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CIPROFLOXACIN 750MG FILM-COATED TABLETS

Active substance(s): CIPROFLOXACIN HYDROCHLORIDE

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Package leaflet: Information for the user
Ciprofloxacin 250 mg Film-Coated Tablets
Ciprofloxacin 500 mg Film-Coated Tablets
Ciprofloxacin 750 mg Film-Coated Tablets
Ciprofloxacin

Read all of this leaflet carefully before you start using 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, 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 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 belongs to a group of antibiotics called fluoroquinolones. It works by killing some
types of bacteria that can cause infections.
Ciprofloxacin is used in adults to treat following bacterial infections:
 respiratory tract infections
 long lasting or recurring ear or sinus infections
 bladder and kidney infections
 infections of the testicles
 genital organ infections in women
 gastro-intestinal tract infections and intra-abdominal infections
 skin and soft tissue infections
 bones or joint infections
 to treat infections in patients with a very low white blood cell count (neutropenia)
 to prevent infections in patients with a very low white blood cell count (neutropenia)
 to prevent infections due 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.

Ciprofloxacin is used in children and adolescents, under specialist medical supervision, to treat:

lung and bronchial infections in children and adolescents who have cystic fibrosis

complicated urinary tract infections, including infection that have reached the kidneys
(pyelonephritis)

anthrax inhalation exposure.
Ciprofloxacin may also be used to treat other specific severe infections in children and adolescents
when your doctor considers this necessary.
2. What you need to know before you take Ciprofloxacin
Do not take Ciprofloxacin if you are:
 allergic to ciprofloxacin or to other antibiotics of the same type (called quinolones or
fluoroquinolones) or any of the other ingredientsof this medicine (listed in section 6).
 currently taking a medication known as tizanidine (see section 2: “Other medicines and
Ciprofloxacin”)
Warnings and precautions
Talk to your doctor or pharmacist before taking Ciprofloxacin.
Before taking Ciprofloxacin
Heart problems
Caution should be taken when using this kind of medicine, if you were born with or have a family
history of prolonged QT interval (seen on ECG, electrical recording of the heart), have salt imbalance
in the blood (especially low level potassium or magnesium in the blood), have a very slow heart
rhythm (called ‘bradycardia’), have a weak heart (heart failure), have a history of heart attack
(myocardial infarction), you are female or olderor you are taking other medicines that result in
abnormal ECG changes (see section Other medicines and Ciprofloxacin)
Tell your doctor or nurse before you start to take this medicine if you have:
 a problem with weakness in your muscles called myasthenia gravis
 a history of tendon disease or disorder related to use with fluoroquinolone antibiotics
 epilepsy or any other central nervous system disorder
 ever had kidney problems because your treatment may need to be adjusted
 or had a family history of deficiency in the blood enzyme called glucose-6-phosphate
dehydrogenase (G6PD).
While taking Ciprofloxacin
Tell your doctor immediately, if any of the following occurs while taking Ciprofloxacin. Your doctor
will decide whether treatment with Ciprofloxacin needs to be stopped.
 Severe, sudden allergic reaction (an anaphylactic reaction/shock, angio-oedema). Even with
the first dose, there is a small chance that you may experience a severe allergic reaction with
the following symptoms: tightness in the chest, feeling dizzy, sick or faint, or experiencing
dizziness when standing up. If this happens, stop taking Ciprofloxacin and contact your
doctor immediately.
 Pain and swelling in the joints and tendinitis may occur occasionally, particularly if you are
elderly and are also being treated with corticosteroids. At the first sign of any pain or
inflammation stop taking Ciprofloxacin and rest the painful area. Avoid any unnecessary
exercise, as this might increase the risk of a tendon rupture.















If you suffer from epilepsy or other neurological conditions such as cerebral ischemia or
stroke, you may experience side effects associated with the central nervous system. If this
happens, stop taking Ciprofloxacin and contact your doctor immediately.
You may experience psychiatric reactions the first time you take Ciprofloxacin. If you suffer
from depression or psychosis, your symptoms may become worse under treatment with
Ciprofloxacin. If this happens, stop taking Ciprofloxacin and contact your doctor
immediately.
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 glucose6- 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.
If your eyesight becomes impaired or if your eyes seem to be otherwise affected, consult an
eye specialist immediately (see section 4: Possible side effects).

Other medicines and Ciprofloxacin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines, including any medicines obtained without a prescription.
You must tell your doctor if you are taking other medicines that can alter your heart rhythm:
medicines that belong to the group of anti-arrythmics (e.g. quinidine, hydroquinidine, disopyramide,
amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some antimicrobials (that belong
to the group of macrolides) and some antipsychotics.
Do not take Ciprofloxacin in combination with
tizanidine (a muscle relaxant) as this may cause side effects such as low blood pressure and
sleepiness (see section 2: “Do not take Ciprofloxacin”).
The following medicines are known to interact with Ciprofloxacin in your body. Taking
Ciprofloxacin together with these medicines can influence the therapeutic effect of those medicines. It
can also increase the probability of experiencing side effects.
Tell your doctor if you are taking:
 warfarin or other oral anti-coagulants (to thin the blood)
 probenecid (for gout)

















other medicines that can alter your heart rhythm: medicines that belong to the group of antiarrhythmics (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide,
ibutilide), tricyclic antidepressants, some antimicrobials (that belong to the group of
macrolides), some antipsychotics
metoclopramide (for nausea/vomiting)
omeprazole (for treating stomach ulcers)
methotrexate (for certain types of cancer, psoriasis, rheumatoid arthritis)
theophylline (for breathing problems)
tizanidine (for muscle spasticity in multiple sclerosis)
ciclosporin (for prevention of transplant rejection)
glibenclamide (for treating diabetes)
duloxetine (for treating depression)
lidocaine (for local anaesthesia)
clozapine (an antipsychotic)
ropinirole (for Parkinson’s disease)
phenytoin (for epilepsy)
sildenafil (for erectile dysfunction)

Ciprofloxacin may increase the levels of the following medicines in your blood:
 pentoxifylline (for circulatory disorders)
 caffeine
Some medicines reduce the effect of Ciprofloxacin. Tell your doctor if you take or wish to take:
 antacids
 mineral supplements
 sucralfate
 a polymeric phosphate binder (e.g. sevelamer)
 medicines or supplements containing calcium, magnesium, aluminium or iron
If these preparations are essential, take Ciprofloxacin about two hours before or no sooner than four
hours after them.

Ciprofloxacin with food and drink
Do not eat or drink any dairy products (such as yoghurt or milk) or calcium fortified drinks at the
same time as you take Ciprofloxacin tablets as this will reduce the effect. If it is essential that you take
these products, Ciprofloxacin should be taken either 1 or 2 hours before or at least 4 hours after the
intake of these dairy products.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning tohave a baby, ask
your doctor or pharmacist for advice before takingthis medicine. It is preferable to avoid use of
ciprofloxacin during pregnancy.
Do not take Ciprofloxacin if you are breast-feeding because ciprofloxacin is excreted in breast milk
and can be harmful for your child.
Driving and using machines
Ciprofloxacin may make you feel less alert, dizzy or confused, which may affect your ability to drive
or operate machinery. This is more likely to happen at the start of treatment, when the dose is
increased, when switching treatment or if you drink alcohol. Make sure you know how you react to
Ciprofloxacin before you drive, use machines, or engage in any other activity that could be dangerous
if you are not alert.

3. How to take Ciprofloxacin
Your doctor will explain to you exactly how much Ciprofloxacin you will have to take as well as how
often and for how long. This will depend on the type of infection you have and how bad it is.
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist
if you are not sure.
 Swallow the tablets with plenty of fluid drink, e.g. water.
 Do not chew the tablets.
 The tablets can be taken before, with or after food.
 Do not eat yoghurt or drink milk at the same time as you take the tablets, as this will reduce the
effect. If it is essential that you take these products, Ciprofloxacin should be taken 1 or 2
hours before or at least 4 hours afterwards.
 Space the doses as evenly as possible throughout the day.
 If you become dehydrated whilst taking the tablets, drink plenty of fluids.
Adults
The usual dose range in adults is 250 mg to 750 mg twice a day. Your doctor will tell you how long
your treatment with Ciprofloxacin will last. The dose you are prescribed will depend on the type and
severity of your infection.
Older people
Your doctor will decide what dose to give you. This may be lower than the usual adult dose.
Kidney problems
Your doctor will decide what dose to give you depending on your kidney function.
Use in children and adolescents
Your doctor will decide the dose based on your child’s weight and severity of infection.
It is very important that you follow your doctor’s instructions as to how many Ciprofloxacin tablets to
take, how often to take them and for how long you should continue to take your tablets. You will
usually need to take your tablets for between 1 and 14 days, but check with your doctor or pharmacist
if you are not sure.
If you take more Ciprofloxacin than you should
If you take more Ciprofloxacin than you should, contact a doctor or hospital immediately. An
overdose is likely to cause dizziness, tremor, headache, tiredness, seizures, hallucinations, confusion,
abdominal discomfort, kidney and liver impairment as well as crystals or red blood cells in the urine.
Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so
that they know which medicine was consumed.
If you forget to take Ciprofloxacin
If you forget to take a dose, take one as soon as you remember, unless it is nearly time to take the next
one. 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
Do not stop taking your medicine without talking to your doctor first even if you feel better. It is
important that you complete your prescribed course of treatment, otherwise the problem may come
back.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
A few people may develop very serious side effects. If you experience any of the following
symptoms, tell your doctor immediately:








swelling of the face, hands, lips, tongue or throat, difficulty swallowing or breathing
severe skin rash with blistering or bleeding of the lips, skin, nose, mouth, eyes and genitals
severe diarrhoea, sometimes with blood or mucus
inflammation of the tendons or a ruptured tendon
fits or seizures
unusual feelings of pain, burning, tingling, numbness or muscle weakness
yellowing of the skin or eyes, dark urine, tenderness in the abdomen or weight loss.

If your eyesight becomes impaired or if your eyes seem to be otherwise affected, consult an eye
specialist immediately (see section 2: What you need to know before you take Ciprofloxacin).
The following side effects have been reported at the approximate frequencies shown:
Common (may affect up to 1 in 10 people):
 nausea, diarrhoea
 joint pain in children.
Uncommon (may affect up to 1 in 100 people):
 fungal superinfections
 loss of appetite (anorexia)
 hyperactivity (unusually active)
 agitation
 headache, dizziness, sleep disorders, changes in taste
 vomiting, abdominal pain, stomach problems such as indigestion/heartburn, wind
 rash, nettle rash or itching
 pain the arms or legs, back pain, chest pain, joint pain
 kidney problems
 loss of strength (asthenia) or fever
 a high concentration of eosinophils (a type of white blood cells), increased amounts of
transaminases and/or bilirubin in the blood, increase of alkaline phosphatase in blood
Rare (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 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)
 high level of blood sugar (hyperglycaemia)
 confusion and disorientation, anxiety, abnormal dreams, depression (potentially culminating
in suicidal thoughts or suicide attempts and completed suicide), hallucinations
 unusual feelings of pain, burning, tingling, numbness, decreased feeling or sensitivity,
especially in the skin, dizziness, fits (see section 2: “Warnings and precautions”)
 eyesight problems
 ringing in the ears, hearing loss or impairment











rapid heart beat (tachycardia)
widening of blood vessels (vasodilatation), low blood pressure, fainting
shortness of breath (including asthmatic condition)
liver problems, jaundice (yellowing of the skin and whites of the eyes) or hepatitis
sensitivity to light (see section 2: “Warnings and precautions”)
muscle pain, painful joint disease (arthritis), increased muscle tone and cramping
kidney problems, blood or crystals in the urine (see section 2: “Warnings and precautions”),
water retention (oedema), abnormal sweating
increased levels of the enzyme amylase in the blood

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, including anaphylactic reaction or anaphylactic shock which can be
fatal – serum sickness (see section 2: “Warnings and precautions”)
 mental disturbances (psychotic reactions, potentially culminating in suicidal thoughts or
suicide attempts and completed suicide) (see section 2: “Warnings and precautions”)
 migraine (headache), disturbed coordination (problems walking – gait disturbance), changes
to sense of smell and taste (olfactory disorders), high pressure within the head (intracranial
pressure)
 visual colour distortions
 inflammation of blood vessels wall, often with skin rash (vasculitis)
 inflammation of the pancreas, which causes severe pain in the abdomen and back
 liver disease which may very rarely lead to death
 serious skin rashes with red, often itchy spots, similar to the rash of measles, which starts on
the limbs and sometimes on the face and the rest of the body. The spots may blister or may
progress to form raised, red, pale-centred marks. Those affected may have fever, sore throat,
headache and/or diarrhoea
 serious illness with blistering of the skin, mouth, eyes and genitals (Stevens-Johnson
syndrome or toxic epidermal necrolysis)
 muscle weakness, inflammation of a tendon, tendon rupture – especially of the large tendon at
the back of the ankle (see section 2: “Warnings and precautions”), worsening of symptoms of
myasthenia gravis (see section 2: “Warnings and precautions”).
Not known (frequency cannot be estimated from the available data):
 abnormal fast heart rhythm, life-threatening irregular heart rhythm, alteration of the heart
rhythm (called ‘prolongation of QT interval’, seen on ECG, electrical activity of the heart)
 a disorder of the nerves which can cause weakness, tingling or numbness
 increase in the blood coagulation parameters (in patients taking oral anticoagulants)
 skin disorder characterised by the rapid appearance of areas of red skin studded with small
blisters filled with white/yellow fluid (pustules).
Reporting of side effects
If you get 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
Keep this medicine out of the sight and reach of children.
Store in the original packaging.
Do not use this medicine after the expiry date which is stated on the carton. 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 Ciprofloxacin contains:
 The active substance is ciprofloxacin (as hydrochloride monohydrate)
The other ingredients are croscarmellose sodium, colloidal silicon dioxide, magnesium stearate,
hypromellose 6cp (E464), magnesium stearate (E572), microcrystalline cellulose (E460), sodium
starch glycolate A, povidone, propylene glycol, talc, titanium dioxide (E171).
What Ciprofloxacin looks like and contents of the pack:
(Manufacturer = MicroLabs Ltd)
- 250 mg: White, biconvex, round film-coated tablets, debossed “CIP breakline 250” on one side
and plain on the other.
OR*
(Manufacturer = Kemwell Pvt Ltd)
- 250 mg: White, biconvex, round film-coated tablets debossed with a breakline on one side and
plain on the other.
(Manufacturer = MicroLabs Ltd)
- 500 mg: White, oval-shaped film-coated tablets, debossed “CIP breakline 500” on one side and
plain on the other.
OR*
(Manufacturer = Kemwell Pvt Ltd)
- 500 mg: White, oval-shaped film-coated tablets debossed with a breakline on one side and plain
on the other.
(Manufacturer = Microlabs Ltd or Kemwell Pvt Ltd)
- 750 mg: White, oval-shaped film-coated tablets, debossed “CIP breakline 750” on one side and a
breakline on the other.
 The product is available in pack sizes of 10, 12, 20, 30, 50, 100 or 160 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation holder: TEVA UK Limited, Eastbourne, BN22 9AG.
Company responsible for manufacture:
Pharmachemie B.V., Haarlem, The Netherlands.
OR*

TEVA UK Limited, Eastbourne, BN22 9AG
This leaflet was last revised: September 2014
PL 00289/0493-0495
* Only the details of the current manufacturing site and corresponding tablet descriptions will be
included in the printed version of the PIL

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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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