XANAX 1 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
   1. It is essential to carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
2. What is Xanax SR and what is it used for
3. Important information before taking Xanax SR
   1. When not to take Xanax SR
   2. Warnings and precautions
   3. Xanax SR and other medicines
   4. Pregnancy and breastfeeding
   5. Driving and operating machinery
   6. Xanax SR contains lactose monohydrate
4. How to take Xanax SR
   1. Use in children and adolescents
   2. Use in patients with kidney or liver function disorders
   3. Use in elderly patients
   4. Use of a higher than recommended dose of Xanax SR
   5. Missing a dose of Xanax SR
   6. Stopping treatment with Xanax SR
5. Possible side effects
   1. Very common – may occur more frequently than 1 in 10 people:
   2. Common – may occur less frequently than 1 in 10 people:
   3. Uncommon – may occur less frequently than 1 in 100 people:
   4. Frequency not known (cannot be estimated from the available data):
   5. Reporting side effects
6. How to store Xanax SR
7. Package contents and other information
   1. What Xanax SR contains
   2. What Xanax SR looks like and what the package contains
   3. Marketing authorization holder:
   4. Manufacturer:
   5. Viatris Healthcare Sp. z o.o.
   6. Date of the last update of the leaflet:

Leaflet attached to the packaging: patient information

Xanax SR, 0.5 mg, prolonged-release tablets
Xanax SR, 1 mg, prolonged-release tablets
Xanax SR, 2 mg, prolonged-release 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 re-read 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 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 inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Xanax SR and what is it used for

The active substance of Xanax SR is alprazolam. It belongs to a group of medicines called benzodiazepines (anxiolytic medicines).
Xanax SR 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 bothersome for the patient. This medicine is intended for short-term use only.

2. Important information before taking Xanax SR

When not to take Xanax SR

• 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.

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

Warnings and precautions

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

• if the medicine is used for a long time (possible development of dependence on the medicine, especially in patients prone to drug or alcohol abuse). The need for further 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 opioids, sleeping pills, sedatives, or alcohol are used at the same time (the effect of these medicines or alcohol may be enhanced);
• if restlessness, excitement, 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 stopped and the doctor should be consulted;
• in patients with glaucoma;
• in patients with kidney or liver function disorders. Like other benzodiazepines, Xanax SR may cause anterograde amnesia, which occurs a few hours after taking the medicine. In such a case, the patient should have the opportunity for 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 Xanax SR in patients with depression.
Before planned surgery, the patient should inform their doctor about taking Xanax SR.

Xanax SR 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 using Xanax SR with opioids, as they have a depressant 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.
• Xanax SR may enhance the effect of antipsychotic, sedative, anxiolytic, antidepressant, narcotic analgesic, anticonvulsant, anesthetic, and antihistamine medicines.
• In the case of narcotic analgesics, there may be an increase in euphoria, which can lead to an increase in psychological dependence.
• Alcohol should not be consumed during treatment with Xanax SR.
• It is not recommended to take Xanax SR with certain oral antifungal medicines (e.g., ketoconazole, itraconazole, posaconazole, voriconazole).
• Particular caution should be exercised and the dose should be considered for reduction during concomitant use of Xanax SR 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 Xanax SR and HIV protease inhibitors (e.g., ritonavir) requires dose modification or discontinuation of alprazolam.
• Concomitant use of Xanax SR and digoxin requires close monitoring of the patient for signs of digoxin toxicity.
• Theophylline may decrease the effect of benzodiazepines.

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 taking this medicine.
Xanax SR should not be used during pregnancy.
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 human milk in small amounts. Xanax SR should not be used during breastfeeding.

Driving and operating machinery

Xanax SR causes impairment of psychophysical fitness. Before taking Xanax SR, the patient should familiarize themselves with current local traffic laws.
While taking Xanax SR, the patient should not drive vehicles or operate machinery.

Xanax SR contains lactose monohydrate

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to take Xanax SR

This medicine should always be taken according to the doctor's instructions. In case of doubts, the patient should consult their doctor or pharmacist.
Treatment should last 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. Long-term 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 of the medicine, and the possibility of withdrawal reactions.
During the use of benzodiazepines, including Xanax SR, 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 side effects occur after administration of the initial dose, the doctor may decide to reduce the dose.
If Xanax SR 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
The recommended initial dose is 1 mg per day, given once or in 2 divided doses.
The doctor may decide to increase it, depending on the patient's needs, to a maximum daily dose of 4 mg given once or in 2 divided doses.

Use in children and adolescents

Xanax SR 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 patients

The 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.

Use of a higher than recommended dose of Xanax SR

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

Missing a dose of Xanax SR

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

Stopping treatment with Xanax SR

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 on a gradual reduction of the dose.
In case of any further doubts related to the use of this medicine, the patient should consult their doctor.

4. Possible side effects

Like all medicines, Xanax SR can cause side effects, although not everybody gets them.
If any of the following side effects persist or are bothersome, the patient should inform their doctor. The occurrence of some side effects depends entirely on the patient's individual susceptibility 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 marketing of the medicine:

Very common – may occur more frequently than 1 in 10 people:

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

Common – may occur less frequently than 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 rash,
• sexual disorders,
• weight loss,
• weight gain.

Uncommon – may occur less frequently than 1 in 100 people:

• mania,
• hallucinations,
• anger,
• excitement,
• dependence,
• amnesia,
• muscle weakness,
• urinary incontinence,
• irregular menstrual cycles,
• withdrawal syndrome.

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

• hyperprolactinemia (elevated prolactin levels),
• hypomania,
• aggressive behavior,
• hostile behavior,
• thought 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 function disorders,
• jaundice,
• angioedema,
• photosensitivity reactions,
• urinary retention,
• peripheral edema (edema 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 (a significant decrease in the number of granulocytes), allergic reactions, or anaphylaxis (severe allergic reactions).
Benzodiazepines may cause physical and psychological dependence. If physical dependence occurs, sudden discontinuation of Xanax SR may cause withdrawal symptoms: headache, muscle pain, increased anxiety, feeling of tension, excitement, disorientation, irritability, changed perception of the environment or oneself, impaired hearing, stiffness, and paresthesia of limbs, hypersensitivity to light, noise, and touch, hallucinations, and seizures. 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.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the patient should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Jerozolimskie Avenue 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder or its representative.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Xanax SR

The medicine should be stored in a place invisible and inaccessible to children.
Store in a temperature below 25°C, in a dry place.
Do not use this medicine after the expiry date stated on the carton after: Expiry Date (EXP). The expiry date refers to the last day of the month.
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 used. This will help protect the environment.

6. Package contents and other information

What Xanax SR contains

• The active substance of Xanax SR is alprazolam.
• The other ingredients of the medicine are: lactose monohydrate, hypromellose 4000 cps, hypromellose 100 cps, colloidal silicon dioxide, magnesium stearate.

In addition, Xanax SR 0.5 mg and Xanax SR 2 mg tablets contain: F.D. & C. Blue No. 2 Aluminum Lake.

What Xanax SR looks like and what the package contains

Xanax SR, 0.5 mg: blue, round, convex tablets marked with "VLE 57" on one side of the tablet.
Xanax SR, 1 mg: white, round, convex tablets marked with "VLE 59" on one side of the tablet.
Xanax SR, 2 mg: blue, pentagonal tablets marked with "VLE 66" on one side of the tablet.
The package contains 30 or 60 tablets in aluminum/OPA/aluminum/PVC blisters in a cardboard box.

Marketing authorization holder:

Upjohn EESV, Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Netherlands

Manufacturer:

Pfizer Italia S.r.l., Localita Marino del Tronto, 63 100 Ascoli Piceno (AP), Italy
Mylan Hungary Kft., Mylan utca 1, Komárom, 2900, Hungary
To obtain more detailed information about this medicine, the patient should contact the representative of the marketing authorization holder:

Viatris Healthcare Sp. z o.o.

phone: 22 546 64 00

Date of the last update of the leaflet: