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 the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet to be able to read it again if necessary.
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 someone else, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

What is Nolicin and what is it 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 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 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 these 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 checked, 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 fluoroquinolones or quinolones, including Nolicin, if the patient has previously experienced any severe adverse reaction during treatment with a quinolone or fluoroquinolone. In such a case, contact the doctor immediately.
seizures or predisposition to seizures, epilepsy, or other brain disorders, such as reduced cerebral blood flow or stroke, because the drug may cause brain damage;
psychiatric disorders; the drug may exacerbate symptoms in patients with known or suspected psychiatric disorders, hallucinations, and (or) disorientation;
myasthenia (a disease causing muscle weakness); norfloxacin may worsen 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 breakdown of red blood cells (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 appropriate lower 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 interval prolongation (visible on ECG – electrocardiogram, a test of the heart's electrical activity);
confirmed electrolyte imbalance in the blood (especially low potassium and magnesium levels);
very slow heart rate (called bradycardia);
poor heart function (heart failure);
history of 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 enlargement of a large blood vessel (aortic aneurysm or large peripheral artery);
if the patient has 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 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, confirmed 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:

Allergic reactions:
itching and hives
swelling of the face, lips, tongue, and (or) throat with difficulty breathing or swallowing (angioedema)
severe skin reactions: blistering erythema multiforme (Stevens-Johnson syndrome), exfoliative dermatitis, and toxic epidermal necrolysis (Lyell's syndrome), manifesting as a 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 large blisters, peeling of large sheets of epidermis, weakness, fever, and joint pain
potentially life-threatening 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 must be made with a doctor or emergency physician who will take appropriate emergency measures.
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 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 breakdown of red blood cells (hemolytic reaction) leading to anemia.
Persistent and severe diarrhea, which may be a symptom of pseudomembranous colitis. This complication, sometimes resulting from antibiotic use, may 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 drugs, as they inhibit the excretion of toxins.
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 inform the doctor immediately 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 their doctor.
Worsening of vision or other visual disturbances. If these occur, consult an ophthalmologist immediately.
Rarely, joint pain, inflammation, or rupture of tendons may occur. The risk is increased in elderly patients (over 60 years), after organ transplantation, in 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. At the first sign of tendon pain or inflammation (e.g. in the ankle, wrist, elbow, shoulder, or knee), stop 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 or dissection, seek immediate emergency care. The risk of these conditions may be higher in patients receiving systemic corticosteroids.
In case of sudden shortness of breath, especially after lying down, or if swelling of the ankles, feet, or abdomen, or palpitations (sensation of rapid or irregular heartbeat) are observed, 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 particularly 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
treatment with Nolicin and immediately after its discontinuation.
Due to the risk of crystal formation in the urine, ensure adequate hydration of the patient. During
treatment with Nolicin, it is recommended to drink large amounts of fluids. Consult your doctor
regarding the appropriate daily fluid intake. In case of prolonged treatment, check for the presence
of crystals in the 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-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 disorders, severe fatigue, and severe sleep disturbances.
If any of these adverse reactions 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 the period of growth and
development.
Nolicin with other medicines
Inform your doctor or pharmacist about all medicines currently taken, recently taken, or planned to
be taken.
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 at the
same time 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.
Concomitant use of Nolicin and cyclosporine may increase cyclosporine adverse effects due to
increased blood concentration of cyclosporine. The doctor will monitor cyclosporine blood levels
and, if necessary, recommend reducing its dose.
Concomitant 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 reduces norfloxacin levels in serum and urine.
It has been shown that the metabolism of caffeine is inhibited by quinolones, including norfloxacin.
During treatment with norfloxacin, avoid taking drugs 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 effect 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 non-steroidal 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 heart function disorders above).
Taking Nolicin with food, drinks, and alcohol
Swallow the 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 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 become
pregnant, 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 alcohol simultaneously, adverse effects are intensified.
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 or 2 hours after a meal or intake of 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 appropriately adjust the dosage.
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 renal function, dosage adjustment is not necessary.
If you feel the effect of this medicine is too strong or too weak, consult your doctor or pharmacist.
Taking more Nolicin than you should
If you have taken more of the medicine than prescribed, contact your doctor or pharmacist immediately.
Excessive doses of the medicine may cause nausea, vomiting, diarrhoea, and in more severe cases also dizziness, fatigue, disorientation, and seizures.
If you forget to take Nolicin
If you miss a dose of the medicine, 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 Nolicin treatment
Nolicin should be taken for the duration prescribed by your doctor, even if symptoms improve earlier. Premature discontinuation of treatment may lead to recurrence of the infection.
If you have any further doubts 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 everybody will experience them.
Serious side effects may occur during treatment with Nolicin. If you experience any of these,
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, abnormal sensations such as pricking, tingling, tickling, burning, numbness or pain (neuropathy), depression, fatigue, sleep disturbances, memory problems, and disturbances of 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):

altered count 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, elevated blood urea and creatinine levels, decreased haematocrit (proportion 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 "Warnings and precautions" in section 2),
mood changes, depression, anxiety, 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,
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 (increased sensitivity to sunlight) (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 membrane forming joint capsules, 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 diseases (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 seen on ECG – a test 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.

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

Reporting of side effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department for 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 to provide more information on the safety of this medicine.

5. How to store the medicine Nolicin

Keep the medicine out of the sight and reach of children.
Store below 25°C 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 month indicated.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Nolicin contains

The active substance is norfloxacin. Each coated tablet contains 400 mg of norfloxacin.
Other ingredients are:
tablet core: sodium carboxymethylstarch (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 the colouring agent 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 blisters, packed 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:
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 Romania, country of export: 7701/2015/01
Parallel import authorisation number: 392/22