ZOMIREN 1 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Zomiren SR, 0.5 mg, Modified Release Tablets
3. Zomiren SR, 1 mg, Modified Release Tablets
   1. Read the Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.
   2. Table of Contents of the Leaflet
4. What is Zomiren SR and what is it used for
5. Important information before taking Zomiren SR
   1. When not to take Zomiren SR
   2. Warnings and precautions
   3. Zomiren SR and other medications
   4. Using Zomiren SR with food, drink, and alcohol
   5. Pregnancy and breastfeeding
   6. Driving and using machines
   7. Zomiren SR contains lactose
6. How to take Zomiren SR
   1. Use in children and adolescents
   2. Use of a higher than recommended dose of Zomiren SR
   3. Missing a dose of Zomiren SR
   4. Stopping treatment with Zomiren SR
7. Possible side effects
   1. Reporting side effects
8. How to store Zomiren SR
9. Contents of the pack and other information
   1. What Zomiren SR contains
   2. What Zomiren SR 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 SR, 0.5 mg, Modified Release Tablets

Zomiren SR, 1 mg, Modified Release Tablets

Alprazolam

Read the Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medication has been prescribed specifically for you. Do not pass it on to others. The medication may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not mentioned in this leaflet, they should inform 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 pack 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 medications 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 symptoms are severe, prevent normal functioning, or are very bothersome for the patient. This medication 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 or other benzodiazepines or any of the other ingredients of this medication (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, the patient should discuss it with their doctor.

• if the medication is used for a long time (possible development of dependence on the medication, especially in patients prone to drug or alcohol abuse). The need for continued treatment should be periodically assessed by the doctor;
• if the dose of the medication is reduced or it is suddenly discontinued [possible occurrence of withdrawal symptoms (see section 4)];
• if the medication is used in patients with depression, with suicidal thoughts or tendencies;
• if the patient is taking other benzodiazepines (increased risk of dependence);
• if opioids, hypnotics, sedatives, or alcohol are used concurrently (the effect of these medications or alcohol may be enhanced);
• if restlessness, psychomotor agitation, irritability, aggression, delusions, anger, nightmares, hallucinations, psychosis, inappropriate behavior, or other behavioral disorders occur. In case of the occurrence of these symptoms, the use of the medication should be discontinued and the doctor should be consulted;
• in patients with glaucoma;
• in patients with impaired renal or hepatic function. Like other benzodiazepines, Zomiren SR may cause anterograde amnesia, which occurs a few hours after taking the medication. 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 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 SR in patients with depression.
Before planned surgery, the patient should inform their doctor about taking Zomiren SR.

Zomiren SR and other medications

The patient should tell their doctor about all medications they are currently taking or have recently taken, as well as any medications they plan to take.

• Particular caution should be exercised when using Zomiren SR concurrently 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 SR may enhance the effect of antipsychotic, hypnotic, anxiolytic, sedative, antidepressant, opioid analgesic, anticonvulsant, anesthetic, and antihistamine medications.
• 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 SR.
• It is not recommended to take Zomiren SR concurrently with certain oral antifungal medications (e.g., ketoconazole, itraconazole, posaconazole, voriconazole).
• Particular caution should be exercised and a dose reduction should be considered when using Zomiren SR concurrently with 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).
• Concurrent use of Zomiren SR and HIV protease inhibitors (e.g., ritonavir) requires dose modification or discontinuation of alprazolam.
• 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 treatment with Zomiren SR.

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 medication.
Zomiren SR should not be used during pregnancy.
If the medication 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 medication 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 SR should not be used during breastfeeding.

Driving and using machines

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

Zomiren SR contains lactose

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

3. How to take Zomiren SR

This medication should always be taken according to the doctor's recommendations. In case of doubts, the patient should consult their 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 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.
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 medication, 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 patient should use the smallest effective dose for the shortest possible time and frequently assess the need to continue treatment with their 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.
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 the dose, depending on the patient's needs, up 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 impaired renal or hepatic function
Use in patients with severe liver failure 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 medication. If side effects occur, the doctor will decide to reduce the initial dose.

Use of a higher than recommended dose of Zomiren SR

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

Missing a dose of Zomiren SR

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

Stopping treatment with Zomiren SR

The patient should not stop taking the medication on their own.
Since the treatment is symptomatic, after its discontinuation, the symptoms of the disease may return.
The doctor will decide to gradually reduce the dose..
In case of any further doubts related to the use of this medication, the patient should consult their doctor.

4. Possible side effects

Like all medications, Zomiren SR can cause side effects, although not everybody gets them.
If any of the following side effects persist or are bothersome, 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 medication. 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 medication 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,
• medication 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,
• medication 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.

Additionally, especially in patients taking other psychotropic medications, 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 medication 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 medication.

Reporting side effects

If any side effects occur, including any not mentioned in this leaflet, the patient should inform their 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
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.
By reporting side effects, more information can be gathered on the safety of the medication.

5. How to store Zomiren SR

The medication should be stored in a place invisible and inaccessible to children.
Do not use this medication after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
There are no special precautions for storage.
Medications should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Zomiren SR contains

• The active substance of Zomiren SR is alprazolam. Each modified-release tablet contains 0.5 mg or 1 mg of alprazolam.
• Other ingredients are: lactose monohydrate, hypromellose, magnesium stearate, indigotine (E 132) - only in 0.5 mg tablets, quinoline yellow (E 104) - only in 0.5 mg tablets. See section 2 "Zomiren SR contains lactose".
• Only in 0.5 mg tablets.

What Zomiren SR looks like and contents of the pack

0.5 mg: greenish-yellow, round, slightly convex modified-release tablets
1 mg: white, round, slightly convex modified-release tablets
Packaging:30 modified-release 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 medication, the patient should 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: