Nolicin

Leaflet attached to 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 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 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 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 sensitivity of the microorganism causing the infection to norfloxacin. However, norfloxacin therapy can be started before the results of the sensitivity test are available.

2. Important information before using Nolicin

When not to use Nolicin

• if the patient is allergic to norfloxacin, other quinolone drugs, or any of the other ingredients of this medicine (listed in section 6),
• in pregnant and breastfeeding women,
• in children and adolescents during growth and development,
• if the patient has experienced pain, inflammation, or tendon rupture after taking quinolone antibiotics (see "Warnings and precautions" and "Possible side effects").

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 conditions, they should inform their doctor before starting treatment:

• do not take antibacterial drugs containing fluoroquinolones or quinolones, including Nolicin, if the patient has experienced any severe side effects while taking a quinolone or fluoroquinolone in the past. 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 drug may cause brain damage;
• psychiatric disorders; the drug may lead to exacerbation 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 the disease has occurred in the patient or someone in their family, they should consult a doctor, as treatment may lead to massive breakdown of red blood cells (hemolytic reaction) causing anemia;
• if the patient has diabetes, as they may be at risk of hypoglycemic coma (see below and section 4);
• renal impairment; the doctor will recommend appropriate lower doses 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 myocardial infarction;
• the patient is a woman or an elderly person;
• use of other medicines that may affect the ECG (see "Nolicin and other medicines");
• if the patient has been diagnosed with aneurysm of a large blood vessel (aortic or large peripheral artery);
• if the patient has had aortic dissection (tear of the aortic wall) in the past;
• the patient has been diagnosed with heart valve regurgitation;
• if there have been cases of aortic aneurysm or aortic dissection in the patient's family, or other risk factors or predisposing conditions (e.g., connective tissue diseases such as Marfan syndrome or vascular 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, or confirmed atherosclerosis, rheumatoid arthritis [joint disease] or endocarditis [heart infection]).

If the patient experiences any of the following symptoms during treatment, they should immediately 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, peeling of large skin flakes, weakness, fever, and joint pain

Antibiotics from the quinolone group 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 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, the patient should be properly hydrated. During treatment with Nolicin, it is recommended to drink a large amount of fluid. The patient should ask their doctor how much fluid they should take per day. In the case of prolonged treatment, it is recommended to check for crystals in the urine.
Prolonged, 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 these have been long-lasting (lasting for months or years) and disabling or potentially irreversible. These include: tendon pain, muscle and joint pain in the upper and lower limbs, walking difficulties, abnormal sensations, such as tingling, burning, itching, numbness, or pain (paresthesia), sensory disturbances, including vision, taste, and smell and hearing disorders, depression, memory impairment, severe fatigue, and severe sleep disorders.
If any of these side effects occur after taking Nolicin, the patient should immediately consult their doctorbefore continuing treatment. The patient and doctor will decide whether to continue treatment, also considering antibiotics from another group.

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 using 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 yoghurt (liquid dairy products) reduce the absorption of Nolicin. The patient should take Nolicin 1 hour before or 2 hours after a dairy meal.
When taking Nolicin and cyclosporine at the same time, the side effects of cyclosporine may be enhanced due to an increase in its blood level. The doctor will monitor the cyclosporine level in the blood and, if necessary, recommend a dose reduction.
Taking Nolicin and oral anticoagulants (warfarin or its derivatives) at the same time 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 and norfloxacin.
During norfloxacin treatment, it is recommended to avoid consuming caffeine-containing medicines (e.g., certain painkillers).
When taking Nolicin and corticosteroids at the same time, 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 may be reduced.
Animal studies have shown that quinolones in combination with fenbufen can cause seizures. Therefore, it is recommended to avoid taking Nolicin and fenbufen at the same time.
Care should be exercised when taking Nolicin and nonsteroidal anti-inflammatory medicines at the same time, as seizures may occur.
If the patient is taking other medicines that may affect 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, they should inform their doctor (see warnings regarding heart rhythm disorders above).

Using Nolicin with food, drink, and alcohol

Tablets should be swallowed whole, 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 baby, they should consult their doctor or pharmacist before using 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 and use machines. If the patient is taking the medicine and drinking alcohol at the same time, 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 use Nolicin

This medicine should always be used 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. The tablets should be swallowed whole, 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 kidney function, there is no need to modify 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 scheduled 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 used 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.
If the patient has any further doubts about using this medicine, they 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. They should read the information provided in "Warnings and precautions" in section 2 and below.
The use of quinolone and fluoroquinolone antibiotics has very rarely caused long-lasting (lasting for months or years) or permanent side effects, such as tendon inflammation, tendon rupture, joint pain, limb pain, walking difficulties, abnormal sensations, such as tingling, burning, itching, numbness, or pain (neuropathy), depression, fatigue, sleep disorders, memory impairment, and hearing, vision, taste, and smell disorders.

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

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

Uncommon side effects (occurring in 1 to 10 in 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 in 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, and psychotic reactions,
• vision disturbances, 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),
• 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),
• tendon inflammation, synovitis, muscle and joint pain,
• kidney inflammation,
• vaginal thrush,
• fatigue.

Very rare side effects (occurring in less than 1 in 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 the available data):

• very rapid heart rate (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 a significant decrease in blood sugar levels (hypoglycemic coma). See section 2.

Patients taking fluoroquinolones have reported cases of aneurysm or aortic wall weakness (aortic aneurysm and dissection), which can lead to rupture and death, 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 Monitoring of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa, Tel.: + 48 22 49 21 30, Faks: + 48 22 49 21 309, Strona internetowa: 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.
Store at a temperature below 25°C. Store 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 stated.
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 film-coated tablet contains 400 mg of norfloxacin.
• 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 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:

Aga Kommerz spol. s r.o., Frydecka 2006, 737 01 Czeski Cieszyn, Czech Republic

Repackaged by:

Medezin Sp. z o.o., ul. Zbąszyńska 3, 91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa, ul. Działkowa 56, 02-234 Warszawa
Wytwórnia Euceryny Laboratorium Farmaceutyczne COEL S.J. E.Z.M. KONSTANTY
ul. Wł. Żeleńskiego 45, 31-353 Kraków
Authorization number in Romania, the country of export:7701/2015/01

Parallel import authorization number: 150/23

Date of leaflet approval: 21.07.2023

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