Package leaflet: Information for the patient

Ciprofloxacin 100 mg, 250 mg , 500 mg, 750 mg film-coated tablets

(ciprofloxacin hydrochloride)

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 pharmacist.

•    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

•

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.    What Ciprofloxacin 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

The name of your medicine is Ciprofloxacin film-coated tablets which will be referred to as Ciprofloxacin throughout the rest of this leaflet.

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

•    genital tract infections in men and women

•    gastro-intestinal tract infections and intra-abdominal infections

•    skin and soft tissue infections

•    bone and j oint infections

•    to prevent infections due to the bacterium Neisseria meningitidis

•    anthrax inhalation exposure

Ciprofloxacin may be used in the management of patients with low white blood cell counts (neutropenia) who have a fever that is suspected to be due to a bacterial infection.

If you have a severe infection or one that is caused by more than one type of bacterium, you may be given additional antibiotic treatment in addition to Ciprofloxacin.

Children and adolescents

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

following bacterial infections:

•    lung and bronchial infections in children and adolescents suffering from cystic fibrosis

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

•    anthrax inhalation exposure

Ciprofloxacin may also be used to treat other specific severe infections in children and adolescents when your doctor considered this necessary.

2. What you need to know before you take Ciprofloxacin Do not take Ciprofloxacin if you are:

•    allergic to the active substance, to other quinolone drugs or to any of the other ingredients of this medicine (listed in section 6)

•    taking tizanidine (see Section 2: Other medicines and Ciprofloxacin)

Warnings and precautions Talk to your doctor before taking Ciprofloxacin 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

•    are diabetic because you may experience a risk of hypoglycaemia with ciprofloxacin

•    have myasthenia gravis (a type of muscle weakness) because symptoms can be exacerbated. have heart problem .Caution should be taken when using this 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 week 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 anemia 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 tendons 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.

•    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.

•    Tell the doctor or pharmacist that you are taking Ciprofloxacin if you have to provide a blood or urine sample for testing.

•    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 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.

•    Your skin becomes more sensitive to sunlight or ultraviolet (UV) light when taking Ciprofloxacin. Avoid exposure to strong sunlight, or artificial UV light such as sunbeds.

Other medicines and Ciprofloxacin Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Do not take Ciprofloxacin together with tizanidine, because this may cause side effects such as low blood pressure and sleepiness (see Section 2: Do not take Ciprofloxacin,).

The following medicines are known to interact with Ciprofloxacin in your body. Taking Ciprofloxacin together with these medicines can influence the therapeutic effect of those medicines. It can also increase the probability of experiencing side effects.

Tell your doctor if you are taking:

• 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)

•    clozapine or olanzapine ( antipsychotics)

•    ropinirole (for Parkinson’s disease)

•    phenytoin (for epilepsy)

•    glibenclamide (for diabetes)

•    cyclosporin (for skin conditions, rheumatoid arthritis and in organ transplantation)

•    metoclopramide (used for preventing nausea and vomiting)

•    a type of antibiotics known as macrolides e.g. azithromycin, clathrithromycin, erythromycin etc.

•    medicines used to treat depression known as tricyclic antidepressants e.g. amitriptyline, clomipramine, nortriptyline etc.

•    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 anesthetic 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

•    omeprezole (for indigestion and GERD)

•    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

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

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 during pregnancy.

Do not take Ciprofloxacin during breast feeding because ciprofloxacin passes into 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

Your doctor will explain to you exactly how much Ciprofloxacin you will have to take as well as how often and for how long. This will depend on the type of infection you have and how bad it is.

Tell your doctor if you suffer from kidney problems because your dose may need to be adjusted.

The treatment usually lasts from 5 to 21 days, but may take longer for severe infections. Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure how many tablets to take and how to take Ciprofloxacin.

•    Swallow the tablets with plenty of fluid. Do not chew the tablets because they do not taste nice.

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

•    You can take the tablets at meal times 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 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 more questions about 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.

STOP taking your medicine IMMEDIATELY and tell your doctor, or go to your nearest hospital casualty department if you experience:

Uncommon side effects (may affect up to 1 in 100 people):

•    increased amounts of certain substances in the blood (transaminases and/or bilirubin)

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

Rare side effects (may affects 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)

•    confusion, disorientation, anxiety reactions, strange dreams, depression (potentially leading to

thoughts of suicide attempts, or completed suicide) or hallucinations

•    seizures (see Section 2: Warnings and precautions),

•    loss of hearing

•    liver disorders, jaundice (yellowing of skin or whites of eyes) or inflammation of the liver (hepatitis)

•    kidney failure, blood or crystals in the urine (see Section 2: Warnings and precautions)

Very rare side effects (may affects up to 1 in 10,000

•    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 which causes difficulty in breathing or dizziness (anaphylactic reaction or anaphylactic shock, which can be fatal-serum sickness) (see Section 2: Warnings and precautions)

•    mental disturbances(psychotic reactions potentially leading to thoughts of suicide, suicide attempts, or completed suicide) (see Section 2: Warnings and precautions)

•    various skin eruptions or rashes (for example the potentially fatal Stevens-Johnson syndrome or Toxic Epidermal Necrolysis - a serious illnesses with blistering of the skin, mouth ,eyes and genitals)

•    muscle pain and/or weakness, inflammation of the joints and joint pain, increase muscle tone and cramping, inflammation of the tendon, tendon rupture, particularly affecting the large tendon at the back of the ankle (Achilles tendon) (see Section 2: Warnings and precautions),

•    worsening of the symptoms of myasthenia gravis (a type of muscle weakness) (see Section 2: Warnings and precautions)

Not known (frequency cannot be estimated from the available data)

•    troubles associated with the nervous system such as pain, burning, tingling, numbness and/or weakness in the extremities (peripheral neuropathy and polyneuropathy) (See Section 2: Warnings and precaution)

•    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).

•    hypersensitivity reaction called DRESS (Drug Reaction with Eosinophilia and Systemic Symptoms)

Tell your doctor straight away if you notice any of the following side effects:

Common side effects (may affect up to 1 in 10 people):

•    nausea, diarrhoea

•    joint pains in children

Uncommon side effects (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

•    rash, itching, or hives

•    joint pain in adults

•    poor kidney function

•    pains in your muscles and bones, feeling unwell (asthenia), or fever

•    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)

•    increased blood sugar (hyperglycaemia)

•    decreased blood sugar (hypoglycaemia) (see section 2: Warnings and precautions)

•

•    pins and needles, unusual sensitivity to stimuli of the senses, decreased skin sensitivity, tremors, or giddiness

•    eyesight problems including double vision (diplopia)

•    ringing in ears, impaired hearing

•    rapid heartbeat (tachycardia)

•    expansion of blood vessels (vasodilation), low blood pressure, or fainting

•    shortness of breath, including asthmatic symptoms

•

•    sensitivity to light (see Section 2: Warnings and precautions)

•    urinary tract inflammation or inflammation of the kidneys

•    fluid retention or excessive sweating

•    abnormal levels of a clotting factor (prothrombin) or increased levels of the enzyme amylase which can be found during routine blood tests

Very rare side effects (may affects up to 1 in 10,000 people):

•    migraine, disturbed coordination, unsteady walk (gait disturbance),

•    disorder of sense of smell (olfactory disorders),

•    increased pressure on the brain (intracranial pressure)

•    visual colour distortions

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

•    inflammation of the pancreas (pancreatitis)

•    death of liver cells (liver necrosis), very rarely leading to life-threatening liver failure

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

Not known (frequency cannot be estimated from the available data)

•    feeling highly excited (mania) or feeling great optimism and overactivity (hypomania)

•    rapid appearance of areas of red skin studded with small blisters filled with white/yellow fluid

•    (acute generalised exanthematous pustulosis)

•    influence on blood clotting (in patients treated with Vitamin K antagonists))

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 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

Ciprofloxacin 100 mg film-coated tablets:

Do not store above 25°C. Store in the original package

Ciprofloxacin 250mg, 500mg, 750 mg film-coated tablets: Store in the original package

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.

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 to protect the environment.

6. Contents of the pack and other information

What Ciprofloxacin contains

The active substance is ciprofloxacin hydrochloride.

Ciprofloxacin 100 mg film-coated tablets

Each film-coated tablet contains 100 mg ciprofloxacin (as hydrochloride).

Ciprofloxacin 250 mg film-coated tablets

Each film-coated tablet contains 250 mg ciprofloxacin (as hydrochloride).

Ciprofloxacin 500 mg film-coated tablets

Each film-coated tablet contains 500 mg ciprofloxacin (as hydrochloride)

Ciprofloxacin 750 mg film-coated tablets

Each film-coated tablet contains 750 mg ciprofloxacin (as hydrochloride) .

The other ingredients are:

Tablet core: microcrystalline cellulose, croscarmellose sodium, povidone, silica colloidal anhydrous, magnesium stearate.

Film-coat: hypromellose, talc, propylene glycol, macrogol and titanium dioxide (E171).

What Ciprofloxacin looks like and contents of the pack

Ciprofloxacin 100 mg film-coated tablets are white round tablet. Plane on one side, and marked with “CPX 100” on the reverse.

Ciprofloxacin 250mg film-coated tablets are white coloured round biconvex tablets. Plain on one side, and marked with 'CPX 250' on the reverse.

Ciprofloxacin 500mg film-coated tablets are white capsule shaped biconvex tablets. Plain one side, and marked with 'CPX 500' and a breakline on the reverse.

Ciprofloxacin 750mg film-coated tablets are white capsule shaped biconvex tablets. Plain on one side, and marked with 'CPX 750' on the reverse.

Ciprofloxacin is presented in blister packs of 6, 10, 20 or 100 tablets. Not all packs may be marketed Marketing Authorisation Holder

Cipla (EU) Limited, Hillbrow House, Hillbrow Road, Esher, Surrey KT10 9NW, United Kingdom Manufacturer

APC Pharmaceuticals & Chemicals (EUROPE) Ltd

9th Floor, CP House, 97-107 Uxbridge Road, Ealing, London W5 5TL

This leaflet was last amended in Feb 2016

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 adopted to her/his illness.

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