XANAX SR

Package leaflet: information for the patient

Warning! Please keep the leaflet. Information on the immediate packaging in a foreign language.
Xanax SR (Xanax XR)
0.5 mg, modified-release tablets
Alprazolamum
Xanax SR and Xanax XR are different brand names for the same medicine.
Please read the entire leaflet carefully before taking 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 share it with others. This medicine may harm another person, 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 of the leaflet:

1. What Xanax SR is and what it is used for
2. Important information before taking Xanax SR
3. How to take Xanax SR
4. Possible side effects
5. How to store Xanax SR
6. 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 (drugs with anxiolytic action).
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 highly 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 hepatic 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 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 opioids, sleeping medicines, sedatives are taken concomitantly, or alcohol is consumed (the effects of these medicines or alcohol may be enhanced);
• 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 their doctor;
• in patients with glaucoma;
• in patients with impaired kidney or liver function. Like other benzodiazepines, Xanax SR may cause transient memory impairment, which may occur 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 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 currently or recently taken by the patient, as well as any medicines the patient intends 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 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, anaesthetics, and antihistamines.
• In the case of narcotic analgesics, euphoria may be intensified, potentially increasing 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 considered when Xanax SR is used 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 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 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 closely monitored.
Benzodiazepines pass into human milk in small amounts. Xanax SR should not be used during breastfeeding.

Driving and operating machinery
Xanax SR may impair psychomotor performance. Before using Xanax SR, patients should familiarize themselves with current local traffic regulations.
Patients should not drive vehicles 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 their doctor before taking this medicine.

3. How to use Xanax SR

This medicine should always be taken exactly as directed 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 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 SR, physical and emotional dependence may develop. This risk may increase with higher doses and longer treatment duration. 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 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.
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 once daily or in two divided doses.
Your doctor may decide to increase the dose, depending on your needs, up to a maximum daily dose of 4 mg, taken once 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 once or in two divided doses. 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.
Taking more Xanax SR than recommended
Taking more than the 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 doubts about using 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 individual patient susceptibility and the dose administered. Adverse effects are usually observed at the beginning of treatment. They tend to resolve with continued treatment or when the dose is reduced.

Frequency of adverse effects observed in clinical trials and after marketing authorization:

Very common – may affect 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 affect up to 1 in 10 people:

• decreased appetite,
• confusion,
• disorientation,
• decreased libido (sexual drive),
• increased libido,
• anxiety,
• insomnia,
• restlessness,
• 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 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,
• thought disorders,
• increased psychomotor activity,
• drug misuse,
• autonomic nervous system dysfunction (which controls the function of internal organs, smooth muscles and glands),
• dystonia (muscle tone disorders),
• gastrointestinal disturbances,
• 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 alcohol abuse, a paradoxical reaction may occur, manifesting as anxiety.

Other adverse effects observed rarely or very rarely include: movement disorders, seizures, psychotic symptoms, 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 SR may lead to withdrawal symptoms such as headache, muscle pain, severe anxiety, tension, agitation, disorientation, irritability, altered perception of surroundings or self, hearing disturbances, 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 drug.

Reporting of adverse effects

If any adverse effects occur, including any not listed in this leaflet, tell 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 49 21 301
Fax: +48 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 SR

Keep this medicine out of 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 specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Xanax SR contains

• The active substance is alprazolam. One modified-release tablet contains 0.5 mg of alprazolam.
• Other ingredients are: lactose, hypromellose 4000 cps, hypromellose 100 cps, colloidal anhydrous silica, magnesium stearate, indigo carmine (E 132).

What Xanax SR looks like and contents of the pack
Blue, round, convex tablets marked with the code “P&U57” on one side of the tablet.
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, 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, country of export: 4579280
Parallel Import Licence Number: 385/22