CIPROFLOXACIN 500MG TABLETS

Active substance: CIPROFLOXACIN HYDROCHLORIDE MONOHYDRATE

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CUSTOMER: Waymade

PRE-PRESS NO.:

02-1808

PRODUCT:

Ciproxin 500mg tabs

ARTWORKER:

DT

Q.A.
APPROVED:

CUSTOMER
APPROVED:

CODE:

6464/1182E

DATE OF PROOF:

23/04/14

DATE:

PROOF HISTORY:
v.1 - waymade - 23/04/14

DATE:

Leaflet Flat Size = 296 x 317

TVT CHECKED

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

UK PIL DATED SEPTEMBER 2013
REPORTING OF SIDE EFFECTS

Pg 4

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

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 SIGHT AND REACH 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. Contents of the pack and other 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
Leaflet revision and issue date (Ref.) 23.04.2014
CIPROXIN is a registered trademark of BAYER AG.
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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CIPROXIN®

500mg TABLETS/
CIPROFLOXACIN 500mg TABLETS
(Ciprofloxacin)
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 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.

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.

Pg 2

CUSTOMER: Waymade

PRE-PRESS NO.:

02-1808

PRODUCT:

Ciproxin 500mg tabs

ARTWORKER:

DT

Q.A.
APPROVED:

CUSTOMER
APPROVED:

CODE:

6464/1182E

DATE OF PROOF:

23/04/14

DATE:

PROOF HISTORY:
v.1 - waymade - 23/04/14

DATE:

Leaflet Flat Size = 296 x 317

TVT CHECKED

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

UK PIL DATED SEPTEMBER 2013
REPORTING OF SIDE EFFECTS

















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. 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.

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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.

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).

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

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.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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)

ciclosporin (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.

4. Possible side effects

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

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!

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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