Nolicin

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE USER

Warning! Keep the leaflet, information on the immediate packaging in a foreign language

Nolicin

400 mg, coated tablets

Norfloxacin

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.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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 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 susceptible to norfloxacin:

• Uncomplicated acute urinary tract infections. In uncomplicated acute urinary tract infections, 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, if possible, the susceptibility of the microorganism causing the infection to norfloxacin. However, norfloxacin therapy can be started before the results of the susceptibility test are available.

2. Important information before taking Nolicin

When not to take Nolicin

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

Warnings and precautions

Before starting treatment with Nolicin, you should discuss it with your doctor.
If the patient has a history of or currently has any of the following conditions, they should inform their doctor before starting treatment:

• do not take antibacterial medicines 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 exacerbate the 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 the patient or someone in their family has had this disease, they should consult a doctor, as treatment may lead to massive red blood cell breakdown (hemolytic reaction) causing anemia;
• renal impairment; the doctor will recommend a suitable dose of the medicine; during treatment with Nolicin, it is recommended to drink an adequate amount of fluids;
• heart rhythm disorders related to risk factors for QT interval prolongation, such as:
• confirmed congenital or familial QT interval prolongation (visible on an ECG - a test of heart 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 heart attack;
• the patient is a woman or an elderly person;
• taking other medicines that may affect the ECG (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 shouldimmediately consult
their 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, exfoliation of large skin flakes, 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, which 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 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 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, and/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, which 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 their 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. When the first symptoms of tendon pain or inflammation occur (e.g., in the ankle, wrist, elbow, shoulder, or knee), the patient should discontinue Nolicin, consult their 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 room. 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 swelling of the ankles, feet, or abdomen, or palpitations (feeling of rapid or irregular heartbeat), the patient should immediately consult their 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 medicines, including Nolicin, have been associated with very rare but severe side effects, including tendonitis, tendon rupture, joint pain, limb pain, walking difficulties, abnormal sensations, such as tingling, burning, itching, numbness, or pain (neuropathy), depression, fatigue, sleep disorders, memory disorders, 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.
When co-administering Nolicin and cyclosporine, the side effects of cyclosporine may be exacerbated 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 causes a decrease in norfloxacin levels in serum and urine.
It has been shown that caffeine metabolism is inhibited by quinolones, as well as by norfloxacin.
During norfloxacin treatment, it is recommended to avoid consuming caffeine-containing medicines (e.g., certain painkillers).
When co-administering Nolicin and corticosteroids, the risk of tendon inflammation or rupture increases.
During treatment with Nolicin, the effect of certain 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 is 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 co-administering Nolicin and non-steroidal anti-inflammatory medicines, as seizures may occur.
If the patient is taking other medicines that may affect heart rhythm, medicines belonging to the group of anti-arrhythmic medicines (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, certain antibacterial medicines (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 exacerbated.

Nolicin contains orange yellow S (E 110) and sodium

Orange yellow S (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 take Nolicin

This medicine should always be taken as directed by the doctor. If the patient has any doubts, they 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.
Indications
Dosage
Duration of treatment
Uncomplicated acute urinary tract infection
400 mg twice a day
3 days
Complicated urinary tract infections (except for complicated pyelonephritis)
400 mg twice a day
7 to 10 days
Bacterial prostatitis
400 mg twice a day
up to 12 weeks
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 modify the dose.

Taking a higher dose of Nolicin than recommended

In case of taking 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 severe cases, dizziness, fatigue, disorientation, and seizures.

Missing a dose of Nolicin

In case of missing a dose of the medicine, 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.

Stopping treatment with Nolicin

Nolicin should be taken for the duration recommended by the doctor, even if the symptoms of the disease disappear earlier. If treatment is stopped prematurely, the disease may recur.
In case of any further doubts about the use of 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.

Nolicin may cause severe side effects. If they occur, the patient should immediately consult their doctor. The patient should read the information provided in "Warnings and precautions" in section 2 and below.

Administration of quinolone and fluoroquinolone antibiotics has, in some cases, regardless of existing risk factors, very rarely caused long-term (lasting for months or years) or permanent side effects, such as tendonitis, tendon rupture, joint pain, limb pain, walking difficulties, abnormal sensations, such as tingling, burning, itching, numbness, or pain (neuropathy), depression, fatigue, sleep disorders, memory disorders, 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),
• 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), exfoliative dermatitis, 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),
• tendonitis, inflammation of the tendon sheath, muscle 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),
• 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),
• 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 this leaflet, they should inform their doctor or pharmacist. 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Nolicin

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C, in the original packaging.
Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. 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 coated tablet contains 400 mg of norfloxacin.
• Other ingredients are:
• tablet core: sodium carboxymethylcellulose (type A), microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate, povidone
• tablet coating: hypromellose, talc, titanium dioxide (E 171), orange yellow S (E 110), propylene glycol. See section 2 "Nolicin contains orange yellow S (E 110) and sodium".

What Nolicin looks like and contents of the pack

The 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 not to divide it into equal doses.
The packaging contains 10 or 20 coated tablets in PVC-PVDC/Al blisters, in a cardboard box.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Romania, 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:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
02-234 Warsaw
Marketing authorization number in Romania, the country of export: 7701/2015/01
Parallel import authorization number: 87/24

Date of leaflet approval: 05.03.2024

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