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CIPROXIN 250 MG/5 ML GRANULES AND SOLVENT FOR ORAL SUSPENSION

Active substance(s): CIPROFLOXACIN

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Very rare (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) (see Section 2: Warnings and
precautions); a drop in the number of red and white blood
cells and platelets (pancytopenia), which may be fatal; and
bone marrow depression, which may also be fatal
allergic reaction called serum sickness-like reaction (see
Section 2: Warnings and precautions)
mental disturbances (psychotic reactions potentially leading
to thoughts of suicide, suicide attempts, or completed
suicide) (see Section 2: Warnings and precautions)
migraine, disturbed coordination, unsteady walk (gait
disturbance), disorder of sense of smell (olfactory
disorders), pressure on the brain (intracranial pressure
and pseudotumor cerebri)
visual colour distortions
inflammation of the wall of the blood vessels (vasculitis)
pancreatitis
death of liver cells (liver necrosis) very rarely leading
to life-threatening liver failure (see Section 2: Warnings
and precautions)
small, pin-point bleeding under the skin (petechiae);
various skin eruptions or rashes
worsening of the symptoms of myasthenia gravis (see
Section 2: Warnings and precautions)

Not known (frequency cannot be estimated from the
available data)
– feeling highly excited (mania) or feeling great optimism
and overactivity (hypomania)
– 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)
– influence on blood clotting (in patients treated with
Vitamin K antagonists)

The other ingredients are:
Granules: hypromellose, magnesium stearate, polyacrylate
dispersion 30 %, polysorbate 20, povidone.
Solvent: Soya lecithin, medium chain triglycerides,
strawberry flavour, sucrose, purified water.

What Ciproxin looks like and contents of the pack
Granules and solvent for oral suspension.

Pack sizes:
Pack with one brown glass bottle containing 7.95 g of
granules and one white HDPE bottle containing 93 mL
of solvent. The pack size is provided with a blue plastic
graduated measuring spoon.
Pack with two brown glass bottles containing 7.95 g of
granules and two white HDPE bottles each containing 93
mL of solvent. The pack size is provided with two blue
plastic graduated measuring spoons.
Pack with five brown glass bottles each containing 7.95 g
of granules and five white HDPE bottles each containing
93 mL of solvent. The pack size is provided with five blue
plastic graduated measuring spoons.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing authorisation holder

Manufacturer:

Bayer AG
Leverkusen
Germany
or
Bayer Healthcare
Manufacturing S.r.l.
20024 Garbagnate
Milanese
Italy

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, Website:
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 Ciproxin

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 carton and bottles after “EXP”: The expiry
date refers to the last day of that month.
Granules:
Do not store above 25 °C.
Solvent:
Do not store above 25 °C.
Protect from freezing. Avoid inverted storage.
When reconstituted, the ready-to-use oral suspension is
stable only for 14 days when stored either at

ambient temperatures up to 30 °C or in a refrigerator
(2 °C-8 °C). After this time, the reconstituted
oral suspension should not be taken. Protect the
reconstituted oral suspension from freezing.
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 Ciproxin contains

The active substance is ciprofloxacin.
1 measuring spoonful (approx 5.0 mL suspension) provides
approx. 250 mg ciprofloxacin.
1/2 measuring spoonful (approx 2.5 mL suspension)
provides approx. 125 mg ciprofloxacin.

Bayer plc
Bayer House
Strawberry Hill
Newbury
Berkshire RG14 1JA

This medicinal product is authorised in the
Member States of the EEA under the following
names:
Austria:
Belgium:
France:
Germany:
Greece:

Ciproxin
Ciproxine
Ciflox
Ciprobay
Ciproxin

Italy
Luxembourg:
Netherlands:
Sweden:
United Kingdom:

Ciproxin
Ciproxine
Ciproxin
Ciproxin
Ciproxin

This leaflet was last revised in March 2017
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

U

0

Package leaflet: Information for the patient

Ciproxin® 250 mg/5 mL granules and solvent
for oral suspension
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.
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 you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.

What is in this leaflet
1.
2.
3.
4.
5.
6.

Warnings and precautions
Talk to your doctor before taking Ciproxin







What Ciproxin is and what it is used for
What you need to know before you take Ciproxin
How to take Ciproxin
Possible side effects
How to store Ciproxin
Contents of the pack and other information

1. What Ciproxin is and what it is used for
Ciproxin 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.
Adults
Ciproxin is used in adults to treat the following bacterial
infections:
• respiratory tract infections
• long lasting or recurring ear or sinus infections
• urinary tract infections
• genital tract infections in men and women
• gastro-intestinal tract infections and intra-abdominal
infections
• skin and soft tissue infections
• bone and joint infections
• to prevent infections due to the bacterium Neisseria
meningitidis
• anthrax inhalation exposure
Ciprofloxacin may be used in the management of patients
with low white blood cell counts (neutropenia) who have a
fever that is suspected to be due to a bacterial infection.
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 Ciproxin.
Children and adolescents
Ciproxin 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
Ciproxin 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
Ciproxin
Do not take Ciproxin:



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)
if you are taking tizanidine (see Section 2: Other
medicines and Ciproxin)



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 Ciproxin.
if you are diabetic because you may experience a risk of
hypoglycaemia with ciprofloxacin.
if you have myasthenia gravis (a type of muscle
weakness) because symptoms can be exacerbated.
if you have heart problems. Caution should be taken
when using Ciprofloxacin, 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 2: Other medicines and Ciproxin).
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.

For the treatment of some genital tract infections, your
doctor can prescribe another antibiotic in addition to
ciprofloxacin. If there is no improvement in symptoms after
3 days of treatment, please consult your doctor.

While taking Ciproxin

Tell your doctor immediately, if any of the following occurs
while taking Ciproxin. Your doctor will decide whether
treatment with Ciproxin needs to be stopped.
• Severe, sudden allergic reaction (an anaphylactic
reaction/shock, angio-oedema). Even with the first
dose, there is a small chance that you may experience
a severe allergic reaction with the following symptoms:
tightness in the chest, feeling dizzy, sick or faint, or
experiencing dizziness when standing up. If this
happens, stop taking Ciproxin and contact your
doctor immediately.
• Pain and swelling in the joints and tendinitis may
occur occasionally, particularly if you are elderly and
are also being treated with corticosteroids. Inflammation
and ruptures of tendons may occur even within the
first 48 hours of treatment or up to several months
after discontinuation of Ciproxin therapy. At the first
sign of any pain or inflammation stop taking Ciproxin,
contact your doctor and 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 seizure happens, stop taking Ciproxin
and contact your doctor immediately.
• You may experience symptoms of neuropathy such
as pain, burning, tingling, numbness and/or muscle
weakness. If this happens, stop taking Ciproxin and
contact your doctor immediately.
• You may experience psychiatric reactions the first
time you take Ciproxin. If you suffer from depression or
psychosis, your symptoms may become worse under
treatment with Ciproxin. In rare cases, depression or
psychosis can progress to thoughts of suicide, suicide
attempts, or completed suicide. If this happens, contact
your doctor immediately.
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Hypoglycemia has been reported most often in diabetic
patients, predominantly in elderly population. If this
happens, contact your doctor immediately.
Diarrhoea may develop while you are taking antibiotics,
including Ciproxin, or even several weeks after you
have stopped taking them. If it becomes severe or
persistent or you notice that your stool contains blood
or mucus, stop taking Ciproxin and contact your doctor
immediately, as this can be life-threatening. Do not take
medicines that stop or slow down bowel movements.
If your eyesight becomes impaired or if your eyes
seem to be otherwise affected, consult an eye specialist
immediately.
Your skin becomes more sensitive to sunlight or
ultraviolet (UV) light when taking Ciproxin. Avoid
exposure to strong sunlight, or artificial UV light such as
sunbeds.
Tell the doctor or laboratory staff that you are taking
Ciproxin 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.
Ciproxin 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,
contact your doctor immediately.
Ciproxin 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.

Other medicines and Ciproxin

Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
Do not take Ciproxin together with tizanidine, because
this may cause side effects such as low blood pressure and
sleepiness (see Section 2: Do not take Ciproxin).
The following medicines are known to interact with Ciproxin in
your body. Taking Ciproxin together with these medicines can
influence the therapeutic effect of those medicines. It can also
increase the probability of experiencing side effects.

Tell your doctor if you are taking:















Vitamin K antagonists (e.g. warfarin, acenocoumarol,
phenprocoumon or fluindione) or other oral anticoagulants (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 (for epilepsy)
metoclopramide (for nausea and vomiting)
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
zolpidem (for sleep disorders)

Ciproxin may increase the levels of the following medicines
in your blood:
• pentoxifylline (for circulatory disorders)
• caffeine
• duloxetine (for depression, diabetic nerve damage or
incontinence)
• lidocaine (for heart conditions or anaesthetic use)
• sildenafil (e.g. for erectile dysfunction)
• agomelatine (for depression)

Some medicines reduce the effect of Ciproxin. Tell your
doctor if you take or wish to take:
• antacids
• omeprazole
• mineral supplements
• sucralfate
• a polymeric phosphate binder (e.g. sevelamer or
lanthanum carbonate)
• medicines or supplements containing calcium,
magnesium, aluminium or iron
If these preparations are essential, take Ciproxin about two
hours before or no sooner than four hours after them.

3. Empty the small brown bottle
containing the granules into the
opening of the larger white bottle
with the solvent. Do not add any
water to the solvent. Discared the
empty small brown bottle.

4. Close the white bottle with the
solvent and added granules, turn it
on its side and shake vigorously for
about 15 seconds.

Ciproxin with food and drink

Unless you take Ciproxin during meals, do not eat or drink
any dairy products (such as milk or yoghurt) or drinks with
added calcium when you take the suspension, as they may
affect the absorption of the active substance.

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

Driving and using machines

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

Ciproxin contains sucrose

If you are sucrose intolerant, please consult your doctor
before taking Ciproxin 250 mg/5 mL granules and solvent
for oral suspension. As Ciproxin contains 1.4 g sucrose
per 5-mL measuring spoonful, this has to be taken into
consideration in terms of daily intake, particularly if you are
on a diabetic diet to control your blood sugar level. This
product can be harmful to teeth.

3. How to take Ciproxin

Your doctor will explain to you exactly how much Ciproxin you
will have to take 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.
The treatment usually lasts from 5 to 21 days, but may
take longer for severe infections. Always take this medicine
exactly as your doctor has told you. Check with your doctor
or pharmacist if you are not sure how to take Ciproxin.

Preparing and taking the suspension

Use only after reconstitution: the small brown bottle contains
granules of ciprofloxacin. Add them to the solvent in the
larger white bottle
1. The product comes in 2 bottles,
a small brown bottle and a larger
white bottle. The small brown
bottle contains granules which
you add to the solvent in the
larger white bottle.

2. Open both bottles. Press down the
child-proof cap and turn it to the left.

5. Shake it vigorously for about 15 seconds before each
dose.
6. Enter the expiry date after reconstitution
(= reconstitution date + 14 days) in the relevant field on
the white solvent bottle. The reconstituted suspension is
stable for no more than 14 days even when stored in a
refrigerator
7. Do try to take the suspension at around the same time
every day.
8. Always use the measuring spoon provided. The full
spoon will give you a dose of 250 mg Ciproxin.
9. Do not chew the granules present in the suspension,
simply swallow them
10. A glass of water may be taken after taking the dose.
11. You can take the suspension at mealtimes or in
between meals. Any calcium you take as part of a meal
will not seriously affect uptake. However, do not take
Ciproxin with dairy products such as milk or yoghurt or
with fortified fruit-juice (e.g. calcium-fortified orangejuice).
Remember to drink plenty of fluids while you are taking this
medicine.

If you take more Ciproxin than you should

If you take more than the prescribed dose, get medical help
immediately. If possible, take the oral suspension or the box
with you to show the doctor.

If you forget to take Ciproxin

Take the normal dose as soon as possible and then continue
as prescribed. However, if it is almost time for your next
dose, do not take the missed dose and continue as usual.
Do not take a double dose to make up for a forgotten dose.
Be sure to complete your course of treatment.

If you stop taking Ciproxin

It is important that you finish the course of treatment even if
you begin to feel better after a few days. If you stop taking 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.

4. Possible side effects

Like all medicines, this medicine can cause side effects,
although not everybody gets them.
The following section contains the most serious side effects
that you can recognize yourself:
Stop taking Ciproxin and contact your doctor
immediately in order to consider another antibiotic treatment
if you notice any of the following serious side effects:

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

– Seizure (see Section 2: Warnings and precautions)

Very rare (may affect up to 1 in 10,000 people)
– Severe, sudden allergic reaction with symptoms such
as tightness in the chest, feeling dizzy, sick or faint, or
experience dizziness when standing up (anaphylactic
reaction/shock) (see Section 2: Warnings and
precautions)

– Muscle weakness, inflammation of the tendons which
could lead to rupture of the tendon, particularly affecting
the large tendon at the back of the ankle (Achilles
tendon) (see Section 2: Warnings and precautions)
– A serious life-threatening skin rash, usually in the form
of blisters or ulcers in the mouth, throat, nose, eyes
and other mucous membranes such as genitals which
may progress to widespread blistering or peeling of
the skin (Stevens-Johnson syndrome, toxic epidermal
necrolysis).

Not known (frequency cannot be estimated from the

available data)
– Unusual feelings of pain, burning tingling, numbness or
muscle weakness in the extremities (neuropathy) (see
Section 2: Warnings and precautions)
– A drug reaction that causes rash, fever, inflammation of
internal organs, hematologic abnormalities and systemic
illness (DRESS Drug Reaction with Eosinophilia
and Systemic Symptoms, AGEP Acute Generalised
Exanthematous Pustulosis).
Other side effects which have been observed during treatment
with Ciproxin are listed below by how likely they are:

Common (may affect up to 1 in 10 people)
– nausea, diarrhoea
– joint pain and joint inflammation in children
Uncommon (may affect up to 1 in 100 people)

– joint pain in adults
– fungal superinfections
– a high concentration of eosinophils, a type of white
blood cell
– decreased appetite
– hyperactivity or agitation
– headache, dizziness, sleeping problems, or taste disorders
– vomiting, abdominal pain, digestive problems such as
stomach upset (indigestion/heartburn), or wind
– increased amounts of certain substances in the blood
(transaminases and/or bilirubin)
– rash, itching, or hives
– poor kidney function
– pains in your muscles and bones, feeling unwell
(asthenia), or fever
– increase in blood alkaline phosphatase (a certain
substance in the blood)

Rare (may affect up to 1 in 1,000 people)
– muscle pain, inflammation of the joints, increased
muscle tone and cramping
– inflammation of the bowel (colitis) linked to antibiotic
use (can be fatal in very rare cases) (see Section 2:
Warnings and precautions)
– changes to the blood count (leukopenia, leukocytosis,
neutropenia, anaemia), increased or decreased
amounts of a blood clotting factor (thrombocytes)
– allergic reaction, swelling (oedema), or rapid swelling of
the skin and mucous membranes (angio-oedema) (see
Section 2: Warnings and precautions)
– increased blood sugar (hyperglycaemia)
– decreased blood sugar (hypoglycaemia) (see Section 2:
Warnings and precautions)
– confusion, disorientation, anxiety reactions, strange
dreams, depression (potentially leading to thoughts of
suicide, suicide attempts, or completed suicide) (see
Section 2: Warnings and precautions), or hallucinations
– pins and needles, unusual sensitivity to stimuli of the
senses, decreased skin sensitivity, tremors, or giddiness
– eyesight problems including double vision (see Section
2: Warnings and precautions)
– tinnitus, loss of hearing, impaired hearing
– rapid heartbeat (tachycardia)
– expansion of blood vessels (vasodilation), low blood
pressure, or fainting
– shortness of breath, including asthmatic symptoms
– liver disorders, jaundice (cholestatic icterus), or hepatitis
– sensitivity to light (see Section 2: Warnings and
precautions)
– kidney failure, blood or crystals in the urine, urinary tract
inflammation
– fluid retention or excessive sweating
– increased levels of the enzyme amylase
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