Package leaflet: Information for the patient

Warning! Keep the leaflet. Information on the immediate packaging is in a foreign language.
XANAX
0.25 mg, tablets
Alprazolamum
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any questions, 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 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, pharmacist, or nurse. 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, but only in situations
where symptoms are severe, interfere with normal functioning, or cause significant distress 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 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, hypnotics, sedatives, or consuming alcohol (the effects of these medicines or alcohol may be enhanced);
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 with the medicine should be discontinued and the patient should contact their doctor;
if the patient has glaucoma;
if the patient has impaired renal 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 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 depressant 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.
It is not recommended to take Xanax simultaneously with certain systemic antifungal medicines (e.g. ketoconazole, itraconazole, posaconazole, voriconazole).
Extreme caution is required and dose reduction should be considered when using Xanax together 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).
Concurrent 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 have a child, 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 should not be used during breastfeeding.
Driving and operating machinery
Xanax affects psychomotor performance.
Before using Xanax, become familiar with current local regulations regarding road traffic laws.
During treatment with Xanax, do not drive vehicles or operate machinery.
Xanax contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking the 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
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, 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 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 your doctor based on the severity of symptoms and your individual response to treatment. If severe adverse effects occur after the initial dose, your 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 your 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 liver dysfunction is contraindicated.
Use in elderly patients
The recommended initial dose is 0.25 mg two or three times daily.
If necessary, your doctor may decide to gradually increase the dose depending on tolerance to the medicine. If adverse effects occur, your 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 of movement), drowsiness, speech disturbances, coma, and respiratory depression. If concerning symptoms occur, contact your doctor immediately.
Missed dose of Xanax
Do not take a double dose to make up for a missed dose.
Discontinuing Xanax
Do not stop taking Xanax on your own.
Since treatment is symptomatic, symptoms may return after stopping the medicine.
Your 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 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 treatment. They 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 (lack of voluntary muscle 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 need for sleep,
lethargy,
tremor,
blurred vision,
nausea,
skin inflammation,
sexual disturbances,
decreased body weight,
increased body weight.

Uncommon – may affect up to 1 in 100 people:

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

Frequency not known (cannot be estimated from the 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 (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, paradoxical reactions may occur, such as anxiety.
Other adverse effects observed rarely or very rarely include: motor disturbances, epilepsy, psychotic symptoms, depersonalisation, 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, feelings of tension, agitation, disorientation, irritability, altered perception of surroundings or of 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 medicine.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects 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 effects allows the collection of further information on the safety of the medicine.

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 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, microcrystalline cellulose, corn starch, colloidal anhydrous silica, magnesium stearate, sodium docusate, sodium benzoate.

What Xanax looks like and contents of the pack
Xanax 0.25 mg: white, elliptical-oval, scored tablets marked with "Upjohn 29" on one side and a division line on the other side of the tablet.
Packaging contains 30 tablets in PVC/Aluminum blisters in a cardboard box.
For more detailed information, please contact the responsible entity or parallel importer.

Responsible entity in Portugal, country of export:
Upjohn EESV
Rivium Westlaan 142
2909 LD Capelle aan den IJssel
The Netherlands

Manufacturer:
Pfizer Italia S.r.l.
Località Marino del Tronto
63100 Ascoli Piceno
Italy

Parallel importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

Marketing Authorization number in Portugal, country of export: 9573345
Parallel import authorization number: 24/24