Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Zomiren SR (Helex SR), 0.5 mg, prolonged-release tablets
Alprazolamum
Zomiren SR and Helex SR are different brand names of the same medicine.
Please read this leaflet carefully before taking 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 effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

What Zomiren SR is and what it is used for
Important information before taking Zomiren SR
How to take Zomiren SR
Possible side effects
How to store Zomiren SR
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 properties.
Zomiren SR is indicated for the treatment of symptoms of anxiety disorders in adults, solely in cases where symptoms are severe, impair normal functioning, or are extremely 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 suffers from 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 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 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 opioids, sleeping medicines, sedatives or alcohol are used concurrently (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 with the medicine 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 patients with depression treated with Zomiren SR.
Before a planned surgery, inform the doctor that you are taking Zomiren SR.
Zomiren SR and other medicines
Tell your doctor about all medicines currently taken or recently taken, as well as any medicines you plan to take.

Extreme caution is required when using Zomiren SR together with opioids, as they have a depressive 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 SR 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 SR.
Concomitant use of Zomiren SR with certain systemic antifungal agents (e.g. ketoconazole, itraconazole, posaconazole, voriconazole) is not recommended.
Extreme caution is required and dose reduction should be considered when Zomiren SR is used concomitantly with nefazodone, fluvoxamine, and cimetidine.
Extreme caution is required when alprazolam is used concomitantly 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.

Use of 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 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 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 closely monitored.
Benzodiazepines pass into human milk in small concentrations. Zomiren SR must not be used during breastfeeding.
Driving and operating machinery
Zomiren SR may impair psychomotor performance. Before using Zomiren SR, patients should familiarize themselves with current local traffic regulations.
Patients should not drive vehicles or operate machinery while taking Zomiren SR.
Zomiren SR contains monohydrate lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking the medicine.

3. How to use Zomiren SR

This medicine should always be used exactly as prescribed by your doctor. If in doubt, consult
your doctor or pharmacist.
Zomiren SR is available in doses of 0.5 mg and 1 mg.
Route of administration
Oral use.
Treatment should be as short as possible. Your doctor should regularly assess your condition and the need
for continuing treatment, especially if your symptoms improve 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, your doctor will inform you 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 reviewed with your 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 effects 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 as a single dose 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 as a single dose 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 as a single dose 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 effects occur, the doctor may 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 (lack of 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.
Stopping Zomiren SR
Do not stop taking this medicine on your own.
Since treatment is symptomatic, symptoms may return after stopping the medicine.
Your doctor will decide on gradual dose reduction.
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 not everybody 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 individual patient susceptibility and the dose administered. Adverse effects are usually observed at the beginning of therapy. They tend to 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 motor 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,
loss of balance,
impaired coordination,
difficulty concentrating,
excessive need for sleep,
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,
withdrawal syndrome.

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

hyperprolactinaemia (increased prolactin levels),
hypomania,
aggressive behaviour,
hostile behaviour,
thinking abnormalities,
increased psychomotor activity,
drug misuse,
autonomic nervous system dysfunction (which controls the function of internal organs, smooth muscles and glands),
dystonia (abnormal muscle tone),
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, a paradoxical reaction may occur, including symptoms such 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 the medicine may lead to withdrawal symptoms such as headache, muscle pain, increased anxiety, feelings of tension, agitation, disorientation, irritability, altered perception of surroundings or self, auditory disturbances, muscle stiffness and limb paraesthesia, 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, inform your doctor or pharmacist. 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 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 conditions 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 pack 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, indigo carmine (E 132), 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, packed in a cardboard box.
For more detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder 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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw, Poland
Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland
Marketing Authorisation Number in Hungary, country of export: OGYI-T-20462/01
Parallel Import Licence Number: 305/23