Package leaflet: Information for the patient

WARNING: Keep the leaflet; information on the immediate packaging in a foreign language.
Xanax, 1 mg, tablets
Alprazolamum
Please read the entire leaflet carefully before using the medicine, because
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 pass it on to others. The medicine may harm another person, even if their symptoms are the same.
If you experience any adverse effects, 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 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 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 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 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, rage, nightmares, hallucinations, delusions, 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 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) 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 connection 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 currently taken or 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 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.
In the case of narcotic analgesics, euphoria may be intensified, which may lead to increased psychological dependence.
Alcohol must not be consumed 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 concomitantly with fluoxetine, propoxyphene, oral contraceptives, sertraline, diltiazem, and macrolide antibiotics (e.g. erythromycin, clarithromycin, or troleandomycin).
Concomitant use of Xanax with HIV protease inhibitors (e.g. ritonavir) requires dose adjustment or discontinuation of alprazolam.
Patients taking alprazolam and digoxin simultaneously should be closely monitored for objective and subjective signs 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 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 risk to the fetus.
If administration of the medicine is necessary during the late stages of pregnancy, high doses should be avoided and the newborn should be monitored.
Benzodiazepines pass into human milk in low 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 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 benzoate (E 211)
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 use Xanax

This medicine should always be used exactly as your doctor has told you. 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. Your doctor should regularly assess your condition
and the need for continuing treatment, particularly 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.
When using 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 according to the severity of symptoms and the
individual patient's response to treatment. If severe adverse effects 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.
Your 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 must 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 effects 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 (impaired
coordination), drowsiness, speech disorders, coma, and respiratory depression. If
worrying 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
Do not stop taking this medicine without consulting your doctor.
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 reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone experiences 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 with continued treatment 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 muscle coordination),
memory impairment,
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,
impaired balance,
incoordination,
attention disturbances,
excessive sleepiness,
lethargy,
tremor,
blurred vision,
nausea,
skin inflammation,
sexual disturbances,
weight decrease,
weight increase.

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

mania,
hallucinations,
anger,
agitation,
dependence,
amnesia,
muscle weakness,
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 disturbances,
increased psychomotor activity,
drug abuse,
autonomic nervous system disorders (which control 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 those abusing alcohol, a paradoxical reaction may occur, manifesting as anxiety.
Other adverse reactions observed rarely or very rarely include: motor disturbances, 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, 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 not listed in this leaflet, inform your doctor or pharmacist. 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 allows the collection of further information on the safety of the medicine.

5. How to store the medicine 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 you no longer use. This will help protect the environment.

6. Contents of the package and other information

What Xanax contains

The active substance is alprazolam. Each tablet contains 1 mg of alprazolam. The other ingredients are: monohydrate lactose, microcrystalline cellulose, sodium lauryl sulfate (85%) + sodium benzoate (15%), colloidal anhydrous silica, magnesium stearate, corn starch, aluminum lake F.D. and C. Blue No. 2, sodium-aluminum lake with erythrosine.

What Xanax looks like and contents of the pack
Xanax 1 mg: lavender-colored, elliptical-oval, scored tablets marked with
"Upjohn 90" on one side and a score line on the other side of the tablet.
The pack contains 30 tablets in PVC/PVDC-Aluminum blisters packed in a cardboard box.
For more detailed information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in Greece, the country of export:
UPJOHN HELLAS Ltd, Messoghion 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:
LABOR Pharmaceutical and Chemical Company Sp. z o.o., ul. Długosza 49, 51-162 Wrocław
IVA Pharm Sp. z o.o., ul. Drawska 14/1, 02-202 Warsaw
Medezin Sp. z o.o., ul. Zbąszyńska 3, 91-342 Łódź
CANPOLAND JOINT STOCK COMPANY, ul. Beskidzka 190, 91-610 Łódź
CEFEA Sp. z o.o. Sp. komandytowa, ul. Działkowa 56, 02-234 Warsaw
Pharma Innovations Sp. z o.o., ul. Jagiellońska 76, 03-301 Warsaw
Marketing Authorisation Number in Greece, the country of export: 23877/26-06-1995
Parallel Import Authorisation Number: 398/17