Ciprofloxacin 250mg Tablets
25Omg/50Omg/75Omg film coated tablets
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read It again.
• If you have further questions, please ask your doctor or your pharmacist.
This medicine has been prescribed for you personally and you should
not pass It on to others. It may harm them, even If their symptoms
are the 3ame as yours.
In this leaflet
r what Ciprofloxacin film coated tablets are and vhat thev are used
for?
> Before you take Ciprofloxacin film coated tablets.
> How to take Ciprofloxacin film coated tablets?
> Possible side effects .
> Storing Ciprofloxacin film coated tablets.
• The active substance is Ciprofloxacin hydrochloride equivalent to iibo/bou/vbtjag ciprofloxacin.
• The other Ingredients are 3odium starch glycollate, lactose mononyarate, povidone, 3odium stearyl fumarate, opadry Y-l- 7000 white (which contains hyproaellose, macrogoi and titanium dloxide7~
product Licence Holder: wise Pharmaceuticals Limited, unit 7, Hani
wells Business Park, Hardlcker Street, Manchester M19 2KB, u.K.
product Manufacturer: Karlb Kemi Pharm Limited, Karlb House, 6365 imperial way, Croydon, surrey cro 4RR, U. K.
WHAT CIPROFLOXACIN FILM COATED TABLETS ARE AND WHAT THEY ARE
USED FORS
•Film coated tablets.
• Each film coated tablet contains 250/500/750mg of ciprofloxacin.
• The ciprofloxacin contained in Ciprofloxacin film coated tablets is one of a group of antibiotics called quinolones which work by killing bacteria that cause infections.
• The film coated tablets come in packs of 10, 20 but your doctor
will prescribe as many as you need.
• ciprofloxacin film coated tablets have been prescribed by your
doctor to treat your bacterial infection, some of the infections which Ciprofloxacin film coated tablets can be used to treat are: Chest infections, e.g. bronchitis. Infections of the urinary tract, e.g. cyst 111s .
Intestinal infections, e.g. Infective diarrhoea. This medicine can also be used if you are five years or older, have cystic fibrosis and get a respiratory tract (lung) Infection caused by a bacteria called P. aeruginosa.
BEFORE YOU TAKE CIPROFLOXACIN FILM COATED TABLETS
Do not take ciprofloxacin film coated tablets
• If vou have previously had an allergic reaction to the active ingredient ciprofloxacin or any other quinolone antibiotics. If you are unsure about this, ask your doctor.
• Generally, with the exception of the treatment of a lung Infection in patients with cy3tic fibrosl3, ciprofloxacin film coated tablets should not be given to children and adolescents unless considered essential by a doctor. A3 with other antibiotics in this group, Ciprofloxacfn film coated tablets may cause pain and swelling in the developing joints of these patients.
Take special care with Ciprofloxacin film coated tablets
• Provided you do not have a problem with your heart or kidneys, you 3hould drink plenty of liquid whilst taking ciprofloxacin film
coated tablets. Ciprofloxacin film coated tablets may cause a problem with your kidnevs called 'crystalluria" which results in tiny crystals forming in" the urine. These crystals cannot be seen bv the naked eye. Drinking plenty of liquid can help prevent this occurring. However, if you experience pain or discomfort when passing urine whilst you are taking Ciprofloxacin film coated tablets, tell your doctor.
• If you have a problem with your kidneys, tell vour doctor before taking Ciprofloxacin film coated tablets. Your doctor may wish to change your dose to allow for any reduced kidney function.
• If you have had previous problems with your liver, tell your doctor before treatment with ciprofloxacin begins. Your doctor may wish to check for any changes in Its function. Also consult your doctor if you have yellowing of the whites of the eves or skin .
• If you have previously had fits or suffer from epilepsy or if you have ever suffered other conditions related to the nervous supply to the brain, tell your doctor before you are given Ciprofloxacin film coated tablets. You mav feel depressed, anxious or confused whilst taking your medicine. If any of these progress to you actually physically harming or wanting to physically harm yourself you should stop taking your medicine immediately and consult your doctor.
• If you have a familv history of or know that you have the hereditary condition G-6PD deficiency, remind your doctor before taking Ciprofloxacin film coated tablets. This condition causes a deficiency of certain chemicals in the red blood cells and, if Ciprofloxacin film coated tablets are taken, it may lead to the breaking down of red blood cells resulting in anaemia and yellowing of the skin (jaundice) .
• ciprofloxacin film coated tablets may occasionally cause pain and inflammation around vour tendons particularly if you are elderly or taking one of a group of medicines called steroids such as hydrocortisone. If you experience these symptoms, seek medical advice immediately and rest the affected limb. Do not take the next dose of Ciprofloxacin film coated tablets unless your doctor tells you to.
• If you develop severe and persistent diarrhoea, which may contain blood and mucus, whilst you are taking your tablets or immediately after stopping your tablets, you should consult your doctor immediately as you may be suffering from the condition pseudomembranous colitis.
• This medicine may make your skin become more sensitive to sunlight or UV light. You should avoid exposure to strong sunlight and should not use a cun-bed or other means of UV exposure.
• If you have been told by your doctor that you have an intolerance to some sugars, such as glucose, galactose, lactose, contact your doctor before taking tnis medicinal product .
Please consult your doctor, even if these statements were applicable to you at any time in the past.
Pregnancy If you are pregnant or planning a family, tell your doctor before taking Ciprofloxacin film coated tablets as it is not recommended for use under these conditions. If you have already informed your doctor, follow his/her instructions carefully.
Ask your doctor' or pharmacist for' advice before taking any medicine,
Breast-feeding: Tell your doctor before taking Ciprofloxacin film coated tablets as it is not commended for use under these conditions. If you have already informed your doctor, follow his/her instructions carefully.
Ask your1 doctor1 or1 pharmacist for1 advice before taking any medicine.
Driving and using machines: Ciprofloxacin film coated tablets mav make you feel less alert, particularly when taken with alcohol. Therefore make sure you know how you react to Ciprofloxacin film coated tablets before you drive or operate machinery. If in doubt, consult your doctor .
Taking other medicines: ’Please note that these statements may also apply to products used some time ago or at some time in the future.‘
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'Pleas© inform your doctor or pharmacist if you are taking, or have recently taken, any other medicine even those not prescribed.'
• Certain medicines are known to affect the action of Ciprofloxacin film coated tablets and are best avoided whilst taking it. Therefore, ask vour doctor for advice if you wish to take antacids for indigestion or any other preparations containing aluminium, calcium, magnesium or iron whilst taking Ciprofloxacin film coated tablets. If these preparations are essential, they must not be taken within four hours of taking Ciprofloxacin film coated tablets. If you take multivitamins or minerals, check that they do not contain iron, calcium or magnesium. If they do, your doctor may want you to stop taking them whilst you are taking Ciprofloxacin film coated tablets.
• Remind your doctor if you are taking drugs that thin the blood (anticoagulants) such as warfarin, or any medicines used to relieve pain ana inflammation (e.g. fenbufen) except for aspirin.
• If you are taking qlibenclamide for diabetes, remind your doctor as ciprofloxacin firm coated tablets sometimes increase the ability of gli bend amid© to lower blood sugar and may result in hypoglycaemia (i.e. a hypo).
• Remind your doctor if you are taking probenecid or metoclopramide as these drugs may affect the level of Ciprofloxacin film coated tablets in your blood.
• If you are taking ciclosporin at the same time as Ciprofloxacin film coated tablets, your doctor may want to take regular blood samples to monitor the level of a substance called creatinine in your blood.
• If you are taking phenytoin for epilepsy, remind your doctor as the levels of this medicine may be altered if used at the same time as Ciprofloxacin film coated tablets.
• If you take theophylline for asthma, remind your doctor as he/she may want to monitor the level of theophylline in vour blood. This is particularly important if you suffer from “fit3"" or convulsions.
If you go into hospital for surgery, have dental treatment which requires an anaesthesia or you need to provide a blood or urine sample, tell the doctor or dentist that you are taking Ciprofloxacin film coated tablets.
HOW TO TAKE CIPROFLOXACIN FILM COATED TABLBTS?
• The dosage of Ciprofloxacin film coated tablets required and the duration of treatment depends upon the severity ana type of your infection. The usual dosage is from 2 50mg to 7 5 0tng twice daily.
• For the treatment of a lung infection in cystic fibrosis patients (aged 5-17 years), a dose of 20mg/kg orally twice daily. (The maximum daily dose is I500mg).
• This product mav also be used in adolescents and children for the treatment of other Infections if the doctor considers it essential. The usual dose in these cases is 4 - 8mg/kg IV twice daily or 5 -15 mg/kg orally twice daily. The exact dosage depends on the severity of the infection.
• Take the tablets as prescribed by your doctor. Usually this will be one tablet taken twice daily. The tablet(s) should be swallowed whole with a glass of water. Drink several more glasses of water during every day of your treatment, unless told otherwise by your doctor.
• Take the tablets for as long as directed by your doctor. The usual duration of treatment is between 3 and 10 days, but it mav be longer if vour infection is more persistent or severe. It is important that you complete the course of treatment, even if you begin to feel better after a few days. The duration of treatment for lung infection in children or adolescents with cystic fibrosis is 10-14 days.
• Do not exceed the prescribed dose.
If you have the Impression that the effect of Ciprofloxacin film coated tablets is too strong or too weak talk to your doctor or pharmacist.
If you take more Ciprofloxacin film coated tablets than you should
• If you may have taken more Ciprofloxacin film coated tablets than you should, talk to a doctor or pharmacist Immediately.
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• If possible, take vour tablets or the box with you to show the doctor.
If you forget to take Ciprofloxacin film coated 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, do not take the missed dose and continue as usual, making sure that you complete your course of treatment.
Bffects when treatment with Ciprofloxacin film coated tablets is stopped
If you stop taking this medicine too soon, your symptoms may return.
POSSIBLE SIDE EFFBCTS
Like all medicines, Ciprofloxacin film coated tablets can have side
effects.
Ciprofloxacin Is generally well tolerated. The most frequently
reported adverse reactions are nausea (feeling sick), diarrhoea and
rash.
•Blood and the lymphatic system disorders
Ciprofloxacin film coated tablets may affect certain components in the blood. This may lead to bruising, jaundice, a persistent sore throat, fever with tiredness or a general feeling of being unwell, which may be due to anaemia. If any of these occur, contact a doctor immediately.
• Metabolism and nutrition disorders
Ciprofloxacin film coated tablets may make you hvperqlycaemic, that is have high levels of the sugar glucose in your 'brood.
If you feel unwell, have an increased need to pass water or drink more than usual, consult your doctor who can test for this condition.
• Nervous system disorders
You may experience headache, dizziness or restlessness. If you experience fits, trembling, a tingling sensation, hallucinations, very severe headache with visual disturbances, increased sleepiness, sleep disorders or feel anxious, confused or depressed which may progress to you actually physically harming or wanting to physically harm yourself, or vou reel unsteady when walking, consult your doctor as soon as possible.
• Bye disorders
Rarely, people have experienced visual disturbances including blurred or double vision and colour vision disturbances.
• Bar and labyrinth disorders
Rarely, people have experienced ringing in the ears and, sometimes, impaired hearing which returns to normal once treatment with Ciprofloxacin film coated tablets finishes.
• Cardiac disorders
You may experience a fast heartbeat.
• Vascular disorders
You may experience fainting, hot flushes, sweating, swelling of the face or limbs whilst taking Ciprofloxacin film coated tablets.
• Gastrointestinal disorders
Ciprofloxacin film coated tablets may cause vomiting, indigestion, stomach-ache, wind, difficulty in swallowing, loss of appetite.
Rarely, a disorder called pseudomembranous colitis can occur which causes attacks of diarrhoea, which may contain blood and mucus.
Consult your doctor immediately if this occurs.
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• Hepato-biliary disorders
Ciprofloxacin film coated tablets has been known to cause effects on the liver ouch as inflammation (hepatitis) and yellow jaundice.
• Hypersensitivity and skin reactions
Fever, general feeling of being unwell or feel unsteady when walking.
Rash, hives, itching, small red spots on the skin.
Very rarely: severe skin reactions ouch as large fluid-filled blisters, sores and ulceration and shortness of breath. Ulceration can also occur in the mouth and throat, around the anus and genital region and on the surface of the eyes.
The skin of some people may become more sensitive to the sun during treatment with Ciprofloxacin film coated tablets. Treatment with ciprofloxacin should be discontinued if any of the above occur upon first administration.
• Musculoskeletal, connective tissue and bone disorders Ciprofloxacin film coated tablets may cause joint or tendon swelling with pain which may lead to tendon rupture especially of the large tendon at the back "of the ankle. If you experience tliese symptoms, seek medical advice immediately and rest the affected limb. Ciprofloxacin film coated tablets can also cause muscle pain.
in case you develop any of these reactions, please consult your doctor IMMEDIATELY, who will decide whether you should discontinue your treatment with ciprofloxacin.
If you suffer from the medical condition myasthenia gravis (a rare disorder of the nervous system), taking Ciprofloxacin film coated tablets may rarely, make the symptoms of your disease become worse. If you think you are affected, consult your doctor.
• Renal and urinary disorder
Ciprofloxacin film coated tablets may also cause effects on the kidney which lead to pain and discomfort when passing water (crvstalluria) or blood in the urine. If you notice yellowing of your skin or any change in your urine output or appearance, possibly accompanied by kidney pain, seek medical advice immediately.
• General disorders and administration site conditions
As with all medicines, some people may be allergic to Ciprofloxacin film coated tablets. Usually, if you are allergic to Ciprofloxacin 250mg, film coated tablets, a reaction will occur soon after you are given the first tablet. If you experience any symptoms, tell your doctor immediately.
impaired sense of taste and smell have also been reported, these usually return to normal once treatment with Ciprofloxacin film coated tablets finishes.
If you notice any side effects not mentioned In this leaflet, please inform your doctor or pharmacist.
STORING CIPROFLOXACIN FILM COATED TABLETS
Keep all medicines out of the reach and sight of children.
Do not store above 2 5°C.
Do not use Ciprofloxacin film coated tablets after the expiry date which Is marked on both the outer carton and on each blister strip of tablets.
If you find that you have tablets after their expiry date, return them to your local pharmacist (chemist) who will dispose them off properly.
Date of Revision of Leaflet: October 2005 __
PL 18374/0003; 18374/0004; 18374/0005 POM