Nolicin

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Nolicin, 400 mg, coated tablets
Norfloxacinum
Please read this leaflet carefully 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 for a specific individual. Do not give it to others. The 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, inform the doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What is Nolicin and what is it 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 package and other information

1. What is Nolicin and what is it used for

Norfloxacin, the active substance in Nolicin, is a chemotherapeutic agent belonging to the quinolone group with a broad spectrum of antibacterial activity. Nolicin is effective against many species of aerobic Gram-positive and Gram-negative bacteria.
Indications for use
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 determined, if possible. However, norfloxacin therapy may be initiated before the results of susceptibility 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 the period of 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 fluorochinolones or quinolones, including Nolicin, if the patient has previously experienced any severe adverse reaction while taking a quinolone or fluorochinolone. 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 exacerbate symptoms of this disease, including life-threatening breathing 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 in a family member, consult a doctor, as hemolysis (destruction of red blood cells) may occur during treatment, leading to anemia;
• if the patient has diabetes, as there may be a risk of hypoglycemic coma (see below and section 4);
• renal insufficiency; the doctor will recommend an appropriately reduced dose of the drug; during treatment with Nolicin, it is recommended to drink adequate amounts of fluids;
• heart function disorders associated with risk factors for QT interval prolongation, such as:
• confirmed congenital or familial QT prolongation (visible on ECG - electrocardiogram);
• confirmed electrolyte imbalance in the blood (especially low potassium and magnesium levels);
• very slow heart rate (called bradycardia);
• poor heart function (heart failure);
• previous myocardial infarction;
• the patient is a woman or elderly person;
• use of other drugs that may cause changes in ECG (see section "Nolicin with other medicines");
• if the patient has been diagnosed with dilation of a 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 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 experiences 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: bullous erythema multiforme (Stevens-Johnson syndrome), exfoliative dermatitis, and toxic epidermal necrolysis (Lyell's syndrome) manifested 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
• giant blisters, peeling of large skin areas, weakness, fever, and joint pain
• potentially fatal anaphylactic shock manifested by low blood pressure, pale skin, rapid breathing, cold sweats, weakness, and fainting. If such reactions occur, treatment must be stopped immediately and contact the 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 sensitivity. The doctor will decide whether to discontinue treatment.
• In case of worsening myasthenia symptoms, including breathing 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 even 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.
• The patient may rarely experience symptoms of nerve damage (neuropathy), such as pain, burning, tingling, numbness, and (or) weakness, especially in the feet and legs, and hands and arms. In such a case, stop taking Nolicin and immediately inform the doctor to prevent the development of potentially irreversible disease.
• Loss of appetite, jaundice, dark urine, itching, or abdominal tenderness, which may be symptoms of cholestatic hepatitis (liver inflammation with bile flow obstruction). If subjective and objective symptoms of liver disease occur, patients should be advised to discontinue treatment and contact the doctor.
• Worsening vision or other visual disturbances. If they 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 treated with corticosteroids. 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), stop taking Nolicin, contact the 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 be a symptom of aortic aneurysm and dissection, seek immediate help at an emergency department. 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 if swelling of the ankles, feet, or abdomen, or palpitations (feeling of rapid or irregular heartbeat) are observed, 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 important for diabetic patients. Diabetic patients are advised to carefully monitor their blood glucose levels.
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.
Because of the risk of crystal formation in urine, ensure proper hydration of the patient. During treatment with Nolicin, it is recommended to drink large amounts of fluids. Ask the doctor what amount of fluid should be consumed daily. In case of prolonged treatment, check for the presence of crystals in urine.
Long-term, disabling, and potentially irreversible serious adverse reactions
Antibacterial drugs containing fluoroquinolones/quinolones, including Nolicin, have been associated with very rare but serious adverse reactions. Some of these were long-term (lasting for months or years), disabling, or potentially irreversible. These include: tendon, muscle, and joint pain in 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 disorders.
If any of these adverse reactions 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 the period of growth and development.
Nolicin with other medicines
Inform the 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 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 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 caffeine metabolism is inhibited by quinolones, including norfloxacin. During treatment with norfloxacin, 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 be intensified.
Do not take Nolicin and nitrofurantoin simultaneously, as the effect of both drugs is weakened.
Animal studies have shown that quinolones in combination with phenylbutazone may cause seizures. Therefore, avoid simultaneous use of Nolicin and phenylbutazone.
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, inform the doctor (see warnings regarding heart function disorders above).
Using Nolicin with food, drink, and alcohol
Take tablets 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 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 the drug and consumes alcoholic beverages simultaneously, adverse effects intensify.
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 used exactly as directed by the doctor. If in doubt, consult a doctor or pharmacist.
Dosage and method of administration
The doctor will determine the dose 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.

In patients with renal impairment, the physician will appropriately modify the dosage of the medicinal product.
Use in children and adolescents
The medicinal product Nolicin should 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 medicine is too strong or too weak, consult your doctor or pharmacist.
Use of a higher than recommended dose of Nolicin
If a higher dose of Nolicin than recommended has been used, contact your doctor or pharmacist.
Excessive doses of the medicine may cause nausea, vomiting, diarrhoea; in more severe cases also dizziness, fatigue, disorientation and seizures.
Missed dose of Nolicin
If a dose of Nolicin has been missed, it should be taken as soon as this is noticed, unless the time for the next dose is approaching. A double dose should not be taken to make up for the missed dose.
Discontinuation of Nolicin treatment
Nolicin should be taken for the duration specified by the physician, even if symptoms of the disease resolve earlier. Premature discontinuation of treatment may lead to recurrence of the disease.
If you have any further questions regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Serious adverse effects may occur during treatment with Nolicin. If any of these occur,
contact your doctor immediately. Please read the information provided in "Warnings and precautions" in section 2 and the information below.
Administration of quinolone and fluoroquinolone antibiotics has very rarely led, even in the absence of pre-existing risk factors, to prolonged (lasting for months or years) or permanent adverse effects, such as tendonitis, 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 impairment, and disturbances of hearing, vision, taste, and smell.

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

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

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

• altered counts 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 "Warnings and precautions" in section 2),
• increased liver enzyme activity, increased blood urea and creatinine levels, decreased hematocrit (proportion of red blood cells in blood).

Rare adverse 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, anxiety, restlessness, irritability, euphoria, disorientation, hallucinations, confusion, psychiatric disorders and psychotic reactions,
• visual disturbances, increased lacrimation (see "Warnings and precautions" in section 2),
• tinnitus (ringing in the ears),
• subcutaneous bleeding with 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 bullosum (Stevens-Johnson syndrome), exfoliative dermatitis and 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 synovial sheath, muscle and (or) joint pain, arthritis,
• nephritis,
• vaginal candidiasis,
• fatigue.

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

• tingling or numbness of hands and feet (paresthesia),
• 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 low blood sugar levels (hypoglycaemic coma). See section 2.

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

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Phone: +48 22 49 21 30, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Nolicin

Keep the medicine out of the sight and reach of children.
Store below 25°C. Keep in the original packaging.
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 in use. This will help protect the environment.

6. Contents of the pack 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, povidone,
• 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 dose division.
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 Romania, 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:
Aga Kommerz spol. s r.o., Frydecka 2006, 737 01 Český Těšín, Czech Republic
Repackaged in:
Medezin Sp. z o.o., ul. Zbąszyńska 3, 91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa, ul. Działkowa 56, 02-234 Warszawa
Euceryn Manufacturing Plant Euceryn Pharmaceutical Laboratory COEL S.J. E.Z.M. KONSTANTY
ul. Wł. Żeleńskiego 45, 31-353 Kraków
Marketing authorisation number in Romania, country of export: 7701/2015/01
Parallel import authorisation number: 150/23