Nolicin

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 the entire 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 pass it on to others. The medicine may harm another person, even if their symptoms are identical.
• If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. 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 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 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.

The sensitivity of the causative microorganism to norfloxacin should be verified, 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 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, contact 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 disease has occurred in the patient or in someone in their family, consult a doctor, as during treatment massive breakdown of red blood cells (hemolytic reaction) causing anemia may occur;
• if the patient has diabetes, because there may be a risk of hypoglycemic coma (see below and section 4);
• renal failure; the doctor will recommend appropriately reduced doses of the drug; during treatment with Nolicin, adequate fluid intake is recommended;
• 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 in the blood);
• 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 the ECG trace (see section "Nolicin and 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 in the family there were cases of aortic aneurysm or aortic dissection 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 blood vessel 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 advice immediately (see section 4):

• Allergic reactions:
• itching and urticaria,
• 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 rash with blisters 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 life-threatening anaphylactic shock manifested by a drop in blood pressure, pale skin, rapid breathing, cold sweats, weakness and fainting. In case of such reactions, 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 occurrence of 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 breakdown (hemolytic reaction) causing 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, potentially 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.
• 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 objective and subjective symptoms of liver disease occur, patients should be advised to discontinue treatment and contact a doctor.
• Worsening of vision or other visual disturbances. If they occur, consult an ophthalmologist immediately.
• Rarely, joint pain and swelling, inflammation or rupture of tendons may occur. The risk is increased in elderly people (over 60 years), after organ transplantation, in case of kidney problems or corticosteroid treatment. Tendon inflammation and rupture may occur within the first 48 hours of treatment, and even up to 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 a doctor and rest the affected area. Avoid excessive 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, go immediately to the emergency department. The risk of these changes may be higher in patients treated with systemic corticosteroids.
• In case of sudden shortness of breath, especially after lying down, or observing swelling of ankles, feet or abdomen or occurrence of palpitations (feeling of rapid or irregular heartbeat), seek medical advice immediately.

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.
Since there is a risk of crystal formation in 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 urine.
Long-term, disabling and potentially irreversible serious adverse reactions
Antibacterial drugs containing fluorochinolones/quinolones, including Nolicin, have been associated with very rare but serious adverse reactions. Some of them 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 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 and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken by the patient, as well as about 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 occurrence of 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 of cyclosporine. 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 a decrease in norfloxacin levels in serum and urine.
It has been shown that caffeine metabolism is inhibited by quinolones, including norfloxacin. 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, inform the doctor (see warnings regarding heart function disorders above).
Taking 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.
Within 2 hours after taking Nolicin, do not take multivitamin preparations, mineral supplements (e.g. iron, zinc, aluminum or magnesium), antacids containing magnesium and aluminum, sucralfate or didanosine.
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 machinery. If the patient takes the drug and drinks 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, i.e. the medicine is considered "sodium-free".

3. How to use Nolicin

This medicine should always be used as directed by the physician. In case of any doubts, consult your doctor or pharmacist.
Dosage and method of administration
The physician 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.

In patients with renal impairment, the physician will appropriately modify the dose of the medicinal product.
Use in children and adolescents
The medicinal product 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 medicine is too strong or too weak, consult your doctor or pharmacist.
Use of a higher than recommended dose of Nolicin
If you take more Nolicin than recommended, contact your doctor or pharmacist.
Excessive doses of the medicine may cause nausea, vomiting, diarrhoea; in more severe cases, dizziness, fatigue, disorientation and convulsions may also occur.
Missed dose of Nolicin
If you miss a dose of Nolicin, 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.
Discontinuation of Nolicin
Nolicin should be taken for the duration specified by the doctor, even if symptoms of the disease disappear earlier. Premature discontinuation of treatment may lead to recurrence of the disease.
If you have any further doubts regarding 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 get them.
Serious side 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 below.
Administration of quinolone and fluoroquinolone antibiotics has very rarely led, in some cases regardless 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), 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 "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, 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 (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 membrane forming the joint capsule, 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 "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 a significant drop in blood sugar levels (hypoglycaemic coma). See section 2.

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

Reporting of side effects
If any adverse effects occur, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. Side effects can be reported directly to the Department for Monitoring Adverse Drug Reactions at 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 the medicine Nolicin

Keep this medicine out of 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 required. Such measures will help protect the environment.

6. Contents of the packaging 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 break line on one side. The break line
on the tablet 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, 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:
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 Romania, country of export: 7701/2015/01
Parallel import authorisation number: 114/23