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Package leaflet: Information for the patient

Ciprofloxacin 500 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 any further questions, ask your doctor or pharmacist.

•    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their 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

These tablets contain ciprofloxacin. They belong to a group of antibiotic medicines called quinolones which work by killing bacteria that cause infections.

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 joint infections

•    To prevent infections due to the bacterium Neisseria meningitidis

•    Anthrax inhalation exposure

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

Children and adolescents

Ciprofloxacin is only used in children and adolescents under specialist medical supervision. It is used 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 severe infections in children and adolescents when considered necessary by your doctor.

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

•    have previously had an allergic reaction to ciprofloxacin, any other quinolone antibiotic or any ingredient of this medicine (listed in section 6). If you are unsure about this, do not take this medicine before asking your doctor.

•    are already taking a medicine called tizanidine (see “Other medicines and Ciprofloxacin tablets”)

Warnings and Precautions

Talk to your doctor or pharmacist before taking these tablets if you:

•    have a problem with your kidneys. Your doctor may wish to change your dose

•    have or have had problems with your liver. Your doctor may wish to check for any changes in its function.

•    have myasthenia gravis (a type of muscle weakness)

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•    have heart problems. Extra care should be taken if any of the following apply to you:

-    You were born with or have family history of a prolonged QT interval (seen on ECG, electrical recording of the heart)

-    You have salt imbalance in the blood (especially low levels of potassium or magnesium)

-    You have a very slow heart rhythm (called ‘bradycardia’)

-    You have a weak heart (heart failure)

-    You have a history of heart attack (myocardial infarction)

-    You are female or elderly, as you may be more sensitive to heart rhythm changes.

-    You are taking other medicines that result in abnormal ECG changes (see ‘Other medicines and Ciprofloxacin tablets’).

•    have previously had “fits”, suffer from epilepsy or other conditions of the nervous system.

•    have had tendon problems after taking quinolone antibiociprofloxacin may be given if tests can show the risk is justified. tics in the past. Where there is severe infection that cannot be treated by other antibiotics,

•    have a family history of, or know that you have, G6PD deficiency. This condition may cause anaemia and yellowing of the skin (jaundice) when taken with this medicine.

Speak to your doctor or pharmacist before taking these tablets if any of the

above statements apply to you or were applicable to you at any time in the past.

While taking Ciprofloxacin tablets

Remember these important points while taking these tablets:

•    This medicine may make your skin more sensitive to sunlight or UV light. Avoid exposure to strong sunlight and do not use a sun-bed or other means of UV exposure.

•    If you have to provide a blood or urine sample tell the doctor or laboratory staff that you are taking Ciprofloxacin tablets as the results may be affected.

•    Drink plenty of liquid whilst taking these tablets (unless you have a problem with your heart or kidneys). Ciprofloxacin may cause a problem with your kidneys which causes tiny crystals to form in the urine. These crystals cannot be seen by the naked eye. Drinking plenty of liquid can help prevent this occurring. Tell your doctor if you experience pain or discomfort when passing urine whilst you are taking this medicine.

Ciprofloxacin can cause side effects in some people. Watch out for the

following effects and tell your doctor straight away if you:

•    feel depressed, anxious or confused whilst taking this medicine. If these progress to you actually or wanting to physically harm yourself stop taking this medicine immediately and talk to your doctor.

•    experience pain, burning, tingling, numbness, and/or weakness stop taking the tablets and talk to your doctor.

•    develop severe and persistent diarrhoea, which may contain blood and mucus, whilst you are taking or immediately after stopping these tablets. You may be suffering from the condition pseudomembranous colitis.

•    have yellowing of the skin or whites of the eyes, weight loss, dark urine, itchy skin or a tender abdomen. Treatment with this medicine may need to be stopped.

•    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. This medicine may cause a decrease in your resistance to infection. A blood test will check for possible reduction in white blood cells (agranulocytosis).

•    have pain and swelling in the joints or tendons. Inflammation or rupture of tendons may occur within the first 48 hours of treatment or up to several months after stopping this medicine. The risk of this is higher if you are elderly or being treated with corticosteroids. At the first sign of any pain or inflammation stop taking this medicine and rest the painful area. Avoid any unnecessary exercise, as this can increase the risk of a tendon rupture.

Children and adolescents

These tablets must not be taken by children under 18 years of age unless considered essential by a doctor. This medicine may cause pain and swelling in the developing joints of these patients. The tablets must never be taken by children aged under 5 years.

Other medicines and Ciprofloxacin tablets

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.

Certain medicines are known to affect the action of Ciprofloxacin tablets and are best avoided whilst taking it. Ask your doctor for advice if you wish to take antacids for indigestion or any other preparations or supplements containing aluminium, calcium, magnesium or iron whilst taking Ciprofloxacin tablets.

Your doctor may want you to stop taking them whilst you are taking this medicine.

If these preparations are essential, they must not be taken within four hours of taking this medicine.

Remind your doctor if you are taking any of the following medicines:

•    drugs that thin the blood, such as warfarin

•    glibenclamide for diabetes, as Ciprofloxacin can sometimes increase the ability of glibenclamide to lower blood sugar and may result in hypoglycaemia

•    probenecid or metoclopramide, as these drugs may affect the level of Ciprofloxacin tablets in your blood

•    cyclosporin as your doctor may want to take regular blood samples to monitor the level of a substance called creatinine in your blood.

•    phenytoin for epilepsy, as Ciprofloxacin tablets may alter the levels of this medicine.

•    theophylline for asthma, as your doctor may want to monitor the level of theophylline in your blood.

•    olanzapine and clozapine, used as antipsychotics

•    ropinirole for Parkinson’s disease

•    medicines that can alter your heart rhythm. This includes anti-arrhythmic medicines (e.g. quinidine, disopyramide, amiodarone, sotalol), tricyclic antidepressants, some macrolide antibiotics, some antipsychotics.

•    pentoxifylline, for circulatory disorders

•    caffeine

•    duloxetine, for depression, nerve damage or incontinence

•    lidocaine, for heart conditions or local anaesthetics

•    sildenafil, for erectile dysfunction

•    omeprazole, for indigestion, reflux and ulcers of the digestive tract

Tell your doctor if you are taking any of the above medicines before you take ciprofloxacin

If you go into hospital for surgery, have dental treatment or you need to provide a blood or urine sample, tell the doctor or dentist that you are taking Ciprofloxacin tablets.

Taking Ciprofloxacin tablets with food and drink

If you take these tablets on an empty stomach, 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 this medicine. If you take your tablets with meals, you can eat dairy products as usual.

Be aware that these tablets can increase the amount of caffeine in your blood so take care when consuming any drink that contains caffeine.

Pregnancy and breastfeeding

If you are pregnant or planning a family, tell your doctor before taking Ciprofloxacin tablets as it is not recommended for use in pregnancy.

If you are breast-feeding, tell your doctor before taking these tablets as Ciprofloxacin is excreted in breast milk and can be harmful to your child.

If you have already informed your doctor, follow his/her instructions carefully. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Ciprofloxacin tablets may make you feel less alert, particularly when taken with alcohol. Make sure you know how you react to Ciprofloxacin tablets before you drive or operate machinery. If in doubt, consult your doctor.

Children and adolescents

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking these tablets.

3.    How to take Ciprofloxacin tablets

Your doctor will explain to you exactly how many Ciprofloxacin tablets 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. Treatment usually lasts from 5 to 21 days, but may take longer for severe infections. Some types of infection may need other antibiotic treatments in addition to Ciprofloxacin. Patients with reduced kidney function may need a lower dose and may be monitored more closely.

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 or how long to take them for.

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

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

•    You can take the tablets at mealtimes or between meals.

•    Calcium can affect how well this medicine is absorbed. Any calcium you eat as part of a meal will not have a serious affect. If taken on an empty stomach do not take this medicine 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 tablets.

If you have the impression that the effect of Ciprofloxacin tablets is too strong or too weak talk to your doctor or pharmacist.

If you take more Ciprofloxacin tablets than you should If you may have taken more Ciprofloxacin tablets than you should, talk to a doctor or pharmacist immediately. If possible, take your tablets or the box with you to show the doctor.

If you forget to take Ciprofloxacin tablets

Do not take a double dose to make up for forgotten individual doses.

Take your normal dose as soon as possible and then continue as prescribed. However, if it is almost time for your next dose, skip the missed dose and continue as usual, making sure that you complete your course of treatment. If you stop taking Ciprofloxacin tablets

If you stop taking this medicine too soon, your symptoms may return.

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.

Serious side effects

Stop taking the tablets and contact your doctor or hospital emergency department IMMEDIATELY if you develop any of the following symptoms:

•    Tightness in your chest, difficulty breathing, swelling of the face, throat, hands or feet, feeling dizzy, sick or faint, or experiencing dizziness when standing up. These could be signs of a severe allergic reaction.

•    Severe skin reactions including peeling and blistering of the skin, mouth, eyes and genitals and numerous pus filled spots with fever. You could be suffering from Stevens-Johnson syndrome or toxic epidermal necrolysis.

•    Severe and persistent diarrhoea, which may contain blood and mucus. You may be suffering from the condition pseudomembranous colitis.

•    Seizures, including seizures without fits known as ‘absence seizures’, worsening of epilepsy and worsening of other neurological conditions such as cerebral ischemia or stroke.

•    Worsening of depression or psychosis, thoughts of suicide, suicide attempts, mental disturbances (psychotic reactions) including ideas of suicide and attempting suicide.

•    Pain, burning, tingling, numbness and/or weakness (symptoms of neuropathy).

•    Loss of appetite, jaundice (yellowing of the skin), dark urine, itching, or tenderness of the stomach. You may be suffering from kidney or liver damage, hepatitis or inflammation of the pancreas (pancreatitis)

•    Fever and serious deterioration of your general condition, or fever with local infection symptoms such as sore throat/mouth or urinary problems. You may be suffering from a reduction in the number of white blood cells (possibly due to bone marrow depression) and your resistance to infection may be decreased.

•    Abnormally slow, fast or irregular heart rhythm

Stop taking the tablets and seek immediate medical advice if any of the above occur.

Other side effects

The following side effects may also occur:

Common side effects (affects 1 to 10 users in 100):

-    nausea, diarrhoea

-    joint pains in children

Uncommon side effects (affects 1 to 10 users in 1,000):

-    fungal super-infections

-    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, indigestion, heartburn, stomach upset 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 (affects 1 to 10 users in 10,000):

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

-    increased blood sugar (hyperglycaemia)

-    confusion, disorientation, anxiety reactions, strange dreams, depression (including ideas of suicide and attempting suicide), or hallucinations

-    pins and needles, unusual sensitivity, or decreased skin sensitivity,

-    tremors or giddiness

-    eyesight problems including double vision (diplopia)

-    loss of hearing, 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 ‘While taking Ciprofloxacin tablets’)

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

-    blood or crystals in the urine (see ‘While taking Ciprofloxacin tablets’)

-    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 (affects less than 1 user in 10,000):

-    reduced red blood cell count (haemolytic anaemia)

-    reduction in a type of white blood cells (agranulocytosis);

-    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)

-    small, pin-point bleeding under the skin

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-    muscle weakness,

-    tendon inflammation,

-    tendon rupture - especially of the large tendon at the back of the ankle (Achilles tendon) (see ‘While taking Ciprofloxacin tablets’)

-    worsening of the symptoms of myasthenia gravis

The following effects have also been reported but the frequency is not known:

-    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 such as Warfarin)

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, talk to your doctor or pharmacist.

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 affects you can help^rovide more information on the safety of this medicine.

5.    How to store Ciprofloxacin tablets

•    Keep all medicines out of the reach and sight of children

•    Do not store above 25 °C

•    Do not use Ciprofloxacin tablets after the expiry date which is marked on both the outer carton and on each blister strip of tablets.

•    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 Ciprofloxacin tablets contain

The active substance is ciprofloxacin hydrochloride equivalent to 500 mg ciprofloxacin.

The other ingredients are sodium starch glycollate, lactose monohydrate, povidone, sodium stearyl fumarate, Methocel E5 premium, polyethylene glycol, titanium dioxide.

What Ciprofloxacin tablets look like and contents of the pack

Ciprofloxacin 500 mg film coated tablets are off-white, capsule shaped, biconvex, film coated tablets with CP/500 on one side and ® on the other The film coated tablets come in packs of 10 or 20 but your doctor will prescribe as many as you need.

This leaflet was last revised in September 2013

NOUMED LIFE SCIENCES

5 Cattle Market, Hexham, Northumberland NE46 1NJ, United Kingdom

Manufacturer:

MEDREICH PLC

Warwick House, Plane Tree Crescent, Feltham TW13 7HF, UK E-mail : info@medreich.co.uk

Ciprofloxacin Tablets - PL 44041/0007