POLSEN 10 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Polsen, 10 mg, coated tablets
   1. You should read the contents of the leaflet before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
3. What is Polsen and what is it used for
   1. Indications for use
4. Important information before taking Polsen
   1. Do not take Polsen if you have:
   2. Warnings and precautions
   3. Psychomotor disorders the next day (see also: Driving and operating machinery)
   4. Children and adolescents
   5. Polsen and other medicines
   6. Using Polsen with food and drink
   7. Pregnancy and breastfeeding
   8. Using Polsen in patients with kidney and/or liver disorders
   9. Using Polsen in elderly patients
   10. Driving and operating machinery
   11. Polsen contains sodium
5. How to take Polsen
   1. Taking a higher dose of Polsen than recommended
   2. Missing a dose of Polsen
6. Possible side effects
   1. Reporting side effects
7. How to store Polsen
8. Contents of the packaging and other information
   1. What Polsen contains
   2. What Polsen looks like and what the pack contains
   3. Marketing authorization holder
   4. Manufacturer
   5. Date of last revision of the leaflet:

Leaflet attached to the packaging: patient information

Polsen, 10 mg, coated tablets

zolpidem tartrate

You should read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor, pharmacist, or nurse.
• 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 you experience any side effects, including those not listed in the leaflet, you should tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

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

1. What is Polsen and what is it used for

Polsen contains the active substance zolpidem tartrate. The medicine has a sedative effect similar to benzodiazepines. It is characterized by a rapid onset of sedative effect, which lasts up to 6 hours.

Indications for use

The medicine is used for short-term treatment of insomnia in adults. The medicine is used only for the treatment of insomnia that disrupts normal functioning or causes significant exhaustion.

2. Important information before taking Polsen

Do not take Polsen if you have:

• hypersensitivity to zolpidem or any other ingredient of the medicine;
• sleep apnea syndrome;
• myasthenia (muscle weakness);
• severe liver failure;
• severe respiratory failure and respiratory center depression;
• the medicine should not be used in children and adolescents under 18 years of age.

Warnings and precautions

In each case, the decision to start taking the medicine is made by a doctor. Patients who are currently or have been dependent on drugs or alcohol in the past should be particularly cautious due to the increased risk of addiction and psychological dependence. The following general information about the use of benzodiazepines and other sedative medicines should be taken into account by the doctor prescribing the medicine. Tolerance, i.e., reduced sedative effect, may occur after a few weeks of taking benzodiazepines and benzodiazepine-like medicines. Taking Polsen may lead to psychological and physical dependence. This risk increases in proportion to the size of the dose and the duration of its use and is greater in patients with a history of drug or alcohol dependence. In the event of sudden cessation of the medicine in physically dependent individuals, withdrawal symptoms may occur, such as headaches and muscle pain, increased anxiety and tension, restlessness, and irritability. In severe cases, additional symptoms may include: derealization (feeling of strangeness of the environment, which is perceived as unreal, changed), depersonalization (feeling of unreality of one's own personality), numbness and tingling of limbs, hypersensitivity to light, noise, and touch, hallucinations, or seizures. During the use of the medicine, "rebound" insomnia may occur. This is a transient syndrome characterized by increased insomnia. It may be a consequence of stopping the use of a sedative medicine. It may be accompanied by other reactions, such as mood changes, anxiety, and restlessness. Withdrawal symptoms may also occur between doses, especially when the doses are large. The occurrence of withdrawal symptoms is very likely in the event of sudden cessation of the medicine, so the dose should be gradually reduced. The duration of treatment should be limited to a minimum. The maximum treatment duration should not exceed 4 weeks, including the period of tapering off the medicine. Polsen may cause anterograde amnesia, most often within a few hours of taking the medicine. Therefore, to avoid this phenomenon, the patient should have the opportunity for 7-8 hours of uninterrupted sleep. During the use of sedative medicines, "paradoxical" reactions may occur, i.e., restlessness, excitement, irritability, aggression, delusions, fits of rage, nightmares, hallucinations, psychoses, inappropriate behavior, and other behavioral disorders. These symptoms occur more frequently in elderly patients. If the above symptoms occur, you should contact a doctor. Particular caution should be exercised when using zolpidem in patients with psychoses, using neuroleptics. Due to the muscle relaxant effect, there is a risk of falls and hip fractures, especially in elderly patients who get up at night. The medicine should be used with caution in patients with chronic respiratory failure, as there may be a risk of respiratory depression. Polsen should be used with caution in patients with symptoms of depression, as suicidal tendencies may occur. Due to the possibility of intentional overdose, such patients should be prescribed the smallest necessary dose of the medicine. Benzodiazepines and other benzodiazepine-like medicines should not be used as the only medicines for the treatment of depression or anxiety associated with depression (in these patients, it may lead to suicide).

Psychomotor disorders the next day (see also: Driving and operating machinery)

The next day after taking Polsen, the risk of psychomotor disorders, including impaired ability to drive vehicles, may be increased if:

• The patient took the medicine less than 8 hours before activities that require increased mental alertness
• The patient took a dose larger than the recommended dose
• The patient took zolpidem during treatment with other medicines that have a central nervous system depressant effect or other medicines that increase the concentration of zolpidem in the blood, while consuming alcohol or taking prohibited substances

You should take a single dose directly before sleep. You should not take another dose on the same night. If any other disturbing symptoms occur during the use of zolpidem, you should stop taking the medicine and consult a doctor. You should consult a doctor, even if the above warnings concern situations that occurred in the past.

Children and adolescents

The medicine should not be used in children and adolescents under 18 years of age, as the safety and efficacy of the medicine have not been established in this group of patients

Polsen and other medicines

You should inform your doctor about all medicines you have taken recently, even those that are available without a prescription. During treatment, you should not consume alcohol, which may enhance the sedative effect of the medicine. During the use of zolpidem with certain medicines, drowsiness and psychomotor disorders the next day, including impaired ability to drive vehicles, may be increased. These medicines include:

• Medicines used to treat certain mental health disorders (antipsychotic medicines)
• Medicines used to treat sleep disorders (sedative medicines)
• Sedative or anxiolytic medicines
• Medicines used to treat depression
• Medicines used to treat moderate to severe pain (narcotic analgesics)
• Medicines used to treat epilepsy
• Medicines used for anesthesia
• Medicines used to treat hay fever, rash, or other allergies that may cause drowsiness in the patient (sedating antihistamines)

During the use of zolpidem with antidepressant medicines, including bupropion, desipramine, fluoxetine, sertraline, and venlafaxine, the patient may see things that are not real (visual hallucinations) Zolpidem should not be taken with fluvoxamine or ciprofloxacin.Opioids The concomitant use of Polsen and opioids (strong painkillers, medicines used for substitution treatment of addiction, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory failure), coma, and can be life-threatening. Therefore, concomitant use of these medicines can only be considered when other treatment methods cannot be used. If, however, the doctor prescribes Polsen together with opioids, the dose and duration of concomitant use should be limited. You should inform your doctor about all opioid medicines you are taking and strictly follow the dosage instructions. It may be helpful to inform friends or family about the risk, so they are aware of the mentioned signs and symptoms. If these symptoms occur, you should contact a doctor. Inhibitors of liver microsomal enzymes, especially the cytochrome P-450 enzyme system, may enhance the effect of Polsen. The effect of zolpidem is reduced during concomitant use with rifampicin.

Using Polsen with food and drink

You should not take the medicine directly after a meal, due to poorer absorption from the gastrointestinal tract.

Pregnancy and breastfeeding

You should consult a doctor before using the medicine.The safety of the medicine during pregnancy has not been established. Therefore, the medicine should not be used by pregnant women, especially during the first trimester. In the event of justified use of zolpidem in the late pregnancy and during childbirth, side effects may occur in the newborn. In newborns born to mothers who have taken the medicine for a long time in the late pregnancy, physical dependence or withdrawal syndrome may occur in the postnatal period. Due to the penetration of zolpidem into breast milk in small amounts, the medicine is not recommended for use in breastfeeding women.

Using Polsen in patients with kidney and/or liver disorders

Although dose adjustment is not necessary in patients with renal failure, the medicine should be used with caution. In patients with liver failure, the dose should be reduced to 5 mg due to reduced metabolism and clearance of zolpidem. The medicine should not be used in patients with severe liver failure due to the possibility of encephalopathy.

Using Polsen in elderly patients

In elderly patients and weakened patients, it is recommended to reduce the dose of the medicine to 5 mg per day due to the possibility of increased sensitivity to the medicine.

Driving and operating machinery

Polsen has a major impact on the ability to drive vehicles and operate machinery, may cause events such as "falling asleep at the wheel". The next day after taking Polsen (like other sedative 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 blurry or double vision,
• the patient may be less alert.

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

Polsen contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, which means that the medicine is considered "sodium-free".

3. How to take Polsen

This medicine should always be used in accordance with the doctor's instructions. In case of doubts, you should consult a doctor. You should not take the medicine directly after a meal. The recommended dose of Polsen is 10 mg per 24 hours. Your doctor may prescribe a smaller dose for some patients. Polsen should be taken:

• in a single dose,
• directly before sleep.

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 patients and weakened patients, it is recommended to reduce the dose of the medicine to 5 mg (half a tablet) per day due to the possibility of increased sensitivity to the medicine. Also, in patients with liver failure, the dose should be reduced to 5 mg due to reduced metabolism and clearance of zolpidem. In adult patients under 65 years of age, there is a possibility of increasing the dose to 10 mg, in the case of good general condition and good tolerance of the medicine. The treatment period should usually last from a few days to 2 weeks. The maximum treatment duration should not exceed 4 weeks. If you feel that the effect of Polsen is too strong or too weak, you should consult a doctor.

Taking a higher dose of Polsen than recommended

In the event of taking a higher dose of the medicine than recommended, you should immediately consult a doctor or pharmacist. After an overdose of zolpidem, consciousness disorders of varying severity may occur - from increased drowsiness to mild coma. These symptoms are reversible. In the event of an overdose, the first step should be to perform gastric lavage, if justified, and then apply symptomatic and supportive treatment, including infusion of fluids, depending on the needs. If there is no effect or possibility of gastric lavage, activated charcoal should be administered to reduce the absorption of the medicine from the gastrointestinal tract. You should avoid administering sedative medicines, even in states of excitement. In severe cases, the administration of flumazenil should be considered. The patient should remain under close supervision during the administration of flumazenil, as flumazenil may cause neurological symptoms (seizures). Zolpidem is not removed by hemodialysis.

Missing a dose of Polsen

You should not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, Polsen can cause side effects, although not everybody gets them. The frequency of possible side effects listed below is defined as follows:

• very common: (occurring in more than 1 in 10 people);
• common: (occurring in 1 to 10 people in 100);
• uncommon: (occurring in 1 to 10 people in 1,000);
• rare: (occurring in 1 to 10 people in 10,000);
• very rare: (occurring in less than 1 in 10,000 people);
• not known: (frequency cannot be estimated from the available data).

There is evidence of a relationship between zolpidem side effects and dose, especially with regard to certain adverse events on the central nervous system and gastrointestinal tract. Side effects seem to be dependent on individual patient sensitivity and occur more frequently within an hour of taking the medicinal product, if the patient does not immediately lie down or fall asleep (see section 4.2). Immune system disordersFrequency not known: angioedema. Psychiatric disordersCommon: hallucinations, excitement, nightmares. Uncommon: confusion, irritability. Frequency not known: psychomotor anxiety, aggression, delusions, anger, psychosis, abnormal behavior, sleepwalking (see section 4.4), dependence (withdrawal symptoms or rebound symptoms may occur after stopping the medicinal product), libido disorders. Most of the above side effects of a psychiatric nature are paradoxical reactions. Nervous system disordersCommon: drowsiness, headache, dizziness, worsening of insomnia, anterograde amnesia (amnesia symptoms may cause inappropriate behavior). Frequency not known: consciousness disorders. Eye disordersUncommon: double vision. Gastrointestinal disordersCommon: diarrhea. Hepatobiliary disordersFrequency not known: increased liver enzyme activity. Skin and subcutaneous tissue disordersFrequency not known: rash, itching, urticaria. Musculoskeletal and connective tissue disordersFrequency not known: muscle weakness. General disorders and administration site conditionsCommon: fatigue. Frequency not known: gait disorders, development of drug tolerance, falls (mainly in elderly patients and in case of using zolpidem not in accordance with the recommendations). If you experience any side effects not listed in this leaflet, you should inform your doctor.

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, you should tell your 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, 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 the medicine.

5. How to store Polsen

The medicine should be stored in a place that is invisible and inaccessible to children. Do not use this medicine after the expiry date stated on the carton and blister after the abbreviation EXP. The expiry date refers to the last day of the month stated. Store in a temperature below 25°C. Store in the original packaging. Medicines should not be disposed of via wastewater or household waste containers. You should ask your pharmacist how to dispose of medicines that are no longer used. This will help protect the environment.

6. Contents of the packaging and other information

What Polsen 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, sodium carboxymethylcellulose (type A), povidone 90, calcium stearate; coating: hypromellose, macrogol 8000, hydroxypropylcellulose, titanium dioxide (E 171).

What Polsen looks like and what the pack contains

The coated tablets are white or almost white, round, biconvex, with a uniform surface and a dividing line. The single-dose packaging contains: 10, 20, or 30 tablets.

Marketing authorization holder

Adamed Pharma S.A. Pieńków, ul. M. Adamkiewicza 6A 05-152 Czosnów

Manufacturer

Adamed Pharma S.A. Pieńków, ul. M. Adamkiewicza 6A 05-152 Czosnów

Date of last revision of the leaflet: