Zolpidem Vitabalans

Leaflet attached to the packaging: information for the user

Zolpidem Vitabalans, 10 mg, coated tablets

Zolpidem tartrate

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Zolpidem Vitabalans and what is it used for
• 2. Important information before taking Zolpidem Vitabalans
• 3. How to take Zolpidem Vitabalans
• 4. Possible side effects
• 5. How to store Zolpidem Vitabalans
• 6. Contents of the pack and other information

1. What is Zolpidem Vitabalans and what is it used for

Zolpidem Vitabalans is a sleeping medicine intended for short-term use in adults only.

2. Important information before taking Zolpidem Vitabalans

When not to take Zolpidem Vitabalans

if the patient is allergic to zolpidem tartrate or any of the other ingredients of this medicine (listed in section 6). if the patient has sleep apnea syndrome (breathing stops for a short time during sleep) if the patient has severe liver impairment if the patient suffers from severe muscle weakness (myasthenia gravis) if the patient has severe breathing difficulties (severe respiratory disorders).

Warnings and precautions

Before starting to take Zolpidem Vitabalans, discuss it with your doctor: if the patient is elderly if the patient has liver impairment if the patient has chronic respiratory disorders if the patient has or has had a mental illness. Zolpidem may reveal or worsen symptoms. if the patient has depression if the patient has a history of substance or alcohol abuse. The risk of dependence on Zolpidem Vitabalans (physical or psychological effect caused by an internal urge to continue taking the medicine) increases in this group of patients, as well as with the dose and duration of treatment. Psychomotor disorders the next day (see also Driving and operating machinery)the next day after taking Zolpidem Vitabalans, the risk of psychomotor disorders, including impaired driving ability, may be increased if:

• less than 8 hours have passed since taking the medicine and the time of performing activities that require increased mental alertness
• the patient has taken a higher dose than recommended
• the patient has taken zolpidem during treatment with other medicines that have a sedative effect on the central nervous system or other medicines that increase the concentration of zolpidem in the blood, while consuming alcohol or taking prohibited substances.

Take a single dose directly before bedtime. Do not take another dose on the same night.

Other possible phenomena during the use of the medicine:

Habituation to the medicine (tachyphylaxis) - if after a few weeks of use, the patient finds that the medicine does not work as well as at the beginning of treatment, they should contact their doctor. It may be necessary to adjust the dose. Dependence - during the use of this type of medicine, there is a risk of dependence, which increases with the dose and duration of treatment. The risk is higher in patients who have abused alcohol and medicines in the past. Withdrawal - the medicine should be discontinued gradually. After discontinuation, the symptoms for which Zolpidem Vitabalans was used may reappear in an exacerbated form. They may also be accompanied by other reactions, including mood changes, anxiety, and restlessness. Amnesia - Zolpidem Vitabalans may cause memory loss. To reduce the risk of its occurrence, the patient should ensure 8 hours of uninterrupted sleep. Psychological reactions and "paradoxical" - taking Zolpidem Vitabalans may cause undesirable effects related to behavior, such as anxiety, agitation, irritability, aggression, delusions (false beliefs), fits of rage, nightmares, hallucinations, psychosis (hallucinations; the patient sees, hears, or feels something that is not there), inadequate behavior, and increased insomnia. Somnambulism and other related behaviors - taking Zolpidem Vitabalans may cause the patient to perform various activities during sleep, which they do not remember after waking up. Such activities include sleepwalking, driving during sleep, preparing meals and eating, making phone calls, and having sex. Alcohol, certain medicines used to treat depression and anxiety, or taking Zolpidem Vitabalans in doses exceeding the maximum recommended dose may increase the risk of such undesirable effects. Zolpidem Vitabalans may cause drowsiness and reduce the level of alertness. This can lead to falls, which can sometimes result in serious injuries. If any of the above situations apply to the patient, they should immediately contact their doctor or pharmacist.

Children and adolescents

Zolpidem Vitabalans is not intended for use in children and adolescents under the age of 18.

Zolpidem Vitabalans and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take. When taking zolpidem with certain medicines, drowsiness and psychomotor disorders the next day, including impaired driving ability, may be increased. These medicines include:

• medicines used to treat certain mental health disorders (antipsychotics)
• medicines used to treat sleep disorders (sleeping medicines)
• sedatives or anxiolytics
• medicines used to treat depression
• medicines used to treat moderate to severe pain (narcotic analgesics)
• medicines used to treat epilepsy
• medicines used in anesthesia
• medicines used to treat colds, allergies, or other allergies that may cause drowsiness in the patient (sedating antihistamines)

Concomitant use of Zolpidem Vitabalans and opioids (strong painkillers, substitution therapy medicines, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be life-threatening. Therefore, concomitant use should only be considered when other treatment options are not possible. However, if your doctor prescribes Zolpidem Vitabalans with opioids, your doctor should limit the dose and duration of concomitant treatment. You should inform your doctor about all opioid medicines you are taking and strictly follow your doctor's dosage instructions. It may be helpful to inform your friends or relatives to be aware of the above signs and symptoms. If such symptoms occur, you should contact your doctor. When taking zolpidem with antidepressants, including bupropion, desipramine, fluoxetine, sertraline, and venlafaxine, the patient may see things that are not real (visual hallucinations). It is not recommended to take zolpidem with fluvoxamine or ciprofloxacin. Caution should be exercised when using it in combination with muscle relaxants. Strong painkillers (narcotic analgesics) may increase anxiety, which can increase dependence on Zolpidem Vitabalans. Medicines that inhibit the activity of certain liver enzymes (such as ketoconazole used as an antifungal medicine) may enhance the effect of Zolpidem Vitabalans. The effect of Zolpidem Vitabalans is weakened when rifampicin (used to treat infectious diseases) is used concomitantly.

Using Zolpidem Vitabalans with food, drink, and alcohol

Zolpidem Vitabalans can be taken with food and drink. However, you should avoid consuming alcohol while taking Zolpidem Vitabalans, as it may enhance the sedative effect of zolpidem and impair the ability to drive and operate machinery.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before taking this medicine. You should not take Zolpidem Vitabalans during pregnancy, especially during the first three months. If you plan to become pregnant or suspect you may be pregnant, do not take Zolpidem Vitabalans and consult your doctor as soon as possible. If, for serious medical reasons, you take Zolpidem Vitabalans during the late stage of pregnancy or during childbirth, the baby may experience low body temperature, muscle weakness, breathing difficulties, and withdrawal symptoms after birth. A small amount of zolpidem passes into breast milk. You should not take Zolpidem Vitabalans while breastfeeding.

Driving and operating machinery

Zolpidem Vitabalans has a major impact on the ability to drive and operate machinery, and may cause events such as falling asleep at the wheel. The next day after taking Zolpidem Vitabalans (like other sleeping medicines), it may happen that:

• the patient feels drowsy, sleepy, has dizziness, or is disoriented,
• the patient needs more time to make quick decisions (impaired reflex),
• the patient may see double or blurred vision,
• the patient may be less alert.

To minimize the risk of the above events, it is recommended to maintain at least an 8-hour interval between taking zolpidem and driving, operating machinery, and working at heights. You should not consume alcohol or psychoactive substances while taking Zolpidem Vitabalans, as it may enhance the above effects.

3. How to take Zolpidem Vitabalans

Take this medicine always as directed by your doctor. If you are unsure, consult your doctor or pharmacist. Take the tablet with a sufficient amount of liquid. The tablet can be divided into equal doses.

Adults

The recommended dose of Zolpidem Vitabalans is 10 mg per 24 hours. Your doctor may prescribe a lower dose. Take Zolpidem Vitabalans:

• in a single dose,
• directly before bedtime

You must maintain a period of at least 8 hours between taking the medicine and starting activities that require increased concentration. Do not exceed the dose of 10 mg per 24 hours.

Elderly (over 65 years) or debilitated patients

The recommended dose is 5 mg (half a tablet).

Patients with liver function disorders

The usual starting dose is 5 mg. Your doctor may decide to increase the dose to 10 mg if it is safe for you. Do not exceed the maximum dose of 10 mg.

Duration of treatment

The duration of treatment should be as short as possible. It usually ranges from a few days to 2 weeks. The maximum duration of treatment, including the tapering-off period, is 4 weeks. Your doctor will determine the tapering-off schedule based on your individual needs. In some cases, the use of Zolpidem Vitabalans may last longer than 4 weeks.

Taking a higher dose of Zolpidem Vitabalans than recommended

If you have taken a higher dose of Zolpidem Vitabalans than recommended, contact your doctor or go to the hospital.

Missing a dose of Zolpidem Vitabalans

Do not take a double dose to make up for a missed dose. If you forgot to take Zolpidem Vitabalans before bedtime, you can take it when you go to bed, provided you are sure you will be able to sleep for the whole night (8 hours).

Stopping Zolpidem Vitabalans

Psychological dependence may occur. Abrupt discontinuation of the medicine may increase the risk of reactions (such as headache, muscle pain, mood changes), so it is recommended to gradually reduce the dose. If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If you experience any of the following symptoms, stop taking Zolpidem Vitabalans and contact your doctor or go to the nearest hospital: allergic reactions, such as skin rash, itching, swelling of the face, lips, throat, or tongue, breathing or swallowing difficulties. The above side effects are rare but serious. Medical attention may be necessary. Common (may affect up to 1 in 10 people)hallucinations, agitation, nightmares drowsiness, headache, dizziness, increased insomnia, amnesia (may be associated with inadequate behavior) feeling of spinning drowsiness the next day, feeling of numbness, reduced alertness, double vision diarrhea, nausea, vomiting fatigue abdominal pain back pain Uncommon (may affect up to 1 in 100 people)feeling of disorientation, irritability muscle weakness, coordination disorders Rare (may affect up to 1 in 1,000 people)paradoxical reactions (anxiety, agitation, irritability, aggression, delusions (false feelings), fits of rage, nightmares, hallucinations, psychosis, inadequate behavior, and other undesirable effects related to behavior). These are more likely to occur in elderly patients. Frequency not known (cannot be estimated from the available data)serious allergic reactions causing swelling of the face and throat anxiety, aggression, delusions (false feelings), fits of rage, psychosis (hallucinations; if the patient sees, hears, or feels something that is not there), inadequate behavior changes in sex drive (libido disorders) depression (feeling of sadness) physical dependence: taking (even in therapeutic doses) may lead to physical dependence; abrupt discontinuation may result in withdrawal symptoms and a relapse of the original symptoms, psychological dependence: occurs if the patient believes they cannot fall asleep without taking Zolpidem Vitabalans somnambulism increased liver enzyme activity (which may be detected during blood tests) skin rash, itching, hives excessive sweating changes in gait need to take increased doses of the medicine to achieve the same effect falls, especially in elderly patients

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, PL-02 222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Zolpidem Vitabalans

Keep the medicine out of sight and reach of children. Do not use this medicine after the expiry date stated on the label and on the carton after EXP. The expiry date refers to the last day of the month. Do not use this medicine if you notice visible signs of deterioration. There are no special precautions for storing the medicine. Medicines should 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 Zolpidem Vitabalans contains

The active substance of the medicine is zolpidem tartrate. Each tablet contains 10 mg of zolpidem tartrate. The other ingredients are: Core: microcrystalline cellulose, calcium hydrogen phosphate dihydrate, colloidal anhydrous silica, magnesium stearate, sodium carboxymethyl cellulose (type A) Coating: polydextrose, hypromellose, titanium dioxide (E171), macrogol.

What Zolpidem Vitabalans looks like and contents of the pack

White, convex tablets in the shape of capsules with a dividing line, 10 mm long and 5 mm wide. The tablet can be divided into equal doses. Pack sizes: 10, 20, 30, 60, 90, 100 coated tablets in blisters. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Vitabalans Oy Varastokatu 7-9 FI-13500 Hämeenlinna FINLAND

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Zolpidem Vitabalans (Czech Republic, Germany, Denmark, Estonia, Finland, Hungary, Lithuania, Latvia, Norway, Poland, Sweden, Slovenia, Slovakia)

Date of last revision of the leaflet: 2023-10-12