Ciprofloxacin 500mg film-coated tablets

• 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 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.

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

• if you are allergic to ciprofloxacin, to other quinolone drugs or to any of the other ingredients of this medicine (listed in section 6).
• if you are taking tizanidine (see Section 2: Other medicines and Ciprofloxacin)

Talk to your doctor or pharmacist before taking Ciprofloxacin.

• You should not take fluoroquinolone/quinolone antibacterial medicines, including Ciprofloxacin, if you have experienced any serious adverse reaction in the past when taking a quinolone or fluoroquinolone. In this situation, you should inform your doctor as soon as possible.
• if you have ever had kidney problems because your treatment may need to be adjusted
• if you 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 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 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 2: Other medicines and Ciprofloxacin).
• 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.
• if you have been diagnosed with an enlargement or “bulge” of a large blood vessel (aortic aneurysm or large vessel peripheral aneurysm).
• if you have experienced a previous episode of aortic dissection (a tear in the aorta wall).
• if you have been diagnosed with leaking heart valves (heart valve regurgitation).
• if you have a family history of aortic aneurysm or aortic dissection or congenital heart valve disease, or other risk factors or predisposing conditions (e.g. connective tissue disorders such as Marfan syndrome, or Ehlers-Danlos syndrome, Turner syndrome, Sjögren’s syndrome [an inflammatory autoimmune disease], or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behcet’s disease, high blood pressure, or known atherosclerosis, rheumatoid arthritis [a disease of the joints] or endocarditis [an infection of the heart]).

If you feel sudden, severe pain in your abdomen, chest or back, which can be symptoms of aortic aneurysm and dissection, go immediately to an emergency room. Your risk may be increased if you are being treated with systemic corticosteroids.

• If you start experiencing a rapid onset of shortness of breath, especially when you lie down flat in your bed, or you notice swelling of your ankles, feet or abdomen, or a new onset of heart palpitations (sensation of rapid or irregular heartbeat), you should inform a doctor immediately.

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 your doctor.

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, chest pain, shortness of breath, feeling dizzy, sick or faint, or experiencing dizziness when standing up. If this happens, stop taking Ciprofloxacin and contact your doctor or medical emergencies immediately.
• Prolonged, disabling and potentially irreversible serious side effects
  Fluoroquinolone/quinolone antibacterial medicines, including ciprofloxacin, have been associated with rare but serious side effects, some of them being long lasting (continuing for months or years), disabling or potentially irreversible. This includes tendon, muscle and joint pain of the upper and lower limbs, difficulty in walking, abnormal sensations such as pins and needles, tingling, tickling, numbness or burning (paraesthesia), sensory disorders including impairment of vision, taste and smell, and hearing, mental health effects which may include, but are not necessarily limited to, anxiety, panic attacks, confusion, or depression, memory impairment, severe fatigue, and severe sleep disorders. There are no medicines that have been established as being effective treatments for the symptoms of long lasting or disabling side effects associated with fluoroquinolones.
  If you experience any of these side effects after taking ciprofloxacin, then do not take any further doses and contact your doctor immediately. You and your doctor will decide on whether to continue treatment, considering alternative options.
• You may experience psychiatric reactions when taking Ciprofloxacin, including when taking it for the first time. If you suffer from depression or psychosis, your symptoms may become worse under treatment with Ciprofloxacin, in rare cases, depression or psychosis can progress to thoughts of suicide or suicide attempts. If this happens, stop taking Ciprofloxacin, and contact your doctor immediately. You may not notice some changes in your mood and behaviour so it is very important to tell your friends and family that you are taking Ciprofloxacin, and that there may be rare psychiatric side effects. Others may notice changes and help you quickly identify any symptoms that you need to talk to your doctor about.
• Pain and swelling in the joints and inflammation or rupture of tendons may occur rarely. Your risk is increased if you are elderly (above 60 years of age), have received an organ transplant, have kidney problems or if you are being treated with corticosteroids. Inflammation and ruptures of tendons may occur within the first 48 hours of treatment and even up to several months after stopping of Ciprofloxacin therapy. At the first sign of pain or inflammation of a tendon (for example in your ankle, wrist, elbow, shoulder or knee), stop taking Ciprofloxacin, contact your doctor 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 seizure happens, stop taking Ciprofloxacin and contact your doctor immediately.
• Quinolone antibiotics may cause an increase of your blood sugar levels above normal levels (hyperglycaemia), or lowering of your blood sugar levels below normal levels, potentially leading to loss of consciousness (hypoglycaemic coma) in severe cases (see section 4). This is important for people who have diabetes. If you suffer from diabetes, your blood sugar should be carefully monitored.
• You may rarely experience symptoms of nerve damage (neuropathy) such as pain, burning, tingling, numbness and/or weakness especially in the feet and legs or hands and arms. If this happens, stop taking Ciprofloxacin and inform your doctor immediately in order to prevent the development of potentially irreversible condition.
• If your eyesight becomes impaired or if your eyes seem to be otherwise affected, consult an eye specialist 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 and contact your doctor immediately, as this can be life-threatening. Do not take medicines that stop or slow down bowel movements.
• Tell the doctor or laboratory staff that you are taking Ciprofloxacin if you 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 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, 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.
• 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.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

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.

• Vitamin K antagonists (e.g. warfarin, acenocoumarol, phenprocoumon or fluindione) or other oral anti-coagulants (to thin the blood)
• theophylline (for breathing problems)
• phenytoin ( for epilepsy)
• probenecid ( for gout)
• ropinirole ( for Parkinson’s disease)
• methotrexate (for certain types of cancer, psoriasis, rheumatoid arthritis)
• tizanidine (for muscle spasticity in multiple sclerosis)
• olanzapine (an antipsychotic)
• clozapine (an antipsychotic)
• 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 antiarrhythmics (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some antimicrobials (that belong to the group of macrolides), some antipsychotics.
• zolpidem (for sleep disorders)

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

• pentoxifylline (for circulatory disorders)
• caffeine
• duloxetine (for depression, diabetic nerve damage or incontinence)
• lidocaine (for heart conditions or anaesthetic use)
• sildenafil (e.g. for erectile dysfunction)
• agomelatine (for depression)

Some medicines reduce the effect of Ciprofloxacin. Tell your doctor if you 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 or iron

If these preparations are essential, take Ciprofloxacin about two hours before or no sooner than four hours after them.

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.

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 during pregnancy.

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

Ciprofloxacin may make you feel less alert. Some neurological adverse events can occur. Therefore, make sure you know how you react to Ciprofloxacin before driving a vehicle or operating machinery. If in doubt, talk to your doctor.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

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.

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.

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.

• Increase of your blood sugar levels (hyperglycaemia) or lowering of your blood sugar levels leading to coma (hypoglycaemic coma). This is important for people that have diabetes.

Cases of an enlargement and weakening of the aortic wall or a tear in the aortic wall (aneurysms and dissections), which may rupture and may be fatal, and of leaking heart valves have been reported in patients receiving fluoroquinolones. See also section 2.

If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed-in this leaflet. You can also report side effects (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

The United Kingdom

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• The active substance is ciprofloxacin (as hydrochloride).
  Each film-coated tablet contains 250 mg ciprofloxacin (as hydrochloride).
  Each film-coated tablet contains 500 mg ciprofloxacin (as hydrochloride).
  Each film-coated tablet contains 750 mg ciprofloxacin (as hydrochloride).
• The other ingredients are:
  Tablet core: Cellulose microcrystalline, sodium starch glycolate (Type A), povidone (K 30), silica, colloidal anhydrous, magnesium stearate.
  Film coating: Hypromellose, titanium dioxide (E 171), macrogol 400.

Film- coated tablet.

Ciprofloxacin 250 mg film-coated tablets

White to off white, round shaped (diameter 11.1 mm), film coated tablets, with a score line on one side and debossed with ‘F’ and ‘23’ with a score line in between on the other side. The tablet can be divided into equal doses.

Ciprofloxacin 500 mg film-coated tablets

White to off white, capsule shaped, film coated tablets, with a score line on one side and debossed with ‘F22’ on the other side. The tablet can be divided into equal doses. The size is 18.2 mm x 8.1 mm

Ciprofloxacin 750 mg film-coated tablets

White to off white, capsule shaped, film coated tablets, debossed with ‘C’ on one side and ‘93’ on the other side. The size is 22.3 mm x 8.2 mm

Ciprofloxacin film-coated tablets are available in blister packs.

Pack sizes: 1, 8, 10, 14, 16, 20, 50 and 100 film-coated tablets

Not all pack sizes may be marketed

Or