Xanax

Package Leaflet: Information for the Patient

Xanax,0.25 mg, tablets
Xanax,0.5 mg, tablets
Xanax,1 mg, tablets
Xanax,2 mg, 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 those not listed in this leaflet, please inform your 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 taking Xanax
• 3. How to take Xanax
• 4. Possible side effects
• 5. How to store Xanax
• 6. Contents of the pack 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 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

When not to take Xanax

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

Warnings and precautions

Before starting treatment with Xanax, discuss it with your 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 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 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, psychomotor agitation, 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 discontinued and the doctor should be contacted;
• 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 a case, the patient should have 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 in patients with depression.
Before planned surgery, inform your doctor about taking Xanax.

Xanax 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 with opioids, as they have a depressive effect on the respiratory system (slow down and shallow breathing). This is associated with the 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 can lead to an increase in psychological dependence.
• Do not drink alcohol while taking Xanax.
• It is not recommended to take Xanax at the same time as certain antifungal medicines for internal use (e.g., ketoconazole, itraconazole, posaconazole, voriconazole).
• Particular caution should be exercised and the dose reduced when taking Xanax and 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).
• The concomitant use of Xanax and HIV protease inhibitors (e.g., ritonavir) requires dose modification or discontinuation of alprazolam.
• Patient taking alprazolam and digoxin should be closely monitored for signs (objective and subjective) 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, consult your doctor before taking this medicine.
Xanax should not be used during pregnancy.
If the medicine is used during pregnancy or if you become pregnant while taking alprazolam, you 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 breast milk in small amounts. Xanax should not be used during breastfeeding.

Driving and using machines

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

Xanax contains lactose monohydrate

If you have been diagnosed with intolerance to some sugars, consult your 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 (E 211)

• Each tablet of this medicine with a strength of 0.25 mg, 0.5 mg, and 1 mg contains 0.11 mg of sodium benzoate.
• Each tablet of this medicine with a strength of 2 mg contains 0.23 mg of sodium benzoate.

3. How to take Xanax

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. The doctor will regularly assess the patient's condition and the need to continue treatment, especially if the severity of the 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 you 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, dependence and emotional or physical dependence may develop. This risk may increase with 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 regularly 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 side effects 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 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, contact your doctor immediately.

Missing a dose of Xanax

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

Stopping treatment with Xanax

Do not stop taking Xanax on your own.
Because the treatment is symptomatic, after its discontinuation, the disease symptoms may return.
The doctor will decide to gradually reduce the dose.
If you have any further questions about the use of this medicine, ask your doctor.
Information about the use of Xanax, 2 mg
If necessary, these tablets can be divided into halves or quarters.
To do this, place the tablet on a hard surface with the indentation facing down. By pressing it with your thumb, you can break the tablet into two equal parts containing 1 mg of alprazolam each.
If necessary, each resulting part (half) can be further divided. To do this, place them again on a hard surface with the indentation facing down and press again with your thumb. In this way, you will get two quarters containing 0.5 mg of alprazolam each.
In this way, the following parts of Xanax tablets are obtained:
The obtained halves and (or) quarters of tablets can be stored in a specially designed cap for a glass bottle.

4. Possible side effects

Like all medicines, Xanax can cause side effects, although not everybody gets them.
If any of the following side effects persist or become troublesome, inform your doctor. The occurrence of some side effects depends entirely on the individual patient's 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 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 no more often 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 no more often than 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 (increased 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 fingers),
• 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 (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 is developed, 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 tingling 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 withdrawal of the medicine.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your 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
Side effects can also be reported to the marketing authorization holder or its representative.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Xanax

Keep this medicine out of the sight and reach of children.
Store in a temperature below 25°C. Store in normal humidity conditions.
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 contains

• The active substance of Xanax is alprazolam.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, sodium octylsulfobursztynian (85%) + sodium benzoate (15%) (E211), colloidal silicon dioxide, magnesium stearate, cornstarch. Additionally, Xanax 0.5 mg tablets contain sodium lake with erythrosine, and Xanax 1 mg tablets contain sodium lake with erythrosine and aluminum lake F.D. and C. Blue No. 2.

What Xanax looks like and contents of the pack

Xanax, 0.25 mg: white, elliptical-oval tablets, divisible, marked with "Upjohn 29" on one side and with a dividing line on the other side of the tablet
Xanax, 0.5 mg: pink, elliptical-oval tablets, divisible, marked with "Upjohn 55" on one side and with a dividing line on the other side of the tablet
Xanax, 1 mg: lavender, elliptical-oval tablets, divisible, marked with "Upjohn 90" on one side and with a dividing line on the other side of the tablet
Xanax, 2 mg: white, elongated tablets, divisible, marked with "U 94" on one side and with a triple dividing line on both sides of the tablet
The pack contains 30, 50, or 100 tablets in PVC/Aluminum blisters in a cardboard box (Xanax, 0.25 mg, Xanax, 0.5 mg, Xanax, 1 mg) or in a glass bottle in a cardboard box (Xanax, 2 mg).

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, 63100 Ascoli Piceno (AP), Italy
Mylan Hungary Kft., Mylan utca 1, Komárom, 2900, Hungary
To obtain more detailed information about this medicine, please contact the representative of the marketing authorization holder:

Viatris Healthcare Sp. z o.o.

tel. 22 546 64 00

Date of last revision of the leaflet: