Nolicin

Leaflet accompanying the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Nolicin, 400 mg, film-coated tablets

Norfloxacin

You should carefully read the contents of this leaflet before taking 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 further questions, you should ask your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your 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.

You should 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 or 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 you have a history of or currently have any of the following conditions, you should tell your doctor before starting treatment:

• you should not take antibacterial agents containing fluoroquinolones or quinolones, including Nolicin, if you have previously experienced any severe side effects while taking a quinolone or fluoroquinolone. In such a situation, you should inform your doctor 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 this disease has occurred in you or someone in your family, you should consult a doctor, as treatment may lead to massive breakdown of red blood cells (hemolytic reaction) causing anemia;
• renal impairment; your 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:
• 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 heart attack;
• you are a woman or an elderly person;
• taking other medicines that may affect the ECG (see "Nolicin and other medicines");

If you experience any of the following symptoms during treatment, you shouldimmediately contact
your 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, peeling off large patches of skin, weakness, fever, and joint pain

Antibiotics from the quinolone group may cause an increasein blood sugar levels above normal
(hyperglycemia) or a decreasein blood sugar levels below normal, which can lead to loss of consciousness
(hypoglycemic coma) (see section 4).
This is important for patients with diabetes. Patients with diabetes are advised to carefully monitor their blood sugar levels.
Due to the possibility of photosensitivity reactions, 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 completion.
As there is a risk of crystal formation in the urine, it is recommended to ensure proper hydration of the patient. During treatment with Nolicin, it is recommended to drink plenty of fluids. You should ask your doctor how much fluid you should take per day. In the case of prolonged treatment, it is recommended to check for crystals in the urine.
Long-term, debilitating, and potentially irreversible severe side effects
Antibacterial agents containing fluoroquinolones/quinolones, 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, prickling, itching, numbness, or pain (neuropathy), depression, fatigue, sleep disturbances, memory impairments, 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

You should tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or 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.
Liquid milk products (milk, yogurt) reduce the absorption of Nolicin. You should take Nolicin 1 hour before or 2 hours after a milk meal.
When taking Nolicin and cyclosporine together, the side effects of cyclosporine may be enhanced due to an increase in its blood level. Your doctor will monitor the cyclosporine level in your blood and, if necessary, recommend a dose reduction.
Taking Nolicin and oral anticoagulants (warfarin or its derivatives) together 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 leads to a decrease in norfloxacin levels in the serum and urine.
It has been shown that caffeine metabolism is inhibited by quinolones, including norfloxacin.
During norfloxacin treatment, you should avoid taking medicines containing caffeine (e.g., certain painkillers).
When taking Nolicin and corticosteroids together, the risk of tendon inflammation and rupture increases.
During treatment with Nolicin, the effect of some antidiabetic medicines (sulfonylurea derivatives, such as glibenclamide) may be enhanced.
You should not take Nolicin and nitrofurantoin 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, you should avoid taking Nolicin and fenbufen together.
Caution should be exercised when taking Nolicin and nonsteroidal anti-inflammatory medicines together, as seizures may occur.
If you are taking other medicines that may affect your heart rhythm, medicines belonging to the group of antiarrhythmic agents (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, certain antibacterial agents (belonging to the macrolide group), or certain antipsychotic agents, you should inform your doctor (see warnings regarding heart rhythm disorders above).

Taking 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 a milk product.
Within 2 hours of taking Nolicin, you should not take multivitamin preparations, mineral supplements (e.g., iron, zinc, aluminum, or magnesium), antacids containing magnesium and aluminum, sucralfate, or didanosine.
You should not drink alcoholic beverages during treatment with Nolicin.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, you should ask your doctor or pharmacist for advice before taking this medicine.
Nolicin should not be used during pregnancy or breastfeeding.

Driving and using machines

Nolicin has a moderate effect on the ability to drive vehicles and operate machinery. If you are taking the medicine and drinking alcohol, the side effects may be enhanced.

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 exactly as your doctor has told you. If you are not sure, you should ask your doctor or pharmacist.

Dosage and administration

Your doctor will determine the dose of the medicine, depending 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 a milk product.
Indications
Duration of treatment
Uncomplicated acute urinary tract infection
Dosage
400 mg twice daily
3 days
Complicated urinary tract infections (except for complicated pyelonephritis)
400 mg twice daily
7 to 10 days
Bacterial prostatitis
400 mg twice daily
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 adjust the dose.
If you feel that the effect of the medicine is too strong or too weak, you should consult your doctor or pharmacist.

Taking a higher dose of Nolicin than recommended

If you have taken more of the medicine than you should, you should contact your doctor or pharmacist.
Taking too much of the medicine may cause nausea, vomiting, diarrhea, and in more severe cases, dizziness, fatigue, disorientation, and seizures.

Missing a dose of Nolicin

If you miss a dose, you should take it as soon as you remember, unless it is almost time for your next dose.
You should not take a double dose to make up for a missed dose.

Stopping treatment with Nolicin

Nolicin should be taken for the duration recommended by your doctor, even if the symptoms of the disease disappear earlier. If you stop treatment too early, the disease may recur.
If you have any further questions about the use of this medicine, you should ask your 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, you should immediately contact your doctor. You should read the information provided in "Warnings and precautions" in section 2 and

below.
The administration of quinolone and fluoroquinolone antibiotics has 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, prickling, itching, numbness, or pain (neuropathy), depression, fatigue, sleep disturbances, memory impairments, and hearing, vision, taste, and smell disorders.

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

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

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

• changes in the number of some blood cells (eosinophilia, leukopenia, neutropenia, thrombocytopenia). If you experience frequent infections, mouth ulcers, bruising, or bleeding, you should contact your doctor.
• reduced blood clotting ability (prolonged prothrombin time). If you experience prolonged bleeding, you should contact your 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 patients in 10,000):

• 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 disturbances, 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),
• photosensitivity (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),
• tendinitis, inflammation of the tendon sheath, muscle pain, and (or) joint pain, arthritis,
• kidney inflammation,
• vaginal thrush,
• fatigue.

Very rare side effects (occurring in less than 1 patient in 10,000):

• 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 the available data):

• very rapid heart rate (see "Warnings and precautions" in section 2),
• life-threatening irregular heart rhythm (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 a significant decrease in blood sugar levels (hypoglycemic coma). See section 2.

Patient reports with fluoroquinolones have included cases of aortic aneurysm and dissection, which may lead to rupture and death, as well as cases of heart valve regurgitation. See also section 2.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Nolicin

The medicine should be stored out of the 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 packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. You should ask your 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 film-coated tablet contains 400 mg of norfloxacin.
• The other ingredients are:
• tablet core: sodium carboxymethylcellulose (type A), microcrystalline cellulose, silicon dioxide, 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 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 not to divide it into equal doses.
The packaging contains 10 or 20 film-coated tablets in blisters, in a cardboard box.
For more detailed information, you 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:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Romania, the country of export:7701/2015/01

Parallel import authorization number: 392/22 Date of leaflet approval: 26.10.2022

[Information about the trademark]