Ciprofloxacin 500 Mg Film-Coated Tablets
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Package leaflet: Information for the patient Ciprofloxacin 250mg and 500mg Film-Coated Tablets
Ciprofloxacin Hydrochloride
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed foryou only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
> If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Ciprofloxacin tablets are and what they are used for
2. What you need to know before you take Ciprofloxacin tablets
3. Howto take Ciprofloxacin tablets
4. Possible side effects
5. Howto store Ciprofloxacin tablets
6. Contents of the pack and other Information.
1. What Ciprofloxacin tablets are and what they are used for
Ciprofloxacin tablet contains the active substance ciprofloxacin. Ciprofloxacin is an antibiotic belonging to the fluoroquinolone family. 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
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
Ciprofloxacin may also be used to treat other specific severe infections in children and adolescents when your doctor considered this necessary.
2. What you need to know before you take Ciprofloxacin tablets
Do not take Ciprofloxacin tablets:
■ if you are allergic to ciprofloxacin, other quinolone drugs or any of the other ingredients of this medicine (listed in section 6)
> if you are taking tizanidine (see section 2: Other medicines and Ciprofloxacin tablets)
Warnings and Precautions
Talk to your doctor before taking Ciprofloxacin tablets
• if you have ever had kidney problems because your treatment may need to be adjusted.
■ ifyou sufferfrom epilepsy or other neurological conditions.
• if you have a history of tendon problems during previous treatment with antibiotics such as Ciprofloxacin tablets.
« if you are diabetic because you may experience a risk of hypoglycaemia with ciprofloxacin.
• if you have myasthenia gravis (a type of muscle weakness) because symptoms can be exacerbated.
• if you have heart problems. Caution should be taken when using Ciprofloxacin, if you were bom 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 2: “Other medicines and Ciprofloxacin tablets”).
■ ifyou ora member of yourfamily is known to have a deficiency in glucose-6-phosphate dehydrogenase (G6PD), since you may experience a risk of anaemia with ciprofloxacin.
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 yourdoctor.
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 ifyou 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-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 yourdoctorimmediately.
• 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.
• Hypoglycaemia has been reported most often in diabetic patients, predominantly in elderly population. If this happens, contact yourdoctorimmediately.
. 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 life-threatening. Do not take medicines that stop or slowdown bowel movements and contact yourdoctor.
• If your eyesight becomes impaired or if your eyes seem to be otherwise affected, consult an eye specialist immediately (see section 4: Possible side effects).
. 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.
• Tell the doctor or laboratory staff that you are taking Ciprofloxacin tablets ifyou 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.
• 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 yourdoctor about your medicine.
Other medicines and Ciprofloxacin tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Do not take Ciprofloxacin 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 ifyou are taking:
. vitamin K antagonists (e.g., warfarin, acenocoumarol, phenprocoumon, or fluindione) 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 Parkinson's disease)
• phenytoin (forepilepsy)
• metoclopramide (for nausea and vomiting)
• cyclosporin (for skin conditions, rheumatoid arthritis and in organ transplantation)
. 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.
Ciprofloxacin can increase the levels of the following medicines in your blood:
. pentoxifylline (for circulatory disorders)
. caffeine
• agomelatine
• zolpidem
• duloxetine (for depression, diabetic nerve damage or incontinence)
. lidocaine (for heart conditions or anaesthetic use)
. sildenafil (e.g. for erectile dysfunction)
Some medicines reduce the effect of Ciprofloxacin tablets. Tell yourdoctor ifyou take or wish to take:
• antacids
• omeprazole
• mineral supplements
• sucralfate
• a polymeric phosphate binder (e.g. sevelamer or lanthanum carbonate)
. medicines or supplements containing calcium, magnesium, aluminium oriron
If these preparations are essential, take Ciprofloxacin tablets about two hours before or no sooner than four hours after them.
Ciprofloxacin tablets with food and drink
Unless you take 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
Ifyou are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
It is preferable to avoid the use of Ciprofloxacin tablets during pregnancy.
Do not take Ciprofloxacin tablets during breastfeeding 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, talkto yourdoctor.
3. How to take Ciprofloxacin tablets
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist ifyou are not sure.
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 ifyou sufferfrom 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.
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 this medicine.
Ifyou 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.
Ifyou 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.
Ifyou 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. Ifyou 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.
Ifyou have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
Stop taking Ciprofloxacin tablets and see a doctor or go to a hospital straight away if you notice any of the following serious side effects- you may need urgent medical attention:
Rare: may affect up to 1 in 1,000 people
• allergic reaction, swelling (oedema), or rapid swelling of the skin and mucous membranes (angio-oedema)
. inflammation of the bowel (colitis) linked to antibiotic use (can be fatal in very rare cases) (see Section 2: Warnings and precautions)
• liverdisorders, jaundice (cholestaticicterus), or hepatitis
• decreased blood sugar (hypoglycaemia) (see Section 2: Warnings and precautions)
Very rare: may affect up to 1 in 10,000 people
• severe allergic reactions (anaphylactic reaction or anaphylactic shock, which can be fatal - serum sickness) (see Section 2: Warnings and precautions)
« 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)
• inflammation of the wall of the blood vessels (vasculitis)
• inflammation of pancreas which includes symptoms such as severe upper stomach pain, often with nausea and vomiting (pancreatitis)
• muscle pain and/or weakness, inflammation of the joints and joint pain, increased muscle tone and cramping, inflammation of the tendons or tendon rupture, particularly affecting the large tendon at the back of the ankle (Achilles tendon) - see section 2
Not known: frequency cannot be estimated from the available data
• 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).
■ unusual feelings of pain, burning tingling, numbness or muscle weakness in the extremities (neuropathy)- see section 2
Other side effects
Common: may affect up to 1 in 10 people
• nausea, diarrhea
• joint pains in children
Uncommon: may affect up to 1 in 100 people
■ fungal superinfections
• a high concentration of eosinophils, a type of white blood cell
• decreased appetite
• hyperactivity or agitation
• headache, dizziness, sleeping problems, ortaste disorders
• vomiting, abdominal pain, digestive problems such as stomach upset (indigestion/heartbum), 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: may affect up to 1 in 1,000 people « changes to the blood count (leukopenia, leukocytosis, neutropenia, anaemia), increased or decreased amounts of a blood clotting factor (thrombocytes)
• increased blood sugar (hyperglycaemia)
• confusion, disorientation, anxiety reactions, strange dreams, depression (potentially leading to thoughts of suicide, suicide attemps, or completed suicide), or hallucinations, pins and needles, unusual sensitivity to stimuli of the senses, decreased skin sensitivity, tremors, seizures (see Section 2: Warnings and precautions), or giddiness
• eyesight problems, including double vision
• tinnitus, lossof hearing, impaired hearing
■ rapid heartbeat (tachycardia)
■ expansion ofblood vessels (vasodilation), lowblood pressure,
orfainting
. shortnessofbreath, including asthmatic symptoms . sensitivity to light (see Section 2: Warning and precautions)
. kidney failure, blood or crystals in the urine (see Section 2: Warnings and precautions), urinary tract inflammation
• fluid retention or excessive sweating
• increased levels of the enzyme amylase
Very rare: may affect up to 1 in 10,000 people
• 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: Warnings and precautions)
• mental disturbances (psychotic reactions potentially leading to thoughts of suicide, suicide attempts, or completed suicide) (see Section 2: Warnings and precautions)
. migraine, disturbed coordination, unsteady walk (gait disturbance), disorder of sense of smell (olfactory disorders), pressure on the brain (intracranial pressure and pseudotumor cerebri)
• visual colour distortions
• death of liver cells (liver necrosis) very rarely leading to life-threatening liverfailure
Not known (frequency cannot be estimated from the available data)
. pustular rash
. influence on blood clotting (in patients treated with Vitamin K antagonists)
• Feeling highly excited (mania) or feeling great optimism and overactivity (hypomania), hypersensitivity reaction called DRESS (Drug Reaction with Eosinophilia and Systemic Symptoms)
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Ciprofloxacin tablets
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date, which is stated on the blister or carton after “EXP”: The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other Information What Ciprofloxacin tablets contain
The active substance is ciprofloxacin.
Other ingredients are microcrystalline cellulose, maize starch, magnesium stearate, talc, colloidal anhydrous silica, sodium starch glycolate (type A), hypromellose, macrogol 400 and titanium dioxide (E171).
Ciprofloxacin tablets come in two strengths containing 250mg and 500mg of ciprofloxacin.
What Ciprofloxacin tablets look like and contents of the pack
Ciprofloxacin 250 mg Film-coated Tablets are white, round film-coated tablets debossed with '250' on one side and plain on the otherside.
Each tablet contains 250 mg of the active ingredient ciprofloxacin (as ciprofloxacin hydrochloride).
Ciprofloxacin 500 mg Film-coated Tablets are white, capletshaped film-coated tablets debossed with '500' on one side and plain on the other side.
Each tablet contains 500 mg of the active ingredient ciprofloxacin (as ciprofloxacin hydrochloride).
The tablets are available as blister packs of 1,8,10,14,16,20, 28,32 or 100 tablets.
Not all pack sizes maybe marketed.
The marketing authorisation holder and manufacturer
Marketing Authorisation Holder:
Ranbaxy (UK) Limited 5th floor, Hyde Park, Hayes 3 11 Millington Road Hayes, UB34AZ United Kingdom
Manufacturer:
TerapiaSA 124 Fabricii Street,
400 632 Cluj Napoca,
Romania
Sun Pharmaceutical Industries Europe BV Polarisavenue87,2132 JH, Hoofddorp The Netherlands
This leaflet was last revised in June 2016.
Advice/medical education
Antibiotics are used to cure bacterial infections. They are ineffective against viral infections.
If yourdoctor has prescribed antibiotics, you need them precisely for yourcurrent 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 ifyou do not respect appropriate:
- dosages
- schedules ?
- duration of treatment §
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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 ifyou 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 chemist's shop to ensure they will be disposed of correctly.