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

Active substance: CIPROFLOXACIN

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Granules:
Do not store above 25 °C.

Marketing Authorisation Holder and Manufacturer
Marketing authorisation holder

Bayer plc
Bayer House
Strawberry Hill
Newbury
Berkshire RG14 1JA

Manufacturer:

Bayer Pharma AG
Leverkusen
Germany
or

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.

Bayer Healthcare
Manufacturing S.r.l.
20024 Garbagnate
Milanese
Italy

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.
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.

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:
Ciproxin
Luxembourg:
Ciproxine
Netherlands:
Ciproxin
Sweden:
Ciproxin
United Kingdom: Ciproxin

This leaflet was last revised in January 2014
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

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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.

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)

Warnings and precautions
Talk to your doctor before taking 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 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 this happens, stop taking
Ciproxin and contact your doctor immediately.
• You may experience psychiatric reactions the first
Y
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, stop
taking Ciproxin and contact your doctor immediately.
• You may experience symptoms of neuropathy such as
Y
pain, burning, tingling, numbness and/or weakness.
If this happens, stop taking Ciproxin and 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
immediately, as this can be life-threatening. Do
not take medicines that stop or slow down bowel
movements and contact your doctor.
• Tell the doctor or laboratory staff that you are taking
T
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, stop taking Ciproxin and 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.
• Your skin becomes more sensitive to sunlight or
Y
ultraviolet (UV) light when taking Ciproxin. Avoid
exposure to strong sunlight, or artificial UV light such
as sunbeds.

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.
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)
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

Remember to drink plenty of fluids while you are taking this
medicine.

If these preparations are essential, take Ciproxin about
two hours before or no sooner than four hours after them.

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.

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.

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 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.

Common:

may affect up to 1 in 10 people
- nausea, diarrhoea
- joint pains in children

Uncommon:

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

Rare:

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 product comes in 2 bottles. The small bottle contains
granules which you add to the solvent in the larger bottle.
1. Open both bottles. Press down the child-proof cap and
turn it to the left.
2. Empty the bottle containing the granules for oral
suspension into the opening of the bottle of solvent. Do
not add any water to the solvent.
3. Close the bottle with the solvent and added granules, turn
it on its side and shake vigorously for about 15 seconds.
4. Shake it vigorously for about 15 seconds before each dose.
Shak
5. Enter the expiry date after reconstitution (= reconstitution
date + 14 days) in the relevant field on the solvent bottle.
The reconstituted suspension is stable for no more than
14 days even when stored in a refrigerator
6. Do try to take the suspension at around the same time
every day.
7. Always use the measuring spoon provided. The full
spoon will give you a dose of 250 mg Ciproxin.
8. Do not chew the granules present in the suspension,
simply swallow them
9. A glass of water may be taken after taking the dose.
10.You can take the suspension at mealtimes or in between
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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 orange-juice).

-

If you forget to take Ciproxin

may affect up to 1 in 100 people
- 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
- joint pain in adults
- 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)

3. How to take Ciproxin

-

may affect up to 1 in 1,000 people
- 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)
- 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), or
hallucinations
- pins and needles, unusual sensitivity to stimuli of the
senses, decreased skin sensitivity, tremors, seizures
(see Section 2: Warnings and precautions), or giddiness
- eyesight problems including double vision
- 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)
muscle pain, inflammation of the joints, increased
muscle tone, or cramp
kidney failure, blood or crystals in the urine (see
Section 2: Warnings and precautions), urinary tract
inflammation
fluid retention or excessive sweating
increased levels of the enzyme amylase

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); 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 (see Section 2:
Warnings and precautions)
- severe allergic reactions (anaphylactic reaction
or anaphylactic shock, which can be fatal - serum
sickness) (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
- small, pin-point bleeding under the skin (petechiae);
various skin eruptions or rashes (for example, the
potentially fatal Stevens-Johnson syndrome or toxic
epidermal necrolysis)
- muscle weakness, tendon inflammation, tendon
rupture – especially of the large tendon at the back of
the ankle (Achilles tendon) (see Section 2: Warnings
and precautions); 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 (peripheral neuropathy and
polyneuropathy)
- 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)
- pustular rash
- influence on blood clotting (in patients treated with
Vitamin K antagonists)

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.

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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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