Zomiren

Leaflet attached to the packaging: patient information

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

Zomiren (Alprazolam TAD), 1 mg, tablets

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

You should carefully read the contents of the leaflet before taking the medicine, 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 medicine has been prescribed to 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 tell 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 taking Zomiren
• 3. How to take Zomiren
• 4. Possible side effects
• 5. How to store Zomiren
• 6. Contents of the packaging and other information

1. What is Zomiren and what is it used for

The active substance of Zomiren, alprazolam, belongs to a group of medicines 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 medicine is intended for short-term use only.

2. Important information before taking Zomiren

When not to take Zomiren

• if the patient is allergic to alprazolam and 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 fatigue and muscle weakness),
• if the patient has severe respiratory failure,
• if the patient has sleep apnea syndrome,
• if the patient has severe liver failure.

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

Warnings and precautions

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

• if the medicine is taken for a long time, as dependence on the medicine may occur, 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 stopped abruptly [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 the patient is taking opioids, sleeping pills, sedatives, or drinking alcohol (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. In case of the occurrence of these symptoms, the use of the medicine should be discontinued and the doctor should be consulted;
• if the patient has glaucoma;
• if the patient has kidney or liver function disorders. Like other benzodiazepines, Zomiren may cause anterograde amnesia, which occurs a few hours after taking the medicine. In such a case, the patient should have uninterrupted sleep for 7-8 hours. Benzodiazepines and similar-acting substances should be used with caution in elderly patients, due to the risk of excessive sedation and (or) muscle weakness, which may 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 in patients with depression.
Before planned surgery, the patient should inform their doctor about taking Zomiren.

Zomiren 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 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 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.
• It is not recommended to take Zomiren with certain oral antifungal medicines (e.g., ketoconazole, itraconazole, posaconazole, voriconazole).
• Particular caution should be exercised and a dose reduction should be considered when taking Zomiren with 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).
• 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.

Taking Zomiren with food, drink, and alcohol

Alcohol should not be consumed during treatment with Zomiren.

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 should not be used during pregnancy.
If the medicine is used 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 should not be used during breastfeeding.

Driving and using machines

Zomiren causes impairment of psychophysical fitness. Before taking Zomiren, the patient should familiarize themselves with the current local traffic laws.
While taking 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 medicine.

3. How to take Zomiren

This medicine should always be taken according to the doctor's recommendations. In case of doubts, the patient should consult their doctor or pharmacist.
Zomiren is available in the following strengths: 0.25 mg, 0.5 mg, 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 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, 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 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

Use in patients with severe liver failure is contraindicated.

Use in elderly patients

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

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

Missing a dose of Zomiren

The patient should not take a double dose to make up for a missed dose.

Stopping treatment with Zomiren

The patient should not stop taking 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 medicine, the patient should consult their doctor.

4. Possible side effects

Like all medicines, Zomiren 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 marketing authorization of the medicine:
Very common side effects(may affect more than 1 in 10 people):

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

Common side effects(may affect up to 1 in 10 people):

• 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 affect up to 1 in 100 people):

• 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 the 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 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. These symptoms are usually more severe in patients treated for a long time, with high doses of benzodiazepines, and in case of sudden or rapid discontinuation of the medicine.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +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

The medicine should be stored out of sight and reach of children.
Zomiren should not be used after the expiration date stated on the packaging. The expiration date refers to the last day of the specified month.
Store at a temperature below 30°C.
Store in the original packaging to protect from moisture.
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. Contents of the packaging and other information

What Zomiren contains

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

What Zomiren looks like and what the packaging contains

Light blue-green to pale blue, marbled, round, biconvex tablets with a score line on one side and the imprint "1" on the other. The score line on the tablet is only to facilitate breaking the tablet and not to divide it into equal doses.
Packaging:30 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 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:

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 Portugal, the country of export:5756366

Parallel import authorization number: 60/23 Date of leaflet approval: 30.03.2023

[Information about the trademark]