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CIPROFLOXACIN 100 MG TABLETS

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Ciprofloxacin 100 mg, 250 mg, 500 mg and 750 mg
Film-coated Tablets

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Ciprofloxacin

Read all of this leaflet carefully before you start taking this medicine because it contains important
information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their
signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed
in this leaflet.

What is in this leaflet
1. What Ciprofloxacin is and what it is used for
2. What you need to know before you take Ciprofloxacin
3. How to take Ciprofloxacin
4. Possible side effects
5. How to store Ciprofloxacin
6. Contents of the pack and other information

1

What Ciprofloxacin is and what it is
used for

Ciprofloxacin 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
Ciprofloxacin 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 Ciprofloxacin.

Children and adolescents
Ciprofloxacin 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.

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

2

What you need to know before you take
Ciprofloxacin

Do not take Ciprofloxacin if you are:
• allergic to ciprofloxacin, to other quinolone drugs or to
any of the other ingredients of this medicine (listed in
section 6).
• taking tizanidine (see Section 2: Other medicines and
Ciprofloxacin).

Warnings and precautions
Before taking Ciprofloxacin
Talk to your doctor before taking Ciprofloxacin 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 Ciprofloxacin.
• have myasthenia gravis (a type of muscle weakness).
• have a history of abnormal heart rhythms (arrythmias)
or other 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 ʻbradycardiaʼ), 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
Ciprofloxacin”).

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, even up to several months after
treatment with ciprofloxacin 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. In
very rare cases depression or mental health problems
have led to suicidal thoughts and self-endangering
behaviour such as suicide attempts. If you develop












such reactions, stop taking Ciprofloxacin 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
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.

Other medicines and Ciprofloxacin
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.

Do not take Ciprofloxacin together with tizanidine,
because 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 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)
• methotrexate (for certain types of cancer, psoriasis,
rheumatoid arthritis)
• theophylline (for breathing problems)
• tizanidine (for muscle spasticity in multiple sclerosis)
• clozapine, olanzapine (antipsychotics)
• ropinirole (for Parkinsonʼs disease)
• duloxetine (for depression)
• phenytoin (for epilepsy)
• cyclosporin (for immune suppression)
• glibenclamide (for diabetes)
• lidocaine (for regional anaesthesia)
• omeprazole (gastric medicine)
• sildenafil (for erectile dysfunction)
• 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.
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.

Ciprofloxacin with food and drink
Unless you take Ciprofloxacin 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 Ciprofloxacin during
pregnancy. Tell your doctor if you are planning to get
pregnant.

Do not take Ciprofloxacin during breast-feeding
because ciprofloxacin is excreted in breast milk and can
be harmful for your child.

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.

Continued on the next page >>

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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.
Continued on the next page >>
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Driving and using machines
Ciprofloxacin may make you feel less alert. Some
neurological adverse events can occur.
Therefore, make sure you know how you react to
Ciprofloxacin before driving a vehicle or operating
machinery. If in doubt, talk to your doctor.

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.

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.
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
Ciprofloxacin 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
Ciprofloxacin.

Ciprofloxacin 250 mg, 500 mg and 750 mg film-coated
tablets can be divided into equal doses.

If you take more Ciprofloxacin 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 Ciprofloxacin
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
It is important that you finish the course of treatment
even if you begin to feel better after a few days. If you
stop taking this medicine too soon, your infection may
not be completely cured and the symptoms of the
infection may return or get worse. You might also
develop resistance to the antibiotic.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

4

Possible side effects

Like all medicines, this medicine can cause side effects,
although not everybody gets them.
If you get any side effects, talk to your doctor or
pharmacist. This includes any side effects not listed in
this leaflet.
Common side effects, affect 1 to 10 per 100 users
• nausea, diarrhoea
• joint pains in children.

Uncommon side effects, affect 1 to 10 per 1,000 users
• 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, affect 1 to 10 per 10,000 users
• 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)
• 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: Warnings and precautions), or giddiness
• eyesight problems, such as 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.

Very rare side effects, affects less than 1 per 10,000
users
• 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) (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)
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).













Frequency not known, according to the available data
• troubles associated with the nervous system such as
pain, burning, tingling, numbness and/or weakness in
extremities
• abnormal fast heart rhythm, life-threatening irregular
heart rhythm, alteration of the heart rhythm (called
ʻprolongation of QT intervalʼ, seen on ECG, electrical
recording of the heart)
• pustular skin rash (called ʻacute generalized
exanthematous pustulosisʼ)
• abnormal levels of a clotting factor (INR) in patients
taking blood thinning medicines (see Section 2: Other
medicines and Ciprofloxacin).

5

How to store Ciprofloxacin

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date, which is
stated on the blister or carton after “EXP”: The expiry
date refers to the last day of that month.

Do not throw away any medicines via wastewater. Ask
your pharmacist how to throw away medicines no longer
use. These measures will help to protect the
environment.

6

Contents of the pack and other
information

What Ciprofloxacin contains
The active substance is ciprofloxacin. This is present in
the form of ciprofloxacin hydrochloride monohydrate,
equivalent to 100 mg/250 mg/500 mg/750 mg
ciprofloxacin.

The other ingredients are microcrystalline cellulose,
sodium starch glycollate, povidone, colloidal silicon
dioxide, stearic acid, magnesium stearate,
croscarmellose sodium, hypromellose, macrogol 6000,
talc, titanium dioxide (E 171).
What Ciprofloxacin looks like and contents of the
pack
Ciprofloxacin 100 mg Film-coated Tablets are white,
round, with the embossment “cip 100”.

Ciprofloxacin 250 mg Film-coated Tablets are white,
round and scored on one side, with the embossment
“cip 250”.

Ciprofloxacin 500 mg Film-coated Tablets are white,
oblong and scored on both sides with the embossment
“cip 500”.

Ciprofloxacin 750 mg Film-coated Tablets are white,
oblong and scored on both sides with the embossment
“cip 750”.

Ciprofloxacin 100 mg Film-coated Tablets:
6, 10, 10 x 1, 20, 30, 100 and 100 x 1 film-coated tablets
in PVC/aluminium or PP/aluminium blisters.
Hospital packages containing 30 and 100 film-coated
tablets.

Ciprofloxacin 250 mg Film-coated Tablets
6, 10, 12, 14, 20, 28 and 100 film-coated tablets in
PVC/aluminium or PP/aluminium blisters.
Hospital package containing 20, 30, 50 (10 x 5) and 160
film-coated tablets.

Ciprofloxacin 500 mg Film-coated Tablets
10, 12, 14, 16, 20, 28, 50 (10 x 5) and 100 film-coated
tablets in PVC/aluminium or PP/aluminium blisters.
Hospital package containing 20, 30, 100, 120 and 160
film-coated tablets.

Ciprofloxacin 750 mg Film-coated Tablets
10, 20 and 100 film-coated tablets in PVC/aluminium or
PP/aluminium blisters.
Hospital package containing 20, 30, 50 (10 x 5) and 160
film-coated tablets.
Not all pack sizes or pack types may be marketed.

Marketing Authorisation Holder and Manufacturer
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.

Manufacturer
S.C. Sandoz S.R.L.,
7A Livezeni Street, 540472 Targu Mures,
Romania
or

Salutas Pharma GmbH,
Otto-von-Gericke-Allee 1, D-39179 Barleben,
Germany.
This leaflet was last revised in 07/2013.

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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 chemistʼs shop to ensure they will be disposed of
correctly.
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Expand Transcript

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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