ZOLPIC 10 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Zolpic, 10 mg, coated tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Zolpic and what is it used for
4. Important information before taking Zolpic
   1. When not to take Zolpic
   2. Warnings and precautions
   3. Children and adolescents
   4. Zolpic and other medicines
   5. Zolpic with food, drink, and alcohol
   6. Pregnancy and breastfeeding
   7. Driving and operating machinery
   8. Zolpic contains lactose
5. How to take Zolpic
   1. Use in children and adolescents
   2. Use in adults
   3. Using a higher dose of Zolpic than recommended
   4. Missing a dose of Zolpic
6. Possible side effects
   1. Side effects that occur frequently (less than 1 in 10 patients, but more than 1 in 100 patients):
   2. Side effects that occur infrequently (less than 1 in 100 patients, but more than 1 in 1,000 patients):
   3. Side effects with an unknown frequency of occurrence (cannot be estimated from available data):
   4. Reporting side effects
7. How to store Zolpic
8. Package contents and other information
   1. What Zolpic contains
   2. What Zolpic looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Date of last revision of the leaflet:

Leaflet attached to the packaging: patient information

Zolpic, 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.
• In case of any doubts, consult a 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 Zolpic and what is it used for
• 2. Important information before taking Zolpic
• 3. How to take Zolpic
• 4. Possible side effects
• 5. How to store Zolpic
• 6. Package contents and other information

1. What is Zolpic and what is it used for

Zolpic contains zolpidem, which is a sedative. The sedative effect of the medicine, after oral administration, occurs quickly (within 10-30 minutes of taking the medicine) and lasts for up to 6 hours.
Zolpic is indicated for short-term treatment of insomnia in adults.

2. Important information before taking Zolpic

When not to take Zolpic

• -if the patient is allergic to zolpidem or any of the other ingredients of this medicine (listed in section 6),
• -if the patient has sleep apnea,
• -if the patient has myasthenia (muscle weakness),
• -if the patient has severe liver failure,
• -if the patient has acute respiratory failure or breathing disorders,
• -if the patient has a mental illness.

Warnings and precautions

Before starting treatment with Zolpic, discuss it with your doctor or pharmacist.
Psychomotor disorders the next day (see also Driving and operating machinery)

The next day after taking Zolpic, the risk of psychomotor disorders, including impaired driving ability, may be increased if:
the patient took the medicine less than 8 hours before activities that require increased alertness,
the patient took a higher dose than recommended,
the patient took zolpidem while being treated 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.
One dose should be taken just before bedtime. Do not take another dose on the same night.
Before starting treatment with a sedative, it is recommended to clarify the cause of insomnia and eliminate the factors that cause it. Persistent insomnia after 7-14 days of treatment may indicate the presence of primary mental or physical disorders, so you should contact your doctor.
Zolpidem, like other sedatives, should be used with caution in patients with symptoms of depression.
Due to the risk of suicidal tendencies in this group of patients, the prescribed amount of medicine should be as small as possible to prevent intentional overdose.
During treatment with zolpidem, previously existing depression may be revealed. A symptom of depression may be insomnia. In case of persistent insomnia, you should consult a doctor.
Due to the fact that sedatives can inhibit the activity of the respiratory center, Zolpic should be used with caution in patients with respiratory function disorders.
During treatment with zolpidem, as with benzodiazepines and other sedatives, the following may occur:

• Tolerance During treatment for more than a few weeks, a decrease in the effectiveness of sedatives is sometimes observed.
• Dependence The use of sedatives can lead to the development of psychological and physical dependence. The risk of dependence increases in proportion to the dose used and the duration of treatment, and it is also higher in patients who have been dependent on alcohol or drugs at any time. Such patients should be under observation during treatment with sedatives. In patients who have developed dependence, withdrawal symptoms may occur after sudden discontinuation of the medicine, such as headaches and muscle pain, anxiety and mental tension, restlessness, disorientation, and irritability, and in severe cases, derealization (feeling of change in the surrounding world), depersonalization (feeling of change in one's own image), hypersensitivity to sound, light, and touch, numbness and tingling of limbs, hallucinations, and convulsions.
• Rebound insomnia This is a transient syndrome in which the symptoms that were the reason for prescribing the medicine are intensified. It may occur after discontinuation of the medicine. Rebound insomnia may be accompanied by other symptoms, such as mood changes, restlessness, anxiety. Since the risk of these symptoms is higher after sudden discontinuation of the medicine, it is recommended to gradually reduce the dose.
• Anterograde amnesia Sedatives can cause anterograde amnesia, which occurs most often a few hours after taking the medicine. Therefore, to reduce the risk of its occurrence, the patient should ensure 7-8 hours of uninterrupted sleep.
• Psychological reactions and "paradoxical" During treatment with sedatives (especially in elderly patients), reactions such as anxiety, agitation, irritation, aggression, delusions, fits of rage, nightmares, hallucinations, psychoses, inadequate behavior, and other behavioral disorders may occur. In such cases, in agreement with the doctor, treatment should be discontinued.
  • Somnambulism (sleepwalking) and similar behaviors In patients who have taken zolpidem and have not fully awakened, the following disorders may occur: sleepwalking and similar behavioral disorders, such as driving while asleep, preparing and eating food, making phone calls, or having sex while asleep with no memory of the actions performed. Consuming alcohol or taking other medicines with a sedative effect on the central nervous system, in combination with zolpidem, increases the risk of such behaviors, as does taking zolpidem in doses exceeding the maximum recommended dose. In case of such behaviors (e.g., driving while asleep), you should consult a doctor. For the safety of the patient and others, the doctor may consider discontinuing the medicine.

  Children and adolescents

  The safety and efficacy of zolpidem in children and adolescents have not been established.
  Due to this, zolpidem should not be used in children and adolescents under the age of 18.

  Zolpic and other medicines

  Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
  During treatment with zolpidem, the sedative effect and psychomotor disorders the next day, including impaired driving ability, may be intensified when combined with certain medicines. These medicines include:
  medicines used to treat certain mental health disorders (antipsychotics),
  medicines used to treat sleep disorders (sedatives),
  medicines that have a calming or anxiolytic effect,
  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 hay fever, rashes, or other allergies that may cause drowsiness in the patient (sedating antihistamines).
  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.
  When taken with ketoconazole (an antifungal medicine), the sedative effect of zolpidem may be intensified.
  Concomitant use of Zolpic and opioids (strong painkillers, substitution therapy, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory failure), coma, and can be life-threatening. For this reason, concomitant use of these medicines should only be considered when other treatment options are not possible.
  If the doctor has prescribed Zolpic with opioids, the dose and treatment duration should be reduced.
  Inform your doctor about all opioid medicines you are taking and strictly follow the doctor's dosage instructions. It may be helpful to inform friends or relatives about the possibility of the above-mentioned signs and symptoms.
  In case of such symptoms, consult a doctor.
  Concomitant use with narcotic analgesics may lead to increased euphoria and thus promote the development of psychological dependence.
  Substances that inhibit the activity of certain liver enzymes (in particular, cytochrome P450) may intensify the effect of benzodiazepine derivatives and other medicines with similar effects.

  Zolpic with food, drink, and alcohol

  Food reduces the absorption of zolpidem. To fall asleep faster, do not take the medicine with a meal or immediately after a meal.
  Do not consume alcohol during treatment. Alcohol intensifies the sedative effect of zolpidem.

  Pregnancy and breastfeeding

  If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
  Do not take this medicine during pregnancy or breastfeeding.

  Driving and operating machinery

  Zolpic has a major impact on the ability to drive and operate machinery, may cause events such as "falling asleep at the wheel".
  The next day after taking Zolpic (like other sedatives), it may happen that:
  the patient feels drowsy, sleepy, has dizziness or is disoriented,
  the patient needs more time to make quick decisions (slowed reflexes),
  the patient may see blurry or double vision,
  the patient may be less alert.
  To minimize the risk of the above-mentioned 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 Zolpic, as this may intensify the above-mentioned effects.

  Zolpic contains lactose

  If you have been diagnosed with intolerance to some sugars, consult your doctor before taking the medicine.
  The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Zolpic

Always take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.
Oral administration.
Zolpidem is a fast-acting medicine, so it should be taken directly before bedtime or in bed.

Use in children and adolescents

The safety and efficacy of zolpidem in children and adolescents under the age of 18 have not been established. Therefore, zolpidem should not be used in this group of patients.

Use in adults

The recommended dose of Zolpic is 10 mg per 24 hours. Your doctor may prescribe a lower dose for some patients. Zolpic should be taken:
in a single dose,
directly before bedtime.
The patient 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.
In elderly or weakened patients who may be particularly sensitive to zolpidem, a dose of 5 mg per day is recommended.
In patients with liver failure, treatment should be started with a dose of 5 mg per day.
In patients under 65 years of age, in good general condition, and in case of insufficient efficacy of a lower dose, the doctor may subsequently increase the daily dose.
The recommended treatment duration is from a few days to two weeks. Like other sedatives, zolpidem should not be used for more than 4 weeks.

Using a higher dose of Zolpic than recommended

In case of taking a large number of tablets, consult a doctor or the nearest hospital as soon as possible. Bring the remaining tablets and this leaflet. Symptoms such as impaired consciousness of varying severity (from pathological drowsiness to mild coma) may occur.

Missing a dose of Zolpic

In case of missing a dose, take it as soon as possible, unless it is time for the next dose. Do not take a double dose to make up for the missed dose.
In case of any further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Zolpic can cause side effects, although not everybody gets them.
Consult a doctor immediatelyif you experience:

• angioedema (swelling of the face, tongue, and trachea, which can cause breathing difficulties). This side effect occurs with an unknown frequency but is severe. If it occurs, immediate medical attention is necessary.
• intensification of insomnia. This side effect occurs frequently.
• restlessness, aggression, delusions, anger, behavioral disorders, psychoses, somnambulism (sleepwalking), dependence, libido disorders, activity during sleep (sleepwalking and similar behavioral disorders, such as driving while asleep, preparing and eating food, making phone calls, or having sex while asleep with no memory of the actions performed). Most psychological side effects are related to paradoxical reactions.

Side effects that occur frequently (less than 1 in 10 patients, but more than 1 in 100 patients):

• -hallucinations, agitation, nightmares;
• -fatigue;
• -drowsiness, headaches, dizziness, anterograde amnesia (amnesia may be related to abnormal behavior);
• -diarrhea, nausea, vomiting, abdominal pain.

Side effects that occur infrequently (less than 1 in 100 patients, but more than 1 in 1,000 patients):

• -confusion, irritability;
• -double vision.

Side effects with an unknown frequency of occurrence (cannot be estimated from available data):

• -drowsiness persisting the next day after taking the medicine, impaired consciousness;
• -gait disorders, tolerance to the medicine, falls (mainly in elderly patients and when zolpidem is not taken as recommended);
• -muscle weakness;
• -rash, itching, urticaria, excessive sweating;
• -increased liver enzyme activity.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, consult a doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Zolpic

Keep the medicine out of sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date stated on the packaging is the last day of the month.
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. Package contents and other information

What Zolpic contains

• The active substance of Zolpic is zolpidem. Each coated tablet contains 10 mg of zolpidem (as tartrate).
• The other ingredients of the medicine are: lactose monohydrate, microcrystalline cellulose, sodium carboxymethylcellulose, magnesium stearate, polysorbate 80, hypromellose, hydroxypropylcellulose, titanium dioxide, talc.

What Zolpic looks like and contents of the pack

Zolpic is a white, bean-shaped, coated tablet with a dividing line and engraving "Z10".
One pack contains 10, 20, or 30 coated tablets.

Marketing authorization holder and manufacturer

Polpharma S.A.
Pelplińska 19, 83-200 Starogard Gdański
Phone: +48 22 364 61 01

Date of last revision of the leaflet: