Package leaflet: information for the patient

Cipropol, 500 mg, coated tablets
Ciprofloxacinum
Please read the entire leaflet carefully before using the medicine, as it contains important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any further questions, please consult your doctor or pharmacist. This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

What Cipropol is and what it is used for
Important information before taking Cipropol
How to take Cipropol
Possible side effects
How to store Cipropol
Contents of the pack and other information

1. What Cipropol is and what it is used for

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

certain respiratory tract infections;
certain chronic or recurrent ear or sinus infections;
urinary tract infections;
genital infections in women and men;
gastrointestinal infections and intra-abdominal infections;
skin and soft tissue infections;
bone and joint infections;
prevention of infections caused by Neisseria meningitidis;
exposure to inhalation of anthrax bacilli.

Ciprofloxacin may be used to treat febrile neutropenic patients, when bacterial infection is suspected.
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 Cipropol.

Children and adolescents
Cipropol is used in children and adolescents under specialist medical supervision to treat the following bacterial infections:

lung and bronchial infections in children and adolescents with cystic fibrosis;
complicated urinary tract infections, including kidney infections (pyelonephritis);
exposure to inhalation of anthrax bacilli.

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

2. Important information before using Cipropol

When not to use Cipropol:

if the patient is allergic to ciprofloxacin, to other drugs in the quinolone group, or to any of the other ingredients of the medicine (listed in section 6);
if the patient is taking tyzanimidine at the same time (see section 2. Cipropol and other medicines).

Warnings and precautions
Before taking this medicine
Do not take antibacterial medicines containing fluoroquinolones or quinolones,
including Cipropol, 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 Cipropol, discuss the following with your doctor:

if the patient has ever had kidney problems, as the dose of the medicine may need to be adjusted,
if the patient suffers from epilepsy or other neurological disorders,
if the patient has previously had tendon problems while being treated with antibiotics such as Cipropol,
if the patient has diabetes, as there may be a risk of hypoglycaemia during treatment with ciprofloxacin,
if the patient has myasthenia gravis (a type of muscle weakness) – symptoms may worsen,
if the patient has been diagnosed with a dilated large blood vessel (aortic aneurysm or large peripheral artery),
if the patient has previously experienced aortic dissection (tearing of the aortic wall),
if the patient has been diagnosed with heart valve insufficiency,
if there have been cases of aortic aneurysm or aortic dissection in the family, or congenital heart valve disease, or other risk factors or predisposing conditions (e.g. connective tissue disorders such as Marfan syndrome or 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, confirmed atherosclerosis, rheumatoid arthritis [joint disease], or endocarditis [heart infection]),
if the patient has heart problems. Caution is advised when using medicines containing ciprofloxacin if:
o the patient has been diagnosed with congenital or familial QT prolongation (visible on ECG – an examination of the heart's electrical activity),
o the patient has electrolyte imbalance in the blood (especially low potassium and magnesium levels),
o the patient has a very slow heart rate (called bradycardia),
o the patient has heart failure,
o the patient has had a myocardial infarction,
o the patient is female or elderly,

o the patient is taking other medicines that may cause changes in the ECG (see section 2.
Cipropol and other medicines).
if the patient or their family has glucose-6-phosphate dehydrogenase (G6PD) deficiency, inform the doctor – anaemia may occur after taking ciprofloxacin.

For the treatment of certain urinary and genital tract infections, the doctor may prescribe another antibiotic in addition to ciprofloxacin. If the patient's condition does not improve after three days of treatment, the patient should consult the doctor.
While taking ciprofloxacin
If any of the following symptoms occur during treatment with Cipropol, the patient should
immediately inform the doctor. The doctor will decide whether treatment with Cipropol should be discontinued.

Severe, sudden allergic reaction (anaphylactic reaction or shock, angioedema). Although unlikely, a severe allergic reaction may occur even after the first dose, with symptoms such as: chest tightness, dizziness, nausea, fainting or dizziness upon standing. If this happens, stop taking Cipropol immediately and contact a doctor.
Long-lasting, disabling and potentially irreversible serious adverse effects. Antibacterial medicines containing fluoroquinolones/quinolones, including Cipropol, have been associated with very rare but serious adverse effects. Some of these effects have been long-lasting (persisting for months or years), disabling or potentially irreversible. These include: tendon, muscle and joint pain in the upper and lower limbs, difficulty walking, abnormal sensations such as prickling, 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 Cipropol, contact a doctor immediately before continuing treatment. The patient and doctor will decide whether to continue treatment, also considering antibiotics from other classes.
Rarely, joint pain and swelling, inflammation or rupture of tendons 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 stopping treatment with Cipropol. If the first symptoms of tendon pain or inflammation occur (e.g. in the ankle, wrist, elbow, shoulder or knee), stop taking Cipropol, contact a 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 be a sign of aortic aneurysm or dissection, seek emergency medical attention immediately. The risk of these conditions may be higher in patients receiving systemic corticosteroids.
If sudden shortness of breath occurs, especially after lying down, or if swelling of the ankles, feet or abdomen is observed, or palpitations (a sensation of rapid or irregular heartbeat) develop, seek medical advice immediately.
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 this happens, stop taking ciprofloxacin and contact a doctor immediately.
Rarely, the patient may 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, stop taking Cipropol and contact a doctor immediately to prevent the development of potentially irreversible disease.
Psychiatric disorders may occur after the first dose of Cipropol. If the patient has depression or psychosis, symptoms of these conditions may worsen during treatment with Cipropol. Rarely, depression or psychosis may progress to suicidal thoughts, potentially leading to suicide attempts or suicide. If this occurs, stop taking Cipropol and contact a doctor immediately.
Quinolone antibiotics may cause increased blood glucose levels above normal (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 are advised to carefully monitor their blood glucose levels.
While taking antibiotics, including Cipropol, or even several weeks after stopping treatment, diarrhoea may occur. If it is severe or persistent, or if the patient notices blood or mucus in the stool, stop taking Cipropol immediately, as this may be life-threatening. Do not take medicines that inhibit or slow intestinal motility and contact a doctor.
If the patient experiences worsening of vision or any other visual disturbances, contact an ophthalmologist immediately.
While taking Cipropol, 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 giving a blood or urine sample for testing, they should inform the doctor or laboratory staff that they are taking Cipropol.
If the patient has kidney problems, they should inform the doctor, as the dose of the medicine may need to be adjusted.
Cipropol may cause liver damage. If the patient notices any of the following symptoms: loss of appetite, jaundice (yellowing of the skin), dark urine, itching or stomach irritation, stop taking Cipropol and contact a doctor immediately.
Cipropol may reduce the number of white blood cells, which may reduce resistance to infections. If the patient notices symptoms such as fever and severe worsening of general condition or fever with local signs of infection such as sore throat, laryngitis, oral cavity problems or urinary tract issues, contact a doctor immediately. The doctor may recommend a blood test to check for reduced white blood cell count (agranulocytosis). Remember to inform the doctor about taking this medicine.

Cipropol and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Cipropol must not be taken at the same time as tyzanimidine, as this may cause adverse effects such as low blood pressure and drowsiness (see section 2. "When not to use ciprofloxacin").
The following medicines may interact with Cipropol in the human body.
Taking Cipropol together with these medicines may affect their therapeutic effect.
It 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 anticoagulants ("blood thinners"),
probenecid (for gout),
methotrexate (for certain types of cancer, psoriasis, rheumatoid arthritis),
theophylline (for respiratory disorders),
tyzanimidine (to reduce excessive muscle tension in multiple sclerosis),
olanzapine (an antipsychotic),
clozapine (an antipsychotic),
ropinirole (for Parkinson's disease),
phenytoin (for epilepsy),
metoclopramide (for nausea and vomiting),
cyclosporine (for skin disorders, rheumatoid arthritis and organ transplantation),
other medicines that may affect heart rhythm: antiarrhythmic drugs (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some antibacterial drugs (macrolide group), some antipsychotics,
zolpidem (for sleep disorders).

Cipropol may increase blood levels of the following medicines:

pentoxifylline (for circulatory disorders),
caffeine,
duloxetine (for depression, diabetic neuropathy and urinary incontinence),
lidocaine (for heart conditions and anaesthetic use),
sildenafil (e.g. for erectile dysfunction),
agomelatine (for depression).

Some medicines reduce the effect of Cipropol. Inform the doctor if the patient is taking or plans to take:

medicines that neutralise gastric acid,
omeprazole,
mineral supplements,
sucralfate,
polymeric phosphate binders (e.g. sevelamer or lanthanum carbonate),
medicines containing calcium, magnesium, aluminium or iron, or supplements containing these minerals.

If the use of these products is necessary, Cipropol should be taken approximately two hours before or at least four hours after taking these products.
Cipropol with food and drink
Taking calcium at the same time, including dairy products and calcium-rich drinks (such as milk or yoghurt) or fortified fruit juices (e.g. calcium-fortified orange juice), may under certain conditions affect the action of Cipropol:

When taken as part of a meal, they will not have a significant effect on the action of this medicine.
However, if Cipropol is taken at the same time as dairy products and calcium-rich drinks taken separately (not as part of a meal), this may reduce the effectiveness of the medicine. Therefore, Cipropol should be taken 1–2 hours before or at least 4 hours after consuming dairy products or calcium-rich drinks taken separately (not as part of a meal) (see also section 3).

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.
It is best to avoid using Cipropol during pregnancy.
Do not take Cipropol while breastfeeding, as ciprofloxacin passes into human milk and may be harmful to the child.
Driving and operating machinery
Cipropol may impair concentration. Some neurological adverse effects may occur. Before driving or operating machinery, the patient should assess how they react to Cipropol. If in doubt, consult a doctor.
Cipropol contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Cipropol

Your doctor will explain exactly what dose of Cipropol to take, 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 for severe infections. Tablets should always be taken exactly as prescribed by the doctor. If in doubt about the number of tablets or how to take Cipropol, consult your doctor or pharmacist.

a. Swallow the tablets whole with a large amount of fluid.
b. Do not chew or crush the tablets. If the patient is unable to swallow the tablet, inform the doctor, who may prescribe a different, more suitable formulation of the medicine.
c. It is best to take the tablets at approximately the same time each day.
d. Tablets may be taken with meals or between meals. Cipropol may be taken during meals containing dairy products (such as milk or yoghurt) or calcium-rich drinks (e.g. calcium-fortified orange juice). However, Cipropol should not be taken at the same time as dairy products or calcium-rich drinks when these are consumed alone (not as part of a meal). The exception is when tablets are taken 1–2 hours before or at least 4 hours after consuming such products.

Remember to drink plenty of fluids while taking this medicine.

If you take more Cipropol than you should
If the patient has taken more than the prescribed dose, seek medical help immediately. If possible, bring the tablets or packaging along to show the doctor.

If you forget to take Cipropol
If the patient misses a dose of Cipropol, and:

6 hours or more remain until the next scheduled dose, take the missed dose immediately. Then take the next dose at the usual time.
less than 6 hours remain until the next scheduled dose, do not take the missed dose. Take the next dose at the usual time.

Do not take a double dose to make up for a missed dose. It is important to take all the tablets prescribed by the doctor.

Stopping Cipropol treatment
It is important not to stop treatment, even if you start feeling better after a few days. Stopping treatment too early may result in incomplete treatment of the infection, and symptoms may return or worsen. Antibiotic resistance may also develop.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The most serious adverse effects observed during treatment with this medicine are listed below:
If you notice any of the symptoms listed below, you must stop taking Cipropol and contact your doctor immediately, as another antibiotic may need to be used.

Rare (may occur in up to 1 in 1,000 patients):

Seizures (see section 2. Warnings and precautions).

Very rare (may occur in up to 1 in 10,000 patients):

Severe, sudden allergic reaction with symptoms such as chest tightness, dizziness, nausea or fainting, or dizziness upon standing (anaphylactic reaction/shock) (see section 2: Warnings and precautions);
Muscle weakness, tendon inflammation which may lead to tendon rupture, especially of the large tendon at the back of the ankle (Achilles tendon) (see section 2. "Warnings and precautions");
Life-threatening skin rash, usually presenting as blisters or ulceration of the mouth, throat, nose, eyes, and mucous membranes of the genital organs, followed by spreading of blisters or skin peeling (e.g. Stevens-Johnson syndrome or toxic epidermal necrolysis).

Frequency unknown (frequency cannot be estimated from available data):

Nervous system disorders such as pain, burning, tingling, numbness, and (or) weakness of limbs (neuropathy) (see section 2. "Warnings and precautions");
Hypersensitivity reaction causing rash, fever, internal organ inflammation, hematological disorders, and systemic illness (drug reaction with eosinophilia and systemic symptoms, DRESS; acute generalized exanthematous pustulosis, AGEP).

Other adverse effects observed during treatment with Cipropol are listed below, categorized by their likelihood of occurrence.

Common (may occur in up to 1 in 10 patients):

Nausea, diarrhoea;
Joint pain and arthritis in children.

Uncommon (may occur in up to 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, or taste disturbances;
Vomiting, stomach pain, digestive disorders such as indigestion (dyspepsia, heartburn) or flatulence;
Increased blood levels of certain substances [aminotransferases and (or) bilirubin];
Rash, itching, or hives;
Impaired kidney function;
Muscle and bone pain, malaise (weakness) or fever;
Increased blood alkaline phosphatase activity (a specific blood substance).

Rare (may occur in up to 1 in 1,000 patients):

Muscle pain, joint inflammation, increased muscle tension or cramps;
Inflammation of the intestine (colon) associated with antibiotic use (very rarely may be fatal) (see section 2. Warnings and precautions);
Changes in blood cell counts (leukopenia, leukocytosis, neutropenia, anaemia), increased or decreased number of platelets (blood cells responsible for clotting);
Allergic reaction, swelling (oedema), or rapid swelling of the skin and mucous membranes (angioedema) (see section 2. "Warnings and precautions");
Increased blood sugar levels (hyperglycaemia);
Decreased blood sugar levels (hypoglycaemia), which in severe cases may lead to hypoglycaemic coma. This is important in patients with diabetes (see section 2. "Warnings and precautions");
Confusion, disorientation, anxiety reactions, unusual dreams, depression (potentially leading to suicidal thoughts, suicide attempts or suicide) (see section 2. "Warnings and precautions") or hallucinations;
Pricking sensation, increased sensitivity to sensory stimuli, reduced skin sensitivity, tremor or dizziness;
Visual disturbances, including double vision (see section 2. "Warnings and precautions");
Tinnitus, hearing loss, hearing disturbances;
Rapid heartbeat (tachycardia);
Blood vessel dilation, low blood pressure, or fainting;
Shallow breathing, including asthma-like symptoms;
Liver function disorders, cholestatic jaundice or hepatitis;
Light sensitivity (see section 2. Warnings and precautions);
Kidney failure, blood or crystals in urine, urinary tract inflammation;
Fluid retention or excessive sweating;
Increased activity of an enzyme called amylase.

Very rare (may occur in up to 1 in 10,000 patients):

A specific type of reduced red blood cell count (haemolytic anaemia), dangerous reduction in white blood cells (agranulocytosis) (see section 2. "Warnings and precautions); reduced red and white blood cells and platelets (pancytopenia), which may be fatal, and bone marrow suppression, which may also be fatal;
Allergic reaction resembling serum sickness (see section 2 "Warnings and precautions");
Mental disturbances (psychotic reactions potentially leading to suicidal thoughts, suicide attempts or suicide) (see section 2. Warnings and precautions);
Migraine, coordination disorders, unsteady gait (gait disturbances), smell disturbances, increased pressure in the skull (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 rashes or eruptions;
Worsening of myasthenia symptoms (see section 2. Warnings and precautions).

Frequency unknown (frequency cannot be estimated from available data):

Syndrome associated with impaired water excretion and reduced sodium concentration in blood (syndrome of inappropriate antidiuretic hormone secretion, SIADH);
Feeling of extreme excitement (mania) or abnormally elevated mood associated with hyperactivity (hypomania);
Heart disorders such as: very rapid heartbeat, life-threatening irregular heartbeat, cardiac arrhythmias (known as "QT prolongation", visible on ECG - electrocardiogram);
Effect on blood coagulation (in patients treated with vitamin K antagonists);
Loss of consciousness due to significant reduction in blood sugar (hypoglycaemic coma). See section 2. Warnings and precautions.

Administration of quinolone and fluoroquinolone antibiotics has, in rare cases and sometimes regardless of pre-existing risk factors, led to long-term (lasting for months or years) or permanent adverse 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, memory and concentration problems, mental health effects (which may include sleep disturbances, anxiety, panic attacks, depression and suicidal thoughts), and disturbances in hearing, vision, taste, and smell.

Cases of arterial wall dilation and weakening or arterial wall rupture (aneurysm and dissection), which may result in rupture and lead to death, as well as cases of heart valve insufficiency, have been reported in patients receiving fluoroquinolones. See also section 2.

Reporting of adverse effects
If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist.
Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps provide more information on the safety of this medicine.

5. How to store Cipropol
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard package. The expiry date refers to the last day of the stated month.
Do not store above 25°C.
Keep in the original packaging.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the pack and other information

What Cipropol contains
The active substance is ciprofloxacin. One coated tablet contains 500 mg of ciprofloxacin in the form of ciprofloxacin hydrochloride monohydrate, equivalent to 583 mg.
The other ingredients are:
microcrystalline cellulose, magnesium stearate, colloidal silicon dioxide, sodium starch glycolate (see section 2. "Cipropol contains sodium"), corn starch; coating OPADRAY OY-S-28842 (white): hypromellose (E 464), polyethylene glycol, titanium dioxide.

What Cipropol looks like and contents of the pack
Oval, biconvex coated tablets with a white film coating, engraved with a line on one side to allow division. The tablet may be divided into equal doses.
The cardboard box contains 10 tablets and a patient leaflet.

Marketing Authorisation Holder
GEDEON RICHTER POLSKA Sp. z o.o.
ul. ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Poland

Manufacturer
Gedeon Richter România S.A.
Cuza Vodă street 99-105
Târgu-Mureş
România – 540306
Romania
GEDEON RICHTER POLSKA Sp. z o.o.
ul. ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Poland

For further information about this medicinal product, please contact:
GEDEON RICHTER POLSKA Sp. z o.o.
Medical Department
ul. ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Tel. +48 22 755 96 48
[email protected]

Advice – Medical education
Antibiotics are used to treat bacterial infections. They are not effective against viral infections.
Antibiotics should only be used for illnesses for which a doctor has prescribed them. Despite antibiotic treatment, some bacteria may survive or multiply. This phenomenon is known as resistance: sometimes antibiotic treatment becomes ineffective.
Improper use of antibiotics increases resistance. It may even cause bacteria to become resistant, leading to prolonged treatment or reduced antibiotic effectiveness if the patient does not follow the doctor's instructions regarding:

dose size
frequency of administration
duration of treatment

Therefore, to preserve the effectiveness of this medicine:
1 – Use antibiotics only when prescribed by a doctor.
2 – Strictly follow the doctor's instructions.
3 – Do not reuse antibiotics without a doctor's prescription, even if the current illness appears similar to the one previously treated with the antibiotic.
4 – Never give antibiotics to another person, as it may be inappropriate for their condition.
5 – After completing treatment, return any unused medicine to the pharmacy for proper disposal.

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