Zomiren Sr

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Zomiren SR (Helex SR), 0.5 mg, prolonged-release tablets

Alprazolam
Zomiren SR and Helex SR are different trade names for the same drug.

You should carefully read the contents of the leaflet before using the drug, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This drug has been prescribed to a specific person. It should not be given to others. The drug 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 tell their doctor or pharmacist. 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. Contents of the packaging 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 drugs called benzodiazepine derivatives and has an anxiolytic effect.
Zomiren SR is indicated for the treatment of symptoms of anxiety disorders in adults, exclusively in situations where the symptoms are severe, prevent normal functioning, or are very troublesome for the patient. This drug 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 and other benzodiazepines or any of the other ingredients of this drug (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 used in children and adolescents under 18 years of age.

Warnings and precautions

Before starting treatment with Zomiren SR, you should discuss it with your doctor.

• if the drug is used for a long time (possible development of drug dependence, 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 drug is reduced or it is suddenly discontinued [possible occurrence of withdrawal symptoms (see section 4)];
• if the drug is used in patients with depression, with suicidal thoughts or tendencies;
• if the patient is taking other benzodiazepines (increased risk of dependence);
• if opioids, sleeping pills, sedatives, or alcohol are used at the same time (the effect of these drugs or alcohol may be enhanced);
• if restlessness, psychomotor agitation, irritability, aggression, delusions, anger, nightmares, hallucinations, psychosis, inappropriate behavior, or other behavioral disorders occur. In the event of the appearance of these symptoms, the use of the drug should be discontinued and the doctor should be contacted;
• in patients with glaucoma;
• in patients with renal or hepatic impairment. Like other benzodiazepines, Zomiren SR may cause anterograde amnesia, which occurs a few hours after taking the drug. 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) muscle weakness, which can lead to falls, often with serious consequences for such a patient.

Episodes of hypomania and mania have been reported in association with the use of Zomiren SR in patients with depression.
Before planned surgery, the doctor should be informed about the use of Zomiren SR.

Zomiren SR and other drugs

The doctor should be told about all drugs currently being taken by the patient, as well as those that the patient plans to take.

• Particular caution should be exercised when using Zomiren SR with opioids, as they have a depressive 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 drugs.
• 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 the use of Zomiren SR.
• It is not recommended to take Zomiren SR at the same time as certain oral antifungal drugs (e.g., ketoconazole, itraconazole, posaconazole, voriconazole).
• Particular caution should be exercised and a dose reduction should be considered when using Zomiren SR and nefazodone, fluvoxamine, and cimetidine.
• Particular caution should be exercised when using alprazolam with fluoxetine, propoxyphene, oral contraceptives, sertraline, diltiazem, and macrolide antibiotics (e.g., erythromycin, clarithromycin, or troleandomycin).
• The concurrent use of Zomiren SR and HIV protease inhibitors (e.g., ritonavir) requires dose modification or discontinuation of alprazolam.
• The concurrent use of Zomiren SR and digoxin requires close monitoring of the patient for signs of digoxin toxicity.
• Theophylline may decrease the effect of benzodiazepines.

Using Zomiren SR with food, drink, and alcohol

Alcohol should not be consumed during the use of Zomiren SR.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects that she may be pregnant, or plans to have a child, she should consult a doctor before using this drug.
Zomiren SR should not be used during pregnancy.
If the drug is used during pregnancy or if the patient becomes pregnant while taking alprazolam, she should be examined for potential fetal risk.
If it is necessary to administer the drug in the last period of pregnancy, high doses should be avoided and the newborn should be monitored.
Benzodiazepines pass into human milk in small amounts. Zomiren SR should not be used during breastfeeding.

Driving and using machines

Zomiren SR causes impairment of psychophysical fitness. Before using Zomiren SR, you should familiarize yourself with current local traffic laws.
During the use of Zomiren SR, you should not drive vehicles or operate machines.

Zomiren SR contains lactose monohydrate

If the patient has previously been diagnosed with intolerance to some sugars, the patient should contact their doctor before taking the drug.

3. How to take Zomiren SR

This drug should always be used in accordance with the doctor's recommendations. In case of doubts, you should consult a doctor or pharmacist.
Zomiren SR is available in a dose of 0.5 mg and 1 mg.
Method of administration
Oral administration.
Treatment should last 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 in the patient decreases and may not require pharmacological treatment. The total treatment time should not exceed 2-4 weeks. Long-term treatment is not recommended.
At the start of treatment, the doctor will inform about the limited duration of therapy, the gradual reduction of the dose during withdrawal of the drug, 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 individual patient's 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 used in children and adolescents under 18 years of age.
Use in patients with renal or hepatic impairment
Use in patients with severe hepatic impairment 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 drug. If side effects occur, the doctor will decide to reduce the initial dose.

Use of a higher than recommended dose of Zomiren SR

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

Missing a dose of Zomiren SR

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

Discontinuation of Zomiren SR

The use of the drug should not be discontinued without consulting a doctor.
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..
In case of any further doubts related to the use of this drug, you should consult a doctor.

4. Possible side effects

Like all drugs, this drug can cause side effects, although they do not occur in everyone.
If any of the following side effects persist or are troublesome, you should inform your doctor. The occurrence of some side effects depends entirely on the individual patient's susceptibility and the dose of the drug. 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 drug 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 (sexual desire),
• 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,
• drug 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 toes), increased intraocular pressure.

In addition, especially in patients taking other psychotropic drugs, 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 develops, sudden discontinuation of the drug may cause withdrawal symptoms: headache, muscle pain, increased anxiety, tension, agitation, disorientation, irritability, changed perception of the environment or oneself, hearing disorders, stiffness, and paresthesia of the limbs, hypersensitivity to light, noise, and touch, hallucinations, and seizures. 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 drug.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor or pharmacist. 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, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
By reporting side effects, you can help gather more information on the safety of the drug.

5. How to store Zomiren SR

The drug should be stored in a place that is invisible and inaccessible to children.
The drug should not be used after the expiration date stated on the packaging. The expiration date indicates the last day of the specified month.
There are no special precautions for storage.
Drugs should not be thrown into the sewage system or household waste containers. You should ask your pharmacist how to dispose of unused drugs. This will help protect the environment.

6. Contents of the packaging and other information

What Zomiren SR contains

• The active substance of the drug 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 packaging contains

Greenish-yellow, round, slightly convex prolonged-release tablets.
Packaging:30 prolonged-release tablets in blisters, in a cardboard box
In order to obtain more detailed information, you 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:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Hungary, the country of export:OGYI-T-20462/01

Parallel import authorization number: 305/23

Date of leaflet approval: 22.12.2023

[Information about the trademark]