Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Xanax
0.25 mg, tablets
Alprazolamum
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 doubts, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not share it with others. The 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 or pharmacist. See section 4.

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 package 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 highly 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 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 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, sleeping medicines, sedatives, or consuming alcohol (the effects of these medicines or alcohol may be intensified);
if restlessness, psychomotor agitation, irritability, aggression, delusions, anger, nightmares, hallucinations, psychosis, inappropriate behaviour or other behavioural 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) 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 connection 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 currently taken or recently taken, as well as any medicines the patient plans to take.

Extreme caution is required when using Xanax together with opioids, as they act depressively on the respiratory system (slowing and weakening 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 antihistamines.
When used with narcotic analgesics, euphoria may be intensified, potentially increasing psychological dependence.
Alcohol consumption must not be taken during treatment with Xanax.
Concomitant use of Xanax with certain oral 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 simultaneously should be closely monitored for signs (objective and subjective) of digoxin toxicity.
Theophylline may reduce the effects 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 risk to the fetus.
If administration of the medicine is necessary in the late stages of 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 a doctor before taking this medicine.
Xanax contains sodium
The 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 (E 211).

3. How to use Xanax

This medicine should always be used exactly as prescribed by the doctor. If in doubt, consult your
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 lessened 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 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, 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 the 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 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 hepatic insufficiency 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 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
Use of 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 this medicine on your own.
Since treatment is symptomatic, symptoms may return after discontinuation.
The doctor will decide on a gradual dose reduction.
If you have any further doubts regarding the use of this medicine, consult your doctor.

4. Possible adverse effects

Like any medicine, this medicine can cause adverse effects, although not everyone will experience them.
If any of the following adverse effects persist or become 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 tend to subside with continued treatment or when the dose is reduced.

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

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

depression,
sedation,
somnolence,
ataxia (impaired motor coordination),
memory disturbances,
speech disorders,
dizziness,
headache,
constipation,
dry mouth,
fatigue,
irritability.

Common – may affect up to 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 dysfunction,
decreased body weight,
increased body weight.

Uncommon – may affect up to 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):

hyperprolactinaemia (increased prolactin levels),
hypomania,
aggressive behaviour,
hostile behaviour,
thinking disorders,
increased psychomotor activity,
drug misuse,
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 oedema (swelling of ankles, feet or fingers),
increased intraocular pressure.

Additionally, particularly in patients taking other psychotropic medicines, those with psychiatric disorders or those abusing alcohol, a paradoxical reaction may occur, including symptoms such as anxiety.

Other adverse effects observed rarely or very rarely include: movement disorders, seizures, psychotic symptoms, depersonalisation, 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, feelings of tension, agitation, disorientation, irritability, altered perception of surroundings or self, hearing disturbances, 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, inform your doctor or pharmacist. Adverse effects 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 effects helps to provide more information on the safety of the medicine.

5. How to store 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. Contents of the packaging and other information

What Xanax contains

The active substance is alprazolam. One tablet contains 0.25 mg of alprazolam.
Other components of the medicine are: lactose monohydrate, microcrystalline cellulose, sodium docusate (85%) + sodium benzoate (E 211) (15%), colloidal anhydrous silica, magnesium stearate, corn starch.

What Xanax looks like and contents of the pack
Xanax 0.25 mg are white, elliptical-oval, scored tablets marked with the imprint "Upjohn 29" on one side and a dividing 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 responsible party 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
Poland
Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland
Marketing Authorisation Number in Hungary, country of export: OGYI-T-4617/04
OGYI-T-4617/05
Parallel Import Authorisation Number: 268/21