Xanax

Package Leaflet: Information for the Patient

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

XANAX

0.5 mg, tablets

Alprazolam

The leaflet should be read carefully before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed for a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is Xanax and what is it used for
• 2. Important information before taking Xanax
• 3. How to take Xanax
• 4. Possible side effects
• 5. How to store Xanax
• 6. Package contents and other information

1. What is Xanax and what is it used for

The active substance of Xanax is alprazolam. It belongs to a group of medicines called benzodiazepines (anxiolytic medicines). Xanax is indicated for the treatment of symptoms of anxiety disorders in adults, only in situations where the symptoms are severe, prevent normal functioning, or are very troublesome for 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 any of the other ingredients of this medicine (listed in section 6);
• if the patient has myasthenia gravis (a disease characterized by excessive fatigue and muscle weakness);
• if the patient has severe respiratory failure;
• if the patient has sleep apnea syndrome;
• if the patient has severe liver failure. Xanax should not be used in children and adolescents under 18 years of age.

Warnings and precautions

Before starting treatment with Xanax, the patient should discuss it with their doctor

• if the medicine is used for a long time, as dependence on the medicine may occur, especially in patients prone to drug or alcohol abuse. The need for continued treatment should be periodically assessed by the doctor;
• if the dose of the medicine is reduced or it is suddenly stopped [possible occurrence of withdrawal symptoms (see section 4)];
• if the medicine is used in patients with depression, with suicidal thoughts or tendencies;
• if the patient is taking other benzodiazepines (increased risk of dependence);
• if the patient is taking opioids, sleeping pills, sedatives, or drinking alcohol (the effect of these medicines or alcohol may be enhanced);
• if restlessness, psychomotor agitation, irritability, aggression, delusions, anger, nightmares, hallucinations, psychosis, or other behavioral disorders occur. In case of the occurrence of these symptoms, the use of the medicine should be discontinued and the doctor should be consulted;
• if the patient has glaucoma;
• if the patient has kidney or liver function disorders. Like other benzodiazepines, Xanax may cause anterograde amnesia, which occurs a few hours after taking the medicine. In such a case, the patient should have uninterrupted sleep for 7-8 hours. Benzodiazepines and similarly acting substances should be used with caution in elderly patients, due to the risk of excessive sedation and (or) muscle weakness, which may lead to falls, often with serious consequences for such a patient.

Episodes of hypomania and mania have been reported in association with the use of Xanax in patients with depression. Before planned surgery, the doctor should be informed about the use of Xanax.

Xanax and other medicines

The patient should tell their doctor about all medicines they are taking, have recently taken, or plan to take.

• Special caution should be exercised when using Xanax with opioids, as they have a depressive effect on the respiratory system (slow down and shallow breathing). This is associated with the risk of excessive sedation, respiratory depression, coma, and even death.
• Xanax may enhance the effect of antipsychotic, sedative, anxiolytic, antidepressant, narcotic analgesic, anticonvulsant, anesthetic, and antihistamine medicines.
• In the case of narcotic analgesics, there may be an increase in euphoria, which can lead to an increase in psychological dependence.
• Alcohol should not be consumed during the use of Xanax.
• It is not recommended to take Xanax with certain oral antifungal medicines (e.g., ketoconazole, itraconazole, posaconazole, voriconazole).
• Special caution should be exercised and the dose should be considered for reduction during concomitant use of Xanax and nefazodone, fluvoxamine, and cimetidine.
• Special caution should be exercised when using alprazolam 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 modification or discontinuation of alprazolam.
• Patients taking alprazolam and digoxin should be closely monitored for signs of digoxin toxicity (objective and subjective).
• Theophylline may decrease the effect of benzodiazepines.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine. The use of Xanax is not recommended during pregnancy. If the medicine is used during pregnancy or if the patient becomes pregnant while taking alprazolam, they should be examined for potential fetal risk. If it is necessary to administer the medicine in the last trimester of pregnancy, high doses should be avoided and the newborn should be monitored. Benzodiazepines pass into human milk in small amounts. Xanax should not be used during breastfeeding.

Driving and using machines

Xanax causes impairment of psychophysical fitness. Before taking Xanax, the patient should familiarize themselves with the current local traffic laws. While taking Xanax, the patient should not drive vehicles or operate machines.

Xanax contains lactose monohydrate

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

Xanax contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

Xanax contains sodium benzoate

Each tablet of this medicine contains 0.11 mg of sodium benzoate.

3. How to take Xanax

This medicine should always be taken according to the doctor's instructions. In case of doubts, the doctor or pharmacist should be consulted. 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 doctor should frequently assess the patient's condition and the need to extend treatment, especially if the severity of the symptoms decreases and may not require pharmacological treatment. The total treatment time should not exceed 2-4 weeks. Long-term treatment is not recommended. When starting treatment, the doctor will inform about the limited duration of therapy, the gradual reduction of the dose during withdrawal of the medicine, and the possibility of withdrawal reactions. During the use of benzodiazepines, including Xanax, dependence and emotional or physical dependence may develop. This risk may increase with the dose and duration of treatment, so the smallest effective dose should be used for the shortest possible time, and the need for continued treatment should be frequently assessed with the 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 side effects occur after administration of the initial dose, the doctor may decide to reduce the dose. Symptomatic treatment of anxiety disorders The recommended initial dose is 0.25 mg or 0.5 mg three times a day. The doctor may decide to increase it, depending on the patient's needs, 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 kidney or liver function disorders

The use of Xanax is contraindicated in patients with severe liver failure.

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 the patient's tolerance to the medicine. If side effects 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 (motor incoordination), drowsiness, speech disorders, coma, and respiratory depression. If worrying symptoms occur, the doctor should be contacted immediately.

Missing a dose of Xanax

A double dose should not be taken to make up for a missed dose.

Stopping the use of Xanax

The use of Xanax should not be stopped without consulting a doctor. Since the treatment is symptomatic, after its discontinuation, the symptoms of the disease may return. The doctor will decide to gradually reduce the dose. In case of any further doubts related to the use of this medicine, the doctor should be consulted.

4. Possible side effects

Like all medicines, Xanax can cause side effects, although not everybody gets them. If any of the following side effects persist or are troublesome, the doctor should be informed. The occurrence of some side effects depends entirely on the individual patient's susceptibility and the dose of the medicine. Side effects are usually observed at the beginning of therapy. They disappear as treatment continues or when the dose is reduced. Frequency of side effects observed in clinical trials and after the marketing authorization of the medicine:

Very common - may occur more often than 1 in 10 people:

• depression,
• sedation,
• drowsiness,
• ataxia (motor incoordination),
• memory disorders,
• speech disorders,
• dizziness,
• headache,
• constipation,
• dry mouth,
• fatigue,
• irritability.

Common - may occur less often than 1 in 10 people:

• decreased appetite,
• confusional state,
• disorientation,
• decreased libido (sexual desire),
• increased libido,
• anxiety,
• insomnia,
• nervousness,
• balance disorders,
• abnormal coordination,
• concentration disorders,
• excessive need for sleep,
• lethargy,
• tremor,
• blurred vision,
• nausea,
• skin rash,
• sexual disorders,
• weight loss,
• weight gain.

Uncommon - may occur less often than 1 in 100 people:

• mania,
• hallucinations,
• anger,
• agitation,
• dependence,
• amnesia,
• muscle weakness,
• urinary incontinence,
• irregular menstrual cycles,
• withdrawal syndrome.

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

• hyperprolactinemia (elevated prolactin levels),
• hypomania,
• aggressive behavior,
• hostile behavior,
• thought disorders,
• increased psychomotor activity,
• drug abuse,
• autonomic nervous system disorders (which controls 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 edema (swelling of the ankles, feet, or toes),
• increased intraocular pressure.

Additionally, especially in patients taking other psychotropic medicines, with mental disorders, or abusing alcohol, a paradoxical reaction may occur with symptoms such as anxiety. Other side effects have been observed rarely or very rarely: motor disorders, epilepsy, psychotic symptoms, a feeling of change in one's own person, agranulocytosis (a significant decrease in the number of granulocytes), allergic reactions, or anaphylaxis (severe allergic reactions). Benzodiazepines may cause physical and psychological dependence. If physical dependence occurs, sudden discontinuation of Xanax may cause withdrawal symptoms: headache, muscle pain, increased anxiety, feeling of tension, agitation, disorientation, irritability, feeling of change in the environment or one's own person, impaired hearing, stiffness, and paresthesia of the limbs, hypersensitivity to light, noise, and touch, hallucinations, and epileptic seizures, insomnia, and mood changes. These symptoms are usually more severe in patients treated for a long time, with high doses of benzodiazepines, and in the case of sudden or rapid discontinuation of the medicine.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the doctor, pharmacist, or nurse should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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 By reporting side effects, more information can be collected on the safety of the use of the medicine.

5. How to store Xanax

The medicine should be stored in a place invisible and inaccessible to children. It should not be stored at a temperature above 25°C. The medicine should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month. Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer used. This will help protect the environment.

6. Package contents and other information

What Xanax contains

• The active substance of Xanax is alprazolam. One tablet contains 0.5 mg of alprazolam.
• The other ingredients of the medicine are: lactose monohydrate, microcrystalline cellulose, cornstarch, colloidal silicon dioxide, magnesium stearate, sodium lauryl sulfate (85%) + sodium benzoate (15%), aluminum lake FD&C Yellow No. 6.

What Xanax looks like and what the package contains

Xanax 0.5 mg: orange, elliptical-oval tablets, scored, marked with "Upjohn 55" on one side and a score line on the other side of the tablet. The package contains 30, 50, or 100 tablets in PVC/PVDC-Al blisters in a cardboard box. For more detailed information, the marketing authorization holder or parallel importer should be contacted.

Marketing authorization holder in Greece, the country of export:

Upjohn Hellas LTD Mesogeion 253-255 154 51 Neo Psichiko Greece

Manufacturer:

Pfizer Italia S.r.l. 63100 Localita Marino del Tronto Ascoli Piceno, Italy

Parallel importer:

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

Repackaged by:

Polfarmex S.A. ul. Józefów 9 99-300 Kutno Delfarma Sp. z o.o. ul. Św. Teresy od Dzieciątka Jezus 111 91-222 Łódź Marketing authorization number in Greece, the country of export: 23876/26-06-1995

Parallel import authorization number: 133/09

Date of leaflet approval: 12.07.2024

[Information about the trademark]