ZOMIREN

Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Zomiren (Alprazolam TAD), 0.5 mg, tablets
Alprazolamum
Zomiren and Alprazolam TAD 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 for future reference.
• Consult your doctor or pharmacist if you have any questions.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm others, even if their symptoms are similar.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents

1. What Zomiren is and what it is used for
2. Important information before taking Zomiren
3. How to take Zomiren
4. Possible side effects
5. How to store Zomiren
6. 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 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 liver 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 reviewed by the doctor;
• if the dose of the medicine is being reduced or the medicine 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 concurrently taking opioids, hypnotics, 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 should be discontinued and the doctor contacted;
• 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 have an uninterrupted sleep of 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) muscular-skeletal weakness, 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 you are currently taking or have recently taken, as well as any medicines you plan to take.

• Extreme caution is required when using Zomiren together with opioids, as they have a depressive effect on the respiratory system (slowing and shallowing breathing). This is associated with a 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 must not be consumed during treatment with Zomiren.
• It is not recommended to take Zomiren together with certain oral antifungal medicines (e.g. ketoconazole, itraconazole, posaconazole, voriconazole).
• 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).
• Concurrent use of Zomiren and HIV protease inhibitors (e.g. ritonavir) requires dose adjustment or discontinuation of alprazolam.
• Patients taking alprazolam and digoxin concurrently 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 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 during 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 psychophysical performance. Before using Zomiren, patients should become familiar with current local traffic regulations.
Patients should not drive 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 the doctor before taking this medicine.

3. How to use Zomiren

This medicine should always be used exactly as directed by the physician. In case of 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 as possible.
The physician should regularly assess the patient's condition and the need for continuing 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 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 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 (lack of coordination of movement), drowsiness, speech disturbances, coma, and respiratory depression. If disturbing symptoms occur, contact a physician 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 physician will decide on a gradual reduction of the dose.
If you have any further doubts concerning the use of this medicine, consult your doctor.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any of the adverse effects listed below persist or become troublesome, inform your doctor.
The occurrence of certain adverse effects depends entirely on the individual patient's susceptibility and the dose administered. Adverse effects are usually observed at the beginning of treatment. They tend to resolve with continued therapy 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 (impaired muscle coordination),
• memory disturbances,
• 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 sleepiness,
• lethargy,
• tremor,
• blurred vision,
• nausea,
• skin inflammation,
• sexual dysfunction,
• weight decrease,
• weight increase.

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 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 disorders,
• 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 abusers, paradoxical reactions such as anxiety may occur.

Other adverse effects observed rarely or very rarely include: motor disturbances, seizures, psychotic symptoms, 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, tension, agitation, disorientation, irritability, altered perception of surroundings 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 drug.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring 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. Package contents and other information

What Zomiren contains

• The active substance is alprazolam. Each tablet contains 0.5 mg of alprazolam.
• The other ingredients are: monohydrate lactose, maize starch, povidone K 25, crospovidone (type A), polysorbate 80, magnesium stearate, carmine (E 120). See section 2 "Zomiren contains monohydrate lactose".

What Zomiren looks like and contents of the pack
Pale pink, marbled, round, biconvex tablets with bevelled edges, with a dividing line on one side and the imprint "0.5" on the other side. The dividing line on the tablet is intended only to facilitate breaking the tablet for easier swallowing, and does not ensure equal dose division.
Packaging: 30 tablets in blister packs, contained in a cardboard box.
For further detailed information, please contact the responsible party or the parallel importer.
Responsible party 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: 5756531
Parallel import authorization number: 58/23