Package leaflet: Information for the user

CIPROFLOXACIN 100 mg TABLETS CIPROFLOXACIN 250 mg TABLETS CIPROFLOXACIN 500 mg TABLETS CIPROFLOXACIN 750 mg TABLETS

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 again.

•    If you have any further questions, ask your doctor or pharmacist.

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

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

What is in this leaflet

1.    What Ciprofloxacin tablets are and what they are used for

2.    What you need to know before you take Ciprofloxacin tablets

3.    How to take Ciprofloxacin tablets

4.    Possible side effects

5.    How to store Ciprofloxacin tablets

6.    Contents of the pack and other information

1. What Ciprofloxacin tablets are and what they are used for

The active substance is Ciprofloxacin. Ciprofloxacin is an antibiotic belonging to the fluoroquinolone family. 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 prevent infections due to the bacterium Neisseria meningitidis

•    anthrax inhalation exposure

•    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)

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 tablets Do not take Ciprofloxacin if you:

•    are allergic to ciprofloxacin, to other quinolone drugs or any of the other ingredients (listed in section 6).

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

Warnings and Precautions

Tell your doctor before taking these tablets if you:

•    have heart problems. Caution should be taken when using this kind of medicine, if you are born with 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 and 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), have a history of abnormal heart rhythms (arrhythmias) you are female or elderly or you are taking other medicines that result in abnormal ECG changes (see section: Other medicines and Ciprofloxacin)

•    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)

•    are diabetic because you may experience a risk of hypoglycaemia 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.

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

•    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 thejoints 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.

•    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.

•    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 anemia 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, 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:

•    warfarin or other anti-coagulants such as acenocoumarol, phenprocoumon or fluindione (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)

•    olanzapine (an antipsychotic)

•    clozapine (an antipsychotic)

•    ropinirole (for Parkinson's disease)

•    phenytoin (for epilepsy)

•    metoclopramide (used to treat nausea)

•    cyclosporin (an immunosuppresant)

•    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.

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)

•    agomelantine

•    zolpidem

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

•    antacids

•    omeprazole

•    mineral supplements

•    sucralfate

•    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 tablets with food, 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 and breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask you doctor or pharmacist for advice before taking this medicine.

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.

Ciprofloxacin Insert SAME SIZEARTWORK 130 x 420 mm Front

3. How to take Ciprofloxacin tablets

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. 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 fruitjuices (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 or pharmacist._

_4. Possible side effects_

Like all medicines, this medicine may sometimes cause side effects, although not everybody gets them.

Severe allergic reactions can occur very rarely. These can happen after the first dose or even after the treatment has stopped.

Signs of allergic reaction are:

•    fast heart beat, hypotension (low blood pressure), fever, breathing problems, shock (anaphylactic reactions progressing in very rare cases of life threatening shock)

•    swelling of the face, tongue and throat, skin reactions such as rash, itchy skin or swelling and redness, blood problems, ulcers in the mouth, eyes, gut and genital organs

•    severe liver problems can develop in some people. Signs of liver problems include yellow skin or yellowing of eyes (jaundice), dark urine, stomach tenderness and loss of appetite.

Stop taking this medicine and contact your doctor immediately if you get any of the following serious side effects:

•    muscle pain and/or weakness, inflammation of thejoints 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

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

Other side effects that may occur include:

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

-    nausea (feeling sick), diarrhoea

-    joint pains 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, feeling unwell (asthenia), or fever

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

Rare (may affect up to 1 in 1000 people):

-    inflammation of the bowel (colitis) linked to antibiotic use (can be fatal in very rare cases) (see Section 2: Warnings and Precautions)

-    changes to the blood count (leucopenia, leucocytosis, neutropenia, anaemia), increased or decreased amounts of a blood dotting 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)

-    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 thejoints, 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 (may affect up to 1 in 10,000 people):

-    a special type of reduced red blood cell count (haemolytic anaemia); a dangerous drop in a type of white blood cells (agranulocytosis); a drop in the number of red and white blood cells and platelets (pancytopenia), which may be fatal; and bone marrow depression, which may also be fatal (see Section 2: Warnings and Precautions)

-    severe allergic reactions (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

-    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)

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

-    hypersensitivity reaction called DRESS (Drug Reaction with Eosinophilia and Systemic Symptoms) which may show up with the following symptoms: fever, skin rash, joint pain, swelling of glands, abnormalities of blood including increase in blood cells called eosinophils, abnormalities of kidney and liver function.

-    Heart problems such as 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)

-    pustular rash

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

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

Reporting of side effects

If you get any side effects, talk to your doctor, pharmaast 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

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

•    Tablet Containers: Do not store above 25⁰C. Keep the container tightly closed.

•    Do not use this medicine after the expiry date which is stated on the 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 protect the environment.

6. Contents of the pack and other information What these tablets contain

•    The active ingredient is ciprofloxacin (as hydrochloride).

•    Each tablet contains either 100mg, 250mg, 500mg or 750mg of the active ingredient.

•    The other ingredients are maize starch, microcrystalline cellulose, colloidal anhydrous silica, sodium starch glycollate, magnesium stearate, hypromellose, purified talc, polyethylene glycol, titanium dioxide E171.

What these tablets look like and contents of the pack

•    The 100 mg tablets are round, white, to cream coloured, film-coated tablets with the tablet markings 'CPR 100' on one side and 'BL' on the reverse.

•    The 250 mg tablets are round, white, to cream coloured, film-coated tablets with the tablet markings 'CPR 250' on one side and 'BL' on the reverse.

•    The 500 mg tablets are capsule shaped, white to cream coloured, film-coated tablets with the tablet markings 'CPR 500' and a breakline on one side and 'BL' on the reverse.

•    The 750 mg tablets are capsule shaped, white, to cream coloured, film-coated tablets with the tablet markings 'CPR 750' on one side and 'BL' on the reverse.

•    The tablets come in packs containing 6, 10, 20, 100,

250 or 500 tablets.

•    Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Bristol Laboratories Ltd,

Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire, HP4 1EG, United Kingdom Telephone: 0044 (0)1442 200922 Fax:    0044 (0)1442 873717

E-mail:    info@brislol-labs.co.uk

Ciprofloxacin 100 mg Tablets; PL 17907/0013 Ciprofloxacin 250 mg Tablets; PL 17907/0014 Ciprofloxacin 500 mg Tablets; PL 17907/0015 Ciprofloxacin 750 mg Tablets; PL 17907/0016 This leaflet was last revised in December 2015 To request a copy of this leaflet in Braille, large print or audio format, please contact the licence holder at the address (or telephone, fax, email) above.

V18 24-12-15 D0

Ciprofloxacin Insert SAME SEE ARTWORK 130 x 420mm back