Package leaflet: Information for the user

Cipronex, 250 mg, coated tablets
Cipronex, 500 mg, coated tablets
Ciprofloxacinum
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for you personally. 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, please inform your doctor or pharmacist. This includes any side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Cipronex is and what it is used for

Cipronex is an antibiotic belonging to the group of fluoroquinolones. The active substance is ciprofloxacin.
Ciprofloxacin works by killing bacteria that cause infections. It acts only on specific strains of bacteria.
Adults

Lower respiratory tract infections caused by Gram-negative bacteria
Exacerbations of chronic obstructive pulmonary disease (COPD); Cipronex should be used in exacerbations of COPD only when other antibacterial agents commonly recommended for the treatment of these infections are considered inappropriate.
Bronchopulmonary infections in cystic fibrosis or bronchiectasis
Community-acquired pneumonia
Chronic suppurative otitis media
Acute exacerbation of chronic sinusitis, particularly caused by Gram-negative bacteria
Uncomplicated acute cystitis. Cipronex should be used in uncomplicated acute cystitis only when other antibacterial agents commonly recommended for the treatment of this infection are considered inappropriate.
Acute pyelonephritis
Complicated urinary tract infections
Bacterial prostatitis
Gonococcal urethritis and cervicitis caused by ciprofloxacin-susceptible strains of Neisseria gonorrhoeae
Epididymitis and orchitis, including those caused by ciprofloxacin-susceptible strains of Neisseria gonorrhoeae
Pelvic inflammatory disease, including that caused by Neisseria gonorrhoeae

If gonococcal infection of the genital tract is suspected or confirmed, it is particularly important to obtain local data on ciprofloxacin resistance patterns and to confirm susceptibility by laboratory testing.

Gastrointestinal infections (e.g. traveller's diarrhoea)
Intra-abdominal infections
Skin and soft tissue infections caused by Gram-negative bacteria
Malignant otitis externa
Bone and joint infections
Prevention of invasive infections caused by Neisseria meningitidis
Inhalational anthrax (post-exposure prophylaxis and treatment)

Ciprofloxacin may be used in the treatment of febrile neutropenia, which is likely to be caused by bacterial infection.
Children and adolescents

Bronchopulmonary infections caused by Pseudomonas aeruginosa in patients with cystic fibrosis
Complicated urinary tract infections and acute pyelonephritis
Inhalational anthrax (post-exposure prophylaxis and treatment)

Ciprofloxacin may also be used to treat severe infections in children and adolescents if considered necessary by the physician.
Treatment should only be initiated by physicians experienced in the management of cystic fibrosis and/or severe infections in children and adolescents.
Official guidelines on appropriate use of antibacterial agents should be taken into account.

2. Important information before using Cipronex

When not to use Cipronex:

if the patient is allergic to ciprofloxacin, to other drugs in the quinolone group, or to any of the other ingredients of this medicine (listed in section 6);
if the patient is taking tizanidine at the same time (see section 2. - "Cipronex with other medicines").

Warnings and precautions
Before starting treatment with Cipronex, discuss the following with your doctor:

if the patient has been diagnosed with aortic or large peripheral artery aneurysm (dilation of a major blood vessel);
if the patient has previously experienced aortic dissection (tearing of the aortic wall);
if the patient has heart valve insufficiency;
if there is a family history of aortic aneurysm or aortic dissection, congenital heart valve disease, or other risk factors or predisposing conditions (e.g. connective tissue disorders such as Marfan syndrome or vascular form of Ehlers-Danlos syndrome, Turner syndrome, Sjögren's syndrome [an autoimmune inflammatory disease], or blood vessel disorders 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 or has previously had kidney problems, as the dosage of the medicine may need to be adjusted;
if the patient has epilepsy or other neurological disorders;
if the patient has previously experienced tendon problems while being treated with antibiotics such as Cipronex;
if the patient has diabetes - see below: subsection "While taking this medicine" and section 4;
if the patient has myasthenia gravis (a type of muscle weakness);
if the patient has previously had an irregular heartbeat (arrhythmia);
if the patient has been diagnosed with congenital or familial QT interval prolongation (visible on ECG - electrocardiogram, a test of the heart's electrical activity);
if the patient has electrolyte imbalance in the blood (especially low levels of potassium and magnesium);
if the patient has a very slow heart rate (called bradycardia);
if the patient has heart failure (weakened heart function);
if the patient has had a myocardial infarction (heart attack);
if the patient is a woman or elderly;
if the patient is taking other medicines that may cause changes in the ECG (see section "Cipronex with other medicines"). Antibacterial medicines containing fluoroquinolones or quinolones (e.g. pefloxacin, moxifloxacin), including Cipronex, should not be taken if the patient has previously experienced any severe adverse reaction during treatment with a quinolone or fluoroquinolone. In such a case, inform your doctor as soon as possible.

While taking this medicine
If any of the following symptoms occur while taking Cipronex, inform your doctor immediately. The doctor will decide whether treatment with Cipronex should be discontinued.

Severe, sudden allergic reaction (anaphylactic reaction or shock, angioedema). Although rare, 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 occurs, stop taking Cipronex and contact your doctor immediately.
While taking this medicine, joint pain and swelling, tendon inflammation, or tendon rupture may rarely occur. The risk is increased in elderly patients (over 60 years), organ transplant recipients, 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 Cipronex. If the first symptoms of tendon pain or inflammation occur (e.g. in the ankle, wrist, elbow, shoulder, or knee), stop taking Cipronex, contact your doctor, and rest the affected area. Avoid excessive physical exertion, as this may increase the risk of tendon rupture.
If the patient has epilepsy or other neurological disorders, such as cerebral ischemia or stroke, adverse effects on the central nervous system may occur. If this happens, stop taking Cipronex and contact your doctor immediately.
Psychiatric reactions may occur after the first dose of Cipronex. If the patient has depression or psychosis, symptoms of these conditions may worsen during treatment with Cipronex. If this occurs, stop taking Cipronex and contact your doctor immediately.
The patient may rarely experience symptoms of nerve damage (neuropathy), such as pain, burning, tingling, numbness, and/or weakness, especially in the feet and legs, and hands. In such a case, stop taking Cipronex and contact your doctor immediately to prevent the development of potentially irreversible disease.
Quinolone antibiotics may cause blood glucose levels to rise above normal (hyperglycemia) or fall below normal, potentially leading to loss of consciousness in severe cases (hypoglycemic coma) (see section 4). This is particularly important for diabetic patients. Diabetic patients are advised to carefully monitor their blood glucose levels.
Diarrhea may occur during treatment with antibiotics, including Cipronex, or even several weeks after treatment has ended. If diarrhea is severe or persistent, or if the patient notices blood or mucus in the stool, stop taking Cipronex immediately, as this may be life-threatening. Do not take medicines that inhibit or slow intestinal motility, and contact your doctor.
If the patient is providing a blood or urine sample for testing, inform the doctor or laboratory staff that Cipronex is being taken.
Cipronex may cause liver damage. If the patient notices any of the following symptoms: loss of appetite, jaundice (yellowing of the skin), dark urine, skin itching, or stomach irritation, stop taking Cipronex and contact your doctor immediately.
Cipronex 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 during an infection, or fever with localized infection symptoms such as sore throat, laryngitis, oral cavity problems, or urinary tract issues, contact your doctor immediately. A blood test will be ordered to check for reduced white blood cell count (agranulocytosis). Remember to inform the doctor about taking this medicine.
If the patient or their family has glucose-6-phosphate dehydrogenase (G6PD) deficiency, inform the doctor, as ciprofloxacin use may increase the risk of anemia.
While taking Cipronex, 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 vision becomes impaired or the patient experiences other eye-related symptoms, consult an ophthalmologist immediately.
In case of sudden, severe abdominal, back, or chest pain, which may indicate 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 when lying down, or if swelling of the ankles, feet, or abdomen, or palpitations (sensation of rapid or irregular heartbeat) are observed, seek medical advice without delay.
Long-term, disabling, and potentially irreversible serious adverse reactions: Antibacterial medicines containing fluoroquinolones/quinolones, including Cipronex, have been associated with very rare but serious adverse reactions. Some of these were 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 pricking, tingling, tickling, numbness, or burning (paresthesia), sensory disturbances, including vision, taste, smell, and hearing disorders, depression, memory disturbances, severe fatigue, and severe sleep disturbances. If any of these adverse reactions occur after taking Cipronex, contact your doctor immediately before continuing treatment. The patient and doctor will decide whether to continue treatment, considering also antibiotics from other classes.

Cipronex with other medicines
Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Cipronex must not be taken simultaneously with tizanidine, as this may cause adverse effects such as low blood pressure and drowsiness (see section 2. "When not to use Cipronex").
The following medicines may interact with Cipronex in the body. Taking Cipronex together with these medicines may affect their therapeutic effect and may also increase the likelihood of adverse effects.
If the patient is taking other medicines that may affect heart rhythm, such as antiarrhythmic drugs (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, certain antibacterial drugs (macrolide group), or certain antipsychotic drugs, it is essential to inform the doctor.
Inform your doctor if the patient is taking any of the following medicines:

warfarin or another oral anticoagulant (e.g. acenocoumarol, phenprocoumon, fluindione);
probenecid (used in gout);
methotrexate (used in certain types of cancer, psoriasis, rheumatoid arthritis);
theophylline (used in respiratory disorders);
tizanidine (used to reduce excessive muscle tension in multiple sclerosis);
clozapine (an antipsychotic medicine);
ropinirole (used in Parkinson's disease);
phenytoin (used in epilepsy);
metoclopramide (used to prevent nausea and vomiting);
cyclosporine (used after organ transplantation);
glibenclamide (used in diabetes).

Cipronex may increase blood levels of the following medicines:

pentoxifylline (used in circulatory disorders);
caffeine;
duloxetine (used in depression, diabetic neuropathy, urinary incontinence);
lidocaine (used in anesthesia, pain relief, and cardiac arrhythmias);
sildenafil (used in erectile dysfunction);
agomelatine;
zolpidem.

Some medicines weaken the effect of Cipronex. Inform your doctor if the patient is taking or plans to take:

antacids (medicines that neutralize gastric acid);
omeprazole (used to treat heartburn and peptic ulcer disease);
didanosine;
mineral supplements;
sucralfate;
polymeric phosphate binders (e.g. sevelamer);
medicines or dietary supplements containing calcium, magnesium, aluminum, or iron. If use of these products is necessary, Cipronex should be taken approximately two hours before or at least four hours after their administration.

Cipronex with food and drink
If Cipronex is not taken with meals, do not eat or drink any dairy products (such as milk or yogurt) or calcium-fortified beverages at the same time as taking the tablet, as this may affect the absorption of the active substance.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
It is best to avoid using Cipronex during pregnancy.
Do not take Cipronex while breastfeeding, as ciprofloxacin passes into breast milk and may be harmful to the infant.

Driving and operating machinery
Cipronex may impair concentration. Certain neurological adverse effects may occur. Before driving or operating machinery, the patient should assess how they react to Cipronex. If in doubt, consult a doctor.

Cipronex contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning the medicine is considered "sodium-free".

3. How to use Cipronex

This medicine should always be used exactly as prescribed by the doctor. In case of doubt, consult
your doctor.
Your doctor will explain in detail what dose of Cipronex to take, how often, and for how long. This
will depend on the type and severity of the infection.
Inform your doctor if the patient has any kidney problems, 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 directed by the doctor. If in doubt about the number of tablets or how to
take Cipronex, contact your doctor or pharmacist.
a. Swallow the tablets with a large amount of fluid. Do not chew the tablets, as they have an
unpleasant taste.
b. It is best to take the tablets at approximately the same time each day.
c. Tablets may be taken with or without food. Calcium contained in food does not significantly
affect absorption. However, Cipronex should not be taken exclusively with dairy products,
such as milk or yogurt, or with fortified fruit juices (e.g. calcium-fortified orange juice).
d. Remember to drink plenty of fluids while taking Cipronex.

Taking more Cipronex than recommended
If a patient has taken more than the recommended dose, seek immediate medical help. If possible,
bring the tablets or packaging along to show the doctor.

Missing a dose of Cipronex
Take the usual dose as soon as possible, then continue treatment as prescribed by the doctor.
However, if it is almost time for the next dose, do not take the missed dose—simply continue with
the regular schedule. Do not take a double dose to make up for a missed one. It is important to take
all the tablets prescribed by the doctor.

Stopping Cipronex treatment
It is important not to stop treatment, even if you start feeling better after a few days of taking the
medicine. If treatment is stopped too early, the infection may not be fully treated, 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 reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The most serious adverse reactions observed during treatment with this medicine are listed
below.
If you notice any of the symptoms listed below, stop taking Cipronex immediately
and contact your doctor straight away, as another antibiotic may need to be used.
Rare adverse reactions (occurring in no more than 1 in 1,000 patients):

seizures (see section 2. Warnings and precautions);
depression (potentially leading to suicidal thoughts, suicide attempts or suicide) (see section 2. Warnings and precautions);
allergic reaction, swelling (oedema) or rapid swelling of the skin and mucous membranes (angioedema) (see section 2. Warnings and precautions).

Very rare adverse reactions (occurring in fewer than 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/anaphylactic 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 ulcers in the mouth, throat, nose, eyes and mucous membranes of the genital organs, followed by spreading blisters or skin peeling (e.g. bullous erythema multiforme - Stevens-Johnson syndrome or toxic epidermal necrolysis - Lyell's syndrome);
liver cell death (hepatic necrosis), very rarely leading to life-threatening liver failure, which may present as: loss of appetite, diarrhoea, fever, skin rash, itching, abdominal bloating, pain in the right upper abdomen, nausea and vomiting (see section 2. Warnings and precautions);
psychiatric disturbances (psychotic reactions potentially leading to suicidal thoughts, suicide attempts or suicide) (see section 2. Warnings and precautions).

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

heart disorders, such as: very rapid heartbeat, life-threatening irregular heartbeat, heart rhythm disorders (known as "QT prolongation", visible on ECG - electrocardiogram);
drug hypersensitivity reaction causing rash, fever, internal organ inflammation, haematological disorders and systemic illness (drug reaction with eosinophilia and systemic symptoms, abbreviated as DRESS, or acute generalised exanthematous pustulosis, abbreviated as AGEP);
nervous system disorders such as pain, burning, tingling, numbness and (or) limb weakness (neuropathy);
loss of consciousness due to a significant drop in blood sugar levels (hypoglycaemic coma). See section 2.

In patients receiving fluorquinolones, cases of dilation and weakening of the arterial wall or arterial rupture (aneurysm and dissection), which may result in rupture and lead to death, as well as cases of heart valve insufficiency have been reported. See also section 2.
Administration of quinolone and fluoroquinolone antibiotics, in some cases regardless of pre-existing risk factors, has very rarely led to long-term (lasting for months or years) or permanent adverse reactions, 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 disorders (which may include sleep disturbances, anxiety, panic attacks, depression and suicidal thoughts), as well as hearing, vision, taste and smell disturbances.
Other adverse reactions observed during treatment with Cipronex are listed below, according to their likelihood of occurrence.
Common adverse reactions (occurring in no more than 1 in 10 patients):

nausea (feeling sick), diarrhoea;
joint pain and arthritis in children.

Uncommon adverse reactions (occurring in no more than 1 in 100 patients):

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

Rare adverse reactions (occurring in no more than 1 in 1,000 patients):

muscle pain, arthritis, increased muscle tension or cramps;
antibiotic-associated inflammation of the intestine (colon) (very rarely may be fatal) (see section 2. Warnings and precautions);
changes in blood cell count (leukopenia, leukocytosis, neutropenia, anaemia), increased or decreased number of blood clotting factors (platelets);
increased blood sugar levels (hyperglycaemia);
confusion, disorientation, anxiety reactions, unusual dreams 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, jaundice (with cholestasis) or hepatitis;
photosensitivity (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 adverse reactions (occurring in fewer than 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 (aplastic anaemia), which may be fatal, and bone marrow suppression, which may also be fatal;
serum sickness-like allergic reaction (see section 2. Warnings and precautions);
migraine, coordination disorders, unsteady gait (gait disturbances), smell disturbances, increased pressure on the brain (increased intracranial pressure and pseudotumour cerebri);
colour vision disturbances;
inflammation of blood vessel walls (vasculitis);
pancreatitis;
small, dark spots visible under the skin (petechiae); various skin lesions or rashes;
worsening of myasthenia symptoms (see section 2. Warnings and precautions).

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

a disease syndrome related to impaired water excretion from the body and reduced sodium concentration in the blood (SIADH, syndrome of inappropriate antidiuretic hormone secretion);
feeling of excessive excitement (mania) or excessive optimism combined with increased activity (hypomania);
effects on blood clotting (in patients treated with vitamin K antagonists).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Cipronex

Keep the medicine out of sight and reach of children.
Store at a temperature not exceeding 25 °C, in a dry place, protected from light.
Do not use Cipronex after the expiry date stated on the blister pack or carton. The expiry date refers to the last day of the stated month.
The label on the packaging shows the expiry date after the abbreviation EXP, and the batch number after the abbreviation Lot/LOT.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Cipronex contains

The active substance is ciprofloxacin. Each 250 mg coated tablet contains 250 mg of ciprofloxacin in the form of hydrochloride (equivalent to 291 mg ciprofloxacin hydrochloride). Each 500 mg coated tablet contains 500 mg of ciprofloxacin in the form of hydrochloride (equivalent to 582 mg ciprofloxacin hydrochloride).
Other ingredients are: tablet core: microcrystalline cellulose, sodium carboxymethyl starch, colloidal anhydrous silica, magnesium stearate; tablet coating: hypromellose, macrogol 6000, titanium dioxide, talc.

What Cipronex looks like and contents of the pack
The 250 mg coated tablets are white, round, biconvex tablets.
The 500 mg coated tablets are white, elongated, biconvex tablets with a score line.
The pack contains 10 coated tablets.

Marketing Authorisation Holder and Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01

Advice – medical education
Antibiotics are used to treat bacterial infections. They are not effective against viral infections.
Antibiotics should only be used for illnesses as prescribed by a doctor. Despite their action,
some bacteria may survive or multiply during antibiotic treatment. This phenomenon is known as
antibiotic resistance: sometimes treatment with an antibiotic becomes ineffective.
Improper use of antibiotics increases the risk of 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:

dosage;
frequency of administration;
duration of treatment.

Therefore, to preserve the effectiveness of this medicine:

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