Xanax

Package Leaflet: Information for the Patient

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

Xanax

0.25 mg, tablets

Alprazolam

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed for a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects 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 and what is it used for
• 2. Important information before taking Xanax
• 3. How to take 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 medicines called benzodiazepines (anxiolytic medicines). Xanax is indicated for the treatment of symptoms of anxiety disorders in adults, only in situations where the symptoms are severe, interfere with normal functioning, or are very bothersome for the patient. This medicine is intended for short-term use only.

2. Important information before taking Xanax

When not to take Xanax:

• 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 muscle fatigue and 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 taken by children and adolescents under 18 years of age.

Warnings and precautions

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

• if the medicine is taken for a long time, as dependence on the medicine 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 is reduced or the medicine is stopped abruptly (possible occurrence of withdrawal symptoms, see section 4);

• if the medicine is taken by 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 medicines or alcohol may be enhanced);
• if restlessness, excitement, irritability, aggression, delusions, anger, nightmares, hallucinations, psychosis, inappropriate behavior, or other behavioral disorders occur. If these symptoms occur, the use of the medicine 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 medicine. In such cases, 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 may lead to falls, often with serious consequences for such patients.

Episodes of hypomania and mania have been reported in association with Xanax in patients with depression. Before planned surgery, the doctor should be informed about the use of Xanax.

Xanax and other medicines

The patient should tell their doctor about all medicines they are taking, have recently taken, or plan to take.

• Particular caution should be exercised when Xanax is taken with opioids, as they have a depressant effect on the respiratory system (slowing and shallowing 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 medicines.
• In the case of narcotic analgesics, there may be an increase in euphoria, which may lead to increased psychological dependence.
• Alcohol should not be consumed during Xanax treatment.
• Xanax should not be taken with certain antifungal medicines for internal use (e.g., ketoconazole, itraconazole, posaconazole, voriconazole).
• Particular caution should be exercised and the dose reduced when Xanax is taken with nefazodone, fluvoxamine, and cimetidine.
• Particular caution should be exercised when Xanax is taken with fluoxetine, propoxyphene, oral contraceptives, sertraline, diltiazem, and macrolide antibiotics (e.g., erythromycin, clarithromycin, or troleandomycin).
• The 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, breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine. Xanax is not recommended during pregnancy. If the medicine is taken 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, high doses should be avoided and the newborn should be monitored. Benzodiazepines pass into human milk in small amounts. Xanax should not be taken during breastfeeding.

Driving and using machines

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

Xanax contains lactose monohydrate

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

Xanax contains sodium

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

Xanax contains sodium benzoate

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

3. How to take Xanax

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist. Xanax is available in the following strengths: 0.25 mg, 0.5 mg, 1 mg, 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 patient's symptoms decreases and may not require pharmacological treatment. The total treatment duration 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, and the possibility of withdrawal reactions. During benzodiazepine treatment, 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 patient's individual response to treatment. If severe side effects occur after 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 the dose, depending on the patient's needs, up 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 taken by 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 medicine. If side effects occur, the doctor will decide to reduce the initial dose.

Taking a higher dose of Xanax than recommended

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

Missing a dose of Xanax

The patient should not take a double dose to make up for a missed dose.

Stopping Xanax treatment

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

4. Possible side effects

Like all medicines, Xanax can cause side effects, although not everybody gets them. If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. 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 medicine was placed on the market:

Very common - may occur more often 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 occur less often than 1 in 10 people:

• decreased appetite,
• confusion,
• disorientation,
• decreased libido (sex drive),

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• 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 often 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 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 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). Page 5 of 7 Benzodiazepines may cause physical and psychological dependence. If physical dependence is developed, abrupt discontinuation of Xanax 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 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 abrupt or rapid discontinuation of the medicine.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Xanax

The medicine should be stored in a place invisible and inaccessible to children. Do not store above 25°C. Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month. Medicines should not be disposed of via wastewater or household waste containers. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. 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 0.25 mg of alprazolam.
• The other ingredients of the medicine are: lactose monohydrate, microcrystalline cellulose, sodium docuzate (85%) + sodium benzoate (15%), colloidal silica anhydrous, magnesium stearate, cornstarch.

What Xanax looks like and what the package contains

White, elliptical-oval tablets, scored, marked with "Upjohn 29" on one side and a score line on the other side of the tablet. The package contains 30, 50, or 100 tablets in PVC/Al blisters in a cardboard box. For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Hungary, the country of export:

Viatris Healthcare Limited, Damastown Industrial Park, Mulhuddart, Dublin 15, Dublin, Ireland

Manufacturer:

Pfizer Italia S.r.l., Località Marino del Tronto, 63100 - Ascoli Piceno (AP), Italy, Mylan Hungary Kft., Mylan utca 1, 2900 Komárom, Hungary

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 Hungary, the country of export: OGYI-T-4617/04, OGYI-T-4617/05

Parallel import authorization number: 163/25

Date of leaflet approval: 08.05.2025

[Information about the trademark]

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