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CIPROFLOXACIN 100MG FILM COATED TABLETS

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CIPROFLOXACIN 100 MG FILM-COATED TABLETS
CIPROFLOXACIN 250 MG FILM-COATED TABLETS
CIPROFLOXACIN 500 MG FILM-COATED TABLETS
CIPROFLOXACIN 750 MG FILM-COATED TABLETS
PATIENT LEAFLET: INFORMATION FOR THE USER
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.
 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:
1. What Ciprofloxacin is and what it is used for
2. Before you take Ciprofloxacin
3. How to take Ciprofloxacin
4. Possible side effects
5. How to store Ciprofloxacin
6. Further 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 considered this necessary.
2. Before you take Ciprofloxacin
Do NOT take Ciprofloxacin if you are
- allergic (hypersensitive) to the active substance, to other quinolone drugs or to any of the other
ingredients of Ciprofloxacin (see section 6)
- taking tizanidine (see Section 2: Taking other medicines)
Take special care with 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 elderly or you are taking other medicines that result in
abnormal ECG changes (see section Taking other medicines).
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 Ciprofloxacin
• have myasthenia gravis (a type of muscle weakness)

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
• 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.
• 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-6phosphate 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.
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.
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-arrhythmics (e.g. quinidine, hydroquinidine, disopyramide,
aminodarone, sotalol, defetilide, ibutilide), tricyclic antidepressants, some antimicrobials (that belong
to the group of macrolides), some antipsychotics.
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) or other oral anti-coagulants (to thin the blood)
• probenecid (for gout)
• metoclopramide (for nausea/vomiting)
• 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)
• clozapine (an antipsychotic)
• olanzapine (an antipsychotic)
• ropinirole (for Parkinson’s disease)
• phenytoin (for epilepsy)
Ciprofloxacin may increase the levels of the following medicines in your blood:
• pentoxifylline (for circulatory disorders)
• caffeine
• duloxetine (for treating depression)
• lidocaine (for local anaesthesia)
• sildenafil (for erectile dysfunction)
Some medicines reduce the effect of Ciprofloxacin. Tell your doctor if you take or wish to take:
• antacids
• omeprazole (for treating stomach ulcers)
• 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.
Taking 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.
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
Dosage
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.
Duration of treatment
The treatment usually lasts from 5 to 21 days, but may take longer for severe infections.
Method of administration
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 product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Ciprofloxacin 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.
The following side effects have been reported at the approximate frequencies shown:
Common side effects (between 1 and 10 in every 100 people are likely to get these):
- nausea, diarrhoea
- joint pains in children
Uncommon side effects (between 1 and 10 in every 1,000 people are likely to get these):
- 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 (between 1 and 10 in every 10,000 people are likely to get these):
- inflammation of the bowel (colitis) linked to antibiotic use (can be fatal in very rare cases) (see
Section 2: Take special care with Ciprofloxacin)
- 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 (angiooedema)
- increased blood sugar (hyperglycaemia)
- confusion, disorientation, anxiety reactions, strange dreams, depression (potentially culminating in
suicidal thoughts or suicide attempts and 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 Ciprofloxacin), or giddiness
- eyesight problems incl. 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: Take special care with Ciprofloxacin)
- 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),
urinary tract inflammation
- fluid retention or excessive sweating
- increased levels of the enzyme amylase in the blood
Very rare side effects (less than 1 in every 10,000 people are likely to get these):
- 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)
- severe allergic reactions (anaphylactic reaction or anaphylactic shock, which can be fatal - serum
sickness) (see Section 2: Take special care with Ciprofloxacin)
- mental disturbances (psychotic reactions, potentially culminating in suicidal thoughts or suicide
attempts and completed suicide) (see Section 2: Take special care with Ciprofloxacin)
- 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: Take special care with Ciprofloxacin); worsening of the
symptoms of myasthenia gravis (see Section 2: Take special care with Ciprofloxacin)
Frequency not known (cannot be estimated from 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 ‘prolongation of QT interval’, seen on ECG, electrical activity of the heart).

- increase in the blood coagulation parameters (in patients treated with vitamin K antagonists)
- skin disorder characterised by the rapid appearance of areas of red skin studded with small blisters
filled with white/yellow fluid (pustular rash)
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.

5. How to store Ciprofloxacin
Keep out of the reach and sight of children.
Expiry date
Do not use Ciprofloxacin after the expiry date which is stated on the packaging. The expiry date refers
to the last day of that month.
This medicinal product does not require any special storage conditions.
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.

6. Further information
What Ciprofloxacin contains
 The active substance is ciprofloxacin.
 Each 100 mg film-coated tablet contains 100 mg ciprofloxacin as ciprofloxacin hydrochloride.
 Each 250 mg film-coated tablet contains 250 mg of ciprofloxacin as hydrochloride.
 Each 500 mg film-coated tablet contains 500 mg of ciprofloxacin as hydrochloride.
 Each 750 mg film-coated tablet contains 750 mg of ciprofloxacin as hydrochloride.
 The other ingredients are microcrystalline cellulose, povidone, croscarmellose sodium, colloidal
silica and magnesium stearate. The coating contains hypromellose, macrogol 400 and the colour
titanium dioxide (E171).
What Ciprofloxacin looks like and contents of the pack
100 mg: White, biconvex, round film-coated tablets, debossed “CIP 100” on one side and plain
on the other.
The product is available in pack sizes* of 6, 8, 10, 16, 20 and 160 tablets.
 250 mg: White, biconvex, round film-coated tablets, debossed “CIP 250” and breakline on one
side and plain on the other. The tablet can be divided into equal halves.
The product is available in pack sizes* of 8, 10, 12, 16, 20, 30, 50, 100 and 160 tablets.
 500 mg: White, capsule shaped film-coated tablets, debossed “CIP 500” and breakline on one
side and plain on the other. The tablet can be divided into equal halves.
The product is available in pack sizes* of 6, 8, 10, 12, 16, 20, 30, 50, 100, 120 and 160 tablets.
 750 mg: White, capsule shaped film-coated tablets, debossed “CIP 750” on one side and plain on
the other.
The product is available in pack sizes* of 8,10, 12, 16, 20, 30, 50, 100 and 160 tablets.


* Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation holder and company responsible for manufacture: TEVA UK Limited,
Eastbourne, BN22 9AG.

This leaflet was last revised in January 2013.
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
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 chemist’s shop to ensure they will be
disposed of correctly.

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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