Xanax

Patient Information Leaflet

Warning! Keep this leaflet. Information on the immediate packaging is in a foreign language.
XANAX, 1 mg, tablets
Alprazolamum
Please read this leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet for future reference.
• 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. It may harm other people, even if their symptoms are the same.
• 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 action).
Xanax is indicated for the treatment of symptoms of anxiety disorders in adults, exclusively in cases where symptoms are severe, impair normal functioning, or are highly distressing 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 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 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 intensified);
• if restlessness, psychomotor agitation, irritability, aggression, delusions, anger, 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 occurs several hours after taking the medicine. In such a case, 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) 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 depressant 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, hypnotics, 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 consumption must not be combined with Xanax during treatment.
• 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 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 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 the late stages of 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 familiarize themselves 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 benzoate
Each tablet of this medicine contains 0.11 mg of sodium benzoate.

Xanax contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

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, 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 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 reactions.
When taking benzodiazepines, including Xanax, physical or emotional dependence may develop. The risk increases 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 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 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 reactions occur, the doctor will decide whether to reduce the initial 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 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 Xanax treatment
Do not stop taking this medicine 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 any medicine, 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 following marketing authorization:
Very common – may affect more than 1 in 10 people:

• depression,
• sedation,
• drowsiness,
• ataxia (lack of voluntary muscle coordination),
• memory disturbances,
• speech disorders,
• dizziness,
• headache,
• constipation,
• dry mouth,
• fatigue,
• irritability.

Common – may affect up to 1 in 10 people:

• decreased appetite,
• confusion,
• disorientation,
• decreased libido (sexual drive),
• increased libido,
• anxiety,
• insomnia,
• restlessness,
• balance disorders,
• impaired coordination,
• attention disturbances,
• excessive need for sleep,
• lethargy,
• tremor,
• blurred vision,
• nausea,
• skin inflammation,
• sexual dysfunction,
• decreased body weight,
• increased body weight.

Uncommon – may affect up to 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 available data):

• hyperprolactinaemia (increased prolactin levels),
• hypomania,
• aggressive behaviour,
• hostile behaviour,
• thinking abnormalities,
• 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 alcohol abuse, 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 (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, intensified anxiety, 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 drug.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects 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, 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 the medicine Xanax

Keep this medicine out of the 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. 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 1 mg of alprazolam.
• The other ingredients are: monohydrate lactose, microcrystalline cellulose, sodium lauryl sulphate (85%) + sodium benzoate (15%), colloidal anhydrous silica, magnesium stearate, corn starch, erythrosine (E 127), brilliant blue FCF, aluminium lake (E 133).

What Xanax looks like and contents of the pack
Lavender-coloured, elliptical-oval, scored tablets marked with the imprint "Upjohn 90" on one side and a dividing line on the other side of the tablet. The pack contains 30 tablets in PVC/Aluminium blisters, packed in a cardboard box.
For more detailed 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:
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, country of export: 7760/2015/01
Parallel import licence number: 6/20