CIPROFLOXACIN 500MG FILM COATED TABLETS

Active substance: CIPROFLOXACIN HYDROCHLORIDE

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231-30-86608-Z LEA CIPROFLOXACIN A/S FC TAB TUK
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15 May 2012

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CIPROFLOXACIN 250 mg, 500 mg AND 750 mg
FILM-COATED TABLETS
PACKAGE LEAFLET: INFORMATION FOR THE USER

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 get serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET:

1.
2.
3.
4.
5.
6.

What Ciprofloxacin is and what it is used for
Before you take Ciprofloxacin
How to take Ciprofloxacin
Possible side effects
How to store Ciprofloxacin
Further information

1

WHAT CIPROFLOXACIN IS AND WHAT IT IS
USED FOR

• Ciprofloxacin belongs to a group of antibiotics
called fluoroquinolones. It works by killing some
types of bacteria that can cause infections
Ciprofloxacin is used in adults to treat the following
bacterial infections:
• respiratory tract infections
• long lasting or recurring ear or sinus infections
• bladder and kidney infections
• infections of the testicles
• genital organ infections in women
• gastro-intestinal tract infections and
intra-abdominal infections
• skin and soft tissue infections
• bone or 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 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
Ciprofloxacin.
Ciprofloxacin is used in children and adolescents,
under specialist medical supervision, to treat:
• lung and bronchial infections in children and
adolescents who have cystic fibrosis
• complicated urinary tract infections, including
infection that have reached the kidneys
(pyelonephritis)
• anthrax inhalation exposure.
Ciprofloxacin may also be used to treat other specific
severe infections in children and adolescents when
your doctor considers this necessary.

2

Pharma Code
Front: 580 (001000101)
Back: 1102 (0001001111)

PANTONE® GREEN
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3rd Party Code: UKI-014

Reason for revision:

Artwork Originator;
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500 mm
150 mm

BEFORE YOU TAKE CIPROFLOXACIN

Approved for Regulatory submission into MHRA/IMB;
Sign & Date:

Final approval by MA Holder confirming receipt of MHRA/IMB
approval; Sign & Date:

• You may experience symptoms of neuropathy
such as pain, burning, tingling, numbness and/or
weakness. If this happens, stop taking Ciprofloxacin
and contact your doctor immediately.
• Diarrhoea may develop while you are taking
antibiotics, including Ciprofloxacin, 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 Ciprofloxacin 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 Ciprofloxacin if you have to provide a
blood or urine sample
• Ciprofloxacin 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
Ciprofloxacin and contact your doctor immediately
• Ciprofloxacin 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 Ciprofloxacin.
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
medicines obtained without a prescription.
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-arrythmics
(e.g. quinidine, hydroquinidine, disopyramide,
amiodarone, sotalol, dofetilide, ibutilide), tricyclic
antidepressants, some antimicrobials (that belong to
the group of macrolides) and some antipsychotics.
Do not take Ciprofloxacin in
combination with:
• tizanidine (a muscle
relaxant) as this may cause
side effects such as low
blood pressure and
sleepiness (see Section 2
“Do not take
Ciprofloxacin”).
The following medicines
are known to interact with
Ciprofloxacin in your body. Taking Ciprofloxacin
together with these medicines can influence the
therapeutic effect of those medicines. It can also

Packing Site Approval (where not TEVA UK Limited)
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sure you know how you react to Ciprofloxacin before
you drive, use machines, or engage in any other
activity that could be dangerous if you are not alert.

3

HOW TO TAKE CIPROFLOXACIN

Your doctor will explain to you exactly how much
Ciprofloxacin 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.
Always take Ciprofloxacin exactly as your doctor has
told you. You should check with your doctor or
pharmacist if you are not sure.
• Swallow the tablets with plenty of fluid drink,
e.g. water
• Do not chew the tablets
• The tablets can be taken before, with or after food
• Do not eat yoghurt or drink milk at the same time
as you take the tablets, as this will reduce the
effect. If it is essential that you take these products,
Ciprofloxacin should be taken 1 or 2 hours before
or at least 4 hours afterwards
• Space the doses as evenly as possible throughout
the day
• If you become dehydrated whilst taking the
tablets, drink plenty of fluids.
Adults
The usual dose range in adults is 250 mg to 750 mg
twice a day. Your doctor will tell you how long your
treatment with Ciprofloxacin will last. The dose you
are prescribed will depend on the type and severity
of your infection.
Elderly
Your doctor will decide what dose to give you. This
may be lower than the usual adult dose.
Kidney problems
Your doctor will decide what dose to give you
depending on your kidney function.
Children and adolescents
Your doctor will decide the dose based on your
child’s weight and severity of infection.
It is very important that you follow your doctor’s
instructions as to how many Ciprofloxacin tablets to
take, how often to take them and for how long you
should continue to take your tablets. You will usually
need to take your tablets for between 1 and 14 days, but
check with your doctor or pharmacist if you are not sure.
If you take more Ciprofloxacin than you should
If you take more Ciprofloxacin than you should,
contact a doctor or hospital immediately. An overdose
is likely to cause dizziness, tremor, headache,
tiredness, seizures, hallucinations, confusion,
abdominal discomfort, kidney and liver impairment as
well as crystals or red blood cells in the urine.
Please take this leaflet, any remaining tablets and
the container with you to the hospital or doctor so
that they know which medicine was consumed.
If you forget to take Ciprofloxacin
If you forget to take a tablet, take one as soon as you
remember, unless it is nearly time to take the next
one. Do not take two doses at the same time to
make up for a forgotten dose. Be sure to complete
your course of treatment.

• high level of blood sugar (hyperglycaemia)
• confusion and disorientation, anxiety, abnormal
dreams, depression (potentially culminating in
suicidal thoughts or suicide attempts and
completed suicide), hallucinations
• unusual feelings of pain, burning, tingling,
numbness, decreased feeling or sensitivity,
especially in the skin, dizziness, fits (see Section 2:
“Take special care with Ciprofloxacin”)
• eyesight problems
• ringing in the ears, hearing loss or impairment
• rapid heart beat (tachycardia)
• widening of blood vessels (vasodilatation), low
blood pressure, fainting
• shortness of breath (including asthmatic condition)
• liver problems, jaundice (yellowing of the skin
and whites of the eyes) or hepatitis
• sensitivity to light (see Section 2: “Take special
care with Ciprofloxacin”)
• muscle pain, painful joint disease (arthritis),
increased muscle tone and cramping
• kidney problems, blood or crystals in the urine (see
Section 2: “Take special care with Ciprofloxacin”)
• water retention (oedema), abnormal sweating
• increased levels of the enzyme amylase in the
blood.
Very rare (affecting less than one person in 10,000):
• 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 Ciprofloxacin”)
• severe allergic reactions, including anaphylactic
reaction or anaphylactic shock which can be fatal
– serum sickness (see Section 2: “Take special
care with Ciprofloxacin”)
• mental disturbances (psychotic reactions,
potentially culminating in suicidal thoughts or
suicide attempts and completed suicide) (see
Section 2: “Take special care with Ciprofloxacin”)
• migraine (headache), disturbed coordination
(problems walking – gait disturbance), changes to
sense of smell and taste (olfactory disorders), high
pressure within the head (intracranial pressure)
• visual colour distortions
• inflammation of blood vessels wall, often with
skin rash (vasculitis)
• inflammation of the pancreas, which causes
severe pain in the abdomen and back
• liver disease which may very rarely lead to death
• serious skin rashes with red, often itchy spots,
similar to the rash of measles, which starts on the
limbs and sometimes on the face and the rest of
the body. The spots may blister or may progress
to form raised, red, pale-centred marks. Those
affected may have fever, sore throat, headache
and/or diarrhoea
• serious illness with blistering of the skin, mouth,
eyes and genitals (Stevens-Johnson syndrome or
toxic epidermal necrolysis)
• muscle weakness, inflammation of a tendon,
tendon rupture – especially of the large tendon at
the back of the ankle (see Section 2: “Take special
care with Ciprofloxacin”), worsening of

Do not take Ciprofloxacin if you are:
• allergic (hypersensitive) to ciprofloxacin or to
other antibiotics of the same type (called
quinolones or fluoroquinolones) or to any of the
other ingredients in these tablets
• currently taking a medication known as tizanidine
(Please see “Taking Ciprofloxacin with other
medicines”).
Take special care with Ciprofloxacin
Before taking Ciprofloxacin
Heart problems
Caution should be taken when using this kind of
medicine, if you were born with or have a family
history of prolonged QT interval (seen on ECG,
electrical recording of the heart), have salt imbalance
in the blood (especially low level 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).
Tell your doctor or nurse before you start to take
this medicine if you have:
• a problem with weakness in your muscles called
myasthenia gravis
• a history of tendon disease or disorder related to
use with flouroquinolone antibiotics
• epilepsy or any other central nervous system
disorder
• ever had kidney problems because your treatment
may need to be adjusted
• or had a family history of deficiency in the blood
enzyme called glucose-6-phosphate
dehydrogenase (G6PD).
While taking Ciprofloxacin
Tell your doctor immediately, if any of the following
occurs while taking Ciprofloxacin. Your doctor will
decide whether treatment with Ciprofloxacin 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 Ciprofloxacin
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. At
the first sign of any pain or inflammation stop
taking Ciprofloxacin 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
Ciprofloxacin and contact your doctor immediately
• You may experience psychiatric reactions the first
time you take Ciprofloxacin. If you suffer from
depression or psychosis, your symptoms may
become worse under treatment with Ciprofloxacin.
If this happens, stop taking Ciprofloxacin and
contact your doctor immediately

Ref:

If you stop taking Ciprofloxacin
Do not stop taking your medicine without talking to
your doctor first even if you feel better. It is
important that you complete your prescribed course
of treatment, otherwise the problem may come back.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.

increase the probability of experiencing side effects.
Tell your doctor if you are taking:
• warfarin or other oral anti-coagulants (to thin the
blood)
• probenecid (for gout)
• 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
• metoclopramide (for nausea/vomiting)
• omeprazole (for treating stomach ulcers)
• methotrexate (for certain types of cancer,
psoriasis, rheumatoid arthritis)
• theophylline (for breathing problems)
• tizanidine (for muscle spasticity in multiple
sclerosis)
• ciclosporin (for prevention of transplant rejection)
• glibenclamide (for treating diabetes)
• duloxetine (for treating depression)
• lidocaine (for local anaesthesia)
• clozapine (an antipsychotic)
• ropinirole (for Parkinson’s disease)
• phenytoin (for epilepsy)
• sildenafil (for erectile dysfunction).
Ciprofloxacin may increase the levels of the
following medicines in your blood:
• pentoxifylline (for circulatory disorders)
• caffeine
Some medicines reduce the effect of Ciprofloxacin.
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 Ciprofloxacin
about two hours before or no sooner than four
hours after them.
Taking Ciprofloxacin with food and drink
Do not eat or drink any dairy products (such as
yoghurt or milk) or calcium fortified drinks at the
same time as you take Ciprofloxacin tablets as this
will reduce the effect. If it is essential that you take
these products, Ciprofloxacin should be taken either
1 or 2 hours before or at least 4 hours after the
intake of these dairy products.
Pregnancy and breast-feeding
If you are pregnant or planning to become pregnant,
ask your doctor for advice before receiving this
medicine. It is preferable to avoid the use of
Ciprofloxacin during pregnancy.
Do not take Ciprofloxacin if you are breast-feeding
because ciprofloxacin is excreted in breast milk and
can be harmful for your child.
Driving and using machines:
Ciprofloxacin may make you feel less alert, dizzy or
confused, which may affect your ability to drive or
operate machinery. This is more likely to happen at the
start of treatment, when the dose is increased, when
switching treatment or if you drink alcohol. Make

231-30-86608-Z LEA CIPROFLOXACIN A/S FC TAB TUK
Version:

1

4

Frequency not known (cannot be estimated from
available data):
• 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)
• a disorder of the nerves which can cause
weakness, tingling or numbness
• increase in the blood coagulation parameters (in
patients taking oral anticoagulants)
• skin disorder characterised by the rapid
appearance of areas of red skin studded with small
blisters filled with white/yellow fluid (pustules).
If any of the side effects get serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor or pharmacist.

5

Medicines should not be disposed of via wastewater
or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These
measures will help to protect the environment.

6

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation holder: TEVA UK Limited,
Eastbourne, BN22 9AG.
Company responsible for manufacture:
Pharmachemie B.V., Haarlem, The Netherlands.

L:
W:

16 May 2012

500 mm
150 mm

Pharma Code
Front: 580 (001000101)
Back: 1102 (0001001111)
3rd Party Code: UKI-014

Approved for Regulatory submission into MHRA/IMB;
Sign & Date:

FURTHER INFORMATION

What Ciprofloxacin contains:
• The active substance is ciprofloxacin (as
hydrochloride monohydrate)
The other ingredients are croscarmellose sodium,
colloidal silicon dioxide, magnesium stearate,
hypromellose 6cp (E464), magnesium stearate
(E572), microcrystalline cellulose (E460), sodium
starch glycolate A, povidone, propylene glycol, talc,
titanium dioxide (E171).
What Ciprofloxacin looks like and contents of the pack:
• 250 mg: White, biconvex, round film-coated
tablets, debossed “CIP breakline 250” on one side
and plain on the other
• 500 mg: White, oval-shaped film-coated tablets,
debossed “CIP breakline 500” on one side and
plain on the other
• 750 mg: White, oval-shaped film-coated tablets,
debossed “CIP breakline 750” on one side and a
breakline on the other
• The product is available in pack sizes of 10, 12, 20,
30, 50, 100 or 160 tablets.
Not all pack sizes may be marketed.

86608-Z
UKI-014

PL 00289/0493-0495

Reason for revision:

Artwork Checker;
Sign & Date:

HOW TO STORE CIPROFLOXACIN

Keep out of the reach and sight of children.
Store in the original package.
Do not use Ciprofloxacin after the expiry date which
is stated on the carton. The expiry date refers to the
last day of that month.

This leaflet was last revised: April 2012

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POSSIBLE SIDE EFFECTS

Like all medicines, Ciprofloxacin can cause side
effects, although not everybody gets them.
A few people may develop very serious side effects.
If you experience any of the following symptoms,
tell your doctor immediately:
• swelling of the face, hands, lips, tongue or throat,
difficulty swallowing or breathing
• severe skin rash with blistering or bleeding of the
lips, skin, nose, mouth, eyes and genitals
• severe diarrhoea, sometimes with blood or mucus
• inflammation of the tendons or a ruptured tendon
• fits or seizures
• unusual feelings of pain, burning, tingling,
numbness or muscle weakness
• yellowing of the skin or eyes, dark urine,
tenderness in the abdomen or weight loss.
The following side effects have been reported at the
approximate frequencies shown:
Common (affecting less than one person in 10 but
more than one person in 100):
• nausea, diarrhoea
• joint pain in children.
Uncommon (affecting less than one person in 100
but more than one person in 1,000):
• fungal superinfections
• loss of appetite (anorexia)
• hyperactivity (unusually active)
• agitation
• headache, dizziness, sleep disorders, changes in
taste
• vomiting, abdominal pain, stomach problems such
as indigestion/heartburn, wind
• rash, nettle rash or itching
• pain in the arms or legs, back pain, chest pain, joint
pain
• kidney problems
• loss of strength (asthenia) or fever
• a high concentration of eosinophils (a type of
white blood cells), increased amounts of
transaminases and/or bilirubin in the blood,
increase of alkaline phosphatase in blood.
Rare (affecting less than one person in 1,000 but
more than one person in 10,000):
• inflammation of the bowel (colitis) linked to
antibiotic use (can be fatal in very rare cases) (see
Section 2 “Take special care with Ciprofloxacin”)
• 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)

symptoms of myasthenia gravis (see Section 2:
“Take special care with Ciprofloxacin”).

Final approval by MA Holder confirming receipt of MHRA/IMB
approval; Sign & Date:

Packing Site Approval (where not TEVA UK Limited)
Sign & Date:

PANTONE® GREEN
BLACK

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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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