Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Xanax, 0.5 mg, tablets
Alprazolam
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

Keep this leaflet so that you can read it again if necessary.
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. This medicine may harm someone else, even if their symptoms are the same.
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
What you need to know 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 properties).
Xanax is indicated for the treatment of symptoms of anxiety disorders in adults, but only in situations 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 taking Xanax

When not to take 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 suffers from 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 the following with your doctor:

if the medicine is to be used long-term, as dependence may occur, especially in patients with a history of 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 enhanced);
if restlessness, psychomotor agitation, irritability, aggression, hallucinations, anger, nightmares, delusions, psychosis, 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 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 similar-acting substances should be used with caution in elderly patients due to the risk of excessive sedation and/or muscle-skeletal system impairment, which may lead to falls, often with serious consequences for such patients.

Episodes of hypomania and mania have been reported in association with Xanax use 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 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, anaesthetics, and antihistamines.
With narcotic analgesics, euphoria may be intensified, which may increase the risk of psychological dependence.
Alcohol must not be consumed during treatment with Xanax.
Concomitant use of Xanax with certain systemic antifungal agents (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 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, 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-motor performance. Before taking Xanax, patients should be aware of the 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 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 used as directed by the physician. 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. The physician should regularly assess the patient's condition and the need
for continuing treatment, especially if the severity of the patient's symptoms decreases 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 start of treatment, the physician 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, 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 evaluated with the physician.
Recommended dose
The dose is determined by the physician based on symptom severity and the individual patient's response to
treatment. If severe adverse reactions occur after the initial dose,
the physician 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 physician 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 hepatic insufficiency is contraindicated.
Use in elderly patients
The recommended initial dose is 0.25 mg two or three times daily.
If necessary, the physician may decide to gradually increase the dose depending on
tolerance to the medicine. If adverse reactions occur, the physician will decide to reduce the initial dose.
Use of a higher than recommended dose of Xanax
Using a higher than recommended dose of Xanax may cause: ataxia (impaired motor coordination),
drowsiness, speech disturbances, coma, and respiratory depression. If disturbing
symptoms occur, contact a physician 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 the medicine on your own.
Since treatment is symptomatic, symptoms may return after discontinuation.
The physician will decide on gradual dose reduction.
If you have any further questions regarding the use of this medicine, consult your
physician.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any of the adverse effects listed below persist or become troublesome, inform your doctor. The occurrence of some adverse effects depends entirely on individual patient susceptibility and the dose administered. Adverse effects are usually observed at the beginning of therapy. They subside with continued treatment or when the dose is reduced.

Frequency of adverse effects observed in clinical trials and after marketing authorization:

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

depression,
sedation,
drowsiness,
ataxia (impaired 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 (sex drive),
increased libido,
anxiety,
insomnia,
nervousness,
balance disorders,
impaired coordination,
attention disturbances,
excessive sleepiness,
lethargy,
tremor,
blurred vision,
nausea,
skin inflammation,
sexual disturbances,
decreased body weight,
increased body weight.

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

mania,
hallucinations,
anger,
agitation,
dependence,
amnesia,
decreased muscle strength,
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 disturbances,
increased psychomotor activity,
drug abuse,
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, a paradoxical reaction may occur, manifesting as anxiety.

Other adverse effects observed rarely or very rarely include: movement disorders, epilepsy, psychotic symptoms, 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 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 epileptic 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 drug.

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 for Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.

Reporting adverse effects helps to gather further information on the safety of the medicine.

5. How to store the medicine Xanax

Keep the 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. This will help protect the environment.

6. Package contents and other information

What Xanax contains

The active substance is alprazolam. One tablet contains 0.5 mg of alprazolam.
Other components of the medicine are: monohydrate lactose, microcrystalline cellulose, sodium lauryl sulfate (85%) + sodium benzoate (E 211) (15%), colloidal anhydrous silica, magnesium stearate, corn starch, erythrosine, aluminium lake (E 127).

What Xanax looks like and contents of the pack
Xanax 0.5 mg are pink, elliptical-oval, scored tablets marked with the inscription "Upjohn 55" on one side and a division line on the other side of the tablet.
The pack contains 30, 50 or 100 tablets in PVC/Al blisters packed in a cardboard box.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Hungary, country of export:
Upjohn EESV
Rivium Westlaan 142
2909 LD Capelle aan den IJssel
The Netherlands
Manufacturer:
Pfizer Italia S.r.l.
Localitá Marino del Tronto
63100 Ascoli Piceno
Italy
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorisation numbers in Hungary, country of export: OGYI-T-4617/06
OGYI-T-4617/07
Parallel import authorisation number: 269/21