CIPROXIN 500MG FILM-COATED TABLETS
Active substance: CIPROFLOXACIN HYDROCHLORIDE MONOHYDRATE
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1. 2. 3. 4. 5. 6.
PACKAGE LEAFLET: INFORMATION FOR THE USER
Ciproxin 500 mg lm-coated tablets
Ciprooxacin
Read all of this leaet carefully before you start taking this medicine.
Keep this leaet. 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 symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaet, please tell your doctor or pharmacist. What Ciproxin is and what it is used for Before you take Ciproxin How to take Ciproxin Possible side effects How to store Ciproxin Further information
In this leaet:
1. WHAT CIPROXIN IS AND WHAT IT IS USED FOR
Ciproxin is an antibiotic belonging to the uoroquinolone family. The active substance is ciprooxacin. Ciprooxacin works by killing bacteria that cause infections. It only works with specic strains of bacteria.
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 Ciproxin and contact your doctor immediately. You may experience psychiatric reactions the rst time you take Ciproxin. If you suffer from depression or psychosis, your symptoms may become worse under treatment with Ciproxin. In rare cases, depression or psychosis can progress to thoughts of suicide, suicide attempts, or completed suicide. If this happens, stop taking Ciproxin 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 Ciproxin and contact your doctor immediately. Diarrhoea may develop while you are taking antibiotics, including Ciproxin, 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 Ciproxin 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 Ciproxin 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. Ciproxin 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 Ciproxin and contact your doctor immediately. Ciproxin 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 deciency in glucose-6-phosphate dehydrogenase (G6PD), since you may experience a risk of anemia with ciprooxacin. Your skin becomes more sensitive to sunlight or ultraviolet (UV) light when taking Ciproxin. Avoid exposure to strong sunlight, or articial UV light such as sunbeds.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including any that you obtained without a prescription. Do not take Ciproxin together with tizanidine, because this may cause side effects such as low blood pressure and sleepiness (see Section 2: Do not take Ciproxin). The following medicines are known to interact with Ciproxin in your body. Taking Ciproxin together with these medicines can inuence the therapeutic effect of those medicines. It can also increase the probability of experiencing side effects.
Adults
Ciproxin 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 Ciprooxacin may be used in the management of patients with low white blood cell counts (neutropenia) who have a fever that is suspected to be due to a bacterial infection. 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 Ciproxin.
Tell your doctor if you are taking:
Vitamin K antagonists (e.g: warfarin) 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) olanzapine (an antipsychotic) clozapine (an antipsychotic) ropinirole (for Parkinsons disease) phenytoin (for epilepsy) metoclopramide (for nausea and vomiting) cyclosporin (for skin conditions, rheumatoid arthritis and in organ transplantation) glibenclamide (for diabetes) 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. Ciproxin 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) sildenal (e.g. for erectile dysfunction) Some medicines reduce the effect of Ciproxin. Tell your doctor if you take or wish to take: antacids omeprazole mineral supplements sucralfate a polymeric phosphate binder (e.g. sevelamer) medicines or supplements containing calcium, magnesium, aluminium or iron If these preparations are essential, take Ciproxin about two hours before or no sooner than four hours after them.
Children and adolescents
Ciproxin 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 brosis complicated urinary tract infections, including infections that have reached the kidneys (pyelonephritis) anthrax inhalation exposure Ciproxin may also be used to treat other specic severe infections in children and adolescents when your doctor considered this necessary.
2. BEFORE YOU TAKE CIPROXIN
Do not take Ciproxin if you are:
allergic (hypersensitive) to the active substance, to other quinolone drugs or to any of the other ingredients of Ciproxin (see section 6) taking tizanidine (see Section 2: Taking other medicines)
Take special care with Ciproxin Before taking Ciproxin
Tell your doctor if you: 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 Ciproxin have myasthenia gravis (a type of muscle weakness) have heart problems. Caution should be taken when using Ciprooxacin, if you were born with or have 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). For the treatment of some genital tract infections, your doctor can prescribe another antibiotic in addition to ciprooxacin. If there is no improvement in symptoms after 3 days of treatment, please consult your doctor.
Taking Ciproxin with food and drink
Unless you take Ciproxin 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
It is preferable to avoid the use of Ciproxin during pregnancy. Tell your doctor if you are planning to get pregnant. Do not take Ciproxin during breast feeding because ciprooxacin is excreted in breast milk and can be harmful for your child.
While taking Ciproxin
Tell your doctor immediately, if any of the following occurs while taking Ciproxin. Your doctor will decide whether treatment with Ciproxin needs to be stopped. Severe, sudden allergic reaction (an anaphylactic reaction/shock, angio-oedema). Even with the rst 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 Ciproxin 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 corticosteroids. Inammation and ruptures of tendons may occur even within the rst 48 hours of treatment or up to several months after discontinuation of Ciproxin therapy. At the rst sign of any pain or inammation stop taking Ciproxin and rest the painful area. Avoid any unnecessary exercise, as this might increase the risk of a tendon rupture.
Driving and using machines
Ciproxin may make you feel less alert. Some neurological adverse events can occur. Therefore, make sure you know how you react to Ciproxin before driving a vehicle or operating machinery. If in doubt, talk to your doctor.
3. HOW TO TAKE CIPROXIN
Your doctor will explain to you exactly how much Ciproxin 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.
81092974
PMR 81092974 (93/02/MU-0201104176) Pantone: Schwarz Reex Blue
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 Ciproxin. a. Swallow the tablets with plenty of uid. 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 Ciproxin tablets with dairy products such as milk or yoghurt or with fortied fruit juices (e.g. calcium-fortied orange juice). Remember to drink plenty of uids while you are taking Ciproxin.
Frequency not known (cannot be estimated from the available data) - troubles associated with the nervous system such as pain, burning, tingling, numbness and/or weakness in extremities - 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 - inuence on blood clotting (in patients treated with Vitamin K antagonists)
5. HOW TO STORE CIPROXIN
Keep out of the reach and sight of children.
Do not use Ciproxin after the expiry date, which is stated on the blister and carton after EXP: The expiry date refers to the last day of that month. This medicinal product does not require any special storage conditions. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of any medicines no longer required. These measures will help to protect the environment.
If you take more Ciproxin 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 Ciproxin
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 Ciproxin
It is important that you nish 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 more questions about the use of this product, ask your doctor or pharmacist.
6. FURTHER INFORMATION
What Ciproxin contains
The active substance is ciprooxacin. Each lm-coated tablet contains 500 mg ciprooxacin (as hydrochloride). The other ingredients are: Tablet core: cellulose microcrystalline, crospovidone, magnesium stearate, maize starch, silica colloidal anhydrous. Film-coat: hypromellose, macrogol 4000, titanium dioxide (E171).
4. POSSIBLE SIDE EFFECTS
Like all medicines, Ciproxin can cause side effects, although not everybody gets them. If any of the side effects gets serious, or if you notice any side effects not listed in this leaet, tell your doctor or pharmacist. 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): - inammation of the bowel (colitis) linked to antibiotic use (can be fatal in very rare cases) (see Section 2: Take special care with Ciproxin) - changes to the blood count (leukopenia, leukocytosis, neutropenia, anaemia), increased or decreased amounts of a blood clotting factor (thrombocytes) - allergic reaction, swelling (oedema), or rapid swelling of the skin and mucous membranes (angio-oedema) - increased blood sugar (hyperglycaemia) - 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: Take special care with Ciproxin), 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: Take special care with Ciproxin) - muscle pain, inammation of the joints, increased muscle tone, or cramp - kidney failure, blood or crystals in the urine (see Section 2: Take special care with Ciproxin), urinary tract inammation - uid retention or excessive sweating - 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: Take special care with Ciproxin) - severe allergic reactions (anaphylactic reaction or anaphylactic shock, which can be fatal - serum sickness) (see Section 2: Take special care with Ciproxin) - mental disturbances (psychotic reactions potentially leading to thoughts of suicide, suicide attempts, or completed suicide) (see Section 2: Take special care with Ciproxin) - migraine, disturbed coordination, unsteady walk (gait disturbance), disorder of sense of smell (olfactory disorders), pressure on the brain (intracranial pressure) - visual colour distortions - inammation 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) - muscle weakness, tendon inammation, tendon rupture especially of the large tendon at the back of the ankle (Achilles tendon) (see Section 2: Take special care with Ciproxin); worsening of the symptoms of myasthenia gravis (see Section 2: Take special care with Ciproxin)
What Ciproxin looks like and contents of the pack
Ciproxin 500 mg tablets: oblong, nearly white to slightly yellowish lm-coated tablets marked with "CIP score 500" on one side and "BAYER" on the other side. The tablets can be divided into equal halves. Pack sizes of 6, 8, 10, 12, 14, 16, 20, 28, 50, 100, 160, or 500 lm-coated tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing authorisation holder Bayer plc Bayer House Strawberry Hill Newbury Berkshire RG14 1JA Bayer Pharma AG
Manufacturer:
This medicinal product is authorised in the Member States of the EEA under the following names:
Austria: Belgium: Bulgaria: Cyprus: Czech Republic: Finland: France: Germany: Greece: Hungary: Ireland: Italy: Luxembourg: Malta: Norway: Poland: Portugal: Slovenia: Spain: United Kingdom: Ciproxin Ciproxine Ciprobay Ciproxin Ciprobay Ciproxin Ciox; Uniox Ciprobay Ciproxin Ciprobay Ciproxin Ciproxin Ciproxine Ciproxin Ciproxin Ciprobay Ciproxina Ciprobay Baycip Ciproxin
This leaet was last revised in June 2012. Advice/medical education
Antibiotics are used to cure bacterial infections. They are ineffective against viral infections. If your doctor has prescribed antibiotics, you need them precisely for your current illness. Despite antibiotics, some bacteria may survive or grow. This phenomenon is called resistance: some antibiotic treatments become ineffective. Misuse of antibiotics increases resistance. You may even help bacteria become resistant and therefore delay your cure or decrease antibiotic efcacy if you do not respect appropriate: - dosages - schedules - duration of treatment
Consequently, to preserve the efcacy of this drug:
1- Use antibiotics only when prescribed. 2- Strictly follow the prescription. 3- Do not re-use an antibiotic without medical prescription, even if you want to treat a similar illness. 4- Never give your antibiotic to another person; maybe it is not adapted to her/his illness. 5- After completion of treatment, return all unused drugs to your chemists shop to ensure they will be disposed of correctly.
U
81092974
PMR 81092974 (93/02/MU-0201104176) Pantone: Schwarz Reex Blue
0
1. 2. 3. 4. 5. 6.
PACKAGE LEAFLET: INFORMATION FOR THE USER
Ciproxin 500 mg lm-coated tablets
Ciprooxacin
Read all of this leaet carefully before you start taking this medicine.
Keep this leaet. 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 symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaet, please tell your doctor or pharmacist.
Tell the doctor or laboratory staff that you are taking Ciproxin 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. Ciproxin 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 Ciproxin and contact your doctor immediately. Ciproxin 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 deciency in glucose-6-phosphate dehydrogenase (G6PD), since you may experience a risk of anemia with ciprooxacin. Your skin becomes more sensitive to sunlight or ultraviolet (UV) light when taking Ciproxin. Avoid exposure to strong sunlight, or articial UV light such as sunbeds.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including any that you obtained without a prescription. Do not take Ciproxin together with tizanidine, because this may cause side effects such as low blood pressure and sleepiness (see Section 2: Do not take Ciproxin). The following medicines are known to interact with Ciproxin in your body. Taking Ciproxin together with these medicines can inuence the therapeutic effect of those medicines. It can also increase the probability of experiencing side effects.
In this leaet:
What Ciproxin is and what it is used for Before you take Ciproxin How to take Ciproxin Possible side effects How to store Ciproxin Further information
Tell your doctor if you are taking:
Vitamin K antagonists (e.g: warfarin) 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) olanzapine (an antipsychotic) clozapine (an antipsychotic) ropinirole (for Parkinsons disease) phenytoin (for epilepsy) metoclopramide (for nausea and vomiting) cyclosporin (for skin conditions, rheumatoid arthritis and in organ transplantation) glibenclamide (for diabetes) 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. Ciproxin 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) sildenal (e.g. for erectile dysfunction) Some medicines reduce the effect of Ciproxin. Tell your doctor if you take or wish to take: antacids omeprazole mineral supplements sucralfate a polymeric phosphate binder (e.g. sevelamer) medicines or supplements containing calcium, magnesium, aluminium or iron If these preparations are essential, take Ciproxin about two hours before or no sooner than four hours after them.
1. WHAT CIPROXIN IS AND WHAT IT IS USED FOR
Ciproxin is an antibiotic belonging to the uoroquinolone family. The active substance is ciprooxacin. Ciprooxacin works by killing bacteria that cause infections. It only works with specic strains of bacteria.
Adults
Ciproxin 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 Ciprooxacin may be used in the management of patients with low white blood cell counts (neutropenia) who have a fever that is suspected to be due to a bacterial infection. 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 Ciproxin.
Children and adolescents
Ciproxin 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 brosis complicated urinary tract infections, including infections that have reached the kidneys (pyelonephritis) anthrax inhalation exposure Ciproxin may also be used to treat other specic severe infections in children and adolescents when your doctor considered this necessary.
2. BEFORE YOU TAKE CIPROXIN
Do not take Ciproxin if you are:
allergic (hypersensitive) to the active substance, to other quinolone drugs or to any of the other ingredients of Ciproxin (see section 6) taking tizanidine (see Section 2: Taking other medicines)
Taking Ciproxin with food and drink
Unless you take Ciproxin 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
It is preferable to avoid the use of Ciproxin during pregnancy. Tell your doctor if you are planning to get pregnant. Do not take Ciproxin during breast feeding because ciprooxacin is excreted in breast milk and can be harmful for your child.
Take special care with Ciproxin Before taking Ciproxin
Tell your doctor if you: 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 Ciproxin have myasthenia gravis (a type of muscle weakness) have heart problems. Caution should be taken when using Ciprooxacin, if you were born with or have 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). For the treatment of some genital tract infections, your doctor can prescribe another antibiotic in addition to ciprooxacin. If there is no improvement in symptoms after 3 days of treatment, please consult your doctor.
Driving and using machines
Ciproxin may make you feel less alert. Some neurological adverse events can occur. Therefore, make sure you know how you react to Ciproxin before driving a vehicle or operating machinery. If in doubt, talk to your doctor.
3. HOW TO TAKE CIPROXIN
Your doctor will explain to you exactly how much Ciproxin 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 Ciproxin. a. Swallow the tablets with plenty of uid. 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 Ciproxin tablets with dairy products such as milk or yoghurt or with fortied fruit juices (e.g. calcium-fortied orange juice). Remember to drink plenty of uids while you are taking Ciproxin.
While taking Ciproxin
Tell your doctor immediately, if any of the following occurs while taking Ciproxin. Your doctor will decide whether treatment with Ciproxin needs to be stopped. Severe, sudden allergic reaction (an anaphylactic reaction/shock, angio-oedema). Even with the rst 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 Ciproxin 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 corticosteroids. Inammation and ruptures of tendons may occur even within the rst 48 hours of treatment or up to several months after discontinuation of Ciproxin therapy. At the rst sign of any pain or inammation stop taking Ciproxin 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 Ciproxin and contact your doctor immediately. You may experience psychiatric reactions the rst time you take Ciproxin. If you suffer from depression or psychosis, your symptoms may become worse under treatment with Ciproxin. In rare cases, depression or psychosis can progress to thoughts of suicide, suicide attempts, or completed suicide. If this happens, stop taking Ciproxin 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 Ciproxin and contact your doctor immediately. Diarrhoea may develop while you are taking antibiotics, including Ciproxin, 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 Ciproxin immediately, as this can be life-threatening. Do not take medicines that stop or slow down bowel movements and contact your doctor.
If you take more Ciproxin 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 Ciproxin
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 Ciproxin
It is important that you nish 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 more questions about the use of this product, ask your doctor or pharmacist.
81092966/UK017
PMR 81092966 (93/02/MU-0201104176) Pantone: Schwarz Reex Blue
4.
POSSIBLE SIDE EFFECTS
6. FURTHER INFORMATION
What Ciproxin contains
The active substance is ciprooxacin. Each lm-coated tablet contains 500 mg ciprooxacin (as hydrochloride). The other ingredients are: Tablet core: cellulose microcrystalline, crospovidone, magnesium stearate, maize starch, silica colloidal anhydrous. Film-coat: hypromellose, macrogol 4000, titanium dioxide (E171).
Like all medicines, Ciproxin can cause side effects, although not everybody gets them. If any of the side effects gets serious, or if you notice any side effects not listed in this leaet, tell your doctor or pharmacist. 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): - inammation of the bowel (colitis) linked to antibiotic use (can be fatal in very rare cases) (see Section 2: Take special care with Ciproxin) - changes to the blood count (leukopenia, leukocytosis, neutropenia, anaemia), increased or decreased amounts of a blood clotting factor (thrombocytes) - allergic reaction, swelling (oedema), or rapid swelling of the skin and mucous membranes (angio-oedema) - increased blood sugar (hyperglycaemia) - 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: Take special care with Ciproxin), 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: Take special care with Ciproxin) - muscle pain, inammation of the joints, increased muscle tone, or cramp - kidney failure, blood or crystals in the urine (see Section 2: Take special care with Ciproxin), urinary tract inammation - uid retention or excessive sweating - 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: Take special care with Ciproxin) - severe allergic reactions (anaphylactic reaction or anaphylactic shock, which can be fatal - serum sickness) (see Section 2: Take special care with Ciproxin) - mental disturbances (psychotic reactions potentially leading to thoughts of suicide, suicide attempts, or completed suicide) (see Section 2: Take special care with Ciproxin) - migraine, disturbed coordination, unsteady walk (gait disturbance), disorder of sense of smell (olfactory disorders), pressure on the brain (intracranial pressure) - visual colour distortions - inammation 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) - muscle weakness, tendon inammation, tendon rupture especially of the large tendon at the back of the ankle (Achilles tendon) (see Section 2: Take special care with Ciproxin); worsening of the symptoms of myasthenia gravis (see Section 2: Take special care with Ciproxin) Frequency not known (cannot be estimated from the available data) - troubles associated with the nervous system such as pain, burning, tingling, numbness and/or weakness in extremities - 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 - inuence on blood clotting (in patients treated with Vitamin K antagonists)
What Ciproxin looks like and contents of the pack
Ciproxin 500 mg tablets: oblong, nearly white to slightly yellowish lm-coated tablets marked with CIP score 500 on one side and BAYER on the other side. The tablets can be divided into equal halves. Pack sizes of 6, 8, 10, 12, 14, 16, 20, 28, 50, 100, 160, or 500 lm-coated tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing authorisation holder Bayer plc Bayer House Strawberry Hill Newbury Berkshire RG14 1JA Manufacturer: Bayer Pharma AG
This medicinal product is authorised in the Member States of the EEA under the following names:
Austria: Belgium: Bulgaria: Cyprus: Czech Republic: Finland: France: Germany: Greece: Hungary: Ireland: Italy: Luxembourg: Malta: Norway: Poland: Portugal: Slovenia: Spain: United Kingdom: Ciproxin Ciproxine Ciprobay Ciproxin Ciprobay Ciproxin Ciox; Uniox Ciprobay Ciproxin Ciprobay Ciproxin Ciproxin Ciproxine Ciproxin Ciproxin Ciprobay Ciproxina Ciprobay Baycip Ciproxin
This leaet was last revised in June 2012. Advice/medical education
Antibiotics are used to cure bacterial infections. They are ineffective against viral infections. If your doctor has prescribed antibiotics, you need them precisely for your current illness. Despite antibiotics, some bacteria may survive or grow. This phenomenon is called resistance: some antibiotic treatments become ineffective. Misuse of antibiotics increases resistance. You may even help bacteria become resistant and therefore delay your cure or decrease antibiotic efcacy if you do not respect appropriate: - dosages - schedules - duration of treatment
Consequently, to preserve the efcacy of this drug:
1- Use antibiotics only when prescribed. 2- Strictly follow the prescription. 3- Do not re-use an antibiotic without medical prescription, even if you want to treat a similar illness. 4- Never give your antibiotic to another person; maybe it is not adapted to her/his illness. 5- After completion of treatment, return all unused drugs to your chemists shop to ensure they will be disposed of correctly.
5. HOW TO STORE CIPROXIN
Keep out of the reach and sight of children.
Do not use Ciproxin after the expiry date, which is stated on the blister and carton after EXP: The expiry date refers to the last day of that month. This medicinal product does not require any special storage conditions. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of any medicines no longer required. These measures will help to protect the environment.
U
81092966/UK017
PMR 81092966 (93/02/MU-0201104176) Pantone: Schwarz Reex Blue
1. 2. 3. 4. 5. 6.
PACKAGE LEAFLET: INFORMATION FOR THE USER
Ciproxin 500 mg lm-coated tablets
Ciprooxacin
Read all of this leaet carefully before you start taking this medicine.
Keep this leaet. 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 symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaet, please tell your doctor or pharmacist. What Ciproxin is and what it is used for Before you take Ciproxin How to take Ciproxin Possible side effects How to store Ciproxin Further information
In this leaet:
1. WHAT CIPROXIN IS AND WHAT IT IS USED FOR
Ciproxin is an antibiotic belonging to the uoroquinolone family. The active substance is ciprooxacin. Ciprooxacin works by killing bacteria that cause infections. It only works with specic strains of bacteria.
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 Ciproxin and contact your doctor immediately. You may experience psychiatric reactions the rst time you take Ciproxin. If you suffer from depression or psychosis, your symptoms may become worse under treatment with Ciproxin. In rare cases, depression or psychosis can progress to thoughts of suicide, suicide attempts, or completed suicide. If this happens, stop taking Ciproxin 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 Ciproxin and contact your doctor immediately. Diarrhoea may develop while you are taking antibiotics, including Ciproxin, 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 Ciproxin 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 Ciproxin 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. Ciproxin 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 Ciproxin and contact your doctor immediately. Ciproxin 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 deciency in glucose-6-phosphate dehydrogenase (G6PD), since you may experience a risk of anemia with ciprooxacin. Your skin becomes more sensitive to sunlight or ultraviolet (UV) light when taking Ciproxin. Avoid exposure to strong sunlight, or articial UV light such as sunbeds.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including any that you obtained without a prescription. Do not take Ciproxin together with tizanidine, because this may cause side effects such as low blood pressure and sleepiness (see Section 2: Do not take Ciproxin). The following medicines are known to interact with Ciproxin in your body. Taking Ciproxin together with these medicines can inuence the therapeutic effect of those medicines. It can also increase the probability of experiencing side effects.
Adults
Ciproxin 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 Ciprooxacin may be used in the management of patients with low white blood cell counts (neutropenia) who have a fever that is suspected to be due to a bacterial infection. 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 Ciproxin.
Tell your doctor if you are taking:
Vitamin K antagonists (e.g: warfarin) 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) olanzapine (an antipsychotic) clozapine (an antipsychotic) ropinirole (for Parkinsons disease) phenytoin (for epilepsy) metoclopramide (for nausea and vomiting) cyclosporin (for skin conditions, rheumatoid arthritis and in organ transplantation) glibenclamide (for diabetes) 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. Ciproxin 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) sildenal (e.g. for erectile dysfunction) Some medicines reduce the effect of Ciproxin. Tell your doctor if you take or wish to take: antacids omeprazole mineral supplements sucralfate a polymeric phosphate binder (e.g. sevelamer) medicines or supplements containing calcium, magnesium, aluminium or iron If these preparations are essential, take Ciproxin about two hours before or no sooner than four hours after them.
Children and adolescents
Ciproxin 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 brosis complicated urinary tract infections, including infections that have reached the kidneys (pyelonephritis) anthrax inhalation exposure Ciproxin may also be used to treat other specic severe infections in children and adolescents when your doctor considered this necessary.
2. BEFORE YOU TAKE CIPROXIN
Do not take Ciproxin if you are:
allergic (hypersensitive) to the active substance, to other quinolone drugs or to any of the other ingredients of Ciproxin (see section 6) taking tizanidine (see Section 2: Taking other medicines)
Take special care with Ciproxin Before taking Ciproxin
Tell your doctor if you: 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 Ciproxin have myasthenia gravis (a type of muscle weakness) have heart problems. Caution should be taken when using Ciprooxacin, if you were born with or have 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). For the treatment of some genital tract infections, your doctor can prescribe another antibiotic in addition to ciprooxacin. If there is no improvement in symptoms after 3 days of treatment, please consult your doctor.
Taking Ciproxin with food and drink
Unless you take Ciproxin 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
It is preferable to avoid the use of Ciproxin during pregnancy. Tell your doctor if you are planning to get pregnant. Do not take Ciproxin during breast feeding because ciprooxacin is excreted in breast milk and can be harmful for your child.
While taking Ciproxin
Tell your doctor immediately, if any of the following occurs while taking Ciproxin. Your doctor will decide whether treatment with Ciproxin needs to be stopped. Severe, sudden allergic reaction (an anaphylactic reaction/shock, angio-oedema). Even with the rst 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 Ciproxin 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 corticosteroids. Inammation and ruptures of tendons may occur even within the rst 48 hours of treatment or up to several months after discontinuation of Ciproxin therapy. At the rst sign of any pain or inammation stop taking Ciproxin and rest the painful area. Avoid any unnecessary exercise, as this might increase the risk of a tendon rupture.
Driving and using machines
Ciproxin may make you feel less alert. Some neurological adverse events can occur. Therefore, make sure you know how you react to Ciproxin before driving a vehicle or operating machinery. If in doubt, talk to your doctor.
3. HOW TO TAKE CIPROXIN
Your doctor will explain to you exactly how much Ciproxin 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.
81092974
PMR 81092974 (93/02/MU-0201104176) Pantone: Schwarz Reex Blue
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 Ciproxin. a. Swallow the tablets with plenty of uid. 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 Ciproxin tablets with dairy products such as milk or yoghurt or with fortied fruit juices (e.g. calcium-fortied orange juice). Remember to drink plenty of uids while you are taking Ciproxin.
Frequency not known (cannot be estimated from the available data) - troubles associated with the nervous system such as pain, burning, tingling, numbness and/or weakness in extremities - 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 - inuence on blood clotting (in patients treated with Vitamin K antagonists)
5. HOW TO STORE CIPROXIN
Keep out of the reach and sight of children.
Do not use Ciproxin after the expiry date, which is stated on the blister and carton after EXP: The expiry date refers to the last day of that month. This medicinal product does not require any special storage conditions. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of any medicines no longer required. These measures will help to protect the environment.
If you take more Ciproxin 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 Ciproxin
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 Ciproxin
It is important that you nish 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 more questions about the use of this product, ask your doctor or pharmacist.
6. FURTHER INFORMATION
What Ciproxin contains
The active substance is ciprooxacin. Each lm-coated tablet contains 500 mg ciprooxacin (as hydrochloride). The other ingredients are: Tablet core: cellulose microcrystalline, crospovidone, magnesium stearate, maize starch, silica colloidal anhydrous. Film-coat: hypromellose, macrogol 4000, titanium dioxide (E171).
4. POSSIBLE SIDE EFFECTS
Like all medicines, Ciproxin can cause side effects, although not everybody gets them. If any of the side effects gets serious, or if you notice any side effects not listed in this leaet, tell your doctor or pharmacist. 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): - inammation of the bowel (colitis) linked to antibiotic use (can be fatal in very rare cases) (see Section 2: Take special care with Ciproxin) - changes to the blood count (leukopenia, leukocytosis, neutropenia, anaemia), increased or decreased amounts of a blood clotting factor (thrombocytes) - allergic reaction, swelling (oedema), or rapid swelling of the skin and mucous membranes (angio-oedema) - increased blood sugar (hyperglycaemia) - 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: Take special care with Ciproxin), 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: Take special care with Ciproxin) - muscle pain, inammation of the joints, increased muscle tone, or cramp - kidney failure, blood or crystals in the urine (see Section 2: Take special care with Ciproxin), urinary tract inammation - uid retention or excessive sweating - 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: Take special care with Ciproxin) - severe allergic reactions (anaphylactic reaction or anaphylactic shock, which can be fatal - serum sickness) (see Section 2: Take special care with Ciproxin) - mental disturbances (psychotic reactions potentially leading to thoughts of suicide, suicide attempts, or completed suicide) (see Section 2: Take special care with Ciproxin) - migraine, disturbed coordination, unsteady walk (gait disturbance), disorder of sense of smell (olfactory disorders), pressure on the brain (intracranial pressure) - visual colour distortions - inammation 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) - muscle weakness, tendon inammation, tendon rupture especially of the large tendon at the back of the ankle (Achilles tendon) (see Section 2: Take special care with Ciproxin); worsening of the symptoms of myasthenia gravis (see Section 2: Take special care with Ciproxin)
What Ciproxin looks like and contents of the pack
Ciproxin 500 mg tablets: oblong, nearly white to slightly yellowish lm-coated tablets marked with "CIP score 500" on one side and "BAYER" on the other side. The tablets can be divided into equal halves. Pack sizes of 6, 8, 10, 12, 14, 16, 20, 28, 50, 100, 160, or 500 lm-coated tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing authorisation holder Bayer plc Bayer House Strawberry Hill Newbury Berkshire RG14 1JA Bayer Pharma AG
Manufacturer:
This medicinal product is authorised in the Member States of the EEA under the following names:
Austria: Belgium: Bulgaria: Cyprus: Czech Republic: Finland: France: Germany: Greece: Hungary: Ireland: Italy: Luxembourg: Malta: Norway: Poland: Portugal: Slovenia: Spain: United Kingdom: Ciproxin Ciproxine Ciprobay Ciproxin Ciprobay Ciproxin Ciox; Uniox Ciprobay Ciproxin Ciprobay Ciproxin Ciproxin Ciproxine Ciproxin Ciproxin Ciprobay Ciproxina Ciprobay Baycip Ciproxin
This leaet was last revised in June 2012. Advice/medical education
Antibiotics are used to cure bacterial infections. They are ineffective against viral infections. If your doctor has prescribed antibiotics, you need them precisely for your current illness. Despite antibiotics, some bacteria may survive or grow. This phenomenon is called resistance: some antibiotic treatments become ineffective. Misuse of antibiotics increases resistance. You may even help bacteria become resistant and therefore delay your cure or decrease antibiotic efcacy if you do not respect appropriate: - dosages - schedules - duration of treatment
Consequently, to preserve the efcacy of this drug:
1- Use antibiotics only when prescribed. 2- Strictly follow the prescription. 3- Do not re-use an antibiotic without medical prescription, even if you want to treat a similar illness. 4- Never give your antibiotic to another person; maybe it is not adapted to her/his illness. 5- After completion of treatment, return all unused drugs to your chemists shop to ensure they will be disposed of correctly.
U
81092974
PMR 81092974 (93/02/MU-0201104176) Pantone: Schwarz Reex Blue
0
1. 2. 3. 4. 5. 6.
PACKAGE LEAFLET: INFORMATION FOR THE USER
Ciproxin 500 mg lm-coated tablets
Ciprooxacin
Read all of this leaet carefully before you start taking this medicine.
Keep this leaet. 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 symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaet, please tell your doctor or pharmacist.
Tell the doctor or laboratory staff that you are taking Ciproxin 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. Ciproxin 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 Ciproxin and contact your doctor immediately. Ciproxin 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 deciency in glucose-6-phosphate dehydrogenase (G6PD), since you may experience a risk of anemia with ciprooxacin. Your skin becomes more sensitive to sunlight or ultraviolet (UV) light when taking Ciproxin. Avoid exposure to strong sunlight, or articial UV light such as sunbeds.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including any that you obtained without a prescription. Do not take Ciproxin together with tizanidine, because this may cause side effects such as low blood pressure and sleepiness (see Section 2: Do not take Ciproxin). The following medicines are known to interact with Ciproxin in your body. Taking Ciproxin together with these medicines can inuence the therapeutic effect of those medicines. It can also increase the probability of experiencing side effects.
In this leaet:
What Ciproxin is and what it is used for Before you take Ciproxin How to take Ciproxin Possible side effects How to store Ciproxin Further information
Tell your doctor if you are taking:
Vitamin K antagonists (e.g: warfarin) 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) olanzapine (an antipsychotic) clozapine (an antipsychotic) ropinirole (for Parkinsons disease) phenytoin (for epilepsy) metoclopramide (for nausea and vomiting) cyclosporin (for skin conditions, rheumatoid arthritis and in organ transplantation) glibenclamide (for diabetes) 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. Ciproxin 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) sildenal (e.g. for erectile dysfunction) Some medicines reduce the effect of Ciproxin. Tell your doctor if you take or wish to take: antacids omeprazole mineral supplements sucralfate a polymeric phosphate binder (e.g. sevelamer) medicines or supplements containing calcium, magnesium, aluminium or iron If these preparations are essential, take Ciproxin about two hours before or no sooner than four hours after them.
1. WHAT CIPROXIN IS AND WHAT IT IS USED FOR
Ciproxin is an antibiotic belonging to the uoroquinolone family. The active substance is ciprooxacin. Ciprooxacin works by killing bacteria that cause infections. It only works with specic strains of bacteria.
Adults
Ciproxin 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 Ciprooxacin may be used in the management of patients with low white blood cell counts (neutropenia) who have a fever that is suspected to be due to a bacterial infection. 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 Ciproxin.
Children and adolescents
Ciproxin 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 brosis complicated urinary tract infections, including infections that have reached the kidneys (pyelonephritis) anthrax inhalation exposure Ciproxin may also be used to treat other specic severe infections in children and adolescents when your doctor considered this necessary.
2. BEFORE YOU TAKE CIPROXIN
Do not take Ciproxin if you are:
allergic (hypersensitive) to the active substance, to other quinolone drugs or to any of the other ingredients of Ciproxin (see section 6) taking tizanidine (see Section 2: Taking other medicines)
Taking Ciproxin with food and drink
Unless you take Ciproxin 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
It is preferable to avoid the use of Ciproxin during pregnancy. Tell your doctor if you are planning to get pregnant. Do not take Ciproxin during breast feeding because ciprooxacin is excreted in breast milk and can be harmful for your child.
Take special care with Ciproxin Before taking Ciproxin
Tell your doctor if you: 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 Ciproxin have myasthenia gravis (a type of muscle weakness) have heart problems. Caution should be taken when using Ciprooxacin, if you were born with or have 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). For the treatment of some genital tract infections, your doctor can prescribe another antibiotic in addition to ciprooxacin. If there is no improvement in symptoms after 3 days of treatment, please consult your doctor.
Driving and using machines
Ciproxin may make you feel less alert. Some neurological adverse events can occur. Therefore, make sure you know how you react to Ciproxin before driving a vehicle or operating machinery. If in doubt, talk to your doctor.
3. HOW TO TAKE CIPROXIN
Your doctor will explain to you exactly how much Ciproxin 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 Ciproxin. a. Swallow the tablets with plenty of uid. 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 Ciproxin tablets with dairy products such as milk or yoghurt or with fortied fruit juices (e.g. calcium-fortied orange juice). Remember to drink plenty of uids while you are taking Ciproxin.
While taking Ciproxin
Tell your doctor immediately, if any of the following occurs while taking Ciproxin. Your doctor will decide whether treatment with Ciproxin needs to be stopped. Severe, sudden allergic reaction (an anaphylactic reaction/shock, angio-oedema). Even with the rst 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 Ciproxin 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 corticosteroids. Inammation and ruptures of tendons may occur even within the rst 48 hours of treatment or up to several months after discontinuation of Ciproxin therapy. At the rst sign of any pain or inammation stop taking Ciproxin 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 Ciproxin and contact your doctor immediately. You may experience psychiatric reactions the rst time you take Ciproxin. If you suffer from depression or psychosis, your symptoms may become worse under treatment with Ciproxin. In rare cases, depression or psychosis can progress to thoughts of suicide, suicide attempts, or completed suicide. If this happens, stop taking Ciproxin 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 Ciproxin and contact your doctor immediately. Diarrhoea may develop while you are taking antibiotics, including Ciproxin, 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 Ciproxin immediately, as this can be life-threatening. Do not take medicines that stop or slow down bowel movements and contact your doctor.
If you take more Ciproxin 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 Ciproxin
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 Ciproxin
It is important that you nish 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 more questions about the use of this product, ask your doctor or pharmacist.
81092966/UK017
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4.
POSSIBLE SIDE EFFECTS
6. FURTHER INFORMATION
What Ciproxin contains
The active substance is ciprooxacin. Each lm-coated tablet contains 500 mg ciprooxacin (as hydrochloride). The other ingredients are: Tablet core: cellulose microcrystalline, crospovidone, magnesium stearate, maize starch, silica colloidal anhydrous. Film-coat: hypromellose, macrogol 4000, titanium dioxide (E171).
Like all medicines, Ciproxin can cause side effects, although not everybody gets them. If any of the side effects gets serious, or if you notice any side effects not listed in this leaet, tell your doctor or pharmacist. 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): - inammation of the bowel (colitis) linked to antibiotic use (can be fatal in very rare cases) (see Section 2: Take special care with Ciproxin) - changes to the blood count (leukopenia, leukocytosis, neutropenia, anaemia), increased or decreased amounts of a blood clotting factor (thrombocytes) - allergic reaction, swelling (oedema), or rapid swelling of the skin and mucous membranes (angio-oedema) - increased blood sugar (hyperglycaemia) - 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: Take special care with Ciproxin), 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: Take special care with Ciproxin) - muscle pain, inammation of the joints, increased muscle tone, or cramp - kidney failure, blood or crystals in the urine (see Section 2: Take special care with Ciproxin), urinary tract inammation - uid retention or excessive sweating - 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: Take special care with Ciproxin) - severe allergic reactions (anaphylactic reaction or anaphylactic shock, which can be fatal - serum sickness) (see Section 2: Take special care with Ciproxin) - mental disturbances (psychotic reactions potentially leading to thoughts of suicide, suicide attempts, or completed suicide) (see Section 2: Take special care with Ciproxin) - migraine, disturbed coordination, unsteady walk (gait disturbance), disorder of sense of smell (olfactory disorders), pressure on the brain (intracranial pressure) - visual colour distortions - inammation 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) - muscle weakness, tendon inammation, tendon rupture especially of the large tendon at the back of the ankle (Achilles tendon) (see Section 2: Take special care with Ciproxin); worsening of the symptoms of myasthenia gravis (see Section 2: Take special care with Ciproxin) Frequency not known (cannot be estimated from the available data) - troubles associated with the nervous system such as pain, burning, tingling, numbness and/or weakness in extremities - 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 - inuence on blood clotting (in patients treated with Vitamin K antagonists)
What Ciproxin looks like and contents of the pack
Ciproxin 500 mg tablets: oblong, nearly white to slightly yellowish lm-coated tablets marked with CIP score 500 on one side and BAYER on the other side. The tablets can be divided into equal halves. Pack sizes of 6, 8, 10, 12, 14, 16, 20, 28, 50, 100, 160, or 500 lm-coated tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing authorisation holder Bayer plc Bayer House Strawberry Hill Newbury Berkshire RG14 1JA Manufacturer: Bayer Pharma AG
This medicinal product is authorised in the Member States of the EEA under the following names:
Austria: Belgium: Bulgaria: Cyprus: Czech Republic: Finland: France: Germany: Greece: Hungary: Ireland: Italy: Luxembourg: Malta: Norway: Poland: Portugal: Slovenia: Spain: United Kingdom: Ciproxin Ciproxine Ciprobay Ciproxin Ciprobay Ciproxin Ciox; Uniox Ciprobay Ciproxin Ciprobay Ciproxin Ciproxin Ciproxine Ciproxin Ciproxin Ciprobay Ciproxina Ciprobay Baycip Ciproxin
This leaet was last revised in June 2012. Advice/medical education
Antibiotics are used to cure bacterial infections. They are ineffective against viral infections. If your doctor has prescribed antibiotics, you need them precisely for your current illness. Despite antibiotics, some bacteria may survive or grow. This phenomenon is called resistance: some antibiotic treatments become ineffective. Misuse of antibiotics increases resistance. You may even help bacteria become resistant and therefore delay your cure or decrease antibiotic efcacy if you do not respect appropriate: - dosages - schedules - duration of treatment
Consequently, to preserve the efcacy of this drug:
1- Use antibiotics only when prescribed. 2- Strictly follow the prescription. 3- Do not re-use an antibiotic without medical prescription, even if you want to treat a similar illness. 4- Never give your antibiotic to another person; maybe it is not adapted to her/his illness. 5- After completion of treatment, return all unused drugs to your chemists shop to ensure they will be disposed of correctly.
5. HOW TO STORE CIPROXIN
Keep out of the reach and sight of children.
Do not use Ciproxin after the expiry date, which is stated on the blister and carton after EXP: The expiry date refers to the last day of that month. This medicinal product does not require any special storage conditions. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of any medicines no longer required. These measures will help to protect the environment.
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81092966/UK017
PMR 81092966 (93/02/MU-0201104176) Pantone: Schwarz Reex Blue
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
