Xanax

Patient Information Leaflet

Warning! Keep this leaflet. Information on the immediate packaging is in a foreign language.
XANAX
0.25 mg, tablets
Alprazolamum
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm others, even if their symptoms are similar.
• If you experience any adverse reactions, including any 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, interfere with 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 or 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 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 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 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 simultaneously taking 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, delusions, psychosis, inappropriate behaviour or other behavioural disturbances occur. If any of these symptoms appear, treatment with the medicine should be stopped and the doctor contacted;
• 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 a case, 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 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 or recently taken by the patient, 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 weakening 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.
• With 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 using Xanax together 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 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 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 fetus.
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-physical performance.
Before using Xanax, become familiar with current local regulations regarding road traffic laws.
During treatment with Xanax, do 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 the 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
Each tablet of this medicine contains 0.11 mg of sodium benzoate.

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 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. 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 reactions.
During treatment with benzodiazepines, including Xanax, dependence may develop, as well as emotional or physical dependence. This 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 continuing 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 response to treatment. If severe adverse effects occur after the initial dose, the doctor may decide to reduce the dose.
Treatment of symptomatic anxiety states
The recommended initial 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 renal or hepatic impairment
Use in patients with severe hepatic insufficiency is contraindicated.
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 to the medicine. If adverse effects occur, the doctor will decide whether 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 (lack of motor 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
Do not stop taking this medicine on your own.
Since treatment is symptomatic, symptoms may return after discontinuation.
Your doctor will decide on gradual dose reduction.
If you have any further questions about the use of this medicine, consult your doctor.

4. Possible adverse effects

Like any medicine, this medicine can cause adverse effects, although not everyone experiences them.
If any of the following adverse effects 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 subside with continued therapy 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,
• drowsiness,
• ataxia (impaired muscle 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,
• impaired coordination,
• attention disturbances,
• excessive need for sleep,
• lethargy,
• tremor,
• blurred vision,
• nausea,
• skin inflammation,
• sexual dysfunction,
• weight loss,
• weight gain.

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 abuse,
• 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 alcohol abuse, a paradoxical reaction may occur, manifesting as anxiety.
Other adverse effects observed rarely or very rarely include: motor disturbances, seizures, psychotic symptoms, depersonalisation, 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 impairment, 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 those not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel: +48 22 4921301, Fax: +48 22 4921309, 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 sight and reach of children.
Store below 25°C in the original packaging.
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. Each tablet contains 0.25 mg of alprazolam.
• The other components are: monohydrate lactose, microcrystalline cellulose, maize starch, colloidal anhydrous silica, magnesium stearate, sodium docuzinate (85%) + sodium benzoate (15%).

What Xanax looks like and contents of the pack
Xanax 0.25 mg: white, elliptical-oval, scored tablets marked with "Upjohn 29" on one side and a division line on the other side of the tablet.
The pack contains 30 tablets in PVC/Aluminium blisters, packed in a cardboard carton.
For further information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder in Romania, the 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
63100 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
Marketing Authorisation Number in Romania, the country of export: 7758/2015/01
Parallel Import Licence Number: 70/23