Xanax

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Xanax (Trankimazin), 2 mg, tablets
Alprazolamum
Xanax and Trankimazin are different brand names for the same medicinal product.
Please read this leaflet carefully before using the 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, please 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 appear identical.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Xanax is and what it is used for
2. What you need to know 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 properties).
Xanax is indicated for the treatment of symptoms of anxiety disorders in adults, but 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 components 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 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 if 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 using other benzodiazepines (increased risk of dependence);
• if the patient is simultaneously using opioids, sleeping medicines, 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 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 kidney or liver function. Like other benzodiazepines, Xanax may cause anterograde amnesia, which occurs several hours after taking the medicine. In such cases, the patient should ensure 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) 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 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 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 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 antipsychotic, hypnotic, anxiolytic, sedative, antidepressant, narcotic analgesic, anticonvulsant, anaesthetic, and antihistamine medicines.
• With narcotic analgesics, euphoria may be intensified, which may lead to increased psychological dependence.
• Alcohol consumption must not be taken during treatment with Xanax.
• It is not recommended to take Xanax concomitantly with certain systemic antifungal medicines (e.g. ketoconazole, itraconazole, posaconazole, voriconazole).
• Extreme caution is required and dose reduction should be considered when using Xanax concomitantly 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).
• 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 (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 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 foetus.
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 low concentrations. Xanax must not be used during breastfeeding.
Driving and operating machinery
Xanax may impair psycho-physical performance. Before using Xanax, patients should familiarize themselves with current local traffic regulations.
During treatment with Xanax, patients must not drive or operate machinery.
Xanax contains lactose monohydrate
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact their doctor before taking the 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 (E 211)
Each tablet of this medicine contains 0.23 mg of sodium benzoate.

3. How to take Xanax

This medicine should always be taken exactly as prescribed by your doctor. If you have any doubts, 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 be as short as possible. Your doctor should regularly assess your condition and the need for continuing treatment, especially if your symptoms improve 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 symptoms.
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 disorders
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
The use of Xanax is contraindicated in patients with severe hepatic insufficiency.

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 your tolerance to the medicine. If adverse effects occur, your doctor will decide to reduce the initial dose.

Taking more than the recommended dose of Xanax
Taking more than the recommended dose of Xanax may cause: ataxia (impaired coordination of movements), drowsiness, speech disturbances, coma, and respiratory depression. If disturbing symptoms occur, contact your doctor immediately.

Missed dose of Xanax
Do not take a double dose to make up for a missed dose.

Stopping treatment with Xanax
Do not stop taking Xanax on your own.
Since treatment is symptomatic, symptoms may return after discontinuation.
Your doctor will decide on a gradual reduction of the dose.

If you have any further doubts regarding the use of this medicine, consult your 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 downwards. Pressing with your thumb, break the tablet into two equal parts, each containing 1 mg of alprazolam.

If necessary, each half can be further divided. To do this, place each half again on a hard surface with the indentation facing downwards and press again with your thumb. In this way, each half yields two quarters, each containing 0.5 mg of alprazolam.

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

4. Possible adverse effects

Like all medicines, 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 tend to subside as treatment continues or when the dose is reduced.

Frequency of adverse effects observed in clinical trials and after marketing of the medicine:

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

• depression,
• sedation,
• somnolence,
• 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,
• loss of balance,
• incoordination,
• attention disturbances,
• excessive sleepiness,
• lethargy,
• tremor,
• blurred vision,
• nausea,
• skin inflammation,
• sexual dysfunction,
• 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,
• 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 misuse,
• autonomic nervous system disorders (which regulate 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 effects observed rarely or very rarely include: motor disturbances, convulsions, psychotic symptoms, depersonalization, 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, 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 drug.

Reporting of adverse effects

If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. 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 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 container. 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 in use. This will help protect the environment.

6. Contents of the packaging and other information

What Xanax contains

• The active substance is alprazolam. Each tablet contains 2 mg of alprazolam.
• The other ingredients are: monohydrate lactose, microcrystalline cellulose, sodium docusate (85%) + sodium benzoate (15%), colloidal silicon dioxide, magnesium stearate, 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 MDPE coating, packed in a cardboard box.
For further detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Spain, the country of export:
Viatris Healthcare, S.L.
Calle General Aranaz, 86, 3rd floor
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
Marketing authorisation number in Spain, the country of export: 705067.4
Parallel import licence number: 170/22