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CIPROXIN 500MG FILM-COATED TABLETS

Active substance: CIPROFLOXACIN HYDROCHLORIDE MONOHYDRATE

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Package leaflet: Information for the patient

0

Ciproxin 500 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.
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 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 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
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.
T
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.
81121168

PMR 81121168 (93/06/MU-0201206591) Pantone: SCHWARZ, REFLEXBLUE

296x315-07508

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 (angiooedema)
- 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 (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 to protect the environment.

6. Contents of the pack and other information
What Ciproxin contains

The active substance is ciprofloxacin.
Each film-coated tablet contains 500 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 500 mg tablets: oblong, nearly white to slightly yellowish film-coated tablets marked with “CIP
score 500” on one side and “BAYER” 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

Manufacturer:





Bayer plc
Bayer House
Strawberry Hill
Newbury
Berkshire RG14 1JA
Bayer Pharma AG

This medicinal product is authorised in the Member States of the EEA under the
following names:
Austria:
Belgium:
Bulgaria:
Cyprus:
Czech Republic:
Finland:
France:
Germany:
Greece:
Hungary:

Ciproxin
Ciproxine
Ciprobay
Ciproxin
Ciprobay
Ciproxin
Ciflox; Uniflox
Ciprobay
Ciproxin
Ciprobay

Ireland:
Italy:
Luxembourg:
Malta:
Norway:
Poland:
Portugal:
Slovenia:
Spain:
United Kingdom:

Ciproxin
Ciproxin
Ciproxine
Ciproxin
Ciproxin
Ciprobay
Ciproxina
Ciprobay
Baycip
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.
U

81121168

PMR 81121168 (93/06/MU-0201206591) Pantone: SCHWARZ, REFLEXBLUE

296x315-07508

Package leaflet: Information for the patient

0

Ciproxin 500 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 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 antiarrhythmics (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.
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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

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
If you take more than the prescribed dose, get medical help immediately. If possible, take your tablets or not listed in this leaflet. You can also report side effects directly (see details below). By reporting side
the box with you to show the doctor.
effects, you can help provide more information on the safety of this medicine.

If you forget to take Ciproxin

United Kingdom

Take the normal dose as soon as possible and then continue as prescribed. However, if it is almost time Yellow Card Scheme
for your next dose, do not take the missed dose and continue as usual. Do not take a double dose to
Website: www.mhra.gov.uk/yellowcard
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 (angiooedema)
- 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)

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 to protect the environment.

6. Contents of the pack and other information
What Ciproxin contains

The active substance is ciprofloxacin.
Each film-coated tablet contains 500 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 500 mg tablets: oblong, nearly white to slightly yellowish film-coated tablets marked with “CIP
score 500” on one side and “BAYER” 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

Manufacturer:





Bayer plc
Bayer House
Strawberry Hill
Newbury
Berkshire RG14 1JA
Bayer Pharma AG

This medicinal product is authorised in the Member States of the EEA under the following
names:
Austria:
Ciproxin
Belgium:
Ciproxine
Bulgaria:
Ciprobay
Cyprus:
Ciproxin
Czech Republic: Ciprobay
Finland:
Ciproxin
France:
Ciflox; Uniflox
Germany:
Ciprobay
Greece:
Ciproxin
Hungary:
Ciprobay

Ireland:
Ciproxin
Italy:
Ciproxin
Luxembourg: Ciproxine
Malta:
Ciproxin
Norway:
Ciproxin
Poland:
Ciprobay
Portugal:
Ciproxina
Slovenia:
Ciprobay
Spain:
Baycip
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.

U
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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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