Patient Information Leaflet

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Xanax SR (Xanax XR)
1 mg, modified-release tablets
Alprazolamum
Xanax SR and Xanax XR are different trade names for the same medicine.
Please read this leaflet carefully before taking the 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 doubts, 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 are similar.
If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

What Xanax SR is and what it is used for
Important information before taking Xanax SR
How to take Xanax SR
Possible side effects
How to store Xanax SR
Contents of the pack and other information

1. What Xanax SR is and what it is used for

The active substance in Xanax SR is alprazolam. It belongs to a group of medicines called benzodiazepines (medicines with anxiolytic properties).
Xanax SR is indicated for the treatment of symptoms of anxiety disorders in adults, only in cases where symptoms are severe, impair normal functioning, or are extremely distressing to the patient. This medicine is intended for short-term use only.

2. Important information before using Xanax SR

When not to use Xanax SR

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 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 liver insufficiency. Xanax SR should not be used in children and adolescents under 18 years of age.

Warnings and precautions
Before starting treatment with Xanax SR, discuss the following with your doctor:

if the medicine is to be used long-term (risk of developing dependence, 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 opioids, sleeping medicines, sedatives are taken concomitantly, or if alcohol is consumed (the effect of these medicines or alcohol may be intensified);
if restlessness, psychomotor agitation, irritability, aggression, rage, nightmares, hallucinations, psychosis, inappropriate behavior or other behavioral disturbances occur. If any of these symptoms appear, treatment should be discontinued and the patient should contact the doctor;
in patients with glaucoma;
in patients with impaired kidney or liver function. Like other benzodiazepines, Xanax SR may cause anterograde amnesia, which occurs several hours after taking the medicine. In such cases, the patient should have the opportunity to sleep uninterrupted 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 SR in patients with depression.
Before a planned surgery, inform the doctor about taking Xanax SR.
Xanax SR 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 should be exercised when using Xanax SR 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 SR may enhance the effects of antipsychotics, hypnotics, anxiolytics, sedatives, antidepressants, narcotic analgesics, anticonvulsants, anesthetics, 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 SR.
Concomitant use of Xanax SR with certain systemic antifungal medicines (e.g. ketoconazole, itraconazole, posaconazole, voriconazole) is not recommended.
Extreme caution should be exercised and dose reduction should be considered when Xanax SR is used 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 SR and HIV protease inhibitors (e.g. ritonavir) requires dose adjustment or discontinuation of alprazolam.
Concomitant use of Xanax SR and digoxin requires close monitoring of the patient for signs of digoxin toxicity.
Theophylline may reduce the effect of benzodiazepines.

Pregnancy and breastfeeding
If the patient is pregnant, 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 late pregnancy, high doses should be avoided and the newborn should be closely monitored.
Benzodiazepines pass into human milk in small concentrations. Xanax SR should not be used during breastfeeding.

Driving and operating machinery
Xanax SR may impair psychomotor performance. Before using Xanax SR, patients should become familiar with current local traffic regulations.
Patients should not drive or operate machinery while taking Xanax SR.

Xanax SR contains monohydrate lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult the doctor before taking this medicine.

3. How to use Xanax SR

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult
your doctor or pharmacist.
Xanax SR is available in doses of 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 SR, 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 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.
If Xanax SR is taken once daily, it is best to take it in the morning. The tablets should be swallowed whole;
do not chew, crush, or divide them.
Treatment of symptomatic anxiety disorders
The recommended initial dose is 1 mg per day, taken as a single dose or in two divided doses.
Your doctor may decide to increase the dose, depending on the patient's needs, up to a maximum daily
dose of 4 mg, taken as a single dose or in two divided doses.
Use in children and adolescents
Xanax SR 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 0.5 mg to 1 mg per day, taken as a single dose or in two divided doses.
If necessary, the doctor may decide to gradually increase the dose depending on tolerance to the medicine.
If adverse effects occur, the doctor may decide to reduce the initial dose.
Use of a higher than recommended dose of Xanax SR
Taking a higher than recommended dose of Xanax SR may cause: ataxia (impaired coordination),
drowsiness, speech disorders, coma, and respiratory depression. If any alarming symptoms occur,
contact your doctor or pharmacist immediately.
Missed dose of Xanax SR
Do not take a double dose to make up for a missed dose.
Stopping Xanax SR
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 all medicines, 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 the individual susceptibility of the patient and the dose administered. Adverse effects usually occur at the beginning of treatment and 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 affect 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 affect up to 1 in 10 people:

decreased appetite,
confusion,
disorientation,
decreased libido (sexual drive),
increased libido,
anxiety,
insomnia,
nervousness,
loss of balance,
impaired coordination,
difficulty concentrating,
excessive need for sleep,
lethargy,
tremor,
blurred vision,
nausea,
skin inflammation,
sexual disturbances,
weight loss,
weight gain.

Uncommon – may affect up to 1 in 100 people:

mania,
hallucinations,
anger,
agitation,
dependence,
amnesia,
muscle weakness,
urinary incontinence,
irregular menstruation,
withdrawal syndrome.

Frequency unknown (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 dysfunction (which controls the function of internal organs, smooth muscles, and glands),
dystonia (muscle tone disorders),
gastrointestinal disorders,
hepatitis,
hepatic function abnormalities,
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: motor disturbances, seizures, psychotic symptoms, depersonalisation, 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 SR may lead to withdrawal symptoms such as headache, muscle pain, increased anxiety, feelings of tension, agitation, disorientation, irritability, altered perception of surroundings or self, hearing disturbances, muscle stiffness and limb paraesthesia, 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 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 of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 4921 301
Fax: +48 4921 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 SR

Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
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. These measures will help protect the environment.

6. Contents of the packaging and other information

What Xanax SR contains

The active substance is alprazolam. One modified-release tablet contains 1 mg of alprazolam.
Other components of the medicine are: lactose, hypromellose 4000 cps, hypromellose 100 cps, colloidal anhydrous silica, magnesium stearate.

What Xanax SR looks like and contents of the pack
White, round, biconvex tablets marked with the code "P&U59" on one side.
The pack contains 30 or 60 tablets in Al/Al blisters within a cardboard box.
For more detailed information, please contact the Marketing Authorisation Holder or the parallel importer.
Marketing Authorisation Holder in Portugal, 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 Portugal, the country of export: 4579488
Parallel Import Licence number: 386/22