Zomiren Sr

Package Leaflet: Information for the Patient

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Zomiren SR (Helex SR 0.5 mg), 0.5 mg, prolonged-release tablets
Alprazolam
Zomiren SR and Helex SR 0.5 mg are different trade names for the same drug.

Before taking the medicine, the patient should carefully read the contents of the leaflet, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, the patient should consult a doctor or pharmacist.
• This medicine has been prescribed for a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is Zomiren SR and what is it used for
• 2. Important information before taking Zomiren SR
• 3. How to take Zomiren SR
• 4. Possible side effects
• 5. How to store Zomiren SR
• 6. Package contents and other information

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

The active substance of Zomiren SR, alprazolam, belongs to a group of medicines called benzodiazepine derivatives and has an anxiolytic effect.
Zomiren SR is indicated for the treatment of symptoms of anxiety disorders in adults, only in situations where the symptoms are severe, prevent normal functioning, or are very troublesome for the patient. This medicine is intended for short-term use only.

2. Important information before taking Zomiren SR

When not to take Zomiren SR

• if the patient is allergic to alprazolam or other benzodiazepines or any of the other ingredients of this medicine (listed in section 6),
• if the patient has myasthenia gravis (a disease characterized by excessive muscle fatigue and weakness),
• if the patient has severe respiratory failure,
• if the patient has sleep apnea syndrome,
• if the patient has severe liver failure.

Zomiren SR should not be taken by children and adolescents under 18 years of age.

Warnings and precautions

Before starting treatment with Zomiren SR, the patient should discuss it with their doctor.

• if the medicine is taken for a long time (possible development of dependence on the medicine, especially in patients prone to drug or alcohol abuse). The need for further treatment should be periodically assessed by the doctor;
• if the dose of the medicine is reduced or it is suddenly stopped [possible occurrence of withdrawal symptoms (see section 4)];
• if the medicine is taken by patients with depression, with suicidal thoughts or tendencies;
• if the patient is taking other benzodiazepines (increased risk of dependence);
• if opioids, sedatives, anxiolytics, antidepressants, opioid analgesics, anticonvulsants, anesthetics, or antihistamines are taken at the same time (the effect of these medicines or alcohol may be enhanced);
• if restlessness, psychomotor agitation, irritability, aggression, delusions, anger, nightmares, hallucinations, psychosis, or other behavioral disorders occur. If these symptoms occur, the use of the medicine should be stopped and the doctor should be consulted;
• in patients with glaucoma;
• in patients with kidney or liver function disorders.

Like other benzodiazepines, Zomiren SR may cause anterograde amnesia, which occurs a few hours after taking the medicine. In such a case, the patient should have the opportunity for 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) weakening of the musculoskeletal system, which may lead to falls, often with serious consequences for such a patient.
Episodes of hypomania and mania have been reported in connection with the use of Zomiren SR in patients with depression.
Before planned surgery, the patient should inform their doctor about taking Zomiren SR.

Zomiren SR and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

• Particular caution should be exercised when taking Zomiren SR with opioids, as they have a depressant effect on the respiratory system (slow down and shallow breathing). This is associated with a risk of excessive sedation, respiratory depression, coma, and even death.
• Zomiren SR may enhance the effect of antipsychotic, sedative, anxiolytic, antidepressant, opioid analgesic, anticonvulsant, anesthetic, and antihistamine medicines.
• In the case of opioid analgesics, there may be an increase in euphoria, which can lead to an increase in psychological dependence.
• Alcohol should not be consumed during treatment with Zomiren SR.
• It is not recommended to take Zomiren SR at the same time as certain oral antifungal medicines (e.g., ketoconazole, itraconazole, posaconazole, voriconazole).
• Particular caution should be exercised and the dose reduced when taking Zomiren SR and nefazodone, fluvoxamine, and cimetidine.
• Particular caution should be exercised when taking alprazolam with fluoxetine, propoxyphene, oral contraceptives, sertraline, diltiazem, and macrolide antibiotics (e.g., erythromycin, clarithromycin, or troleandomycin).
• Concomitant use of Zomiren SR and HIV protease inhibitors (e.g., ritonavir) requires dose modification or discontinuation of alprazolam.
• Concomitant use of Zomiren SR and digoxin requires close monitoring of the patient for signs of digoxin toxicity.
• Theophylline may decrease the effect of benzodiazepines.

Taking Zomiren SR with food, drink, and alcohol

Alcohol should not be consumed during treatment with Zomiren SR.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine.
Zomiren SR should not be taken during pregnancy.
If the medicine is taken during pregnancy or if the patient becomes pregnant while taking alprazolam, they should be examined for potential fetal risk.
If it is necessary to administer the medicine in the last trimester of pregnancy, high doses should be avoided and the newborn should be monitored.
Benzodiazepines pass into breast milk in small amounts. Zomiren SR should not be taken during breastfeeding.

Driving and operating machinery

Zomiren SR causes impairment of psychophysical fitness. Before taking Zomiren SR, the patient should familiarize themselves with current local traffic laws.
While taking Zomiren SR, the patient should not drive vehicles or operate machinery.

Zomiren SR contains lactose monohydrate

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to take Zomiren SR

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
Zomiren SR is available in a dose of 0.5 mg and 1 mg.
Method of administration
Oral administration.
Treatment should be as short as possible. The doctor should frequently assess the patient's condition and the need to extend treatment, especially if the severity of the symptoms decreases and may not require pharmacological treatment. The total treatment time should not exceed 2-4 weeks. Long-term treatment is not recommended.
When starting treatment, the doctor will inform the patient about the limited duration of therapy, the gradual reduction of the dose during withdrawal of the medicine, and the possibility of withdrawal reactions.
During the use of benzodiazepines, including Zomiren SR, dependence and emotional or physical dependence may develop. This risk may increase with the dose and duration of treatment, so the smallest effective dose should be used for the shortest possible time, and the need for continued treatment should be frequently assessed with the doctor.
Recommended dose
The dose is determined by the doctor based on the severity of symptoms and the patient's individual response to treatment. If severe side effects occur after administration of the initial dose, the doctor may decide to reduce the dose.
If Zomiren SR is taken once a day, it is best to take it in the morning. The tablets should be swallowed whole; they should not be chewed, crushed, or divided.
Symptomatic treatment of anxiety disorders
The recommended initial dose is 1 mg per day, given once or in 2 divided doses.
The doctor may decide to increase it, depending on the patient's needs, to a maximum daily dose of 4 mg given once or in 2 divided doses.

Use in children and adolescents

Zomiren SR should not be taken by children and adolescents under 18 years of age.
Use in patients with kidney or liver function disorders
Use in patients with severe liver failure is contraindicated.
Use in elderly patients
The recommended initial dose is 0.5 mg to 1 mg per day, given once or in 2 divided doses. If necessary, the doctor may decide to gradually increase the dose, depending on the patient's tolerance to the medicine. If side effects occur, the doctor will decide to reduce the initial dose.

Taking a higher dose of Zomiren SR than recommended

Taking a higher dose of Zomiren SR than recommended may cause: ataxia (motor incoordination), drowsiness, speech disorders, coma, and respiratory depression. If worrying symptoms occur, the patient should immediately consult their doctor or pharmacist.

Missing a dose of Zomiren SR

A double dose should not be taken to make up for a missed dose.

Stopping treatment with Zomiren SR

The patient should not stop taking the medicine on their own.
Since the treatment is symptomatic, after its discontinuation, the symptoms of the disease may return.
The doctor will decide on a gradual reduction of the dose.
If the patient has any further doubts about the use of this medicine, they should consult their doctor.

4. Possible side effects

Like all medicines, Zomiren SR can cause side effects, although not everybody gets them.
If any of the following side effects persist or are troublesome, the patient should inform their doctor. The occurrence of some side effects depends entirely on the patient's individual susceptibility and the dose of the medicine. Side effects are usually observed at the beginning of therapy. They disappear as treatment continues or when the dose is reduced.
Frequency of side effects observed in clinical trials and after the medicine was placed on the market:
Very common side effects(may occur in more than 1 in 10 patients):

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

Common side effects(may occur in up to 1 in 10 patients):

• decreased appetite,
• confusion,
• disorientation,
• decreased libido (sex drive),
• increased libido,
• anxiety,
• insomnia,
• nervousness,
• balance disorders,
• coordination disorders,
• concentration disorders,
• excessive need for sleep,
• lethargy,
• tremors,
• blurred vision,
• nausea,
• skin rash,
• sexual disorders,
• weight loss,
• weight gain.

Uncommon side effects(may occur in up to 1 in 100 patients):

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

Side effects with unknown frequency(frequency cannot be estimated from available data):

• hyperprolactinemia (elevated prolactin levels),
• hypomania,
• aggressive behavior,
• hostile behavior,
• thought disorders,
• increased psychomotor activity,
• drug abuse,
• autonomic nervous system disorders (which controls the function of internal organs, smooth muscles, and glands),
• dystonia (muscle tone disorders),
• gastrointestinal disorders,
• hepatitis,
• liver function disorders,
• jaundice,
• angioedema,
• photosensitivity reactions,
• urinary retention,
• peripheral edema (swelling of the ankles, feet, or fingers),
• increased intraocular pressure.

Additionally, especially in patients taking other psychotropic medicines, with mental disorders, or abusing alcohol, a paradoxical reaction may occur with symptoms such as anxiety.
Other side effects have been observed rarely or very rarely: motor disorders, epilepsy, psychotic symptoms, a feeling of changed self, agranulocytosis (a significant decrease in the number of granulocytes), allergic reactions, or anaphylaxis (severe allergic reactions).
Benzodiazepines may cause physical and psychological dependence. If physical dependence occurs, sudden discontinuation of the medicine may cause withdrawal symptoms: headache, muscle pain, increased anxiety, tension, agitation, disorientation, irritability, a feeling of changed environment or self, hearing disorders, stiffness, and paresthesia of the limbs, hypersensitivity to light, noise, and touch, hallucinations, and seizures, insomnia, and mood changes. These symptoms are usually more severe in patients treated for a long time, with high doses of benzodiazepines, and in the case of sudden or rapid discontinuation of the medicine.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the patient should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Zomiren SR

The medicine should be stored in a place that is out of sight and reach of children.
The medicine should not be taken after the expiration date stated on the packaging. The expiration date refers to the last day of the specified month.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Zomiren SR contains

• The active substance of Zomiren SR is alprazolam. Each prolonged-release tablet contains 0.5 mg of alprazolam.
• Other ingredients are: lactose monohydrate, hypromellose, magnesium stearate, indigo carmine (E 132), quinoline yellow (E 104). See section 2 "Zomiren SR contains lactose monohydrate".

What Zomiren SR looks like and what the package contains

Greenish-yellow, round, slightly convex prolonged-release tablets
Packaging:30 prolonged-release tablets in blisters, in a cardboard box
To obtain more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Hungary, the country of export:

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer:

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
KRKA-FARMA d.o.o., V. Holjevca 20/E, 10450 Jastrebarsko, Croatia

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Hungarian, export country authorization number: OGYI-T-20462/01

Parallel import authorization number: 270/20

Date of leaflet approval: 18.08.2023

[Information about the trademark]