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CIPROFLOXACIN 2MG/ML SOLUTION FOR INFUSION

Active substance(s): CIPROFLOXACIN LACTATE

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Package leaflet: Information for the user
Ciprofloxacin 2 mg/ml Solution for Infusion
Ciprofloxacin
Read all of this leaflet carefully before you
start taking 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
or pharmacist or nurse.
• This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
• If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist. See section 4.
What is in this leaflet:
1. What Ciprofloxacin 2 mg/ml Solution for Infusion
is and what it is used for
2. What you need to know before you are given
Ciprofloxacin 2 mg/ml Solution for Infusion
3. How to use Ciprofloxacin 2 mg/ml Solution for
Infusion
4. Possible side effects
5. How to store Ciprofloxacin 2 mg/ml Solution for
Infusion
6. Contents of the pack and other information
1. What Ciprofloxacin 2 mg/ml Solution for
Infusion is and what it is used for
Ciprofloxacin 2 mg/ml Solution for 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 2 mg/ml Solution for 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 intraabdominal 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 2 mg/ml Solution for Infusion.
Children and adolescents
Ciprofloxacin 2 mg/ml Solution for 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 2 mg/ml Solution for Infusion may
also be used to treat other specific severe infections
in children and adolescents when your doctor
considered this necessary.
2. What you need to know before you take
Ciprofloxacin 2 mg/ml Solution for Infusion
You must not be given Ciprofloxacin 2 mg/ml
Solution for Infusion:
- if you are allergic to the active substance ciprofloxacin, to other quinolone drugs or to any of the
other ingredients of this medicine (listed in section
6)
- if you are taking tizanidine (see Section 2: Other
medicines and Ciprofloxacin 2 mg/ml Solution for
Infusion )
Warnings and precautions
Talk to your doctor, pharmacist or nurse before
taking Ciprofloxacin 2 mg/ml Solution for Infusion
• if you have ever had kidney problems because
your treatment may need to be adjusted
• if you suffer from epilepsy or other neurological
conditions
• if you have a history of tendon problems during
previous treatment with antibiotics such as Ciprofloxacin 2 mg/ml Solution for Infusion,
• if you have myasthenia gravis (a type of muscle
weakness)
• if you have a history of abnormal heart rhythms
(arrythmias)
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 Other
medicines and Ciprofloxacin 2 mg/ml Solution for
Infusion ).
While under treatment with Ciprofloxacin 2
mg/ml Solution for Infusion
Tell your doctor immediately, if any of the following
occurs during treatment with Ciprofloxacin 2 mg/ml
Solution for Infusion. Your doctor will decide
whether treatment with Ciprofloxacin 2 mg/ml
Solution for Infusion 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 2 mg/ml Solution for 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 2 mg/ml Solution for 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 2 mg/ml Solution for
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 2 mg/ml Solution for Infusion. If this
happens, stop taking Ciprofloxacin 2 mg/ml
Solution for 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
2 mg/ml Solution for Infusion and contact your
doctor immediately.
• Diarrhoea may develop while you are on antibiotics, including Ciprofloxacin 2 mg/ml Solution for
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 2 mg/ml Solution for 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 2 mg/ml Solution for Infusion if
you have to provide a blood or urine sample.
• Ciprofloxacin 2 mg/ml Solution for 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 2 mg/ml Solution for
Infusion must be stopped immediately.
• Ciprofloxacin 2 mg/ml Solution for 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-6phosphate 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 2 mg/ml Solution for 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.
Οther medicines and Ciprofloxacin 2 mg/ml
Solution for Infusion:
Tell your doctor or pharmacist if you are taking,
have recently taken, or might take any other
medicines.
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.

Remember to drink plenty of fluids while you are
taking Ciprofloxacin 2mg/ml Solution for Infusion.
If you stop your course of Ciprofloxacin 2
mg/ml Solution for 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
Like all medicines, this medicine 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 (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)

Pregnancy and breast-feeding

- 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: Warnings and precautions)
- 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: Warnings and precautions)

Ciprofloxacin 2 mg/ml Solution for Infusion may
increase the levels of the following medicines in
your blood:
• pentoxifylline (for circulatory disorders)
• caffeine

It is preferable to avoid the use of Ciprofloxacin 2
mg/ml Solution for Infusion during pregnancy. Tell
your doctor if you are planning to get pregnant.
Do not take Ciprofloxacin 2 mg/ml Solution for
Infusion during breast feeding because ciprofloxacin is excreted in breast milk and can be harmful for
your child.
Driving and using machines
Ciprofloxacin 2 mg/ml Solution for Infusion may
make you feel less alert. Some neurological adverse
events can occur. Therefore, make sure you know
how you react to Ciprofloxacin 2 mg/ml Solution for
Infusion before driving a vehicle or operating
machinery. If in doubt, talk to your doctor.
Important information about some of the
ingredients of Ciprofloxacin 2 mg/ml Solution for Infusion
This medicinal product contains 177/354/708 mg
(7.7/15.4/30.8 mmol) sodium per 50/100/200
milliliter of solution.
To be taken into consideration by patients on a
controlled sodium diet.
3. How to take Ciprofloxacin 2mg/ml Solution for Infusion
Your doctor will explain to you exactly how much
Ciprofloxacin 2 mg/ml Solution for 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, infusion time is 60 minutes for 400 mg
Ciprofloxacin 2 mg/ml Solution for Infusion and 30
minutes for 200 mg Ciprofloxacin 2 mg/ml Solution
for Infusion. Administering the infusion slowly helps
prevent immediate side effects occurring.

Do not refrigerate or freeze.
Keep the container in the outer carton in order to
protect from light.
Do not throw away any medicinesvia wastewater or
household waste. Ask your pharmacist how to
throw away medicines you no longer required.
These measures will help to protect the
environment.
6. Contents of the pack and other information
What Ciprofloxacin 2 mg/ml Solution for
Infusion contains

Marketing Authorisation Holder(s)

Very rare side effects (may affect up to 1 in
10000 people):

• warfarin, or oral anticoagulants (to thin 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).

Do not use Ciprofloxacin 2 mg/ml Solution for
Infusion after the expiry date which is stated on the
carton after “EXP”: The expiry date refers to the
last day of that month.

Rare side effects (may affect up to 1 in 1000
people):

Food and drink does not affect your treatment with
Ciprofloxacin 2 mg/ml Solution for Infusion.

Tell your doctor if you are taking:

Keep out of the sight and reach of children.

The active ingredient is ciprofloxacin (as ciprofloxacin lactate).
1 ml solution for infusion contains 2 mg of Ciprofloxacin (as lactate).
The other ingredients are: Lactic Acid (90%),
Sodium Chloride, Hydrochloric Acid 1N, Water for
Injections.

Taking Ciprofloxacin 2mg/ml Solution for
Infusion with food and drink

The following medicines are known to interact with
Ciprofloxacin 2 mg/ml Solution for Infusion in your
body. Using Ciprofloxacin 2 mg/ml Solution for
Infusion together with these medicines can
influence the therapeutic effect of these medicines.
It can also increase the probability of experiencing
side effects.

5. How to store Ciprofloxacin 2 mg/ml
Solution for Infusion

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 2 mg/ml Solution for
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)

- 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), severe allergic reaction
(anaphylactic shock) which can be life-threatening
(see Section 2: Warnings and precautions)
- 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
- 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
- abnormal levels of a clotting factor (prothromibin)
increased levels of the enzyme amylase

Do not use Ciprofloxacin 2 mg/ml Solution
for 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 2 mg/ml Solution
for Infusion if you are").

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

What Ciprofloxacin 2 mg/ml Solution for
Infusion looks like and contents of the pack
Ciprofloxacin 2mg/ml Solution for Infusion is
supplied in a transparent Type I glass vial with
rubber stopper and aluminium cap. The appearance
of the product is a clear yellowish to slightly yellow,
odourless solution free from foreign bodies with a
pH 3.9 – 4.5.
Pack sizes:
One vial with
50 ml solution for infusion contains 100 mg
ciprofloxacin (as lactate).
100 ml solution for infusion contains 200 mg
ciprofloxacin (as lactate).
200 ml solution for infusion contains 400 mg
ciprofloxacin (as lactate).
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer

For United Kingdom:
Pharmathen S.A., 153 51, Pallini-Attiki, Greece
tel.: +30.210.6665067
fax: +30.210.6666749
e-mail: info@pharmathen.com
For Greece
Pharmathen Hellas S.A., 153 51, Pallini, Attiki
Tel.: +30 210 66 64 805
Fax: +30 210 66 64 804
E-mail: info@pharmathen.com
Manufacturer(s)
Pharmathen S.A., 153 51, Pallini-Attiki, Greece
tel.: +30.210.6665067
fax: +30.210.6666749
e-mail: info@pharmathen.com
And
ANFARM HELLAS S.A., Sximatari Viotias, Sximatari
Viotias 32009, Greece
This medicinal product is authorised in the
Member States of the EEA under the following names:
Greece Ladinin
United Kingdom Ciprofloxacin 2mg/ml Solution for
Infusion
This leaflet was last revised in 11/2013
Detailed information on this medicine is available on
the web site of MA.
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:
- dosages
- 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.

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
- 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)

The following information is intended for medical or healthcare professionals only:
Ciprofloxacin 2 mg/ml Solution for Infusion 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
2 mg/ml Solution for Infusion and 30 minutes for 200 mg Ciprofloxacin 2 mg/ml Solution for 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. penicillin, heparin solutions), especially in combination with solutions adjusted to
an alkaline pH (pH of the ciprofloxacin infusion solutions: 3.9-4.5).
After intravenous initiation of treatment, the treatment can be continued orally as well.

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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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