Package leaflet: Information for the patient

Ciprinol, 10 mg/ml, concentrate for solution for infusion
Ciprofloxacinum
Please read carefully the entire leaflet before use, as it contains
important information for the patient.

Keep this leaflet for future reference.
If you have any doubts, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

What Ciprinol is and what it is used for
Important information before using Ciprinol
How to use Ciprinol
Possible side effects
How to store Ciprinol
Contents of the package and other information

1. What Ciprinol is and what it is used for

Ciprinol contains the active substance ciprofloxacin. Ciprofloxacin is an antibiotic belonging to the fluoroquinolone group. Ciprofloxacin kills bacteria causing infections. It acts only against certain bacterial strains.

Adults
Ciprinol is used in adults for the treatment of certain bacterial infections:

Respiratory tract infections
Chronic or recurrent ear or sinus infections
Urinary tract infections
Genitourinary infections in men and women
Gonococcal urethritis or cervicitis caused by susceptible strains of Neisseria gonorrhoeae
Epididymo-orchitis, including that caused by susceptible strains of Neisseria gonorrhoeae
Pelvic inflammatory disease, including that caused by susceptible strains of Neisseria gonorrhoeae. If the physician suspects or has diagnosed that the above-mentioned genital infections are caused by Neisseria gonorrhoeae, it is particularly important to obtain local data from the physician on the prevalence of ciprofloxacin resistance and to confirm susceptibility based on appropriate laboratory tests.
Gastrointestinal tract infections and intra-abdominal infections
Skin and soft tissue infections
Bone and joint infections
Treatment and post-exposure prophylaxis of pulmonary anthrax due to inhalation of Bacillus anthracis

Ciprofloxacin may be used in the treatment of neutropenic patients (low white blood cell count) with fever suspected to be of bacterial origin.
If the infection is severe or caused by more than one type of bacteria, your doctor may prescribe an additional antibiotic to be used together with Ciprinol.

Children and adolescents
Ciprinol is used in children and adolescents under specialist medical supervision for the following bacterial infections:

Lung and bronchial infections caused by Pseudomonas aeruginosa in children and adolescents with cystic fibrosis
Complicated urinary tract infections and acute pyelonephritis
Pulmonary anthrax (post-exposure prophylaxis and treatment)

Ciprinol may also be used for the treatment of other severe infections in children and adolescents, if deemed necessary by the physician.

2. Important Information Before Using Ciprinol

When not to use Ciprinol

if the patient is allergic to the active substance, other drugs in the quinolone group, or any of the other ingredients of this medicine (listed in section 6),
in patients taking tizanidine concomitantly (see section 2 "Ciprinol with other medicines").

Warnings and precautions
Before starting treatment with Ciprinol, discuss this with your doctor, pharmacist, or
nurse.
Before using Ciprinol
Do not take antibacterial medicines containing fluoroquinolones or quinolones, including Ciprinol, if the patient has previously experienced any severe adverse reaction during treatment with a quinolone or fluoroquinolone. In such a case, inform the doctor as soon as possible.
Before starting treatment with Ciprinol, discuss this with your doctor if:

the patient has ever had kidney problems, as the dose of the medicine may need to be adjusted,
the patient suffers from epilepsy or other neurological disorders,
the patient has previously experienced tendon problems while being treated with antibiotics such as Ciprinol,
the patient has diabetes, as treatment with ciprofloxacin may carry a risk of hypoglycaemia,
the patient has myasthenia gravis (a type of muscle weakness),
the patient has been diagnosed with an aneurysm (dilatation) of a large blood vessel (aortic aneurysm or large peripheral artery),
the patient has previously experienced aortic dissection (tearing of the aortic wall),
the patient has been diagnosed with heart valve insufficiency,
there is 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 vascular Ehlers-Danlos syndrome, Turner syndrome, Sjögren's syndrome [an autoimmune inflammatory disease], or vascular diseases such as Takayasu arteritis, giant cell arteritis, Behçet's disease, hypertension, or confirmed arterial atherosclerosis, rheumatoid arthritis [joint disease], or endocarditis [heart infection]),
the patient or their family has glucose-6-phosphate dehydrogenase (G6PD) deficiency, inform the doctor – haemolytic anaemia may occur after administration of ciprofloxacin.

In the treatment of certain genitourinary infections, the doctor may prescribe another antibiotic in addition to
ciprofloxacin. If the patient's condition does not improve after three days of treatment, consult the doctor.
Heart-related disorders
Exercise caution when using this type of medicine if:

the patient has congenital or familial QT interval prolongation (visible on ECG – a test of the heart's electrical activity),
the patient has electrolyte imbalance in the blood (especially low potassium and magnesium levels),
the patient has a very slow heart rate (called bradycardia),
the patient has impaired heart function (heart failure),
the patient has suffered a myocardial infarction,
the patient is female or elderly,
the patient is taking other medicines that may cause changes in the ECG (see section 2 "Ciprinol with other medicines").

While using Ciprinol
If any of the following symptoms occur during treatment with Ciprinol, inform the doctor immediately. The doctor will decide whether treatment with Ciprinol should be discontinued:

Severe, sudden allergic reaction (anaphylactic reaction or shock, angioedema). Rare cases have been reported where even after the first dose, a severe allergic reaction may occur, with symptoms such as chest tightness, dizziness, malaise, or fainting, or dizziness upon standing. If this occurs, inform the doctor immediately, as treatment with Ciprinol must be discontinued.
Long-lasting, disabling, and potentially irreversible severe adverse effects. Antibacterial medicines containing fluoroquinolones or quinolones, including Ciprinol, have been associated with very rare but serious adverse effects (lasting for months or years), which may be disabling or potentially irreversible. These include: tendon, muscle, and joint pain in the upper and lower limbs, difficulty walking, abnormal sensations such as pricking, tingling, tickling, numbness, or burning (paresthesia), sensory disturbances, including disturbances of vision, taste, smell, and hearing, depression, memory disturbances, severe fatigue, and severe sleep disturbances. If any of these adverse effects occur after taking Ciprinol, contact the doctor immediately before continuing treatment. The patient and doctor will decide whether to continue treatment, also considering antibiotics from other groups.
Rarely, joint pain and swelling, tendon inflammation, or tendon rupture may occur. The risk is increased in elderly patients (over 60 years), after organ transplantation, in patients with kidney problems, or those receiving corticosteroid treatment. Tendon inflammation and rupture may occur within the first 48 hours of treatment or even several months after discontinuation of Ciprinol. If the first symptoms of tendon pain or inflammation occur (e.g. in the ankle, wrist, elbow, shoulder, or knee), discontinue Ciprinol, contact the doctor, and rest the affected area. Avoid excessive physical exertion, as this may increase the risk of tendon rupture.
If sudden severe abdominal, back, or chest pain occurs, which may indicate an aortic aneurysm or dissection, seek immediate emergency care. The risk of these events may be higher in patients receiving systemic corticosteroids.
If sudden shortness of breath occurs, especially when lying down, or if swelling of the ankles, feet, or abdomen, or palpitations (sensation of rapid or irregular heartbeat) are observed, consult the doctor without delay.
If the patient has epilepsy or other neurological disorders, such as cerebral ischaemia or stroke, adverse effects on the central nervous system may occur. If such an attack occurs, discontinue Ciprinol and contact the doctor immediately.
The patient may rarely experience symptoms of nerve damage (neuropathy), such as pain, burning, tingling, numbness, and/or weakness, especially in the feet and legs, and hands and arms. In such a case, discontinue Ciprinol and inform the doctor immediately to prevent the development of potentially irreversible disease.
Psychotic reactions may occur after the first dose of Ciprinol. If the patient has depression or psychosis, symptoms of these conditions may worsen during treatment with Ciprinol. Rarely, depression or psychosis may progress to suicidal thoughts, potentially leading to suicide attempts or suicide (see section 4 "Possible side effects"). If depression, psychosis, or suicidal thoughts or behaviours occur, contact the doctor immediately.
Quinolone antibiotics may cause increased blood glucose levels (hyperglycaemia) or decreased blood glucose levels below normal, which in severe cases may lead to loss of consciousness (hypoglycaemic coma) (see section 4). This is important for diabetic patients. Diabetic patients should carefully monitor their blood glucose levels.
While taking antibiotics, including Ciprinol, or even several weeks after treatment has ended, diarrhoea may occur. If it is severe or persistent, or if the patient notices blood or mucus in the stool, inform the doctor immediately. Treatment with Ciprinol will be discontinued immediately, as this may be life-threatening. Do not take medicines that inhibit or slow intestinal motility and contact the doctor.
Vision disturbances or other eye-related problems should be reported immediately to an ophthalmologist.
While taking Ciprinol, the skin becomes more sensitive to sunlight and ultraviolet (UV) radiation. Avoid exposure to strong sunlight or artificial UV radiation (e.g. in a solarium).
If the patient is providing a blood or urine sample for testing, inform the doctor or laboratory staff that Ciprinol is being taken.
If the patient has kidney problems, they should inform the doctor, as the dose of the medicine may need to be adjusted.
Ciprinol may cause liver damage. If the patient experiences symptoms such as loss of appetite, jaundice (yellowing of the skin), dark urine, itching, or stomach irritation, inform the doctor, who will advise discontinuation of Ciprinol.
Ciprinol may reduce the number of white blood cells, which may reduce resistance to infections. If, during an infection, symptoms such as fever and severe worsening of general condition or fever with local signs of infection (e.g. sore throat, pharynx, oral cavity, or urinary tract problems) occur, contact the doctor immediately. A blood test will be ordered to check for reduced white blood cell count (agranulocytosis). Remember to inform the doctor about taking this medicine.

Ciprinol with other medicines
Inform the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.
Do not take Ciprinol with tizanidine, as this may cause adverse effects such as low blood pressure and drowsiness (see section 2 "When not to use Ciprinol").
The following medicines may interact with Ciprinol in the body.
Taking Ciprinol together with these medicines may affect their therapeutic effect and may also increase the likelihood of adverse effects.
If the patient is taking any of the following medicines, inform the doctor:

vitamin K antagonists (e.g. warfarin, acenocoumarol, phenprocoumon, fluindione) or other
oral anticoagulant (blood "thinner"),
probenecid (a medicine used in gout),
metoclopramide (an antiemetic),
methotrexate (a medicine used in certain types of cancer, psoriasis, and rheumatoid arthritis),
theophylline (a medicine used in respiratory disorders),
tizanidine (a medicine reducing excessive muscle tension in multiple sclerosis),
clozapine (an antipsychotic),
olanzapine (an antipsychotic),
ropinirole (a medicine used in Parkinson's disease),
phenytoin (a medicine used in epilepsy),
cyclosporine (a medicine used in skin disorders, rheumatoid arthritis, and organ transplantation),
other medicines that may affect heart rhythm:
antiarrhythmic medicines (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide),
tricyclic antidepressants,
some antibacterial medicines (belonging to the macrolide group),
some antipsychotics,
zolpidem (a medicine used in insomnia).

Ciprinol may increase blood levels of the following medicines:

pentoxifylline (a medicine used in circulatory disorders),
caffeine,
duloxetine (a medicine used in depression, diabetic neuropathy, and urinary incontinence),
lidocaine (a medicine used in heart conditions and anaesthesia),
sildenafil (a medicine used, e.g. in erectile dysfunction),
agomelatine (a medicine used in depression).

Taking Ciprinol with food and drink
Food and drink do not affect the use of Ciprinol.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
Ciprinol is not recommended during pregnancy. If the patient plans to become pregnant, she should inform her doctor.
Breastfeeding
Do not take Ciprinol while breastfeeding, as ciprofloxacin passes into human milk and may be harmful to the child.
Driving and operating machinery
Ciprinol may impair concentration. Some neurological adverse effects may occur. Before driving or operating machinery, the patient should assess how they react to Ciprinol. If neurological adverse reactions occur or if the patient does not feel well, do not drive or operate machinery. If in doubt, consult the doctor.
Ciprinol contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning it is considered "sodium-free".

3. How to use Ciprinol

Your doctor will explain exactly what dose of Ciprinol should be used, how often and for how long. This will depend on the type and severity of the infection.
If the patient has kidney problems, it is important to inform the doctor, as the dose may need to be adjusted.
Treatment usually lasts from 5 to 21 days, but may be longer in severe infections.
Your doctor will administer each dose as a slow intravenous infusion (drip) into the bloodstream. The infusion time in children is 60 minutes. In adult patients, the infusion time for a 400 mg dose is 60 minutes, and for a 200 mg dose, 30 minutes. Administering the infusion slowly helps prevent sudden adverse reactions.
It is important to drink plenty of fluids while receiving Ciprinol.

Overdose of Ciprinol
If the patient thinks they have been given more Ciprinol than recommended, they should immediately inform the doctor or nurse.

Missed dose of Ciprinol
If the patient thinks a dose of Ciprinol has been missed, they should immediately inform the doctor or nurse.

Stopping Ciprinol treatment
It is important not to stop treatment early, even if the patient feels better after a few days of treatment. Stopping the medicine too soon may result in incomplete treatment of the infection, and symptoms may return or worsen. Bacteria may also become resistant to the antibiotic.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Below are serious side effects that may occur during treatment with this
medicine.
You must stop taking Ciprinol and contact your doctor immediately, who may consider using a different antibiotic if the patient experiences any of the following serious side effects.
Rare side effects (may occur in no more than 1 in 1,000 patients):

inflammation of the intestine (colon) associated with antibiotic use (very rarely may be fatal) (see section 2 "Warnings and precautions"),
allergic reactions, swelling (oedema) of allergic origin or rapid swelling of the skin and mucous membranes (angioedema), (see section 2 "Warnings and precautions"),
seizures (see section 2 "Warnings and precautions").

Very rare side effects (may occur in fewer than 1 in 10,000 patients):

severe allergic reactions with symptoms such as chest tightness, dizziness, nausea or fainting, or dizziness upon standing (anaphylactic reaction, anaphylactic shock) (see section 2 "Warnings and precautions"),
muscle weakness, tendon inflammation, tendon rupture – especially of the large tendon at the back of the ankle (Achilles tendon) (see section 2 "Warnings and precautions"),
severe, life-threatening skin rash, usually presenting as blisters or ulceration of the mouth, throat, nose, eyes and other mucous membranes such as genital organs, which may progress to large blisters and peeling of skin layers (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Frequency not known (frequency cannot be estimated from available data):

nervous system disorders: unusual pain sensations, burning, tingling, numbness or muscle weakness in limbs (peripheral neuropathy and polyneuropathy) (see section 2 "Warnings and precautions")
drug reaction which may present with rash, fever, internal organ inflammation, abnormal blood test results and general malaise (DRESS - Drug Reaction with Eosinophilia and Systemic Symptoms; AGEP - Acute Generalised Exanthematous Pustulosis)

Administration of quinolone and fluoroquinolone antibiotics has, in some cases and regardless of pre-existing risk factors, very rarely led to long-term (lasting for months or years) or permanent side effects such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as pricking, tingling, tickling, burning, numbness or pain (neuropathy), fatigue, psychiatric symptoms (including sleep disturbances, anxiety, panic attacks, depression and suicidal thoughts), memory and concentration problems, hearing, vision, taste and smell disturbances.
Other side effects:
Common side effects (may occur in no more than 1 in 10 patients):

nausea, diarrhoea, vomiting,
joint pain and inflammation in children,
injection site reaction, rash.

Uncommon side effects (may occur in no more than 1 in 100 patients):

joint pain in adults,
fungal superinfections,
high levels of eosinophils, a type of white blood cell,
decreased appetite,
excessive activity or restlessness,
headache, dizziness, sleep disturbances, taste disturbances,
vomiting, abdominal pain, digestive disturbances such as indigestion (dyspepsia, heartburn) or flatulence,
increased levels of certain substances in the blood [aminotransferases and (or) bilirubin],
rash, itching, urticaria,
impaired kidney function,
muscle and bone pain, malaise (weakness), fever,
increased blood alkaline phosphatase activity (a specific blood substance).

Rare side effects (may occur in no more than 1 in 1,000 patients):

muscle pain, joint inflammation, increased muscle tension or muscle cramps (see section 2 "Warnings and precautions"),
changes in blood cell counts (leukopenia, leukocytosis, neutropenia, anaemia, increased or decreased platelet count (clotting factor)),
elevated blood sugar levels (hyperglycaemia) (see section 2 "Warnings and precautions"),
decreased blood sugar levels (hypoglycaemia), which in severe cases may lead to diabetic coma. This is important for people with diabetes (see section 2 "Warnings and precautions"),
confusion, disorientation, anxiety reactions, unusual dreams, depression (which may lead to suicidal thoughts, suicidal ideation or attempts and suicide) (see section 2 "Warnings and precautions"), hallucinations,
tingling sensation, increased sensitivity to sensory stimuli, reduced skin sensitivity, tremor or vertigo (spinning sensation),
vision problems, including double vision (see section 2 "Warnings and precautions"),
tinnitus, hearing loss, hearing disturbances,
rapid heartbeat (tachycardia),
blood vessel dilation (vasodilation), low blood pressure,
fainting,
shallow breathing, including asthma-like symptoms,
liver function disorders, jaundice (with cholestasis) or hepatitis,
photosensitivity (see section 2 "Warnings and precautions"),
kidney failure, blood or crystals in urine (see section 2 "Warnings and precautions"), urinary tract inflammation,
fluid retention or excessive sweating,
increased activity of an enzyme called amylase.

Very rare side effects (may occur in fewer than 1 in 10,000 patients):

a specific type of reduced red blood cell count (haemolytic anaemia) (see section 2 "Warnings and precautions"); dangerous reduction in white blood cells (agranulocytosis) (see section 2 "Warnings and precautions"); reduction in red and white blood cells and platelets (pancytopenia), which may be life-threatening, bone marrow suppression, which may also be life-threatening (see section 2 "Warnings and precautions"),
psychiatric disorders [psychotic reactions which may lead to suicidal thoughts, suicide attempts or suicide (see section 2 "Warnings and precautions")],
an allergic reaction known as serum sickness-like reaction (see section 2 "Warnings and precautions"),
migraine, coordination disorders, unsteady gait (gait disturbances), smell disturbances, increased pressure in the brain (increased intracranial pressure and pseudotumour cerebri),
colour vision disturbances,
inflammation of blood vessel walls (vasculitis),
pancreatitis,
liver cell death (hepatic necrosis), very rarely leading to life-threatening liver failure (see section 2 "Warnings and precautions"),
small dark spots visible under the skin (petechiae), various skin eruptions or rashes,
worsening of myasthenia symptoms (see section 2 "Warnings and precautions").

Frequency not known (frequency cannot be estimated from available data):

a syndrome associated with impaired water excretion from the body and reduced sodium concentration in blood (SIADH, syndrome of inappropriate antidiuretic hormone secretion),
feeling of unusual excitement (mania) or extremely good mood and hyperactivity (hypomania),
disturbed fast heart rhythm: life-threatening irregular heartbeat, rapid heartbeat (known as "QT prolongation", visible on ECG - electrocardiogram),
increased risk of bleeding (in patients treated with vitamin K antagonists),
loss of consciousness due to significant decrease in blood sugar (hypoglycaemic coma) (see section 2 "Warnings and precautions").

In patients receiving fluoroquinolones, cases of arterial wall dilation and weakening or arterial rupture (aneurysm and dissection), which may result in rupture and lead to death, as well as cases of heart valve insufficiency, have been reported. See also section 2.
Reporting of side effects
If any side effects occur, including any side effects not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorisation holder.
Reporting side effects helps to provide more information on the safety of the medicine.

5. How to store Ciprinol

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Ciprinol contains

The active substance is ciprofloxacin. 10 ml of concentrate for solution for infusion (1 ampoule) contains 100 mg of ciprofloxacin. 1 ml of concentrate for solution for infusion contains 10 mg of ciprofloxacin.
Other ingredients: lactic acid, hydrochloric acid concentrated, disodium edetate, water for injections. See section 2 "Ciprinol contains sodium".

What Ciprinol looks like and contents of the pack
The concentrate for solution for infusion is yellow-green in colour.
Packaging: 5 ampoules containing 10 ml concentrate each.

Marketing Authorisation Holder and Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
KRKA-POLSKA Sp. z o.o.
Równoległa Street 5
02-235 Warsaw, Poland
Tel.: (22) 57 37 500

Information intended exclusively for medical professionals:

The infusion solution must be prepared immediately before administration.
Ciprinol infusion must be administered intravenously over 60 minutes. Slow infusion into large veins reduces the risk of damage to smaller veins and increases patient comfort during the procedure.
Compatibility
The infusion solution is compatible with 0.9% (physiological) NaCl solution, Ringer's solution, Hartmann's solution (Ringer's solution with lactate), 5% or 10% glucose solution, 10% fructose solution, 5% glucose with 0.225% NaCl, or 0.45% NaCl.
Incompatibilities
The infusion solution may be administered simultaneously with solutions whose compatibility has been established. If compatibility with other solutions (medications) has not been confirmed, the infusion solution must always be administered separately. Visible signs of incompatibility include, for example, precipitation, turbidity, and discoloration. Instability occurs with all infusion solutions (medications) that are physically or chemically unstable at the pH of these solutions (e.g., penicillins, heparin solutions), especially when combined with solutions adjusted to alkaline pH (pH of ciprofloxacin solutions: 3.9–4.5).
Preparation of infusion solution from concentrate
The concentrate for infusion solution must be diluted with a compatible infusion fluid before use. The minimum volume is 50 ml.