Ciprofloxacin 750mg Film-Coated Tablets
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Package leaflet: Information for the patient
Ciprofloxacin 250, 500 and 750 mg 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 further questions, ask your doctor or pharmacist.
• 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 or pharmacist. This includes any possible side effects not listed in this leaflet.
See section 4.
What is in this leaflet:
1. What Ciprofloxacin is and what it is used for
2. What you need to know before you take Ciprofloxacin
3. How to take Ciprofloxacin
4. Possible side effects
5. How to store Ciprofloxacin
6. Contents of the pack and other information
The name of your medicine is Ciprofloxacin Film Coated Tablets which will be referred to as Ciprofloxacin throughout the rest of this leaflet.
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.
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.
Do not take Ciprofloxacin:
• allergic (hypersensitive) to the active substance, to other quinolone drugs or to any of the other ingredients of Ciprofloxacin (see section 6)
• taking tizanidine (see Section 2: Taking other medicines)
Warnings and precautions
Before taking Ciprofloxacin 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
• have myasthenia gravis (a type of muscle weakness)
• have a history of abnormal heart rhythms (arrythmias) including being born with the condition “congenital prolonged QT interval”
• elderly
• have a history of heart disease (including heart failure, heart attack, slow heartbeat)
Before taking Ciprofloxacin
Tell your doctor immediately, if any of the following occurs while
taking Ciprofloxacin. Your doctor will decide whether treatment with
Ciprofloxacin 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, swelling of face or throat. If this happens, stop taking Ciprofloxacin and contact your doctor immediately.
• Pain and swelling in the joints and tendons 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 and rest the painful area. Avoid any unnecessary exercise, as this might increase the risk of a tendon rupture. This risk can last several months after stopping treatment with Ciprofloxacin.
• 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 and contact your doctor immediately.
• You may experience psychiatric reactions the first time you take Ciprofloxacin. If you suffer from depression or mental illness, your symptoms may become worse under treatment with Ciprofloxacin. You may have thoughts of suicide or attempt suicide. If any of this happens, stop taking Ciprofloxacin 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 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
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 pharmacist that you are taking Ciprofloxacin if you have to provide a blood or urine sample for testing.
• 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 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 symptoms such as sore throat 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 anaemia 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.
• If your eyesight becomes impaired or if your eyes seem to be otherwise affected, consult an eye specialist immediately
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 week 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).
Other medicines and Ciprofloxacin
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), trycyclic antidepressants, some antimicrobials (that belong to the group of macrolides), some antipsychotics.
Do not take Ciprofloxacin together with tizanidine, because this may cause side effects such as low blood pressure and sleepiness (see Section 2: Do not take Ciprofloxacin).
The following medicines are known to interact with Ciprofloxacin in your body. Taking Ciprofloxacin together with these medicines can influence the therapeutic effect of those medicines. It can also increase the risk of side effects.
Tell your doctor if you are taking:
• warfarin or other oral anti-coagulants (to thin the blood) such as acenocoumarol, phenprocoumon, or fluindione).
• probenecid (for gout)
• methotrexate (for certain types of cancer, psoriasis, rheumatoid arthritis)
• theophylline (for breathing problems)
• clozapine or olanzapine ( antipsychotics)
• ropinirole (for Parkinson’s disease)
• phenytoin (for epilepsy)
• duloxetine (for depression)
• glibenclamide (for diabetes)
• lidocaine (a local anaesthetic)
• sildenafil (for erectile dysfunction)
• cyclosporin (for preventing rejection of transplanted organs)
• omeprezole (for indigestion and GERD)
• metoclopramide (used for preventing nausea and vomiting)
• a type of antibiotics known as macrolides e.g. azithromycin, clathrithromycin, erythromycin etc.
• medicines used to treat depression known as tricyclic antidepressants e.g. amitriptyline, clomipramine, nortriptyline etc.
• medicines used to treat irregular heartbeat e.g. quinidine, procainamide, amiodarone etc.
• medicines used for treating psychotic illnesses such as schizophrenia and bipolar disorder
Ciprofloxacin may increase the levels of the following medicines in your blood:
• pentoxifylline (for circulatory disorders)
• caffeine
Some medicines reduce the effect of Ciprofloxacin. 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 about two hours before or no sooner than four hours after them.
Ciprofloxacin with food and drink
Unless you take Ciprofloxacin 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 medicine.
Pregnancy and breast-feeding
It is preferable to avoid the use of Ciprofloxacin during pregnancy. Tell your doctor if you are planning to get pregnant.
Do not take Ciprofloxacin during breast feeding because ciprofloxacin passes into breast milk and can be harmful for your child.
Driving and using machines
Ciprofloxacin may make you feel less alert, and affect your ability to react. Therefore, make sure you know how you react to Ciprofloxacin before driving a vehicle or operating machinery. If in doubt, talk to your doctor.
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. Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. xxxxx
• 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. However, do not take Ciprofloxacin tablets with dairy products such as milk or yoghurt or drinks with added calcium (e.g. calcium-fortified orange juice)
Remember to drink plenty of fluids while you are taking Ciprofloxacin.
If you take more Ciprofloxacin 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
- 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
- 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.
Not known (frequency cannot be estimated from the available data)
- troubles associated with the nervous system such as pain, burning, tingling, numbness and/or weakness in limbs
- rapid appearance of areas of red skin studded with small blisters filled with white/yellow fluid (acute generalised exanthematous pustulosis)
- if you are taking anticoagulants the bleed time measurements (INR) being taken by your doctor may be higher (see Section 2: Take special care with Ciprofloxacin)
- 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)
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.
Store in the original package
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.
Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longeruse.
These measures will help to protect the environment.
Like all medicines, Ciprofloxacin 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 (may affect up to 1 in 10 people):
- nausea, diarrhoea
- 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
- 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 (may affect up to 1 in 1,000 people):
- inflammation of the bowel (colitis) linked to antibiotic use (can be fatal in very rare cases. See Section 2: Take special care with Ciprofloxacin)
- 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 (including ideas of suicide and attempting suicide), or hallucinations
- pins and needles, unusual sensitivity, or decreased skin sensitivity,
- tremors, seizures including seizures without fits sometime known as ‘absence seizures (non-convulsive status epilepticus) (see Section 2: Take special care with Ciprofloxacin), or giddiness
- eyesight problems including double vision (diplopia)
- loss of hearing, ringing in ears, 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)
- 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)
- urinary tract inflammation or inflammation of the kidneys
- fluid retention or excessive sweating
- abnormal levels of a clotting factor (prothrombin) or increased levels of the enzyme amylase which can be found during routine blood tests
Very rare (may affect up to 1 in 10, 000 people):
- reduced red blood cell count (haemolytic anaemia)
- reduction in a type of white blood cells (agranulocytosis );
- a reduction in the number of red and white blood cells and platelets (pancytopenia), which may be fatal;
- bone marrow depression, which may be fatal (see Section 2: Take special care with Ciprofloxacin)
- severe allergic reactions (anaphylactic reaction or anaphylactic shock, which can be fatal - serum) (see Section 2: Take special care with Ciprofloxacin)
- mental disturbances (psychotic reactions) including ideas of suicide and attempting suicide (see Section 2: Take special care with Ciprofloxacin)
- migraine, disturbed coordination, unsteady walk (gait disturbance),
- disorder of sense of smell (olfactory disorders),
- increased pressure on the brain (intracranial pressure)
- visual colour distortions
- inflammation of the wall of the blood vessels (vasculitis)
- inflammation of the pancreas (pancreatitis)
- death of liver cells (liver necrosis), very rarely leading to life-threatening liver failure
- small, pin-point bleeding under the skin
- 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);
- worsening of the symptoms of myasthenia gravis (see Section 2: Take special care with Ciprofloxacin)
What Ciprofloxacin contains
The active substance is Ciprofloxacin Hydrochloride.
One 250mg film-coated tablet contains 291.08mg of ciprofloxacin hydrochloride which is equivalent to 250mg Ciprofloxacin.
One 500mg film-coated tablet contains 582.16mg ciprofloxacin hydrochloride which is equivalent to 500mg Ciprofloxacin.
One 750mg film-coated tablet contains 873.24mg ciprofloxacin hydrochloride which is equivalent to 750mg Ciprofloxacin.
The ingredients in the tablets core are microcrystalline cellulose, croscarmellose sodium, povidone, silica colloidal anhydrous, magnesium stearate, hypromellose, talc, propylene glycol, macrogol and titanium dioxide (E171).
What Ciprofloxacin looks like and contents of the pack
Ciprofloxacin 250mg Film-coated Tablets are white coloured round biconvex tablets. Plain on one side, and marked with “CPX 250” on the reverse.
Ciprofloxacin 500mg film-coated Tablets are white capsule shaped biconvex tablets. Plain one side, and marked with 'CPX 500' and a breakline on the reverse.
Ciprofloxacin 750mg film-coated Tablets are white capsule shaped biconvex tablets. Plain on one side, and marked with 'CPX 750' on the reverse.
Ciprofloxacin is presented in blister packs of 6, 10, 20 or 100 tablets. Not all packs may be marketed.
Marketing Authorisation Holder
APC Pharmaceuticals & Chemicals (EUROPE) Ltd 9th Floor, CP House,
97-107 Uxbridge Road,
Ealing, London W5 5TL
Manufacturer
APC Pharmaceuticals & Chemicals (EUROPE) Ltd 9th Floor, CP House,
97-107 Uxbridge Road,
Ealing, London W5 5TL and
Basic Pharma Manufacturing B.V., Burgemeester Lemmensstraat 352, 6163 JT Geleen, 3 The Netherlands
This leaflet was last revised in 04/2015.
Advice/medical education
Antibiotics are used to cure bacterial infections. They are not effective against viral infections.
If your doctor has prescribed antibiotics, you need them only for your current illness.
Despite taking antibiotics, some bacteria may survive or grow. This is known as resistance, where 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 abide by the correct:
- dosages
- schedules
- duration of treatment
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. It may not be the correct medicine for their illness.
5. After completion of treatment, return all unused drugs to your pharmacist to ensure they will be disposed of correctly.
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