CIPROXIN TABLETS 500MG

Active substance: CIPROFLOXACIN HYDROCHLORIDE MONOHYDRATE

View full screen / Print PDF » Download PDF ⇩

Transcript
S1431 LEAFLET Ciproxin 20130215

5. How to store Ciproxin

PACKAGE LEAFLET: INFORMATION FOR THE USER



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store above 25°C.



Do not take the tablets after the date shown on the pack.



If your doctor tells you to stop taking the tablets, please take
them back to the pharmacist for safe disposal. Only keep them
if your doctor tells you to.



If the tablets become discoloured or show any other signs of
deterioration, please seek the advice of your pharmacist.



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.

CIPROXIN TABLETS 500mg
(ciprofloxacin hydrochloride)
The name of your medicine is Ciproxin Tablets 500mg but will be
referred as Ciproxin throughout the following patient information
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.

6. Further information


What Ciproxin contains


Each tablet contains 500mg of the active ingredient
ciprofloxacin (as ciprofloxacin hydrochloride monohydrate).



The tablets also contain microcrystalline cellulose, maize
starch, crospovidone, colloidal silicon dioxide, magnesium
stearate, hypromellose 2910, macrogol 4000 and titanium
dioxide (E171).
What Ciproxin looks like and contents of the pack
Ciproxin is a white, capsule-shaped tablet marked Bayer on one
side and with a score-line and CIP 500 on the other.
Ciproxin is available as blister packs of 10 or 20 tablets.

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:

This product is manufactured by Bayer Pharma AG, Leverkusen,
Germany.
POM

PL No: 19488/1431

Do not take Ciproxin if you are:


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 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: Taking other medicines).

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:

Leaflet revision date: 15 February 2013






If your doctor has prescribed antibiotics, you need them precisely
for your current illness.

gastro-intestinal tract infections and intra-abdominal infections



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.



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.

to prevent infections due to the bacterium Neisseria
meningitidis





bone and joint infections



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.

skin and soft tissue infections





genital tract infections in men and women



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.

urinary tract infections

Antibiotics are used to cure bacterial infections. They are ineffective
against viral infections.

While taking Ciproxin

long lasting or recurring ear or sinus infections

Advice/medical education

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.

respiratory tract infections

Ciproxin is a registered trade mark of Bayer AG, Germany.

anthrax inhalation exposure

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:

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.

1 - Use antibiotics only when prescribed.
Children and adolescents

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.
S1431 LEAFLET Ciproxin 20130215

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.

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

1. What Ciproxin is and what it is used for

Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Alperton
Lane, Wembley, HA0 1DX.
Manufacturer

2. Before you take Ciproxin



Tell the doctor or laboratory staff that you are taking Ciproxin if
you have to provide a blood or urine sample.

Some medicines reduce the effect of Ciproxin. Tell your doctor if
you take or wish to take:



If you suffer from kidney problems, tell the doctor because your
dose may need to be adjusted.



antacids



omeprazole

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.



mineral supplements



sucralfate



a polymeric phosphate binder (e.g. sevelamer)

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.



medicines or supplements containing calcium, magnesium,
aluminium or iron









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 anemia 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.
Tell your doctor if you are taking:


Vitamin K antagonists (e.g: warfarin) or other oral anticoagulants (to thin the blood)



probenecid (for gout)



methotrexate (for certain types of cancer, psoriasis, rheumatoid
arthritis)



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 the 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.

4. Possible side effects
Like all medicines, Ciproxin can cause side effects, although not
everybody gets them.

Common side effects (between 1 and 10 in every 100 people are
likely to get these):
-

joint pains in children

Uncommon side effects (between 1 and 10 in every 1,000 people
are likely to get these):

-

visual colour distortions

hyperactivity or agitation

-

inflammation of the wall of the blood vessels (vasculitis)

headache, dizziness, sleeping problems, or taste disorders

-

pancreatitis

-

vomiting, abdominal pain, digestive problems such as stomach
upset (indigestion/heartburn), or wind

-

death of liver cells (liver necrosis) very rarely leading to lifethreatening liver failure

-

increased amounts of certain substances in the blood
(transaminases and/or bilirubin)

-

-

rash, itching, or hives

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)

-

joint pain in adults

-

-

poor kidney function

-

pains in your muscles and bones, feeling unwell (asthenia), or
fever

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)

-

increase in blood alkaline phosphatase (a certain substance in
the blood)

-

-

troubles associated with the nervous system such as pain,
burning, tingling, numbness and/or weakness in extremities

-

inflammation of the bowel (colitis) linked to antibiotic use (can
be fatal in very rare cases) (see Section 2: Take special care
with Ciproxin)

-

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)

-

changes to the blood count (leukopenia, leukocytosis,
neutropenia, anaemia), increased or decreased amounts of a
blood clotting factor (thrombocytes)

-

pustular rash

-

influence on blood clotting (in patients treated with Vitamin K
antagonists)

b. Do try to take the tablets at around the same time every day.



olanzapine (an antipsychotic)



-

clozapine (an antipsychotic)



ropinirole (for Parkinson’s disease)

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).

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:
Take special care with Ciproxin), or giddiness



phenytoin (for epilepsy)

Remember to drink plenty of fluids while you are taking Ciproxin.

-

eyesight problems including double vision

metoclopramide (for nausea and vomiting)

-

tinnitus, loss of hearing, impaired hearing

cyclosporin (for skin conditions, rheumatoid arthritis and in
organ transplantation)

If you take more Ciproxin than you should

-

rapid heartbeat (tachycardia)

 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.

-

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

-

increased levels of the enzyme amylase



pentoxifylline (for circulatory disorders)



caffeine



duloxetine (for depression, diabetic nerve damage or
incontinence)



lidocaine (for heart conditions or anesthetic use)



sildenafil (e.g. for erectile dysfunction)

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.

Frequency not known (cannot be estimated from the available
data)

Rare side effects (between 1 and 10 in every 10,000 people are
likely to get these):

tizanidine (for muscle spasticity in multiple sclerosis)

Ciproxin may increase the levels of the following medicines in your
blood:

migraine, disturbed coordination, unsteady walk (gait
disturbance), disorder of sense of smell (olfactory disorders),
pressure on the brain (intracranial pressure)

loss of appetite (anorexia)



 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.

-

a high concentration of eosinophils, a type of white blood cell

increased blood sugar (hyperglycaemia)

If you forget to take Ciproxin

mental disturbances (psychotic reactions potentially leading to
thoughts of suicide, suicide attempts, or completed suicide)
(see Section 2: Take special care with Ciproxin)

-

-

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.

-

-

-

glibenclamide (for diabetes)

severe allergic reactions (anaphylactic reaction or anaphylactic
shock, which can be fatal - serum sickness) (see Section 2:
Take special care with Ciproxin)

fungal superinfections

theophylline (for breathing problems)



-

-

a. Swallow the tablets with plenty of fluid. Do not chew the tablets
because they do not taste nice.



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)

nausea, diarrhoea

allergic reaction, swelling (oedema), or rapid swelling of the skin
and mucous membranes (angio-oedema)



-

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.

-



Very rare side effects (less than 1 in every 10,000 people are
likely to get these):

5. How to store Ciprofloxacin Tablet

S1431 LEAFLET Ciprofloxacin 20130215

PACKAGE LEAFLET: INFORMATION FOR THE USER

2. Before you take Ciprofloxacin tablets
Do not take Ciprofloxacin Tablets if you are:



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store above 25°C.



Do not take the tablets after the date shown on the pack.



If your doctor tells you to stop taking the tablets, please take
them back to the pharmacist for safe disposal. Only keep them
if your doctor tells you to.



If the tablets become discoloured or show any other signs of
deterioration, please seek the advice of your pharmacist.

Read all of this leaflet carefully before you start taking this
medicine.

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.



Keep this leaflet. You may need to read it again.





If you have any further questions, ask your doctor or
pharmacist.

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 Ciprofloxacin Tablets



have myasthenia gravis (a type of muscle weakness)



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: Taking other medicines).



6. Further information

CIPROFLOXACIN TABLETS 500mg
(ciprofloxacin hydrochloride)
The name of your medicine is Ciprofloxacin Tablets 500mg but will
be referred as Ciprofloxacin Tablets throughout the following patient
information leaflet.



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.

What Ciprofloxacin Tablets contain


Each tablet contains 500mg of the active ingredient
ciprofloxacin (as ciprofloxacin hydrochloride monohydrate).



The tablets also contain microcrystalline cellulose, maize
starch, crospovidone, colloidal silicon dioxide, magnesium
stearate, hypromellose 2910, macrogol 4000 and titanium
dioxide (E171).
What Ciprofloxacin Tablets look like and contents of the pack



 taking tizanidine (see Section 2: Taking other medicines)
Take special care with Ciprofloxacin Tablets
Before taking Ciprofloxacin Tablets
Tell your doctor if you:

In this leaflet:
1. What Ciprofloxacin Tablets are and what they are used for
2. Before you take Ciprofloxacin Tablets
3. How to take Ciprofloxacin Tablets

Ciprofloxacin Tablets are white, capsule-shaped tablets marked
Bayer on one side and with a score-line and CIP 500 on the other.

4. Possible side effects

Ciprofloxacin Tablets are available as blister packs of 10 or 20
tablets.

6. Further information

5. How to store Ciprofloxacin Tablets

Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.
Manufacturer
This product is manufactured by Bayer Pharma AG, Leverkusen,
Germany.
POM

PL No: 19488/1431

Leaflet revision date: 15 February 2013

1. What Ciprofloxacin Tablets are and what they are used for
Ciprofloxacin Tablets are 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.

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 Ciprofloxacin Tablets
Tell your doctor immediately if any of the following occurs while
taking Ciprofloxacin Tablets. Your doctor will decide whether
treatment with Ciprofloxacin Tablets 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
Tablets 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 Ciprofloxacin
Tablets therapy. At the first sign of any pain or inflammation
stop taking Ciprofloxacin Tablets 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 Tablets and contact your
doctor immediately.



You may experience psychiatric reactions the first time you
take Ciprofloxacin Tablets. If you suffer from depression or
psychosis, your symptoms may become worse under
treatment with Ciprofloxacin Tablets. In rare cases, depression
or psychosis can progress to thoughts of suicide, suicide
attempts, or completed suicide. If this happens, stop taking
Ciprofloxacin Tablets 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 Ciprofloxacin Tablets and contact your doctor
immediately.



Diarrhoea may develop while you are taking antibiotics,
including Ciprofloxacin Tablets, 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 Tablets immediately, as this can be lifethreatening. 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 Tablets if you have to provide a blood or urine
sample.

Adults
Ciprofloxacin Tablets are used in adults to treat the following
bacterial infections:


respiratory tract infections



long lasting or recurring ear or sinus infections



urinary tract infections

If your doctor has prescribed antibiotics, you need them precisely
for your current illness.



genital tract infections in men and women

Despite antibiotics, some bacteria may survive or grow. This
phenomenon is called resistance: some antibiotic treatments
become ineffective.



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

Advice/medical education
Antibiotics are used to cure bacterial infections. They are ineffective
against viral infections.

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

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.

Consequently, to preserve the efficacy of this drug:
1 - Use antibiotics only when prescribed.

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 Tablets.

2 - Strictly follow the prescription.
3 - Do not re-use an antibiotic without medical prescription, even if
you want to treat a similar illness.

Children and adolescents

4 - Never give your antibiotic to another person; maybe it is not
adapted to her/his illness.

Ciprofloxacin Tablets are used in children and adolescents, under
specialist medical supervision, to treat the following bacterial
infections:

5 - After completion of treatment, return all unused drugs to your
chemist’s shop to ensure they will be disposed of correctly.



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

S1431 LEAFLET Ciprofloxacin 20130215

allergic (hypersensitive) to the active substance, to other
quinolone drugs or to any of the other ingredients of
Ciprofloxacin Tablets (see section 6)

Ciprofloxacin Tablets may also be used to treat other specific
severe infections in children and adolescents when your doctor
considered this necessary.



If you suffer from kidney problems, tell the doctor because your
dose may need to be adjusted.

Some medicines reduce the effect of Ciprofloxacin Tablets. Tell
your doctor if you take or wish to take:



Ciprofloxacin Tablets 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 Tablets and contact your doctor
immediately.



antacids



omeprazole



mineral supplements



sucralfate

Ciprofloxacin Tablets 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.



a polymeric phosphate binder (e.g. sevelamer)



medicines or supplements containing calcium, magnesium,
aluminium or iron







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 anemia with
ciprofloxacin.
Your skin becomes more sensitive to sunlight or ultraviolet
(UV) light when taking Ciprofloxacin Tablets. 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 Ciprofloxacin Tablets together with tizanidine,
because this may cause side effects such as low blood pressure
and sleepiness (see Section 2: “Do not take Ciprofloxacin Tablets”).
The following medicines are known to interact with Ciprofloxacin
Tablets in your body. Taking Ciprofloxacin Tablets 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) or other oral
anticoagulants (to thin the blood)



probenecid (for gout)



methotrexate (for certain types of cancer, psoriasis, rheumatoid
arthritis)



4. Possible Side Effects
Like all medicines, Ciprofloxacin Tablets can cause side effects,
although not everybody gets them.

Common side effects (between 1 and 10 in every 100 people are
likely to get these):
-

If these preparations are essential, take Ciprofloxacin Tablets about
two hours before or no sooner than four hours after them.

-

joint pains in children

Taking Ciprofloxacin Tablets with food and drink

Uncommon side effects (between 1 and 10 in every 1,000 people
are likely to get these):

Unless you take the Ciprofloxacin Tablets 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.

-

visual colour distortions

hyperactivity or agitation

-

inflammation of the wall of the blood vessels (vasculitis)

headache, dizziness, sleeping problems, or taste disorders

-

pancreatitis

-

vomiting, abdominal pain, digestive problems such as stomach
upset (indigestion/heartburn), or wind

-

death of liver cells (liver necrosis) very rarely leading to lifethreatening liver failure

-

increased amounts of certain substances in the blood
(transaminases and/or bilirubin)

-

-

rash, itching, or hives

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)

joint pain in adults

-

Driving and using machines

-

Ciprofloxacin Tablets may make you feel less alert. Some
neurological adverse events can occur. Therefore, make sure you
know how you react to Ciprofloxacin Tablets before driving a
vehicle or operating machinery. If in doubt, talk to your doctor.

-

poor kidney function

-

pains in your muscles and bones, feeling unwell (asthenia), or
fever

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 Ciprofloxacin
Tablets); worsening of the symptoms of myasthenia gravis(see
Section 2: Take special care with Ciprofloxacin Tablets)

-

increase in blood alkaline phosphatase (a certain substance in
the blood)

Pregnancy and breast-feeding
It is preferable to avoid the use of Ciprofloxacin Tablets during
pregnancy. Tell your doctor if you are planning to get pregnant.
Do not take Ciprofloxacin Tablets during breast feeding because
ciprofloxacin is excreted in breast milk and can be harmful for your
child.

-

3. How to take Ciprofloxacin Tablets
Your doctor will explain to you exactly how much Ciprofloxacin
Tablets 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.

-

troubles associated with the nervous system such as pain,
burning, tingling, numbness and/or weakness in extremities

-

inflammation of the bowel (colitis) linked to antibiotic use (can
be fatal in very rare cases) (see Section 2: Take special care
with Ciprofloxacin Tablets)

-

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)

-

changes to the blood count (leukopenia, leukocytosis,
neutropenia, anaemia), increased or decreased amounts of a
blood clotting factor (thrombocytes)

-

pustular rash

-

influence on blood clotting (in patients treated with Vitamin K
antagonists)

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 Ciprofloxacin Tablets.

tizanidine (for muscle spasticity in multiple sclerosis)



olanzapine (an antipsychotic)

confusion, disorientation, anxiety reactions, strange dreams,
depression (potentially leading to thoughts of suicide, suicide
attempts, or completed suicide), or hallucinations



clozapine (an antipsychotic)

-



ropinirole (for Parkinson’s disease)

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 Ciprofloxacin Tablets with dairy
products such as milk or yoghurt or with fortified fruit juices (e.g.
calcium-fortified orange juice).

pins and needles, unusual sensitivity to stimuli of the senses,
decreased skin sensitivity, tremors, seizures (see Section 2:
Take special care with Ciprofloxacin Tablets), or giddiness



phenytoin (for epilepsy)

-

eyesight problems including double vision



metoclopramide (for nausea and vomiting)

-

tinnitus, loss of hearing, impaired hearing



cyclosporin (for skin conditions, rheumatoid arthritis and in
organ transplantation)

-

rapid heartbeat (tachycardia)

If you take more Ciprofloxacin Tablets 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.

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
Ciprofloxacin Tablets)

-

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 Ciprofloxacin Tablets), urinary tract
inflammation

-

fluid retention or excessive sweating

-

increased levels of the enzyme amylase

caffeine
duloxetine (for depression, diabetic nerve damage or
incontinence)



lidocaine (for heart conditions or anesthetic use)



sildenafil (e.g. for erectile dysfunction)

Remember to drink plenty of fluids while you are taking
Ciprofloxacin Tablets.

If you forget to take Ciprofloxacin Tablets
 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 Ciprofloxacin Tablets
 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.

Frequency not known (cannot be estimated from the available
data)

Rare side effects (between 1 and 10 in every 10,000 people are
likely to get these):





migraine, disturbed coordination, unsteady walk (gait
disturbance), disorder of sense of smell (olfactory disorders),
pressure on the brain (intracranial pressure)

loss of appetite (anorexia)

increased blood sugar (hyperglycaemia)

pentoxifylline (for circulatory disorders)

-

a high concentration of eosinophils, a type of white blood cell

-



mental disturbances (psychotic reactions potentially leading to
thoughts of suicide, suicide attempts, or completed suicide)
(see Section 2: Take special care with Ciprofloxacin Tablets)

-

-



-

-

b. Do try to take the tablets at around the same time every day.

Ciprofloxacin Tablets may increase the levels of the following
medicines in your blood:

severe allergic reactions (anaphylactic reaction or anaphylactic
shock, which can be fatal - serum sickness) (see Section 2:
Take special care with Ciprofloxacin Tablets)

fungal superinfections

theophylline (for breathing problems)

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.

-

-

allergic reaction, swelling (oedema), or rapid swelling of the skin
and mucous membranes (angio-oedema)



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 Tablets)

nausea, diarrhoea

-

glibenclamide (for diabetes)

-

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.

a. Swallow the tablets with plenty of fluid. Do not chew the tablets
because they do not taste nice.



Very rare side effects (less than 1 in every 10,000 people are
likely to get these):

Expand view ⇕

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.

Hide
(web3)