Ciprinol

Leaflet attached to 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. Package contents 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
• genitourinary 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 genitourinary 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

• in patients taking tyramine concurrently (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 medicine. In such a situation, 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 a dose adjustment may be necessary,
• you have epilepsy or other neurological disorders,
• you have had tendon problems in the past while 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 a dilated blood vessel (aortic aneurysm or large peripheral artery aneurysm),
• you have had a tear in the aorta (aortic dissection),
• you have a heart valve problem,
• you have had a heart attack,
• you are a woman or an elderly person,
• you are taking other medicines that may affect your ECG (see section 2 "Ciprinol and other medicines").

When treating certain genitourinary infections, the doctor may 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
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 your 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 your ECG (see section 2 "Ciprinol and other medicines").

While taking Ciprinol

If while taking Ciprinolany of the following symptoms occur, you should tell your doctor immediately. 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, 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 contact your doctor immediately before continuing treatment. The patient and doctor will decide whether to continue treatment, also considering antibiotics from another group.
• Rarely, joint pain and swelling, as well as tendon inflammation or rupturemay occur. The risk is increased in elderly people (over 60 years), after organ transplantation, in the presence 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 Ciprinol. After the first symptoms of tendon pain or inflammation (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 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 (a feeling of rapid or irregular heartbeat), you should immediately consult your 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 contact your doctor immediately.
• 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 contact your doctor immediately.
• Quinolone antibiotics may cause an increasein blood sugar levels above normal (hyperglycemia) or a decrease in blood sugar levels below normal, which can lead to loss of consciousness in severe cases (hypoglycemic coma)(see section 4). This is important for patients with diabetes. Patients with diabetes 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 problems or other eye disordersshould be reported to your doctor or ophthalmologist immediately.
• While taking 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 give a blood or urine sample for analysis, you should inform your doctor or laboratory staff that you are taking Ciprinol.
• If you have kidney problems, you should tell your doctor, as a dose adjustment may be necessary.
• 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 contact your doctor immediately.
• Ciprinol may reduce the number of white blood cells, which can reduce resistance to infections. If you experience symptoms of infection, such as fever and severe deterioration of your general condition or fever with local symptoms of infection, such as throat, larynx, mouth, and urinary tract problems, you should contact your doctor immediately. A blood test will be ordered to check if you have a reduced white blood cell count (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 tyramine, 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 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 in gout),
• metoclopramide (a medicine for nausea and vomiting),
• methotrexate (a medicine used in certain types of cancer, psoriasis, and rheumatoid arthritis),
• theophylline (a medicine used in respiratory disorders),
• tyramine (a medicine that reduces excessive muscle tension in multiple sclerosis),
• clozapine (an antipsychotic medicine),
• olanzapine (an antipsychotic medicine),
• 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 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 in insomnia).

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

• 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 anesthesiological applications),
• sildenafil (a medicine used, e.g., in erectile dysfunction),
• agomelatine (a medicine used in depression).

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

• 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 it is necessary to take these medicines, Ciprinol should be taken about 2 hours before their administration or at least 4 hours after their intake.

Taking Ciprinol with food and drink

Calcium in meals, including dairy products and calcium-rich beverages (such as milk or juice), or calcium-fortified fruit juices (e.g., orange juice with added calcium), will not significantly affect the absorption of this medicine. However, taking ciprofloxacin in tablet form 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 effect 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). You should remember to drink plenty of fluids while taking Ciprinol.

Ciprinol and pregnancy/breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, you should ask your doctor or pharmacist for advice before taking this medicine.
Ciprinol is not recommended during pregnancy.
You should 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 Ciprinol affects you. If you experience unwanted neurological reactions or do not feel well, you should not drive or operate machinery. If in 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 take Ciprinol

Your doctor will explain exactly how much 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 a dose adjustment may be necessary.
Treatment usually lasts from 5 to 21 days, but in severe infections, it may be longer. You should always take Ciprinol 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 fluid.
• 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 tablets at approximately the same time each day.
• Tablets can be taken with or without food. Ciprofloxacin tablets can be taken during meals containing dairy products (such as milk or yogurt) or with calcium-rich beverages (e.g., orange juice fortified with calcium). However, ciprofloxacin tablets should not be taken at the same time as dairy products or calcium-rich beverages when these 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, 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:

• 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.
• there are less than 6 hoursuntil the next dose, do 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 develop resistance 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 contact your doctor immediately if you experience any of the following serious side effects, and the doctor may consider using another antibiotic.

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

• 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 people):

• 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")
• 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 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):

• nervous system 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, swelling 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 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, 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 according to their frequency:

Common side effects(may occur in less than 1 in 10 people):

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

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

• fungal infections
• 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 function impairment
• muscle pain, bone pain, malaise (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 people):

• 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 people with diabetes (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
• shallow breathing, including asthma symptoms
• liver function disturbances, jaundice (with bile stasis), or hepatitis
• sensitivity to light (see section 2 "Warnings and precautions")
• kidney function impairment, blood or crystals in the urine (see section 2 "Warnings and precautions"), urinary tract infection
• fluid retention or excessive sweating
• increased activity of the enzyme amylase

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

• a specific type of reduced red blood cell count (hemolytic anemia); dangerous reduction in white blood cell count (agranulocytosis) (see section 2 "Warnings and precautions"), reduction 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")
• 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 syndrome associated with water imbalance and low sodium levels in the blood (SIADH, syndrome of inappropriate secretion of antidiuretic hormone)
• feeling of unusual excitement (mania) or 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 dissection (aortic dilatation or rupture) and heart valve problems, which can be fatal, as well as cases of aortic aneurysm or dissection. 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.
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. Package contents 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 glycolate starch, 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