ZOLPIDEM STADA 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Zolpidem Stada 10 mg film-coated tablets EFG

Zolpidem tartrate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Zolpidem Stada and what is it used for
2. What you need to know before you take Zolpidem Stada
3. How to take Zolpidem Stada
4. Possible side effects
5. Storage of Zolpidem Stada
6. Contents of the pack and other information

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

Zolpidem Stada is a hypnotic that belongs to a group of medicines known as benzodiazepine analogs.

Zolpidem is used for the short-term treatment of insomnia in patients over 18 years of age, in situations where insomnia is debilitating or causing severe anxiety.

Do not take this medicine for a long time. Treatment should be as short as possible, because the risk of dependence increases with the duration of treatment.

Zolpidem is indicated for sleep rhythm disorders and for all forms of insomnia, especially when there are difficulties falling asleep, either initially or after premature waking.

2. What you need to know before you take Zolpidem Stada

Do not take Zolpidem Stada

• If you are allergic to zolpidem or to the group of benzodiazepines in general or to any of the other components of this medicine (listed in section 6).
• If you have acute and/or severe respiratory difficulties.
• If you have problems breathing during sleep (sleep apnea syndrome).
• If you have weakness, muscle fatigue (myasthenia gravis).
• If you have severe liver problems (hepatic).
• As long-term treatment. Treatment should be as short as possible, because the risk of dependence increases with the duration of treatment.
• If you have experienced sleepwalking or other unusual behaviors while sleeping (such as driving, eating, making phone calls, or having sex, etc.) without being fully awake after taking zolpidem or other medicines that contain zolpidem.

Warnings and precautions

Consult your doctor or pharmacist before starting to take zolpidem.

• Your doctor should identify the causes of insomnia whenever possible and treat the underlying factors before prescribing zolpidem.
• After taking zolpidem, you should ensure that you will be able to have an uninterrupted sleep period of 8 hours to reduce the risk of anterograde amnesia (not remembering what happened while you were awake).
• If you have ever had any mental disorder or problems of abuse or dependence on alcohol or drugs.
• Risk of dependence: The use of zolpidem may lead to the development of abuse and/or physical and psychological dependence. The risk of dependence is greater when zolpidem is used for more than 4 weeks. The risk of abuse and dependence is greater in patients with a history of mental disorders and/or abuse of alcohol, illicit substances, or drugs.
• To minimize the risk of dependence, the following precautions should be taken:
• the intake of these medicines will only be done under medical prescription (never because they have been effective in other patients) and will never be recommended to other people,
• do not increase the prescribed doses by the doctor, nor prolong the treatment for a longer time than recommended,
• consult your doctor regularly so that he decides whether to continue treatment.

Once physical dependence has developed, abrupt interruption of treatment will be accompanied by a withdrawal syndrome that may consist of the appearance of restlessness, anxiety, headache, muscle pain, confusion, irritability, and tension. Therefore, it is recommended to gradually reduce the dose, according to the doctor's instructions.

In severe cases, the following symptoms may appear: alteration of the perception of reality, depersonalization, decreased tolerance to usual sounds (hyperacusis), numbness and tingling in the limbs, hypersensitivity to light, noise, and physical contact, hallucinations, or epileptic seizures.

• Rebound insomnia: in some cases, after interruption of treatment, a transient syndrome may occur in which the symptoms that led to the initiation of treatment reappear but in an increased form. They may be accompanied by other reactions such as mood changes, anxiety, sleep disorders, and restlessness. It is essential that you know that there is a possibility that this rebound phenomenon may occur to minimize the anxiety that may produce the appearance of these effects when interrupting treatment. In the case of short-acting hypnotic/sedative medications, the dose withdrawal phenomenon may appear within the dose interval. The probability of rebound insomnia is greater with abrupt withdrawal. Therefore, it is recommended to gradually reduce the dose, according to the doctor's instructions.

• It is known that other psychiatric and "paradoxical" reactions such as restlessness, agitation, worsening of insomnia, irritability, aggressiveness, delirium, fits of rage, nightmares, psychosis, hallucinations, abnormal behavior, and other alterations of conduct occur with zolpidem. Treatment should be discontinued when these reactions appear. It is more likely that these reactions occur in elderly patients.

• Zolpidem may cause sleepwalking or other unusual behaviors while sleeping (such as driving, eating, making phone calls, or having sex, etc.) without being fully awake, some of which have been associated with serious injuries or even death. The next morning, you may not remember anything you did during the night. If you experience any of the above symptoms, discontinue treatment with zolpidem immediately and contact your doctor or healthcare professional, as these sleep behaviors can put you and others at serious risk of injury.

Drinking alcohol or taking other medicines that cause drowsiness along with zolpidem could increase the risk of these sleep behaviors.

The use of zolpidem with alcohol and with other medicines that act on the central nervous system, or taking higher doses than the recommended dose, may increase the risk of these behaviors. Your doctor should consider discontinuing treatment in these cases, due to the risk it may pose to you and others.

• This medicine may cause drowsiness and a decrease in the level of consciousness, which can cause falls and consequently cause serious injuries.

• After repeated use for a few weeks, some tolerance to the product may appear, so it may lose some of its hypnotic effects.

• If you have a history of drug or alcohol dependence, you should not take zolpidem unless your doctor indicates it.

• If you have congenital long QT syndrome, your doctor should carefully consider the benefit/risk ratio before starting treatment with zolpidem.

• In patients with mental illnesses (psychosis), its use is not recommended as primary treatment.

• If you have suicidal tendencies and depression, it should be used with extreme caution. Consult your doctor before using this medicine, as it may unmask existing depression. Some studies have shown an increased risk of suicidal ideation, suicide attempt, and suicide in patients taking certain sedatives and hypnotics, including this medicine. However, it has not been established whether this is caused by the medicine or if there may be other reasons. If you have suicidal thoughts, contact your doctor as soon as possible for additional medical advice.

• If you have any liver disorder or respiratory problems, your doctor will decide whether it is convenient for you to take a lower dose of zolpidem or not to take it.

• In patients with severe hepatic insufficiency, zolpidem should not be taken, as it may contribute to the appearance of encephalopathy (brain disease).

• Do not take zolpidem at the same time as opioids (medicines used to relieve severe pain, such as morphine or codeine) unless your doctor prescribes it, due to the possible risk of suffering sedation, respiratory depression, coma, or even death (see "Use of Zolpidem Stada with other medicines"). In the event that your doctor finally prescribes zolpidem concomitantly

with opioids, they should prescribe the minimum effective dose and for the shortest time of concomitant use. Your doctor will monitor the appearance of signs and symptoms of respiratory depression and sedation.

• In elderly patients, the dose should be reduced. See section 3. How to take Zolpidem Stada.

• Children and adolescents: zolpidem is not recommended in children and adolescents under 18 years of age.

Psychomotor alteration the next day (see also "Driving and use of machines")

Like other hypnotic/sedative medicines, zolpidem has depressant effects on the central nervous system.

The next day after taking zolpidem, the risk of psychomotor alteration, including alteration of the ability to drive, may be increased if:

• You take this medicine with less than 8 hours of margin before performing activities that require a state of mental alertness
• You take a higher dose than the recommended dose
• You take zolpidem at the same time as another central nervous system depressant or another medicine that increases the concentration of zolpidem in your blood, combined with alcohol or with illegal substances.

Take the dose once and immediately before going to bed at night.

Do not take another dose during the same night.

Taking Zolpidem Stada with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

This is extremely important because the simultaneous use of more than one medicine can increase or decrease its effect.

Therefore, you should not use other medicines at the same time as zolpidem unless your doctor is informed and approves it beforehand.

If you take zolpidem with the following medicines, effects such as drowsiness or psychomotor alteration the next day, including alteration of the ability to drive, may be increased.

• Medicines for some mental disorders (antipsychotics)
• Medicines for sleep problems (hypnotics)
• Medicines to relieve or reduce anxiety
• Medicines for depression
• Medicines for moderate to severe pain (narcotic analgesics)
• Medicines for epilepsy
• Anesthetic medicines
• Medicines for seasonal allergic rhinitis, skin rashes, or other allergies that can cause drowsiness (sedating antihistamines)

• If you take zolpidem with antidepressants, including bupropion, desipramine, fluoxetine, sertraline, and venlafaxine, you may see things that are not real (hallucinations).

• It is not recommended to take zolpidem with fluvoxamine or ciprofloxacin.
• If you take zolpidem with narcotic analgesics, it may produce an increase in euphoria that could lead to an increase in psychological dependence.
• Opioid medicines: the use of zolpidem at the same time as opioids (potent analgesics, substitution therapy medicines, and some cough medicines) increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and can be potentially fatal. Due to this, concomitant use should only be considered when other treatment options are not possible.

However, if your doctor prescribes zolpidem along with opioids, the dose and duration of concomitant treatment should be limited by your doctor.

Tell your doctor about all opioid medicines you are taking and follow your doctor's dosing recommendation closely. It may be useful to inform friends or relatives so that they are aware of the signs and symptoms indicated above. Contact your doctor when you experience these symptoms.

• Some medicines that inhibit/induce certain liver enzymes (CYP450) may affect the action of zolpidem.
• The concomitant administration with ketoconazole (used to treat fungal infections) may increase the sedative effects.
• The concomitant administration with rifampicin (used to treat infections) and with St. John's Wort may decrease the effect of zolpidem.
• Concomitant use of zolpidem with St. John's Wort is not recommended, as it may decrease the blood levels of zolpidem.
• Concomitant use with medicines that contain alcohol is not recommended. It may increase the sedative effect.

Taking Zolpidem Stada with food, drinks, and alcohol

During treatment, avoid alcoholic beverages. The effect of alcohol may potentiate sedation, and this may affect the ability to drive or use machinery. If you need additional information on this point, consult your doctor.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Zolpidem is not recommended during pregnancy. If you are pregnant, think you may be pregnant, or are planning to have a baby, consult your doctor.

If used during pregnancy, there is a risk that the baby may be affected. Some studies have shown an increased risk of cleft lip and palate (sometimes called "hare lip") in newborns.

Reduced fetal movement and variability of fetal heart rate may occur after taking zolpidem during the second and/or third trimester of pregnancy.

If zolpidem is taken at the end of pregnancy or during delivery, the baby may show muscle weakness, a decrease in body temperature, difficulty feeding, and breathing problems (respiratory depression).

If you take this medicine regularly at the end of pregnancy, your baby may develop symptoms of physical dependence and may be at risk of developing withdrawal symptoms such as agitation or tremors. In this case, the newborn should be closely monitored during the postnatal period.

Breastfeeding

This medicine passes into breast milk, so you should not take zolpidem during breastfeeding.

Driving and use of machines

Zolpidem is a medicine that causes sleep. Do not drive or use machines if you feel drowsy or if you notice that your attention and reaction capacity are reduced. Pay special attention at the start of treatment or if the dose is increased.

Zolpidem has a significant effect on the ability to drive and use machines, such as "driving while drowsy". On days when you take zolpidem (as with other hypnotics), you should consider the following:

• You may feel drowsy, sleepy, dizzy, or confused
• You may take longer to make decisions
• You may experience blurred or double vision
• Your state of alertness may be decreased

In order to reduce the aforementioned effects, a minimum margin of 8 hours is recommended between the administration of zolpidem and driving, using machinery, or performing any work at heights.

Do not consume alcohol or any other psychoactive substance while taking zolpidem, as this may increase the aforementioned effects.

Zolpidem Stada contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Zolpidem Stada contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is, essentially "sodium-free".

3. How to take Zolpidem Stada

Follow the administration instructions for this medication exactly as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

• The recommended dose is 10 mg of zolpidem every 24 hours. A lower dose may be prescribed for some patients. Zolpidem should be taken:
  • once; and
  • right before bedtime.

Ensure that you leave a minimum margin of 8 hours from taking the medication until you engage in activities that require mental alertness.

Do not take more than 10 mg every 24 hours.

• In elderly patients, debilitated patients, and patients with liver disorders, the doctor will prescribe a lower dose.

The recommended daily dose is half a tablet, i.e., 5 mg of zolpidem.

• Children (under 18 years): its use is not recommended

Treatment should be started with the lowest dose. Do not exceed the maximum dose.

Each individual dose should not exceed the indicated limits, and the total daily dose should not either, unless your doctor prescribes a higher dose.

Take zolpidem right before bedtime and swallow the tablet without chewing, with water or another non-alcoholic beverage.

Under normal conditions, it should not take more than 20 minutes to fall asleep after taking zolpidem, and it is advisable to ensure that you can rest without being awakened for at least 8 hours. Otherwise, although this happens rarely, it is possible that you will not remember what happened while you were awake.

In most cases, only short-term treatment with zolpidem is needed (generally not exceeding two weeks). The maximum treatment duration is four weeks, including gradual withdrawal of the medication. Treatment extension will not be performed without a reevaluation of your condition, as the risk of abuse and dependence increases with treatment duration (see section 2).

To avoid withdrawal symptoms, do not stop taking zolpidem abruptly, especially if you have been taking it for a long time.

If you think the effect of zolpidem is too strong or too weak, inform your doctor or pharmacist.

Ifyou take more Zolpidem Stada than you should

If you have taken more zolpidem than you should, consult your doctor or pharmacist immediately.

In cases of overdose involving zolpidem alone or with other central nervous system depressants (including alcohol), cases have been reported ranging from altered consciousness to coma and more severe symptoms, including death.

In moderate cases, symptoms include: drowsiness, mental confusion, and feeling of fatigue, exhaustion (lethargy). In more severe cases, symptoms may include lack of coordination in movement (ataxia), decreased muscle tone (hypotonia), low blood pressure (hypotension), respiratory depression, cases of decreased consciousness up to coma, and more severe symptoms, including a fatal outcome.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forget to take Zolpidem Stada

Do not take a double dose to make up for forgotten doses.

If you interrupt treatment with Zolpidem Stada

Abrupt interruption of treatment may cause withdrawal syndrome, which manifests as headache or muscle pain, anxiety, tension, restlessness, confusion, and irritability (see section "Warnings and precautions").

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medications, this medication can cause adverse effects, although not all people experience them.

Most patients tolerate zolpidem well, but some, especially at the beginning of treatment, may feel somewhat tired or drowsy during the day.

The following criterion has been used for the classification of the frequency of adverse reactions:

Very common: may affect more than 1 in 10 patients

Common: may affect up to 1 in 10 patients

Uncommon: may affect up to 1 in 100 patients

Rare: may affect up to 1 in 1,000 patients

Very rare: may affect up to 1 in 10,000 patients

Frequency not known: cannot be estimated from the available data.

A relationship between adverse effects and dose has been demonstrated. These effects should be less if zolpidem is administered immediately before bedtime.

These effects are more frequent in elderly patients.

Immune system disorders

Frequency not known: allergic inflammation that can be localized in feet, hands, throat, lips, and respiratory tract (angioneurotic edema).

Psychiatric disorders

Common: hallucinations, agitation, nightmares, depression.

Uncommon: confusional state, irritability, restlessness, aggressiveness, sleepwalking, mood elevation. Zolpidem may cause sleepwalking or other unusual behaviors while sleeping (such as driving, eating, making phone calls, or having sexual relations, etc.), without being fully awake, see section "Warnings and precautions".

Rare: changes in sexual desire.

Very rare: delirium, dependence (treatment interruption may cause withdrawal symptoms or rebound effects).

Frequency not known: anger attacks, psychosis, abnormal behavior.

Nervous system disorders

Common: drowsiness, headache, dizziness, worsening of insomnia, cognitive disorders such as anterograde amnesia (not remembering what happened while awake after taking the medication). Amnesia may be associated with inappropriate behavior.

Uncommon: feeling of tingling, numbness (paresthesia), tremor, attention disorder, speech disorder.

Rare: decreased level of consciousness.

Eye disorders

Uncommon: double vision, blurred vision. Rare: visual impairment.

Respiratory, thoracic, and mediastinal disorders

Very rare: breathing difficulties (respiratory depression).

Gastrointestinal disorders

Common: diarrhea, nausea, vomiting, abdominal pain.

Hepatobiliary disorders

Uncommon: increased liver enzymes.

Rare: liver damage (hepatocellular, cholestatic, or mixed injury).

Metabolism and nutrition disorders

Uncommon: appetite disorder.

Skin and subcutaneous tissue disorders

Uncommon: itching, skin rash, excessive sweating. Rare: hives.

Musculoskeletal and connective tissue disorders

Common: back pain.

Uncommon: joint pain (arthralgia), muscle pain (myalgia), muscle spasms, neck pain, muscle weakness

Infections and infestations

Common: respiratory tract infection (upper and lower respiratory tract infection).

General disorders and administration site conditions

Common: fatigue.

Rare: gait disturbances, falls (predominantly in elderly patients and when the doctor's recommendations are not followed).

Frequency not known: tolerance to the product.

Depression

The use of the medication may unmask existing depression. Since insomnia can be a symptom of depression, if insomnia persists, inform your doctor to evaluate your situation.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Zolpidem Stada

Keep this medication out of sight and reach of children.

No special storage conditions are required. Store in the original packaging.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Zolpidem Stada

• The active ingredient is zolpidem tartrate. Each tablet contains 10 mg of zolpidem, as zolpidem tartrate.
• The other components are cellulose, lactose monohydrate, sodium croscarmellose, colloidal silicon dioxide, magnesium stearate, hydroxypropyl methylcellulose, titanium dioxide (E171), polyethylene glycol, polysorbate 80, and a natural wax emulsion in an aqueous base.

Appearance of the product and package contents

Zolpidem Stada 10 mg are film-coated tablets, white, oblong, with rounded edges and scored on one side.

The score line is only for breaking the tablet if you find it difficult to swallow it whole.

Each package contains 30 or 500 (clinical package) film-coated tablets.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona) Spain

[email protected]

Manufacturer

STADA Arzneimittel AG

Stadastraße 2-18

61118 Bad Vilbel

Germany

Date of the last revision of thisleaflet: June 2021

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/