PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Ciprofloxacin 250mg / 500mg / 750mg 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 any further questions, ask your doctor, pharmacist or nurse.

•    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 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 and men

•    gastro-intestinal tract infections and intra-abdominal infections

•    skin and soft tissue infections

•    bone and joint infections

•    to treat & prevent infections in patients with a very low white blood cell count (neutropenia) who have a fever that is suspected to be due to a bacterial infection

•    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. WHAT YOU NEED TO KNOW 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)

•    if you are taking tizanidine (see Section 2: Taking other medicines) Warnings and precautions:

Talk to your doctor, pharmacist or nurse before taking Ciprofloxacin.

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

•    if you suffer from epilepsy or other neurological conditions

•    if you have a history of tendon problems during previous treatment with antibiotics such as Ciprofloxacin

•    if you have myasthenia gravis (a type of muscle weakness because symptoms can be exacerbated))

•    if you have a history of abnormal heart rhythms (arrythmias)

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.

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 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 'Taking other medicines').

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 corticosteroid. 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 immediately.

•    Hypoglycemia has been reported most often in diabetic patients, predominantly in elderly population. If this happens, contact your doctor immediately.

•    If your eyesight becomes impaired or if your eyes seem to be otherwise affected, consult an eye specialist immediately.

•    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-6- 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.

Other medicines and ciprofloxacin

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.

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.

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 (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, olanzapine (an antipsychotic)

•    ropinirole (for Parkinson's disease)

•    phenytoin (for epilepsy)

•    metoclopramide (for nausea and vomiting)

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

•    other medicines that can alter your heart rhythm: medicines that belong to the group of antiarrhythmics (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some antimicrobials (that belong to the group of macrolides), some antipsychotics.

Ciprofloxacin may increase the levels of the following medicines in your blood:

•    pentoxifylline (for circulatory disorders)

•    caffeine

•    duloxetine (for depression, diabetic nerve damage or incontinence)

•    lidocaine (for heart conditions or anaesthetic use)

•    sildenafil (e.g. for erectile dysfunction)

CIPROFLOXACIN 250mg/500mg/750mg film coated tablets

Size: 180 (w) x 360 (h)mm

Main Heading type style: 13pt Helvetica Bold Condensed Caps_

Sub Heading type style: 10pt Helvetica Bold Condensed Caps_

Text type style: 9pt Helvetica Light Condensed & Bold Condensed Line spacing: 9.5pt

Some medicines reduce the effect of Ciprofloxacin. Tell your doctor if you take or wish to take:

•    antacids

•    omeprazole

•    mineral supplements

•    sucralfate (for stomach and bowel ulcers)

•    a polymeric phosphate binder (e.g. sevelamer or lanthanum carbonate)

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

If these preparations are essential, take Ciprofloxacin about two hours before or no sooner than four hours after them.

Ciprofloxacin with food and drink and alcohol

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, breast-feeding and fertility

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. 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. do not drive or operate machines until you know how you react. If in doubt, talk to your doctor.

3. HOW TO TAKE CIPROFLOXACIN

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. 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.

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 medicine, ask your doctor, pharmacist or nurse.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Ciprofloxacin can cause side effects, although not everybody gets them.

Stop taking Ciprofloxacin and seek urgent medical attention, if you have:

-    serious allergic reaction with the following symptoms: tightness in the chest, feeling dizzy, sick or faint, or experiencing dizziness when standing up) (see Section 2: Warnings and precautions)

-    muscle pain and/or weakness, inflammation of the joints and joint pain, increased muscle tone and cramping, inflammation of the tendons or tendon rupture, particularly affecting the large tendon at the back of the ankle (Achilles tendon) - see section 2.

-    serious skin reactions such as Stevens -Johnson syndrome or toxic epidermal necrolysis (severe peeling and blistering of the skin)

-    mental disturbances

-    unusual feelings of pain, burning tingling, numbness or muscle weakness in the extremities (neuropathy)- see section 2

Tell a doctor or pharmacist if any of the following side effects gets serious:

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: Warnings and precautions)

-    changes to blood count (leucopenia, leukocytosis, neutropenia, anaemia), increased or decreased amounts of blood clotting factor (thrombocytes)

-    allergic reaction, swelling (oedema), or rapid swelling of the skin and mucous membranes (angiooedema)

-    increased blood sugar (hyperglycaemia)

-    decreased blood sugar (Ir/poglycaemia) (see Section 2: Warnings and precautions)

-    confusion, disorientation, anxiety reactions, strange dreams, depression (potentially leading to thoughts of suicide, suicide attempts, or completed suicide), or hallucinations

-    pins and needles, unusual sensitivity to stimuli of the senses, decreased skin sensitivity, tremors, seizures (see Section 2: Warnings and precautions), or giddiness

-    eyesight problems including 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: Warnings and precautions)

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

-    kidney failure, blood or crystals in the urine (see Section 2: Warnings and precautions), urinary tract inflammation

-    fluid retention or excessive sweating

-    abnormal levels of a clotting factor (prothrombin) or increased levels of the enzyme amylase

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: Warnings and precautions)

-    severe allergic reactions (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)

-    migraine, disturbed coordination, unsteady walk (gait disturbance), disorder of sense of smell (olfactory disorders), pressure on the brain (intracranial pressure and pseudotumor cerebri)

-    visual colour distortions

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

-    pancreatitis (inflammation of the pancreas, symptoms include severe upper stomach pain, often with nausea and vomiting)

-    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: Warnings and precautions); worsening of the symptoms of myasthenia gravis (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 extremities (peripheral neuropathy and polyneuropathy)

-    abnormal fast heart rhythm, life-threatening irregular heart rhythm, alteration of the heart rhythm (called 'prolongation of QT interval', seen on ECG, electric activity of the heart)

-    pustular rash

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

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.

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 (see details below). By reporting side effects, you can help provide more information on the safety of this medicine. Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard'

5. HOW TO STORE CIPROFLOXACIN

Do not store above 25°C.

Keep this medicine out of the sight and reach of children.

Do not use Ciprofloxacin after the expiry date, which is stated on the blister or carton after “EXP”:

The expiry date refers to the last day of the month concerned.

Medicines should not be disposed of down the drain or with household rubbish. 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

Each film coated tablet contains 250/500/750mg of the active ingredient ciprofloxacin.

The film-coated tablets also contain Lactose monohydrate, Sodium starch glycollate, Povidone, Sodium stearyl fumarate and Methocel E5 premium. The tablet film-coat consists of a mixture of Hypromellose, Polyethylene glycol, and Titanium dioxide.

What Ciprofloxacin looks like and contents of the pack

Ciprofloxacin 250mg Tablets: Off-white, round, biconvex, film coated tablets with CP/250 on one side and plain on the other.

Ciprofloxacin 500mg Tablets: Off-white,capsule shaped biconvex, film coated tablets with CP/500 on one side and plain on the other.

Ciprofloxacin 750mg Tablets: Off-white, capsule shaped, biconvex, film coated tablets with CP/750 on one side and plain on the other.

Marketing Authorisation Holder: Special Concept Development (UK) Limited, Units 1-7 Colonial Way, Watford, Hertfordshire, WD24 4YR

Manufacturer

<To be confirmed>

This leaflet was last revised in January 2016 PL 36722/0039, 36722/0040, 36722/0041 - POM

CIPROFLOXACIN 250mg/500mg/750mg film coated tablets

Size: 180 (w) x 360 (h)mm

Main Heading type style: 13pt Helvetica Bold Condensed Caps_

Sub Heading type style: 10pt Helvetica Bold Condensed Caps_

Text type style: 9pt Helvetica Light Condensed & Bold Condensed Line spacing: 9.5pt