ZOMIREN SR

Patient Information Leaflet

Warning! Keep this leaflet. Information on the immediate packaging is in a foreign language.
Zomiren SR (Helex SR 0.5 mg), 0.5 mg, prolonged-release tablets
Alprazolamum
Zomiren SR and Helex SR 0.5 mg are different trade 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 questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents

1. What Zomiren SR is and what it is used for
2. What you need to know 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 Zomiren SR is and what it is used for

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

2. Important information before using Zomiren SR

When not to use Zomiren SR

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

• if the medicine is used long-term (risk of developing dependence, 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 opioids, sleeping medicines, sedatives or alcohol are used simultaneously (the effects of these medicines or alcohol may be enhanced);
• 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 patient should contact their doctor;
• in patients with glaucoma;
• in patients with impaired kidney or liver function.

Like other benzodiazepines, Zomiren SR may cause anterograde amnesia, which occurs several hours after taking the medicine. In such cases, the patient should have the opportunity to sleep uninterrupted 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 connection with the use of Zomiren SR in patients with depression.
Before a planned surgery, inform the doctor about taking Zomiren SR.
Zomiren SR and other medicines
Tell your doctor about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.

• Extreme caution is required when using Zomiren SR together 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 SR may enhance the effects of antipsychotic, hypnotic, anxiolytic, sedative, antidepressant, opioid analgesic, anticonvulsant, anaesthetic, and antihistamine medicines.
• 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 SR.
• Concomitant use of Zomiren SR 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 using Zomiren SR 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 SR and HIV protease inhibitors (e.g. ritonavir) requires dose adjustment or discontinuation of alprazolam.
• Concomitant use of Zomiren SR and digoxin requires close monitoring of the patient for signs of digoxin toxicity.
• Theophylline may reduce the effect of benzodiazepines.

Taking Zomiren SR with food, drink and alcohol
Alcohol must not be consumed during treatment with Zomiren SR.
Pregnancy and breastfeeding
If the patient is pregnant, 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 fetal risk.
If administration of the medicine is necessary during late pregnancy, high doses should be avoided and the newborn should be closely monitored.
Benzodiazepines pass into human milk in small concentrations. Zomiren SR should not be used during breastfeeding.
Driving and operating machinery
Zomiren SR may impair psycho-physical performance. Before using Zomiren SR, patients should familiarize themselves with current local traffic regulations.
Patients should not drive or operate machinery while taking Zomiren SR.
Zomiren SR contains lactose monohydrate
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

3. How to use Zomiren SR

This medicine should always be used as directed by the physician. In case of doubt, consult your
doctor or pharmacist.
Zomiren SR is available in doses of 0.5 mg and 1 mg.
Method of administration
Oral administration.
Treatment should be as short as possible. The doctor should frequently 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. 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 SR, 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 assessed 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.
If Zomiren SR is taken once daily, it is best to take it in the morning. Tablets should be swallowed whole; do not chew, crush, or divide them.
Treatment of symptomatic anxiety states
The recommended initial dose is 1 mg per day, administered once daily or in two 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, administered once daily or in two 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 renal or hepatic impairment
Use in patients with severe hepatic insufficiency is contraindicated.
Use in elderly patients
The recommended initial dose is 0.5 mg to 1 mg per day, administered once daily or in two divided doses. If necessary, the doctor may decide to gradually increase the dose depending on the patient's tolerance to the medicine. If adverse reactions occur, the doctor will decide to reduce the initial dose.
Use of a higher than recommended dose of Zomiren SR
Use of a higher than recommended dose of Zomiren SR may cause: ataxia (impaired motor coordination), drowsiness, speech disturbances, coma, and respiratory depression. If disturbing symptoms occur, contact your doctor or pharmacist immediately.
Missed dose of Zomiren SR
Do not take a double dose to make up for a missed dose.
Discontinuation of Zomiren SR
Do not discontinue the medicine independently.
Since treatment is symptomatic, symptoms may return after discontinuation.
The doctor will decide on gradual dose reduction.
If you have any further questions regarding the use of this medicine, consult your doctor.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
If any of the adverse effects listed below persist or become troublesome, inform your doctor.
The occurrence of some adverse effects depends entirely on individual patient 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 (lack of coordination of movement),
• 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,
• loss of balance,
• impaired coordination,
• difficulty concentrating,
• 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 disorders,
• 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 disorders,
• 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 who misuse alcohol, a paradoxical reaction may occur, manifesting as symptoms such as anxiety.

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 the medicine may lead to withdrawal symptoms such as headache, muscle pain, severe anxiety, feelings of tension, agitation, disorientation, irritability, altered perception of surroundings or self, auditory disturbances, stiffness and tingling of limbs, 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 medicine.

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 also be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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 effects helps to provide more information on the safety of the medicine.

5. How to store Zomiren SR

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.
No special storage instructions apply.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Zomiren SR contains

• The active substance is alprazolam. Each prolonged-release tablet contains 0.5 mg of alprazolam.
• The other ingredients are: monohydrate lactose, hypromellose, magnesium stearate, indigotine (E 132), and quinoline yellow (E 104). See section 2 "Zomiren SR contains monohydrate lactose".

What Zomiren SR looks like and contents of the pack
Greenish-yellow, round, slightly biconvex prolonged-release tablets
Packaging: 30 prolonged-release tablets in blisters, in a cardboard box
For more detailed information, please contact the responsible party or parallel importer.
Responsible party in Hungary, 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
KRKA-FARMA d.o.o., V. Holjevca 20/E, 10450 Jastrebarsko, Croatia
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
Hungary, country of export, licence number: OGYI-T-20462/01
Parallel import licence number: 270/20