CIPROXIN 250MG FILM-COATED TABLETS

Active substance: CIPROFLOXACIN HYDROCHLORIDE MONOHYDRATE

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- 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 (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
The Medicines Authority
Post-Licensing Directorate
203 Level 3, Rue D’Argens
GŻR-1368 Gżira
Website: www.medicinesauthority.gov.mt
e-mail: postlicensing.medicinesauthority@gov.mt

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 Pharma 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:
Ciproxin
Austria:
Ciproxin Italy:
Ciproxine
Belgium:
Ciproxine Luxembourg:
Ciproxin
Bulgaria:
Ciprobay Malta:
Ciproxin
Czech Republic: Ciprobay Norway:
Ciprobay
Finland:
Ciproxin Poland:
Portugal:
Ciproxina
France:
Ciflox
Ciprobay
Germany:
Ciprobay Slovenia:
Baycip
Hungary:
Ciprobay Spain:
Ireland:
Ciproxin United Kingdom: Ciproxin
This leaflet was last revised in September 2013
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 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
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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
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
pain, burning, tingling, numbness and/or weakness. If this
happens, stop taking Ciproxin and 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 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
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
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 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.
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
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.
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.
Common:
may affect up to 1 in 10 people
- nausea, diarrhoea
- joint pains in children
Uncommon:
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)
Rare:
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 lifethreatening 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)
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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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