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CIPROXIN 750MG FILM-COATED TABLETS

Active substance: CIPROFLOXACIN HYDROCHLORIDE MONOHYDRATE

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Package leaflet: Information for the patient

0

Ciproxin® 750 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.

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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

- 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 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 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.

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 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

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
any 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 750 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 750 mg tablets: oblong, nearly white to slightly yellowish tablets marked with “CIP 750” on one side
and “BAYER” on the reverse side.
Pack sizes of 6, 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

Manufacturer:





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:
France:
Germany:

Ciproxin
Ciproxine
Ciflox
Ciprobay

Ireland:
Italy:
Luxembourg:
Portugal:

Ciproxin
Ciproxin
Ciproxine
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
may affect up to 1 in 10,000 people
treatments become ineffective.
- a special type of reduced red blood cell count (haemolytic anaemia); a dangerous drop in a type of white blood Misuse of antibiotics increases resistance. You may even help bacteria become resistant and therefore delay
cells (agranulocytosis); a drop in the number of red and white blood cells and platelets (pancytopenia), which
your cure or decrease antibiotic efficacy if you do not respect appropriate:
may be fatal; and bone marrow depression, which may also be fatal (see Section 2: Warnings and precautions) - dosages
- severe allergic reactions (anaphylactic reaction or anaphylactic shock, which can be fatal - serum sickness) - schedules
(see Section 2: Warnings and precautions)
- duration of treatment
- mental disturbances (psychotic reactions potentially leading to thoughts of suicide, suicide attempts, or
Consequently, to preserve the efficacy of this drug:
completed suicide) (see Section 2: Warnings and precautions)
1 - Use antibiotics only when prescribed.
- migraine, disturbed coordination, unsteady walk (gait disturbance), disorder of sense of smell (olfactory
2 - Strictly follow the prescription.
disorders), pressure on the brain (intracranial pressure and pseudotumor cerebri)
3 - Do not re-use an antibiotic without medical prescription, even if you want to treat a similar illness.
- visual colour distortions
4 - Never give your antibiotic to another person; maybe it is not adapted to her/his illness.
- inflammation of the wall of the blood vessels (vasculitis)
5 - After completion of treatment, return all unused drugs to your chemist’s shop to ensure they will be
- pancreatitis
disposed of correctly.
U
- death of liver cells (liver necrosis) very rarely leading to life-threatening liver failure

Very rare:

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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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