CIPROXIN TABLETS 500MG

5. How to store Ciproxin KEEP OUT OF THE SIGHT AND REACH OF CHILDREN. Do not store above 25C. Do not take the tablets after the date shown on the pack. If your doctor tells you to stop taking the tablets, please take them back to the pharmacist for safe disposal. Only keep them if your doctor tells you to. If the tablets become discoloured or show any other signs of deterioration, please seek the advice of your pharmacist. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

S1431 LEAFLET Ciproxin 20130215

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)

PACKAGE LEAFLET: INFORMATION FOR THE USER

CIPROXIN TABLETS 500mg (ciprofloxacin hydrochloride)
The name of your medicine is Ciproxin Tablets 500mg but will be referred as Ciproxin throughout the following patient information leaflet. Read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. If you have 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.

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 Ciprofloxacin, 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).



6. Further information What Ciproxin contains Each tablet contains 500mg of the active ingredient ciprofloxacin (as ciprofloxacin hydrochloride monohydrate).

The tablets also contain microcrystalline cellulose, maize starch, crospovidone, colloidal silicon dioxide, magnesium stearate, hypromellose 2910, macrogol 4000 and titanium dioxide (E171). What Ciproxin looks like and contents of the pack Ciproxin is a white, capsule-shaped tablet marked Bayer on one side and with a score-line and CIP 500 on the other. Ciproxin is available as blister packs of 10 or 20 tablets. Product Licence holder Procured from within the EU and repackaged by the Product Licence holder: S&M Medical Ltd, Chemilines House, Alperton Lane, Wembley, HA0 1DX. Manufacturer This product is manufactured by Bayer Pharma AG, Leverkusen, Germany. POM PL No: 19488/1431 Leaflet revision date: 15 February 2013 Ciproxin is a registered trade mark of Bayer AG, Germany. 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 efficacy if you do not respect appropriate: dosages schedules duration of treatment

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Ciproxin is and what it is used for 2. Before you take Ciproxin 3. How to take Ciproxin 4. Possible side effects 5. How to store Ciproxin 6. Further information 1. What Ciproxin is and what it is used for Ciproxin is an antibiotic belonging to the fluoroquinolone family. The active substance is ciprofloxacin. Ciprofloxacin works by killing bacteria that cause infections. It only works with specific 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

For the treatment of some genital tract infections, your doctor can prescribe another antibiotic in addition to ciprofloxacin. If there is no improvement in symptoms after 3 days of treatment, please consult your doctor. While taking 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 first dose, there is a small chance that you may experience a severe allergic reaction with the following symptoms: tightness in the chest, feeling dizzy, sick or faint, or experiencing dizziness when standing up. If this happens, stop taking 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. Inflammation and ruptures of tendons may occur even within the first 48 hours of treatment or up to several months after discontinuation of Ciproxin therapy. At the first sign of any pain or inflammation 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 first 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.



Ciprofloxacin 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 fibrosis complicated urinary tract infections, including infections that have reached the kidneys (pyelonephritis) anthrax inhalation exposure



Consequently, to preserve the efficacy 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.
S1431 LEAFLET Ciproxin 20130215







Ciproxin may also be used to treat other specific severe infections in children and adolescents when your doctor considered this necessary.



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 deficiency in glucose-6-phosphate dehydrogenase (G6PD), since you may experience a risk of anemia with ciprofloxacin. Your skin becomes more sensitive to sunlight or ultraviolet (UV) light when taking Ciproxin. Avoid exposure to strong sunlight, or artificial UV light such as sunbeds.

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

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 leaflet, 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

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 inflammation of the wall of the blood vessels (vasculitis) pancreatitis death of liver cells (liver necrosis) very rarely leading to lifethreatening 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 inflammation, 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)



-

If these preparations are essential, take Ciproxin about two hours before or no sooner than four hours after them. Taking Ciproxin with food and drink Unless you take the 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 ciprofloxacin is excreted in breast milk and can be harmful for your child. 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 fluid. Do not chew the tablets because they do not taste nice. b. Do try to take the tablets at around the same time every day. c. You can take the tablets at mealtimes or between meals. Any calcium you take as part of a meal will not seriously affect uptake. However, do not take Ciproxin tablets with dairy products such as milk or yoghurt or with fortified fruit juices (e.g. calcium-fortified orange juice). Remember to drink plenty of fluids while you are taking Ciproxin. 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 finish the course of treatment even if you begin to feel better after a few days. If you stop taking this medicine too soon your infection may not be completely cured and the symptoms of the infection may return or get worse. You might also develop resistance to the antibiotic. If you have any more questions about the use of this product, ask your doctor or pharmacist.

-

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)

-



-



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 influence the therapeutic effect of those medicines. It can also increase the probability of experiencing side effects. Tell your doctor if you are taking: Vitamin K antagonists (e.g: warfarin) or other oral anticoagulants (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.

-

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

Rare side effects (between 1 and 10 in every 10,000 people are likely to get these): inflammation 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, inflammation 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 inflammation fluid retention or excessive sweating increased levels of the enzyme amylase

-

-

-

-

-

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) sildenafil (e.g. for erectile dysfunction)

5. How to store Ciprofloxacin Tablet KEEP OUT OF THE SIGHT AND REACH OF CHILDREN. Do not store above 25C. Do not take the tablets after the date shown on the pack. If your doctor tells you to stop taking the tablets, please take them back to the pharmacist for safe disposal. Only keep them if your doctor tells you to. If the tablets become discoloured or show any other signs of deterioration, please seek the advice of your pharmacist. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

S1431 LEAFLET Ciprofloxacin 20130215

2. Before you take Ciprofloxacin tablets Do not take Ciprofloxacin Tablets if you are: allergic (hypersensitive) to the active substance, to other quinolone drugs or to any of the other ingredients of Ciprofloxacin Tablets (see section 6)

PACKAGE LEAFLET: INFORMATION FOR THE USER

CIPROFLOXACIN TABLETS 500mg (ciprofloxacin hydrochloride)
The name of your medicine is Ciprofloxacin Tablets 500mg but will be referred as Ciprofloxacin Tablets throughout the following patient information leaflet. Read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. If you have 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 leaflet, please tell your doctor or pharmacist.

taking tizanidine (see Section 2: Taking other medicines) Take special care with Ciprofloxacin Tablets Before taking Ciprofloxacin Tablets 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 Ciprofloxacin Tablets have myasthenia gravis (a type of muscle weakness) have heart problems. Caution should be taken when using Ciprofloxacin, 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).



6. Further information What Ciprofloxacin Tablets contain Each tablet contains 500mg of the active ingredient ciprofloxacin (as ciprofloxacin hydrochloride monohydrate).



The tablets also contain microcrystalline cellulose, maize starch, crospovidone, colloidal silicon dioxide, magnesium stearate, hypromellose 2910, macrogol 4000 and titanium dioxide (E171). What Ciprofloxacin Tablets look like and contents of the pack Ciprofloxacin Tablets are white, capsule-shaped tablets marked Bayer on one side and with a score-line and CIP 500 on the other. Ciprofloxacin Tablets are available as blister packs of 10 or 20 tablets. Product Licence holder Procured from within the EU and repackaged by the Product Licence holder: S&M Medical Ltd, Chemilines House, Alperton Lane, Wembley, HA0 1DX. Manufacturer This product is manufactured by Bayer Pharma AG, Leverkusen, Germany. POM PL No: 19488/1431 Leaflet revision date: 15 February 2013 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 efficacy if you do not respect appropriate: dosages schedules duration of treatment

In this leaflet: 1. What Ciprofloxacin Tablets are and what they are used for 2. Before you take Ciprofloxacin Tablets 3. How to take Ciprofloxacin Tablets 4. Possible side effects 5. How to store Ciprofloxacin Tablets 6. Further information 1. What Ciprofloxacin Tablets are and what they are used for Ciprofloxacin Tablets are an antibiotic belonging to the fluoroquinolone family. The active substance is ciprofloxacin. Ciprofloxacin works by killing bacteria that cause infections. It only works with specific strains of bacteria. Adults Ciprofloxacin Tablets are 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

For the treatment of some genital tract infections, your doctor can prescribe another antibiotic in addition to ciprofloxacin. If there is no improvement in symptoms after 3 days of treatment, please consult your doctor. While taking Ciprofloxacin Tablets Tell your doctor immediately if any of the following occurs while taking Ciprofloxacin Tablets. Your doctor will decide whether treatment with Ciprofloxacin Tablets needs to be stopped. Severe, sudden allergic reaction (an anaphylactic reaction/shock, angio-oedema). Even with the first dose, there is a small chance that you may experience a severe allergic reaction with the following symptoms: tightness in the chest, feeling dizzy, sick or faint, or experiencing dizziness when standing up. If this happens, stop taking Ciprofloxacin Tablets 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. Inflammation and ruptures of tendons may occur even within the first 48 hours of treatment or up to several months after discontinuation of Ciprofloxacin Tablets therapy. At the first sign of any pain or inflammation stop taking Ciprofloxacin Tablets and rest the painful area. Avoid any unnecessary exercise, as this might increase the risk of a tendon rupture. If you suffer from epilepsy or other neurological conditions such as cerebral ischemia or stroke, you may experience side effects associated with the central nervous system. If this happens, stop taking Ciprofloxacin Tablets and contact your doctor immediately. You may experience psychiatric reactions the first time you take Ciprofloxacin Tablets. If you suffer from depression or psychosis, your symptoms may become worse under treatment with Ciprofloxacin Tablets. In rare cases, depression or psychosis can progress to thoughts of suicide, suicide attempts, or completed suicide. If this happens, stop taking Ciprofloxacin Tablets and contact your doctor immediately. You may experience symptoms of neuropathy such as pain, burning, tingling, numbness and/or weakness. If this happens, stop taking Ciprofloxacin Tablets and contact your doctor immediately. Diarrhoea may develop while you are taking antibiotics, including Ciprofloxacin Tablets, or even several weeks after you have stopped taking them. If it becomes severe or persistent or you notice that your stool contains blood or mucus, stop taking Ciprofloxacin Tablets immediately, as this can be lifethreatening. Do not take medicines that stop or slow down bowel movements and contact your doctor. Tell the doctor or laboratory staff that you are taking Ciprofloxacin Tablets if you have to provide a blood or urine sample.



Ciprofloxacin 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 Ciprofloxacin Tablets. Children and adolescents Ciprofloxacin Tablets are used in children and adolescents, under specialist medical supervision, to treat the following bacterial infections: lung and bronchial infections in children and adolescents suffering from cystic fibrosis complicated urinary tract infections, including infections that have reached the kidneys (pyelonephritis) anthrax inhalation exposure

Consequently, to preserve the efficacy 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.
S1431 LEAFLET Ciprofloxacin 20130215

Ciprofloxacin Tablets may also be used to treat other specific severe infections in children and adolescents when your doctor considered this necessary.



If you suffer from kidney problems, tell the doctor because your dose may need to be adjusted. Ciprofloxacin Tablets may cause liver damage. If you notice any symptoms such as loss of appetite, jaundice (yellowing of the skin), dark urine, itching, or tenderness of the stomach, stop taking Ciprofloxacin Tablets and contact your doctor immediately. Ciprofloxacin Tablets may cause a reduction in the number of white blood cells and your resistance to infection may be decreased. If you experience an infection with symptoms such as fever and serious deterioration of your general condition, or fever with local infection symptoms such as sore throat/ pharynx/mouth or urinary problems you should see your doctor immediately. A blood test will be taken to check possible reduction of white blood cells (agranulocytosis). It is important to inform your doctor about your medicine. Tell your doctor if you or a member of your family is known to have a deficiency in glucose-6-phosphate dehydrogenase (G6PD), since you may experience a risk of anemia with ciprofloxacin. Your skin becomes more sensitive to sunlight or ultraviolet (UV) light when taking Ciprofloxacin Tablets. Avoid exposure to strong sunlight, or artificial UV light such as sunbeds.

Some medicines reduce the effect of Ciprofloxacin Tablets. 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

4. Possible Side Effects Like all medicines, Ciprofloxacin Tablets 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 leaflet, 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

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 Ciprofloxacin Tablets) severe allergic reactions (anaphylactic reaction or anaphylactic shock, which can be fatal - serum sickness) (see Section 2: Take special care with Ciprofloxacin Tablets) mental disturbances (psychotic reactions potentially leading to thoughts of suicide, suicide attempts, or completed suicide) (see Section 2: Take special care with Ciprofloxacin Tablets) migraine, disturbed coordination, unsteady walk (gait disturbance), disorder of sense of smell (olfactory disorders), pressure on the brain (intracranial pressure) visual colour distortions inflammation of the wall of the blood vessels (vasculitis) pancreatitis death of liver cells (liver necrosis) very rarely leading to lifethreatening 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 inflammation, tendon rupture especially of the large tendon at the back of the ankle (Achilles tendon) (see Section 2: Take special care with Ciprofloxacin Tablets); worsening of the symptoms of myasthenia gravis(see Section 2: Take special care with Ciprofloxacin Tablets)



-

If these preparations are essential, take Ciprofloxacin Tablets about two hours before or no sooner than four hours after them. Taking Ciprofloxacin Tablets with food and drink Unless you take the Ciprofloxacin Tablets 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 Ciprofloxacin Tablets during pregnancy. Tell your doctor if you are planning to get pregnant. Do not take Ciprofloxacin Tablets during breast feeding because ciprofloxacin is excreted in breast milk and can be harmful for your child. Driving and using machines Ciprofloxacin Tablets may make you feel less alert. Some neurological adverse events can occur. Therefore, make sure you know how you react to Ciprofloxacin Tablets before driving a vehicle or operating machinery. If in doubt, talk to your doctor. 3. How to take Ciprofloxacin Tablets Your doctor will explain to you exactly how much Ciprofloxacin Tablets you will have to take as well as how often and for how long. This will depend on the type of infection you have and how bad it is. Tell your doctor if you suffer from kidney problems because your dose may need to be adjusted. The treatment usually lasts from 5 to 21 days, but may take longer for severe infections. Take the tablets exactly as your doctor has told you. Ask your doctor or pharmacist if you are not sure how many tablets to take and how to take Ciprofloxacin Tablets. a. Swallow the tablets with plenty of fluid. Do not chew the tablets because they do not taste nice. b. Do try to take the tablets at around the same time every day. c. You can take the tablets at mealtimes or between meals. Any calcium you take as part of a meal will not seriously affect uptake. However, do not take Ciprofloxacin Tablets with dairy products such as milk or yoghurt or with fortified fruit juices (e.g. calcium-fortified orange juice). Remember to drink plenty of fluids while you are taking Ciprofloxacin Tablets. If you take more Ciprofloxacin Tablets than you should If you take more than the prescribed dose, get medical help immediately. If possible, take your tablets or the box with you to show the doctor. If you forget to take Ciprofloxacin Tablets Take the normal dose as soon as possible and then continue as prescribed. However, if it is almost time for your next dose, do not take the missed dose and continue as usual. Do not take a double dose to make up for a forgotten dose. Be sure to complete your course of treatment. If you stop taking Ciprofloxacin Tablets It is important that you finish the course of treatment even if you begin to feel better after a few days. If you stop taking this medicine too soon your infection may not be completely cured and the symptoms of the infection may return or get worse. You might also develop resistance to the antibiotic. If you have any more questions about the use of this product, ask your doctor or pharmacist.

-

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)

-



-



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 Ciprofloxacin Tablets together with tizanidine, because this may cause side effects such as low blood pressure and sleepiness (see Section 2: Do not take Ciprofloxacin Tablets). The following medicines are known to interact with Ciprofloxacin Tablets in your body. Taking Ciprofloxacin Tablets together with these medicines can influence the therapeutic effect of those medicines. It can also increase the probability of experiencing side effects. Tell your doctor if you are taking: Vitamin K antagonists (e.g: warfarin) or other oral anticoagulants (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.

-

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

Rare side effects (between 1 and 10 in every 10,000 people are likely to get these): inflammation of the bowel (colitis) linked to antibiotic use (can be fatal in very rare cases) (see Section 2: Take special care with Ciprofloxacin Tablets) 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 Ciprofloxacin Tablets), 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 Ciprofloxacin Tablets) muscle pain, inflammation of the joints, increased muscle tone, or cramp kidney failure, blood or crystals in the urine (see Section 2: Take special care with Ciprofloxacin Tablets), urinary tract inflammation fluid retention or excessive sweating increased levels of the enzyme amylase

-

-

-

-

-

Ciprofloxacin Tablets may increase the levels of the following medicines in your blood: pentoxifylline (for circulatory disorders) caffeine duloxetine (for depression, diabetic nerve damage or incontinence) lidocaine (for heart conditions or anesthetic use) sildenafil (e.g. for erectile dysfunction)

-