NEUROL 0.5 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Neurol SR 0.5
3. 5 mg, prolonged-release tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet:
4. What is Neurol SR 0.5 and what is it used for
5. Important information before taking Neurol SR 0.5
   1. When not to take Neurol SR 0.5:
   2. Warnings and precautions
   3. Neurol SR 0.5 and other medicines
   4. Pregnancy, breastfeeding, and fertility
   5. Driving and using machines
   6. Neurol SR 0.5 contains lactose monohydrate
6. How to take Neurol SR 0.5
   1. Children and adolescents
   2. Patients with renal or hepatic impairment
   3. Elderly patients
   4. Taking a higher dose of Neurol SR 0.5 than recommended
   5. Missing a dose of Neurol SR 0.5
   6. Stopping treatment with Neurol SR 0.5
7. Possible side effects
   1. Very common (may affect more than 1 in 10 patients):
   2. Common (may affect up to 1 in 10 patients):
   3. Uncommon (may affect up to 1 in 100 patients):
   4. Frequency not known (frequency cannot be estimated from the available data):
   5. Reporting side effects
8. How to store Neurol SR 0.5
9. Contents of the pack and other information
   1. What Neurol SR 0.5 contains
   2. What Neurol SR 0.5 looks like and contents of the pack
   3. Marketing authorization holder and manufacturer:
   4. This medicine is authorized in the Member States of the European Economic Area under the following names:

Package Leaflet: Information for the User

Neurol SR 0.5

0.5 mg, prolonged-release tablets

Alprazolam

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a 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 the patient experiences any side effects, including any not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Neurol SR 0.5 and what is it used for
• 2. Important information before taking Neurol SR 0.5
• 3. How to take Neurol SR 0.5
• 4. Possible side effects
• 5. How to store Neurol SR 0.5
• 6. Contents of the pack and other information

1. What is Neurol SR 0.5 and what is it used for

Neurol SR 0.5 contains the active substance alprazolam, which belongs to a group of medicines called benzodiazepines (anxiolytic medicines).
Neurol SR 0.5 is used to treat anxiety disorders in adults, only in situations where 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 SR 0.5

When not to take Neurol SR 0.5:

Neurol SR 0.5 should not be taken by children and adolescents under 18 years of age.

Warnings and precautions

Before starting treatment with Neurol SR 0.5, the patient should discuss it with their doctor:

Like other benzodiazepines, Neurol SR 0.5 may cause anterograde amnesia (complete or partial loss of the ability to remember events after taking the medicine). This usually occurs within a few hours of taking the medicine. In such cases, the patient should have the opportunity for uninterrupted sleep for 7 to 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 can lead to falls, often with serious consequences for such patients.
Episodes of hypomania and mania have been reported in association with the use of alprazolam in patients with depression.
Before planned surgery, the patient should inform their doctor that they are taking Neurol SR 0.5.

Neurol SR 0.5 and other medicines

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

• Particular caution should be exercised when taking Neurol SR 0.5 with opioids, as they can depress the respiratory system (slow down and shallow breathing). This is associated with a risk of excessive sedation, respiratory depression, coma, and even death.
• Neurol SR 0.5 may enhance the effect of antipsychotic, sedative, anxiolytic, antidepressant, anticonvulsant, anesthetic, and antihistamine medicines.
• In the case of narcotic painkillers, there may be an increase in euphoria, which can lead to increased psychological dependence.
• Alcohol should not be consumed during treatment with Neurol SR 0.5.
• It is not recommended to take Neurol SR 0.5 at the same time as certain oral antifungal medicines (e.g., ketoconazole, itraconazole, posaconazole, voriconazole).
• Particular caution should be exercised and the dose should be considered for reduction when taking Neurol SR 0.5 and nefazodone, fluvoxamine, and cimetidine.
• Particular caution should be exercised when taking Neurol SR 0.5 with fluoxetine, propoxyphene, oral contraceptives, sertraline, diltiazem, and macrolide antibiotics (e.g., erythromycin, clarithromycin, or troleandomycin).
• Concomitant use of Neurol SR 0.5 with HIV protease inhibitors, e.g., ritonavir, requires dose adjustment or discontinuation of Neurol SR 0.5.
• Patients taking Neurol SR 0.5 and digoxin (a substance used to treat various heart diseases) should be closely monitored for signs of digoxin toxicity (objective and subjective).
• Concomitant use of Neurol SR 0.5 with clozapine may increase the risk of respiratory arrest and (or) cardiac arrest.
• Concomitant treatment with dextropropoxyphene should be avoided. Dextropropoxyphene may enhance the effect of alprazolam.
• Theophylline may decrease the effect of benzodiazepines.
• Omeprazole may enhance the effect of alprazolam.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine.
It is not recommended to take the medicine during pregnancy or when planning a pregnancy.
If the medicine is taken during pregnancy or if the patient becomes pregnant while taking alprazolam, they should be examined for potential fetal risk.
If it is necessary to take 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. Neurol SR 0.5 should not be taken during breastfeeding.

Driving and using machines

Neurol SR 0.5 causes impairment of psychophysical abilities. Before taking the medicine, the patient should familiarize themselves with the current traffic regulations. While taking Neurol SR 0.5, the patient should not drive vehicles or operate machines.

Neurol SR 0.5 contains lactose monohydrate

If the patient has been informed by their doctor that they have an intolerance to some sugars, they should contact their doctor before taking the medicine.

3. How to take Neurol SR 0.5

This medicine should always be taken exactly as directed by the doctor. 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. Long-term treatment is not recommended.
When starting treatment, the doctor will inform the patient about the limited duration of treatment, the gradual reduction of the dose during withdrawal, and the possibility of withdrawal reactions.
During treatment with benzodiazepines, including Neurol SR 0.5, 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 of Neurol SR 0.5 is determined by the doctor based on the severity of symptoms and the patient's individual response to treatment. If severe side effects occur after administration of the initial dose, the doctor may decide to reduce the dose.
If Neurol SR 0.5 is taken once a day, it is best to take it in the morning. The tablets should be swallowed whole; they should not be chewed, crushed, or divided.
Symptomatic treatment of anxiety disorders
Recommended initial dose: 1 mg per day, given once or in 2 divided doses.
The doctor may decide to increase the dose, depending on the patient's needs, up to a maximum daily dose of 4 mg, given once or in 2 divided doses.

Children and adolescents

Neurol SR 0.5 should not be taken by children and adolescents under 18 years of age.

Patients with renal or hepatic impairment

Use in patients with severe liver impairment is contraindicated.

Elderly patients

Recommended initial dose is 0.5 mg to 1 mg per day, given once or in 2 divided doses. 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.

Taking a higher dose of Neurol SR 0.5 than recommended

Taking a higher dose of Neurol SR 0.5 than recommended may cause: ataxia (lack of coordination), drowsiness, speech disorders, coma, and respiratory depression. If worrying symptoms occur, the patient should immediately contact their doctor or pharmacist.

Missing a dose of Neurol SR 0.5

The patient should not take a double dose to make up for a missed dose.

Stopping treatment with Neurol SR 0.5

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

4. Possible side effects

Like all medicines, Neurol SR 0.5 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 only on the individual sensitivity of the patient and the dose used. Side effects are usually observed at the beginning of therapy.
They disappear as treatment continues or after the dose is reduced.
The frequency of side effects observed in clinical trials and after marketing:

Very common (may affect more than 1 in 10 patients):

• depression,
• sedation,
• drowsiness,
• ataxia (lack of coordination),
• memory disorders,
• slurred speech,
• dizziness,
• headache,
• constipation,
• dry mouth,
• fatigue,
• irritability.

Common (may affect up to 1 in 10 patients):

• decreased appetite,
• confusion,
• disorientation,
• decreased libido,
• increased libido,
• anxiety,
• insomnia,
• nervousness,
• balance disorders,
• coordination disorders,
• concentration disorders,
• excessive need for sleep,
• lethargy,
• tremors,
• blurred vision,
• nausea,
• vomiting,
• skin rash,
• sexual function disorders,
• weight loss,
• weight gain,
• anorexia,
• increased appetite.

Uncommon (may affect up to 1 in 100 patients):

• mania,
• hallucinations,
• anger,
• agitation,
• dependence,
• memory loss,
• muscle weakness,
• urinary incontinence,
• irregular menstruation,
• drug withdrawal syndrome,
• feeling of intoxication.

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

• hyperprolactinemia (elevated prolactin levels)
• hypomania,
• aggressive behavior,
• hostile behavior,
• delusions,
• increased psychomotor activity,
• shortened reaction times,
• speech disorders,
• hypotonia (decreased muscle tone),
• drug abuse,
• autonomic nervous system disorders (which controls the function of internal organs, smooth muscles, and glands),
• gastrointestinal disorders,
• dysphagia (difficulty swallowing)
• hepatitis,
• liver function disorders,
• jaundice,
• angioedema,
• photosensitivity reactions
• urinary retention,
• peripheral edema (swelling of the ankles, feet, or fingers),
• increased intraocular pressure,

In addition, especially in patients taking other psychotropic medicines, patients with mental disorders, or those 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, depersonalization, agranulocytosis (significant decrease in white blood cell count), allergic reactions, or anaphylaxis (severe allergic reactions).
Taking benzodiazepines can lead to physical and psychological dependence. If physical dependence occurs, sudden discontinuation of the medicine may cause withdrawal symptoms such as headache, muscle pain, increased anxiety and tension, agitation, disorientation, and irritability, feeling of changed surroundings or self, hearing disorders, hypersensitivity to sound, stiffness, and tingling of limbs, hypersensitivity to light, noise, and touch, hallucinations, and seizures.
Withdrawal symptoms are usually more severe and frequent in patients treated for a long time, with high doses of benzodiazepines, and in case of sudden or rapid discontinuation of the medicine.

Reporting side effects

If side effects occur, including any not listed in this leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, ul. 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 can help gather more information on the safety of the medicine.
Side effects can also be reported to the marketing authorization holder or its representative.

5. How to store Neurol SR 0.5

The medicine should be stored out of sight and reach of children.
Do not take this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the given month.
No special precautions for storage are necessary.
Glass bottles
After first opening, store below 25°C.
The recommended shelf life after first opening is 30 days.
Do not take this medicine if any changes in the appearance of the tablets are observed.
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 pack and other information

What Neurol SR 0.5 contains

The active substance of the medicine is alprazolam. Each tablet contains 0.5 mg of alprazolam.
Other ingredients are: lactose monohydrate, hypromellose 2208/4000, hypromellose 2208/100, colloidal anhydrous silica, indigo carmine (E132) lake, magnesium stearate.

What Neurol SR 0.5 looks like and contents of the pack

Light blue, slightly speckled, round, biconvex tablets, with the inscription “N05” on one side.
Each pack contains 30 tablets.

Marketing authorization holder and manufacturer:

Zentiva k.s., U kabelovny 130, Dolní Měcholupy, 102 37 Prague 10, Czech Republic.

This medicine is authorized in the Member States of the European Economic Area under the following names:

Poland: Neurol SR 0.5
To obtain more detailed information about the medicine, the patient should contact the local representative of the marketing authorization holder:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
tel.: +48 22 375 92 00
Date of last revision of the leaflet:January 2023