Ciprofloxacin 750mg Film-Coated Tablets
Package leaflet: Information for the user Ciprofloxacin 250 mg, 500 mg and 750 mg Film-coated Tablets
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, pharmacist or nurse.
- This medicine has been prescribed for you 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
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. How to take Ciprofloxacin Tablets
4. Possible side effects
5. How to store Ciprofloxacin Tablets
6. Contents of the pack and other information
1. What Ciprofloxacin Tablets are and what they are used for
Ciprofloxacin 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
Ciprofloxacin is used in adults to treat the following bacterial infections:
- respiratory tract infections
- long lasting or recurring ear or sinus infections
- urinary tract infections
- infections of the testicles
- genital organ infections in women
- gastro-intestinal tract infections and intra-abdominal infections
- skin and soft tissue infections
- bone and joint infections
- to treat infections in patients with a very low white blood cell count (neutropenia)
- to prevent infections in patients with a very low white blood cell count (neutropenia)
- to prevent infections due to the bacterium Neisseria meningitidis
- anthrax inhalation exposure
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 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
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 the active substance, to other quinolone drugs or to any of the other ingredients of this medicine (listed in section 6)
- taking tizanidine (see Section 2: Taking other medicines)
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Ciprofloxacin Tablets:
- if you have ever had kidney problems because your treatment may need to be adjusted
- suffer from epilepsy or other neurological conditions
- if you have a history of tendon problems during previous treatment with antibiotics such as ciprofloxacin
- if you have myasthenia gravis (a type of muscle weakness)
- if you have a history of abnormal heart rhythms (arrythmias)
Heart problems
Caution should be taken when using this kind of medicine, 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 Other medicines and Ciprofloxacin Tablets).
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. 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. If you suffer from depression, psychosis or suicidal thoughts, your symptoms may become worse under treatment with ciprofloxacin. 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, 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 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 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 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. Avoid exposure to strong sunlight, or artificial UV light such as sunbeds.
Other medicines and Ciprofloxacin Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
You must tell your doctor if you are taking 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.
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 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, acenocoumarol, phenprocoumon or fluindione (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)
- clozapine (an antipsychotic)
- ropinirole (for Parkinson’s disease)
- phenytoin (for epilepsy)
- olanzapine (for schizophrenia and bipolar disorder)
- metoclopramide (for nausea)
- omeprazole (for indigestion and peptic ulcer disease)
- cyclosporin (for immune suppression post organ transplant)
- glibenclamide (for diabetes)
- duloxetine (for depression)
- lidocaine (a local anesthetic)
- sildenafil (for erectile dysfunction)
Ciprofloxacin may increase the levels of the following medicines in your blood:
- pentoxifylline (for circulatory disorders)
- caffeine
Some medicines reduce the effect of Ciprofloxacin Tablets. Tell your doctor if you take or wish to take:
- antacids
- 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 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
If you 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 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
Always take this medicine exactly as your doctor or pharmacist has told you. Check with you
doctor or pharmacist if you are not sure.
Your doctor will explain to you exactly how much ciprofloxacin 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.
- Swallow the tablets with plenty of fluid. Do not chew the tablets because they do not taste nice.
- Do try to take the tablets at around the same time every day.
- 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 further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you get any of the side effects talk to you doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet.
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):
- 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, suicidal thoughts 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
- 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
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, suicidal thoughts (psychotic reactions) (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 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 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)
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
- Heart problems - 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)
- red swollen area with numerous small pustules (Acute generalised exanthematous putulosis (AGEP))
- changes in blood test results in patients also receiving Vitamins K antagonists e.g. warfarin, acenocoumarol, phenprocoumon or fluindione
5. How to store Ciprofloxacin Tablets
Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Store in the original packaging.
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.
Do not throw away any medicines via wastewater or with household waste. Ask your pharmacist how to throw away any medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information What Ciprofloxacin Tablets contain
- The active substance (the ingredient that makes the tablets work) is ciprofloxacin hydrochloride. Each tablet contains either 250 mg, 500 mg or 750 mg of the active ingredient.
- The other ingredients are microcrystalline cellulose, crospovidone, silica colloidal anhydrous, magnesium stearate, hypromellose, macrogol 400 and titanium dioxide (E171).
What Ciprofloxacin Tablets look like and contents of the pack
Ciprofloxacin Tablets are white or yellowish, biconvex, film-coated tablets with the following sizes, shape and markings:
- 250 mg tablets are 11 mm, round, scored on both sides and side wall scored, marked C250 on one side.
- 500 mg tablets are 8.2 x 17 mm, oval, scored on one side and side wall scored, marked C500 on one side.
- 750 mg tablets are 10 x 19 mm, oval, scored on one side and side wall scored, marked C750 on one side.
The pack sizes are 10, 20 and 100 tablets.
Not all pack sizes may be available.
Marketing Authorisation Holder
Aptil Pharma Limited, 9th Floor, CP House, 97-107 Uxbridge Road, Ealing, London, W5 5TL Manufacturer
Actavis hf, Reykjavikurvegi 78, 222 Hafnarfjordur, Iceland. or
Actavis Limited, BLB016 Bulebel Industrial Estate, Zejtun ZTN 3000, Malta. or
Actavis Nordic A/S, Ornegardsvej 16, 2820 Gentofte, Denmark.
This leaflet was last revised in 09/2012
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
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 chemist’s shop to ensure they will be disposed of correctly.