Nolicin

Package Leaflet: Information for the Patient

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

Nolicin, 400 mg, Film-Coated Tablets

Norfloxacin

Before taking the medicine, carefully read the contents of this leaflet, as it contains important information for the patient.

• The leaflet should be kept so that it can be read again if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed for 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 those not listed in this leaflet, they should inform 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 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 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.

Whenever possible, the susceptibility of the microorganism causing the infection to norfloxacin should be checked. 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

• 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 doctor should be consulted.

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 previously experienced any severe side effects while taking a quinolone or fluoroquinolone. In such cases, 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 exacerbation 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 there may be a risk of hypoglycemic coma (see below and section 4);
• renal impairment; the doctor will recommend appropriate lower doses of the drug; 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;
• the patient is a woman or an elderly person;
• use of other drugs that may affect the ECG (see "Nolicin and Other Drugs");
• if the patient has been diagnosed with an aneurysm of a large blood vessel (aortic or large peripheral artery);
• if the patient has had an aortic dissection (tear in the aortic wall);
• if 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 conditions (e.g., 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 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. In the event of such reactions, treatment should be stopped immediatelyand the patient should contact their 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.
• Convulsive seizures; Norfloxacin 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 drug. If necessary, the doctor will decide on appropriate treatment. Anti-diarrheal drugs 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.
• Anorexia, 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 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), 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 appear (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 an aneurysm and aortic dissection, the patient should immediately go to the emergency room. 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 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, patients should avoid excessive exposure to sunlight or ultraviolet radiation during treatment.
Due to the risk of tendon inflammation and rupture, patients should avoid excessive physical exertion during treatment with Nolicin and immediately after its discontinuation.
As there is a risk of crystal formation in the urine, patients should ensure adequate hydration. During treatment with Nolicin, patients are advised to drink plenty of fluids. The patient should ask their doctor how much fluid they should take per day. In case of prolonged treatment, the patient should be checked for crystal formation in the urine.
Long-term, disabling, and potentially irreversible severe side effects
Fluoroquinolone and quinolone antibacterial drugs, including Nolicin, have been associated with very rare but severe side effects. Some of these have been long-term (lasting for months or years), 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, fatigue, sleep disturbances, memory impairments, and hearing disorders.
If any of these side effects occur after taking Nolicin, the patient should immediately contact their doctor before 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 Drugs

The patient should inform their doctor or pharmacist about all the drugs they are currently taking or have recently taken, as well as any drugs 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 drugs.
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 drug used in HIV infections, should not be administered simultaneously with 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, including norfloxacin.
During norfloxacin treatment, the patient should avoid consuming caffeine-containing drugs (e.g., certain painkillers) as much as possible.
During concomitant use of Nolicin and corticosteroids, the risk of tendon inflammation or rupture increases.
During treatment with Nolicin, the effect of some antidiabetic drugs (sulfonylurea derivatives, such as glibenclamide) may be enhanced.
Nolicin and nitrofurantoin should not be taken at the same time, as the effect of both drugs 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 concomitantly using Nolicin and non-steroidal anti-inflammatory drugs, as seizures may occur.
If the patient is taking other drugs that may affect heart rhythm, drugs belonging to the group of antiarrhythmic drugs (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, certain antibacterial drugs (belonging to the macrolide group), or certain antipsychotic drugs, they should inform their doctor (see warnings regarding heart rhythm disorders above).

Using Nolicin with Food, Drinks, 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 child, they should consult their doctor or pharmacist 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 the patient is taking the drug and drinking alcohol, the side effects are enhanced.

Nolicin Contains Orange Yellow S (E 110) and Sodium

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

3. How to Take Nolicin

This medicine should always be taken as directed by the doctor. In case of doubts, the doctor or pharmacist should be consulted.

Dosage and Administration

The doctor will determine the dose of the drug based on the severity and type of infection. 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 drug 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.
If the patient feels that the effect of the drug is too strong or too weak, they should consult their doctor or pharmacist.

Overdose of Nolicin

In case of overdose, the patient should contact their doctor or pharmacist.
Excessive doses of the drug may cause nausea, vomiting, diarrhea, and in severe cases, dizziness, fatigue, disorientation, and seizures.

Missed Dose of Nolicin

In case of a missed 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 taken 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 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 contact their doctor. See "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 permanent drug side effects, such as tendon inflammation, tendon rupture, joint pain, limb pain, walking difficulties, abnormal sensations (e.g., tingling, burning, itching, numbness, or pain), sensory disturbances (including vision, taste, smell, and hearing disorders), depression, fatigue, sleep disturbances, memory impairments, and hearing 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 blood urea and creatinine levels, 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),
• 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 and joint pain, arthritis,
• 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 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 aortic 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 those 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 of 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 will help gather more information on the safety of the drug.

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 specified month.
Medicines should not be disposed of via 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 Pack 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 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 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:

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
Romanian marketing authorization number: 7701/2015/01

Parallel Import Authorization Number: 114/23

Leaflet Approval Date: 14.06.2023

[Information about the trademark]