Xanax

Package leaflet: Information for the patient

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Xanax (Xanor)
0.5 mg, tablets
Alprazolamum
Xanax and Xanor are different brand names for the same medicine.
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are similar.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Xanax is and what it is used for
2. What you need to know 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 Xanax is and what it is used for

The active substance in Xanax is alprazolam. It belongs to a group of medicines called benzodiazepines (medicines with anxiolytic action).
Xanax is indicated for the treatment of symptoms of anxiety disorders in adults, but only in cases where symptoms are severe, impair normal functioning, or cause significant distress to the patient. This medicine 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 to any of the other ingredients of this medicine (listed in section 6);
• if the patient has muscle weakness ( myasthenia gravis ) (a disease characterized by excessive fatigue and muscle weakness);
• if the patient has severe respiratory insufficiency;
• if the patient has sleep apnoea syndrome;
• if the patient has severe liver impairment.

Xanax must not be used in children and adolescents under 18 years of age.
Warnings and precautions
Before starting treatment with Xanax, discuss this with your doctor:

• if the medicine is used long-term, as dependence may occur, especially in patients prone to drug or alcohol abuse. The need for continued treatment should be periodically evaluated by the doctor;
• if the dose of the medicine is being reduced or if it is suddenly discontinued [withdrawal symptoms may occur (see section 4)];
• if the medicine is used in patients with depression, suicidal thoughts or tendencies;
• if the patient is taking other benzodiazepines (increased risk of dependence);
• if the patient is simultaneously taking opioids, sleeping medicines, sedatives or consuming alcohol (the effects of these medicines or alcohol may be enhanced);
• if restlessness, psychomotor agitation, irritability, aggression, hallucinations, anger, nightmares, illusions, psychosis, inappropriate behaviour or other behavioural disturbances occur. If any of these symptoms appear, treatment with the medicine should be discontinued and the patient should contact their doctor;
• if the patient has glaucoma;
• if the patient has impaired kidney or liver function. Like other benzodiazepines, Xanax may cause anterograde amnesia, which occurs several hours after taking the medicine. In such a case, the patient should ensure 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) musculoskeletal 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 in patients with depression.
Before a planned surgery, inform the doctor about taking Xanax.
Xanax with other medicines
Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

• Extreme caution is required when using Xanax together with opioids, as they have a depressant effect on the respiratory system (slowing and shallowing breathing). This is associated with the risk of excessive sedation, respiratory depression, coma, and even death.
• Xanax may enhance the effects of antipsychotics, sleeping medicines, anxiolytics, sedatives, antidepressants, narcotic analgesics, anticonvulsants, anaesthetics, and antihistamine medicines.
• When narcotic analgesics are used, euphoria may be intensified, which may lead to increased psychological dependence.
• Alcohol must not be consumed during treatment with Xanax.
• It is not recommended to take Xanax concomitantly with certain systemic antifungal medicines (e.g. ketoconazole, itraconazole, posaconazole, voriconazole).
• Extreme caution is required and dose reduction should be considered when Xanax is used concomitantly with nefazodone, fluvoxamine, and cimetidine.
• Extreme caution is required when using alprazolam together 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 adjustment or discontinuation of alprazolam.
• Patients taking alprazolam and digoxin simultaneously should be closely monitored for signs (objective and subjective) of digoxin toxicity.
• Theophylline may reduce the effect of benzodiazepines.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.
Use of this medicine during pregnancy is not recommended.
If the medicine is used during pregnancy or if the patient becomes pregnant while taking alprazolam, she should be evaluated for potential fetal risk.
If administration of the medicine is necessary during late pregnancy, high doses should be avoided and the newborn should be monitored.
Benzodiazepines pass into human milk in small concentrations. Xanax must not be used during breastfeeding.
Driving and operating machinery
Xanax may impair psycho-motor performance. Before using Xanax, become familiar with current local traffic regulations.
Patients should not drive or operate machinery while taking Xanax.
Xanax contains lactose monohydrate
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact their doctor before taking this medicine.
Xanax contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. 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 use Xanax

This medicine should always be taken exactly as directed by the doctor. If in doubt, consult the 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 regularly assess the patient's condition and the need for continuing treatment, especially if the patient's symptoms have improved and may no longer require pharmacological treatment. The total duration of treatment should not exceed 2–4 weeks. Long-term treatment is not recommended.
At the beginning of treatment, the doctor will inform the patient about the limited duration of therapy, the need for gradual dose reduction when discontinuing the medicine, and the possibility of withdrawal reactions.
During treatment with benzodiazepines, including Xanax, physical or emotional dependence may develop. This risk may increase with dose and duration of treatment. Therefore, the lowest effective dose should be used for the shortest possible time, and the need for continuing treatment should be regularly reviewed 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 the initial dose, the doctor may decide to reduce the dose.

Treatment of anxiety symptoms
The recommended initial dose is 0.25 mg or 0.5 mg three times daily.
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 used in children and adolescents under 18 years of age.

Use in patients with renal or hepatic impairment
Use in patients with severe liver dysfunction is contraindicated.

Use in elderly patients
The recommended initial dose is 0.25 mg two or three times daily.
If necessary, the doctor may decide to gradually increase the dose depending on the patient's tolerance. If adverse reactions occur, the doctor may decide to reduce the initial dose.

Use of a higher than recommended dose of Xanax
Taking a higher than recommended dose of Xanax may cause: ataxia (impaired coordination), drowsiness, speech disturbances, coma, and respiratory depression. If disturbing symptoms occur, contact a doctor immediately.

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

Discontinuation of Xanax
Do not stop taking Xanax on your own.
Since treatment is symptomatic, symptoms may return after stopping the medicine. The doctor will decide on a gradual dose reduction.

If you have any further questions about the use of this medicine, consult your doctor.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone experiences them.
If any of the adverse reactions listed below persist or become troublesome, inform your doctor. The occurrence of certain adverse reactions depends entirely on individual patient susceptibility and the dose administered. Adverse reactions are usually observed at the beginning of treatment. They tend to subside as treatment continues or when the dose is reduced.
Frequency of adverse reactions observed in clinical trials and after marketing authorization:

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

• depression,
• sedation,
• somnolence,
• ataxia (lack of muscular coordination),
• memory disturbances,
• speech disorders,
• dizziness,
• headache,
• constipation,
• dry mouth,
• fatigue,
• irritability.

Common – may occur in no more than 1 in 10 people:

• decreased appetite,
• confusion,
• disorientation,
• decreased libido (sexual drive),
• increased libido,
• anxiety,
• insomnia,
• nervousness,
• balance disorders,
• incoordination,
• attention disturbances,
• excessive sleepiness,
• lethargy,
• tremor,
• blurred vision,
• nausea,
• skin inflammation,
• sexual disturbances,
• weight loss,
• weight gain.

Uncommon – may occur in no more than 1 in 100 people:

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

Frequency not known (cannot be estimated from available data):

• hyperprolactinaemia (increased prolactin levels),
• hypomania,
• aggressive behaviour,
• hostile behaviour,
• thought disorders,
• increased psychomotor activity,
• drug abuse,
• autonomic nervous system disorders (controlling 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 oedema (swelling of ankles, feet or fingers),
• increased intraocular pressure.

Additionally, particularly in patients taking other psychotropic medicines, those with psychiatric disorders or alcohol abuse, a paradoxical reaction may occur, manifesting as anxiety.

Other adverse reactions observed rarely or very rarely include: motor disturbances, seizures, psychotic symptoms, feelings of depersonalization, agranulocytosis (marked decrease in granulocyte count), allergic reactions or anaphylaxis (severe allergic reactions).

Benzodiazepines may cause physical and psychological dependence. If physical dependence develops, abrupt discontinuation of Xanax may lead to withdrawal symptoms: headache, muscle pain, increased anxiety, tension, agitation, disorientation, irritability, altered perception of surroundings or self, hearing impairment, stiffness and tingling of limbs, hypersensitivity to light, noise and touch, hallucinations and seizures, insomnia and mood changes. These symptoms are usually more severe in patients treated long-term with high doses of benzodiazepines and in cases of abrupt or rapid discontinuation of the drug.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Xanax

Keep this medicine out of the sight and reach of children.
Do not store at temperatures above 25°C. Store in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the package. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Xanax contains

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

What Xanax looks like and contents of the pack
Xanax 0.5 mg are pink, elliptical-oval, scored tablets marked with "Upjohn 55" on one side and a score line on the other side of the tablet.
The pack contains 30, 50 or 100 tablets in PVC/Aluminium blisters within a cardboard box.
For further information, please contact the responsible party or the parallel importer.
Marketing Authorisation 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, Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland
Marketing Authorisation Number in Austria, the country of export: 1-18639
Parallel Import Authorisation Number: 287/20