Package leaflet: Information for the patient

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Xanax
0.25 mg, tablets
Alprazolamum
Please read this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet so that you can read it again if necessary.
If you have any doubts, 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 another person, even if their symptoms are the same.
If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.

Table of contents of the leaflet

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 action).
Xanax is indicated for the treatment of symptoms of anxiety disorders in adults, only in situations where symptoms are severe, impair normal functioning, or are very 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 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 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 the following 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 stopped abruptly [withdrawal symptoms may occur (see section 4)];

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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, hypnotics, sedatives, or consuming alcohol (the effects of these medicines or alcohol may be intensified);
if restlessness, psychomotor agitation, irritability, aggression, rage, nightmares, hallucinations, 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 with caution in elderly patients due to the risk of excessive sedation and/or musculoskeletal impairment, which may lead to falls, often with serious consequences for such patients.

Episodes of hypomania and mania have been reported during 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 using Xanax together with opioids, as they have a depressive 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, anesthetics, 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 using Xanax together with nefazodone, fluvoxamine, or 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 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 have a child, she should consult her doctor before using this medicine.
Use of this medicine during pregnancy is not recommended.
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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 using Xanax, patients should familiarize themselves 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 consult their doctor before taking this medicine.
Xanax contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet; therefore, 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 used 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 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 start 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 anxiety symptoms
The recommended initial dose is 0.25 mg or 0.5 mg three times a day.
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.
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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 a day.
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.

Use of a higher than recommended dose of Xanax
Taking a higher than recommended dose of Xanax may cause: ataxia (impaired coordination), drowsiness, speech disorders, 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 Xanax treatment
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 regarding 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 side effects 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 subside with continued therapy 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 in 10 people:

depression,
sedation,
drowsiness,
ataxia (lack of motor coordination),
memory impairment,
speech disorders,
dizziness,
headache,
constipation,
dry mouth,
fatigue,
irritability.

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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,
difficulty concentrating,
excessive need for sleep,
lethargy,
tremor,
blurred vision,
nausea,
skin inflammation,
sexual disorders,
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,
withdrawal syndrome.

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

hyperprolactinemia (increased prolactin levels),
hypomania,
aggressive behaviour,
hostile behaviour,
thinking disorders,
increased psychomotor activity,
drug abuse,
autonomic nervous system disorders (which control the function of internal organs, smooth muscles and glands),
dystonia (abnormal muscle tone),
gastrointestinal disorders,
hepatitis,
liver disorders,
jaundice,
angioedema,
photosensitivity reactions,
urinary retention,
peripheral edema (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, such as anxiety.
Other adverse reactions observed rarely or very rarely include: movement disorders, seizures, psychotic symptoms, depersonalization, agranulocytosis (marked decrease in granulocyte count), allergic reactions or anaphylaxis (severe allergic reactions).
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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, feelings of altered surroundings or self, impaired hearing, 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 adverse reactions not listed in this leaflet, tell your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring 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 reactions helps to provide more information on the safety of the medicine.

5. How to store Xanax

Keep the 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 practice helps protect the environment.

6. Contents of the package and other information

What Xanax contains

The active substance is alprazolam. Each tablet contains 0.25 mg of alprazolam.
Other ingredients are: lactose monohydrate, microcrystalline cellulose, sodium lauryl sulfate (85%) + sodium benzoate (15%), colloidal anhydrous silica, magnesium stearate, maize starch.

What Xanax looks like and contents of the pack
White, elliptical-oval, scored tablets marked with the inscription "Upjohn 29" 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 within a cardboard box.
For further information, please contact the responsible entity or the parallel importer.
Responsible entity in Hungary, country of export:
Viatris Healthcare Limited, Damastown Industrial Park, Mulhuddart, Dublin 15
Dublin, Ireland
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Manufacturer:
Pfizer Italia S.r.l., Località Marino del Tronto, 63100 - Ascoli Piceno (AP), Italy
Mylan Hungary Kft., Mylan utca 1, 2900 Komárom, Hungary
Parallel importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Hungarian marketing authorisation number, country of export: OGYI-T-4617/04
OGYI-T-4617/05
Parallel import authorisation number: 163/25
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