Ciprinol

Leaflet accompanying the packaging: patient information

Ciprinol, 250 mg, film-coated tablets

Ciprinol, 500 mg, film-coated tablets

Ciprofloxacin

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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 taking Ciprinol
• 3. How to take 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
• prolonged 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 cases caused by susceptible Neisseria gonorrhoeae strains
• pelvic inflammatory disease, including cases 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 prevent infections caused by the bacterium Neisseria meningitidis
• to treat pulmonary anthrax and prevent infection after exposure to inhaled 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 recommend an additional antibiotic to be used in combination with Ciprinol.
Children and adolescents
Ciprinol is used in children and adolescents, under specialist medical supervision, for the following bacterial infections:

• Pulmonary exacerbations of cystic fibrosis 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 taking Ciprinol

When not to take Ciprinol

• if the patient is allergic to the active substance, other quinolone antibiotics, or any of the other ingredients of this medicine (listed in section 6),
• in patients taking tyzanidine (see section 2 "Ciprinol and other medicines").

Warnings and precautions

Before taking Ciprinol

You should not take fluoroquinolone or quinolone antibacterial medicines, including Ciprinol, if you have ever had a severe side effect with a quinolone or fluoroquinolone. In such a case, you should inform your doctor as soon as possible.
Before starting treatment with Ciprinol, you should discuss it with your doctor if:

• you have ever had kidney problems, as the dose of the medicine may need to be changed,
• you have epilepsy or other neurological disorders,
• you have had tendon problems in the past when taking antibiotics such as Ciprinol,
• you have diabetes - ciprofloxacin may significantly lower your blood sugar level (hypoglycemia),
• you have myasthenia gravis (a type of muscle weakness)
• you have an aortic aneurysm or a large peripheral arterial aneurysm,
• you have had an aortic dissection (tear in the aortic wall),
• you have a heart valve problem,
• you have a family history of aortic aneurysm or aortic dissection or congenital heart valve problems, or other risk factors or conditions (e.g. Marfan syndrome or Ehlers-Danlos vascular type, 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 confirmed atherosclerosis, rheumatoid arthritis [joint disease] or endocarditis [heart infection]),
• you or a family member have a deficiency of glucose-6-phosphate dehydrogenase (G6PD), you should 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 after three days of treatment, they should consult a doctor.
Heart problems
You should be cautious when taking this type of medicine if:

• you have a congenital or familial prolonged QT interval (visible on an ECG - a test of the heart's 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").

While taking Ciprinol

If while taking Ciprinolany of the following symptoms occur, you should immediately tell your doctor. The doctor will decide whether to stop taking Ciprinol:

• Severe, sudden allergic reaction(anaphylactic reaction or shock, angioedema). Although rare, a severe allergic reaction can occur even after the first dose, with symptoms such as chest tightness, dizziness, nausea, fainting, or dizziness when standing up. If this happens, you should stop taking Ciprinol and contact your doctor immediately.
• 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. Some of these have been long-lasting (lasting for months or years) or disabling. They include: tendon pain, muscle pain, joint pain in the upper and lower limbs, walking difficulties, abnormal sensations, such as tingling, numbness, prickling, burning, or itching (paresthesia), sensory disturbances, including vision, taste, and smell and hearing disturbances, depression, memory disturbances, severe fatigue, and severe sleep disturbances. If any of these side effects occur after taking Ciprinol, you should immediately contact your doctor before continuing treatment. You and your doctor will decide whether to continue treatment, also considering antibiotics from another group.
• Rarely, pain and swelling of the joints and tendon inflammation or rupturemay occur. 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 up to several months after stopping Ciprinol. After the first symptoms of pain or tendon inflammation appear (e.g., in the ankle, wrist, elbow, shoulder, or knee), you should stop taking Ciprinol, contact your doctor, and rest the affected area. You should avoid excessive strain, as it may increase the risk of tendon rupture.
• In case of sudden severe abdominal, back, or chest pain, which may be a sign of an aortic aneurysm or aortic dissection, you should immediately go to the emergency room. The risk of these changes may be higher during treatment with systemic corticosteroids.
• In case of sudden shortness of breath, especially when lying down, or swelling of the ankles, feet, or abdomen, or palpitations (feeling of rapid or irregular heartbeat), you should immediately consult a doctor.
• If you have epilepsyor other neurological disorders, such as cerebral ischemia (insufficient blood flow to the brain) or stroke, side effects from the central nervous system may occur. If such symptoms occur, you should stop taking Ciprinol and immediately contact your doctor.
• You may rarely experience nerve damage(neuropathy) symptoms, such as pain, burning, tingling, numbness, and (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.
• After the first dose of Ciprinol, psychotic reactionsmay occur. If you experience depressionor psychosis, the symptoms of these diseases may worsen during treatment with Ciprinol. Rarely, depression or psychosis may develop into suicidal thoughts, which may lead to suicide attempts or suicide (see section 4 "Possible side effects"). If this happens, you should stop taking Ciprinol and immediately contact your doctor.
• Quinolone antibiotics may cause an increase in blood sugar levelsabove normal (hyperglycemia) or a decrease in blood sugar levels below normal, which can lead to loss of consciousness(hypoglycemic coma) (see section 4). This is important for diabetic patients. Diabetic patients are advised to carefully monitor their blood sugar levels.
• While taking antibiotics, including Ciprinol, or even for several weeks after stopping treatment, diarrheamay occur. If it is severe or persistent, or if you notice blood or mucus in your stool, you should immediately stop taking Ciprinol, as it can be life-threatening. You should not take medicines that slow down or stop bowel movements.
• Vision disturbances or other eye problemsshould be reported to your doctor or ophthalmologist immediately.
• While taking Ciprinol, the skin becomes more sensitive to sunlight and ultraviolet radiation. You should avoid exposure to strong sunlight or artificial UV radiation (e.g., in a solarium).
• If you are having 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 the dose of the medicine may need to be changed.
• 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 immediately contact your doctor.
• Ciprinol may decrease the number of white blood cells, which can lead to decreased resistance to infections. If you experience symptoms of infection, 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 contact your doctor. A blood test will be prescribed to check if your white blood cell count has decreased (agranulocytosis). You should remember to inform your doctor that you are taking this medicine.

Ciprinol and other medicines

You should tell your doctor or pharmacist about all the medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Do not take Ciprinol at the same time as tyzanidine, as it may cause side effects such as low blood pressure and drowsiness (see section 2 "When not to take Ciprinol").
The following medicines will interact with Ciprinol in the human 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, you should tell your doctor:

• vitamin K antagonists (e.g., warfarin, acenocoumarol, phenprocoumon, fluindione) or other oral anticoagulant medicines ("blood thinners"),
• probenecid (a medicine used for gout),
• metoclopramide (a medicine for nausea and vomiting),
• methotrexate (a medicine used for certain types of cancer, psoriasis, or rheumatoid arthritis),
• theophylline (a medicine used for respiratory disorders),
• tyzanidine (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 diseases, rheumatoid arthritis, and organ transplants),
• other medicines that may affect heart rhythm:
• antiarrhythmic 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 circulation disorders),
• caffeine,
• duloxetine (a medicine used for depression, diabetic neuropathy, and urinary incontinence),
• lidocaine (a medicine used for heart problems and anesthesiological applications),
• sildenafil (a medicine used, e.g., for erectile dysfunction),
• agomelatine (a medicine used for depression).

Some medicines weakenthe effect of Ciprinol. You should tell your doctor if you are taking them or plan to take them:

• antacids,
• omeprazole,
• mineral supplements,
• sucralfate,
• phosphate-binding polymers (e.g., sevelamer or lanthanum carbonate),
• medicines containing calcium, magnesium, aluminum, or iron, or supplements of these substances.

If the use of these medicines is necessary, Ciprinol should be taken about 2 hours before their use or at least 4 hours after their administration.

Taking Ciprinol with food and drink

Calcium contained in a meal, including dairy products and calcium-rich beverages (such as milk or orange juice with added calcium), will not significantly affect the absorption of this medicine. However, taking ciprofloxacin in the form of tablets at the same time as dairy products and calcium-rich beverages, when these dairy products or beverages are taken separately (not as part of a meal), may reduce the effectiveness of the medicine. Therefore, ciprofloxacin tablets should be taken 1-2 hours before a meal or at least 4 hours after consuming dairy products or calcium-rich beverages taken separately (not as part of a meal) (see also section 3).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, you should consult your doctor or pharmacist before taking this medicine.
Ciprinol is not recommended during pregnancy.
You should not take Ciprinol while breastfeeding, as ciprofloxacin passes into human milk and may harm the 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 unwanted neurological reactions or do not feel well, you should not drive or operate machinery. In case of doubt, you should consult your doctor.

Ciprinol contains sodium

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

3. How to take Ciprinol

Your doctor will explain exactly what dose of Ciprinol to take, 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 the dose of the medicine may need to be changed.
Treatment usually lasts from 5 to 21 days, but in severe infections, it may be longer. You should always take the medicine as directed by your doctor. If you are unsure about the number of tablets to take or how to take Ciprinol, you should consult your doctor or pharmacist.

• Tablets should be swallowed with a large amount of liquid.
• Tablets should not be chewed or crushed. If you are unable to swallow a tablet, you should inform your doctor, so they can prescribe a more suitable medicine for you.
• It is best to take the tablets at about the same time every day.
• Tablets can be taken with or without food. Ciprofloxacin in the form of tablets can be taken during meals containing dairy products (such as milk or yogurt) or with calcium-rich beverages (e.g., orange juice with added calcium). However, ciprofloxacin tablets should not be taken at the same time as dairy products or calcium-rich beverages when these dairy products or beverages are taken separately (not as part of a meal). Ciprofloxacin tablets should be taken about 1-2 hours before a meal or at least 4 hours after consuming dairy products or calcium-rich beverages taken separately (not as part of a meal). You should remember to drink plenty of fluids while taking Ciprinol.

Taking a higher dose of Ciprinol than recommended

If you have taken a higher dose than recommended, you should immediately seek medical attention. If possible, you should take the tablets or packaging with you to show the doctor.

Missing a dose of Ciprinol

If you have missed a dose of Ciprinol, and:
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there are more than 6 hoursuntil the next dose, you should take the missed dose immediately. Then, take the next dose at the usual time.
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there are less than 6 hoursuntil the next dose, you should not take the missed dose. Take the next dose at the usual time.
You should not take a double dose to make up for a missed dose. It is important to take all the tablets prescribed by your doctor.

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 taking the medicine too early, the infection may not be fully treated, and the symptoms of the infection may return or worsen. The bacteria may also become resistant to the antibiotic.
If you have any further doubts about taking this medicine, you should consult 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 taking this medicine.

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

Rare side effects(may occur in less than 1 in 1000 patients):

• seizures (see section 2 "Warnings and precautions")
• antibiotic-associated colitis (very rarely can be fatal) (see section 2 "Warnings and precautions")
• allergic reaction, swelling (edema), or rapid swelling of the skin and mucous membranes (angioedema) (see section 2 "Warnings and precautions")

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

• severe allergic reactions with symptoms such as chest tightness, dizziness, nausea, or fainting, or dizziness when standing up (anaphylactic reaction or anaphylactic shock) (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 the skin (Stevens-Johnson syndrome, toxic epidermal necrolysis)
• 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")

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

• neurological disorders: unusual pain sensation, burning sensation, tingling, numbness, or weakness of the muscles in the limbs (peripheral neuropathy and polyneuropathy) (see section 2 "Warnings and precautions")
• drug reaction that can occur with rash, fever, liver and kidney problems, blood abnormalities, and general feeling of being unwell (DRESS - Drug Reaction with Eosinophilia and Systemic Symptoms; AGEP - Acute Generalised Exanthematous Pustulosis)

Administration of quinolone and fluoroquinolone antibiotics, in some cases regardless of existing risk factors, has very rarely caused long-lasting (lasting for months or years) or irreversible adverse reactions, such as tendon inflammation, tendon rupture, joint pain, limb pain, walking difficulties, abnormal sensations, such as tingling, numbness, prickling, burning, or itching (neuropathy), fatigue, psychiatric symptoms (including sleep disturbances, anxiety, panic attacks, depression, and suicidal thoughts), memory and concentration disturbances, hearing, vision, taste, and smell disturbances.
Other side effects that have been reported during treatment with Ciprinol are listed below by frequency of occurrence:
Common side effects(may occur in less than 1 in 10 patients):

• nausea (vomiting), diarrhea
• joint pain and inflammation in children

Uncommon side effects(may occur in less than 1 in 100 patients):

• fungal superinfections
• high levels of eosinophils (a type of white blood cell)
• decreased appetite
• excessive activity, restlessness
• headache, dizziness, sleep disturbances, taste disturbances
• vomiting, abdominal pain, digestive disturbances, such as indigestion (dyspepsia) or gas
• increased levels of certain substances in the blood [transaminases and (or) bilirubin]
• rash, itching, or hives
• joint pain in adults
• kidney problems
• muscle pain, bone pain, general feeling of being unwell (weakness) or fever
• increased activity of the enzyme alkaline phosphatase in the blood (a specific substance in the blood)

Rare side effects(may occur in less than 1 in 1000 patients):

• muscle pain, joint inflammation, increased muscle tension, or muscle spasms
• blood cell count changes (leukopenia, leukocytosis, neutropenia, anemia), increased or decreased platelet count (coagulation factor)
• high blood sugar levels (hyperglycemia) (see section 2 "Warnings and precautions")
• low blood sugar levels (hypoglycemia), which can lead to hypoglycemic coma in severe cases. This is important for diabetic patients (see section 2 "Warnings and precautions")
• confusion, disorientation, anxiety reactions, unusual dreams, depression (which can lead to suicidal thoughts or suicide attempts and suicide) (see section 2 "Warnings and precautions") , hallucinations
• tingling sensation, excessive sensitivity to stimuli, decreased skin sensitivity, tremors, or dizziness (balance disturbances)
• vision disturbances, including double vision (see section 2 "Warnings and precautions")
• ringing in the ears, hearing loss, hearing disturbances
• rapid heartbeat (tachycardia)
• vasodilation, low blood pressure, or fainting
• shortness of breath, including asthma symptoms
• liver function disturbances, jaundice (with bile stagnation), or hepatitis
• sensitivity to light (see section 2 "Warnings and precautions")
• kidney problems, 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 less than 1 in 10,000 patients):

• a specific type of decreased red blood cell count (hemolytic anemia); dangerous decrease in white blood cell count (agranulocytosis) (see section 2 "Warnings and precautions"), decrease in red and white blood cell count and platelets (pancytopenia), which can be fatal, and bone marrow failure, which can also be fatal (see section 2 "Warnings and precautions")
• mental disorders (psychotic reactions that can lead to suicidal thoughts, suicide attempts, or suicide) (see section 2 "Warnings and precautions")
• an allergic reaction called serum sickness (see section 2 "Warnings and precautions")
• migraine, coordination disturbances, unstable gait (gait disturbances), smell disturbances, increased intracranial pressure (pseudotumor cerebri)
• color vision disturbances
• blood vessel inflammation (vasculitis)
• pancreatitis
• liver cell death (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 gravis symptoms (see section 2 "Warnings and precautions")

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

• a disease related to 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 a tendency to feel unusually good and overactive (hypomania)
• heart problems, such as very rapid heartbeat, life-threatening irregular heartbeat, heart rhythm disturbances (called "QT interval prolongation", visible on an ECG)
• effect on blood clotting (in patients treated with vitamin K antagonists)
• loss of consciousness due to a significant drop in blood sugar levels (hypoglycemic coma). See section 2.

Patients taking fluoroquinolones have reported cases of aortic aneurysm or aortic dissection (a tear in the aortic wall), which can be fatal, as well as cases of heart valve problems. See also section 2.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month stated.
The batch number is stated on the packaging after "Lot".
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Ciprinol contains

• The active substance of Ciprinol is ciprofloxacin. Each film-coated tablet contains 250 mg or 500 mg of ciprofloxacin in the form of ciprofloxacin hydrochloride.
• The other ingredients are: microcrystalline cellulose, sodium starch glycolate, povidone, sodium carboxymethylcellulose, colloidal silicon dioxide, magnesium stearate, hypromellose, talc, titanium dioxide (E 171), propylene glycol. See section 2 "Ciprinol contains sodium".

What Ciprinol looks like and contents of the pack

Ciprinol, 250 mg: white, round, film-coated tablets with a score line on one side
Ciprinol, 500 mg: white, oval, film-coated tablets with a score line on one side
Packaging:10 film-coated tablets in a blister pack, in a cardboard box

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, you should 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