Patient Information Leaflet

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Xanax SR
0.5 mg, prolonged-release tablets
Alprazolamum
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

Keep this leaflet as you may need to read it again.
If you have any questions, ask 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.

Leaflet Contents:

What Xanax SR is and what it is used for
What you need to know 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 action).
Xanax SR is indicated for the treatment of symptoms of anxiety disorders in adults, but only in
situations 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 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 suffers from muscle weakness ( myasthenia gravis ) (a condition 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 is being reduced or 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 tablets, sedatives are taken concomitantly, or if alcohol is consumed (the effects of these medicines or alcohol may be enhanced);
if restlessness, psychomotor agitation, irritability, aggression, rage, nightmares, hallucinations, delusions, psychosis, inappropriate behaviour or other behavioural disturbances occur. If any of these symptoms appear, treatment should be discontinued and the patient should contact their doctor;
in patients with glaucoma;
in patients with impaired renal or hepatic function. Like other benzodiazepines, Xanax SR may cause anterograde amnesia, which occurs several hours after taking the medicine. In such cases, 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 taken or recently taken, as well as any medicines the patient plans to take.

Extreme caution is required 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, anaesthetics, 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.
It is not recommended to take Xanax SR concomitantly with certain systemic antifungal medicines (e.g. ketoconazole, itraconazole, posaconazole, voriconazole).
Extreme caution is required and dose reduction should be considered when Xanax SR is used concomitantly with nefazodone, fluvoxamine, and cimetidine.
Extreme caution is required 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 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 during the last stage of 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 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 the following strengths: 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.
During treatment with benzodiazepines, including Xanax SR, dependence may develop, including 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 continuing treatment should be regularly reviewed with your doctor.
Recommended dose
The dose is determined by the doctor according to 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.
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 states
The recommended starting dose is 1 mg daily, taken once or in two divided doses.
The doctor may decide to increase the dose, depending on the patient's needs, up to a maximum daily dose of 4 mg, taken once or in two divided doses.
Use in children and adolescents
Xanax SR 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 starting dose is 0.5 mg to 1 mg daily, 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.
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 disturbing 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 stopping the medicine.
Your doctor will decide on gradually reducing the dose.
If you have any further doubts regarding 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 therapy and tend to resolve with continued treatment 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 coordination of movement),
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 disturbances,
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,
drug withdrawal syndrome.

Frequency not known (cannot be estimated from available data):

hyperprolactinaemia (increased prolactin levels),
hypomania,
aggressive behaviour,
hostile behaviour,
thinking disturbances,
increased psychomotor activity,
drug abuse,
autonomic nervous system dysfunction (which controls the function of internal organs, smooth muscles, and glands),
dystonia (abnormal muscle tone),
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 those who misuse alcohol, 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 SR may lead to withdrawal symptoms such as headache, muscle pain, intensified anxiety, feelings of tension, agitation, disorientation, irritability, altered perception of surroundings or self, impaired hearing, muscle stiffness and tingling in 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, 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 22 4921 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse effects allows the collection of additional information on the safety of the medicine.

5. How to store Xanax SR

Keep the medicine out of the sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.
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 pack and other information

What Xanax SR contains

The active substance is alprazolam. One prolonged-release tablet contains 0.5 mg of alprazolam.
Other components of the medicine are: monohydrate lactose, hypromellose 4000 cps, hypromellose 100 cps, anhydrous colloidal silicon dioxide, magnesium stearate, indigo carmine (E 132).

What Xanax SR looks like and contents of the pack
Blue, round, convex tablets marked with "P&U57" on one side of the tablet.
The pack contains 30 or 60 tablets in Al/Al blisters within a cardboard box.
For further detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder in Hungary, the country of export:
Viatris Healthcare Limited
Damastown Industrial Park
Mulhuddart, Dublin 15, Dublin, Ireland
Manufacturer:
Pfizer Italia S.r.l.
Marino del Tronto, 63100 Ascoli Piceno
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 Hungary, the country of export: OGYI-T-4617/01
Parallel Import Licence Number: 402/24