Alprazolam
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.
Zomiren SR should not be used in children and adolescents under 18 years of age.
Before starting treatment with Zomiren SR, the patient should discuss it with their doctor.
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.
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.
Alcohol should not be consumed during treatment with Zomiren SR.
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.
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.
If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medication.
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.
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.
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.
A double dose should not be taken to make up for a missed dose.
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.
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):
Common side effects(may occur in up to 1 in 10 patients):
Uncommon side effects(may occur in up to 1 in 100 patients):
Side effects with unknown frequency(frequency cannot be estimated from the available data):
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.
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.
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.
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
KRKA, d. d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
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
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