ZOLPIDEM VITABALANS

Package leaflet: Information for the user

Zolpidem Vitabalans, 10 mg, coated tablets
Zolpidemi tartras
Please read the entire leaflet carefully before taking this medicine, because 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 other people, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

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

Zolpidem Vitabalans is a hypnotic medicine intended exclusively for adults for short-term use.

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 suffers from sleep apnoea syndrome (temporary interruption of breathing during
sleep).
if the patient has severe hepatic insufficiency.
if the patient suffers from severe muscle weakness ( myasthenia gravis ).
if the patient has serious breathing difficulties (serious respiratory disorders).

Warnings and precautions
Before starting treatment with Zolpidem Vitabalans, discuss with your doctor:
if the patient is elderly
if the patient has hepatic insufficiency
if the patient suffers from chronic respiratory disorders
if the patient has or has had a psychiatric disorder. Zolpidem may unmask or
worsen symptoms.
if the patient suffers from depression
if the patient has previously abused drugs or alcohol. The risk of dependence on Zolpidem Vitabalans (physical or psychological dependence caused by an internal compulsion to continue taking the medicine) increases in this group of patients, as well as with dose and duration of treatment.

Next-day psychomotor impairment (see also Driving and operating machinery)
The risk of impaired psychomotor performance, including reduced ability to drive, may be increased the day after taking Zolpidem Vitabalans if:

• less than 8 hours have passed between taking the medicine and performing an activity requiring full mental alertness
• the patient has taken a dose higher than the recommended dose
• the patient has taken zolpidem concurrently with other medicines that depress the central nervous system or other medicines that increase zolpidem blood levels, while consuming alcohol, or while using illicit substances.

A single dose should be taken immediately before bedtime.
Do not take another dose during the same night.

Other possible effects during treatment:
Tolerance – if after several weeks of treatment the patient notices that the medicine is less effective than at the beginning of therapy, they should contact their doctor. Dose adjustment may be necessary.
Dependence – there is a risk of dependence when taking this type of medicine, which increases with dose and duration of treatment. The risk is higher in patients with a history of alcohol or drug abuse.
Withdrawal – the medicine should be discontinued gradually. After stopping treatment, the symptoms for which Zolpidem Vitabalans was prescribed may reappear in an intensified form. They may be accompanied by other reactions, including mood changes, anxiety, and restlessness.
Memory loss – Zolpidem Vitabalans may cause memory loss. To reduce the risk, the patient should ensure 8 hours of uninterrupted sleep.
Psychiatric and "paradoxical" reactions – use of Zolpidem Vitabalans may cause adverse behavioural effects such as restlessness, agitation, irritability, aggression, delusions (false beliefs), rage attacks, nightmares, hallucinations, psychosis (hallucinations; the patient sees, hears or feels something that is not there), inappropriate behaviour, and increased insomnia.
Sleepwalking and related behaviours – use of Zolpidem Vitabalans may cause the performance of various activities during sleep, which the patient does not remember upon waking. These activities include walking during sleep, driving during sleep, preparing and eating food, making phone calls, and engaging in sexual activity. Alcohol, certain medicines used to treat depression and anxiety, or taking Zolpidem Vitabalans at doses exceeding the maximum recommended dose may increase the risk of such adverse effects.
Zolpidem Vitabalans may cause drowsiness and reduce alertness. This may lead to falls, sometimes resulting in serious injuries.
If any of the above situations apply to the patient, contact a doctor or pharmacist immediately.

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

Zolpidem Vitabalans and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.
Concurrent use of zolpidem with certain medicines may increase drowsiness and next-day psychomotor impairment, including impaired ability to drive. These medicines include:

• medicines used to treat certain mental health disorders (antipsychotics)
• medicines used to treat sleep problems (hypnotics)
• sedatives or anxiolytics
• antidepressants
• medicines used to treat moderate to severe pain (opioid analgesics)
• medicines used to treat epilepsy
• anaesthetics
• medicines used to treat hay fever, rashes or other allergies, which may cause drowsiness (sedating antihistamines)

Concurrent use of Zolpidem Vitabalans and opioids (strong painkillers, medicines used in substitution treatment, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and potentially life-threatening outcomes. Therefore, concurrent use should only be considered when no other treatment options are available.
However, if a doctor prescribes Zolpidem Vitabalans together with opioids, the doctor should limit the dose and duration of combined treatment.
Inform your doctor about all opioid medicines being taken and strictly follow the doctor's dosing instructions. It may be helpful to inform friends or family members to be aware of the symptoms listed above. If such symptoms occur, contact your doctor immediately.
When zolpidem is taken with antidepressants, including bupropion, desipramine, fluoxetine, sertraline, and venlafaxine, the patient may see unreal things (visual hallucinations).
Concomitant use of zolpidem with fluvoxamine or ciprofloxacin is not recommended.
Exercise caution when using in combination with muscle relaxants.
Strong opioid analgesics may increase anxiety, which may worsen 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 reduced when taken concurrently with rifampicin (used to treat infectious diseases).

Taking Zolpidem Vitabalans with food, drink and alcohol
Zolpidem Vitabalans may be taken with food and drink. However, alcohol consumption should be avoided during treatment with Zolpidem Vitabalans, as it may intensify the sedative effect of zolpidem and impair the ability to drive and operate machinery.

Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor before using this medicine.
Do not use Zolpidem Vitabalans during pregnancy, especially during the first three months. If the patient plans to become pregnant or suspects she may be pregnant, she should not use Zolpidem Vitabalans and should consult her doctor as soon as possible.
If for serious medical reasons the patient uses Zolpidem Vitabalans in late pregnancy or during delivery, the newborn may experience low body temperature, muscle weakness, breathing difficulties, and withdrawal symptoms due to physical dependence.
A small amount of zolpidem passes into breast milk. Do not use Zolpidem Vitabalans during breastfeeding.

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

• the patient feels drowsy, sleepy, dizzy, or disoriented
• the patient needs more time to make quick decisions (impaired reflexes)
• the patient may have blurred or double vision
• the patient may be less alert

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

3. How to take Zolpidem Vitabalans

This medicine should always be taken as directed by the physician. In case of any doubts, consult
your doctor or pharmacist.
The tablet should be taken with an adequate amount of liquid.
The tablet may be divided into equal doses.

Adults
The recommended dose of Zolpidem Vitabalans is 10 mg every 24 hours. Some patients may be
prescribed a lower dose by their doctor. Zolpidem Vitabalans should be taken:

• as a single dose,
• immediately before bedtime.

The patient must ensure a period of at least 8 hours between taking the medicine and performing
activities requiring increased concentration.
Do not exceed the dose of 10 mg every 24 hours.

Elderly patients (over 65 years of age) or debilitated patients
The recommended dose is 5 mg (half a tablet).

Patients with impaired liver function
The usual starting dose is 5 mg. The physician may decide to increase the dose to 10 mg if this is
safe for the patient. The maximum dose of 10 mg must not be exceeded.

Duration of treatment
The duration of treatment should be as short as possible, usually ranging from a few days to 2 weeks.
The maximum duration of treatment, including the tapering-off phase, is 4 weeks. The physician will
determine the tapering schedule based on the individual needs of the patient. In some cases,
treatment with Zolpidem Vitabalans may last longer than 4 weeks.

Taking more than the recommended dose of Zolpidem Vitabalans
If more than the recommended dose of Zolpidem Vitabalans has been taken, contact a doctor or go
to hospital immediately.

Missed dose of Zolpidem Vitabalans
Do not take a double dose to make up for a missed dose.
If the patient forgets to take Zolpidem Vitabalans before going to sleep, they may still take it while
in bed, provided they are certain they will be able to sleep for a full night (8 hours).

Stopping treatment with Zolpidem Vitabalans
Psychological dependence may occur. Abrupt discontinuation of the medicine may increase the risk
of reactions (such as headache, muscle pain, mood changes); therefore, gradual dose reduction is
recommended.

If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any of the following symptoms occur, stop taking the medicine
Zolpidem Vitabalans immediately 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,
difficulty breathing or swallowing.
The above adverse effects are rare but serious. Medical help may be required.

Common (may affect up to 1 in 10 people)
hallucinations, restlessness, nightmares
drowsiness, headache, dizziness, worsening of insomnia, memory loss (may be associated with
inappropriate behaviour)
sensation of spinning
drowsiness the following day, feeling of numbness, reduced alertness, double vision
diarrhoea, 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, restlessness, irritability, aggression, delusions (false sensations), rage, nightmares, hallucinations, psychosis, inappropriate behaviours and other adverse effects related to behaviour). These are more likely in elderly patients.

Frequency not known (cannot be estimated from available data)
serious allergic reactions causing swelling of the face and throat
anxiety, aggression, delusions (false sensations), rage, psychosis (hallucinations; when the patient sees, hears or feels something that is not there), inappropriate behaviours
changes in sexual drive (libido disorders)
depression (feeling of sadness)
physical dependence: use (even at therapeutic doses) may lead to physical dependence; abrupt discontinuation may result in withdrawal symptoms and recurrence of original symptoms
psychological dependence: occurs when the patient believes they cannot sleep without taking Zolpidem Vitabalans
sleepwalking
increased liver enzyme activity (which may be detected during blood laboratory tests)
skin rash, itching, urticaria
excessive sweating
change in manner of movement
need to use increased doses of the medicine to achieve the same effect
falls, particularly in elderly patients

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

5. How to store Zolpidem Vitabalans
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and on the cardboard package after EXP. The expiry date refers to the last day of the stated month.
Do not use this medicine if visible signs of deterioration are noticed.
No special precautions for storage are required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the packaging and other information

What Zolpidem Vitabalans contains
The active substance is zolpidem tartrate. Each tablet contains 10 mg of zolpidem tartrate.
Other ingredients are:
Tablet core: microcrystalline cellulose, calcium hydrogen phosphate dihydrate, colloidal anhydrous silica, magnesium stearate, sodium carboxymethyl starch (type A)
Tablet coating: polydextrose, hypromellose, titanium dioxide (E171), polyethylene glycol.

What Zolpidem Vitabalans looks like and contents of the pack
White, convex, capsule-shaped coated tablets with a score line, 10 mm long and 5 mm wide.
The tablet can be divided into equal doses.
Pack sizes: 10, 20, 30, 60, 90, 100 film-coated tablets in blisters.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Vitabalans Oy
Varastokatu 7-9
FI-13500 Hämeenlinna
FINLAND

This medicinal product is authorised for marketing in the European Economic Area countries under the following names:
Zolpidem Vitabalans (Czech Republic, Germany, Denmark, Estonia, Finland, Hungary, Lithuania, Latvia, Norway, Poland, Sweden, Slovenia, Slovakia)