Xanax

Patient Information Leaflet

Warning! Keep this leaflet. Information on the immediate packaging is in a foreign language.
XANAX, 0.5 mg, tablets
Alprazolamum
Please read this leaflet carefully before taking this 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 questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents

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 properties).
Xanax is indicated for the treatment of symptoms of anxiety disorders in adults, only in cases 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 characterised 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 to be 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 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 concurrently taking opioids, sleeping medicines, sedatives, or consuming alcohol (the effects of these medicines or alcohol may be enhanced);
• if restlessness, psychomotor agitation, irritability, aggression, rage, 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 kidney or liver function. Like other benzodiazepines, Xanax may cause anterograde amnesia, which may occur 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 muscle weakness, 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 Xanax is used concomitantly with opioids, as they have a depressive effect on the respiratory system (slowing and shallowing of breathing). This is associated with the risk of excessive sedation, respiratory depression, coma, and even death.
• Xanax may enhance the effects of antipsychotics, sleeping medicines, 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.
• Concomitant use of Xanax with certain systemic antifungal medicines (e.g. ketoconazole, itraconazole, posaconazole, voriconazole) is not recommended.
• Extreme caution is required and dose reduction should be considered when Xanax is used concomitantly with nefazodone, fluvoxamine, and cimetidine.
• Extreme caution is required when alprazolam is used concomitantly 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 concomitantly 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 fetal risk.
If administration of the medicine is necessary during late pregnancy, high doses should be avoided and the newborn should be monitored.
Benzodiazepines pass into human milk in small concentrations. Xanax must not be used during breastfeeding.
Driving and operating machinery
Xanax may impair psycho-motor performance. Before using Xanax, patients should familiarise themselves with current local traffic regulations.
Patients should not drive vehicles or operate machinery while taking Xanax.
Xanax contains lactose
If the patient has previously been diagnosed with an intolerance to certain sugars, the patient should contact their doctor before taking this 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 taken exactly as directed 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, 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 have improved and may no longer require pharmacological treatment. The total duration of treatment should not exceed 2–4 weeks. Prolonged 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 symptoms.
When taking benzodiazepines, including Xanax, physical and emotional dependence may develop. This risk may increase with higher doses and longer 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 initial dose is 0.25 mg or 0.5 mg three times daily.
Your 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 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 liver dysfunction.

Use in elderly patients
The recommended initial 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 initial dose.

Taking a higher than recommended dose of Xanax
Taking a higher than recommended dose of Xanax may cause: ataxia (loss of coordination), drowsiness, speech disturbances, coma, and respiratory depression. If any concerning 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
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 questions about the use of this medicine, consult your doctor.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any of the side 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 treatment. They tend to subside with continued therapy 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 motor coordination),
• memory disturbances,
• 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,
• balance disorders,
• 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 not known (cannot be estimated from available data):

• hyperprolactinaemia (increased prolactin levels),
• hypomania,
• aggressive behaviour,
• hostile behaviour,
• thinking disorders,
• 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 (oedema of ankles, feet or fingers),
• increased intraocular pressure.

Additionally, particularly in patients taking other psychotropic medicines, those with psychiatric disorders or alcohol abusers, a paradoxical reaction may occur, manifesting as anxiety.
Other adverse effects observed rarely or very rarely include: motor disturbances, seizures, psychotic symptoms, feelings of 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, altered perception of surroundings or self, hearing disturbances, limb stiffness and tingling, 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, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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 the medicine out of the sight and reach of children.
Do not store above 25℃.
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 0.5 mg of alprazolam.
• The other ingredients are: lactose, microcrystalline cellulose, sodium docusate, sodium benzoate, colloidal anhydrous silica, magnesium stearate, maize starch, erythrosine lake.

What Xanax looks like and contents of the packaging
Xanax 0.5 mg: pink, elliptical-oval, scored tablets marked with "Upjohn 55" on one side and a score line on the other side of the tablet. The packaging contains 30 tablets in PVC/Aluminium blisters in a cardboard box.
For more detailed information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder 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
Ascoli Piceno, Italy
Mylan Hungary Kft., Mylan utca 1, Komárom 2900, Hungary
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
Marketing Authorisation number in Portugal, country of export: 5787791
Parallel import licence number: 414/19