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Ciprofloxacin 500mg Film-Coated Tablets

Document: leaflet MAH GENERIC_PL 11311-0413 change

PATIENT INFORMATION LEAFLET

Ciprofloxacin 100mg, 250mg, 500mg and 750mg Film-Coated Tablets

Read all of this leaflet carefully before you start using 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, please ask your doctor or your 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:

Q What Ciprofloxacin is and what it is used for    M Possible side effects

2 What you need to know before you take Ciprofloxacin    Q How to store Ciprofloxacin

3    How to take Ciprofloxacin    Q Contents of the pack and other information


What Ciprofloxacin is and what it is 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 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 and prevent infections in patients with a very low white blood cell count (neutropenia)

■    To prevent infections caused by 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 other 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 if your doctor considers this necessary.

What you need to know before you take Ciprofloxacin_

Do not take Ciprofloxacin if:

■    You are allergic (hypersensitive) to Ciprofloxacin, to other quinolone medicines or any of the other ingredients of Ciprofloxacin (see section 6 "Contents of the pack and other information”)

■    You are taking tizanidine (see "Other medicines and Ciprofloxacin” section)

Warnings and precautions

Talk to your doctor before taking Ciprofloxacin:

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 "Other medicines and Ciprofloxacin” section).

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 (arrhythmias)

■    Are suffering from an infection caused by a bacteria called neisseria gonorrhoeae that is resistant to Ciprofloxacin treatment

■    Are suffering from an infection caused by E-coli as it may be resistant to Ciprofloxacin treatment

■    Are diabetic, especially if you are older. Careful monitoring of blood sugar levels is recommended

If your eyesight becomes impaired or if your eyes seem to be otherwise affected, consult an eye specialist immediately.

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 (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 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 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 and contact your doctor immediately.

■    You may experience psychiatric reactions the first time you take Ciprofloxacin. If you suffer from depression or psychosis, your symptoms may become worse under treatment with Ciprofloxacin. You may have distressing thoughts of harming yourself or committing suicide. If 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 laboratory staff that you are taking Ciprofloxacin 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 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 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.

Other medicines and Ciprofloxacin

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription. This includes herbal 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 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 probability of experiencing side effects.

Tell your doctor if you are taking:

■    Warfarin, acenocoumarol, phenprocoumon or fluindione or other vitamin K antagonists (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) [See "Do not take Ciprofloxacin together with tizanidine” section above]

■    Clozapine, Olanzapine (antipsychotics)

■    Ropinirole (for Parkinson's disease)

■    Phenytoin (for epilepsy)

■    Metoclopramide, a medicine used to relieve feelings of sickness (nausea) or being sick (vomiting) [antiemetic]

■    Omeprazole, a medicine used to treat stomach ulcers and to relieve heartburn and indigestion (proton-pump inhibitor)

■    Cyclosporin, a medicine used to reduce the body's immunity when receiving organ transplant (immunosuppressant)

■    Duloxetine, a medicine used to treat mood and nerve disorders (serotonin-norepinephrine reuptake inhibitor)

■    Lidocaine, a medicine used to relieve pain

■    Sildenafil, a medicine used to treat erectile dysfunction

Ciprofloxacin may increase the levels of the following medicines in your blood:

■    Pentoxifylline (for circulatory disorders)

■    Caffeine

■    Agomelatine

■    Zolpidem

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 or Lanthanum Carbonate)

■    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 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 for advice before taking this medicine.

Pregnancy

It is preferable to avoid the use of Ciprofloxacin during pregnancy.

Breast-feeding

Do not take Ciprofloxacin during breast-feeding because Ciprofloxacin is excreted in breast milk and can be harmful for your child.

Driving and using machines

Ciprofloxacin may affect your reaction time. If this is experienced, avoid driving or operating machinery or pursuing any activity in which full attention is required.

How to take Ciprofloxacin

Always take Ciprofloxacin exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

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