Xanax sr

Patient Information Leaflet

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Xanax SR (Trankimazin Retard)
0.5 mg, prolonged-release tablets
Alprazolamum
Xanax SR and Trankimazin Retard are different brand 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, as you may need to read it again.
• If you have any further 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 someone else, 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:

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 properties).
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 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 liver impairment. 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; Page 1 of 7
• 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 medicines, sedatives or alcohol are used concurrently (the effects of these medicines or alcohol may be intensified);
• if restlessness, psychomotor agitation, irritability, aggression, rage, nightmares, hallucinations, psychosis, inappropriate behaviour or other behavioural disturbances occur. If any of these symptoms appear, treatment should be stopped 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 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 similarly acting substances should be used with caution in elderly patients due to the risk of excessive sedation and (or) muscular-skeletal weakness, which may lead to falls, often with serious consequences for such patients.

Episodes of hypomania and mania have been reported in patients with depression treated with Xanax SR.
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, as well as any medicines the patient intends to take.

• Extreme caution is required when using Xanax SR together with opioids, as they have a depressant effect on the respiratory system (slowing and weakening breathing). This may lead to excessive sedation, respiratory depression, coma, or 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 agents (e.g. ketoconazole, itraconazole, posaconazole, voriconazole) is not recommended.
• Extreme caution is required and dose reduction should be considered when Xanax SR is used concomitantly with nefazodone, fluvoxamine or 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 become pregnant, she should consult her doctor before using 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 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 psycho-motor performance. Before using Xanax SR, patients should be aware of 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 used as directed by the physician. If in doubt, consult your
doctor or pharmacist.
Xanax SR is available in the following strengths: 0.5 mg, 1 mg, 2 mg.
Treatment should be as short as possible. The doctor should regularly assess the patient's condition and the need
for continuing treatment, especially if the patient's symptoms have diminished and
may no longer require pharmacological treatment. The total duration of treatment should not exceed 2–
4 weeks. Prolonged treatment is not recommended.
At the start of treatment, the doctor will inform the patient 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, physical and emotional
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 the 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. 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, administered once daily 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, administered once daily 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
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, administered once daily 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 disturbances, 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.
Discontinuation of Xanax SR
Do not stop taking this medicine without medical advice.
Since treatment is symptomatic, symptoms may return after discontinuation.
The 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 may cause adverse effects, although not everyone experiences 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 typically 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 occur in more than 1 in 10 people:

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

Common – may occur in up to 1 in 10 people:

• decreased appetite,
• confusion,
• disorientation,
• decreased libido (sex 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 occur in up to 1 in 100 people:

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

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

• hyperprolactinaemia (increased prolactin levels),
• hypomania,
• aggressive behaviour,
• hostile behaviour,
• thinking 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 abusing 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, feelings of 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, tension, agitation, disorientation, irritability, feelings of altered surroundings or self, hearing impairment, 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 medicine.

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 the medicine out of the sight and reach of children.
Store below 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. This will help protect the environment.

6. Contents of the pack and other information

What Xanax SR contains

• The active substance is alprazolam.
• The other ingredients are: lactose monohydrate, hypromellose 4000 cps, hypromellose 100 cps, colloidal silicon dioxide, magnesium stearate, F.D. & C. Blue No. 2 Aluminium Lake.

What Xanax SR looks like and contents of the pack
Xanax SR, 0.5 mg: 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 Spain, the country of export:
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Pfizer GEP, S.L.
Avda. de Europa, 20-B
Parque Empresarial La Moraleja
28108 Alcobendas (Madrid)
Spain

Manufacturer:
Pfizer Italia S.r.L.
Localitá 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

Marketing authorisation number in Spain, the country of export: 678656.7
Parallel import licence number: 472/16
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