NEUROL 0.25 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
   1. NEUROL 1.0, 1 mg, tablets
   2. It is essential to carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.
   3. Table of contents of the leaflet:
2. What is Neurol and what is it used for
3. Important information before taking Neurol
   1. When not to take Neurol
   2. Warnings and precautions
   3. Neurol and other medicines
   4. Neurol with food, drink, and alcohol
   5. Pregnancy and breastfeeding
   6. Driving and operating machinery
4. How to take Neurol
   1. Use in children and adolescents
   2. Use in patients with kidney or liver function disorders
   3. Use in elderly or weakened patients
   4. Use of a higher than recommended dose of Neurol
   5. Missing a dose of Neurol
   6. Stopping treatment with Neurol
5. Possible side effects
   1. Very common - may affect more than 1 in 10 people:
   2. Common - may affect up to 1 in 10 people:
   3. Uncommon - may affect up to 1 in 100 people:
   4. Frequency not known (frequency cannot be estimated from the available data):
   5. Reporting side effects
6. How to store Neurol
7. Package contents and other information
   1. What Neurol contains
   2. What Neurol looks like and what the package contains
   3. Marketing authorization holder and manufacturer:
   4. Date of the last update of the leaflet:

Leaflet attached to the packaging: patient information

NEUROL 0.25, 0.25 mg, tablets

NEUROL 1.0, 1 mg, tablets

Alprazolam

It is essential to carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• The leaflet should be kept, so it can be read again if necessary.
• In case of any doubts, the patient 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 their symptoms are the same.
• If the patient experiences any adverse reactions, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Neurol and what is it used for
• 2. Important information before taking Neurol
• 3. How to take Neurol
• 4. Possible side effects
• 5. How to store Neurol
• 6. Package contents and other information

1. What is Neurol and what is it used for

The active substance of Neurol is alprazolam. It belongs to a group of medicines called benzodiazepines (anxiolytic drugs).
Neurol is indicated for the treatment of symptoms of anxiety disorders in adults, only in situations where the symptoms are severe, prevent normal functioning, or are very troublesome for the patient. This medicine is intended for short-term use only

2. Important information before taking Neurol

When not to take Neurol

• if the patient is allergic to alprazolam and other benzodiazepines or any of the other ingredients of this medicine (listed in section 6);
• if the patient has myasthenia gravis (a disease characterized by excessive fatigue and muscle weakness);
• if the patient has severe respiratory failure;
• if the patient has sleep apnea syndrome;
• if the patient has severe liver failure.

Neurol should not be used in children and adolescents under 18 years of age.

Warnings and precautions

Before starting treatment with Neurol, the patient should discuss it with their doctor:

• if the medicine is used for a long time, as dependence on the medicine may occur, especially in patients prone to drug or alcohol abuse. The need for continued treatment should be periodically assessed by the doctor;
• if the dose of the medicine is reduced or it is suddenly stopped [possible occurrence of withdrawal symptoms (see section 4)];
• if the medicine is used in patients with depression, with suicidal thoughts or tendencies;
• if the patient is taking other benzodiazepines (increased risk of dependence);
• if the patient is taking opioids, sleeping pills, sedatives, or drinking alcohol (the effect of these medicines or alcohol may be enhanced);
• if restlessness, psychomotor agitation, irritability, aggression, delusions, anger, nightmares, hallucinations, psychosis, or other behavioral disorders occur. In case of these symptoms, the use of the medicine should be discontinued and the doctor should be consulted;
• if the patient has glaucoma;
• if the patient has kidney or liver function disorders.

Like other benzodiazepines, Neurol may cause anterograde amnesia, which occurs a few hours after taking the medicine. In such a case, the patient should have uninterrupted sleep for 7-8 hours.
Benzodiazepines and similar-acting substances should be used with caution in elderly patients, due to the risk of excessive sedation and (or) muscle weakness, which may lead to falls, often with serious consequences for such a patient.
Episodes of hypomania and mania have been reported in association with the use of Neurol in patients with depression.
Before planned surgery, the patient should inform their doctor about taking Neurol.
A decrease in the efficacy of the sedative effect of alprazolam (and other benzodiazepines) may occur with repeated use of the medicine for several weeks.

Neurol and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as those they plan to take.

• Particular caution should be exercised when using Neurol with opioids, as they have a depressive effect on the respiratory system (slow down and shallow breathing). This is associated with a risk of excessive sedation, respiratory depression, coma, and even death.
• Neurol may enhance the effect of antipsychotic, sedative, anxiolytic, antidepressant, narcotic analgesic, anticonvulsant, anesthetic, and antihistamine medicines.
• In the case of opioid analgesics, there may be an increase in euphoria, which can lead to increased psychological dependence.
• Alcohol should not be consumed during treatment with Neurol.
• It is not recommended to take Neurol with certain antifungal medicines for internal use (e.g., ketoconazole, itraconazole, posaconazole, voriconazole).
• Particular caution should be exercised and the dose reduced when using Neurol with nefazodone, fluvoxamine, and cimetidine.
• Particular caution should be exercised when using alprazolam with fluoxetine, propoxyphene, oral contraceptives, sertraline, diltiazem, and macrolide antibiotics (e.g., erythromycin, clarithromycin, or troleandomycin).
• The concomitant use of Neurol and HIV protease inhibitors (e.g., ritonavir) requires dose modification or discontinuation of alprazolam.
• Patients taking alprazolam and digoxin should be closely monitored for signs of digoxin toxicity.
• Theophylline may decrease the effect of benzodiazepines

Neurol with food, drink, and alcohol

The medicine should be taken before a meal or during a meal, with a small amount of liquid. Alcohol should not be consumed during treatment with Neurol.

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 before using this medicine.
It is not recommended to use the medicine during pregnancy or when trying to conceive.
If the medicine is used during pregnancy or if the patient becomes pregnant while taking alprazolam, they should be examined for potential fetal risk. If it is necessary to administer the medicine in the last trimester of pregnancy, high doses should be avoided and the newborn should be monitored.
Benzodiazepines pass into breast milk in small amounts. This medicine should not be used during breastfeeding.

Driving and operating machinery

Neurol causes impairment of psychophysical abilities. Before taking Neurol, the patient should familiarize themselves with local traffic laws.
The patient should not drive vehicles or operate machinery while taking Neurol.
Neurol contains lactose monohydrate.
If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to take Neurol

This medicine should always be taken according to the doctor's recommendations. In case of doubts, the patient should consult their doctor or pharmacist.
Treatment should be as short as possible. The doctor should frequently assess the patient's condition and the need to continue treatment, especially if the severity of the symptoms decreases and may not require pharmacological treatment. The total treatment duration should not exceed 2-4 weeks. Prolonged treatment is not recommended.
When starting treatment, the doctor will inform the patient about the limited duration of therapy, the gradual reduction of the dose during withdrawal, and the possibility of withdrawal reactions.
During the use of benzodiazepines, including Neurol, dependence and emotional or physical dependence may develop. This risk may increase with the dose and duration of treatment, so the smallest effective dose should be used for the shortest possible time, and the need for continued treatment should be frequently assessed with the doctor.
Recommended dose
The dose is determined by the doctor based on the severity of symptoms and the patient's individual response to treatment. If severe adverse reactions occur after the initial dose, the doctor may decide to reduce the dose.
Symptomatic treatment of anxiety disorders
The recommended initial dose is 0.25 mg or 0.5 mg three times a day.
The doctor may decide to increase the dose depending on the patient's needs, up to a maximum daily dose of 4 mg, divided into smaller doses, taken throughout the day.

Use in children and adolescents

Neurol should not be used in children and adolescents under 18 years of age.

Use in patients with kidney or liver function disorders

Use in patients with severe liver failure is contraindicated.

Use in elderly or weakened patients

The recommended initial dose is 0.25 mg two or three times a day.
If necessary, the doctor may decide to gradually increase the dose depending on the patient's tolerance to the medicine. If adverse reactions occur, the doctor will decide to reduce the initial dose.

Use of a higher than recommended dose of Neurol

Taking a higher than recommended dose of Neurol may cause: ataxia (motor incoordination), drowsiness, speech disorders, coma, and respiratory depression. If worrying symptoms occur, the patient should immediately consult their doctor.

Missing a dose of Neurol

A double dose should not be taken to make up for a missed dose.

Stopping treatment with Neurol

The patient should not stop taking the medicine on their own.
Since the treatment is symptomatic, after its discontinuation, the symptoms of the disease may return.
The doctor will decide to gradually reduce the dose.
In case of any further doubts about the use of this medicine, the patient should consult their doctor.

4. Possible side effects

Like all medicines, Neurol can cause side effects, although not everybody gets them.
If any of the following side effects persist or are troublesome, the patient should inform their doctor. The occurrence of some side effects depends on the individual susceptibility of the patient and the dose of the medicine. Side effects are usually observed at the beginning of therapy. They disappear as treatment continues or when the dose is reduced.
The frequency of side effects observed in clinical trials and after the marketing of the medicine:

Very common - may affect more than 1 in 10 people:

• depression,
• sedation,
• drowsiness,
• ataxia (motor incoordination),
• memory disorders,
• speech disorders,
• dizziness,
• headache,
• constipation,
• dry mouth,
• fatigue,
• irritability.

Common - may affect up to 1 in 10 people:

• decreased appetite,
• confusion,
• disorientation,
• decreased libido (sexual desire),
• increased libido,
• anxiety,
• insomnia,
• nervousness,
• balance disorders,
• coordination disorders,
• concentration disorders,
• excessive need for sleep,
• lethargy,
• tremors,
• blurred vision,
• nausea,
• skin inflammation,
• sexual disorders,
• weight loss,
• weight gain.

Uncommon - may affect up to 1 in 100 people:

• mania (excessively euphoric mood, increased activity),
• hallucinations,
• anger,
• agitation,
• dependence,
• amnesia,
• muscle weakness,
• urinary incontinence,
• irregular menstrual cycles
• withdrawal syndrome.

Frequency not known (frequency cannot be estimated from the available data):

• hyperprolactinemia (elevated prolactin levels),
• hypomania (mild mania),
• aggressive behavior,
• hostile behavior,
• thinking disorders,
• increased psychomotor activity,
• drug abuse,
• autonomic nervous system disorders (which controls the function of internal organs, smooth muscles, and glands),
• dystonia (muscle tone disorders),
• gastrointestinal disorders,
• hepatitis,
• liver disorders,
• jaundice,
• angioedema,
• photosensitivity reactions,
• urinary retention,
• peripheral edema (swelling of the ankles, feet, or toes),
• increased intraocular pressure.

Additionally, especially in patients taking other psychotropic medicines, with mental disorders, or abusing alcohol, a paradoxical reaction may occur with symptoms such as anxiety.
Other side effects have been observed rarely or very rarely: motor disorders, epilepsy, psychotic symptoms, a feeling of changed self, agranulocytosis (significant decrease in granulocyte count), allergic reactions, or anaphylaxis (severe allergic reactions).
Benzodiazepines may cause physical and psychological dependence. If physical dependence occurs, sudden discontinuation of Neurol may cause withdrawal symptoms: headache, muscle pain, increased anxiety, feeling of tension, agitation, disorientation, irritability, changed perception of the environment or oneself, impaired hearing, stiffness, and paresthesia of the limbs, hypersensitivity to light, noise, and touch, hallucinations, and seizures, insomnia, and mood changes. These symptoms are usually more severe in patients treated for a long time, with high doses of benzodiazepines, and in case of sudden or rapid discontinuation of the medicine.
There have been reports of benzodiazepine abuse.

Reporting side effects

If any side effects occur, including those not listed in this leaflet, the patient should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C
02-222 Warsaw
Tel.: 22 49 21 301
Fax: 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder or its representative in Poland.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Neurol

The medicine should be stored out of sight and reach of children.
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.
Store in a temperature below 25°C, in the original packaging.
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. Package contents and other information

What Neurol contains

• The active substance of Neurol is alprazolam. One tablet of Neurol 0.25 contains 0.25 mg of alprazolam. One tablet of Neurol 1.0 contains 1 mg of alprazolam.
• Other ingredients are: lactose monohydrate, cornstarch, microcrystalline cellulose granules, calcium stearate, colloidal silicon dioxide.

What Neurol looks like and what the package contains

Neurol 0.25: white or almost white tablets without a dividing line.
Neurol 1.0: white or almost white tablets with a dividing line; the tablet can be divided into equal doses.
Package size: 30 tablets.

Marketing authorization holder and manufacturer:

Zentiva k.s., U kabelovny 130, Dolní Měcholupy, 102 37 Prague 10, Czech Republic
To obtain more detailed information about this medicine, the patient should contact the local representative of the marketing authorization holder in Poland:
Zentiva Polska Sp. z o.o.
Bonifraterska Street 17
00-203 Warsaw
Tel. +48 22 375 92 00

Date of the last update of the leaflet: