Nolicin

Leaflet accompanying the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Nolicin (Нолицин), 400 mg, film-coated tablets

Norfloxacin
Nolicin and Нолицин are trade names of the same drug written in Polish and Bulgarian.

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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 using Nolicin
• 3. How to use Nolicin
• 4. Possible side effects
• 5. How to store Nolicin
• 6. Contents of the packaging and other information

1. What is Nolicin and what is it used for

Norfloxacin, the active substance of Nolicin, is a chemotherapeutic agent from the quinolone group with a broad spectrum of antibacterial activity. Nolicin acts on many species of aerobic Gram-positive and Gram-negative bacteria.

Indications for use

Nolicin is used to treat the following infections caused by microorganisms sensitive to norfloxacin:

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

It is recommended to check the sensitivity of the microorganism causing the infection to norfloxacin, if possible. However, norfloxacin therapy can be started before the results of the sensitivity test are received.

2. Important information before using Nolicin

When not to use Nolicin

• in pregnant and breastfeeding women,
• in children and adolescents during growth and development,

Warnings and precautions

Before starting treatment with Nolicin, the patient should discuss it with their doctor.

If the patient has a history of or currently has any of the following diseases, they should inform their doctor before starting treatment:

• do not take antibacterial drugs containing fluoroquinolones or quinolones, including Nolicin, if the patient has previously experienced any severe side effects while taking a quinolone or fluoroquinolone. In such a situation, the doctor should be informed as soon as possible.
• seizures or a tendency to seizures, epilepsy, or other brain diseases, such as reduced blood flow to the brain, stroke, as the medicine may cause brain damage;
• psychiatric disorders; the medicine may lead to worsening and intensification of symptoms in patients with known or suspected psychiatric disorders, hallucinations, and/or disorientation;
• myasthenia (a disease that causes muscle weakness); norfloxacin may cause worsening of symptoms of this disease, including life-threatening respiratory disorders;
• glucose-6-phosphate dehydrogenase deficiency (a hereditary disease of red blood cells, related to the abnormal structure of this enzyme); if this disease has occurred in the patient or someone in their family, they should consult a doctor, as hemolytic reaction (causing anemia) may occur during treatment;
• renal impairment; the doctor will recommend a suitable dose of the medicine; during treatment with Nolicin, it is recommended to drink plenty of fluids;
• heart rhythm disorders related to risk factors for QT interval prolongation, such as:
• congenital or familial QT interval prolongation (visible on an ECG - a test of heart electrical activity);
• 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 an elderly person;
• taking other medicines that may affect the heart rhythm (see "Nolicin and other medicines");
• if the patient has been diagnosed with heart valve regurgitation;

If the patient experiences any of the following symptoms during treatment, they should immediately consult a doctor (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: blistering rash (Stevens-Johnson syndrome), exfoliative dermatitis, and toxic epidermal necrolysis (Lyell's syndrome) characterized by a rash with blisters all over the body, ulcers in the mouth, eyes, genitals, and skin, red spots on the torso, often with blisters in the center, large blisters bursting, skin peeling, 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 should be stopped immediatelyand the patient should contact a doctor or emergency doctor who will take appropriate action in emergency situations.
• Fever, rash, itching, or small red spots on the skin may be symptoms of an allergic reaction to sunlight or ultraviolet radiation. The doctor will decide whether to discontinue treatment.
• In case of worsening myasthenia symptoms, including respiratory disorders (which can be life-threatening), the patient should immediately seek medical help.
• Seizures; Nolicin treatment should be discontinued.
• Weakness, shortness of breath, and pale skin, especially in patients with glucose-6-phosphate dehydrogenase deficiency, may be symptoms of a hemolytic reaction (causing anemia).
• Persistent and severe diarrhea, which can be a symptom of pseudomembranous colitis. This complication, sometimes resulting from the use of antibiotics, can range from mild to severe and potentially life-threatening. Mild cases usually resolve after discontinuation of the medicine. If necessary, the doctor will decide on appropriate treatment. Anti-diarrheal medicines should not be taken, as they can prevent the elimination of toxins.
• The patient may rarely experience symptoms of nerve damage (neuropathy), such as pain, burning, tingling, numbness, or weakness, especially in the hands and feet. In such cases, the patient should discontinue Nolicin and immediately inform their doctor to prevent the development of potentially irreversible disease.
• Lack of appetite, jaundice, dark urine, itching, or abdominal tenderness may be symptoms of liver inflammation with bile flow obstruction (cholestatic hepatitis). If symptoms of liver disease occur, the patient should discontinue treatment and consult a doctor.
• Worsening vision or other vision disorders. If they occur, the patient should immediately consult an ophthalmologist.
• Rarely, joint pain and swelling, as well as tendon inflammation or rupture, may occur. The risk is increased in elderly patients (over 60 years old), after organ transplantation, in cases of kidney problems, or during corticosteroid treatment. Tendon inflammation and rupture can occur within the first 48 hours of treatment and even several months after discontinuation of Nolicin. After the first symptoms of pain or tendon inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), the patient should discontinue Nolicin, consult a doctor, and rest the affected area. The patient should avoid excessive physical exertion, as it may increase the risk of tendon rupture.
• Crystals in the urine, which cause pain and discomfort during urination (crystaluria).
• In case of sudden severe abdominal, back, or chest pain, which may be a symptom of aneurysm and aortic dissection, the patient should immediately go to the emergency department. The risk of these changes may be higher during treatment with systemic corticosteroids.
• In case of sudden shortness of breath, especially after lying down, or swelling of the ankles, feet, or abdomen, or palpitations (feeling of rapid or irregular heartbeat), the patient should immediately consult a doctor.

Quinolone antibiotics may cause an increase in blood sugar levelsabove normal (hyperglycemia) or a decrease in blood sugar levels below normal, which can 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 sugar levels.
Due to the possibility of allergic reactions to sunlight, it is recommended to avoid excessive exposure to sunlight or ultraviolet radiation during treatment.
Due to the risk of tendon inflammation and rupture, it is recommended to avoid excessive physical exertion during treatment with Nolicin and immediately after its discontinuation.
As there is a risk of crystal formation in the urine, the patient should ensure proper hydration. During treatment with Nolicin, it is recommended to drink plenty of fluids. The patient should ask their doctor how much fluid they should take per day. In case of prolonged treatment, it is recommended to check for crystals in the urine.
Long-term, disabling, and potentially irreversible severe side effects
Fluoroquinolone and quinolone antibacterial agents, including Nolicin, have been associated with very rare but severe side effects, some of which have been long-term (lasting for months or years) or irreversible. These include tendon pain, muscle pain, joint pain, walking difficulties, abnormal sensations such as tingling, burning, itching, numbness, or pain (paresthesia), depression, fatigue, sleep disorders, memory impairment, and hearing, vision, taste, and smell disorders.

Children and adolescents

Nolicin should not be used in children and adolescents during growth and development.

Nolicin and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Norfloxacin is a known inhibitor of the CYP1A2 enzyme. Caution should be exercised when co-administering norfloxacin with other substances that are metabolized by the same enzymatic pathway (theophylline, caffeine, and others). Norfloxacin, by inhibiting the metabolic conversion of these substances, may lead to an increase in their blood levels, resulting in specific side effects of 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 at the same time or within 2 hours of taking norfloxacin, as they may affect norfloxacin absorption, reducing its blood and urine levels. Therefore, it is recommended to take Nolicin 2 hours after taking these medicines.
Milk and yogurts (liquid dairy products) reduce the absorption of Nolicin. The patient should take Nolicin 1 hour before or 2 hours after a dairy meal.
During concomitant use of Nolicin and cyclosporine, the side effects of cyclosporine may be enhanced due to an increase in its 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 effect of anticoagulants.
Didanosine, a medicine used in HIV infections, should not be administered at the same time as norfloxacin or within 2 hours before or after norfloxacin administration, as it affects its absorption and reduces norfloxacin levels in serum and urine.
It has been shown that caffeine metabolism is inhibited by quinolones, including norfloxacin.
During norfloxacin treatment, it is recommended to avoid consuming caffeine-containing medicines (e.g., certain painkillers).
During concomitant use of Nolicin and corticosteroids, the risk of tendon inflammation or rupture increases.
During treatment with Nolicin, the effect of some antidiabetic medicines (sulfonylurea derivatives, such as glibenclamide) may be enhanced.
Nolicin and nitrofurantoin should not be taken at the same time, as the effect of both medicines may be reduced.
Animal studies have shown that quinolones in combination with fenbufen can cause seizures. Therefore, concomitant use of Nolicin and fenbufen should be avoided.
Care should be taken when concomitantly using Nolicin and non-steroidal anti-inflammatory medicines, as seizures may occur.
If the patient is taking other medicines that may affect heart rhythm, such as anti-arrhythmic medicines (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, certain antibacterial agents (belonging to the macrolide group), or certain antipsychotic medicines, they should inform their doctor (see warnings regarding heart rhythm disorders above).

Using Nolicin with food, drink, and alcohol

Tablets should be swallowed, washed down with a glass of water at least 1 hour before or 2 hours after a meal or after taking dairy products.
Within 2 hours of taking Nolicin, the patient should not take multivitamin preparations, mineral supplements (e.g., iron, zinc, aluminum, or magnesium), antacids containing magnesium and aluminum, sucralfate, or didanosine.
The patient should not drink alcoholic beverages during treatment with Nolicin.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Nolicin should not be used during pregnancy or in breastfeeding women.

Driving and using machines

Nolicin has a moderate effect on the ability to drive vehicles and operate machinery. If the patient is taking the medicine and drinking alcoholic beverages, the side effects are enhanced.

Nolicin contains orange yellow FCF (E 110) and sodium

Orange yellow FCF (E 110) may cause allergic reactions.
The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means the medicine is considered "sodium-free".

3. How to use Nolicin

This medicine should always be used as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.

Dosage and administration

The doctor will determine the dose of the medicine based on the severity and type of infection. Tablets should be swallowed whole, washed down with a glass of water at least 1 hour before or 2 hours after a meal or after taking dairy products.

In patients with renal impairment, the doctor will adjust the dose of the medicine accordingly.

Use in children and adolescents

Nolicin should not be used in children and adolescents during growth and development.

Dosage in elderly patients

In elderly patients with normal renal function, there is no need to adjust the dose.
If the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor or pharmacist.

Using a higher dose of Nolicin than recommended

In case of using a higher dose of the medicine than recommended, the patient should contact their doctor or pharmacist.
Excessive doses of the medicine may cause nausea, vomiting, diarrhea, and in more severe cases, dizziness, fatigue, disorientation, and seizures.

Missing a dose of Nolicin

In case of missing a dose, the patient should take it as soon as they remember, unless it is almost time for the next dose.
The patient should not take a double dose to make up for the missed dose.

Discontinuing Nolicin

Nolicin should be used for the duration recommended by the doctor, even if the symptoms of the disease disappear earlier. If treatment is discontinued prematurely, the disease may recur.
In case of any further doubts about using this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Nolicin can cause side effects, although not everybody gets them.

During treatment with Nolicin, severe side effects may occur. If they occur, the patient should immediately consult a doctor. The patient should also read the information in "Warnings and precautions" in section 2 and below.

Administration of quinolone and fluoroquinolone antibiotics has very rarely caused long-term (lasting for months or years) or irreversible side effects, such as tendon inflammation, tendon rupture, joint pain, limb pain, walking difficulties, abnormal sensations (e.g., tingling, burning, itching, numbness, or pain), depression, fatigue, sleep disorders, memory impairment, and hearing, vision, taste, and smell disorders.

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

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

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

• changes in the number of some blood cells (eosinophilia, leukopenia, neutropenia, thrombocytopenia). If the patient experiences frequent infections, mouth ulcers, bruising, or bleeding, they should contact their doctor;
• decreased blood clotting ability (prolonged prothrombin time). If the patient experiences prolonged bleeding, they should contact their doctor;
• headache, dizziness,
• abdominal pain and cramps, heartburn, diarrhea, nausea,
• crystals in the urine, which cause pain and discomfort during urination (crystaluria) (see "Warnings and precautions" in section 2),
• increased liver enzyme activity, increased urea and creatinine levels in the blood, decreased hematocrit value (percentage of red blood cells in the blood).

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

• allergic reactions (hives, 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,
• vision disorders, increased tearing (see "Warnings and precautions" in section 2),
• ringing in the ears (tinnitus),
• subcutaneous bleeding with vasculitis,
• vomiting, loss of appetite,
• severe and persistent diarrhea (pseudomembranous colitis) (see "Warnings and precautions" in section 2),
• pancreatitis,
• severe skin reactions: exfoliative dermatitis, blistering rash (Stevens-Johnson syndrome), and toxic epidermal necrolysis (Lyell's syndrome) (see "Warnings and precautions" in section 2),
• sensitivity to sunlight (see "Warnings and precautions" in section 2),
• itching and hives,
• swelling of the face, lips, tongue, and/or throat with difficulty breathing or swallowing (angioedema) (see "Warnings and precautions" in section 2),
• tendon inflammation, synovitis, muscle pain, and/or joint pain, arthritis,
• kidney inflammation,
• vaginal thrush,
• fatigue.

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

• tingling or numbness of the hands and feet (paresthesia),
• neuropathic 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),
• hemolytic anemia,
• worsening of myasthenia symptoms (see "Warnings and precautions" in section 2).

Frequency not known (frequency 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 an ECG - a test of heart electrical activity (see "Warnings and precautions" in section 2),
• jaundice,
• loss of consciousness due to significantly decreased blood sugar levels (hypoglycemic coma). See section 2.

Patients taking fluoroquinolones have reported cases of aneurysm and aortic dissection, which can be fatal, as well as cases of heart valve regurgitation. See also section 2.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
phone: +48 22 49 21 301, fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Nolicin

The medicine should be stored out of sight and reach of children.
There are no special storage recommendations.
The medicine should not be used after the expiration date stated on the packaging. The expiration date refers to the last day of the specified month.
Medicines should not be disposed of in wastewater or household waste. The patient should ask their pharmacist how to dispose of unused medicines. This will help protect the environment.

6. Contents of the packaging and other information

What Nolicin contains

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

What Nolicin looks like and contents of the pack

The film-coated tablets are orange, round, slightly convex, with a dividing line on one side. The dividing line on the tablet is only to facilitate breaking the tablet and does not divide it into equal doses.
The packaging contains 10 or 20 film-coated tablets in PVC-PVDC/Al blisters in a cardboard box.
For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization 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 by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorization number in Bulgaria, the country of export: 20000707

Parallel import authorization number: 367/24

Date of leaflet approval: 18.10.2024

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