Package leaflet: Information for the patient

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

Keep this leaflet, as you may need to read it again.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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, but only 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 has muscle weakness ( myasthenia gravis ) (a disease characterized 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 may occur, especially in patients prone to drug or alcohol abuse. The need for continued treatment should be periodically evaluated 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 using other benzodiazepines (increased risk of dependence);
if the patient is simultaneously using opioids, hypnotics, sedatives or consuming alcohol (the effects of these medicines or alcohol may be intensified);
if restlessness, psychomotor agitation, irritability, aggression, hallucinations, rage, nightmares, delusions, 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 their doctor;
if the patient has glaucoma;
if the patient has impaired kidney or liver function. Like other benzodiazepines, Zomiren may cause anterograde amnesia, which occurs several hours after taking the medicine. In such cases, the patient should ensure uninterrupted sleep for 7-8 hours. Benzodiazepines and similar-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 and other medicines
Tell your doctor about all medicines currently or recently taken by the patient, as well as any medicines the patient plans to take.

Extreme caution is required when using Zomiren together with opioids, as they have a depressant effect on the respiratory system (slowing and shallowing of 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.
In the case of 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.
Extreme caution is required and dose reduction should be considered when Zomiren is used concomitantly with nefazodone, fluvoxamine, and cimetidine.
Extreme caution is required when using alprazolam together 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 simultaneously should be closely monitored for signs (objective and subjective) related to digoxin toxicity.
Theophylline may reduce the effect of benzodiazepines.

Use of 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 have a child, 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 fetal risk.
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-motor performance. Before using Zomiren, patients should familiarize themselves with current local traffic regulations.
Patients should not drive vehicles or operate machinery while taking Zomiren.
Zomiren contains monohydrate lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact their doctor before taking the medicine.

3. How to use Zomiren

This medicine should always be used exactly as prescribed by the doctor. In case of doubt, consult
your doctor or pharmacist.
Zomiren is available in the following strengths: 0.25 mg, 0.5 mg, 1 mg.
Route of administration
Oral administration.
Treatment should be as short as possible.
The doctor should regularly assess the patient's condition and the need for continued treatment, especially if
the severity of the patient's symptoms decreases and may no longer require pharmacological treatment.
The total duration of treatment 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 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 continued treatment should be
regularly reviewed 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 adverse reactions occur after the initial dose, the doctor may decide to reduce the dose.
Treatment of symptoms of anxiety
The recommended initial dose is 0.25 mg or 0.5 mg three times daily.
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 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 doctor may decide to gradually increase the dose depending on the patient's tolerance.
If adverse reactions occur, the doctor may decide to reduce the initial dose.
Use of a higher than recommended dose of Zomiren
Use of a higher than recommended dose of Zomiren may cause: ataxia (impaired motor coordination),
drowsiness, speech disturbances, coma, and respiratory depression. If disturbing symptoms occur, contact a
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 medical advice.
Since treatment is symptomatic, symptoms may return after discontinuation.
The doctor will decide on a gradual reduction of the dose.
If you have any further questions about the use of this medicine, consult your doctor.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
If any of the adverse effects listed below persist or become troublesome, inform your doctor.
The occurrence of some adverse effects depends entirely on the individual susceptibility of the patient and the dose administered. Adverse effects are usually observed at the beginning of therapy. They subside with continued treatment or when the dose is reduced.

Frequency of adverse effects observed in clinical trials and after marketing authorization:

Very common adverse effects (may occur in more than 1 in 10 patients):

depression,
sedation,
somnolence,
ataxia (lack of coordination of movement),
memory impairment,
speech disorders,
dizziness,
headache,
constipation,
dry mouth,
fatigue,
irritability.

Common adverse effects (may occur in up to 1 in 10 patients):

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

Uncommon adverse effects (may occur in up to 1 in 100 patients):

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

Adverse effects 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 misuse,
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 (oedema of ankles, feet or fingers),
increased intraocular pressure.

Additionally, particularly in patients taking other psychotropic medicines, those with psychiatric disorders, or those abusing alcohol, a paradoxical reaction may occur, manifesting as anxiety.

Other adverse effects observed rarely or very rarely include: motor disturbances, seizures, psychotic symptoms, depersonalization, agranulocytosis (severe reduction 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, feelings of tension, agitation, disorientation, irritability, altered perception of surroundings or self, auditory disturbances, limb stiffness and tingling, hypersensitivity to light, noise and touch, hallucinations and epileptic 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 drug.

Reporting of adverse effects

If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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 effects helps to provide more information on the safety of the medicine.

5. How to store the medicine 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 stated month.
Store below 30°C.
Keep 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 package and other information

What Zomiren contains

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

What Zomiren looks like and contents of the pack
Light greenish-blue to pale blue, mottled, round, biconvex tablets with bevelled edges, marked with a
score line on one side and an imprint "1" on the other. The score line is intended only to facilitate
breaking the tablet for easier swallowing and does not ensure equal dosing.
Packaging: 30 tablets in blister packs, contained in a cardboard box.
For more detailed information, please contact the responsible party or the parallel importer.
Responsible entity in Portugal, country of export:
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw, Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland
Marketing authorization number in Portugal, country of export: 5756366
Parallel import authorization number: 60/23