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Package leaflet: Information for the user

CIPROFLOXACIN 250 mg FILM-COATED TABLETS CIPROFLOXACIN 500 mg

film-coated tablets

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 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 is Ciprofloxacin 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 (such as moxifloxacin, norfloxacin, ofloxacin or nalidixic acid) 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')

Warnings and precautions

Talk to your doctor or pharmacist before taking

Ciprofloxacin if you:

•    have ever had kidney problems because your treatment may need to be adjusted

•    suffer from epilepsy (fits) or other neurological conditions that predispose you to fits

•    have a history of tendon problems during previous treatment with quinolone antibiotics such as ciprofloxacin

•    have myasthenia gravis (a type of muscle weakness)

•    have a history of abnormal heart rhythms (arrythmias)

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 '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').

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. Tendon inflammation and ruptures may occur even up to several months after you stop taking Ciprofloxacin.

•    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. You may have thoughts of killing or harming yourself. 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 and eyes), 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.

•    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.

Other medicines and Ciprofloxacin

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including any that you obtained without a prescription.

•    Do not take Ciprofloxacin together with tizanidine (for muscle spasticity in multiple sclerosis or spinal injury or disease) because this may cause side effects such as low blood pressure and sleepiness (see Section 2 'Do not take Ciprofloxacin').

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, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some antimicrobials (that belong to the group of macrolides), some antipsychotics.

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 chance of you getting side effects.

Tell your doctor if you are taking:

•    warfarin, acenocoumarol, phenprocoumon, fluindione or other oral anti-coagulants (to thin the blood)

•    probenecid (for gout)

•    metoclopramide (for nausea and vomiting)

•    methotrexate (for certain types of cancer, psoriasis, rheumatoid arthritis)

•    theophylline (for breathing problems)

•    clozapine (an antipsychotic)

•    ropinirole (for Parkinson's disease)

•    phenytoin (for epilepsy)

•    cyclosporin (an immunosuppressant)

•    glibenclamide (for diabetes)

Ciprofloxacin may increase the levels of the following medicines in your blood and your doctor may need to adjust your dose. Tell your doctor if you are taking or wish to take:

•    pentoxifylline (for circulatory disorders)

•    duloxetine (for depression, anxiety, pain and stress incontinence)

•    olanzapine (an antipsychotic)

•    lidocaine given as an injection (an anaesthetic often used in surgical procedures)

•    sildenafil (for impotence)

•    caffeine

Some medicines reduce the effect of Ciprofloxacin.

Tell your doctor if you are taking or wish to take:

•    antacids (for indigestion)

•    mineral supplements

•    sucralfate (for stomach ulcers)

•    medicines used to bind phosphate and reduce phosphate levels in the blood (e.g. sevelamer)

•    medicines or supplements containing calcium, magnesium, aluminium or iron

•    omeprazole (for gastric reflux often known as heartburn, stomach or intestinal ulcers)

•    didanosine (used to treat HIV infection)

If these medicines must be taken, take Ciprofloxacin about two hours before or at least four hours after them. Ciprofloxacin with food and drink Ciprofloxacin is best taken on an empty stomach but it can be taken with or without food. 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 medicine.

Pregnancy and breast feeding Pregnancy

It is preferable to avoid the use of Ciprofloxacin during pregnancy. Tell your doctor if you are pregnant, think you may be pregnant or are planning to have a baby. Breast-feeding

Do not take Ciprofloxacin during breast feeding because Ciprofloxacin is passed into breast milk and can be harmful for your baby.

Driving and using machines

Ciprofloxacin may make you feel dizzy, less alert and affect your reaction time. Make sure you know how you react to Ciprofloxacin before driving a vehicle or operating machinery. If in doubt, talk to your doctor or pharmacist. Ciprofloxacin contains glucose and sorbitol Ciprofloxacin tablets contain polydextrose (glucose and sorbitol). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Ciprofloxacin.

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 have 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.

Route and method of administration

•    For oral use. Swallow the tablets with plenty of fluid.

Do not chew the tablets because they do not taste nice.

•    Ciprofloxacin 250 mg and 500 mg tablets have a score line. The score line is only there to help you break the tablet if you have difficulty swallowing the tablet whole.

•    Try to take the tablets at around the same time every day.

•    You can take the tablets at mealtimes or between meals. Any calcium you take as part of a meal will not seriously affect uptake.

•    Do not take Ciprofloxacin tablets with dairy products such as milk or yoghurt or with fortified fruit-juices (e.g. orange juice containing added calcium).

Remember to drink plenty of fluids while you are taking Ciprofloxacin.

If you take more Ciprofloxacin than you should

If you take more tablets than you should, get medical help immediately. Take the remaining tablets and the container with you to show the doctor.

The following effects may be observed: dizziness, tremor, headache, tiredness, fits, seeing, feeling or hearing things that are not there (hallucinations), confusion, abdominal pain, liver problems, kidney problems, crystals or blood in the urine.

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.

Stop taking Ciprofloxacin and contact you doctor immediately if you experience any of the following serious side effects which can occur rarely (may affect up to 1 in every 1,000 people), very rarely (may affect up to 1 in 10,000 people) or not known (frequency cannot be estimated from the available data):

•    allergic reaction, build-up of fluid in the body due to allergic reaction (allergic oedema), rapid swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing (angio-oedema)

•    inflammation of the bowel (colitis) linked to antibiotic use (this can be life-threatening in very rare cases) (see Section 2 'While taking Ciprofloxacin')

•    seizures, fits or convulsions (including prolonged or repeated fits without any recovery in between) (see Section 2 'While taking Ciprofloxacin')

•    severe allergic reactions may appear in the form of:

*    an anaphylactic reaction (symptoms include rash, angioedema, difficulty breathing)

*    anaphylactic shock (symptoms include sudden wheezing, swelling of your lips, tongue and throat or body, fainting, difficulties in swallowing) (see Section 2 'While taking Ciprofloxacin')

*    serum sickness (symptoms include fever, swelling, skin rash and enlargement of the lymph nodes)

•    mental illness (depression or psychotic reactions which may lead to suicidal thoughts or actions) (see Section 2 'While taking Ciprofloxacin')

•    inflammation of the pancreas (pancreatitis) which causes severe upper stomach pain, often with feeling sick (nausea) and being sick (vomiting)

•    liver disease including inflammation of the liver (hepatitis), death of liver cells (liver necrosis) leading very rarely to life-threatening liver failure (see Section 2 'While taking Ciprofloxacin')

•    skin rash which may blister and looks like small targets (central dark spots surrounded by a paler area with dark ring around the edge) called erythema multiforme

•    a widespread rash with blisters and peeling skin, around the mouth, nose, eyes, genitals or body (the potentially fatal Stevens-Johnson syndrome or toxic epidermal necrolysis)

•    tendon inflammation or tendon rupture - especially of the large tendon at the back of the ankle (Achilles tendon) (see Section 2 'While taking Ciprofloxacin')

•    troubles associated with the nervous system such as pain, burning, tingling, numbness and/or weakness in extremities (see Section 2 'While taking Ciprofloxacin')

•    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)

•    blistered and reddened skin rash sometimes with a fever (acute generalised exanthematous pustulosis)

•    eyesight problems such as blurred vision

Tell your doctor or pharmacist if any of the following side effects gets serious or lasts longer than a few days: 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

•    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 (e.g. back pain, chest pain, pain in extremities), unusual weakness (asthenia), or fever

•    increase in blood alkaline phosphatase (a certain substance in the blood)

Rare (may affect up to 1 in every 1,000 people)

•    increased or decreased numbers of certain types of white blood cells (leukopenia, leukocytosis, neutropenia)

•    decreases in red blood cells (anaemia) which may lead to symptoms such as tiredness, headaches, being short of breath when exercising, dizziness and looking pale.

•    increased or decreased amounts of blood platelets (thrombocytes)

•    increased blood sugar (hyperglycaemia)

•    confusion, disorientation, anxiety reactions, strange or abnormal dreams or hallucinations (seeing, feeling or hearing things that are not there)

•    tingling or numbness of the hands or feet, pins and needles (paraesthesia), unusual sensitivity to stimuli of the senses (dysaesthesia), decreased sense of touch, sensation or skin sensitivity (hypoaesthesia), tremors

•    giddiness, spinning sensation (vertigo)

•    buzzing, hissing, whistling, ringing or other persistent noise in the ears (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 problems like jaundice (cholestatic icterus) with symptoms including yellowing of the skin and eyes

•    sensitivity to light (see Section 2 'While taking Ciprofloxacin')

•    muscle pain, inflammation of the joints, increased muscle tone, or cramp

•    kidney failure (symptoms like nausea, loss of appetite, weakness, little or no urine), blood or crystals in the urine (see Section 2 'While taking Ciprofloxacin'), urinary tract inflammation

•    fluid retention or excessive sweating

•    increased levels of the liver enzyme (amylase)

Very rare (may affect up to 1 in 10,000 people)

•    a special type of anaemia resulting from destruction of red blood 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 'While taking Ciprofloxacin')

•    migraine, changes in coordination, unsteady walk (gait disturbance), changes in sense of smell (olfactory disorders), increased pressure on the brain (intracranial pressure)

•    inflammation of the wall of the blood vessels (vasculitis)

•    small, pin-point bleeding under the skin (petechiae)

•    red-purple swellings on the shins, thighs and less commonly the arms. Joint, muscle pains and fever may also occur (erythema nodosum)

•    muscle weakness, tendon inflammation, worsening of the symptoms of myasthenia gravis (see Section 2 'While taking Ciprofloxacin')

Not known (cannot be estimated from the available data)

•    increased clotting time in people taking warfarin or other oral anti-coagulants (to thin the blood)

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

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. 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.

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or with household waste. Ask your pharmacist how to throw away medicines you 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. Each tablet contains 250 mg or 500 mg of ciprofloxacin (as ciprofloxacin hydrochloride).

The other ingredients of the tablets are cellulose microcrystalline, maize starch, crospovidone, starch pregelatinised, silica colloidal anhydrous and magnesium stearate. The film-coating contains hypromellose, titanium dioxide (E171), glucose and sorbitol (polydextrose), glycerol triacetate and macrogol. What Ciprofloxacin looks like and contents of the pack Ciprofloxacin 250 mg are white, round film-coated tablets marked 'CF scoreline 250' on one side and 'G' on the other side.

Ciprofloxacin 500 mg are white capsule-shaped film-coated tablets and marked 'CF scoreline 500' on one side and 'G' on the other.

Ciprofloxacin 250 mg and 500 mg tablets are available in blister packs of 1, 6, 8, 10, 12, 14, 16, 20, 100 and 120 tablets.

Ciprofloxacin tablets are available in bottles of 6, 10, 12, 14, 16, 20, 100 and 120 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder Mylan, Potters Bar, Hertfordshire, EN61TL,

United Kingdom Manufacturers

Generics [UK] Limited, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

Gerard Laboratories, 35/36 Baldoyle Industrial Estate,

Grange Road, Dublin 13, Ireland

Mylan Hungary Kft., H-2900 Komarom, Mylan utca 1,

Hungary

Date of revision: 2014-09 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 which may lead to some antibiotic treatments becoming 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 follow the prescribed:

•    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; as it may not be appropriate for her/his illness.

5.    After completion of treatment, return all unused drugs to your pharmacist to ensure they will be disposed of correctly.

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