ZOMIREN 0.25 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Zomiren, 0.25 mg, tablets
3. Zomiren, 0.5 mg, tablets
4. Zomiren, 1 mg, tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
5. What is Zomiren and what is it used for
6. Important information before taking Zomiren
   1. When not to take Zomiren
   2. Warnings and precautions
   3. Zomiren and other medicines
   4. Taking Zomiren with food, drink, and alcohol
   5. Pregnancy and breastfeeding
   6. Driving and using machines
   7. Zomiren contains lactose
7. How to take Zomiren
   1. Use in children and adolescents
   2. Use in patients with kidney or liver function disorders
   3. Use in elderly patients
   4. Taking a higher dose of Zomiren than recommended
   5. Missing a dose of Zomiren
   6. Stopping treatment with Zomiren
8. Possible side effects
   1. Reporting side effects
9. How to store Zomiren
10. Contents of the pack and other information
    1. What Zomiren contains
    2. What Zomiren looks like and contents of the pack
    3. Marketing authorization holder
    4. Manufacturer
    5. Date of last revision of the leaflet:

Package Leaflet: Information for the Patient

Zomiren, 0.25 mg, tablets

Zomiren, 0.5 mg, tablets

Zomiren, 1 mg, tablets

Alprazolam

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. 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 pack 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, exclusively in situations where 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

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

Warnings and precautions

Before starting treatment with Zomiren, discuss it with your doctor.

withdrawal symptoms (see section 4)];

Episodes of hypomania and mania have been reported in association with the use of Zomiren in patients with depression.
Before planned surgery, inform your doctor that you are taking Zomiren.

Zomiren and other medicines

Tell your doctor about all medicines you are taking now or have recently taken, as well as any medicines you plan to take.

• Particular caution should be exercised when taking Zomiren with opioids, as they have a depressant effect on the respiratory system (slowing and shallowing 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, tranquilizing, 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 increased psychological dependence.
• Do not drink alcohol 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.
• Patientstaking 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

Do not drink alcohol during treatment with Zomiren.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before taking this medicine.
Zomiren should not be taken during pregnancy.
If the medicine is taken during pregnancy or if you become pregnant while taking alprazolam, you 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 taken during breastfeeding.

Driving and using machines

Zomiren causes impairment of psychophysical fitness. Before taking Zomiren, familiarize yourself with current local traffic laws.
Do not drive vehicles or operate machines while taking Zomiren.

Zomiren contains lactose

If you have been diagnosed with intolerance to some sugars, consult your doctor before taking the medicine.

3. How to take Zomiren

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Method of administration
Oral use.
Treatment should be as short as possible.
The doctor should frequently assess the patient's condition and the need to continue 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 you 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, dependence and emotional or physical dependence may develop. This risk may increase with dose and duration of treatment, so the smallest effective dose should be used for the shortest possible time, and the need to continue 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.
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 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 0.25 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, contact your doctor immediately.

Missing a dose of Zomiren

Do not take a double dose to make up for a missed dose.

Stopping treatment with Zomiren

Do not stop taking the medicine on your 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 you have any further questions about the use of this medicine, ask your 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 bother you, tell your doctor.
The occurrence of some side effects depends entirely on the individual patient's 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 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 (sexual desire),
• increased libido,
• anxiety,
• insomnia,
• nervousness,
• balance disorders,
• coordination disorders,
• concentration disorders,
• excessive need for sleep,
• lethargy,
• tremor,
• 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 control 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 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, insomnia, and mood changes.
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 you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Zomiren

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Store in a temperature below 25°C. Store in the original packaging to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Zomiren contains

• The active substance of Zomiren is alprazolam. Each tablet contains 0.25 mg, 0.5 mg, or 1 mg of alprazolam.
• The other ingredients are: lactose monohydrate, cornstarch, povidone K25, crospovidone (type A), polysorbate 80, magnesium stearate, carmine (E 120) (only in 0.5 mg tablets), patent blue V (E 131) (only in 1 mg tablets). See section 2 "Zomiren contains lactose".

What Zomiren looks like and contents of the pack

0.25 mg: white to almost white, round, biconvex tablets with a score line on one side and an imprint of "0.25" on the other side. The score line on the tablet is only to facilitate breaking and not to divide into equal doses.
0.5 mg: pale pink, marbled, round, biconvex tablets with a score line on one side and an imprint of "0.5" on the other side. The score line on the tablet is only to facilitate breaking and not to divide into equal doses.
1 mg: light greenish-blue to pale blue, marbled, round, biconvex tablets with a score line on one side and an imprint of "1" on the other side. The score line on the tablet is only to facilitate breaking and not to divide into equal doses.
Packaging:30 tablets in blisters, in a cardboard box

Marketing authorization holder

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
To obtain more detailed information about this medicine, please contact the local representative of the marketing authorization holder:
Krka - Polska Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
Poland
phone: +48 22 573 75 00

Date of last revision of the leaflet: