Ciprinol

Leaflet accompanying the packaging: patient information

Ciprinol, 10 mg/ml, concentrate for solution for infusion

Ciprofloxacin

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• 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 symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Ciprinol and what is it used for
• 2. Important information before using Ciprinol
• 3. How to use Ciprinol
• 4. Possible side effects
• 5. How to store Ciprinol
• 6. Contents of the pack and other information

1. What is Ciprinol and what is it used for

Ciprinol contains the active substance ciprofloxacin. Ciprofloxacin is an antibiotic belonging to the fluoroquinolone group. Ciprofloxacin kills bacteria that cause infections. It only works on certain strains of bacteria.

Adults

Ciprinol is used in adults:

• to treat certain bacterial infections:
• respiratory tract infections
• chronic or recurrent ear or sinus infections
• urinary tract infections
• genital and urinary tract infections in women and men
• gonococcal urethritis or cervicitis caused by susceptible Neisseria gonorrhoeae strains
• epididymitis and orchitis, including those caused by susceptible Neisseria gonorrhoeae strains
• pelvic inflammatory disease, including those caused by susceptible Neisseria gonorrhoeae strains. If the doctor suspects or diagnoses that the above-mentioned genital infections are caused by Neisseria gonorrhoeae, it is particularly important to obtain local data on the spread of resistance to ciprofloxacin and to confirm susceptibility based on appropriate laboratory tests.
• gastrointestinal and intra-abdominal infections
• skin and soft tissue infections
• bone and joint infections
• to treat pulmonary anthrax and prevent infection after inhalation of anthrax spores.

Ciprofloxacin can be used to treat patients with neutropenia (low white blood cell count) with fever, which is likely to be caused by a bacterial infection. If the infection is severe or caused by more than one type of bacteria, the doctor may prescribe an additional antibiotic to be used with Ciprinol.

Children and adolescents

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

• Pneumonia and bronchitis caused by Pseudomonas aeruginosa in children and adolescents with cystic fibrosis
• Complicated urinary tract infections and acute pyelonephritis
• Pulmonary anthrax (prevention of infection after contact with bacteria and treatment)

Ciprinol may also be used to treat other severe infections in children and adolescents, if the doctor considers it necessary.

2. Important information before using Ciprinol

When not to use Ciprinol

Warnings and precautions

Before starting treatment with Ciprinol, discuss it with your doctor, pharmacist, or nurse.

Before using Ciprinol

Do not take antibacterial medicines containing fluoroquinolones or quinolones, including Ciprinol, if you have ever experienced any severe side effects while taking a quinolone or fluoroquinolone antibiotic. In such a case, inform your doctor as soon as possible. Before starting treatment with Ciprinol, discuss it with your doctor if:

• you have ever had kidney problems, as your dose may need to be adjusted,
• you have epilepsy or other neurological disorders,
• you have ever had tendon problems while taking antibiotics like Ciprinol,
• you have diabetes, as ciprofloxacin may increase the risk of hypoglycemia,
• you have myasthenia gravis (a type of muscle weakness),
• you have an aortic aneurysm or a large peripheral arterial aneurysm,
• you have a history of aortic dissection (tear in the aortic wall),
• you have aortic valve regurgitation,
• there is a history of aortic aneurysm or aortic dissection in your family, or other risk factors or conditions (e.g., Marfan syndrome, Ehlers-Danlos syndrome, Turner syndrome, or Sjögren's syndrome [an autoimmune inflammatory disease] or vascular diseases such as Takayasu arteritis, giant cell arteritis, Behçet's disease, hypertension, or atherosclerosis),
• you or a family member has a deficiency of glucose-6-phosphate dehydrogenase (G6PD), inform your doctor - ciprofloxacin may cause anemia.

In the treatment of certain genital and urinary tract infections, the doctor may also prescribe another antibiotic in addition to ciprofloxacin. If the patient does not improve within three days of treatment, they should consult their doctor.

Heart problems

Caution should be exercised when using this type of medicine if:

• you have a congenital or familial prolonged QT interval (visible on an ECG - a test of heart electrical activity),
• you have an electrolyte imbalance in the blood (especially low potassium and magnesium levels),
• you have a very slow heart rate (called bradycardia),
• you have poor heart function (heart failure),
• you have had a heart attack,
• you are a woman or an elderly person,
• you are taking other medicines that may affect the ECG (see section 2 "Ciprinol and other medicines").

During treatment with Ciprinol

If any of the following symptoms occur during treatment with Ciprinol, tell your doctor immediately. The doctor will decide whether to stop treatment with Ciprinol:

• Severe, sudden allergic reaction(anaphylactic reaction or shock, angioedema). There have been rare cases where even after the first dose, a severe allergic reaction may occur, with symptoms such as chest tightness, dizziness, malaise, or fainting or dizziness when standing up. If this happens, you should tell your doctor immediately, as it may be necessary to stop taking Ciprinol.
• Long-lasting, disabling, and potentially irreversible severe side effects.Fluoroquinolone and quinolone antibacterial medicines, including Ciprinol, have been associated with very rare but severe side effects (lasting for months or years) that can cause disability or be potentially irreversible. These include: tendon pain, muscle pain, joint pain in the upper and lower limbs, walking difficulties, abnormal sensations such as tingling, burning, itching, numbness, or pain (paresthesia), sensory disturbances, including vision, taste, and smell and hearing disorders, depression, memory impairment, severe fatigue, and severe sleep disturbances. If any of these side effects occur after taking Ciprinol, you should contact your doctor immediately before continuing treatment. You and your doctor will decide whether to continue treatment, also considering antibiotics from another group.
• Pain and swelling of the joints and tendon inflammation or rupture. The risk is increased in elderly people (over 60 years), after organ transplantation, in cases of kidney problems, or during corticosteroid treatment. Tendon inflammation and rupture can occur within the first 48 hours of treatment and even several months after stopping treatment with Ciprinol. When the first symptoms of pain or tendon inflammation occur (e.g., in the ankle, wrist, elbow, shoulder, or knee), you should stop taking Ciprinol, consult your doctor, and rest the affected area. Avoid excessive strain, as it may increase the risk of tendon rupture.
• Sudden, severe abdominal, back, or chest pain, which may be a sign of an aortic aneurysm and aortic dissection, you should immediately go to the emergency department. The risk of these changes may be higher in patients treated with systemic corticosteroids.
• Sudden shortness of breath, especially when lying down, or swelling of the ankles, feet, or abdomen, or an irregular heartbeat(feeling of rapid or irregular heartbeats), you should immediately consult your doctor.
• Epilepsy or other neurological disorders, such as cerebral ischemia or stroke, may cause side effects affecting the central nervous system. If such an attack occurs, you should stop taking Ciprinol and immediately consult your doctor.
• Nerve damage (neuropathy) symptoms, such as pain, burning, tingling, numbness, or weakness, especially in the feet and legs and hands and arms. In such a case, you should stop taking Ciprinol and immediately inform your doctor to prevent the development of potentially irreversible disease.
• Psychotic reactionsmay occur after the first dose of Ciprinol. If you experience depression or psychosis, the symptoms of these conditions may worsen during treatment with Ciprinol. Rarely, depression or psychosis may develop into suicidal thoughts, which can lead to suicide attempts or suicide (see section 4 "Possible side effects"). If you experience depression, psychosis, suicidal thoughts, or behaviors, you should immediately consult your doctor.
• Fluoroquinolone antibiotics may increase blood sugar levels above normal (hyperglycemia) or decrease blood sugar levels below normal, which can lead to loss of consciousness (hypoglycemic coma) in severe cases(see section 4). This is important for patients with diabetes. Patients with diabetes are advised to carefully monitor their blood sugar levels.
• Diarrheamay occur during or even several weeks after treatment with antibiotics, including Ciprinol. If it becomes severe or persistent, or if you notice blood or mucus in your stool, you should immediately tell your doctor. Treatment with Ciprinol will be stopped immediately, as it can be life-threatening. Do not take medicines that slow down or stop bowel movements, and consult your doctor.
• Vision or eye problemsshould be reported to your doctor or ophthalmologist immediately.
• During treatment with Ciprinol, the skin becomes more sensitive to sunlight and ultraviolet radiation (UV). You should avoid exposure to strong sunlight or artificial UV radiation (e.g., in a solarium).
• If you are going to have a blood or urine test, you should inform your doctor or laboratory staff that you are taking Ciprinol.
• If you have kidney problems, you should tell your doctor, as your dose may need to be adjusted.
• Ciprinol may cause liver damage. If you experience any of the following symptoms: loss of appetite, jaundice (yellowing of the skin), dark urine, itching, or stomach upset, you should tell your doctor, who will advise you to stop taking Ciprinol.
• Ciprinol may decrease the number of white blood cells, which can reduce the body's ability to fight infections. If you experience symptoms such as fever and severe deterioration of your general condition or fever with local signs of infection, such as sore throat, laryngitis, oral cavity problems, or urinary tract problems, you should immediately consult your doctor. A blood test will be ordered to check if the number of white blood cells has decreased (agranulocytosis). Remember to inform your doctor that you are taking this medicine.

Ciprinol and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
Do not take Ciprinol at the same time as tizanidine, as it may cause side effects such as low blood pressure and drowsiness (see section 2 "When not to use Ciprinol").
The following medicines will interact with Ciprinol in the body.
Taking Ciprinol at the same time as these medicines may affect their therapeutic effect.
This may also increase the likelihood of side effects.

If you are taking any of the following medicines, tell your doctor:

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

Ciprinol may increasethe levels of the following medicines in the blood:

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

Using Ciprinol with food and drink

Food and drink do not affect the use of Ciprinol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Ciprinol should not be used during pregnancy. If you plan to become pregnant, inform your doctor.
Breastfeeding
Do not take Ciprinol while breastfeeding, as ciprofloxacin passes into breast milk and may harm your baby.

Driving and using machines

Ciprinol may cause drowsiness. Certain neurological side effects may occur. Before driving or operating machinery, you should check how you react to Ciprinol. If you experience any undesirable neurological reactions or do not feel well, do not drive or operate machinery. In case of doubt, consult your doctor.

Ciprinol contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per dose, which means it is essentially "sodium-free".

3. How to use Ciprinol

Your doctor will explain exactly what dose of Ciprinol will be used, how often, and for how long. This will depend on the type of infection and its severity.
If you have kidney problems, you should tell your doctor, as your dose may need to be adjusted.
Treatment usually lasts from 5 to 21 days, but in severe infections, it may be longer.
Your doctor will administer each dose in a slow infusion (drip) into a vein. The infusion time for children is 60 minutes. For adult patients, the infusion time for a 400 mg dose is 60 minutes, and for a 200 mg dose, it is 30 minutes. Slow infusion helps avoid sudden side effects.
Remember to drink plenty of fluids while taking Ciprinol.

Taking more Ciprinol than prescribed

If you think you have received too much Ciprinol, you should immediately inform your doctor or nurse.

Missing a dose of Ciprinol

If you think a dose of Ciprinol has been missed, you should immediately inform your doctor or nurse.

Stopping treatment with Ciprinol

It is important not to stop treatment, even if you feel better after a few days of taking the medicine. If you stop treatment too early, the infection may not be fully treated, and the symptoms of the infection may return or worsen. Resistance to the antibiotic may also develop.
If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Ciprinol can cause side effects, although not everybody gets them.
The following are serious side effects that may occur when using this medicine.

You should stop taking Ciprinol and immediately consult your doctor, who may consider using another antibiotic, if you experience any of the following serious side effects.

Rare side effects(may occur in up to 1 in 100 people):

• antibiotic-associated colitis (inflammation of the colon) (very rarely can be fatal) (see section 2 "Warnings and precautions"),
• allergic reactions, angioedema (swelling on an allergic basis), 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 up to 1 in 10,000 people):

• severe allergic reactions with symptoms such as chest tightness, dizziness, nausea, or fainting, or dizziness when standing up (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"),
• a severe, life-threatening skin rash, usually in the form of blisters or ulcers in the mouth, throat, nose, eyes, and other mucous membranes, such as the genitals, which can develop into giant blisters and peeling of skin layers (Stevens-Johnson syndrome, toxic epidermal necrolysis).

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

• nervous system disorders: unusual pain sensation, burning sensation, tingling, numbness, or muscle weakness in the limbs (peripheral neuropathy and polyneuropathy) (see section 2 "Warnings and precautions"),
• a drug reaction that can occur with a rash, fever, inflammation of internal organs, blood abnormalities, and general malaise (DRESS - Drug Reaction with Eosinophilia and Systemic Symptoms; AGEP - Acute Generalised Exanthematous Pustulosis)

Administration of quinolone and fluoroquinolone antibiotics, in some cases regardless of pre-existing risk factors, has very rarely caused long-lasting (lasting for months or years) or permanent drug side effects, such as tendon inflammation, tendon rupture, joint pain, limb pain, walking difficulties, abnormal sensations such as tingling, burning, itching, numbness, or pain (neuropathy), fatigue, psychiatric symptoms (including sleep disturbances, anxiety, panic attacks, depression, and suicidal thoughts), memory and concentration disorders, hearing, vision, taste, and smell disorders.

Other side effects:

Common side effects(may occur in up to 1 in 10 people):

• nausea (vomiting), diarrhea, vomiting,
• joint pain in children,
• reaction at the injection site, rash.

Uncommon side effects(may occur in up to 1 in 100 people):

• joint pain in adults,
• fungal superinfections,
• high levels of eosinophils, a type of white blood cell,
• decreased appetite,
• excessive activity or agitation,
• headache, dizziness, sleep disturbances, taste disturbances,
• vomiting, abdominal pain, digestive disorders, such as stomach upset (indigestion, heartburn) or gas,
• increased levels of certain substances in the blood [transaminases and/or bilirubin],
• rash, itching, hives,
• poor kidney function,
• muscle and bone pain, malaise (weakness), fever,
• increased activity of the enzyme alkaline phosphatase in the blood (a specific substance in the blood).

Rare side effects(may occur in up to 1 in 1,000 people):

• muscle pain, joint inflammation, increased muscle tension, or muscle spasms (see section 2 "Warnings and precautions"),
• blood cell count changes (leukopenia, leukocytosis, neutropenia, anemia, increased or decreased platelet count),
• high blood sugar levels (hyperglycemia) (see section 2 "Warnings and precautions"),
• low blood sugar levels (hypoglycemia), which can lead to loss of consciousness (hypoglycemic coma) in severe cases. This is important for people with diabetes (see section 2 "Warnings and precautions"),
• confusion, disorientation, anxiety reactions, unusual dreams, depression (which can lead to suicidal thoughts or suicidal attempts and suicide) (see section 2 "Warnings and precautions"), hallucinations,
• tingling sensation, increased sensitivity to stimuli, decreased skin sensitivity, tremors, or dizziness of vestibular origin (feeling of spinning),
• vision problems, including double vision (see section 2 "Warnings and precautions"),
• tinnitus, hearing loss, hearing disturbances,
• rapid heartbeat (tachycardia),
• development of blood vessels (vasodilation), low blood pressure,
• fainting,
• shallow breathing, including asthma symptoms,
• liver function disorders, jaundice (with bile stasis), or hepatitis,
• increased sensitivity to light (see section 2 "Warnings and precautions"),
• poor kidney function, blood, or crystals in the urine (see section 2 "Warnings and precautions"), urinary tract inflammation,
• fluid retention or excessive sweating,
• increased activity of the enzyme amylase.

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

• a specific type of decreased red blood cell count (hemolytic anemia) (see section 2 "Warnings and precautions"); a dangerous decrease in the number of white blood cells (agranulocytosis) (see section 2 "Warnings and precautions"); a decrease in the number of red and white blood cells and platelets (pancytopenia), which can be life-threatening, bone marrow failure, which can also be life-threatening (see section 2 "Warnings and precautions"),
• psychiatric disorders [psychotic reactions that can lead to suicidal thoughts, suicidal attempts, or suicide (see section 2 "Warnings and precautions")],
• an allergic reaction called serum sickness (see section 2 "Warnings and precautions"),
• migraine, coordination disorders, unstable gait (gait disturbances), smell disorders, increased intracranial pressure (increased pressure inside the skull and pseudo-brain tumor),
• color vision disturbances,
• inflammation of the blood vessel walls (vasculitis),
• pancreatitis,
• death of liver cells (liver necrosis) very rarely leading to life-threatening liver failure (see section 2 "Warnings and precautions"),
• small dark spots visible under the skin (purpura), various skin rashes or eruptions,
• worsening of myasthenia symptoms (see section 2 "Warnings and precautions").

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

• a disease associated with water imbalance in the body and decreased sodium levels in the blood (SIADH, syndrome of inappropriate secretion of antidiuretic hormone),
• a feeling of unusual excitement (mania) or feeling unusually good mood and overactivity (hypomania),
• disturbed fast heart rhythm: life-threatening irregular heartbeat (called "QT interval prolongation", visible on an ECG),
• increased risk of bleeding (in patients treated with vitamin K antagonists),
• loss of consciousness due to significantly low blood sugar levels (hypoglycemic coma) (see section 2 "Warnings and precautions").

Patients treated with fluoroquinolones have reported cases of aortic aneurysm and aortic dissection (tear in the aortic wall), which can be fatal, as well as cases of aortic valve regurgitation. See also section 2.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +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 authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ciprinol

Keep this medicine out of the 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 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. These measures will help protect the environment.

6. Contents of the pack and other information

What Ciprinol contains

• The active substance of Ciprinol 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 ingredientsare: lactic acid, hydrochloric acid, 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 yellowish-green in color.
Packaging: 5 ampoules of 10 ml concentrate

Marketing authorization holder and manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
To obtain more detailed information on this medicine, please contact the local representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
Poland
Phone: (22) 57 37 500
Date of last revision of the leaflet:28.02.2025
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Information intended for healthcare professionals only:

The solution for infusion should be prepared immediately before administration.
Ciprinol infusion should be administered over 60 minutes. Slow infusion into large veins reduces the risk of damage to smaller veins, and the patient has greater comfort during the procedure.

Compatibility

The solution for infusion is compatible with 0.9% (physiological) sodium chloride solution, Ringer's solution, Hartmann's solution (Ringer's solution with lactate), 5% or 10% glucose solution, 10% fructose solution, 5% glucose solution with 0.225% sodium chloride, or 0.45% sodium chloride.

Incompatibilities

The solution for infusion can be administered simultaneously with solutions whose compatibility has been established. If compatibility with other solutions (medicines) has not been confirmed, the solution for infusion should always be administered separately. Visible signs of incompatibility are, for example, precipitate, cloudiness, and discoloration. Instability occurs in the case of all infusion solutions (medicines) that are physically or chemically unstable at the pH of these solutions (e.g., penicillins, heparin solutions), especially in combination with solutions adjusted to alkaline pH (pH of ciprofloxacin solutions: 3.9-4.5).

Preparation of the solution for infusion from the concentrate

The concentrate for solution for infusion should be diluted with a compatible infusion fluid before use. The minimum volume is 50 ml.