Xanax Sr

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Xanax SR (Xanax XR)

0.5 mg, tablets with modified release
Alprazolam
Xanax SR and Xanax XR are different trade names for the same drug.

It is necessary to carefully read the contents of the leaflet before using the drug, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This drug has been prescribed to a specific person. It should not be given to others. The drug may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. 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 drugs called
benzodiazepines (drugs with anxiolytic action).
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
troublesome for the patient. This drug 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 drug (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 drug is used for a long time (possible development of drug dependence, 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 drug is reduced or it is suddenly discontinued [possible occurrence of withdrawal symptoms (see section 4)];
• if the drug 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 action of these drugs or alcohol may be enhanced);
• if restlessness, psychomotor agitation, irritability, aggression, delusions, anger, nightmares, hallucinations, psychosis, inappropriate behavior, or other behavioral disorders occur. In the event of the occurrence of these symptoms, the use of the drug should be discontinued and the doctor should be consulted;
• in patients with glaucoma;
• in patients with impaired renal or hepatic function. Like other benzodiazepines, Xanax SR may cause anterograde amnesia, which occurs a few hours after taking the drug. 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 can 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 doctor should be informed about the use of Xanax SR.

Xanax SR and other drugs

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

• Particular caution should be exercised when using Xanax SR with opioids, as they have a depressive 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 drugs.
• In the case of narcotic analgesics, there may be an intensification of euphoria, which can lead to an increased psychological dependence.
• Alcohol should not be consumed during the use of Xanax SR.
• It is not recommended to take Xanax SR at the same time as certain antifungal drugs for internal use (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, suspects that she may be pregnant, or plans to have
a child, she should consult her doctor before using this drug.
Xanax SR is not recommended during pregnancy.
If the drug is used during pregnancy or if the patient becomes pregnant while taking alprazolam, she should be examined for potential fetal risk.
If it is necessary to administer the drug 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. Xanax SR should not be used during breastfeeding.

Driving and operating machinery

Xanax SR causes impairment of psychophysical fitness. Before using Xanax SR, the patient should familiarize themselves with the current local traffic laws.
While using 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 drug.

3. How to take Xanax SR

This drug should always be used in accordance with the doctor's recommendations. In case of doubts, the patient should consult their doctor or pharmacist.
Xanax SR is available in a dose of 0.5 mg, 1 mg, and 2 mg.
Treatment should be 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.
At the start of treatment, the doctor will inform the patient about the limited duration of therapy, the gradual reduction of the dose during withdrawal of the drug, 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 individual patient's response to
treatment. If severe adverse reactions 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 impaired renal or hepatic function

Use in patients with severe hepatic impairment is contraindicated.

Use in elderly patients

The recommended initial dose is from 0.5 mg to 1 mg per day, given once or in two divided doses. If necessary, the doctor may decide to gradually increase the dose, depending on the patient's tolerance to the drug. If adverse reactions occur, the doctor will decide to reduce the initial dose.

Use of a higher than recommended dose of Xanax SR

Use of 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.

Discontinuation of Xanax SR

The patient should not stop taking the drug on their own.
Since the treatment is symptomatic, after its discontinuation, the symptoms of the disease may return.
The doctor will decide to gradually reduce the dose.
If there are any further doubts about the use of this drug, the patient should consult their doctor.

4. Possible side effects

Like all drugs, Xanax SR can cause side effects, although they do not occur in every patient.
If any of the following side effects persist or are troublesome, 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 drug. 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 drug was introduced to the market:

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

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

Common – may occur no more frequently than in 1 in 10 patients:

• decreased appetite,
• confusional state,
• disorientation,
• decreased libido (sexual drive),
• increased libido,
• anxiety,
• insomnia,
• nervousness,
• balance disorders,
• impaired coordination,
• concentration disorders,
• excessive need for sleep,
• lethargy,
• tremors,
• blurred vision,
• nausea,
• skin rash,
• sexual disorders,
• weight loss,
• weight gain.

Uncommon – may occur no more frequently than in 1 in 100 patients:

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

Frequency not known (cannot be estimated from 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 (swelling of the ankles, feet, or toes),
• increased intraocular pressure.

In addition, especially in patients taking other psychotropic drugs, 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, tension, agitation, disorientation, irritability, changed perception of the environment or oneself, impaired hearing, stiffness, and paresthesia of the 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 the case of sudden or rapid discontinuation of the drug.

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 of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting side effects can help gather more information on the safety of the drug.

5. How to store Xanax SR

The drug should be stored in a place that is invisible and inaccessible to children.
Do not store at a temperature above 30°C.
Do not use this drug after the expiration date stated on the packaging. The expiration date indicates the last day of the specified month.
Drugs should not be disposed of in the sewage system or household waste containers. The patient should ask their pharmacist how to dispose of unused drugs. This will help protect the environment.

6. Package contents and other information

What Xanax SR contains

• The active substance of Xanax SR is alprazolam. One modified-release tablet contains 0.5 mg of alprazolam.
• The other ingredients of the drug are: lactose, hypromellose 4000 cps, hypromellose 100 cps, colloidal anhydrous silica, magnesium stearate, indigo carmine (E 132).

What Xanax SR looks like and what the package contains

Blue, round, convex tablets marked with the inscription "P&U57" on one side of the tablet.
The package contains 30 or 60 tablets in Al/Al blisters in a cardboard box.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Portugal, the country of export:

Upjohn EESV
Rivium Westlaan 142
2909 LD Capelle aan den Ijssel
Netherlands

Manufacturer:

Pfizer Italia S.r.l.
Località Marino del Tronto, 63100 Ascoli Piceno (AP)
Italy

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing authorization number in Portugal, the country of export:
4579280
2381085
4579389
5816087

Parallel import authorization number: 385/22 Date of approval of the leaflet: 24.10.2022

[Information about the trademark]