PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet; the information on the immediate packaging is in a foreign language!
Xanax
0.25 mg, tablets
Alprazolamum
Please read the following leaflet carefully before using this medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm others, even if their symptoms are similar.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

What Xanax is and what it is used for
Important information before taking Xanax
How to take Xanax
Possible side effects
How to store Xanax
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 activity).
Xanax is indicated for the treatment of symptoms of anxiety disorders in adults, exclusively in situations where symptoms are severe, impair normal functioning, or are extremely distressing to 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 or 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 hepatic insufficiency.

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 concurrently taking opioids, sleeping medicines, sedatives, or consuming alcohol (the effects of these medicines or alcohol may be intensified);
if restlessness, psychomotor agitation, irritability, aggression, hallucinations, anger, nightmares, delusions, psychosis, inappropriate behavior, or other behavioral disturbances occur. If any of these symptoms appear, treatment 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 cases, the patient should ensure uninterrupted sleep for 7–8 hours. Benzodiazepines and similar-acting substances should be used cautiously in elderly patients due to the risk of excessive sedation and (or) weakening of the musculoskeletal system, which may lead to falls, often with serious consequences for such patients.

Episodes of hypomania and mania have been reported with the use of Xanax in patients with depression.
Before a planned surgery, inform the doctor about taking Xanax.
Xanax and 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 Xanax is used concomitantly with opioids, as they have a depressive effect on the respiratory system (slowing and shallowing of breathing). This is associated with the risk of excessive sedation, respiratory depression, coma, and even death.
Xanax may enhance the effects of antipsychotics, hypnotics, anxiolytics, sedatives, antidepressants, narcotic analgesics, anticonvulsants, anesthetics, and antihistamines.
With narcotic analgesics, euphoria may be intensified, potentially increasing psychological dependence.
Alcohol must not be consumed during treatment with Xanax.
Concomitant use of Xanax with certain systemic antifungal medicines (e.g. ketoconazole, itraconazole, posaconazole, voriconazole) is not recommended.
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 alprazolam is used 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 concurrently 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, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor before taking 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 in 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-physical performance. Before taking Xanax, patients should familiarize themselves with current local traffic regulations.
Patients should not drive vehicles 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 consult their doctor before taking this medicine.
Xanax contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".
Xanax contains sodium benzoate (E 211)
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 prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
Xanax is available in the following doses: 0.25 mg, 0.5 mg, 1 mg, and 2 mg.
Treatment should last as short a time as possible. Your doctor should regularly assess your condition and the need for continuing treatment, especially if your 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, your doctor will inform you 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, dependence and emotional or physical 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 your 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 symptomatic anxiety conditions
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
The use of Xanax is contraindicated in patients with severe hepatic impairment.

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 to the medicine. 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 (loss of coordination), drowsiness, speech disorders, coma, and respiratory depression. If any alarming symptoms occur, contact your doctor immediately.

Missed 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.
Since treatment is symptomatic, symptoms may return after stopping the medicine.
Your doctor will decide on a gradual reduction of the dose.

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

4. Possible adverse effects

Like any medicine, this medicine may cause adverse effects, although not everyone experiences them.
If any of the following adverse effects persist or are troublesome, inform your doctor. The occurrence of certain adverse effects depends entirely on individual patient susceptibility and the dose administered. Adverse effects are usually observed at the beginning of therapy. They subside as treatment continues or when the dose is reduced.
Frequency of adverse effects observed in clinical trials and after marketing of the medicine:
Very common – may occur in more than 1 in 10 people:

depression,
sedation,
somnolence,
ataxia (lack of voluntary muscle 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,
impaired coordination,
attention disturbances,
excessive need for sleep,
lethargy,
tremor,
blurred vision,
nausea,
skin inflammation,
sexual dysfunction,
decreased body weight,
increased body weight.

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

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

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

hyperprolactinaemia (increased prolactin levels),
hypomania,
aggressive behaviour,
hostile behaviour,
thinking disorders,
increased psychomotor activity,
drug misuse,
autonomic nervous system disorders (which regulate 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 abusers, paradoxical reactions such as anxiety may occur.
Other adverse effects observed rarely or very rarely include: motor disturbances, seizures, psychotic symptoms, depersonalization, agranulocytosis (severe reduction 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 cause withdrawal symptoms: headache, muscle pain, increased anxiety, feelings of 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 pronounced in patients treated long-term with high doses of benzodiazepines and in cases of abrupt or rapid discontinuation of the medicine.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions 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 adverse effects 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 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Xanax contains

The active substance is alprazolam. Each tablet contains 0.25 mg of alprazolam.
The other ingredients are: monohydrate lactose, microcrystalline cellulose, anhydrous colloidal silicon dioxide, sodium docusate (85%) + sodium benzoate (E 211) (15%), corn starch, magnesium stearate.

What Xanax looks like and contents of the pack
Xanax 0.25 mg tablets: white, oval tablets with a break line. The score is for decorative purposes only and does not facilitate breaking the tablet into two equal doses.
The pack contains 30, 50 or 100 tablets in PVC/PVDC-Aluminium blisters packed in a cardboard box.
For further information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder in Greece, the country of export:
VIATRIS HELLAS LTD
Messogeion Ave 253-255
154 51 Neo Psychiko
Athens, Greece
Manufacturer:
Pfizer Italia S.r.l.
Localita Marino del Tronto
63100 – Ascoli Piceno (AP)
Italy
Pfizer Ireland Pharmaceuticals
Little Connell, Newbridge
County Kildare
Ireland
Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing Authorisation number in Greece, the country of export: 23875/26-06-1995
Parallel Import Licence number: 347/18