Xanax

Package leaflet: Information for the patient

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Xanax (Trankimazin)
2 mg, tablets
Alprazolamum
Xanax and Trankimazin are different trade names for the same medicine.
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, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor, pharmacist or nurse. See section 4.

Table of contents of the leaflet

1. What Xanax is and what it is used for
2. Important information before taking Xanax
3. How to take Xanax
4. Possible side effects
5. How to store Xanax
6. 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 effects).
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 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 liver impairment. Xanax must not be used in children and adolescents under 18 years of age.

Warnings and precautions
Before starting treatment with Xanax, discuss this 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 the medicine 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 concurrently taking opioids, hypnotics, sedatives, or consuming alcohol (the effects of these medicines or alcohol may be enhanced);
• if restlessness, psychomotor agitation, irritability, aggression, hallucinations, anger, nightmares, illusions, psychosis, inappropriate behavior, or other behavioral 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 transient memory impairment, 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 weakness, which may lead to falls, often with serious consequences for such patients.

Episodes of hypomania and mania have been reported in association 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 using Xanax together with opioids, as they have a depressant effect on the respiratory system (slowing and shallow 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, anesthetics, and antihistamines.
• In the case of narcotic analgesics, euphoria may be intensified, potentially increasing psychological dependence.
• Alcohol must not be consumed during treatment with Xanax.
• Concomitant use of Xanax with certain systemic antifungal agents (e.g. ketoconazole, itraconazole, posaconazole, voriconazole) is not recommended.
• Extreme caution is required and dose reduction should be considered when using Xanax together with nefazodone, fluvoxamine, or 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).
• 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 effect of benzodiazepines.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans 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 fetal risk.
If administration of the medicine is necessary in late 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 may impair psycho-motor performance. Before using Xanax, patients should become familiar with current local traffic regulations.
Patients should not drive vehicles 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
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

Xanax contains sodium benzoate (15%)
Each tablet of this medicine contains 0.23 mg of sodium benzoate (15%).

3. How to take Xanax

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
Xanax is available in the following strengths: 0.25 mg, 0.5 mg, 1 mg, and 2 mg.
Treatment should last as short a time 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 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 experiencing withdrawal symptoms.

During treatment with benzodiazepines, including Xanax, physical and emotional dependence may develop. The risk increases with dose and duration of treatment. Therefore, the lowest effective dose should be used for the shortest possible time, and the need for continued treatment should be regularly reviewed with your 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 adverse effects occur after the initial dose, the doctor may decide to reduce the dose.

Treatment of anxiety symptoms

The recommended starting 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 must not be used in children and adolescents under 18 years of age.

Use in patients with impaired kidney or liver function
Xanax is contraindicated in patients with severe hepatic impairment.

Use in elderly patients
The recommended starting 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. If adverse effects occur, the doctor may decide to reduce the starting dose.

Taking more than the recommended dose of Xanax
Taking more than the recommended dose of Xanax may cause ataxia (loss of coordination), drowsiness, speech disorders, coma, and respiratory depression. If any alarming 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 treatment
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 reduction of the dose.

If you have any further questions about the use of this medicine, consult your doctor.

Instructions for use of Xanax 2 mg tablets

If necessary, these tablets can be divided into halves or quarters.
To do this, place the tablet on a hard surface with the scored side facing down. Press down with your thumb to break the tablet into two equal parts, each containing 1 mg of alprazolam.

If needed, each half can be further divided. To do so, place the half on a hard surface with the scored side down and press down again with your thumb. This will divide each half into two quarters, each containing 0.5 mg of alprazolam.

In this way, the following tablet portions of Xanax can be obtained:

The resulting halves and/or quarters of tablets may be stored in a bottle.

4. Possible adverse effects

Like any medicine, this medicine can cause adverse effects, although not everyone experiences them.
If any of the adverse effects listed below 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 subside with continued treatment or when the dose is reduced.
Frequency of adverse effects observed in clinical trials and after marketing authorization:
Very common – may occur in more than 1 in 10 people:

• depression,
• sedation,
• somnolence,
• ataxia (lack of voluntary coordination of muscle movements),
• 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,
• loss of balance,
• incoordination,
• attention disturbances,
• excessive need for sleep,
• lethargy,
• tremor,
• blurred vision,
• nausea,
• skin inflammation,
• sexual dysfunction,
• decreased body weight,
• increased body weight.

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 unknown (cannot be estimated from available data):

• hyperprolactinaemia (increased prolactin levels),
• hypomania,
• aggressive behaviour,
• hostile behaviour,
• thought 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 who misuse alcohol, a paradoxical reaction may occur, manifesting as anxiety.
Other adverse effects observed rarely or very rarely include: motor disturbances, convulsions, psychotic symptoms, depersonalization, 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, tension, agitation, disorientation, irritability, depersonalization or derealization, 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 effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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 helps to provide more information on the safety of the medicine.

5. How to store Xanax

Keep this medicine out of sight and reach of children.
Store below 25°C.
Store under normal humidity conditions.
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. Such measures help protect the environment.

6. Contents of the pack and other information

What Xanax contains

• The active substance is alprazolam. One tablet contains 2 mg of alprazolam.
• Other components of the medicine are: monohydrate lactose, microcrystalline cellulose (E 460), sodium docucinate (85%) + sodium benzoate (15%), colloidal silicon dioxide, magnesium stearate (E 572), corn starch.

What Xanax looks like and contents of the pack
White, elongated, scored tablets marked with the code "U 94" on one side and with a triple score line on both sides of the tablet.
The pack contains 30 tablets in an HDPE bottle with a child-resistant cap made of PP and an inner layer of MDPE, placed in a cardboard box.
For more detailed information, please contact the responsible entity or the parallel importer.
Responsible entity in Spain, country of export:
Pfizer GEP, S.L.
Avda. de Europa 20 B, Parque Empresarial La Moraleja, 28108 Alcobendas - Madrid, Spain
Manufacturer:
Pfizer Italia S.r.l., 63100, Località Marino del Tronto, Ascoli Piceno (AP), Italy
Parallel importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Spanish licence number, country of export: 705067.4
Parallel import licence number: 8/20