Patient Information Leaflet

Warning! Keep this leaflet. Information on the immediate packaging is in a foreign language.
Zomiren (Alprazolam Krka 1 mg)
1 mg, tablets
Alprazolamum
Zomiren and Alprazolam Krka 1 mg are different brand names for the same medicine.
Please read this leaflet carefully before taking the medicine, as it contains important information for the patient.

Keep this leaflet so that you can read it again if necessary.
If you have any doubts, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents

What Zomiren is and what it is used for
Important information before taking Zomiren
How to take Zomiren
Possible side effects
How to store Zomiren
Contents of the pack and other information

1. What Zomiren is and what it is used for

The active substance in Zomiren, alprazolam, belongs to a group of medicines called benzodiazepine derivatives and has anxiolytic (anti-anxiety) properties.
Zomiren is indicated for the treatment of symptoms of anxiety disorders in adults, exclusively in situations where symptoms are severe, impair normal functioning, or cause significant distress to the patient. This medicine is intended for short-term use only.

2. Important information before using Zomiren

When not to use Zomiren

if the patient is allergic to alprazolam and other benzodiazepines or to any of the other ingredients of this medicine (listed in section 6),
if the patient suffers from muscle weakness ( myasthenia gravis ) (a disease characterised by excessive fatigue and muscle weakness),
if the patient has severe respiratory insufficiency,
if the patient has sleep apnoea syndrome,
if the patient has severe hepatic insufficiency.

Zomiren must not be used in children and adolescents under 18 years of age.
Warnings and precautions
Before starting treatment with Zomiren, discuss this with your doctor.

if the medicine is used long-term, as dependence on the medicine may occur, especially in patients prone to drug or alcohol abuse. The need for continued treatment should be periodically reviewed by the doctor;
if the dose of the medicine is being reduced or if it is suddenly discontinued [withdrawal symptoms may occur (see section 4)];
if the medicine is used in patients with depression, suicidal thoughts or tendencies;
if the patient is taking other benzodiazepines (increased risk of dependence);
if the patient is simultaneously taking opioids, sleeping medicines, sedatives or consuming alcohol (the effects of these medicines or alcohol may be intensified);
if restlessness, psychomotor agitation, irritability, aggression, hallucinations, anger, nightmares, illusions, psychosis, inappropriate behaviour or other behavioural disturbances occur. If any of these symptoms appear, treatment with the medicine should be discontinued and the patient should contact the doctor;
if the patient has glaucoma;
if the patient has impaired renal or hepatic function. Like other benzodiazepines, Zomiren may cause anterograde amnesia, which occurs several hours after taking the medicine. In such a case, the patient should ensure 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) weakening of the musculoskeletal system, which may lead to falls, often with serious consequences for such patients.

Episodes of hypomania and mania have been reported in association with the use of Zomiren in patients with depression.
Before a planned surgery, inform the doctor about taking Zomiren.
Zomiren with other medicines
Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as about medicines the patient plans to take.

Exercise particular caution when using Zomiren concomitantly with opioids, as they have a depressant effect on the respiratory system (slowing and shallowing breathing). This is associated with the risk of excessive sedation, respiratory depression, coma, and even death.
Zomiren may enhance the effects of antipsychotics, hypnotics, anxiolytics, sedatives, antidepressants, opioid analgesics, anticonvulsants, anaesthetics, and antihistamines.
With opioid analgesics, euphoria may be intensified, which may lead to increased psychological dependence.
Alcohol consumption must not be taken during treatment with Zomiren.
Concomitant use of Zomiren with certain systemic antifungal medicines (e.g. ketoconazole, itraconazole, posaconazole, voriconazole) is not recommended.
Exercise particular caution and consider dose reduction when using Zomiren concomitantly with nefazodone, fluvoxamine, and cimetidine.
Exercise particular caution when using alprazolam with fluoxetine, propoxyphene, oral contraceptives, sertraline, diltiazem, and macrolide antibiotics (e.g. erythromycin, clarithromycin, or troleandomycin).
Concomitant use of Zomiren and HIV protease inhibitors (e.g. ritonavir) requires dose adjustment or discontinuation of alprazolam.
Patients taking alprazolam and digoxin concomitantly should be closely monitored for signs (objective and subjective) of digoxin toxicity.
Theophylline may reduce the effect of benzodiazepines.

Taking Zomiren with food, drink and alcohol
Alcohol must not be consumed during treatment with Zomiren.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor before using this medicine.
Use of this medicine during pregnancy is not recommended.
If the medicine is used during pregnancy or if the patient becomes pregnant while taking alprazolam, she should be evaluated for potential risk to the foetus.
If administration of the medicine is necessary in the late stages of pregnancy, high doses should be avoided and the newborn should be monitored.
Benzodiazepines pass into human milk in small concentrations.
Zomiren must not be used during breastfeeding.
Driving and operating machinery
Zomiren may impair psycho-physical performance. Before using Zomiren, patients should familiarise themselves with current local traffic regulations.
Patients should not drive vehicles or operate machinery while taking Zomiren.
Zomiren contains monohydrate lactose
If a patient has previously been diagnosed with intolerance to certain sugars, the patient should contact the doctor before taking the medicine.

3. How to use Zomiren

This medicine should always be used exactly as directed by the physician. If in doubt, consult
your doctor or pharmacist.
Zomiren is available in the following doses: 0.25 mg, 0.5 mg, 1 mg.
Method of administration
Oral administration.
Treatment should last as short a time as possible.
The physician should regularly assess the patient's condition and the need for continuing treatment, especially if the severity of symptoms has decreased and may no longer require pharmacological treatment. The total duration of treatment should not exceed 2–4 weeks. Prolonged treatment is not recommended.
At the beginning of treatment, the physician will inform the patient about the limited duration of therapy, the need for gradual dose reduction when discontinuing the medicine, and the possibility of withdrawal reactions.
During treatment with benzodiazepines, including Zomiren, dependence and emotional or physical dependence may develop. This risk may increase with dose and duration of treatment; therefore, the lowest effective dose should be used for the shortest possible time, and the need for continuing treatment should be regularly reviewed with the physician.
Recommended dose
The dose is determined by the physician based on symptom severity and the individual patient's response to treatment. If severe adverse reactions occur after the initial dose, the physician may decide to reduce the dose.
Treatment of symptomatic anxiety states
The recommended initial dose is 0.25 mg or 0.5 mg three times daily.
The physician 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 used in children and adolescents under 18 years of age.
Use in patients with renal or hepatic impairment
Use in patients with severe hepatic insufficiency is contraindicated.
Use in elderly patients
The recommended initial dose is 0.25 mg two or three times daily.
If necessary, the physician may decide to gradually increase the dose depending on the patient's tolerance to the medicine. If adverse reactions occur, the physician will decide whether to reduce the initial dose.
Use of a higher than recommended dose of Zomiren
Taking a higher than recommended dose of Zomiren may cause: ataxia (impaired coordination of movement), drowsiness, speech disturbances, coma, and respiratory depression. If disturbing symptoms occur, contact your doctor immediately.
Missed dose of Zomiren
Do not take a double dose to make up for a missed dose.
Discontinuation of Zomiren
Do not stop taking this medicine without consulting your doctor.
Since treatment is symptomatic, symptoms may return after discontinuation.
The physician will decide on a gradual dose reduction.
If you have any further questions about the use of this medicine, consult your doctor.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the adverse reactions listed below persist or become troublesome, inform your doctor.
The occurrence of certain adverse reactions depends entirely on individual patient susceptibility and the dose administered. Adverse reactions
are usually observed at the beginning of therapy. They subside with continued treatment or when the dose is reduced.
Frequency of adverse reactions observed in clinical trials and after marketing of the medicine:
Very common adverse reactions (may affect more than 1 in 10 people):

depression,
sedation,
somnolence,
ataxia (impaired muscle coordination),
memory disturbances,
speech disorders,
dizziness,
headache,
constipation,
dry mouth,
fatigue,
irritability.

Common adverse reactions (may affect up to 1 in 10 people):

decreased appetite,
confusion,
disorientation,
decreased libido (sex drive),
increased libido,
anxiety,
insomnia,
nervousness,
impaired balance,
incoordination,
attention disturbances,
excessive need for sleep,
lethargy,
tremor,
blurred vision,
nausea,
skin inflammation,
sexual dysfunction,
weight decrease,
weight increase.

Uncommon adverse reactions (may affect up to 1 in 100 people):

mania,
hallucinations,
anger,
agitation,
dependence,
amnesia,
muscle weakness,
urinary incontinence,
irregular menstruation,
drug withdrawal syndrome.

Adverse reactions with unknown frequency (frequency cannot be estimated from available data):

hyperprolactinaemia (increased prolactin levels),
hypomania,
aggressive behaviour,
hostile behaviour,
thinking disturbances,
increased psychomotor activity,
drug abuse,
autonomic nervous system dysfunction (which controls the function of internal organs, smooth muscles and glands),
dystonia (muscle tone disorders),
gastrointestinal disturbances,
hepatitis,
hepatic function abnormalities,
jaundice,
angioedema,
photosensitivity reactions,
urinary retention,
peripheral oedema (swelling of ankles, feet or fingers),
increased intraocular pressure.

Additionally, particularly in patients taking other psychotropic medicines, those with psychiatric disorders or alcohol abuse, paradoxical reactions such as anxiety may occur.
Other adverse reactions observed rarely or very rarely include: motor disturbances, seizures, psychotic symptoms, feelings of depersonalization, agranulocytosis (marked decrease in granulocyte count), allergic reactions or anaphylaxis (severe allergic reactions).
Benzodiazepines may cause physical and psychological dependence. If physical dependence develops, abrupt discontinuation of Zomiren may lead to withdrawal symptoms:
headache, muscle pain, increased anxiety, feeling of tension, agitation, disorientation, irritability, feelings of altered environment or self, auditory disturbances, limb stiffness and tingling,
hypersensitivity to light, noise and touch, hallucinations and seizures, insomnia and mood changes.
These symptoms are usually more pronounced in patients treated long-term with high doses of benzodiazepines and in cases of abrupt or rapid discontinuation of the medicine.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
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 adverse reactions allows the collection of further information on the safety of the medicine.

5. How to store Zomiren

Keep this 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 stated month.
Do not store above 30°C. Store in the original packaging to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Zomiren contains

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

What Zomiren looks like and contents of the pack
Light greenish-blue to pale blue, marbled, round, biconvex tablets with bevelled edges, marked with a dividing line on one side and an embossed "1" on the other side. The dividing line is intended only to facilitate tablet fragmentation for easier swallowing, and does not ensure division into equal doses.
30 tablets in PVC/PE/PVDC-Al blisters, packed in a cardboard box.
For more detailed information, please contact the Marketing Authorisation Holder or the parallel importer.
Marketing Authorisation Holder in Spain, the country of export:
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
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
Parallel importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing Authorisation number in Spain, the country of export: 723969.7
Parallel import licence number: 72/20