Cipronex

Package Leaflet: Information for the User

Cipronex, 250 mg, Film-Coated Tablets

Cipronex, 500 mg, Film-Coated Tablets

Ciprofloxacin

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medication has been prescribed for your current condition only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

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

1. What Cipronex is and what it is used for

Cipronex is an antibiotic belonging to the fluoroquinolone group. The active substance is ciprofloxacin.
Ciprofloxacin works by killing bacteria that cause infections. It only works against certain strains of bacteria.
Adults

• Lower respiratory tract infections caused by Gram-negative bacteria
• exacerbations of chronic obstructive pulmonary disease; In exacerbations of chronic obstructive pulmonary disease, Cipronex should only be used when other commonly recommended antibacterial agents for the treatment of these infections are considered inappropriate.
• pulmonary infections in patients with cystic fibrosis or bronchiectasis;
• community-acquired pneumonia.
• Chronic suppurative otitis media.
• Exacerbation of chronic sinusitis, especially when caused by Gram-negative bacteria.
• Uncomplicated acute urinary tract infection. In uncomplicated acute urinary tract infection, Cipronex should only be used when other commonly recommended antibacterial agents for the treatment of this infection are considered inappropriate.
• Acute pyelonephritis.
• Complicated urinary tract infections.
• Bacterial prostatitis.
• Gonococcal urethritis and cervicitis caused by susceptible strains of Neisseria gonorrhoeae.
• Epididymo-orchitis, including cases caused by susceptible strains of Neisseria gonorrhoeae.
• Pelvic inflammatory disease, including cases caused by Neisseria gonorrhoeae.

If the above-mentioned genital infections are suspected or diagnosed to be caused by Neisseria gonorrhoeae, it is particularly important to obtain local data on the prevalence of resistance to ciprofloxacin and to confirm susceptibility based on laboratory tests.

• Gastrointestinal infections (e.g., traveler's diarrhea).
• 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.
• Pulmonary anthrax (prevention and treatment of anthrax infections after contact with bacteria).

Ciprofloxacin can be used to treat patients with neutropenia and fever, which is presumed to be caused by a bacterial infection.
Children and adolescents

• Pulmonary infections caused by Pseudomonas aeruginosa in patients with cystic fibrosis.
• Complicated urinary tract infections and acute pyelonephritis.
• Pulmonary anthrax (prevention and treatment of anthrax infections after contact with bacteria).

Ciprofloxacin can also be used to treat severe infections in children and adolescents when a doctor considers it necessary.
Treatment should only be recommended by doctors with experience in treating cystic fibrosis and/or severe infections in children and adolescents.
Official guidelines on the appropriate use of antibacterial agents should be taken into account.

2. Important information before taking Cipronex

When not to take Cipronex:

• if you are allergic to ciprofloxacin, other quinolone antibiotics, or any of the other ingredients of this medication (listed in section 6);
• if you are taking tizanidine (see section 2 - "Cipronex and other medications").

Warnings and precautions

Before starting treatmentwith Cipronex, you should discuss it with your doctor:

• if you have a history of aortic aneurysm or large vessel peripheral artery aneurysm;
• if you have a history of aortic dissection (tear in the aortic wall);
• if you have a history of heart valve problems;
• if 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, Ehlers-Danlos syndrome, Turner syndrome, or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behcet's disease, hypertension, or atherosclerosis);
• if you have kidney problems, as your dose may need to be adjusted;
• if you have epilepsy or other neurological disorders;
• if you have had tendon problems during previous treatment with antibiotics such as Cipronex;
• if you have diabetes - see below: subsection "During treatment with this medication" and section 4;
• if you have myasthenia gravis (a type of muscle weakness);
• if you have a history of abnormal heart rhythm (arrhythmia);
• if you have a history of congenital or familial prolongation of the QT interval (visible on an ECG - a test of the heart's electrical activity);
• if you have electrolyte disturbances (especially low potassium or magnesium levels in the blood);
• if you have a very slow heart rate (called bradycardia);
• if you have poor heart function (heart failure);
• if you have had a heart attack;
• if you are a woman or an elderly person;
• if you are taking other medications that may affect your heart rhythm (see section - "Cipronex and other medications"). You should not take antibacterial medications containing fluoroquinolones or quinolones (e.g., pefloxacin, moxifloxacin), including Cipronex, if you have experienced any severe side effects while taking a quinolone or fluoroquinolone in the past. In such cases, you should inform your doctor immediately.

During treatment with this medication

If you experience any of the following symptoms while taking Cipronex, inform your doctor immediately. Your doctor will decide whether to stop treatment with Cipronex.

• Severe, sudden allergic reaction(anaphylactic reaction or anaphylactic 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, stop taking Cipronex and contact your doctor immediately.
• During treatment with this medication, rare cases of joint and muscle pain, joint inflammation, and tendon inflammation or rupturehave been reported. The risk is increased in elderly people (over 60 years), after organ transplantation, in patients with 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 Cipronex. If you experience the first symptoms of tendon pain or inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking Cipronex, contact your doctor, and rest the affected area. Avoid excessive strain, as it may increase the risk of tendon rupture.
• If you have epilepsyor other neurological disorders, such as cerebral ischemia or stroke, side effects affecting the central nervous system may occur. If this happens, stop taking Cipronex and contact your doctor immediately.
• After the first dose of Cipronex, psychotic reactionsmay occur. If you have depressionor psychosis, symptoms of these conditions may worsen during treatment with Cipronex. If this happens, stop taking Cipronex and contact your doctor immediately.
• You 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 and arms. In such cases, stop taking Cipronex and inform your doctor immediately to prevent the development of potentially irreversible disease.
• Fluoroquinolone antibiotics may cause high blood sugar levelsor low blood sugar levelsthat can lead to loss of consciousness (hypoglycemic coma) (see section 4). This is important for patients with diabetes. Patients with diabetes are advised to carefully monitor their blood sugar levels.
• During treatment with antibiotics, including Cipronex, or even several weeks after stopping treatment, diarrheamay occur. If it becomes severe or persistent, or if you notice blood or mucus in your stool, stop taking Cipronex immediately, as it can be life-threatening. Do not take medications that slow down or stop bowel movements, and contact your doctor.
• If you are going to have a blood or urine test, inform your doctor or laboratory staff that you are taking Cipronex.
• Cipronex may cause liver damage. If you notice any of the following symptoms: loss of appetite, jaundice (yellowing of the skin), dark urine, itching, or stomach upset, stop taking Cipronex and contact your doctor immediately.
• Cipronex may decrease the number of white blood cells, which can lead to a decreased immune response to infections. If you notice any of the following symptoms during an infection, such as fever and severe deterioration of your general condition or fever with local signs of infection, such as sore throat, pharyngitis, or urinary problems, contact your doctor immediately. A blood test will be ordered to check if you have a decreased white blood cell count (agranulocytosis). Remember to inform your doctor that you are taking this medication.
• If you or a family member has a deficiency of glucose-6-phosphate dehydrogenase (G6PD), inform your doctor, as ciprofloxacin may cause anemia.
• During treatment with Cipronex, your skin becomes more sensitive to sunlight and ultraviolet radiation (UV). Avoid exposure to strong sunlight or artificial UV radiation (e.g., in a solarium).
• If your vision becomes impaired or you experience other eye problems, consult an ophthalmologist immediately.
• In case of sudden, severe abdominal, back, or chest pain, which may be a sign of aortic aneurysm or dissection, seek emergency medical attention immediately. The risk of these changes may be higher in patients treated 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), seek medical attention immediately.
• Long-term, disabling, and potentially irreversible severe side effects: Fluoroquinolone and quinolone antibacterial agents, including Cipronex, have been associated with very rare but severe side effects. Some of these have been long-lasting (lasting for months or years), disabling, or potentially irreversible. These include tendon pain, muscle and joint pain in the upper and lower limbs, walking difficulties, abnormal sensations (such as tingling, burning, prickling, numbness, or pain), sensory disturbances (including vision, taste, and smell disorders), depression, memory impairment, severe fatigue, and severe sleep disturbances. If you experience any of these side effects after taking Cipronex, contact your doctor immediately before continuing treatment. You and your doctor will decide whether to continue treatment, also considering antibacterial agents from other classes.

Cipronex and other medications

Tell your doctor about all medications you are currently taking or have recently taken, and about any medications you plan to take.
Do not take Cipronex at the same time as tizanidine, as it may cause side effects such as low blood pressure and drowsiness (see section 2. "When not to take Cipronex").
The following medications will interact with Cipronex in the body.
Taking Cipronex at the same time as these medications may affect their therapeutic effect.
This may also increase the likelihood of side effects.
If you are taking other medications that may affect your heart rhythm, such as antiarrhythmic medications (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, certain antibacterial agents (belonging to the macrolide group), or certain antipsychotic medications, you must inform your doctor.

Tell your doctor if you are taking any of the following medications:

• warfarin or other oral anticoagulants (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 medication);
• 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 increasethe levels of the following medications in the blood:

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

Some medications weakenthe effect of Cipronex. Inform your doctor if you are taking them or plan to take them:

• antacids;
• omeprazole (used in the treatment of heartburn and stomach ulcers);
• didanosine;
• mineral supplements;
• sucralfate;
• phosphate-binding polymers (e.g., sevelamer);
• medications containing calcium, magnesium, aluminum, or iron, or dietary supplements used to supplement these components. If the use of these products is necessary, Cipronex should be taken approximately 2 hours before their use or at least 4 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 beverages with added calcium during treatment with the tablets, as this may affect the absorption of the active substance.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medication.
It is recommended to avoid taking Cipronex during pregnancy.
Do not take Cipronex while breastfeeding, as ciprofloxacin passes into breast milk and may harm your baby.

Driving and using machines

Cipronex may cause drowsiness. Some neurological side effects may occur. Before driving or operating machinery, check how Cipronex affects you. In case of doubt, consult your doctor.

Cipronex contains sodium

The medication contains less than 1 mmol (23 mg) of sodium per film-coated tablet, which means it is considered "sodium-free".

3. How to take Cipronex

Always take this medication exactly as your doctor has told you. If you are not sure, ask 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 of infection and its severity.
Inform your doctor if you have kidney problems, as your dose may need to be adjusted.
Treatment usually lasts from 5 to 21 days, but in severe infections, it may be longer. Take the tablets exactly as your doctor has told you. If you are unsure about the number of tablets to take or how to take Cipronex, contact your doctor or pharmacist.
a.
Swallow the tablets with a large amount of liquid. Do not chew the tablets, as they have an unpleasant taste.
b.
It is best to take the tablets at about the same time each day.
c.
You can take the tablets with or without food. Calcium in food does not significantly affect the absorption of the active substance. However, do not takeCipronex only with dairy products, such as milk or yogurt, or with calcium-fortified fruit juices (e.g., calcium-fortified orange juice).
d.
Remember to drink plenty of fluids during treatment with Cipronex.

What to do if you take more Cipronex than you should

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

What to do if you forget to take Cipronex

Take the normal dose as soon as you remember, and then continue treatment as prescribed by your doctor. However, if it is time for your next dose, do not take the missed dose, and continue as usual. Do not take a double dose to make up for a forgotten dose. It is important to take all the tablets prescribed by your doctor.

What to do if you stop taking Cipronex

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

4. Possible side effects

Like all medications, Cipronex can cause side effects, although not everybody gets them.
The most serious side effectsobserved during treatment with this medication are listed below.

If you experience any of the following symptoms, stop taking Cipronex and contact your doctor immediately, as you may need to take a different antibiotic.

Rare side effects(occurring in less than 1 in 100 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, angioedema (see section 2. Warnings and precautions).

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

• severe, sudden allergic reaction with symptoms such as chest tightness, dizziness, nausea, fainting, or dizziness when standing up (anaphylactic reaction/anaphylactic shock) (see section 2. Warnings and precautions);
• muscle weakness;
• tendon inflammation, which can 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 with blisters or ulcers in the mouth, throat, nose, eyes, and genital areas, with subsequent spread of blisters or peeling of the skin (e.g., Stevens-Johnson syndrome or toxic epidermal necrolysis);
• death of liver cells (liver necrosis), very rarely leading to life-threatening liver failure, with symptoms such as loss of appetite, diarrhea, fever, rash, itching, abdominal swelling, nausea, and vomiting (see section 2. Warnings and precautions);
• mental disorders (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 the available data):

• heart problems, such as very fast heartbeat, life-threatening irregular heartbeat, or heart rhythm disorders (known as "QT interval prolongation," visible on an ECG - a test of the heart's electrical activity);
• allergic reaction that causes a rash, fever, inflammation of internal organs, blood disorders, and systemic diseases (drug reaction with eosinophilia and systemic symptoms, or DRESS, and acute generalized exanthematous pustulosis, or AGEP);
• nervous system disorders, such as pain, burning, tingling, numbness, and/or weakness in the limbs (neuropathy);
• loss of consciousness due to significantly low blood sugar levels (hypoglycemic coma). See section 2.

Patients taking fluoroquinolones have reported cases of aortic aneurysm or aortic dissection, which can lead to rupture and death, as well as cases of heart valve problems. See also section 2.
Administration of quinolone and fluoroquinolone antibiotics, in some cases regardless of pre-existing risk factors, has very rarely caused long-term (lasting for months or years) or permanent medication side effects, such as tendon inflammation, tendon rupture, joint pain, limb pain, walking difficulties, abnormal sensations (e.g., tingling, burning, prickling, numbness, or pain), neuropathy, fatigue, memory impairment, concentration disorders, mental health disorders (including sleep disturbances, anxiety, panic attacks, depression, and suicidal thoughts), as well as hearing, vision, taste, and smell disorders.
Other side effectsthat have been observed during treatment with Cipronex are listed below, according to their frequency.

• Common side effects(occurring in less than 1 in 10 patients):
• nausea (vomiting), diarrhea;
• joint pain and arthritis in children.

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

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

Rare side effects(occurring in less than 1 in 1,000 patients):

• muscle pain, arthritis, increased muscle tone, or muscle spasms;
• antibiotic-associated colitis (very rarely can be fatal) (see section 2. Warnings and precautions);
• changes in blood cell count (leukopenia, leukocytosis, neutropenia, anemia), increased or decreased platelet count;
• high blood sugar levels (hyperglycemia);
• confusion, disorientation, anxiety reactions, unusual dreams, or hallucinations;
• tingling sensation, increased sensitivity to stimuli, decreased skin sensitivity, tremors, or dizziness;
• vision disturbances, including double vision (see section 2. Warnings and precautions);
• ringing in the ears, hearing loss, or hearing disturbances;
• rapid heartbeat (tachycardia);
• vasodilation, low blood pressure, or fainting;
• shortness of breath, including asthma symptoms;
• liver function disorders, jaundice (with bile duct obstruction), or hepatitis;
• sensitivity to light (see section 2. Warnings and precautions);
• kidney failure, blood or crystals in the urine, or urinary tract inflammation;
• fluid retention or excessive sweating;
• increased activity of the enzyme amylase.

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

• a specific type of decreased red blood cell count (hemolytic anemia); life-threatening decreased white blood cell count (agranulocytosis) (see section 2. Warnings and precautions); decreased red and white blood cell count and platelet count (aplastic anemia), which can be fatal, as well as bone marrow failure, which can also be fatal;
• allergic reaction similar to serum sickness (see section 2. Warnings and precautions);
• migraine, coordination disorders, unstable gait (gait disturbances), smell disturbances, increased intracranial pressure (pseudotumor cerebri);
• color vision disturbances;
• blood vessel inflammation (vasculitis);
• pancreatitis;
• small, dark spots 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):

• syndrome of inappropriate secretion of antidiuretic hormone (SIADH);
• feeling of excessive excitement (mania) or excessive optimism accompanied by increased activity (hypomania);
• effect on blood clotting (in patients treated with vitamin K antagonists).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform 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 medication.

5. How to store Cipronex

Keep the medication out of the sight and reach of children.
Store in a temperature not exceeding 25°C, in a dry place, protected from light.
Do not take Cipronex after the expiry date stated on the blister or carton. The expiry date refers to the last day of the month.
The notation on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number.
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Cipronex contains

• The active substance of Cipronex is ciprofloxacin. Each 250 mg film-coated tablet contains 250 mg of ciprofloxacin in the form of hydrochloride (equivalent to 291 mg of ciprofloxacin hydrochloride). Each 500 mg film-coated tablet contains 500 mg of ciprofloxacin in the form of hydrochloride (equivalent to 582 mg of ciprofloxacin hydrochloride).
• Other ingredients are: tablet core: microcrystalline cellulose, sodium carboxymethylcellulose, silicon dioxide, magnesium stearate; tablet coating: hypromellose, macrogol 6000, titanium dioxide, talc.

What Cipronex looks like and contents of the pack

250 mg film-coated tablets are white, round, biconvex.
500 mg film-coated tablets are white, oblong, biconvex, with a score line.
The pack contains 10 film-coated tablets.

Marketing authorization holder and manufacturer

Polpharma S.A.
Pelplińska 19, 83-200 Starogard Gdański
Phone: +48 22 364 61 01

Date of last revision of the leaflet: ---------------------------------------------------------------------------------------------------------------------------

Medical advice - medical education

Antibiotics are used to treat bacterial infections. They do not work against viral infections.
Antibiotics should only be used for conditions in which they have been prescribed by a doctor. Despite the effects of antibiotics, some bacteria may survive or multiply. This phenomenon is called resistance: sometimes treatment with an antibiotic becomes ineffective.
Improper use of antibiotics increases resistance. You can even cause bacteria to become resistant and prolong treatment or reduce the effectiveness of the antibiotic if you do not follow your doctor's instructions regarding:

• dose size;
• frequency of administration;
• duration of treatment.

Consequently, to maintain the effectiveness of this medication:

• 1. Only take an antibiotic when prescribed by a doctor.
• 2. Strictly follow the doctor's instructions.
• 3. Do not take an antibiotic again without a doctor's recommendation, even if your current illness is similar to the illness for which the antibiotic was prescribed.
• 4. Never give an antibiotic to another person, as it may be inappropriate for their illness.
• 5. After completing treatment, return any unused medication to the pharmacy for proper disposal.