ml
solution for infusion

Ciprofloxacin and associated names 400 mg/200 ml, solution for infusion
Ciprofloxacin (as hydrogen sulphate)
Read all of this leaflet carefully before you start using 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

Before you are given Ciprofloxacin
Talk to your doctor, pharmacist, nurse or healthcare professional 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
• have myasthenia gravis (a type of muscle weakness)
• have a history of abnormal heart rhythms (arrhythmia)
Heart problems
Caution should be taken when using this kind of medicine, if you were born 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
Taking other medicines).

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 considered this necessary.

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.
• Ciprofloxacin 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

must be stopped immediately.
• Ciprofloxacin 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 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.

2. What you need to know before you use Ciprofloxacin
You must NOT be given Ciprofloxacin if you are:
• allergic to the active substance, to other quinolone drugs or to any of the other ingredients of this

medicine listed in section 6.
• taking tizanidine (see Section 2: Taking other medicines)

Other medicines and Ciprofloxacin
You must tell your doctor if you are taking 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.

What is in this leaflet:
1. What Ciprofloxacin is and what it is used for
2. What you need to know before you use Ciprofloxacin
3. How to use Ciprofloxacin
4. Possible side effects
5. How to store Ciprofloxacin
6. Contents of the pack and other information
1. What Ciprofloxacin is what it is used for
Ciprofloxacin 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 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.

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 if you are").
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.
Tell your doctor if you are taking:
• 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 may increase the levels of the following medicines in your blood:
pentoxifylline (for circulatory disorders)
caffeine
Ciprofloxacin with food and drink
Food and drink does not affect your treatment with Ciprofloxacin.
Pregnancy and breast-feeding
It is preferable to avoid the use of Ciprofloxacin during pregnancy. 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
Do not take Ciprofloxacin during breast feeding because ciprofloxacin is excreted in breast milk and 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. How to 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.
Remember to drink plenty of fluids while you are taking Ciprofloxacin.
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 on the use of this medicine, ask your doctor, pharmacist, nurse or healthcare
professional.

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

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4. Possible side effects
Like all medicines, this medicine 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 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), 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 (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: Take special care with Ciprofloxacin)
- 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: Take special care with Ciprofloxacin)
- 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)
- increased blood sugar (hyperglycemia)
- anxiety reaction, strange dreams, depression, mental disturbances (psychotic reactions)

(see Section 2: Take special care with Ciprofloxacin)
- 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: Take special care with Ciprofloxacin), 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: Take special care with

Ciprofloxacin)
- blood or crystals in the urine (see Section 2: Take special care with Ciprofloxacin),

urinary tract inflammation
- excessive sweating
- abnormal levels of a clotting factor (prothrombin) increased levels of the enzyme amylase

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
- 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)
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.
5. How to store Ciprofloxacin
Keep 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 you no longer require. These measures will help protect the environment.
6. Contents of the pack and other 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 clear flexible polyolefine bag with aluminium overpouch (Excel bags and
Freeflex bags) or in a polyethylene bottle (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 United Kingdom

This medicinal product is authorised in the Member States of the EEA under following names:
AT: Ciprofloxacin Kabi 100 mg/50 ml, -200 mg/ 100 ml, -400 mg/200 ml Infusionslösung
BE: Ciprofloxacin Fresenius Kabi 200 mg/100 ml, -400 mg/200 ml solution pour perfusion/Infusionslösung/

oplossing voor intraveneuze infusie
CY: Ciprofloxacin Kabi 100 mg/50 ml, -200mg/100ml, -400 mg/ 200 ml διάλυμα για έγχυση
CZ: Ciprofloxacin Kabi 100 mg/50 ml, -200 mg/ 100 ml, -400 mg/200 ml infuzní roztok
DE: Ciprofloxacin Kabi 100 mg/50 ml, -200 mg/100 ml, 400 mg/200 ml Infusionslösung
DK: Ciprofloxacin Fresenius Kabi 2 mg/ml infusionsvæske, opløsning
EL: Ciprofloxacin Kabi 100 mg/50 ml, -200 mg/ 100 ml, -400 mg/200 ml διάλυμα για έγχυση
ES: Ciprofloxacin Kabi 2 mg/ml solución para perfusión
FI: Ciprofloxacin Fresenius Kabi 2 mg/ml infuusioneste, liuos
HU: Ciprofloxacin Kabi 200 mg/100 ml, -400 mg/200 ml oldatos infúzió
IT: Ciprofloxacin Kabi 100 mg/50 ml, -200 mg/ 100 ml, -400 mg/200 ml soluzione per infusione
NL: Ciprofloxacin Kabi 100 mg/50 ml, -200 mg/ 100 ml, -400 mg/200 ml oplossing voor intraveneuze infusie
PL: Ciprofloxacin Kabi 100 mg/50 ml, -200 mg/ 100 ml, -400 mg/200 ml roztwór do infuzji
PT: Ciprofloxacin Kabi 100 mg/50 ml, -200 mg/ 100 ml, -400 mg/200 ml Solução para perfusão
SE: Ciprofloxacin Fresenius Kabi 2 mg/ml infusionsvätska, lösning
SK: Ciprofloxacin Kabi 100 mg/50 ml, -200 mg/ 100 ml, -400 mg/200 ml infúzny intravenózny roztok
UK: Ciprofloxacin Kabi 100 mg/50 ml, -200 mg/ 100 ml, -400 mg/200 ml solution for infusion
This leaflet was last revised in August 2012
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 drug:
1. Use antibiotics only when prescribed.
2. Strictly follow the prescription.
3. Do not re-use an antibiotic without medical prescription, even if you want to treat a similar illness.
4. Never give your antibiotic 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
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Manufacturers:
Fresenius Kabi Norge AS
Postboks 430
N-1753 Halden
Norway

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.

Fresenius Kabi Polska Sp. z o.o.
Wytwórnia Płynów Infuzyjnych
99-300 Kutno
Sienkiewicza 25
Poland

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.

Very rare side effects (may affect up to 1 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: Take special care with Ciprofloxacin)
- 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: Take special care with Ciprofloxacin)

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.

V003
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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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