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CIPROFLOXACIN 750MG TABLETS

Active substance(s): CIPROFLOXACIN HYDROCHLORIDE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

Ciprofloxacin 250 mg,
500 mg and 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 it again.
• If you have further questions, please ask your doctor or
your 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, pharmacist
or nurse. This includes any possible side effects not listed
in this leaflet. See section 4.
What is in this leaflet:
1. What Ciprofloxacin is and what is it 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
The name of this medicine is Ciprofloxacin 250 mg, 500 mg
or 750 mg Film-coated Tablets.
1. What Ciprofloxacin is and what is it 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 to treat bacterial infections including:
• Lung infections such as pneumonia
• Infections of the bladder and kidneys
• Severe gastro-enteritis
• Infections in the abdomen around the gut
• Infections of the gall bladder and bile
• Infections of the skin and spreading infections under the
skin
• Infections in the womb and tubes leading to the ovaries
and in the area around these organs
• Infections of the genital organs, including gonorrhoea
(a sexually transmitted disease) and inflammation of the
prostate gland in men
• Infections in the bones and joints
• Infections that have spread to the blood
• Infections in people who have poor immunity to infections
• Prevention of infections after surgery on the gut or after
procedures that involve passing cameras (endoscopes) into
the gut or other organs
Ciprofloxacin Tablets may also be used for treating lung
infections in children (aged five years or older) and teenagers
who have cystic fibrosis.
2. What you need to know before you take Ciprofloxacin
Tablets
Do not take Ciprofloxacin Tablets:
• If you are allergic to ciprofloxacin, to other quinolone
drugs or to any of the other ingredients of this medicine
(listed in section 6)
• If you are taking tizanidine (see Section 2: Other medicines
and Ciprofloxacin Tablets).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking
Ciprofloxacin Tablets:
• If you have ever had kidney problems because your
treatment may need to be adjusted.
• If you suffer from epilepsy or other neurological conditions.
• If you have a history of tendon problems during previous
treatment with antibiotics such as Ciprofloxacin.
• If you are diabetic because you may experience a risk of
hypoglycaemia with ciprofloxacin.
• If you have myasthenia gravis (a type of muscle weakness)
because symptoms can be exacerbated.
• If you have heart problems. Caution should be taken
when using Ciprofloxacin, if you were born with or have
family history of prolonged QT interval (seen on ECG,
electrical recording of the heart), have salt imbalance in
the blood (especially low level of potassium or magnesium
in the blood), have a very slow heart rhythm (called
‘bradycardia’), have a weak heart (heart failure), have a
history of heart attack (myocardial infarction), you are
female or elderly or you are taking other medicines that
result in abnormal ECG changes (see section 2: Other
medicines and Ciprofloxacin).
• If you or a member of your family is known to have
a deficiency in glucose-6-phosphate dehydrogenase
(G6PD), since you may experience a risk of anaemia with
ciprofloxacin.
For the treatment of some genital tract infections, your doctor
can prescribe another antibiotic in addition to ciprofloxacin.
If there is no improvement in symptoms after 3 days of
treatment, please consult your doctor.
While taking 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. 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.

Font size: Times New Roman; 9 pt.

• 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.
• If your eyesight becomes impaired or if your eyes
seem to be otherwise affected, consult an eye specialist
immediately.
• 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.
• 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.
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:
• Vitamin K antagonists (e.g. warfarin, acenocoumarol,
phenprocoumon or fluindione) or other oral anti-coagulants
(to thin the blood)
• probenecid (for gout)
• methotrexate (for certain types of cancer, psoriasis,
rheumatoid arthritis)
• theophylline (for breathing problems)
• tizanidine (for muscle spasticity in multiple sclerosis)
• olanzapine (an antipsychotic)
• clozapine (an antipsychotic)
• ropinirole (for Parkinson’s disease)
• phenytoin (for epilepsy)
• metoclopramide (for nausea and vomiting)
• cyclosporin (for skin conditions, rheumatoid arthritis and
in organ transplantation)
• other medicines that can alter your heart rhythm: medicines
that belong to the group of antiarrhythmics (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 anaesthetic use)
• sildenafil (e.g. for erectile dysfunction)
• agomelatine
• 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.
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor or
pharmacist for advice before taking this medicine.
It is preferable to avoid the use of Ciprofloxacin Tablets
during pregnancy.
Do not take Ciprofloxacin during breast-feeding because
ciprofloxacin is excreted in breast milk and can be harmful
for your child.

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Ciprofloxacin 250 mg, 500 mg and 750 mg Tablets
Co-Pharma

Pack Insert
----

180 x 420 mm
1026887
Black
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Front & Back Printing. To be supplied in single folded size -180 x 210mm
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PRINTING CLARITY TO BE CLEAR AND SHARP.

1026546
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3. How to take Ciprofloxacin Tablets
You should always take this medicine as prescribed by your
doctor. Do not take more than the doctor told you to. Read
and follow the instructions on the pharmacist’s label. If you’re
not sure about anything please ask your doctor or pharmacist.
The dose you are prescribed will depend on the type and
severity of your infection. The usual dose range in adults is
100 mg to 750 mg twice a day. Your doctor will tell you how
long your treatment with ciprofloxacin will last.
In lung infections it is usual to use 250 mg or 500 mg twice a
day for up to two weeks.
In infections of the bladder and kidneys the dose may
be as low as 100-250 mg twice a day for only three days
or as high as 500 mg twice a day for up to two weeks (or
even four weeks for certain infections of the prostate gland
in men).
In gonorrhoea infections that have not spread beyond the
lower genital organs in men or women, a single dose of
250-500 mg may be enough.
For other infections 500 mg twice a day is the usual dose,
but 750 mg twice a day may be used for more severe
infections.
For the treatment of lung infections in cystic fibrosis
patients (aged 5 to 17 years), the dose is 20 mg/kg twice
a day for up to two weeks. The maximum daily dose in
this age group is 1500 mg.
To prevent infections after gut surgery or after endoscopy
(see above), 750 mg is usually given 1 to 1½ hours before the
procedure.
If you are elderly or have kidney problems your doctor may
give you a single daily dose or a lower dose.
Also, special dosing instructions are needed if you are on
haemodialysis or having CAPD (continuous ambulatory
peritoneal dialysis) to treat kidney problems. In these cases,
it is very important to follow your doctor’s instructions
carefully.
• 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. You should avoid eating yoghurt or
drinking milk at the same time as you take a tablet as this
will reduce the effect. You should either take ciprofloxacin
1-2 hours before eating or drinking dairy products or avoid
eating and drinking these products for four hours after
taking ciprofloxacin.
• There are also several medicines that should not be taken at
the same time as ciprofloxacin. See under Other medicines
and Ciprofloxacin Tablets.
• Space the doses as evenly as possible throughout the day.
• It is important that you keep taking Ciprofloxacin Tablets
until the prescribed course is finished. Do not stop taking
the tablets just because you feel better. If you stop too
soon, the infection may start up again.
• If you still feel unwell at the end of your prescribed course
of treatment, tell your doctor.
If you forget to take Ciprofloxacin Tablets at the right time,
take them as soon as you remember. Do not take a double dose
to make up for forgotten individual doses.
If you have taken more Ciprofloxacin Tablets than you
should, drink plenty of water and consult your doctor or
the nearest hospital casualty department immediately.
Take this leaflet or some tablets with you so your doctor
will know what you have taken.
4. Possible side effects
Like all medicines, this medicine can have side effects.
If any of the following happen, stop taking Ciprofloxacin
Tablets and tell your doctor immediately or go to the casualty
department at your nearest hospital.
These are very serious side effects. If you have them you
may have had a serious allergic reaction or other type
of reaction to ciprofloxacin. You may need urgent
medical attention or hospitalisation.
- Severe skin disorders including skin rash, itching, peeling,
blistering or crusting (for example the potentially fatal
Steven-Johnson syndrome or toxic epidermal necrolysis,
Erythema multiforme, Acute generalised exanthematous
pustulosis), small, pin point bleeding under the skin
(petechiae)
- Allergic reaction, swelling (oedema), or rapid swelling of
the skin and mucous membranes (angio-oedema), swelling
of the face or throat, difficulty breathing (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)
- 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), worsening of the symptoms of myasthenia gravis
(see Section 2: Warnings and precautions)
- 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)
- Reduction in red blood cells due to extensive destruction
of these cells (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 diarrhoea with bleeding or mucous.
- Unusual feelings of pain, burning, tingling, numbness or
muscle weakness in the extremities (peripheral neuropathy
and polyneuropathy) (see Section 2: Warnings and
precautions)
Other side effects have also been reported. These are shown
below:
Common: may affect up to 1 in 10 people:
- Nausea (feeling sick), diarrhoea

Font size: Times New Roman; 9 pt.

Uncommon: may affect up to 1 in 100 people:
- Fungal super infections
- Increased numbers of a type of blood cell called an
eosinophil.
- Vomiting (being sick), indigestion, decreased appetite,
flatulence (wind), abdominal pain
- Dizziness, headache, sleep problems, fever, feeling unwell
(asthenia)
- Hyperactivity or agitation
- Disturbances in taste, increase in blood alkaline
phosphatase (a certain substance in the blood)
- Poor kidney function
- Palpitations, itching or hives
- Skin rashes and itching
- Increased amount of certain substances in the blood
(transaminase and/or bilirubin)
Rare: may affect up to 1 in 1,000 people:
- Inflammation of the bowel (colitis) linked to antibiotic use
(can be fatal in very rare cases) (See section 2: Warnings and
precautions)
- Changes to the blood cell count (leukopenia, leukocytosis,
neutropenia, anaemia), increased or deceased amounts of a
blood clotting factor (thrombocytes)
- Increases in blood sugar levels (hyperglycaemia) and
decreases in blood sugar levels (hypoglycaemia)
- Confusion, disorientation, anxiety reactions, strange
dreams, hallucinations
- Fluid retention or excessive sweating
- Pins and needles, unusual sensitivity to stimuli of the
senses, decreased skin sensitivity, tremors, seizures (See
Section 2: Warnings and precautions)
- Spinning sensation (vertigo), ringing in the ears (tinnitus),
temporary loss of hearing, impaired hearing
- Visual disturbances (diplopia)
- Increased heart rate (tachycardia)
- Widening of blood vessel (vasodilation), low blood
pressure, fainting
- Shortness of breath (dyspnoea), including asthmatic
symptoms
- Liver disorders, jaundice (cholestatic icterus), or hepatitis
- Sensitivity to light (see Section 2: Warnings and precautions)
- Sudden (acute) kidney failure, blood or crystals in the
urine with discomfort when passing urine (crystalluria),
increases in some blood chemicals that normally pass through
the kidneys (see Section 2: Warnings and precautions),
urinary tract inflammation
- increased levels of the enzyme amylase
Very rare: and may affect up to 1 in 10,000 people.
- 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 (severe stomach pain)
- Death of liver cells (liver necrosis) very rarely leading to
life-threatening liver failure
Frequency not know:
- Influence on blood clotting (in patients treated with
Vitamin K antagonists)
- Feeling highly excited (mania) or feeling great optimism
and over-activity (hypomania)
- Serious hypersensitivity reaction called DRESS (Drug
Reaction with Eosinophilia and Systemic Symptoms).
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via the Yellow
Card Scheme, Website: 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 Ciprofloxacin Tablets out of the sight and reach of
children
• Do not take after the expiry date on the labelling
• There are no special storage instructions, however,
as with all medicines do not store Ciprofloxacin tablets
anywhere too hot or damp
• If you notice any visible signs of deterioration in the
tablets, such as chipped, broken or discoloured tablets,
take them to your pharmacist for advice before taking
them
• If you have any tablets left after taking all the doses
prescribed for you, please return these to your pharmacist
6. Contents of the pack and other information
What Ciprofloxacin Tablets contains
• The active ingredient is ciprofloxacin.
• The other ingredients are lactose monohydrate, sodium
starch glycollate, povidone, sodium stearyl fumarate and
a coating consisting of methocel, polyethylene glycol and
titanium dioxide (E171).
What Ciprofloxacin Tablets looks like and contents of the
pack
Ciprofloxacin 250mg Film-coated Tablets are off-white,
round, biconvex film coated tablets. Scored on one side
and plain on the other.
Ciprofloxacin 500mg Film-coated Tablets are off-white,
capsule shaped, biconvex film coated tablets. Scored on
both the sides.
Ciprofloxacin 750mg Film-coated Tablets are off-white,
capsule shaped, biconvex, film coated tablets.
The 250mg and 500mg tablets are available in blister packs
of 10, 20 or 100 tablets.
The 750mg tablets are available as blister packs of 10 or
100 tablets.
Marketing Authorisation Holder and Manufacturer
Co-pharma Ltd
Unit 4, Metro Centre,
Tolpits Lane, Watford
Hertfordshire, WD18 9SS
United Kingdom

1026887

Driving or using machines
Ciprofloxacin may make you feel less alert.
Some neurological adverse events can occur. Therefore, make
sure that you know how you react to Ciprofloxacin Tablets
before driving or operating machinery.

This leaflet was last revised in March 2016.

180 x 420 mm

Back Page

Ciprofloxacin 250 mg, 500 mg and 750 mg Tablets
Co-Pharma

Pack Insert
----

180 x 420 mm
1026887
Black
***
Front & Back Printing. To be supplied in single folded size -180 x 210mm
40/45 GSM Paper.
PRINTING CLARITY TO BE CLEAR AND SHARP.

1026546
ONE
3.0

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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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