Nolicin

Package leaflet: information for the patient

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.
Nolicin (Nolicin), 400 mg, coated tablets
Norfloxacinum
Nolicin and Nolicin are trade names of the same medicinal product written in Polish and Bulgarian.
Please read the leaflet carefully before use, as it contains important information for the patient.

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

Table of contents

1. What Nolicin is and what it is used for
2. Important information before taking Nolicin
3. How to take Nolicin
4. Possible side effects
5. How to store Nolicin
6. 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 quinolone group with broad-spectrum antibacterial activity. Nolicin is active against many species of aerobic Gram-positive and Gram-negative bacteria.

Indications for use

Nolicin is indicated for 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.

The sensitivity of the causative microorganism to norfloxacin should be determined, if possible. However, norfloxacin therapy may be initiated before the results of sensitivity testing 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 pain, inflammation, or rupture of tendons 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 had or currently has any of the following conditions, inform the doctor before starting treatment:

• do not take antibacterial drugs containing fluoroquinolones or quinolones, including Nolicin, 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, because 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 hemolysis (hemolytic reaction) leading to anemia may occur during treatment;
• if the patient has diabetes, because there is 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;
• cardiac disorders associated with risk factors for QT interval prolongation, such as:
• congenital or familial QT prolongation (visible on ECG – a test measuring electrical activity of the heart);
• documented electrolyte imbalance in the blood (especially low potassium and magnesium levels);
• very slow heart rate (called bradycardia);
• impaired heart function (heart failure);
• history of myocardial infarction;
• the patient is female or elderly;
• use of other drugs that may cause changes in ECG (see section "Nolicin and Other Medicines");
• if the patient has been diagnosed with aortic or large peripheral artery aneurysm (dilation of a major blood vessel);
• if the patient previously experienced aortic dissection (tearing of the aortic wall);
• the patient has been diagnosed with 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 Ehlers-Danlos syndrome, Turner syndrome, Sjögren's syndrome [an autoimmune inflammatory disease], or vascular diseases such as Takayasu arteritis, giant cell arteritis, Behçet's disease, hypertension, confirmed atherosclerosis, rheumatoid arthritis [joint disease], or endocarditis [heart infection]).

If the patient develops any of the symptoms described below during treatment, seek medical advice 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: erythema multiforme bullosum (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 skin, red spots on the trunk, often with blisters in the center, giant ruptured blisters, peeling of large sheets of skin, weakness, fever, and joint pain,
• potentially fatal anaphylactic shock, characterized by low blood pressure, pale skin, rapid breathing, cold sweats, weakness, and fainting. If such reactions occur, treatment must be stopped immediately, and the patient should contact a doctor or emergency physician who will take appropriate emergency measures.
• Fever, rash, itching, or small red spots on the skin, which may be symptoms of photosensitivity or ultraviolet radiation allergy. The doctor will decide whether to discontinue treatment.
• Worsening of myasthenia symptoms, including respiratory disorders (which may be 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 indicate massive red blood cell breakdown (hemolytic reaction) leading to anemia.
• Persistent and severe diarrhea, which may be a sign of pseudomembranous colitis. This complication, sometimes resulting from antibiotic use, may range from mild to severe and can 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 medications, as they inhibit toxin elimination.
• Rarely, patients may 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 cases, discontinue Nolicin and inform the doctor immediately to prevent the development of potentially irreversible disease.
• Loss of appetite, jaundice, dark urine, itching, or abdominal tenderness, which may indicate cholestatic hepatitis (liver inflammation with bile flow obstruction). If subjective or objective symptoms of liver disease occur, patients should be advised to stop treatment and contact their doctor.
• Worsening of vision or other visual disturbances. If these occur, consult an ophthalmologist immediately.
• Rarely, tendon pain and swelling, inflammation, or 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 Nolicin, contact a doctor, and rest the affected area. Avoid excessive physical exertion, as it may increase the risk of tendon rupture.
• Crystals in urine, causing pain and discomfort during urination (crystalluria).
• In case of sudden, severe abdominal, back, or chest pain, which may indicate aortic aneurysm or dissection, seek immediate emergency care. The risk of these events may be higher in patients receiving systemic corticosteroids.
• If sudden shortness of breath occurs, especially when lying down, or if ankle, foot, or abdominal swelling is observed, or palpitations (sensation of rapid or irregular heartbeat) appear, seek immediate medical advice.

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 particularly important for patients with diabetes. Diabetic patients should carefully monitor their blood glucose levels.
Due to the possibility of photosensitivity reactions, avoid excessive exposure to sunlight or ultraviolet radiation during treatment.
Because of 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 urine, ensure adequate hydration. During treatment with Nolicin, drink plenty of fluids. Ask your doctor how much fluid should be consumed daily. In prolonged treatment, monitor for the presence of crystals in 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-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 disorders.
If any of these adverse effects occur after taking Nolicin, contact your 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 and Other Medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.
Norfloxacin is a known inhibitor of the CYP1A2 enzyme. Exercise caution when using norfloxacin concomitantly with other substances metabolized via the same enzymatic pathway (theophylline, caffeine, and others). By inhibiting the metabolism of these substances, norfloxacin may increase their blood concentrations, leading to substance-specific adverse effects.
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 norfloxacin, as they may affect norfloxacin absorption, reducing its blood and urine concentrations. Therefore, it is recommended to take Nolicin two hours after these medications.
Milk and yogurt (liquid dairy products) reduce the absorption of Nolicin. The patient should take Nolicin one hour before or two hours after a dairy meal.
Concomitant use of Nolicin and cyclosporine may increase cyclosporine-related adverse effects due to elevated cyclosporine blood levels. The doctor will monitor cyclosporine blood levels and, if necessary, recommend a dose reduction.
Concomitant use of Nolicin and oral anticoagulants (warfarin or its derivatives) may enhance the anticoagulant effect.
Didanosine, used in HIV infections, should not be administered simultaneously with norfloxacin or within two hours before or after norfloxacin, as it affects its absorption and reduces norfloxacin levels in serum and urine.
It has been shown that quinolones, including norfloxacin, inhibit caffeine metabolism. During norfloxacin treatment, avoid taking medications containing caffeine (e.g., certain painkillers) as much as possible.
Concomitant 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 be intensified.
Do not take Nolicin and nitrofurantoin simultaneously, as the efficacy of both drugs is reduced.
Animal studies have shown that quinolones in combination with fenbufen may cause seizures. Therefore, avoid concomitant use of Nolicin and fenbufen.
Exercise caution when using Nolicin concomitantly with nonsteroidal anti-inflammatory drugs, as seizures may occur.
If the patient is taking other drugs that may affect heart rhythm, such as antiarrhythmics (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, certain antibacterial drugs (macrolide group), or certain antipsychotics, inform the doctor (see warnings regarding cardiac function disorders above).

Taking Nolicin with Food, Drink, and Alcohol
Swallow tablets with a glass of water at least 1 hour before or 2 hours after a meal or dairy product.
Do not take multivitamin preparations, mineral supplements (e.g., iron, zinc, aluminum, or magnesium), antacids containing magnesium or aluminum, sucralfate, or didanosine within 2 hours of taking Nolicin.
Do not consume 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 machinery. If the patient takes this medicine together with alcohol, adverse effects may be intensified.

Nolicin Contains 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 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 or 2 hours after a meal or after consuming dairy products.

In patients with renal impairment, the physician will appropriately modify the dosage of the drug.
Use in children and adolescents
Nolicin must not be used in children and adolescents during the period of growth and development.
Dosage in elderly patients
In elderly patients with normal renal function, there is no need to modify the dose.
If you feel that the effect of the drug is too strong or too weak, consult your doctor or pharmacist.
Use of a higher than recommended dose of Nolicin
If you take more of the drug than recommended, contact your doctor or pharmacist.
Excessive doses of the drug may cause nausea, vomiting, diarrhea; in more severe cases also dizziness, fatigue, disorientation, and seizures.
Missed dose of Nolicin
If you miss a scheduled dose, take it as soon as you remember, unless it is almost time for the 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 specified by the physician, even if symptoms resolve earlier. Premature discontinuation of treatment may lead to recurrence of the disease.
If you have any further questions concerning 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 in "Warnings and
Precautions" in section 2 and below.
Administration of quinolone and fluoroquinolone antibiotics has very rarely led, even in the absence of 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), fatigue, psychiatric symptoms (including sleep disturbances, anxiety, panic attacks, depression and suicidal thoughts), memory and concentration difficulties, disturbances in hearing, vision, taste and smell.

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

• cholestatic hepatitis, hepatitis (see "Warnings and Precautions" in section 2),
• 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 you experience frequent infections, mouth ulcers, bruising or bleeding, 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 the urine causing pain and discomfort during urination (crystalluria) (see "Warnings and Precautions" in section 2),
• increased liver enzyme activity, increased blood urea and creatinine levels, decreased haematocrit (proportion of red blood cells in the 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 "Warnings and Precautions" in section 2),
• mood changes, depression, feeling anxious, nervousness, irritability, euphoria, disorientation, hallucinations, confusion, psychiatric disorders and psychotic reactions,
• visual disturbances, increased tearing (see "Warnings and Precautions" in section 2),
• ringing in the ears (tinnitus),
• subcutaneous bleeding with inflammation of blood vessels (vasculitis),
• vomiting, loss of appetite,
• severe and persistent diarrhoea (pseudomembranous colitis) (see "Warnings and Precautions" in section 2),
• pancreatitis,
• severe skin reactions: exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome) (see "Warnings and Precautions" in section 2),
• photosensitivity (see "Warnings and Precautions" in section 2),
• itching and urticaria,
• swelling of the face, lips, tongue and/or throat with difficulty breathing or swallowing (angioedema) (see "Warnings and Precautions" in section 2),
• tendon inflammation, inflammation of the membrane forming the joint capsule (tenosynovitis), 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 (paraesthesia),
• degenerative nerve disorders (polyneuropathy), including Guillain-Barré syndrome (see "Warnings and Precautions" in section 2),
• seizures (see "Warnings and Precautions" in section 2),
• insomnia,
• tendon rupture (e.g. Achilles tendon), usually in combination with other harmful factors (see "Warnings and Precautions" in section 2),
• haemolytic anaemia,
• exacerbation of myasthenia symptoms (see "Warnings and Precautions" in section 2).

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

• very rapid heartbeat (see "Warnings and Precautions" in section 2),
• life-threatening irregular heartbeat (see "Warnings and Precautions" in section 2),
• QT interval prolongation visible on ECG – an examination of the heart's electrical activity (see "Warnings and Precautions" in section 2),
• jaundice,
• loss of consciousness due to significantly reduced blood sugar levels (hypoglycaemic coma). See section 2.

In patients receiving fluoroquinolones, cases of aortic aneurysm and dissection (aortic wall dilation and weakening or rupture) 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 you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. Side effects can also 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
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Nolicin

Keep this medicine out of sight and reach of children.
No special storage conditions apply.
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 wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What the medicinal product 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, povidone, purified water,
• tablet coating: hypromellose, talc, titanium dioxide (E 171), sunset yellow FCF (E 110), propylene glycol.

See section 2 "Nolicin contains 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 pack contains 10 or 20 coated tablets in PVC-PVDC/Al blisters in a cardboard box.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing Authorisation Holder in Bulgaria, the 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:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing Authorisation number in Bulgaria, the country of export: 20000707
Parallel import authorisation number: 367/24