Package leaflet: information for the patient

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.
Xanax SR (Trankimazin Retard)
1 mg, prolonged-release tablets
Alprazolamum
Xanax SR and Trankimazin Retard are different trade names for the same medicine.
Please read the leaflet carefully before using 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, 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 the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

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 action).
Xanax SR is indicated for the treatment of symptoms of anxiety disorders in adults, only in
situations 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 taking Xanax SR

When not to take 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 evaluated by the doctor; Page 1 of 7
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, hypnotics, sedatives are taken concurrently, or if alcohol is consumed (the effects of these medicines or alcohol may be enhanced);
if restlessness, psychomotor agitation, irritability, aggression, hallucinations, anger, nightmares, illusions, psychosis, inappropriate behavior or other behavioral disturbances occur. If any of these symptoms appear, treatment with the medicine should be stopped 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 a case, 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) muscular-skeletal system weakness, 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 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 antipsychotic, hypnotic, anxiolytic, sedative, antidepressant, narcotic analgesic, anticonvulsant, anesthetic, and antihistaminic medicines.
When narcotic analgesics are used, euphoria may be intensified, potentially leading to increased psychological dependence.
Alcohol must not be consumed during treatment with Xanax SR.
Concomitant use of Xanax SR with certain systemic antifungal agents (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 should be exercised 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 become pregnant, she should consult her doctor before taking this medicine.
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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 the late stages 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 psycho-physical performance. Before taking Xanax SR, patients should familiarize themselves 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 contact their doctor before taking the 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.
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 experiencing withdrawal symptoms.
During treatment with benzodiazepines, including Xanax SR, physical and 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 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.
Xanax SR is available in strengths of 0.5 mg, 1 mg, and 2 mg.

Treatment of anxiety symptoms
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 should not be used in children and adolescents under 18 years of age.
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Use in patients with renal or hepatic impairment
Xanax SR is contraindicated in patients with severe hepatic impairment.

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 gradually increase the dose depending on the patient's tolerance. If adverse effects occur, the doctor may decide to reduce the initial dose.

Taking more than the recommended dose of Xanax SR
Taking more than the recommended dose of Xanax SR may cause ataxia (impaired coordination), drowsiness, speech disturbances, coma, and respiratory depression. If any concerning 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 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 they do not occur in everyone.
If any of the adverse effects listed below persist or become troublesome,
you should inform your doctor. The occurrence of some adverse effects
depends entirely on individual patient susceptibility and the dose administered. Adverse effects
are usually observed at the beginning of therapy. They tend to resolve 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 (lack of voluntary coordination of muscle movements),
memory impairment,
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,
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 unknown (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 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 alcohol abusers, a paradoxical reaction may occur, manifesting as anxiety.
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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 SR may lead to 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 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, you should 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 49 21 301
Fax: + 48 49 21 309
Website: https://smz.ezdrowie.gov.pl
By reporting adverse effects, additional information on the safety of the medicine can be collected.

5. How to store the medicine Xanax SR

Keep the 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. Such measures 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 1 mg of alprazolam.
The other ingredients are: lactose monohydrate, hypromellose 4000 cps, hypromellose 100 cps, colloidal silicon dioxide, magnesium stearate.

What Xanax SR looks like and contents of the pack
White, round, convex tablets marked with the code "P&U59" on one side of the tablet.
The pack contains 30 or 60 tablets in Al/Al blisters within a cardboard carton.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
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Marketing Authorisation Holder in Spain, country of export:
Pfizer GEP, S.L., Avenida de Europa 20 B, Parque Empresarial La Moraleja, 28108 Alcobendas (Madrid), Spain
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, Poland
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Spanish marketing authorisation number, country of export: 678672.7
Parallel import authorisation number: 257/21
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