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CIPROXIN 250 MG FILM-COATED TABLETS

Active substance(s): CIPROFLOXACIN / CIPROFLOXACIN HYDROCHLORIDE MONOHYDRATE / CIPROFLOXACIN / CIPROFLOXACIN HYDROCHLORIDE MONOHYDRATE

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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)
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 (see details below). By
reporting side effects, you can help provide more information on
the safety of this medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Malta
ADR Reporting
Website: www.medicinesauthority.gov.mt/adrportal

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 blister and carton after “EXP”: The expiry date refers to the
last day of that month.
This medicinal product does not require any special storage
conditions.
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.
Each film-coated tablet contains 250 mg ciprofloxacin (as
hydrochloride).
The other ingredients are:
Tablet core: cellulose microcrystalline, crospovidone, magnesium
stearate, maize starch, silica colloidal anhydrous.

Film-coat: hypromellose, macrogol 4000, titanium dioxide (E171).
What Ciproxin looks like and contents of the pack
Ciproxin 250 mg tablets: round, nearly white to slightly yellowish
film-coated tablets marked with “CIP score 250” on one side and
a Bayer cross on the other side.
The tablets can be divided into equal doses.
Pack sizes of 6, 8, 10, 12, 14, 16, 20, 28, 50, 100, 160, or 500
film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing authorisation holder
Bayer plc
Bayer House
Strawberry Hill
Newbury
Berkshire RG14 1JA
Manufacturer:
Bayer AG
Leverkusen
Germany
or
Bayer Healthcare
Manufacturing S.r.l.
20024 Garbagnate Milanese
Italy
This medicinal product is authorised in the Member States
of the EEA under the following names:
Austria:
Ciproxin
Italy:
Ciproxin
Belgium:
Ciproxine
Luxembourg:
Ciproxine
Bulgaria:
Ciprobay
Malta:
Ciproxin
France:
Ciflox
Norway:
Ciproxin
Germany:
Ciprobay
Portugal:
Ciproxina
Hungary:
Ciprobay
Slovenia:
Ciprobay
Ireland:
Ciproxin
United Kingdom: 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

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Package leaflet: Information for the patient

Ciproxin® 250 mg film-coated
tablets
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. What Ciproxin is and what it is used for
2. What you need to know before you take Ciproxin
3. How to take Ciproxin
4. Possible side effects
5. How to store Ciproxin
6. 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
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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.
• 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 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)
• 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.
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 tablets, 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.

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.

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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 many tablets to take and how to take Ciproxin.
a. Swallow the tablets with plenty of fluid. Do not chew the
tablets because they do not taste nice.
b. Do try to take the tablets at around the same time every day.
c. You can take the tablets at mealtimes or between meals. Any
calcium you take as part of a meal will not seriously affect
uptake. However, do not take Ciproxin tablets with dairy
products such as milk or yoghurt or with fortified fruit juices
(e.g. calcium-fortified orange juice).
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 your tablets 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
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);
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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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