Zomiren

Leaflet attached to the packaging: patient information

Zomiren, 0.25 mg, tablets

Zomiren, 0.5 mg, tablets

Zomiren, 1 mg, tablets

Alprazolam

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms 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 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. 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 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

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 Zomiren in patients with depression.
Before planned surgery, the doctor should be informed about the use of Zomiren.

Zomiren and other medicines

Tell your doctor about all medicines you are taking now or have taken recently, 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 (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 increased 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 the dose reduced when taking Zomiren 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).
• 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

Alcohol should not be consumed during treatment with Zomiren.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult her doctor before taking this medicine.
Zomiren should not be taken during pregnancy.
If the medicine is taken 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 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 operating machinery

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

Zomiren contains lactose

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 as directed by the doctor. If in doubt, consult the doctor or pharmacist.
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 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.
At the start of 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, 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 the dose, depending on the patient's needs, up 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 (motor incoordination), drowsiness, speech disorders, coma, and respiratory depression. If worrying symptoms occur, the doctor should be contacted immediately.

Missing a dose of Zomiren

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

Stopping treatment with Zomiren

Treatment should not be stopped 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.
If there are any further doubts about the use of this medicine, the doctor should be consulted.

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 doctor should be informed. 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 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,
• 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.

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. 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 doctor or pharmacist should be informed. 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 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.
Do not use this medicine 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 25°C. Store in the original packaging to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer used. 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 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 what the pack contains

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 the tablet to make it easier to swallow and not to divide it 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 the tablet to make it easier to swallow and not to divide it 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 the tablet to make it easier to swallow and not to divide it 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, 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: