Xanax

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Xanax (Xanor), 0.5 mg,tablets
Alprazolamum
Xanax and Xanor are different trade names for the same drug.

You should carefully read the contents of the leaflet before using the drug, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again 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 or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Xanax and what is it used for

The active substance of Xanax is alprazolam. It belongs to a group of drugs called benzodiazepines (drugs with anxiolytic activity).
Xanax 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 using Xanax

When not to use Xanax:

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

Warnings and precautions

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

• if the drug is used for a long time, as dependence on the drug may occur, especially in patients prone to drug or alcohol abuse. The need for continued 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 the patient is taking opioids, sleeping pills, sedatives, or drinking alcohol (the effect of these drugs or alcohol may be enhanced);
• if restlessness, psychomotor agitation, irritability, aggression, delusions, anger, nightmares, hallucinations, psychosis, or other behavioral disorders occur. In case of the occurrence of these symptoms, the use of the drug should be discontinued and the doctor should be consulted;
• if the patient has glaucoma;
• if the patient has kidney or liver function disorders. Like other benzodiazepines, Xanax may cause anterograde amnesia, which occurs a few hours after taking the drug. In such a case, the patient should have 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 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 in patients with depression.
Before planned surgery, the patient should inform their doctor about taking Xanax.

Xanax and other drugs

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

• Particular caution should be exercised when using Xanax 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 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 increase in euphoria, which can lead to an increase in psychological dependence.
• Alcohol should not be consumed during Xanax treatment.
• It is not recommended to take Xanax with 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 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 and HIV protease inhibitors (e.g., ritonavir) requires dose modification or discontinuation of alprazolam.
• Patients taking alprazolam and digoxin should be closely monitored for signs of digoxin toxicity (objective and subjective).
• 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 should not be used 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 should not be used during breastfeeding.

Driving and operating machinery

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

Xanax contains lactose monohydrate

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

Xanax contains sodium

The drug contains less than 1 mmol (23 mg) of sodium per tablet, which means the drug is considered "sodium-free".

Xanax contains sodium benzoate

Each tablet of this drug contains 0.11 mg of sodium benzoate.

3. How to use Xanax

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 is available in the following doses: 0.25 mg, 0.5 mg, 1 mg, 2 mg.
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 drug, and the possibility of withdrawal reactions.
During the use of benzodiazepines, including Xanax, 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.
Symptomatic treatment of anxiety disorders
The recommended initial dose is 0.25 mg or 0.5 mg three times a day.
The doctor may decide to increase it, depending on the patient's needs, to a maximum daily dose of 4 mg divided into smaller doses, taken throughout the day.

Use in children and adolescents

Xanax 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 0.25 mg two or three times a day.
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

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

Missing a dose of Xanax

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

Discontinuation of Xanax

The patient should not discontinue Xanax on their own.
Since the treatment is symptomatic, after its discontinuation, the disease symptoms 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 drug, the patient should consult their doctor.

4. Possible side effects

Like all drugs, Xanax can cause side effects, although they do not occur in everyone.
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 individual patient's sensitivity 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 in more 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 in up to 1 in 10 people:

• decreased appetite,
• confusion,
• disorientation,
• decreased libido (sexual drive),
• 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 in 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 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 disorders,
• jaundice,
• angioedema,
• photosensitivity reactions,
• urinary retention,
• peripheral edema (swelling of the ankles, feet, or toes),
• increased intraocular pressure.

Additionally, 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 may cause withdrawal symptoms: headache, muscle pain, increased anxiety, feeling of tension, agitation, disorientation, irritability, feeling of changed environment or self, 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 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 or pharmacist. 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, tel.: +48 22 49 21 301, fax: +48 22 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

The drug should be stored in a place invisible and inaccessible to children.
Do not store above 25°C. Store in the original packaging to protect from light.
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 contains

• The active substance of Xanax is alprazolam. One tablet contains 0.5 mg of alprazolam.
• The other ingredients of the drug are: lactose monohydrate, microcrystalline cellulose, sodium docuzate (85%) + sodium benzoate (15%), colloidal silica anhydrous, magnesium stearate, corn starch, erythrosine.

What Xanax looks like and what the package contains

Xanax, 0.5 mg, are pink, elliptical-oval tablets, scored, marked with "Upjohn 55" on one side and a score line on the other side of the tablet.
The package contains 30, 50, or 100 tablets in PVC/Aluminum blisters in a cardboard box.
For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Austria, the country of export:

Pfizer Corporation Austria Ges.m.b.H.
Floridsdorfer Hauptstraße 1
1210 Vienna, Austria

Manufacturer:

Pfizer Italia S.r.l.
Località Marino del Tronto, Ascoli Piceno, Italy

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Austrian marketing authorization number:1-18639
Parallel import authorization number:287/20

Date of leaflet approval: 02.08.2023

[Information about the trademark]