PATIENT INFORMATION LEAFLET PLEASE READ THIS LEAFLET CAREFULLY BEFORE TAKING CIPROXIN SUSPENSION

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1 PATIENT INFORMATION LEAFLET PLEASE READ THIS LEAFLET CAREFULLY BEFORE TAKING CIPROXIN SUSPENSION CIPROXIN SUSPENSION Ciprofloxacin What does Ciproxin Suspension contain? Each 5ml spoonful of product contains 250mg of the active ingredient ciprofloxacin. Ciproxin Suspension also contains copolymer of ethyl acrylate and methyl methacrylate, magnesium stearate, hypromellose, polysorbate 20, polyvidone 25, lecithin, medium chain triglycerides, sucrose, purified water and strawberry flavours. The suspension is available in bottles containing 100ml of ready-to-use product. The ciprofloxacin contained in Ciproxin is one of a group of antibiotics called quinolones which work by killing bacteria that cause infections. Product Licence Holder: Manufacturer: Bayer plc Pharmaceutical Division Bayer House Strawberry Hill Newbury Berkshire RG14 1JA Bayer S.p.A. Garbagnate Milanese Italy Why have I been prescribed Ciproxin Suspension by my doctor? Ciproxin Suspension has been prescribed by your doctor to treat your bacterial infection. Some of the infections which Ciproxin can be used to treat are: - Chest infections, e.g. bronchitis. Infections of the urinary tract, e.g. cystitis. Intestinal infections, e.g. infective diarrhoea. Anthrax 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. When should I not take Ciproxin Suspension? Do not take Ciproxin Suspension if you 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. CIPROXIN/CIPROXIN SUSPENSION/PIL/Approved/UK/PIL CipSusp UK008.DOC (8/) 1

2 Generally, with the exception of the treatment of a lung infection in patients with cystic fibrosis or for the treatment of anthrax, Ciproxin should not be given to children and adolescents unless considered essential by a doctor. As with other antibiotics in this group, Ciproxin may cause pain and swelling in the developing joints of these patients. In particular, Ciproxin Suspension should not be given to children of less than two years of age. What special precautions should I take? If you are pregnant, planning a family or breast-feeding, tell your doctor before taking Ciproxin as it is not recommended for use under these conditions. If you have already informed your doctor, follow his/her instructions carefully. Providing you do not have a problem with your heart or kidneys, you should drink plenty of liquid whilst taking Ciproxin. Ciproxin may cause a problem with your kidneys called "crystalluria" which results in tiny crystals forming in the urine. These crystals cannot be seen by the naked eye. Drinking plenty of liquid can help prevent this occurring. However, if you experience a new pain or discomfort when passing urine whilst you are taking Ciproxin, tell your doctor. If you have a problem with your kidneys, tell your doctor before taking Ciproxin. 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 eyes 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 Ciproxin. You may 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. Ciproxin may make you feel less alert, particularly when taken with alcohol. Therefore, make sure you know how you react to Ciproxin before you drive or operate machinery. If in doubt, consult your doctor. If you have a family history of or know that you have the hereditary condition G6PD deficiency, remind your doctor before taking Ciproxin. This condition causes a deficiency of certain chemicals in the red blood cells and, if Ciproxin is taken, it may lead to the breaking down of red blood cells resulting in anaemia and yellowing of the skin (jaundice). Ciproxin may occasionally cause pain and inflammation around your 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 Ciproxin Suspension unless your doctor tells you to do so. If you develop severe and persistent diarrhoea which may contain blood and mucus whilst you are taking your suspension, or after stopping your suspension, you should consult your doctor immediately as you may be suffering from the condition pseudomembranous colitis which can sometimes be life-threatening. CIPROXIN/CIPROXIN SUSPENSION/PIL/Approved/UK/PIL CipSusp UK008.DOC (8/) 2

3 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 sun-bed or other means of UV exposure. Certain medicines are known to affect the action of Ciproxin and are best avoided whilst taking it. Therefore, ask your doctor for advice if you wish to take antacids for indigestion, any other preparations containing aluminium, calcium, magnesium or iron or highly buffered drugs such as didanosine whilst taking Ciproxin. If these preparations are essential, they must not be taken within four hours of taking Ciproxin Suspension. This is because if taken within this time period, they will affect the absorption of Ciproxin Suspension into your body, decreasing the amount available to treat your infection. 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 Ciproxin. Remind your doctor if you are taking drugs that thin the blood (anticoagulants) such as warfarin, or any medicines used to relieve pain and inflammation (e.g. fenbufen), except for aspirin. If you are taking glibenclamide for diabetes, remind your doctor as Ciproxin sometimes increases the ability of glibenclamide to lower blood sugar and may result in hypoglycaemia (i.e. feeling cold, dizzy, confused, or a headache due to a lack of blood sugar). Remind your doctor if you are taking probenecid or metoclopramide as these drugs may affect the level of Ciproxin in your blood. If you are taking cyclosporin at the same time as Ciproxin, 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 Ciproxin. If you are taking methotrexate at the same time as Ciproxin, remind your doctor as he/she may want to do additional blood tests. If you take theophylline for asthma, remind your doctor as he/she should monitor the level of theophylline in your blood. This is particularly important if you suffer from "fits" or convulsions. High levels of theophylline in the blood may be life-threatening. If you go into hospital for surgery, have dental treatment which requires an anaesthetic or you need to provide a blood or urine sample, tell the doctor or dentist that you are taking Ciproxin Suspension. When and how do I take Ciproxin Suspension? The dosage of Ciproxin Suspension required and the duration of treatment depends upon the severity and type of your infection. The usual dosage is from 250mg to 750mg 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 1500 mg.) For the treatment of anthrax in children, a dose of 15mg/kg twice daily (the maximum daily dose is 1000mg). CIPROXIN/CIPROXIN SUSPENSION/PIL/Approved/UK/PIL CipSusp UK008.DOC (8/) 3

4 This product may 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 suspension as prescribed by your doctor. Usually this will be one to three spoonfuls taken twice daily. In order to get the correct dose, it is important to use the measuring spoon provided. A spoonful (5ml) is measured by pouring the suspension into the spoon up to the line marked 1/1. Before each dose, the bottle must be shaken vigorously for approximately 15 seconds. The suspension should be swallowed whole and the granules should not be chewed. A glass of water may be taken after dosing. Ensure you reclose the bottle according to the instructions on the cap. Drink several more glasses of water during every day of your treatment, unless told otherwise by your doctor. If you are taking Ciproxin Suspension on an empty stomach, do not eat or drink dairy products (such as milk or yoghurt) or drinks with added calcium at the same time as the suspension Take the suspension for as long as directed by your doctor. The usual duration of treatment is between three and 10 days, but it may be longer if your 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. If you stop taking this medicine too soon, your infection may return and the bacteria responsible for your symptoms may become resistant to Ciproxin. This means that your medicine will no longer be able to work in treating your bacterial infection. The duration of treatment for a lung infection in children or adolescents with cystic fibrosis is days. The duration of treatment in patients with anthrax is 60 days. DO NOT EXCEED THE PRESCRIBED DOSE If you take more than the prescribed dose, or in the event of an overdose, seek medical advice immediately and, if possible, take the bottle of suspension or the box with you to show the doctor. What should I do if I forget to take my Ciproxin Suspension? 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. What side-effects may I experience? As can happen with some antibiotics, certain side-effects have been reported after Ciproxin. You may experience diarrhoea, feeling sick (nausea) and skin rashes. As with all medicines, some people may be allergic to Ciproxin. Usually, if you are allergic to Ciproxin, a reaction will occur soon after you start taking the suspension. An allergic reaction can appear as a rash, hives, itching, small red spots on the skin or a fever. Very rarely, an allergy to Ciproxin can cause facial swelling, swelling of the blood vessels in the skin and CIPROXIN/CIPROXIN SUSPENSION/PIL/Approved/UK/PIL CipSusp UK008.DOC (8/) 4

5 severe skin reactions such 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. These symptoms are often accompanied by sickness, headache and fever. If you experience any of these symptoms, stop the treatment and seek medical advice immediately. The skin of some people may become more sensitive to the sun whilst taking Ciproxin. You may experience thrush, a general feeling of being unwell or feel unsteady when walking. Ciproxin may make you hyperglycaemic, that is have high levels of the sugar glucose in your blood. 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. Rarely, you may experience pain, pain in your fingers and/or toes, chest pain or back pain. Rarely, you may experience inflammation in the blood vessels of the skin. You may experience a headache, dizziness, restlessness and either an increased or a decreased sensitivity to touch. If you experience "fits", trembling, a tingling sensation, hallucinations, very severe headaches 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 you feel unsteady when walking, consult your doctor as soon as possible. Ciproxin 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. You may experience a fast heartbeat, fainting, hot flushes, lowered blood pressure, sweating, swelling of the face or limbs whilst taking Ciproxin Suspension. Ciproxin 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. In some cases this may be life-threatening. Ciproxin 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 these symptoms, seek medical advice immediately and rest the affected limb. Do not take the next dose of Ciproxin Suspension unless your doctor tells you to. Ciproxin can also cause muscle pain, increased muscle tone, weakness or twitching. If you suffer from the medical condition myasthenia gravis (a rare disorder of the nervous system), taking Ciproxin may rarely, make the symptoms of your disease become worse. If you think you are affected consult your doctor. Ciproxin has been known to cause effects on the liver such as inflammation (hepatitis) and yellow jaundice which may rarely progress to life-threatening hepatic failure. It may cause inflammation of the pancreas, which may lead to severe pain in the upper abdomen or back. It may also cause effects on the kidney which lead to pain and discomfort when passing water (crystalluria) 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, or pain in your abdomen or back, seek medical advice immediately. CIPROXIN/CIPROXIN SUSPENSION/PIL/Approved/UK/PIL CipSusp UK008.DOC (8/) 5

6 Rarely, people have experienced visual disturbances including blurred or double vision and colour vision disturbances, ringing in the ears and, sometimes, impaired hearing which returns to normal once treatment with Ciproxin finishes. Impaired sense of taste and smell have also been reported; these usually return to normal once treatment with Ciproxin finishes. IF YOU EXPERIENCE ANY OF THESE EFFECTS OR ANY OTHER UNDESIRABLE EFFECTS, TELL YOUR DOCTOR IMMEDIATELY. YOUR DOCTOR WILL GIVE YOU ADVICE. How should I store my Ciproxin Suspension? Ciproxin Suspension should be stored in the original box avoiding inverted storage, and in a cool, dry place. Ciproxin Suspension may be stored in a refrigerator (2-8 C), but ensure that it does not freeze. The ready-to-use product should be kept for a maximum of 14 days. KEEP ALL MEDICINES OUT OF THE REACH OF CHILDREN Do not use the suspension after the expiry date which is marked on the label of the bottle and on the outer carton. If you find that you have kept the suspension after its expiry date, or some is left in the bottle after your course of treatment, return it to your local pharmacist (chemist) who will dispose of it properly. Date of Preparation of Leaflet: June 2003 REMEMBER: This medicine has been prescribed for you. Do not give it to anyone else under any circumstances, even if they have the same condition as you. If you have any doubts about taking Ciproxin Suspension correctly, seek the advice of your doctor or pharmacist. Product Licence Number: PL 0010/0211 CIPROXIN/CIPROXIN SUSPENSION/PIL/Approved/UK/PIL CipSusp UK008.DOC (8/) 6