Zolpidem Stada 10 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Zolpidem Stada 10 mg film-coated tablets EFG

Zolpidem tartrate

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, since it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet Contents

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

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

Zolpidem Stada is a hypnotic medicine belonging to a group of medicines known as benzodiazepine-like analogues.

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

Do not take this medicine for a long time. Treatment should be as short as possible, since 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 in falling asleep, either initially or after early morning awakening.

2. What you need to know before taking Zolpidem Stada

Do not take Zolpidem Stada

• If you are allergic to zolpidem or to benzodiazepines in general, or to any of the other ingredients of this medicine (listed in section 6).
• If you have acute and/or severe breathing difficulties.
• If you suffer from breathing problems during sleep (sleep apnoea syndrome).
• If you have muscle weakness or fatigue (myasthenia gravis).
• If you have severe liver problems (hepatic impairment).
• As a long-term treatment. Treatment should be as short as possible, because the risk of dependence increases with the duration of treatment.
• If you have previously experienced sleepwalking or other unusual behaviours during sleep (such as driving, eating, making phone calls, or engaging in sexual activity, etc.) while not fully awake after taking zolpidem or other medicines containing zolpidem.

Warnings and precautions

Talk to your doctor or pharmacist before starting zolpidem.

• Your doctor should identify the causes of insomnia whenever possible and treat any underlying conditions before prescribing zolpidem.
• After taking zolpidem, you must ensure you have an uninterrupted 8-hour period for sleep to reduce the risk of anterograde amnesia (not remembering events that occurred while awake).
• If you have ever had a mental disorder or problems with alcohol or drug abuse or dependence.
• Risk of dependence: The use of zolpidem may lead to the development of physical and/or psychological abuse and dependence. The risk of dependence is higher 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 alcohol, illicit substances, or drug abuse.
• To minimize the risk of dependence, the following precautions should be observed:
• These medicines should only be taken under medical prescription (never because they worked for someone else) and should never be recommended to others.
• Do not increase the dose prescribed by your doctor, or extend the treatment beyond the recommended duration.
• Consult your doctor regularly so they can decide whether treatment should continue.

Once physical dependence has developed, abruptly stopping treatment may lead to a withdrawal syndrome, which may include restlessness, anxiety, headache, muscle pain, confusion, irritability, and tension. Therefore, it is recommended to gradually reduce the dose according to your doctor's instructions.

In severe cases, the following symptoms may occur: altered 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 stopping treatment, a transient syndrome may occur in which the symptoms that led to starting treatment reappear, but in a more intense form. These may be accompanied by other reactions such as mood changes, anxiety, sleep disturbances, and restlessness. It is important to be aware that this rebound phenomenon may occur, to minimize anxiety caused by the appearance of these effects when stopping treatment. For short-acting hypnotic/sedative medicines, dose withdrawal symptoms may appear within the dosing interval. The likelihood of rebound insomnia is higher with abrupt discontinuation. Therefore, it is recommended to gradually reduce the dose, as directed by your doctor.

• It is known that other psychiatric and "paradoxical" reactions such as restlessness, agitation, worsening of insomnia, irritability, aggression, delirium, rage attacks, nightmares, psychosis, hallucinations, abnormal behaviour, and other behavioural disturbances may occur with zolpidem. Treatment should be discontinued if these reactions occur. These reactions are more likely in elderly patients.

• Zolpidem may cause sleepwalking or other unusual behaviours during sleep (such as driving, eating, making phone calls, or engaging in sexual activity, etc.) while not 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, stop taking zolpidem immediately and contact your doctor or healthcare provider, as these sleep-related behaviours may place you and others at serious risk of injury.

Drinking alcohol or taking other medicines that cause drowsiness together with zolpidem may increase the risk of these sleep-related behaviours.

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

• This medicine may cause drowsiness and a reduced level of consciousness, which may lead to falls and consequently cause serious injuries.

• After repeated use over several weeks, tolerance to the medicine may develop, leading to a loss of hypnotic effectiveness.

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

• 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 illness (psychosis), it is not recommended as primary treatment.

• If you have suicidal tendencies or depression, use with extreme caution. Consult your doctor before using this medicine, as it may unmask an existing depression. Some studies have shown an increased risk of suicidal ideation, suicide attempts, 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 further medical advice.

• If you have liver disorders or respiratory problems, your doctor will decide whether you should take a lower dose of zolpidem or not take it at all.

• Zolpidem should not be taken in patients with severe hepatic insufficiency, as it may contribute to the development 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 prescribed by your doctor, due to the possible risk of sedation, respiratory depression, coma, or even death (see “Use of Zolpidem Stada with other medicines”). If your doctor does prescribe zolpidem concomitantly with opioids, the lowest effective dose should be prescribed for the shortest possible duration of concomitant use. Your doctor will monitor for 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 for children and adolescents under 18 years of age.

Next-day psychomotor impairment (see also “Driving and use of machines”)

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

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

• You take this medicine with less than 8 hours before performing activities requiring mental alertness.
• You take a higher dose than the recommended dose.
• You take zolpidem together with another central nervous system depressant or another medicine that increases zolpidem blood levels, combined with alcohol or illicit 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 need to use any other medicines.

This is extremely important because taking more than one medicine at the same time may increase or decrease their effects.

Therefore, you should not use other medicines together with zolpidem unless your doctor is informed and has approved it.

If you take zolpidem with the following medicines, effects such as drowsiness or next-day psychomotor impairment, including impaired ability to drive, may be enhanced:

• Medicines for certain 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

• Anaesthetic medicines

• Medicines for seasonal allergic rhinitis, skin rashes, or other allergies that may 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).

• Concomitant use of zolpidem with fluvoxamine or ciprofloxacin is not recommended.

• If you take zolpidem with narcotic analgesics, increased euphoria may occur, potentially leading to increased psychological dependence.

• Opioid medicines: Using zolpidem together with opioids (strong analgesics, medicines for substitution therapy, and some cough medicines) increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and may be potentially fatal. Therefore, concomitant use should only be considered when no other treatment options are possible.

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

Inform your doctor about all opioid medicines you are taking and closely follow your doctor's dosing recommendations. It may be helpful to inform friends or family members about the signs and symptoms mentioned above. Contact your doctor if you experience such symptoms.

• Some medicines that inhibit or induce certain liver enzymes (CYP450) may affect the action of zolpidem.
• Concomitant administration with ketoconazole (used to treat fungal infections) may increase sedative effects.
• Concomitant administration with rifampicin (used to treat infections) and St. John’s wort may reduce the effect of zolpidem.
• Concurrent use of zolpidem with St. John’s wort is not recommended, as it may reduce zolpidem blood levels.
• Concomitant use with medicines containing alcohol is not recommended. It may increase the sedative effect.

Taking Zolpidem Stada with food, drinks, and alcohol

During treatment, avoid alcoholic beverages. Alcohol may enhance sedation, which may affect your ability to drive or operate machinery. If you need further information on this, consult your doctor.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

The use of zolpidem during pregnancy is not recommended. If you are pregnant, think you may be pregnant, or plan to become pregnant, 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 "cleft lip") in newborns.

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

If zolpidem is taken towards the end of pregnancy or during childbirth, your baby may show muscle weakness, decreased body temperature, feeding difficulties, and breathing problems (respiratory depression).

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

Breastfeeding

This medicine passes into breast milk; therefore, zolpidem should not be taken during breastfeeding.

Driving and use of machines

Zolpidem is a medicine that causes sleepiness. Do not drive or operate machinery if you feel drowsy or notice that your attention and reaction ability are reduced. Pay special attention at the beginning of treatment or when the dose is increased.

Zolpidem has a significant effect on the ability to drive and operate machinery, 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 alertness may be reduced

To reduce the above-mentioned effects, a minimum interval of 8 hours between taking zolpidem and driving, operating machinery, or performing work at heights is recommended.

Do not consume alcohol or any other psychoactive substances while taking zolpidem, as this may increase the above-mentioned effects.

Zolpidem Stada contains lactose

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

Zolpidem Stada contains sodium

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

3. How to take Zolpidem Stada

Follow exactly the instructions for use of this medicine as given by your doctor. If in 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:
  • as a single dose; and
  • just before going to bed.

You must ensure that you leave a minimum interval of 8 hours between taking the medicine and engaging in activities requiring mental alertness.

Do not take more than 10 mg every 24 hours.

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

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

• Children (under 18 years of age): use is not recommended.

Treatment should be initiated with the lowest dose. The maximum dose must not be exceeded.

Each individual dose must not exceed the limits indicated, nor must the total daily dose, unless your doctor prescribes a higher dose.

Take zolpidem just before going to bed, swallowing the tablet whole with water or another non-alcoholic drink.

Under normal conditions, you should fall asleep within 20 minutes after taking zolpidem, and it is advisable to ensure that you can rest undisturbed for at least 8 hours. Otherwise, although this occurs rarely, you may 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 duration of treatment is four weeks, including gradual withdrawal of the medicine. Prolongation of treatment should not occur without re-evaluation of your condition, as the risk of abuse and dependence increases with the duration of treatment (see section 2).

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

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

If you take more Zolpidem Stada than you should

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

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

In moderate cases, symptoms include: drowsiness, mental confusion, and feelings of tiredness, 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, impaired consciousness progressing to coma, and more severe symptoms including fatal outcomes.

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at: 91 562 04 20, indicating the medicine and the amount ingested. It is recommended to bring the medicine packaging and 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 stop taking Zolpidem Stada

Abruptly stopping treatment may cause withdrawal syndrome, manifested by headache or muscle pain, anxiety, tension, restlessness, confusion, and irritability (see section "Warnings and precautions").

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences 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 criteria have been used to classify 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 available data.

A dose-dependent relationship has been established for adverse effects. These effects should be minimized if zolpidem is taken immediately before going to bed.

These effects are more frequent in elderly patients.

Immune system disorders

Frequency not known: allergic inflammation that may affect the feet, hands, throat, lips, and respiratory tract (angioneurotic edema).

Psychiatric disorders

Common: hallucinations, agitation, nightmares, depression.
Uncommon: confusion, irritability, restlessness, aggression, sleepwalking, euphoric mood. Zolpidem may cause sleepwalking or other unusual behaviors during sleep (such as driving, eating, making phone calls, or engaging in sexual activity, etc.) while not fully awake; see section "Warnings and precautions".
Rare: changes in sexual desire.
Very rare: delirium, dependence (discontinuation of treatment may lead to withdrawal symptoms or rebound effects).
Frequency not known: rage attacks, psychosis, abnormal behavior.

Nervous system disorders

Common: drowsiness, headache, dizziness, worsening of insomnia, cognitive disorders such as anterograde amnesia (inability to recall events that occurred after taking the medicine). Amnesia may be associated with inappropriate behavior.
Uncommon: tingling sensation, numbness (paresthesia), tremor, attention disturbance, 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 difficulty (respiratory depression).

Gastrointestinal disorders

Common: diarrhea, nausea, vomiting, abdominal pain.

Hepatobiliary disorders

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

Metabolism and nutrition disorders

Uncommon: appetite disturbance.

Skin and subcutaneous tissue disorders

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

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 infections).

General disorders and administration site conditions

Common: fatigue.
Rare: gait disturbance, falls (predominantly in elderly patients and when physician recommendations have not been followed).
Frequency not known: tolerance to the product.

Depression

Use of the medicine may unmask an underlying depression. Since insomnia may be a symptom of depression, if insomnia persists, inform your doctor so that your condition can be evaluated.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Zolpidem Stada

Keep this medicine out of the sight and reach of children.

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point in your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Zolpidem Stada

• The active substance is zolpidem tartrate. Each tablet contains 10 mg of zolpidem as zolpidem tartrate.
• The other components are cellulose, monohydrate lactose, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate, hypromellose, titanium dioxide (E171), polyethylene glycol, polysorbate 80, and aqueous emulsion of natural waxes.

Appearance of the product and contents of the pack

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

The score line is provided only to facilitate breaking the tablet if you have difficulty swallowing it whole.

Each pack contains 30 or 500 tablets (hospital pack) of film-coated tablets.

Only certain pack 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 most recent revision of the package leaflet: June 2021

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/