CIPROXIN 500MG TABLETS

Active substance: CIPROFLOXACIN HYDROCHLORIDE MONOHYDRATE

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Var. 14: To change the name of the manufacturer from Bayer AG to Bayer Schering Pharma AG at D-51368 Leverkusen Germany

CUSTOMER: Waymade

PRE-PRESS NO.:

02-1808

PRODUCT:

Ciproxin 500mg tabs

ARTWORKER:

DT

Q.A.
APPROVED:

CUSTOMER
APPROVED:

CODE:

6464/1182 E

DATE OF PROOF:

11/10/11

DATE:

PROOF HISTORY:
v.2 - waymade - 11/10/11

DATE:

Leaflet Flat Size = 296 x 317
ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

TO APRIL 2010 UK PIL
INC SAFETY WARNING

Pg 4










mental disturbances (psychotic reactions) (see Section 2: Take special care with Ciproxin)
migraine, disturbed coordination, unsteady walk (gait disturbance), disorder of sense of smell
(olfactory disorders), pressure on the brain (intracranial pressure)
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: Take special care with Ciproxin);
worsening of the symptoms of myasthenia gravis (see Section 2: Take special care with
Ciproxin)

Frequency not known (cannot be estimated from the available data)
• troubles associated with the nervous system such as pain, burning, tingling, numbness and/or
weakness in extremities
• severe cardiac rhythm abnormalities, irregular heart beat (Torsades de Pointes)
Heart problems
Not known: 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)

5. How to store Ciproxin
Ciproxin 500mg tablets/Ciprofloxacin 500mg tablets should be stored in a dry place below 25°C
Do not use after the expiry date printed on the carton label or blister strip. The expiry date refers to the
last day of the month concerned.
KEEP ALL MEDICINES OUT OF THE REACH AND SIGHT OF CHILDREN.
If your doctor tells you to stop taking the tablets, please take them back to the pharmacist for safe
disposal. Only keep the tablets if your doctor tells you to.
If the tablets become discoloured or show any other signs of deterioration, you should consult your
pharmacist who will advise you what to do.
Medicines should not be disposed of down the drain or with household rubbish. Ask your pharmacist
how to dispose of any medicines no longer required. These measures will help to protect the
environment.

6. Further information
Your medicine is called Ciproxin 500mg tablets/Ciprofloxacin 500mg tablets. Each tablet contains
500mg of the active ingredient, ciprofloxacin (as the hydrochloride monohydrate) in a white,
capsule-shaped tablet marked 'BAYER' on one side and marked 'CIP' breakline '500' on the reverse.
Ciproxin 500mg tablets/Ciprofloxacin 500mg tablets also contain the following inactive ingredients:
maize starch, microcrystalline cellulose, crospovidone, colloidal silicon dioxide, magnesium stearate,
hydroxypropylmethyl cellulose, polyethylene glycol and titanium dioxide (E171).
Ciproxin 500mg tablets/Ciprofloxacin 500mg tablets are available as blister packs of 10 and 20 tablets.
POM

PL No: 6464/1182

This product is manufactured by Bayer Schering Pharma AG, D-51368 Leverkusen, Germany and is
procured from within the EU and repackaged by the Product Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR
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.
Leaflet revision and issue date (Ref.) 05.10.2011
Ciproxin is a registered trademark of Bayer AG.

®
CIPROXIN® 500mg TABLETS/
CIPROFLOXACIN 500mg TABLETS
(Ciprofloxacin)

Pg 1

Patient Information Leaflet

This product is known as the above names but will be referred to as Ciproxin throughout this leaflet.
Read all of this leaflet carefully before you start taking this medicine.
• 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. Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. What Ciproxin is and what it is used for
2. Before you take Ciproxin
3. How to take Ciproxin
4. Possible side effects
5. How to store Ciproxin
6. Further information

1. What Ciproxin is and what it is used for
Ciproxin is an antibiotic belonging to the fluoroquinolone family. The active substance is ciprofloxacin.
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
• infections of the testicles
• genital organ infections in women
• gastro-intestinal tract infections and intra-abdominal infections
• skin and soft tissue infections
• bone and joint infections
• to treat infections in patients with a very low white blood cell count (neutropenia)
• to prevent infections in patients with a very low white blood cell count (neutropenia)
• to prevent infections due to the bacterium Neisseria meningitidis
• anthrax inhalation exposure
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. Before you take Ciproxin
Do not take Ciproxin if you are:
• allergic (hypersensitive) to the active substance, to other quinolone drugs or to any of the other
ingredients of Ciproxin (see section 6)
• taking tizanidine (see Section 2: Taking other medicines)
Take special care with Ciproxin
Before taking Ciproxin
Tell your doctor if you:
• have ever had kidney problems because your treatment may need to be adjusted
• suffer from epilepsy or other neurological conditions
• have a history of tendon problems during previous treatment with antibiotics such as Ciproxin
• have myasthenia gravis (a type of muscle weakness)
• have a history of abnormal heart rhythms (arrhythmias)
Heart problems
Caution should be taken when using this kind of medicine, 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 Taking other medicines).
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.
Pg 2

WARNING!

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

WARNING!

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

Var. 14: To change the name of the manufacturer from Bayer AG to Bayer Schering Pharma AG at D-51368 Leverkusen Germany

CUSTOMER: Waymade

PRE-PRESS NO.:

02-1808

PRODUCT:

Ciproxin 500mg tabs

ARTWORKER:

DT

Q.A.
APPROVED:

CUSTOMER
APPROVED:

CODE:

6464/1182E

DATE OF PROOF:

11/10/11

DATE:

PROOF HISTORY:
v.2 - waymade - 11/10/11

DATE:

Leaflet Flat Size = 296 x 317

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

TO APRIL 2010 UK PIL
INC SAFETY WARNING

Pg 2















Pain and swelling in the joints and tendinitis may occur occasionally, particularly if you are
elderly and are also being treated with corticosteroids. 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.
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.
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.
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.
Tell your doctor 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.
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.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including any that you obtained without a prescription.
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.
You must tell your doctor if you are taking 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.
Tell your doctor if you are taking:
• warfarin 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)
• clozapine (an antipsychotic)
• ropinirole (for Parkinson’s disease)
• phenytoin (for epilepsy)
Ciproxin may increase the levels of the following medicines in your blood:
• pentoxifylline (for circulatory disorders)
• caffeine
Some medicines reduce the effect of Ciproxin. Tell your doctor if you take or wish to take:
• antacids
• mineral supplements
• sucralfate
• a polymeric phosphate binder (e.g. sevelamer)
• 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.
Taking 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
It is preferable to avoid the use of Ciproxin during pregnancy. Tell your doctor if you are planning to get
pregnant.
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. Take the
tablets exactly as your doctor has told you. Ask 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 Ciproxin.
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 more questions about the use of this product, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, Ciproxin can cause side effects, although not everybody gets them.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, tell your
doctor or pharmacist.
Common side effects (between 1 and 10 in every 100 people are likely to get these):
• nausea, diarrhoea
• joint pains in children
Uncommon side effects (between 1 and 10 in every 1,000 people are likely to get these):
• fungal superinfections
• a high concentration of eosinophils, a type of white blood cell
• loss of appetite (anorexia)
• 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 side effects (between 1 and 10 in every 10,000 people are likely to get these):
• inflammation of the bowel (colitis) linked to antibiotic use (can be fatal in very rare cases) (see
Section 2: Take special care with Ciproxin)
• 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)
• confusion, disorientation, anxiety reactions, strange dreams, depression, or hallucinations
• pins and needles, unusual sensitivity to stimuli of the senses, decreased skin sensitivity,
tremors, seizures (see Section 2: Take special care with Ciproxin), or giddiness
• eyesight problems
• 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: Take special care with Ciproxin)
• muscle pain, inflammation of the joints, increased muscle tone, or cramp
• kidney failure, blood or crystals in the urine (see Section 2: Take special care with Ciproxin),
urinary tract inflammation
• fluid retention or excessive sweating
• abnormal levels of a clotting factor (prothrombin) or increased levels of the enzyme amylase
Very rare side effects (less than 1 in every 10,000 people are likely to get these):
• 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: Take special care with Ciproxin)
• severe allergic reactions (anaphylactic reaction or anaphylactic shock, which can be fatal –
serum sickness) (see Section 2: Take special care with Ciproxin)

Pg 3

WARNING!

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

WARNING!

Pg 3

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

Pg 4

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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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