Tallenj Medicine Company

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 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 Ciproxin is and what it is used for
2. Before you take Ciproxin
3. How to take Ciproxin
4. Possible side effects
5. How to store Ciproxin
6. Further in

Do not take Ciproxin if you are:

• allergic (hypersensitive) to the active substance, to other quinolone drugs or to any of the other ingredients of Ciproxin (see section 6)
• taking tizanidine (see Section 2: Taking other medicines)

Take special care with Ciproxin

Before taking Ciproxin

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 Ciproxin
• have myasthenia gravis (a type of muscle weakness)
• have a history of abnormal heart rhythms (arrythmias)

While taking Ciproxin

Tell your doctor immediately, if any of the following occurs while taking Ciproxin. Your doctor will decide whether treatment with Ciproxin 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 Ciproxin 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 Ciproxin 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 Ciproxin and contact your doctor immediately.
• You may experience psychiatric reactions the first time you take Ciproxin. If you suffer from depression or psychosis, your symptoms may become worse under treatment with Ciproxin. If this happens, stop taking Ciproxin 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 Ciproxin and contact your doctor immediately.
• Diarrhoea may develop while you are taking antibiotics, including Ciproxin, 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 Ciproxin 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 Ciproxin if you have to provide a blood or urine sample.
• Ciproxin 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 Ciproxin and contact your doctor immediately.
• Ciproxin 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 Ciproxin.
  Avoid exposure to strong sunlight, or artificial UV light such as sunbeds.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including any that you obtained without a prescription.

Do not take Ciproxin together with tizanidine, because this may cause side effects such as low blood pressure and sleepiness (see Section 2: "Do not take Ciproxin").

The following medicines are known to interact with Ciproxin in your body. Taking Ciproxin 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 or other oral anti-coagulants (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)

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

• pentoxifylline (for circulatory disorders)
• caffeine

Some medicines reduce the effect of Ciproxin. 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 Ciproxin about two hours before or no sooner than four hours after them.

Taking Ciproxin with food and drink

Unless you take Ciproxin 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

It is preferable to avoid the use of Ciproxin during pregnancy. Tell your doctor if you are planning to get pregnant.

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

Driving and using machines

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

If you take more Ciproxin 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 Ciproxin

• 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 Ciproxin

• 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.

What Ciproxin contains

The active substance is ciprofloxacin.

Each film-coated tablet contains 500 mg ciprofloxacin (as hydrochloride).

The other ingredients are:

Tablet core: cellulose microcrystalline, crospovidone, magnesium stearate, maize starch, silica colloidal anhydrous.

Film-coat: hypromellose, macrogol 4000, titanium dioxide (E171).

What Ciproxin looks like and contents of the pack

Ciproxin 500 mg tablets: oblong, nearly white to slightly yellowish film-coated tablets marked with "CIP score 500" on one side and "BAYER" on the other side.

The tablets can be divided into equal halves.

Pack sizes of 6, 8, 10, 12, 14, 16, 20, 28, 50, 100, 160, or 500 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing authorisation holder

Manufacturer:

Bayer Pharma AG

Advice/medical education

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.