Package leaflet: Information for the patient

Ciproxin® solution for infusion 100mg/50ml, 200mg/100ml, or 400mg/200ml

Ciprofloxacin

Read all of this leaflet carefully before you are given 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, 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 Ciproxin is and what it is used for

2.    What you need to know before you are given Ciproxin

3.    How to use Ciproxin

4.    Possible side effects

5.    How to store Ciproxin

6.    Contents of the pack and other information

1. What Ciproxin is and what it is used for

Ciproxin contains the active substance ciprofloxacin. Ciprofloxacin is an antibiotic belonging to the fluoroquinolone family. Ciprofloxacin works by killing bacteria that cause infections. It only works with specific strains of bacteria.

Adults

Ciproxin is used in adults to treat the following bacterial infections:

•    respiratory tract infections

•    long lasting or recurring ear or sinus infections

•    urinary tract infections

•    genital tract infections in men and women

•    gastro-intestinal tract infections and intra-abdominal infections

•    skin and soft tissue infections

•    bone and joint infections

•    anthrax inhalation exposure

Ciprofloxacin may be used in the management of patients with low white blood cell counts (neutropenia) who have a fever that is suspected to be due to a bacterial infection.

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 Ciproxin.

Children and adolescents

Ciproxin 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

Ciproxin may also be used to treat other specific severe infections in children and adolescents when your doctor considered this necessary.

2. What you need to know before you are given Ciproxin

You must not be given Ciproxin:

•    if you are allergic to the active substance, 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 Ciproxin)

Warnings and precautions

Talk to your doctor before you are given Ciproxin

•    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 Ciproxin.

•    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 Ciproxin).

•    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.

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.

While under treatment with Ciproxin

Tell your doctor immediately, if any of the following occurs during treatment with 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 rare chance that you may experience a severe allergic reaction with the following symptoms: tightness in the chest, feeling dizzy, feeling sick or faint, or experience dizziness on standing. If this happens, tell your doctor immediately since the administration of Ciproxin will have to be stopped.

•    Pain and swelling in the joints, and tendinitis may occur occasionally, particularly if you are elderly and are also being treated with corticosteroids. Inflammation and ruptures of tendons may occur even within the first 48 hours of treatment or up to several months after discontinuation of Ciproxin therapy. At the first sign of any pain or inflammation Ciproxin will have to be stopped, 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 after first administration of ciprofloxacin. If you suffer from depression or psychosis, your symptoms may become worse under treatment with Ciproxin. In rare cases, depression or psychosis can progress to thoughts of suicide, suicide attempts, or completed suicide. 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.

•    Hypoglycemia has been reported most often in diabetic patients, predominantly in elderly population. If this happens, contact your doctor immediately.

•    Diarrhoea may develop while you are on antibiotics, including Ciproxin, or even several weeks after you have stopped using them. If it becomes severe or persistent or you notice that your stool contains blood or mucus tell your doctor immediately. Ciproxin treatment will have to be stopped 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 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, Ciproxin must be stopped 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.

•    If you suffer from kidney problems, tell the doctor because your dose may need to be adjusted.

•    Your skin becomes more sensitive to sunlight or ultraviolet (UV) light under treatment with Ciproxin. Avoid exposure to strong sunlight or artificial UV light such as sunbeds.

Other medicines and Ciproxin

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

Do not use Ciproxin together with tizanidine, because this may cause side effects such as low blood pressure and sleepiness (see Section 2: You must not be given Ciproxin).

The following medicines are known to interact with Ciproxin in your body. Using Ciproxin together with these medicines can influence the therapeutic effect of these medicines. It can also increase the probability of experiencing side effects.

Tell your doctor if you are taking:

•    Vitamin K antagonists (e.g. warfarin, acenocoumarol, phenprocoumon or fluindione) 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)

•    olanzapine (an antipsychotic)

•    clozapine (an antipsychotic)

•    ropinirole (for Parkinson’s disease)

•    phenytoin (for epilepsy)

•    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 anti-arrhythmics (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some antimicrobials (that belong to the group of macrolides), some antipsychotics.

Ciproxin 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)

Ciproxin with food and drink

Food and drink does not affect your treatment with Ciproxin.

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 or pharmacist for advice before taking this medicine.

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

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 doctor.

Ciproxin contains sodium

Ciproxin contains 900mg sodium chloride per 100ml of solution, therefore this medicine may not be suitable for you if you are on a low sodium diet. Check with your doctor if you are unsure about this.

3. How to use Ciproxin

Your doctor will explain to you exactly how much Ciproxin you will be given 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.

Treatment usually lasts between 5 and 21 days, but may be longer for severe infections.

Your doctor will give you each dose by slow infusion through a vein into your bloodstream. For children, the infusion duration is 60 minutes. In adult patients, infusion time is 60 minutes for 400 mg Ciproxin and 30 minutes for 200 mg Ciproxin. Administering the infusion slowly helps prevent immediate side effects occurring.

Remember to drink plenty of fluids while you are taking this medicine.

If you stop your course of 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 using 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 further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common:

may affect up to 1 in 10 people

-    nausea, diarrhoea, vomiting

-    joint pains in children

-    local reaction at the injection site, rash

-    temporary increased amounts of substances in the blood (transaminases)

Uncommon:

may affect up to 1 in 100 people

-    fungal superinfections

-    a high concentration of eosinophils, a type of white blood cell, increased or decreased amounts of a blood cloting factor (thrombocytes)

-    decreased appetite

-    hyperactivity, agitation, confusion, disorientation, hallucinations

-    headache, dizziness, sleeping problems, taste disorders, pins and needles, unusual sensitivity to stimuli of the senses, seizures (see Section 2: Warnings and precautions), giddiness

-    eyesight problems including double vision

-    loss of hearing

-    rapid heartbeat (tachycardia)

-    expansion of the blood vessels (vasodilation), low blood pressure

-    abdominal pain, digestive problems such as stomach upset (indigestion/heartburn), wind

-    liver disorders, increased amounts of one substance in the blood (bilirubin), jaundice (cholestatic icterus)

-    itching, hives

-    joint pain in adults

-    poor kidney function, kidney failure

-    pains in your muscles and bones, feeling unwell (asthenia), fever, fluid retention

-    increase in blood alkaline phosphatase (a certain substance in the blood)

The following information is intended for medical or healthcare professionals only

Ciproxin should be administered by intravenous infusion. For children, the infusion duration is 60 minutes. In adult patients, infusion time is 60 minutes for 400 mg Ciproxin and 30 minutes for 200 mg Ciproxin. Slow infusion into a large vein will minimise patient discomfort and reduce the risk of venous irritation. The infusion solution can be infused either directly or after mixing with other compatible infusion solutions.

Unless compatibility with other infusion solutions/drugs has been confirmed, the infusion solution must always be administered separately. The visual signs of incompatibility are e.g. precipitation, clouding, and discolouration.

Incompatibility appears with all infusion solutions/drugs that are physically or chemically unstable at the pH of the solution (e.g. penicillin, heparin solutions), especially in combination with solutions adjusted to an alkaline pH (pH of the ciprofloxacin infusion solutions: 3.9-4.5).

After intravenous initiation of treatment, the treatment can be continued orally as well.

81122083

PMR 81122083 (93/04/MU-0201206629) Pantone: SCHWARZ, REFLEXBLUE

Rare:

may affect up to 1 in 1,000 people

-    inflammation of the bowel (colitis) linked to antibiotic use (can be fatal in rare cases) (see Section 2: Warnings and precautions)

-    changes to the blood count (leukopenia, leukocytosis, neutropenia, anaemia), a drop in the number of red and white blood cells and platelets (pancytopenia), which may be fatal, bone-marrow depression which may also be fatal (see Section 2: Warnings and precautions)

-    allergic reaction, allergic swelling (oedema), rapid swelling of the skin and mucous membranes (angiooedema), severe allergic reaction (anaphylactic shock) which can be life-threatening (see Section 2: Warnings and precautions)

-    increased blood sugar (hyperglycemia)

-    decreased blood sugar (hypoglycaemia) (see Section 2: Warnings and precautions)

-    anxiety reaction, strange dreams, depression (potentially leading to thoughts of suicide, suicide attempts, or completed suicide), mental disturbances (psychotic reactions potentially leading to thoughts of suicide, suicide attempts, or completed suicide) (see Section 2: Warnings and precautions)

-    decreased skin sensitivity, tremor, migraine, disorder of sense of smell (olfactory disorders)

-    tinnitus, impaired hearing

-    fainting, inflammation of the blood vessel (vasculitis)

-    shortness of breath including asthmatic symptoms

-    pancreatitis

-    hepatitis, death of liver cells (liver necrosis) very rarely leading to life-threatening liver failure

-    sensitivity to light (see Section 2: Warnings and precautions), small, pin-point bleeding under the skin (petechiae)

-    muscle pain, inflammation of the joints, increased muscle tone, cramping, tendon rupture - especially of the large tendon at the back of the ankle (Achilles tendon) (see Section 2: Warnings and precautions)

-    blood or crystals in the urine (see Section 2: Warnings and precautions), urinary tract inflammation

-    excessive sweating

-    increased levels of the enzyme amylase

Very rare:

may affect up to 1 in 10,000 people

-    a special type of reduced red blood cell count (haemolytic anaemia); a dangerous drop in a type of white blood cells (agranulocytosis)

-    severe allergic reaction (anaphylactic reaction, anaphylactic shock, serum sickness) which can be fatal (see Section 2: Warnings and precautions)

-    disturbed coordination, unsteady walk (gait disturbance), pressure on the brain (intracranial pressure and pseudotumor cerebri)

-    visual colour distortions

-    various skin eruptions or rashes (e.g. the potentially fatal Stevens-Johnson syndrome or toxic epidermal necrolysis)

-    muscle weakness, tendon inflammation, worsening of the symptoms of myasthenia gravis (see Section 2: Warnings and precautions)

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 extremities (peripheral neuropathy and polyneuropathy)

-    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)

-    pustular rash

-    influence on blood clotting (in patients treated with Vitamin K antagonists)

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 (see details below). By reporting side effects, you can help provide more information on the safety of this medicine.

United Kingdom

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

Malta

ADR Reporting The Medicines Authority Post-Licensing Directorate 203 Level 3, Rue D’Argens GZR-1368 Gzira

Website: www.medicinesauthority.gov.mt e-mail: postlicensing.medicinesauthority@gov.mt

5. How to store Ciproxin

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 carton and the bottle after “EXP”: The expiry date refers to the last day of that month.

Keep the bottle in the outer carton in order to protect from light. Do not refrigerate or freeze.

At cool storage temperatures precipitation may occur, which will re-dissolve at room temperature (15°C - 25°C).

Chemical and physical in-use stability has been demonstrated for 24 hours at room temperature (15°C to 25°C). From a microbiological point of view, unless the method of opening and mixing with co-infusion solutions precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Ciproxin contains

The active substance is ciprofloxacin.

Each glass bottle with 50 mL infusion solution contains 100 mg of ciprofloxacin.

Each glass bottle with 100 mL infusion solution contains 200 mg of ciprofloxacin.

Each glass bottle with 200 mL infusion solution contains 400 mg of ciprofloxacin.

The other ingredients are: lactic acid solution 20%, sodium chloride, hydrochloric acid concentrated, water for injections.

What Ciproxin looks like and contents of the pack

Solution for infusion

Clear, nearly colourless to slightly yellowish solution.

Pack sizes of 1 or 5 bottles containing 50 mL of solution for infusion each.

Pack sizes of 1, 5 or 40 bottles containing 100 mL of solution for infusion each.

Pack sizes of 1 or 5 bottles containing 200 mL of solution for infusion each.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation holder:    Bayer plc,

Bayer House,

Strawberry Hill,

Newbury,

Berkshire RG14 1JA

Manufacturer:    Bayer Pharma AG, Leverkusen, Germany

This medicinal product is authorised in the Member States of the EEA under the following names:

Austria:    Ciproxin

Belgium:    Ciproxine

Cyprus:    Ciproxin

Czech Republic    Ciprobay

France:    Ciflox

Germany:    Ciprobay

Greece:    Ciproxin

Ireland:    Ciproxin

Italy:    Ciproxin

Luxembourg:    Ciproxine

Malta:    Ciproxin

Portugal:    Ciproxina

Slovenia:    Ciprobay

United Kingdom: Ciproxin

This leaflet was last revised in September 2013 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:

-    dosage

-    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.

Bayer 81122083

PMR 81122083 (93/04/MU-0201206629) Pantone: SCHWARZ, REFLEXBLUE

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