Ciprofloxacin 100mg Film-Coated Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Ciprofloxacin 100 mg Film Coated Tablets
(Ciprofloxacin Hydrochloride)
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 your 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.
In this leaflet:
1. What Ciprofloxacin is and what it is used for
2. Before you take Ciprofloxacin
3. How to take Ciprofloxacin
4. Possible side effects
5. How to store Ciprofloxacin
6. Further information
1. WHAT CIPROFLOXACIN IS AND WHAT IT IS USED FOR
The name of your medicine is Ciprofloxacin 100mg Film Coated Tablets. In the rest of this leaflet your medicine will be called Ciprofloxacin.
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
• to prevent infections in patients with a very low white blood cell count
• 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 (a hereditary disease affecting multiple organs of the body mainly the lung)
• complicated urinary tract infections, including infections that have reached the kidneys
• anthrax inhalation exposure
Ciprofloxacin may also be used to treat other specific severe infections in children and adolescents when your doctor considers this necessary.
2. BEFORE YOU TAKE CIPROFLOXACIN
Do not take Ciprofloxacin
• if you are allergic (hypersensitive) to the active substance, to other quinolone drugs or to any of the other ingredients of Ciprofloxacin (see section 6)
• if you are taking tizanidine (see Section 2)
Take special care with Ciprofloxacin
Before taking Ciprofloxacin, tell your doctor:
• if you have ever had kidney problems because your treatment may need to be adjusted
• if you suffer from fits/seizures (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 beats (arrhythmias)
Heart problems
Caution should be taken when using this kind of medicine, if you were born with or have family history ofprolonged 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).
While 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 which causes difficulty in breathing or dizziness or swelling of the face or throat. If this happens, you should 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. You should avoid any unnecessary exercise, as this might increase the risk of a tendon rupture.
• If you suffer from epilepsy (fits/seizure) or other neurological conditions such as stroke, you may experience side effects associated with the central nervous system. If this happens, you should 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. If this happens, you should 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, you should 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, you should 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 or whites of eyes), dark urine, itching, or tenderness of the stomach, you should 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. (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 reduction in red blood cells which can make the skin pale and cause weakness or breathlessness
• Your skin becomes more sensitive to sunlight or ultraviolet (UV) light when taking Ciprofloxacin. You should avoid exposure to strong sunlight, or artificial UV light such as sunbeds while taking ciprofloxacin.
Taking 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), 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.
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
• probenecid (for gout)
• methotrexate (for certain types of cancer, psoriasis (a skin disorder), rheumatoid arthritis)
• theophylline (for breathing problems)
• tizanidine (for muscle spasticity in multiple sclerosis)
• clozapine (an antipsychotic)
• ropinirole {for Parkinson’s disease (a neurological disorder with tremor or shaking, stiffness and shuffling)}
• phenytoin (for (fits/seizure(epilepsy)}
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 (usually used for stomach disorders)
• 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.
Taking 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
If you are pregnant, think you might be pregnant or are planning to become pregnant, you should talk to your doctor who will decide if you can take Ciprofloxacin
Do not take Ciprofloxacin if you are breast feeding, as small amounts of the medicine may get into the milk and can be harmful for your baby.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Do not drive if you feel dizzy, tired or sleepy after taking Ciprofloxacin.
Do not use any tools or machines if you feel tired or sleepy after taking Ciprofloxacin.
3. HOW TO TAKE CIPROFLOXACIN
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. Take the tablets exactly as your doctor has told you.
Swallow the tablets with plenty of fluid. Do not chew.
Do try to take the tablets at around the same time every day.
• You can take the tablets at meal times 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.
4. POSSIBLE SIDE EFFECTS
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 side effects (affects 1 to 10 users in 100)
• Feeling sick (nausea) , diarrhoea
• joint pains in children
Uncommon side effects (affects 1 to 10 users in 1,000):
• fungal superinfections
• a high concentration of a type of white blood cell called eosinophils
• loss of appetite
• 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 weak or fever
• increase in blood alkaline phosphatase (a certain substance in the blood)
Rare side effects (affects 1 to 10 users in 10,000):
• inflammation of the bowel which causes abdominal pain or diarrhoea (colitis) linked to antibiotic use (can be fatal in very rare cases. See Section 2)
• changes to the blood count, seen in blood tests
• allergic reaction or rapid swelling of the face or throat
• increased blood sugar
• confusion, disorientation, anxiety reactions, strange dreams, depression or hallucinations
• pins and needles, unusual sensitivity or decreased skin sensitivity
• tremors (shaking), seizures (see Section 2), or giddiness
• eyesight problems
• loss of hearing, ringing in the ears (tinnitus), impaired hearing
• faster heartbeat
• expansion of the blood vessels, low blood pressure or fainting
• shortness of breath including asthmatic symptoms
• liver disorders, jaundice (yellowing of skin or whites of eyes) or inflammation of the liver (hepatitis)
• sensitivity to light (see Section 2)
• muscle pain, inflammation of the joints, increased muscle tone, or cramp
• kidney failure, blood or crystals in the urine (see Section 2)
• urinary tract inflammation
• fluid retention or excessive sweating
• abnormal levels of a clotting factor (prothrombin) or increased levels of the enzyme amylase in blood
Very rare side effects (affects less than 1 user in 10,000)
• reduced red blood cell count which can make the skin pale yellow and cause weakness or breathlessness
• a severe reduction in number of white blood cells which makes infection more likely
• a severe reduction in the number of red and white blood cells and platelets which can cause weakness, bruising or make infections more likely (pancytopenia), which may be fatal
• bone marrow depression which may be fatal (see Section 2)
• severe allergic reactions which causes difficulty in breathing or dizziness (anaphylactic reaction or anaphylactic shock, which can be fatal) (see Section 2)
• mental disturbances (see Section 2)
• migraine, disturbed coordination, unsteady walk
• disorder of the sense of smell
• increased pressure in the brain
• visual colour distortions
• inflammation of the blood vessels often with skin rash
• inflammation of the pancreas which causes severe pain in the abdomen and back (pancreatitis)
• death of liver cells 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 - a serious illnesses with blistering of the skin, mouth ,eyes and genitals)
• muscle weakness
• tendon inflammation
• tendon rupture, especially of the large tendon at the back of the ankle (Achilles tendon) (see Section 2)
• worsening of the symptoms of myasthenia gravis (a type of muscle weakness) (see Section 2)
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 limbs
- 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).
5. HOW TO STORE CIPROFLOXACIN
Store in the original package.
Keep out of the reach and sight of children.
Do not use Ciprofloxacin after the expiry date, which is stated on the blister or carton after “EXP”: The expiry date refers to the last day of the month concerned.
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.
6. FURTHER INFORMATION What Ciprofloxacin contains
The active substance is Ciprofloxacin hydrochloride. One film-coated tablet contains 116.43 mg of ciprofloxacin hydrochloride which is equivalent to 100 mg Ciprofloxacin.
The other ingredients 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 100mg Film-coated Tablets are white coloured round biconvex tablets, plain on one side, and marked with “CPX 100” 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 Aptil Pharma Limited 9th Floor, C.P House,
97-107 Uxbridge Road,
Ealing, London W5 5TL
Manufacturer
APC Pharmaceuticals and Chemicals (Europe) Limited 9th Floor, C.P House,
97-107 Uxbridge Road,
Ealing, London W5 5TL
This leaflet was last revised in 02/2013.
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:
1. dosages
2. schedules
3. 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.