Package leaflet: Information for the patient

WARNING: Keep the leaflet, information on the immediate packaging in a foreign language.
XANAX, 0.25 mg, tablets
Alprazolamum
Please read the entire leaflet carefully before using this medicine, because
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 pass it on to others. It may harm someone else, even if their symptoms are the same.
If the patient experiences any adverse effects, including any adverse effects not listed in this leaflet, inform the doctor or pharmacist immediately. See section 4.

Table of contents of the leaflet

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 action).
Xanax is indicated for the treatment of symptoms of anxiety disorders in adults, only
in cases 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 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 condition 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 reviewed 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, hypnotics, sedatives, or consuming alcohol (the effects of these medicines or alcohol may be intensified);
if restlessness, psychomotor agitation, irritability, aggression, hallucinations, anger, nightmares, illusions, psychoses, inappropriate behaviour or other behavioural disturbances occur. If any of these symptoms appear, treatment with the medicine should be stopped and the patient should contact their doctor;
if the patient has glaucoma;
if the patient has impaired renal or hepatic 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 with caution 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 in association 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 should be exercised when Xanax is used concomitantly with opioids, as they have a depressant effect on the respiratory system (slowing and shallow 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, anaesthetics, and antihistamines.
With narcotic analgesics, euphoria may be intensified, which could lead to increased psychological dependence.
Alcohol must not be consumed during treatment with Xanax.
Concomitant use of Xanax with certain systemic antifungals (e.g. ketoconazole, itraconazole, posaconazole, voriconazole) is not recommended.
Extreme caution should be exercised and dose reduction 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 become pregnant, 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 the last stages of pregnancy, high doses should be avoided and the newborn should be monitored.
Benzodiazepines pass into human milk in small concentrations. Xanax should not be used during breastfeeding.
Driving and operating machinery
Xanax may impair psycho-motor performance. Before using 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 contact their doctor before taking this medicine.
Xanax contains sodium benzoate (E211)
The medicine contains 0.11 mg of sodium benzoate per tablet.
Xanax contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take 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, 2 mg.
Treatment should be as short 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 may develop, as well as
emotional or physical dependence. 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 according to 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 states
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 impaired kidney or liver function
Use in patients with severe liver impairment 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 tolerance to the medicine. If adverse reactions occur, the doctor will decide to
reduce the initial dose.
Taking a higher than recommended dose of Xanax
Taking a higher than recommended dose of Xanax may cause: ataxia
(impaired coordination of movement), drowsiness, speech disturbances, coma, and respiratory depression. If
disturbing 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 discontinuation.
Your doctor will decide on gradually reducing the dose.
If you have any further doubts about using this medicine, consult your doctor.

4. Possible adverse reactions

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

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

Common – may occur in no more than 1 out of 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 out of 100 people:

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

Frequency unknown (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 dysfunction (controls internal organs, smooth muscles and glands),
dystonia (abnormal muscle tone),
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 those who misuse alcohol, a paradoxical reaction may occur, manifesting as anxiety.
Other adverse reactions have been observed rarely or very rarely: 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 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 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 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 allows the collection of additional information on the safety of medicine use.

5. How to store Xanax

Keep this medicine out of 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 in use.
This will help protect the environment.

6. Contents of the pack and other information

What Xanax contains

The active substance is alprazolam. The other ingredients are: monohydrate lactose, microcrystalline cellulose, sodium docusate (85%) + sodium benzoate (15%), colloidal anhydrous silica, magnesium stearate, corn starch.

What Xanax looks like and contents of the pack
Xanax 0.25 mg: white, elliptical-oval, scored tablets marked with the inscription "Upjohn
29" on one side and a score line on the other side of the tablet.
Pack contains 30 tablets in PVC/PVDC-Aluminum blisters, packed in a cardboard
box.
For more detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder in Greece, country of export:
Upjohn Hellas Ltd, Mesogion Ave 253-255, 154 51 Neo Psychiko, Athens, Greece
Manufacturer:
Pfizer Italia S.r.l., Localita Marino del Tronto, 63100 - Ascoli Piceno (AP), Italy
Parallel Importer:
PharmaVitae Sp. z o.o. sp. k., ul. E. Orzeszkowej 3/35, 59-820 Leśna
Repackaged in:
Synoptis Industrial Sp. z o.o., ul. Szosa Bydgoska 58, 87-100 Toruń
Prodlekpol Sp. z o.o., ul. Chełmżyńska 249, 04-458 Warszawa
Pharma Innovations Sp. z o.o., ul. Jagiellońska 76, 03-301 Warszawa
Natur Produkt Zdrovit Sp. z o.o., ul. Nocznickiego 31, 01-918 Warszawa
Prespack Jacek Karoński, ul. Św. Wawrzyńca 34, 60-541 Poznań
CEFEA Sp. z o.o. Sp. komandytowa, ul. Działkowa 56, 02-234 Warszawa
Marketing Authorisation Number in Greece, country of export: 23875/26-06-1995
Parallel Import Licence Number: 227/18