Patient Information Leaflet

NEUROL 0.25, 0.25 mg, tablets
NEUROL 1.0, 1 mg, tablets
Alprazolamum
Please read all of this leaflet carefully before taking this medicine, because it contains important information for you.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
If you experience any side effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet Contents:

What Neurol is and what it is used for
Important information before taking Neurol
How to take Neurol
Possible side effects
How to store Neurol
Contents of the pack and other information

1. What Neurol is and what it is used for

The active substance in Neurol is alprazolam. It belongs to a group of medicines called benzodiazepines (medicines with anxiolytic action).
Neurol is indicated for the treatment of symptoms of anxiety disorders in adults, but only in cases where symptoms are severe, impair normal functioning, or cause significant distress to the patient. This medicine is intended for short-term use only.

2. Important information before using Neurol

When not to use Neurol

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

Neurol should not be used in children and adolescents under 18 years of age.
Warnings and precautions
Before starting treatment with Neurol, discuss this with your doctor:

if the medicine is used long-term, as dependence on the medicine may occur, especially in patients prone to drug or alcohol abuse. The need for continued treatment should be periodically evaluated by the doctor;
if the dose of the medicine is being reduced or if it is suddenly discontinued [withdrawal symptoms may occur (see section 4)];
if the medicine is used in patients with depression, suicidal thoughts or tendencies;
if the patient is taking other benzodiazepines (increased risk of dependence);
if the patient is simultaneously taking opioids, sleeping tablets, sedatives or consuming alcohol (the effects of these medicines or alcohol may be intensified);
if restlessness, psychomotor agitation, irritability, aggression, hallucinations, anger, nightmares, illusions, psychosis, inappropriate behaviour or other behavioural disturbances occur. If any of these symptoms appear, treatment with the medicine should be discontinued and the patient should contact the doctor;
if the patient has glaucoma;
if the patient has impaired kidney or liver function.

Like other benzodiazepines, Neurol may cause anterograde amnesia, which occurs several
hours after taking the medicine. In such a case, the patient should ensure 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) weakening of the musculoskeletal system, which may lead to falls, often with serious consequences for such patients.
Episodes of hypomania and mania have been reported in connection with the use of Neurol in patients with depression.
Before a planned surgery, inform the doctor about taking Neurol.
Reduced effectiveness of the hypnotic action of alprazolam (and other benzodiazepines) may occur after repeated use of the medicine over several weeks.
Neurol and other medicines
Tell your doctor about all medicines currently or recently taken, as well as about medicines the patient plans to take.

Extreme caution should be exercised when using Neurol together with opioids, as they have a depressive effect on the respiratory system (slowing and shallowing breathing). This is associated with the risk of excessive sedation, respiratory depression, coma, and even death.
Neurol may enhance the effects of antipsychotics, hypnotics, anxiolytics, sedatives, antidepressants, narcotic analgesics, anticonvulsants, anaesthetics and antihistamines.
When using opioid analgesics, euphoria may be intensified, which may lead to increased psychological dependence.
Alcohol consumption must not occur during treatment with Neurol.
Concomitant use of Neurol with certain systemic antifungal medicines (e.g. ketoconazole, itraconazole, posaconazole, voriconazole) is not recommended.
Extreme caution should be exercised and dose reduction considered when using Neurol together with nefazodone, fluvoxamine and cimetidine.
Extreme caution should be exercised when using alprazolam together 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 adjustment or discontinuation of alprazolam.
Patients taking alprazolam and digoxin simultaneously should be closely monitored for signs (objective and subjective) of digoxin toxicity.
Theophylline may reduce the effect of benzodiazepines Neurol with food, drink and alcohol The medicine should be taken before or during a meal, with a small amount of liquid. Alcohol must not be consumed during treatment with Neurol.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a
child, she should consult her doctor before using this medicine.
Use of the medicine during pregnancy or when trying to conceive is not recommended.
If the medicine is used during pregnancy or if the patient becomes pregnant while taking alprazolam,
she should be evaluated for potential risks to the fetus. If administration of the medicine is necessary
in the late stages of pregnancy, high doses should be avoided and the newborn should be monitored.
Benzodiazepines pass into human milk in small concentrations. This medicine should not be used
during breastfeeding.
Driving and operating machinery
Neurol causes disturbances in psychophysical performance. Before using Neurol, patients should
familiarize themselves with current local traffic regulations.
Patients should not drive vehicles or operate machinery while taking Neurol.
Neurol contains monohydrate lactose.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact
the doctor before taking the medicine.

3. How to use Neurol

This medicine should always be used exactly as directed by the doctor. If in doubt, consult your
doctor or pharmacist.
Treatment should be as short as possible. The doctor should regularly assess the patient's condition and the need for continuing
treatment, especially if the patient's symptoms have improved and may no longer require
pharmacological treatment. The total duration of treatment should not exceed 2–4 weeks. Long-term treatment is not recommended.
At the start of treatment, the doctor will inform the patient about the limited duration of therapy, the need for gradual dose reduction when discontinuing the medicine, and the possibility of withdrawal reactions.
During treatment with benzodiazepines, including Neurol, dependence may develop, including emotional or physical dependence. This risk may increase with dose and duration of treatment; therefore, the lowest effective dose should be used for the shortest possible time, and the need for continuing treatment should be regularly reviewed with the doctor.
Recommended dose
The dose is determined by the doctor according to the severity of symptoms and the individual patient's response to treatment. If severe adverse reactions occur after the initial dose, the doctor may decide to reduce the dose.
Treatment of symptomatic anxiety states
The recommended initial dose is 0.25 mg or 0.5 mg three times daily.
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 renal or hepatic impairment
Use in patients with severe liver dysfunction is contraindicated.
Use in elderly or debilitated patients
The recommended initial dose is 0.25 mg two or three times daily.
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 may 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 (impaired coordination of movement),
drowsiness, speech disorders, coma, and respiratory depression. If disturbing symptoms occur, contact a doctor immediately.
Missed dose of Neurol
Do not take a double dose to make up for a missed dose.
Discontinuation of Neurol
Do not stop taking this medicine on your own.
Since treatment is symptomatic, symptoms may return after stopping the medicine.
The doctor will decide on a gradual reduction of the dose.
If you have any further questions about the use of this medicine, consult your doctor.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any of the adverse effects listed below persist or become troublesome,
you should inform your doctor. The occurrence of some adverse effects depends entirely on
the individual susceptibility of the patient and the dose administered. Adverse effects usually occur at
the beginning of therapy. They subside with continued treatment or when the dose is reduced.
Frequency of adverse effects observed in clinical trials and after marketing of the
medicine:
Very common – may affect more than 1 in 10 people:

depression,
sedation,
somnolence,
ataxia (impaired motor coordination),
memory disturbances,
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 drive),
increased libido,
anxiety,
insomnia,
nervousness,
balance disorders,
impaired coordination,
attention disturbances,
excessive need for sleep,
lethargy,
tremor,
blurred vision,
nausea,
skin inflammation,
sexual disorders,
decreased body weight,
increased body weight.

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 menstruation,
drug withdrawal syndrome.

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

hyperprolactinaemia (increased prolactin levels),
hypomania (mild mania),
aggressive behaviour,
hostile behaviour,
thought disorders,
increased psychomotor activity,
drug abuse,
autonomic nervous system disorders (which regulate 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 oedema (swelling of ankles, feet or fingers),
increased intraocular pressure.

Additionally, particularly in patients taking other psychotropic medicines, those with psychiatric disorders or alcohol abuse, a paradoxical reaction may occur, manifesting as anxiety.
Other adverse effects observed rarely or very rarely include: motor disturbances, seizures, psychotic symptoms, depersonalisation, agranulocytosis (marked decrease in granulocyte count), allergic reactions or anaphylaxis (severe allergic reactions).
Benzodiazepines may cause physical and psychological dependence. If physical dependence develops, abrupt discontinuation of Neurol may cause withdrawal symptoms: headache, muscle pain, increased anxiety, feelings of tension, agitation, disorientation, irritability, altered perception of surroundings or self, hearing impairment, stiffness and tingling of limbs, hypersensitivity to light, noise and touch, hallucinations and seizures, insomnia and mood changes. These symptoms are usually more pronounced in patients treated long-term with high doses of benzodiazepines and in cases of abrupt or rapid discontinuation of the medicine.
Cases of benzodiazepine abuse have been reported.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, you should inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: 22 49 21 301
Fax: 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder or its representative in Poland.
Reporting adverse effects helps to provide more information on the safety of the medicine.
5. How to store Neurol
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Store below 25°C, in the original packaging.
Medicines should not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Neurol contains

The active substance 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: monohydrate lactose, corn starch, granulated microcrystalline cellulose, calcium stearate, colloidal silicon dioxide.

What Neurol looks like and contents of the pack
Neurol 0.25: white or almost white tablets without a division line.
Neurol 1.0: white or almost white tablets with a division line; the tablet can be divided into equal doses.
Pack size: 30 tablets.
Marketing Authorisation Holder and Manufacturer:
Zentiva k.s., U kabelovny 130, Dolní Měcholupy, 102 37 Prague 10, Czech Republic
For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder in Poland:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
Tel. +48 22 375 92 00