Zomiren

Leaflet attached to the packaging: patient information

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

Zomiren (Alprazolam TAD)

1 mg, tablets
Alprazolamum
Zomiren and Alprazolam TAD 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.

• The leaflet should be kept so that it can be read 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 inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

1. What is Zomiren and what is it used for

The active substance of Zomiren, alprazolam, belongs to a group of drugs called benzodiazepine derivatives and has an anxiolytic effect.
Zomiren 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 drug is intended for short-term use only.

2. Important information before using Zomiren

When not to use Zomiren

Zomiren should not be used in children and adolescents under 18 years of age.

Warnings and precautions

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

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

Zomiren and other drugs

The doctor should be told about all the drugs the patient is currently taking or has recently taken, as well as about the drugs the patient plans to take.

• Particular caution should be exercised when using Zomiren 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 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.
• It is not recommended to take Zomiren at the same time as certain antifungal drugs for internal use (e.g., ketoconazole, itraconazole, posaconazole, voriconazole).
• Particular caution should be exercised and a dose reduction should be considered when using Zomiren 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 concomitant use of Zomiren and HIV protease inhibitors (e.g., ritonavir) requires dose modification or discontinuation of alprazolam.
• Patients taking alprazolam and digoxin should be closely monitored for signs of digoxin toxicity (objective and subjective).
• Theophylline may decrease the effect of benzodiazepines.

Using Zomiren with food, drink, and alcohol

Alcohol should not be consumed during the use of Zomiren.

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 her doctor before using this drug.
Zomiren should not be used during pregnancy.
If the drug is used during pregnancy or if the patient becomes pregnant while using alprazolam, she should be examined for potential fetal risk.
If it is necessary to administer the drug 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 should not be used during breastfeeding.

Driving and using machines

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

Zomiren contains lactose monohydrate

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

3. How to use Zomiren

This drug should always be used in accordance with the doctor's recommendations. In case of doubts, the patient should consult their doctor or pharmacist.
Zomiren is available in the following doses: 0.25 mg, 0.5 mg, 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 drug, and the possibility of withdrawal reactions.
During the use of benzodiazepines, including Zomiren, 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.
Symptomatic treatment of anxiety disorders
The recommended initial dose is 0.25 mg or 0.5 mg three times a day.
The doctor may decide to increase it, depending on the patient's needs, to a maximum daily dose of 4 mg divided into smaller doses, taken throughout the day.

Use in children and adolescents

Zomiren should not be used in children and adolescents under 18 years of age.

Use in patients with kidney or liver function disorders

The use of Zomiren in patients with severe liver failure is contraindicated.

Use in elderly patients

The recommended initial dose is 0.25 mg two or three times a day.
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

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

Missing a dose of Zomiren

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

Discontinuing use of Zomiren

The patient should not discontinue the use of Zomiren on their own.
Because 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, the patient should consult their doctor.

4. Possible side effects

Like all drugs, Zomiren may cause side effects, although they do not occur in every patient.
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 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 introduced to 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 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,
• 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 fingers),
• 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 occurs, sudden discontinuation of Zomiren 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 drug.

Reporting side effects

If any side effects occur, including any side effects not listed in the 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:
Aleje 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 drug.

5. How to store Zomiren

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.
Store at a temperature below 30°C.
Store in the original packaging to protect against moisture.
Drugs should not be thrown into the sewage system or household waste containers. The patient should ask their pharmacist how to dispose of unused drugs. This will help protect the environment.

6. Package contents and other information

What Zomiren contains

• The active substance of Zomiren is alprazolam. Each tablet contains 1 mg of alprazolam.
• Other ingredients are: lactose monohydrate, cornstarch, povidone K 25, crospovidone (type A), polysorbate 80, magnesium stearate, blue patent V (E 131). See section 2 "Zomiren contains lactose monohydrate".

What Zomiren looks like and what the package contains

Light blue-green to pale blue, marbled, round, biconvex tablets with a broken edge, with a dividing line on one side and an embossing "1" on the other. The dividing line on the tablet only facilitates its breaking for easier swallowing and does not divide it into equal doses.
Packaging:30 tablets in blisters, in a cardboard box.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Portugal, the country of export:

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

Manufacturer:

Krka, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

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
Portuguese marketing authorization number, country of export: 5756366
5756358

Parallel import authorization number: 204/24

Date of leaflet approval: 16.05.2024

[Information about the trademark]