Cipronex

Leaflet attached to the packaging: information for the user

Cipronex, 250 mg, film-coated tablets

Cipronex, 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you 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 tell your doctor or pharmacist. See section 4.

Contents of the 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 the 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 it is suspected or confirmed that the above-mentioned genital infections are 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. 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.
• Pulmonary anthrax (prevention of infection after contact with bacteria and treatment).

Ciprofloxacin can be used for the treatment of patients with neutropenia and fever that 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 of infection after contact with bacteria and treatment).

Ciprofloxacin can also be used for the treatment of severe infections in children and adolescents when this is considered necessary by the doctor.
Treatment should only be initiated by doctors who have experience in the treatment of cystic fibrosis and/or severe infections in children and adolescents.
Official guidelines regarding 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, to other quinolone antibiotics, or to any of the other ingredients of this medicine (listed in section 6);
• if you are taking tizanidine (see section 2 - "Cipronex and other medicines").

Warnings and precautions

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

• if you have a history of aortic aneurysm or large vessel peripheral artery aneurysm;
• if you have had a previous aortic dissection (tear in the aortic wall);
• if you have a heart valve problem;
• if you have a family history of aortic aneurysm or aortic dissection or other risk factors or conditions (e.g. Marfan syndrome, Ehlers-Danlos syndrome, Turner syndrome, or Sjögren's syndrome [an autoimmune disease] or vascular diseases such as Takayasu arteritis, giant cell arteritis, Behçet's disease, hypertension, or confirmed atherosclerosis, rheumatoid arthritis [joint disease] or endocarditis [infection of the heart]);
• if you have kidney problems, as you may need a dose adjustment;
• 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: sub-section "During treatment with this medicine" and section 4;
• if you have myasthenia gravis (a type of muscle weakness);
• if you have had abnormal heart rhythms;
• if you have a congenital or familial prolonged QT interval (visible on an ECG - a test of the heart's electrical activity);
• if you have disturbances in the levels of salts (electrolytes) in your blood (especially low potassium and magnesium levels);
• if you have a very slow heart rate (called bradycardia);
• if you have a weak heart (heart failure);
• if you have had a heart attack;
• if you are a woman or an elderly person;
• if you are taking other medicines that may affect your heart rhythm (see section "Cipronex and other medicines"). You should not take antibacterial agents containing fluoroquinolones or quinolones (e.g. pefloxacin, moxifloxacin), including Cipronex, if you have had any severe side effects when taking a quinolone or fluoroquinolone in the past. In such cases, you should inform your doctor immediately.

During treatment with this medicine

If while taking Cipronexyou experience any of the following, tell your doctor immediately. Your doctor will decide whether you should stop taking 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.
• While taking this medicine, it is rare to experience pain and swelling of the joints and inflammation or rupture of tendons. The risk is increased in elderly people (over 60 years), after organ transplantation, in people with kidney problems, or during treatment with corticosteroids. Tendon inflammation and rupture can occur within the first 48 hours of treatment and even up to several months after stopping treatment with 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 exercise, as this 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, the 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.
• Quinolone antibiotics may cause high blood sugar levels(hyperglycaemia) or low blood sugar levels(hypoglycaemia) that can lead to loss of consciousness (hypoglycaemic coma) (see section 4). This is important for patients with diabetes. Diabetic patients are advised to monitor their blood sugar levels carefully.
• During treatment with antibiotics, including Cipronex, or even for several weeks after stopping treatment, diarrhoeamay occur. If it is severe or persistent, or if you notice blood or mucus in your stool, stop taking Cipronex immediately, as this can be life-threatening. Do not take medicines that slow down or stop bowel movements and contact your doctor.
• If you are going to have a blood or urine test, tell 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, yellowing of the skin (jaundice), 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 increase the risk of infections. If you notice any of the following symptoms: 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 decrease in the number of white blood cells (agranulocytosis). Remember to tell your doctor that you are taking this medicine.
• If you or a member of your family has a deficiency of glucose-6-phosphate dehydrogenase (G6PD), you should inform your doctor, as ciprofloxacin may cause haemolytic anaemia (a condition where red blood cells are destroyed).
• 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. sunbeds).
• If your vision becomes impaired or you experience other eye problems, you should immediately consult an ophthalmologist.
• 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 irregular heartbeat (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 (paresthesia), sensory disturbances, including vision, taste, and smell and hearing 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 another class.

Cipronex and other medicines

Tell your doctor about all the medicines you are taking now or have taken recently, and about any medicines you plan to take.
Do not take Cipronex at the same time as tizanidine, as this may cause side effects such as low blood pressure and drowsiness (see section 2 "When not to take Cipronex").
The following medicines will interact with Cipronex in the body.
Taking Cipronex 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 other medicines that may affect your heart rhythm, such as anti-arrhythmic agents (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, certain antibacterial agents (belonging to the macrolide group), or certain antipsychotic agents, you must tell your doctor.

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

• 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);
• ropinirole (used in Parkinson's disease);
• phenytoin (used in epilepsy);
• metoclopramide (used to prevent nausea and vomiting);
• cyclosporin (used after organ transplantation);
• glibenclamide (used in diabetes).

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

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

Some medicines weakenthe effect of Cipronex. Tell your doctor if you are taking or plan to take:

• antacids;
• omeprazole (used to treat heartburn and stomach ulcers);
• didanosine;
• mineral supplements;
• sucralfate;
• polymeric phosphate binders (e.g. sevelamer);
• medicines containing calcium, magnesium, aluminium, or iron, or dietary supplements used to supplement these ingredients. If the use of these products is necessary, Cipronex should be taken about 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 yoghurt) or drinks 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 medicine.
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, you should check how you react to Cipronex. If in doubt, consult your doctor.

Cipronex contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. it is essentially "sodium-free".

3. How to take Cipronex

Always take this medicine 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 you should take, how often, and for how long. This will depend on the type of infection and its severity.
Tell your doctor if you have kidney problems, as you may need a dose adjustment.
Treatment usually lasts from 5 to 21 days, but in severe infections, it may be longer. Always take the tablets as prescribed by your doctor. 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.
Try to take the tablets at 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 yoghurt, or with calcium-fortified fruit juices (e.g. orange juice fortified with calcium).
d.
Remember to drink plenty of fluids while taking Cipronex.

What to do if you take more Cipronex than you should

If you have taken more than the prescribed 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 with the treatment as prescribed by your doctor. However, if it is time for the next dose, do not take the missed dose and continue as usual. Do not take a double dose to make up for the missed 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 medicine. If you stop taking the medicine 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 medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Cipronex can cause side effects, although not everybody gets them.
The most serious side effectsreported with this medicine are listed below.

If you experience any of the following, 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 peeling of the skin, and possibly affecting the mouth, throat, eyes, and genitals (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, diarrhoea, fever, rash, itching, abdominal swelling, and 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 (called "QT interval prolongation", visible on an ECG - a test of the heart's electrical activity);
• allergic reaction, which causes a rash, fever, inflammation of internal organs, blood disorders, and systemic diseases (drug reaction with eosinophilia and systemic symptoms, also known as DRESS, or acute generalized exanthematous pustulosis, also known as AGEP);
• nervous system disorders, such as pain, burning, tingling, numbness, and/or weakness of the arms and legs (neuropathy);
• loss of consciousness due to significantly low blood sugar levels (hypoglycaemic coma). See section 2.

Patients taking fluoroquinolones have reported cases of aortic aneurysm or aortic dissection (tear in the aortic wall), which can lead to rupture and be fatal, 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 led to long-term (lasting for months or years) or permanent side effects, such as tendon inflammation, tendon rupture, joint pain, pain in the arms and legs, walking difficulties, abnormal sensations, such as tingling, burning, prickling, numbness, or pain (paresthesia), sensory disturbances, including vision, taste, and smell and hearing 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 another class.
Other side effectsthat have been reported with Cipronex are listed below, according to their frequency.

• Common side effects(occurring in less than 1 in 10 patients):
• nausea (feeling sick), diarrhoea;
• 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 agitation;
• headache, dizziness, sleep problems, or taste disturbances;
• vomiting, stomach pain, digestive problems, 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 (inflammation of the colon) (very rarely can be fatal) (see section 2. Warnings and precautions);
• changes in blood cell counts (leukopenia, leukocytosis, neutropenia, anaemia), increased or decreased blood clotting factors;
• high blood sugar levels (hyperglycaemia);
• 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;
• shallow breathing, including asthma symptoms;
• liver problems, jaundice (with bile obstruction), or liver inflammation;
• sensitivity to light (see section 2. Warnings and precautions);
• kidney problems, 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 (haemolytic anaemia); a dangerous decrease in the number of white blood cells (agranulocytosis) (see section 2. Warnings and precautions); a decrease in the number of red and white blood cells and platelets (aplastic anaemia), which can be fatal, and bone marrow failure, which can also be fatal;
• allergic reaction similar to serum sickness (see section 2. Warnings and precautions);
• migraine, coordination problems, unsteady gait (gait disturbances), smell disturbances, increased intracranial pressure (pseudotumour cerebri);
• colour vision disturbances;
• inflammation of blood vessel walls (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):

• a condition related to the regulation of water in the body and decreased sodium levels in the blood (SIADH, syndrome of inappropriate secretion of antidiuretic hormone);
• feeling of excessive excitement (mania) or excessive optimism with 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 tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug 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 authorisation holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Cipronex

Keep this medicine 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 use Cipronex after the expiry date stated on the blister or carton. The expiry date refers to the last day of that month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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).
• The other ingredients are: tablet core: microcrystalline cellulose, sodium carboxymethylcellulose, 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 film-coated tablets are white, round, and biconvex.
The 500 mg film-coated tablets are white, oval, and biconvex, with a score line.
The pack contains 10 film-coated tablets.

Marketing authorisation 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 in viral infections.
Antibiotics should only be used for the diseases for which they have been prescribed by the doctor. Despite the action of antibiotics, some bacteria may survive or multiply. This phenomenon is called resistance: sometimes treatment with an antibiotic becomes ineffective.
Incorrect 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 the doctor's instructions regarding:

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

Consequently, to maintain the effectiveness of this medicine:

• 1. Only take an antibiotic when prescribed by a doctor.
• 2. Always follow the doctor's instructions.
• 3. Do not take an antibiotic again without the 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 medicine to the pharmacy, so that it can be disposed of properly.