XANAX 2 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
   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:
2. What Xanax SR is and what it is 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 using machines
   6. Xanax SR contains lactose monohydrate
4. How to take Xanax SR
   1. Use in children and adolescents
   2. Use in patients with renal or hepatic impairment
   3. Use in elderly patients
   4. Overdose of Xanax SR
   5. Missed dose of Xanax SR
   6. Stopping treatment with Xanax SR
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 (cannot be estimated from the available data):
   5. Reporting side effects
6. How to store Xanax SR
7. Contents of the pack and other information
   1. What Xanax SR contains
   2. What Xanax SR looks like and contents of the pack
   3. Marketing authorization holder:
   4. Manufacturer:
   5. Viatris Healthcare Sp. z o.o.
   6. Date of last revision of the leaflet:

Package Leaflet: Information for the Patient

Xanax SR, 0.5 mg, prolonged-release tablets
Xanax SR, 1 mg, prolonged-release tablets
Xanax SR, 2 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.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What Xanax SR is and what it is 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. Contents of the pack and other information

1. What Xanax SR is and what it is 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 anxiety symptoms in adults, only in situations where symptoms are severe, interfere with normal functioning, or are very troublesome 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 you are allergic to alprazolam or other benzodiazepines, or any of the other ingredients of this medicine (listed in section 6);
• if you have myasthenia gravis (a disease characterized by excessive fatigue and muscle weakness);
• if you have severe respiratory failure;
• if you have sleep apnea syndrome;
• if you have severe liver failure.

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

Warnings and precautions

Before starting treatment with Xanax SR, discuss with your doctor:

• if the medicine is taken 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 taken by patients with depression, with suicidal thoughts or tendencies;
• if you are taking other benzodiazepines (increased risk of dependence);
• if you are taking opioids, sleeping pills, sedatives, or drinking alcohol (the effect of these medicines or alcohol may be enhanced);
• if you experience restlessness, psychomotor agitation, irritability, aggression, delusions, anger, nightmares, hallucinations, psychosis, or other behavioral disorders. If these symptoms occur, the use of the medicine should be discontinued and you should contact your doctor;
• in patients with glaucoma;
• in patients with renal or hepatic impairment. Like other benzodiazepines, Xanax SR may cause anterograde amnesia, which occurs a few hours after taking the medicine. In such cases, the patient should be ensured the possibility of uninterrupted sleep for 7-8 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 may lead to falls, often with serious consequences for such patients.

Episodes of hypomania and mania have been reported in association with the use of Xanax SR in patients with depression.
Before planned surgery, inform your doctor about taking Xanax SR.

Xanax SR and other medicines

Tell your doctor about all medicines you are taking now or have taken recently, as well as any medicines you plan to take.

• Particular caution should be exercised when taking 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 increased psychological dependence.
• Do not drink alcohol 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 a dose reduction considered when taking Xanax SR with nefazodone, fluvoxamine, and cimetidine.
• Particular caution should be exercised when taking 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 you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor for advice before taking this medicine.
Xanax SR should not be used during pregnancy.
If you are taking this medicine and become pregnant, or if you plan to become pregnant, you should be examined for potential fetal risk.
If it is necessary to administer the medicine during the last trimester of pregnancy, you should avoid high doses and monitor the newborn.
Benzodiazepines pass into breast milk in small amounts. You should not take Xanax SR while breastfeeding.

Driving and using machines

Xanax SR causes impairment of psychophysical fitness. Before taking Xanax SR, familiarize yourself with current local traffic laws.
Do not drive or operate machinery while taking Xanax SR.

Xanax SR contains lactose monohydrate

If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.

3. How to take Xanax SR

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Treatment should be as short as possible. Your doctor will regularly assess your condition and the need to continue treatment, especially if the severity of your symptoms decreases and may not require pharmacological treatment. The total treatment period should not exceed 2-4 weeks. Long-term treatment is not recommended.
When starting treatment, your doctor will inform you about the limited duration of therapy, the gradual reduction of the dose during withdrawal, and the possibility of withdrawal reactions.
During treatment with benzodiazepines, including Xanax SR, dependence and emotional or physical dependence may develop. This risk may increase with dose and duration of treatment, so you should take the smallest effective dose for the shortest possible time and regularly assess the need to continue treatment with your doctor.
Recommended dose
The dose is determined by the doctor based on the severity of symptoms and individual patient 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; do not chew, crush, or divide them.
Symptomatic treatment of anxiety states
The recommended initial dose is 1 mg per day, given once or in 2 divided doses.
Your doctor may decide to increase the dose, depending on your needs, up 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 renal or hepatic impairment

Use in patients with severe hepatic impairment 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, your doctor may decide to gradually increase the dose, depending on tolerance to the medicine. If side effects occur, your doctor will decide to reduce the initial dose.

Overdose of Xanax SR

Taking more than the recommended dose of Xanax SR may cause: ataxia (lack of coordination), drowsiness, speech disorders, coma, and respiratory depression. If you experience worrying symptoms, contact your doctor or pharmacist immediately.

Missed dose of Xanax SR

Do not take a double dose to make up for a missed dose.

Stopping treatment with Xanax SR

Do not stop taking the medicine on your own.
Because the treatment is symptomatic, after its discontinuation, the symptoms of the disease may return.
Your doctor will decide on a gradual reduction of the dose.
If you have any further questions about the use of this medicine, ask your 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 worsen, tell your doctor. The occurrence of some side effects depends entirely on individual patient 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 marketing:

Very common – may affect more than 1 in 10 people:

• depression,
• sedation,
• drowsiness,
• ataxia (lack of coordination),
• memory disorders,
• 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 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 affect up to 1 in 100 people:

• mania,
• hallucinations,
• anger,
• agitation,
• 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 (significant decrease in granulocyte count), allergic reactions, or anaphylaxis (severe allergic reactions).
Benzodiazepines may cause physical and psychological dependence. If physical dependence develops, sudden discontinuation of Xanax SR may cause withdrawal symptoms: headache, muscle pain, increased anxiety, tension, agitation, 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, insomnia, and mood changes. These symptoms are usually more severe in patients treated for a long time, with high doses of benzodiazepines, and in the case of sudden or rapid discontinuation of the medicine.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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

Keep the medicine out of the sight and reach of 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. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Xanax SR contains

• The active substance is alprazolam.
• The other ingredients 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 contents of the pack

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 pack 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, contact the representative of the marketing authorization holder:

Viatris Healthcare Sp. z o.o.

phone: 22 546 64 00

Date of last revision of the leaflet: