Zolpidem ViatriS 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Zolpidem Viatris 10 mg film-coated tablets EFG

zolpidem tartrate

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

• Keep this leaflet, as you may need to read it again.

• If you have any questions, ask your doctor, pharmacist or nurse.

• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.

• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if such effects are not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

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

Zolpidem is used for the short-term treatment of insomnia in adults, in situations where insomnia is debilitating or causing severe anxiety.

Do not take this medicine for long. 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, particularly when there are difficulties in falling asleep, either initially or after an early awakening.

2. What you need to know before taking Zolpidem Viatris

Do not take Zolpidem Viatris

• If you are allergic to zolpidem, to the benzodiazepine group of medicines in general, or to any of the other components of this medicine (listed in section 6).
• If you have acute and/or severe breathing difficulties.
• If you suffer from severe muscle weakness (myasthenia gravis).
• If you have sleep apnoea (a condition in which your breathing stops for very short periods of time while you are sleeping).
• If you have any liver or kidney disorder.
• 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 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 taking Zolpidem Viatris.

• Your doctor should identify the causes of insomnia whenever possible and treat any underlying factors before prescribing zolpidem.

• After taking zolpidem, you must ensure you can have an uninterrupted 8-hour sleep period to reduce the risk of anterograde amnesia (not remembering what happened while you were 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 abuse and/or physical and psychological 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 have worked for other patients) and should never be recommended to other people.

• Do not increase the dose prescribed by your doctor or extend 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, reduced 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 that you are aware of the possibility of this rebound phenomenon occurring, to minimize anxiety that may arise when these effects appear upon stopping treatment. For short-acting hypnotic/sedative medicines, a dose-withdrawal phenomenon may occur within the dosing interval. The likelihood of rebound insomnia is higher with abrupt withdrawal. Therefore, it is recommended to gradually reduce the dose according to your doctor's instructions.
• It is known that other psychiatric and "paradoxical" reactions such as restlessness, agitation, worsening of insomnia, irritability, aggressiveness, 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 to occur 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 following morning, you may not remember anything you did during the night. If you experience any of the above symptoms, stop treatment with zolpidem immediately and contact your doctor or healthcare provider, as these sleep-related behaviours may put 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 acting on the central nervous system, or taking doses higher than the recommended dose, may increase the risk of these behaviours. 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 may lead to falls and consequently cause serious injuries.

• After repeated use over several weeks, some tolerance to the product may develop, leading to a loss of hypnotic efficacy.

• If you have a history of drug or alcohol dependence, you should not take zolpidem unless directed 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 disorders (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 thoughts, 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 any liver disorder 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 by patients with severe hepatic insufficiency, as it may contribute to the development of encephalopathy (brain disease).

• Do not take zolpidem together with 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 "Other medicines and Zolpidem Viatris"). If your doctor does prescribe zolpidem concomitantly with opioids, they should prescribe the lowest effective dose 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 Viatris".

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 of sleep time before engaging in 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.

Children and adolescents

Do not give zolpidem to children and adolescents under 18 years of age.

Other medicines and Zolpidem Viatris

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take 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 at the same time as 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).

• It is not recommended to take zolpidem with fluvoxamine or ciprofloxacin.

• If you take zolpidem with narcotic analgesics, increased euphoria may occur, which could lead to increased psychological dependence.

• Opioid medicines: using zolpidem together with opioids (strong painkillers, 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 so they are aware of the signs and symptoms mentioned above. Contact your doctor if you experience such symptoms.

• Some medicines that inhibit/induce certain liver enzymes (CYP450) may affect the action of zolpidem.
• Co-administration with ketoconazole (used to treat fungal infections) may increase sedative effects.
• Co-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 Viatris with food and drinks

During treatment, avoid alcoholic drinks. The effect of alcohol may enhance sedation, which may affect your ability to drive or operate machinery. If you need further information on this point, consult your doctor.

Pregnancy, lactation and fertility

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

Pregnancy:

Zolpidem is not recommended during pregnancy.

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 cleft palate (sometimes referred to as "hare 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 labor, your baby may show muscle weakness, decreased body temperature, difficulty feeding, 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 developing withdrawal symptoms such as agitation or tremors. In such cases, close monitoring of the newborn will be required during the postnatal period.

Lactation:

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

Driving and using machines

Zolpidem is a medicine that causes drowsiness. Do not drive or operate machinery if you feel sleepy 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 the days you take zolpidem (as with other hypnotics), you should consider the following:

• You may feel drowsy, sleepy, dizzy, or confused.
• It may take you longer to make decisions.
• You may experience blurred or double vision.
• Your alertness may be reduced.

To reduce the aforementioned effects, a minimum interval of 8 hours between zolpidem administration and driving, operating machinery, or performing any work at heights is recommended.

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

Zolpidem Viatris contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Zolpidem Viatris

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. 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
• immediately before bedtime.

You must ensure that you allow a minimum of 8 hours between taking the medicine and performing activities requiring mental alertness.

Do not take more than 10 mg every 24 hours.

Elderly patients (over 65 years of age) or debilitated patients

The recommended dose is half a tablet, i.e. 5 mg. The recommended dose must not be exceeded.

Patients with liver problems

The recommended starting dose is 5 mg. Your doctor may decide to increase it to 10 mg if considered safe.

Do not take zolpidem if you have severe liver problems.

Patients with respiratory problems

A lower dose is recommended for patients with respiratory problems.

Use in children and adolescents

Zolpidem must not be used in children and adolescents under 18 years of age.

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

Take zolpidem immediately before going to bed and swallow 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 will be able to rest undisturbed for at least 8 hours. Otherwise, although this rarely occurs, you may not remember what happened while you were awake.

In most cases, only short-term treatment with zolpidem is needed (generally, it should not exceed two weeks). The maximum duration of treatment is four weeks, including gradual withdrawal of the medicine. Treatment extension will not occur without a 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 must 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 Viatris than you should

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

In overdose cases 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), reduced muscle tone (hypotonia), low blood pressure (hypotension), respiratory depression, impaired consciousness progressing to coma, and more serious symptoms, including fatal outcomes.

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service immediately: Tel. 91 562 04 20, stating the medicine and the amount ingested.

If you forget to take Zolpidem Viatris

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

If you forget to take a dose, you must never try to correct it by taking a double dose next time, but instead continue with your normal dose.

If you stop taking Zolpidem Viatris

Abruptly stopping treatment may cause withdrawal syndrome, which may manifest as 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 can cause adverse effects, although not everyone will 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 classification has been used for the frequency of adverse effects:

Very common: may affect more than 1 in 10 people.
Common: may affect up to 1 in 10 people.
Uncommon: may affect up to 1 in 100 people.
Rare: may affect up to 1 in 1,000 people.
Very rare: may affect up to 1 in 10,000 people.
Frequency not known: cannot be estimated from available data.

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

These effects are more common in elderly patients.

Immune system disorders

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

Psychiatric disorders

Common: hallucinations, agitation, nightmares, depression.
Uncommon: confusional state, 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) 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 injury).

Metabolism and nutrition disorders

Uncommon: appetite disturbance.

Skin and subcutaneous tissue disorders

Uncommon: itching, 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 infection).

General disorders and administration site conditions

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

Depression

Use of this 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, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via 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 Viatris

Empty section

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

This medicine does not require any special storage conditions.

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

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Zolpidem Viatris

• The active substance is zolpidem. Each film-coated tablet contains 10 mg of zolpidem tartrate.
• The other components are: lactose monohydrate, microcrystalline cellulose, pregelatinized corn starch, magnesium stearate, titanium dioxide (E-171), hypromellose 2910 (E-464), macrogol 400, polysorbate 80 (E-433), and purified water.

Appearance of the product and contents of the container

Zolpidem Viatris are film-coated tablets, oblong, white, scored, marked with “ZM” and “10” on one side and with the letter “G” on the reverse.

It is available in blister packs containing 30 or 500 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

Manufacturer:

Mylan Hungary Kft.

H-2900 Komárom

Mylan utca 1

Hungary

Date of the most recent revision of this leaflet: April 2024

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