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CIPROFLOXACIN 100MG TABLETS

Active substance(s): CIPROFLOXACIN HYDROCHLORIDE

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CIPROFLOXACIN 100 mg TABLETS
CIPROFLOXACIN 250 mg TABLETS
CIPROFLOXACIN 500 mg TABLETS
CIPROFLOXACIN 750 mg TABLETS
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 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 Ciprofloxacin tablets are and what they are
used for
2. What you need to know before you take
Ciprofloxacin tablets
3. How to take Ciprofloxacin tablets
4. Possible side effects
5. How to store Ciprofloxacin tablets
6. Contents of the pack and other information

1. What Ciprofloxacin tablets are and
what they are used for
The active substance is 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
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 prevent infections due to the bacterium Neisseria
meningitidis
• anthrax inhalation exposure
• 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)
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 considered this necessary.

2. What you need to know before you take
Ciprofloxacin tablets
Do not take Ciprofloxacin if you:
• are allergic to ciprofloxacin, to other quinolone drugs or
any of the other ingredients (listed in section 6).
• are taking tizanidine (see Section 2: Other medicines
and Ciprofloxacin)
Warnings and Precautions
Tell your doctor before taking these tablets if you:
• have heart problems. Caution should be taken when
using this kind of medicine, if you are born with a
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 and
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), have a history of abnormal heart rhythms
(arrhythmias) you are female or elderly or you are
taking other medicines that result in abnormal ECG
changes (see section: Other medicines and
Ciprofloxacin)
• 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)
• are diabetic because you may experience a risk of
hypoglycaemia 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 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.
• If your eyesight becomes impaired or if your eyes
seem to be otherwise affected, consult an eye
specialist immediately.
• 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.
Inflammation and ruptures of tendons may occur even
within the first 48 hours of treatment or up to several
months after discontinuation of Ciprofloxacin therapy.
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.

Ciprofloxacin Insert
SAME SIZE ARTWORK
130 x 420 mm
Front

• 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 rare cases, depression or psychosis can progress
to thoughts of suicide, suicide attempts, or completed
suicide. If this happens, 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.
• 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 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.
• If you suffer from kidney problems, tell the doctor
because your dose may need to be adjusted.
• 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 anemia 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 anti-coagulants such as
acenocoumarol, phenprocoumon or fluindione (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 (used to treat nausea)
• cyclosporin (an immunosuppresant)
• 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
• duloxetine (for depression, diabetic nerve damage or
incontinence)
• lidocaine (for heart conditions or anesthetic use)
• sildenafil (e.g. for erectile dysfunction)
• agomelantine
• zolpidem
Some medicines reduce the effect of Ciprofloxacin. 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 Ciprofloxacin
about two hours before or no sooner than four hours after
them.
Ciprofloxacin tablets with food, drink and alcohol
• 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 and fertility
If you are pregnant or breast-feeding, think you may
be pregnant or are planning to have a baby, ask you
doctor or pharmacist for advice before taking this
medicine.
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.

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Package leaflet: Information for the user

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.
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 may sometimes cause side
effects, although not everybody gets them.
Severe allergic reactions can occur very rarely. These can
happen after the first dose or even after the treatment has
stopped.
Signs of allergic reaction are:
• fast heart beat, hypotension (low blood pressure),
fever, breathing problems, shock (anaphylactic
reactions progressing in very rare cases of life
threatening shock)
• swelling of the face, tongue and throat, skin reactions
such as rash, itchy skin or swelling and redness,
blood problems, ulcers in the mouth, eyes, gut and
genital organs
• severe liver problems can develop in some people.
Signs of liver problems include yellow skin or yellowing
of eyes (jaundice), dark urine, stomach tenderness
and loss of appetite.
Stop taking this medicine and contact your doctor
immediately if you get any of the following serious side
effects:
• muscle pain and/or weakness, inflammation of the joints
and joint pain, increased muscle tone and cramping,
inflammation of the tendons or tendon rupture,
particularly affecting the large tendon at the back of the
ankle (Achilles tendon) – see section 2
• unusual feelings of pain, burning tingling, numbness or
muscle weakness in the extremities (neuropathy)- see
section 2
Other side effects that may occur include:
Common (may affect up to 1 in 10 people):
- nausea (feeling sick), 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
- 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 (may affect up to 1 in 1000 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 (leucopenia, leucocytosis,
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)
Ciprofloxacin Insert
SAME SIZE ARTWORK
130 x 420mm
back

- 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
- abnormal levels of a clotting factor (prothrombin) or
increased levels of the enzyme amylase
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)
Not known (cannot be estimated from the available data):
- hypersensitivity reaction called DRESS (Drug Reaction
with Eosinophilia and Systemic Symptoms) which may
show up with the following symptoms: fever, skin rash,
joint pain, swelling of glands, abnormalities of blood
including increase in blood cells called eosinophils,
abnormalities of kidney and liver function.
- Heart problems such as 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)
- Feeling highly excited (mania) or feeling great optimism
and overactivity (hypomania)
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in
this leaflet. You can also report side effects directly via the
Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By
reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Ciprofloxacin tablets
• Keep this medicine out of the sight and reach of
children
• Blisters: Do not store above 250C. Store in the original
package
• Tablet Containers: Do not store above 250C. Keep
the container tightly closed.
• Do not use this medicine after the expiry date which
is stated on the carton after {EXP.}. The expiry date
refers to the last day of that month.
• Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These
measures will help protect the environment.

6. Contents of the pack and other information
What these tablets contain
• The active ingredient is ciprofloxacin (as
hydrochloride).
• Each tablet contains either 100mg, 250mg, 500mg or
750mg of the active ingredient.
• The other ingredients are maize starch, microcrystalline
cellulose, colloidal anhydrous silica, sodium starch
glycollate, magnesium stearate, hypromellose, purified
talc, polyethylene glycol, titanium dioxide E171.
What these tablets look like and contents of the pack
• The 100 mg tablets are round, white, to cream
coloured, film-coated tablets with the tablet markings
‘CPR 100’ on one side and ‘BL’ on the reverse.
• The 250 mg tablets are round, white, to cream
coloured, film-coated tablets with the tablet markings
‘CPR 250’ on one side and ‘BL’ on the reverse.
• The 500 mg tablets are capsule shaped, white to
cream coloured, film-coated tablets with the tablet
markings ‘CPR 500’ and a breakline on one side and
‘BL’ on the reverse.
• The 750 mg tablets are capsule shaped, white, to
cream coloured, film-coated tablets with the tablet
markings ‘CPR 750’ on one side and ‘BL’ on the
reverse.
• The tablets come in packs containing 6, 10, 20, 100,
250 or 500 tablets.
• Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Bristol Laboratories Ltd,
Unit 3, Canalside, Northbridge Road, Berkhamsted,
Hertfordshire, HP4 1EG, United Kingdom
Telephone: 0044 (0)1442 200922
Fax:
0044 (0)1442 873717
E-mail:
info@bristol-labs.co.uk
Ciprofloxacin 100 mg Tablets; PL 17907/0013
Ciprofloxacin 250 mg Tablets; PL 17907/0014
Ciprofloxacin 500 mg Tablets; PL 17907/0015
Ciprofloxacin 750 mg Tablets; PL 17907/0016
This leaflet was last revised in December 2015
To request a copy of this leaflet in Braille, large print or
audio format, please contact the licence holder at the
address (or telephone, fax, email) above.

V18 24-12-15 D0

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3. How to take Ciprofloxacin tablets

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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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