Xanax

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Xanax (Trankimazin), 2 mg, tablets

Alprazolam
Xanax and Trankimazin are different trade names for the same drug.

You should carefully read the contents of the leaflet before using the drug, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This drug has been prescribed to a specific person. It should not be given to others. The drug 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 tell their doctor or pharmacist. 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 drugs called benzodiazepines (drugs with anxiolytic activity). 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 drug is intended for short-term use only.

2. Important information before taking Xanax

When not to take Xanax:

Xanax should not be taken by children and adolescents under 18 years of age.

Warnings and precautions

Before starting Xanax, you should discuss it with your doctor:

Before planned surgery, you should inform your doctor about taking Xanax.

Xanax and other drugs

You should tell your doctor about all the drugs you are currently taking or have recently taken, as well as any drugs you plan to take.

• Particular caution should be exercised when taking Xanax with opioids, as they have a depressant effect on the respiratory system (slow down and shallow breathing). This is associated with a 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 drugs.
• 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 Xanax treatment.
• Xanax should not be taken with certain oral antifungal drugs (e.g., ketoconazole, itraconazole, posaconazole, voriconazole).
• Particular caution should be exercised and the dose should be considered for reduction when taking Xanax and nefazodone, fluvoxamine, and cimetidine.
• Particular caution should be exercised when taking alprazolam with fluoxetine, propoxyphene, oral contraceptives, sertraline, diltiazem, and macrolide antibiotics (e.g., erythromycin, clarithromycin, or troleandomycin).
• The 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, suspects she may be pregnant, or plans to have a child, she should consult a doctor before taking this drug. The use of Xanax during pregnancy is not recommended. If the drug is used during pregnancy or if the patient becomes pregnant while taking alprazolam, she should be examined for potential fetal risk. If it is necessary to administer the drug in the last period of pregnancy, high doses should be avoided and the newborn should be monitored. Benzodiazepines pass into breast milk in small amounts. Xanax should not be taken during breastfeeding.

Driving and operating machinery

Xanax causes impairment of psychophysical fitness. Before taking Xanax, you should familiarize yourself with current local traffic laws. While taking Xanax, you should not drive vehicles or operate machinery.

Xanax contains lactose monohydrate

If the patient has previously been diagnosed with intolerance to some sugars, the patient should contact their doctor before taking the drug.

Xanax contains sodium

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

Xanax contains sodium benzoate (E 211)

Each tablet of this drug contains 0.23 mg of sodium benzoate.

3. How to take Xanax

This drug should always be taken as directed by the doctor. In case of doubts, you should consult a 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. 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. At the start of treatment, the doctor will inform about the limited duration of therapy, gradual dose reduction during withdrawal, 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 dose and treatment duration, 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 taken by children and adolescents under 18 years of age.

Use in patients with kidney or liver function disorders

The use of Xanax in patients with severe liver failure 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 the patient's tolerance to the drug. 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 (clumsiness), drowsiness, speech disorders, coma, and respiratory depression. If worrying symptoms occur, you should immediately contact a doctor.

Missing a dose of Xanax

You should not take a double dose to make up for a missed dose.

Stopping Xanax treatment

You should not stop taking Xanax on your own. Since the treatment is symptomatic, after its cessation, the symptoms of the disease may return. The doctor will decide to gradually reduce the dose. If you have any further doubts about taking this drug, you should consult a doctor. If necessary, these tablets can be divided into halves or quarters. To do this, place the tablet on a hard surface with the indentation facing down. By pressing it with your thumb, you can break the tablet into two equal parts containing 1 mg of alprazolam.

If necessary, each resulting part (half) can be further divided. To do this, place them on a hard surface with the indentation facing down and press again with your thumb. In this way, two quarters containing 0.5 mg of alprazolam are obtained from each half.

In this way, the following parts of Xanax tablets are obtained:

4. Possible side effects

Like all drugs, Xanax can cause side effects, although they do not occur in everyone. If any of the following side effects persist or are troublesome, you should inform your doctor. The occurrence of some side effects depends entirely on the individual patient's susceptibility and the dose of the drug. Side effects are usually observed at the beginning of therapy. They disappear as treatment continues or when the dose is reduced. The frequency of side effects observed in clinical trials and after the drug was introduced to the market:

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

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

Common - may occur in up to 1 in 10 people:

• decreased appetite,
• confusion,
• disorientation,
• decreased libido (sex drive),
• increased libido,
• anxiety,
• insomnia,
• nervousness,
• balance disorders,
• coordination disorders,
• concentration disorders,
• excessive need for sleep,
• lethargy,
• tremors,
• blurred vision,
• nausea,
• skin rash,
• sexual disorders,
• weight loss,
• weight gain.

Uncommon - may occur in up to 1 in 100 people:

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

Frequency not known (cannot be estimated from 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 drugs, 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 changed self, 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 cessation of Xanax may cause withdrawal symptoms: headache, muscle pain, increased anxiety, feeling of tension, agitation, disorientation, irritability, feeling of changed environment or self, impaired hearing, stiffness, and tingling of limbs, hypersensitivity to light, noise, and touch, hallucinations, and seizures. 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 withdrawal of the drug.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. 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, you can help gather more information on the safety of the drug.

5. How to store Xanax

The drug should be stored out of sight and reach of children. Store at a temperature below 25°C. Store in normal humidity conditions. Do not use this drug after the expiration date stated on the packaging. The expiration date indicates the last day of the given month. Medicines should not be disposed of via wastewater or household waste containers. You should ask your pharmacist how to dispose of unused medicines. 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 2 mg of alprazolam.
• The other ingredients of the drug are: lactose monohydrate, microcrystalline cellulose, sodium docuzate (85%) + sodium benzoate (15%), colloidal silica, magnesium stearate, cornstarch.

What Xanax looks like and what the package contains

White, elongated tablets divisible with the inscription "U 94" on one side and a triple dividing line on both sides of the tablet. The package contains 30 tablets in an HDPE bottle with a child-resistant cap made of PP with an inner MDPE coating in a cardboard box. For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Spain, the country of export:

Viatris Healthcare, S.L. Calle General Aranaz, 86, 3ª planta, 28027 Madrid, Spain

Manufacturer:

Pfizer Italia S.r.l. Localitá Marino del Tronto, 63100 Ascoli Piceno (AP), Italy

Parallel importer:

InPharm Sp. z o.o. ul. Strumykowa 28/11, 03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k. ul. Chełmżyńska 249, 04-458 Warsaw Spanish marketing authorization number, country of export: 705067.4

Parallel import authorization number: 170/22 Date of leaflet approval: 13.04.2022

[Information about the trademark]