NEUROL 1 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
   1. NEUROL 1.0, 1 mg, tablets
   2. You should 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 the use of 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. Contents of the packaging and other information
   1. What Neurol contains
   2. What Neurol looks like and what the packaging 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

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 give it 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 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 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. Contents of the packaging 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 (medicines with anxiolytic activity).
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, you should discuss it with your 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 discontinued [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 action of these medicines or alcohol may be enhanced);
• if restlessness, psychomotor agitation, irritability, aggression, delusions, anger, nightmares, hallucinations, psychosis, inappropriate behavior, or other behavioral disorders occur. In case of the occurrence 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 similarly 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 doctor should be informed about the use of 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

You should tell your doctor about all medicines you are taking now or have taken recently, as well as about medicines you 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 an increase in psychological dependence.
• Alcohol should not be consumed during the use of Neurol.
• It is not recommended to take Neurol at the same time as certain antifungal medicines for internal use (e.g., ketoconazole, itraconazole, posaconazole, voriconazole).
• Particular caution should be exercised and the dose should be considered for reduction during concomitant use of Neurol and 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).
• 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 (objective and subjective) related to 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 the use of Neurol.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects that she may be pregnant, or plans to have a child, she should consult a 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, she 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 fitness. Before using Neurol, you should familiarize yourself with current local traffic laws.
While using Neurol, you should not drive vehicles or operate machinery.
Neurol contains lactose monohydrate.
If the patient has been diagnosed with intolerance to some sugars, the patient should consult a doctor before taking the medicine.

3. How to take Neurol

This medicine should always be used in accordance with the doctor's recommendations. In case of doubts, you should consult a doctor or pharmacist.
Treatment should be as short as possible. The doctor should frequently assess the patient's condition and the need to extend treatment, especially if the severity of the symptoms decreases and may not require pharmacological treatment. The total treatment time should not exceed 2-4 weeks. Prolonged treatment is not recommended.
When starting treatment, the doctor will inform about the limited duration of therapy, gradual dose reduction during withdrawal of the medicine, 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 individual patient's response to treatment. If severe side effects occur after administration of 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 side effects occur, the doctor will decide to reduce the initial dose.

Use of a higher than recommended dose of Neurol

Use of a higher than recommended dose of Neurol may cause: ataxia (motor incoordination), drowsiness, speech disorders, coma, and respiratory depression. If worrying symptoms occur, you should immediately contact a doctor.

Missing a dose of Neurol

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

Stopping the use of Neurol

You should not stop using the medicine on your 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.
If you have any further doubts about the use of this medicine, you should consult a doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of the following side effects persist or are troublesome, you should inform your doctor. The occurrence of some side effects depends entirely on the individual patient's sensitivity 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.
Frequency of side effects observed in clinical trials and after the medicine was introduced to the market:

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,
• confusional state,
• disorientation,
• decreased libido (sexual desire),
• increased libido,
• anxiety,
• insomnia,
• nervousness,
• balance disorders,
• incoordination,
• concentration disorders,
• excessive need for sleep,
• lethargy,
• tremor,
• blurred vision,
• nausea,
• skin rash,
• 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, symptoms of psychosis, 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, feeling of changed environment or self, impaired hearing, stiffness, and paresthesia of 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 you experience any side effects, including any side effects not listed in this leaflet, you should tell your 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
Phone: 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.
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Neurol

The medicine should be stored in a place invisible and inaccessible to children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the given month.
Store in a temperature below 25°C, in the original packaging.
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 used. This will help protect the environment.

6. Contents of the packaging 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.
• The other ingredients are: lactose monohydrate, cornstarch, microcrystalline cellulose granules, calcium stearate, colloidal silicon dioxide.

What Neurol looks like and what the packaging 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.
Packaging 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, you should contact the local representative of the marketing authorization holder in Poland:
Zentiva Polska Sp. z o.o.
Bonifraterska Street 17
00-203 Warsaw
Phone: +48 22 375 92 00

Date of the last update of the leaflet: