Xanax

PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep the leaflet, information on the immediate packaging in a foreign language
Xanax
0.5 mg, tablets
Alprazolamum
Please read the following leaflet carefully before using this 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. This medicine may harm others, even if their symptoms are the same as yours.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. 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, but 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 suffers from 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, you should 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 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 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 intensified);
• if restlessness, psychomotor agitation, irritability, aggression, anger, nightmares, hallucinations, delusions, 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 the 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 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 in association with the use of Xanax in patients with depression.
Before a planned surgery, inform the doctor about taking Xanax.

Xanax with other medicines
You should 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 should be exercised 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 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.
• It is not recommended to take Xanax concomitantly with certain systemic antifungal medicines (e.g. ketoconazole, itraconazole, posaconazole, voriconazole).
• Extreme caution should be exercised and dose reduction considered when using Xanax concomitantly with nefazodone, fluvoxamine, and cimetidine.
• Extreme caution should be exercised when using alprazolam 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 simultaneously should be closely monitored for signs (objective and subjective) related to 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 fetus. 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 must not be used during breastfeeding.

Driving and operating machinery
Xanax causes impairment of psychomotor performance. Before using Xanax, you should familiarise yourself 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 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 (E 211)
Each 0.5 mg tablet of this medicine contains 0.11 mg of sodium benzoate (E 211).

3. How to use Xanax

This medicine should always be used as directed by the physician. If in doubt, consult your doctor or pharmacist.

Xanax is available in the following doses: 0.25 mg, 0.5 mg, 1 mg, 2 mg.

Treatment should last as short a time as possible. The doctor should regularly assess the patient's condition and the need for continuing treatment, especially if the patient's symptoms have diminished and may no longer require pharmacological treatment. The total duration of treatment should not exceed 2–4 weeks. Long-term treatment is not recommended.

When starting treatment, the doctor will inform the patient 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 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 continued treatment should be regularly evaluated with the doctor.

Recommended dose

The dose is determined by the doctor based on symptom severity and the individual patient's response to treatment. If severe adverse reactions 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 should 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 reactions occur, the doctor may 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 (impaired coordination of movement), drowsiness, speech disturbances, coma, and respiratory depression. If disturbing symptoms occur, contact a doctor immediately.

Missed dose of Xanax

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

Discontinuation of Xanax

Do not stop taking this medicine without medical advice. Since treatment is symptomatic, symptoms may return after discontinuation. The 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 will experience 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 treatment. They typically 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,
• somnolence,
• ataxia (lack of voluntary 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,
• difficulty concentrating,
• 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,
• thought 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 those who misuse alcohol, a paradoxical reaction may occur, including symptoms such as anxiety.

Other adverse effects observed rarely or very rarely include: movement disorders, seizures, psychotic symptoms, feelings of 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 trigger 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 epileptic 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 adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can 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 49 21 301, fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl

Reporting adverse effects helps to collect more information on the safety of the medicine.

5. How to store the medicine 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 0.5 mg of alprazolam.
• The other ingredients are: monohydrate lactose, microcrystalline cellulose, sodium docusate (85%) + sodium benzoate (E 211) (15%), colloidal anhydrous silica, magnesium stearate, corn starch, erythrosine (E 127).

What Xanax looks like and contents of the pack
Xanax 0.5 mg: pink, elliptical-oval, scored tablets marked with the inscription "Upjohn 55" on one side and a score line on the other side of the tablet.
Pack contains 30 tablets in PVC/Aluminium blisters, in a cardboard box.
For further information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder in Romania, 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:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
Poland
Repackaged in:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
Poland
Marketing Authorisation number in Romania, country of export: 7759/2015/01
Parallel Import Licence number: 311/24