Package leaflet: Information for the patient

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.
Nolicin, 400 mg, coated tablets
Norfloxacinum
Please read carefully the entire leaflet 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 doubts, please consult your doctor or pharmacist.
This medicine has been prescribed strictly for a specific individual. Do not pass it on to others. This medicine may harm another person, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What Nolicin is and what it is used for

Norfloxacin, the active substance in Nolicin, is a chemotherapeutic agent belonging to the group of fluoroquinolones with a broad spectrum of antibacterial activity. Nolicin acts against many species of aerobic Gram-positive and Gram-negative bacteria.
Indications
Nolicin is used in the treatment of the following infections caused by microorganisms sensitive to norfloxacin:

Uncomplicated acute cystitis. In uncomplicated acute cystitis, Nolicin should be used only when the use of other antibacterial agents commonly recommended for the treatment of such infections is considered inappropriate.
Complicated urinary tract infections (with the exception of complicated pyelonephritis)
Bacterial prostatitis.

Susceptibility of the causative microorganism to norfloxacin should be verified, if possible. However, norfloxacin therapy may be initiated before the results of the sensitivity test are available.

2. Important information before using Nolicin

When not to use Nolicin

if the patient is allergic to norfloxacin, other drugs in the quinolone group, or any of the other ingredients of this medicine (listed in section 6),
in pregnant and breastfeeding women,
in children and adolescents during growth and development,
if the patient has experienced tendon pain, inflammation, or rupture after taking quinolone antibiotics (see section "Warnings and precautions" and section "Possible side effects").

Warnings and precautions
Before starting treatment with Nolicin, discuss this with your doctor.
If the patient has ever had or currently has any of the following conditions, inform the doctor
before starting treatment:

antibacterial drugs containing fluoroquinolones or quinolones, including Nolicin, should not be taken if the patient has previously experienced any severe adverse reaction while taking a quinolone or fluoroquinolone. In such a case, inform the doctor as soon as possible.
seizures or predisposition to seizures, epilepsy, or other brain disorders, such as reduced blood flow to the brain, stroke, as the drug may cause brain damage;
psychiatric disorders; the drug may lead to worsening and intensification of symptoms in patients with known or suspected psychiatric disorders, hallucinations, and (or) disorientation;
myasthenia (a disease causing muscle weakness); norfloxacin may cause exacerbation of symptoms of this disease, including life-threatening respiratory disorders;
glucose-6-phosphate dehydrogenase deficiency (an inherited red blood cell disorder associated with abnormal structure of this enzyme); if this condition has occurred in the patient or a family member, consult a doctor, as massive destruction of red blood cells (hemolytic reaction) leading to anemia may occur during treatment;
if the patient has diabetes, as there may be a risk of hypoglycemic coma (see below and section 4);
renal impairment; the doctor will recommend an appropriately reduced dose of the drug; adequate fluid intake is recommended during treatment with Nolicin;
heart function disorders associated with risk factors for QT interval prolongation, such as:
confirmed congenital or familial QT interval prolongation (visible on ECG - examination of the heart's electrical activity);
confirmed electrolyte imbalance in the blood (especially low potassium and magnesium levels);
very slow heart rate (called bradycardia);
impaired heart function (heart failure);
previous myocardial infarction;
the patient is a woman or elderly person;
use of other drugs that may cause changes in the ECG (see section "Nolicin with other medicines");
if the patient has been diagnosed with a dilated large blood vessel (aortic aneurysm or large peripheral artery);
if the patient previously experienced aortic dissection (tearing of the aortic wall);
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 diseases such as Marfan syndrome or vascular form of 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, or confirmed arterial atherosclerosis, rheumatoid arthritis [joint disease], or endocarditis [heart infection]).

If the patient develops any of the symptoms described below during treatment, seek medical
attention immediately (see section 4):

Allergic reactions:
itching and hives
swelling of the face, lips, tongue, and (or) throat with difficulty breathing or swallowing (angioedema)
severe skin reactions: bullous erythema multiforme (Stevens-Johnson syndrome), exfoliative dermatitis, and toxic epidermal necrolysis (Lyell's syndrome) characterized by blistering rash all over the body, erosions in the mouth, eyes, genital organs, and on the skin, red spots on the trunk, often with blisters in the center, bursting into giant blisters, peeling of large sheets of epidermis, weakness, fever, and joint pain
potentially fatal anaphylactic shock characterized by a drop in blood pressure, pale skin, rapid breathing, cold sweats, weakness, and fainting. If such reactions occur, treatment must be stopped immediately and contact a doctor or emergency physician who will take appropriate actions in emergencies.
Fever, rash, itching, or small red spots on the skin may be symptoms of photosensitivity or ultraviolet radiation allergy. The doctor will decide whether to discontinue treatment.
In case of worsening myasthenia symptoms, including respiratory disorders (which are life-threatening), seek immediate medical help.
Convulsive seizures; treatment with norfloxacin must be discontinued.
Weakness, shortness of breath, and pale skin, especially in patients with glucose-6-phosphate dehydrogenase deficiency, may be symptoms of massive red blood cell destruction (hemolytic reaction) leading to anemia.
Persistent and severe diarrhea, which may be a symptom of pseudomembranous colitis. This complication, sometimes resulting from antibiotic use, can range from mild to severe and may be fatal. Mild cases usually resolve after discontinuation of the drug. If necessary, the doctor will decide on appropriate treatment. Do not take anti-diarrheal drugs, as they inhibit toxin excretion.
Patients 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 a case, discontinue taking Nolicin and immediately inform the doctor to prevent the development of potentially irreversible disease.
Loss of appetite, jaundice, dark urine color, itching, or abdominal tenderness, which may be symptoms of cholestatic hepatitis (liver inflammation with bile flow obstruction). If objective and subjective symptoms of liver disease occur, patients should be advised to discontinue treatment and contact a doctor.
Vision deterioration or other visual disturbances. If these occur, consult an ophthalmologist immediately.
Rarely, joint pain, swelling, inflammation, or tendon rupture may 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 discontinuation of Nolicin. After the first symptoms of tendon pain or inflammation (e.g. in the ankle, wrist, elbow, shoulder, or knee), discontinue taking Nolicin, contact a doctor, and rest the affected area. Avoid excessive physical exertion, as it may increase the risk of tendon rupture.
Crystals in the urine causing pain and discomfort during urination (crystalluria).
In case of sudden severe abdominal, back, or chest pain, which may be a symptom of aortic aneurysm and dissection, immediately go to the emergency department. The risk of these conditions may be higher during systemic corticosteroid treatment.
In case of sudden shortness of breath, especially after lying down, or observing swelling of the ankles, feet, or abdomen, or experiencing palpitations (feeling of rapid or irregular heartbeat), seek immediate medical attention.

Quinolone antibiotics may cause increased blood glucose levels above normal
(hyperglycemia) or decreased blood glucose levels below normal, which in severe cases may lead to
(loss of consciousness) (hypoglycemic coma) (see section 4) .
This is important for patients with diabetes . In diabetic patients, careful monitoring of blood glucose levels is recommended.
Due to the possibility of photosensitivity reactions, avoid excessive exposure to sunlight or ultraviolet radiation during treatment.
Due to the risk of tendon inflammation and rupture, avoid excessive physical exertion during and immediately after treatment with Nolicin.
Due to the risk of crystal formation in the urine, ensure proper hydration of the patient. During treatment with Nolicin, drink plenty of fluids. Ask your doctor how much fluid should be consumed daily. In case of prolonged treatment, check for the presence of crystals in the urine.
Long-term, disabling, and potentially irreversible serious adverse effects
Antibacterial drugs containing fluoroquinolones/quinolones, including Nolicin, have been associated with very rare but serious adverse effects. Some of these were long-term (lasting 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 disorders, severe fatigue, and severe sleep disturbances.
If any of these adverse effects occur after taking Nolicin, contact the doctor immediately before continuing treatment. The patient and doctor will decide whether to continue treatment, also considering antibiotics from other groups.
Children and adolescents
Nolicin should not be used in children and adolescents during growth and development.
Nolicin with other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as medicines the patient plans to take.
Norfloxacin is a known inhibitor of the CYP1A2 enzyme. Exercise caution when using norfloxacin simultaneously with other substances metabolized via the same enzymatic pathway (theophylline, caffeine, and others). Norfloxacin, by inhibiting the metabolic transformation of these substances, may lead to increased blood concentrations and, consequently, to adverse effects specific to these substances.
Multivitamin preparations, mineral supplements (e.g. iron, zinc, aluminum, or magnesium), antacids containing magnesium or aluminum, sucralfate, or didanosine should not be taken simultaneously or within 2 hours of taking norfloxacin, as they may affect norfloxacin absorption, reducing its blood and urine concentrations. Therefore, it is recommended to take Nolicin two hours after taking these drugs.
Milk and yogurts (liquid dairy products) reduce the absorption of Nolicin. The patient should take Nolicin one hour before or two hours after a dairy meal.
Simultaneous use of Nolicin and cyclosporine may intensify cyclosporine adverse effects due to increased cyclosporine blood concentration. The doctor will monitor cyclosporine blood levels and, if necessary, recommend reducing its dose.
Simultaneous use of Nolicin and oral anticoagulants (warfarin or its derivatives) may enhance the anticoagulant effect.
Didanosine, a drug used in HIV infections, should not be administered simultaneously with norfloxacin or within two hours before or after norfloxacin administration, as it affects its absorption and causes reduced norfloxacin levels in serum and urine.
It has been shown that quinolones, including norfloxacin, inhibit caffeine metabolism. During norfloxacin treatment, avoid taking drugs containing caffeine (e.g. certain painkillers) as much as possible.
Simultaneous use of Nolicin and corticosteroids increases the risk of tendon inflammation or rupture.
During treatment with Nolicin, the effect of certain antidiabetic drugs (sulfonylurea derivatives, such as glibenclamide) may intensify.
Do not take Nolicin and nitrofurantoin simultaneously, as the effect of both drugs is weakened.
Animal studies have shown that quinolones in combination with fenbufen may cause seizures. Therefore, avoid simultaneous use of Nolicin and fenbufen.
Exercise caution when using Nolicin simultaneously with non-steroidal anti-inflammatory drugs, as seizures may occur.
If the patient is taking other drugs 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 antipsychotics, they must inform the doctor (see warnings regarding heart function disorders above).
Using Nolicin with food, drink, and alcohol
Tablets should be swallowed with a glass of water at least 1 hour before or 2 hours after a meal or dairy product intake.
Do not take multivitamin preparations, mineral supplements (e.g. iron, zinc, aluminum, or magnesium), antacids containing magnesium and aluminum, sucralfate, or didanosine within 2 hours of taking Nolicin.
Do not drink alcoholic beverages during treatment with Nolicin.
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.
Nolicin should not be used during pregnancy or in breastfeeding women.
Driving and operating machinery
Nolicin has a moderate effect on the ability to drive motor vehicles and operate moving machinery. If the patient takes the drug and drinks alcoholic beverages simultaneously, adverse effects intensify.
Nolicin contains the colorant Sunset Yellow FCF (E 110) and sodium
Sunset Yellow FCF (E 110) may cause allergic reactions.
The medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning the medicine is considered "sodium-free".

3. How to use Nolicin

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
Dosage and method of administration
Your doctor will determine the dose of the medicine depending on the severity and type of infection.
The tablets should be swallowed whole, with a glass of water, at least 1 hour before a meal or 2 hours after a meal
or after consuming dairy products.

Indications Dosage Duration of treatment
Uncomplicated acute cystitis 400 mg twice daily 3 days
Complicated urinary tract infections 400 mg twice daily 7 to 10 days
(except complicated pyelonephritis)
Bacterial prostatitis 400 mg twice daily up to 12 weeks

In patients with renal impairment, the doctor will adjust the dosage accordingly.
Use in children and adolescents
Nolicin should not be used in children and adolescents during periods of growth and development.
Dosage in elderly patients
In elderly patients with normal kidney function, dosage adjustment is not necessary.
If you feel that the effect of the medicine is too strong or too weak, consult your doctor or pharmacist.
Taking more Nolicin than prescribed
If you take more Nolicin than prescribed, contact your doctor or pharmacist immediately.
Excessive doses of the medicine may cause nausea, vomiting, diarrhoea; in more severe cases, dizziness,
fatigue, disorientation, and seizures may occur.
Missed dose of Nolicin
If you miss a dose, take it as soon as you remember, unless it is almost time for your next dose.
Do not take a double dose to make up for a missed dose.
Stopping treatment with Nolicin
Nolicin should be taken for the duration indicated by your doctor, even if symptoms of the illness resolve earlier.
Premature discontinuation of treatment may lead to recurrence of the infection.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Serious side effects may occur during treatment with Nolicin. If any of these occur, you should
contact your doctor immediately. Please read the information provided under "Warnings and
precautions" in section 2 and below.
Administration of quinolone and fluoroquinolone antibiotics has very rarely led, even in cases without
pre-existing risk factors, to long-term (lasting for months or years) or permanent adverse reactions,
such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, sensory disturbances such as pricking, tingling, tickling, burning, numbness or pain (neuropathy), depression, fatigue, sleep disturbances, memory problems, and disturbances in hearing, vision, taste, and smell.

Common side effects (occur in 1 to 10 out of 100 patients):

cholestatic hepatitis, hepatitis (see section 2 "Warnings and precautions"),
rash.

Uncommon side effects (occur in 1 to 10 out of 1,000 patients):

changes in the number of certain blood cells (eosinophilia, leukopenia, neutropenia, thrombocytopenia). If recurrent infections, mouth ulcers, petechiae, or bleeding occur, contact your doctor.
reduced blood clotting ability (prolonged prothrombin time). If bleeding persists, contact your doctor.
headache, dizziness,
abdominal pain and cramps, heartburn, diarrhoea, nausea,
crystals in urine causing pain and discomfort during urination (crystalluria) (see section 2 "Warnings and precautions"),
increased liver enzyme activity, increased blood urea and creatinine levels, decreased hematocrit (percentage of red blood cells in blood).

Rare side effects (occur in 1 to 10 out of 10,000 patients):

allergic reactions (urticaria, rash, itching),
severe allergic reactions, including anaphylactic shock (anaphylaxis) (see section 2 "Warnings and precautions"),
mood changes, depression, anxiety, nervousness, irritability, euphoria, disorientation, hallucinations, confusion, psychiatric disorders and psychotic reactions,
visual disturbances, increased lacrimation (see section 2 "Warnings and precautions"),
ringing in the ears (tinnitus),
subcutaneous bleeding with inflammation of blood vessels,
vomiting, loss of appetite,
severe and persistent diarrhoea (pseudomembranous colitis) (see section 2 "Warnings and precautions"),
pancreatitis,
severe skin reactions: exfoliative dermatitis, erythema multiforme bullous (Stevens-Johnson syndrome), exfoliative dermatitis and toxic epidermal necrolysis (Lyell's syndrome) (see section 2 "Warnings and precautions"),
photosensitivity (see section 2 "Warnings and precautions"),
itching and urticaria,
swelling of the face, lips, tongue and (or) throat with difficulty breathing or swallowing (angioedema) (see section 2 "Warnings and precautions"),
tendon inflammation, inflammation of the bursa (bursitis), muscle and/or joint pain, arthritis,
kidney inflammation,
vaginal candidiasis,
fatigue.

Very rare side effects (occur in fewer than 1 out of 10,000 patients):

tingling or numbness of hands and feet (paresthesia),
degenerative nerve diseases (polyneuropathy), including Guillain-Barré syndrome (see section 2 "Warnings and precautions"),
seizures (see section 2 "Warnings and precautions"),
insomnia,
tendon rupture (e.g. Achilles tendon), usually in combination with other harmful factors (see section 2 "Warnings and precautions"),
hemolytic anaemia,
exacerbation of myasthenia symptoms (see section 2 "Warnings and precautions").

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

very rapid heartbeat (see section 2 "Warnings and precautions"),
life-threatening irregular heartbeat (see section 2 "Warnings and precautions"),
QT interval prolongation visible on ECG – a test measuring the electrical activity of the heart (see section 2 "Warnings and precautions"),
jaundice,
loss of consciousness due to significantly reduced blood sugar levels (hypoglycaemic coma). See section 2.

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

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Nolicin

Keep the medicine out of the sight and reach of children.
Store below 25°C in the original packaging, protected from light and moisture.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Nolicin contains

The active substance is norfloxacin. Each coated tablet contains 400 mg of norfloxacin.
The other ingredients are:
tablet core: sodium carboxymethyl starch (type A), microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate, purified water, povidone,
tablet coating: hypromellose, talc, titanium dioxide (E 171), sunset yellow FCF (E 110), propylene glycol. See section 2 "Nolicin contains the colour sunset yellow FCF (E 110) and sodium".

What Nolicin looks like and contents of the pack
The coated tablets are orange, round, slightly convex, with a score line on one side. The score line is intended only to facilitate breaking the tablet for easier swallowing and does not ensure equal dosing.
The packaging contains 10 or 20 coated tablets in blisters, packed in a cardboard box.
For more detailed information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in the Czech Republic, country of export:
KRKA d. d., Novo mesto
Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Manufacturer:
KRKA d. d., Novo mesto
Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw, Poland
Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland
Marketing Authorisation Number in the Czech Republic, country of export: 15/053/87-S/C
Parallel Import Authorisation Number: 413/24