Package leaflet: Information for the user

Neurol SR 0.5
0.5 mg, prolonged-release tablets
Alprazolamum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

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

Table of contents of the leaflet:

What Neurol SR 0.5 is and what it is used for
Important information before taking Neurol SR 0.5
How to take Neurol SR 0.5
Possible side effects
How to store Neurol SR 0.5
Contents of the pack and other information

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

Neurol SR 0.5 contains alprazolam as the active substance, which belongs to a group of medicines called benzodiazepines (medicines with anxiolytic activity).
Neurol SR 0.5 is used in the treatment of anxiety states in adults, exclusively in situations where symptoms are severe, impair normal functioning, or are highly distressing to the patient. This medicine is intended for short-term use only.

2. Important information before using Neurol SR 0.5

When not to use Neurol SR 0.5:

if the patient is allergic to alprazolam, to 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 characterised 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;
in case of acute intoxication caused by alcohol or medicines acting on the central nervous system.

Neurol SR 0.5 should not be used in children and adolescents under 18 years of age.
Warnings and precautions
Before starting treatment with Neurol SR 0.5, discuss the following with your doctor:

if Neurol SR 0.5 is used long-term (dependence may develop, especially in patients prone to drug or alcohol abuse). The need for continued treatment should be periodically evaluated by the doctor;
if the medicine is stopped suddenly or its dose is abruptly reduced, withdrawal symptoms may occur (see section 4);
if the patient has depression or suicidal thoughts or tendencies;
if the patient is using other benzodiazepines (increased risk of dependence);
if opioids, sleeping medicines, sedatives, or alcohol are used concurrently (the effects of these medicines or alcohol may be enhanced);
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 this medicine should be discontinued and the patient should contact their doctor;
if the patient has glaucoma (increased intraocular pressure);
if the patient has chronic respiratory insufficiency;
if the patient has ever abused alcohol or drugs;
if the patient has liver or kidney problems.

Like other benzodiazepines, Neurol SR 0.5 may cause anterograde amnesia (complete or partial loss of ability to recall events after taking the medicine). This most commonly occurs within a few hours after taking the medicine. In such cases, the patient should be ensured uninterrupted sleep for 7 to 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 alprazolam use in patients with depression.
Before a planned surgery, inform the doctor that the patient is taking Neurol SR 0.5.
Neurol SR 0.5 and other medicines
Tell your doctor about all medicines currently or recently taken, as well as any medicines the patient plans to take.

Extreme caution is required when using Neurol SR 0.5 together with opioids, as they have a depressant effect on the respiratory system (slowing and shallowing of breathing). This is associated with a risk of excessive sedation, respiratory depression, coma, and even death.
Neurol SR 0.5 may enhance the effects of antipsychotic, hypnotic, anxiolytic, sedative, antidepressant, anticonvulsant, anaesthetic, and antihistamine medicines.
With narcotic analgesics, euphoria may be intensified, which may lead to increased psychological dependence.
Alcohol must not be consumed during treatment with Neurol SR 0.5.
Concomitant use of Neurol SR 0.5 with certain systemic antifungal medicines (e.g. ketoconazole, itraconazole, posaconazole, voriconazole) is not recommended.
Extreme caution is required and dose reduction should be considered when using Neurol SR 0.5 together with nefazodone, fluvoxamine, and cimetidine.
Extreme caution is required when using Neurol SR 0.5 together 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 in the treatment of various heart conditions) simultaneously should be closely monitored for (objective and subjective) signs of digoxin toxicity.
Concomitant use of Neurol SR 0.5 with clozapine may increase the risk of cessation of breathing and (or) cardiac function.
Concomitant treatment with dextropropoxyphene should be avoided. Dextropropoxyphene may enhance the effect of alprazolam.
Theophylline may reduce the effect of benzodiazepines.
Omeprazole may enhance the effect of alprazolam.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.
Use of this medicine during pregnancy or when planning pregnancy is not recommended.
If the medicine is used during pregnancy or if the patient becomes pregnant while taking alprazolam, she should be examined for potential risks to the foetus.
If use 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. Neurol SR 0.5 should not be used during breastfeeding.
Driving and operating machinery
Neurol SR 0.5 causes impairment of psychophysical performance. Before using the medicine, patients should familiarise themselves with current road traffic regulations. Patients should not drive vehicles or operate machinery while taking Neurol SR 0.5.
Neurol SR 0.5 contains monohydrate lactose
If the patient has been informed by their doctor that they have an intolerance to certain sugars, they should contact their doctor before taking this medicine.

3. How to use Neurol SR 0.5

This medicine should always be used exactly as directed by the doctor. In case of doubt, consult a
doctor or pharmacist.
Treatment should last as short a time as possible. The doctor should regularly assess the patient's
condition and the need for continuing treatment, especially if the patient's symptoms have
diminished 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 beginning of treatment, the doctor will inform the patient about the limited duration of
treatment, the need for gradual dose reduction when discontinuing the medicine, and the
possibility of withdrawal reactions.
During treatment with benzodiazepines, including Neurol SR 0.5, dependence may develop, both
emotional and physical. 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 continued
treatment should be regularly reviewed 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
individual patient's response to treatment. If severe adverse reactions occur after the initial dose,
the doctor may decide to reduce the dose.
If Neurol SR 0.5 is taken once daily, it is best taken in the morning. Tablets should be swallowed
whole; they should not be chewed, crushed, or divided.
Treatment of symptomatic anxiety states
Recommended initial dose: 1 mg per day, administered as a single dose or in two 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, administered as a single dose or in two divided doses.
Children and adolescents
Neurol SR 0.5 should not be used in children and adolescents under 18 years of age.
Patients with renal or hepatic impairment
Use in patients with severe hepatic impairment is contraindicated.
Elderly patients
Recommended initial dose is 0.5 mg to 1 mg per day, administered as a single dose or in two
divided doses. If necessary, the doctor may decide to gradually increase the dose depending on
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 SR 0.5
Use of a higher than recommended dose of Neurol SR 0.5 may cause: ataxia (impaired coordination),
drowsiness, speech disorders, coma, and respiratory depression. In case of disturbing symptoms,
contact a doctor or pharmacist immediately.
Missed dose of Neurol SR 0.5
Do not take a double dose to make up for a missed dose.
Discontinuation of Neurol SR 0.5
Do not stop taking this medicine without consulting your doctor. Since treatment is symptomatic,
symptoms may return after stopping the medicine. The doctor will decide on gradual dose reduction.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any of the following adverse effects persist or are troublesome, you should inform your doctor.
The occurrence of some adverse effects depends solely on individual patient sensitivity and the dose used. Adverse effects are usually observed at the beginning of therapy. They subside with continued treatment or after dose reduction.
Frequency of adverse effects observed in clinical trials and after marketing authorization:
Very common (may affect more than 1 in 10 people):

depression,
sedation,
somnolence,
ataxia (lack of coordination of movement),
memory disturbances,
slurred speech,
dizziness,
headache,
constipation,
dry mouth,
fatigue,
irritability.

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

decreased appetite,
confusion,
disorientation,
decreased libido,
increased libido,
anxiety,
insomnia,
nervousness,
balance disorders,
abnormal coordination,
difficulty concentrating,
excessive need for sleep,
lethargy,
tremor,
blurred vision,
nausea,
vomiting,
skin inflammation,
sexual dysfunction,
decreased body weight,
increased body weight,
anorexia,
increased appetite.

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

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

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

hyperprolactinaemia (increased prolactin levels),
hypomania,
aggressive behaviour,
hostile behaviour,
delusions,
increased psychomotor activity,
shortened reaction times,
speech disorders,
hypotonia (reduced muscle tone),
drug abuse,
autonomic nervous system dysfunction (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 oedema (swelling of ankles, feet or fingers),
increased intraocular pressure.

Additionally, particularly in patients taking other psychotropic medicines, patients with psychiatric disorders or those who abuse alcohol, a paradoxical reaction may occur, with symptoms such as anxiety.
Other adverse effects observed rarely or very rarely include: motor disturbances, epilepsy, psychotic symptoms, depersonalization, agranulocytosis (marked decrease in white blood cell count), allergic reactions or anaphylaxis (severe allergic reactions).
The use of benzodiazepines may lead to physical and psychological dependence. If physical dependence develops, abrupt discontinuation may result in withdrawal symptoms such as headache, muscle pain, increased anxiety and tension, agitation, disorientation and irritability, altered perception of surroundings or self, auditory disturbances, hypersensitivity to sound, stiffness and tingling of limbs, hypersensitivity to light, noise and touch, hallucinations and epileptic seizures, insomnia and mood changes.
Withdrawal symptoms are usually more severe and more frequent in patients treated long-term with high doses of benzodiazepines and in cases of abrupt or rapid discontinuation of the medicine.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, you should inform your doctor or pharmacist. 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, Jerozolimskie Avenue 181C, 02-222 Warsaw.
Tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
By reporting adverse effects, additional information on the safety of the medicine can be collected.
Adverse effects may also be reported to the marketing authorization holder or its representative.

5. How to store Neurol SR 0.5

Keep this 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.
No special storage conditions are required.
Glass bottles
After first opening, store below 25°C.
The recommended shelf-life after first opening is 30 days.
Do not use this medicine if any changes in the appearance of the tablets are observed.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures help protect the environment.

6. Contents of the pack and other information

What Neurol SR 0.5 contains
The active substance is alprazolam. Each tablet contains 0.5 mg of alprazolam.
The other ingredients are: monohydrate lactose, hypromellose 2208/4000, hypromellose 2208/100,
anhydrous colloidal silicon dioxide, indigo carmine (E132) aluminium lake, magnesium stearate.

What Neurol SR 0.5 looks like and contents of the pack
Light blue, slightly mottled, round, biconvex tablets, embossed with "N05" on one side.
Each pack contains 30 tablets.

Marketing Authorisation Holder and Manufacturer:
Zentiva k.s., U kabelovny 130, Dolní Měcholupy, 102 37 Prague 10, Czech Republic.

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Poland: Neurol SR 0.5

For further information regarding this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
tel.: +48 22 375 92 00