ZOLPIDEM VIR 10 mg FILM-COATED TABLETS

Introduction

Patient Information Leaflet: Information for the User

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

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

Zolpidem Vir belongs to a group of medicines known as benzodiazepine-related drugs used for sleep disorders.

Zolpidem has a calming and sleep-inducing effect. As a result, zolpidem shortens the time it takes to fall asleep, can prevent frequent awakenings during the night, and prolongs the period of deep sleep.

Zolpidem Vir is used for the short-term treatment of insomnia in adults, only when the disorder is severe, disabling, or causing significant distress.

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.

2. What you need to know before taking Zolpidem Vir

Do not take Zolpidem Vir

• If you are allergic to zolpidem or any of the other ingredientsof this medicine (listed in section 6)
• If you have severe muscle weakness (myasthenia gravis).
• If your breathing stops for short periods while you sleep (sleep apnea syndrome).
• If you have severe liver damage.
• If you have acute and/or severe respiratory weakness.
• If you have experienced sleepwalking or other unusual behaviors while asleep after taking zolpidem or other medicines containing zolpidem. This may include driving, eating, making phone calls, or having sex without being fully awake.

Warnings and precautions

General

Talk to your doctor or pharmacist before taking zolpidem

The cause of the sleep disturbance should be clear and, if possible, underlying diseases should be treated before prescribing sleeping pills, especially if it has been going on for more than 6 weeks.

If the treatment does not improve the sleep problem after 7-14 days of treatment, further investigation will be necessary. The duration of treatment should be as short as possible and never exceed 4 weeks, including the gradual withdrawal process. This period can only be extended after re-evaluation of the patient's condition.

Special care is required when taking zolpidem,

• If you have chronic respiratory problems (prolonged). Your respiratory problems may worsen.
• If you have a liver function disorder

Children and adolescents < 18 years

Since the safety and efficacy of zolpidem have not been adequately studied, the doctor will not prescribe zolpidem.

Elderly and disabled patients

Older people (> 65 years) or debilitated patients may react especially sensitively to zolpidem. In this case, symptoms of fatigue may persist after waking up. Be careful when getting up at night: there is a risk of falls!

Liver damage

Pay special attention to the recommended dose, as the effects of zolpidem may last longer. Your doctor will regularly monitor your treatment.

Tolerance

Repeated use of zolpidem with other sleeping pills for a period of several weeks may affect its efficacy.

Dependence

Long-term use of zolpidem with other sedatives may lead to physical or psychological dependence. The risk of dependence is greater when zolpidem is used for more than 4 weeks. The risk of abuse or dependence increases with the dose and duration of treatment and is greater in patients with a history of mental disorders and/or alcoholism, illicit substances, or drug use. Inform your doctor if you have had any mental disorder or problems with abuse or dependence on alcohol or drugs.

If physical dependence has developed, sudden interruption of treatment may be accompanied by withdrawal symptoms such as headache, muscle pain, fear, and severe tension, restlessness, confusion, and irritability.

In severe cases, the following symptoms may occur: loss of sense of reality, isolation from others, intensified hearing, sensation of numbness and tingling in arms and legs, hypersensitivity to light, sound, and touch, delirium, or epileptic seizures.

Rebound insomnia

After stopping treatment with zolpidem or other sedatives, symptoms may reappear and worsen. Other reactions may also occur, such as mood changes, fear, and restlessness.

The probability of rebound symptoms is greater when treatment is stopped suddenly. This is why the use of zolpidem should be gradually reduced.

Depression

Like other hypnotic or tranquilizing medicines, zolpidem should be used with caution in patients with symptoms of depressionor anxiety accompanied by depression. In certain circumstances, it may increase depressive symptoms if there is no adequate treatment of the underlying disease with appropriate medications (antidepressants). This may increase the risk of suicide for these patients. Depression may appear previously unrecognized due to zolpidem. Some studies show a higher incidence of suicide or attempted suicide in patients taking certain sleeping pills or sedatives, including zolpidem. However, it has not been established whether this is due to medical treatment or if it may have other causes. Inform your doctor immediately if you have suicidal thoughts (thoughts of harming yourself or suicide) or suicidal behavior.

Memory disorders (amnesia)

Zolpidem may cause memory loss (amnesia). It usually occurs a few hours after taking zolpidem. To minimize this risk, you should ensure that you sleep uninterrupted for at least 8 hours.

Paradoxical psychiatric reactions and contradictory reactions

The following reactions may occur when taking zolpidem: increased sleep disturbances, agitation, irritability, aggressiveness, delirium, restlessness, nightmares, mental disorders, sleepwalking, inappropriate behavior, and other adverse effects on behavior.

The use of zolpidem in elderly patients and in combination with alcohol and other medicines seems to increase the risk of these behaviors. The use of a higher dose of zolpidem than the maximum recommended dose also seems to increase the risk of this behavior.

Sleepwalking and other associated behaviors

Cases of sleepwalking and other associated behaviors, such as "sleep-driving", cooking, and eating, making phone calls, or having sex with amnesia for these events, have been reported in patients who had taken zolpidem and were not fully awake.

Concomitant use with alcohol and other medicines seems to increase the risk of these behaviors. The use of a higher dose than the maximum recommended dose also seems to increase the risk of this behavior.

Discontinuation of zolpidem should be considered for patients who report such behaviors (e.g., sleep-driving), due to the risk to the patient and others. Please tell your doctor if such behaviors occur.

Falls

The use of benzodiazepines, including zolpidem, has been associated with an increased risk of falls. Falls may be caused by the side effects of benzodiazepines, such as coordination problems, muscle weakness, dizziness, drowsiness, and fatigue. The risk of falls is greater in older patients and if a higher dose than recommended is taken.

Psychomotor impairment the next day (see also "Driving and using machines")

The day after taking zolpidem, the risk of psychomotor impairment, including impaired driving ability, may be increased if:

• You take this medicine with less than 8 hours of margin before performing activities that require mental alertness
• You take a higher dose than recommended
• 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 illicit substances.

Take the dose once and immediately before bedtime.

Do not take another dose during the same night.

Special patient groups

Zolpidem or other sedatives should be used with caution in patients:

• With respiratory difficulties (respiratory disorders).
• Who have depressive symptoms (risk of suicidal tendencies). Underlying depression may appear during the use of sedatives (pre-existing depression).
• With a history of mental illness and/or alcohol or drug abuse.
• With hereditary cardiac arrhythmia (long QT syndrome).
• The lowest available dose of zolpidem should be administered.

Other medicines and Zolpidem Vir

Consult your doctor or pharmacist if you are taking, have recently taken, or might take any other

If you take zolpidem with the following medicines, the effects such as drowsiness or psychomotor impairment the next day, including impaired driving ability, may be increased.

• Medicines for some mental disorders(antipsychotics)
• Medicines for sleep disorders(hypnotics)
• Medicines for anxiety(sedatives)
• Medicines for depression
• Medicines for moderate to severe pain(narcotic analgesics)
• Medicines for epilepsy
• Medicines anesthetics
• Medicines for seasonal allergic rhinitis, skin rash, or other allergiesthat may cause drowsiness
• Central-acting muscle relaxants; the muscle relaxant effect and the risk of falls, especially in elderly patients, could be greater.

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.

Medicines that significantly increase the activity of certain liver enzymes may reduce the effect of zolpidem, e.g., rifampicin (an antibioticused to treat, for example, tuberculosis).

Taking Zolpidem Vir with food, drinks, and alcohol

Grapefruit juice may increase the effect of zolpidem. Therefore, you should not drink grapefruit juice during treatment with zolpidem. During treatment, avoid alcoholic beverages, as the effect of alcohol may potentiate sedation.

Opioids

Concomitant use of zolpidem and opioids (strong painkillers, substitution therapy medicines, and some cough medicines) increases the risk of drowsiness, respiratory difficulties (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.

Please consult your doctor about all opioid medicines you are taking and strictly follow your doctor's dosage recommendations. It may be useful to inform friends or family members to be aware of the signs and symptoms mentioned above. Contact your doctor when you experience such symptoms.

Analgesics

In the case of concomitant use with narcotic analgesics, you may experience an increased sense of well-being, which could lead to increased mental dependence (psychological).

St. John's Wort and rifampicin

Concomitant administration with St. John's Wort or rifampicin (a medicine used to combat tuberculosis) may reduce the effectiveness of zolpidem.

Ketoconazole

Concomitant use with ketoconazole, an antifungal medicine, may intensify the effect of zolpidem.

Pregnancy, breastfeeding, and fertility

Pregnancy

The use of zolpidem during pregnancy is not recommended.

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

If zolpidem is 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 "harelip" in newborns.

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

If you take zolpidem in the last months of pregnancy or during childbirth, your baby may experience abnormal low body temperature (hypothermia), low muscle tone (hypotonia), and moderate respiratory failure (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

You should not take zolpidem during breastfeeding because zolpidem passes into breast milk.

Driving and using machines

Zolpidem Vir has a significant effect on the ability to drive and use machines, such as "driving in a somnolent state". On days when you take Zolpidem Vir (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 these effects, a minimum margin of 8 hours is recommended between the administration of zolpidem and driving, using machinery, or any work at heights.

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

Zolpidem Vir 10 mg tablets contain lactose.

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

Zolpidem Vir contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet, i.e., it is essentially "sodium-free".

3. How to take Zolpidem Vir

Always take this medication exactly as your doctor or pharmacist has indicated. Consult your doctor or pharmacist if you have any doubts.

The recommended dose is 10 mg of zolpidem every 24 hours. A lower dose may be prescribed to some patients. Zolpidem should be taken:

• once
• right before bedtime
• with a drink (e.g., a glass of water).

You should ensure that you leave a minimum margin of 8 hours from taking the medication to performing activities that require mental alertness.

You should not exceed 10 mg in 24 hours.

Adults

The normal dose is 10 mg (one tablet).

Elderly or debilitated patients

The initial dose is 5 mg (1/2 tablet).

Hepatic impairment

The initial dose is 5 mg (1/2 tablet).

Renal impairment

The normal dose is 10 mg (1 tablet).

Children

Zolpidem is not recommended in children and adolescents under 18 years of age due to the lack of data supporting its use in this age group.

Route of administration

Oral use.

Swallow the tablet with sufficient liquid (e.g., 1 glass of water) right before bedtime. It is recommended to sleep for 7 to 8 hours after taking the tablet.

Duration of treatment

The duration of treatment should be as short as possible and should not exceed four weeks, including gradual withdrawal of the medication, as the risk of abuse and dependence increases with the duration of treatment. Your doctor may provide you with more information about the duration of treatment. Your doctor may extend the duration of treatment in some cases.

If you take moreZolpidem Virthan you should

In cases of overdose, symptoms can range from extreme drowsiness to mild coma.

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

If you (or someone else) ingest many tablets at the same time, or if you think a child has ingested some of the tablets, contact your doctor or the emergency department of the nearest hospital immediately. Take the package and the remaining tablets with you. Do not go alone to seek medical help. If you have taken an overdose, drowsiness can increase rapidly, and high doses can lead to coma or even death. If zolpidem is taken with other central nervous system medications (including alcohol), it can have a severe outcome that can also be fatal. In moderate cases, symptoms include: drowsiness, mental confusion, and feeling of fatigue, exhaustion (lethargy). In more severe cases, symptoms can include lack of coordination (ataxia), decreased muscle tone (hypotonia), low blood pressure (hypotension), respiratory depression, altered consciousness up to coma, and more severe symptoms, including a fatal outcome.

If you forget to takeZolpidem Vir

It may happen that you forget to take zolpidem. In this case, it is not necessary to take the forgotten dose. Instead, take the dose prescribed by your doctor at the usual time. Do not take a double dose to make up for the forgotten doses.

If you interrupt treatment with Zolpidem Vir

Do not stop taking zolpidem suddenly, as you may experience withdrawal symptoms such as headache, muscle pain, fear, and severe tension, restlessness, confusion, and irritability. Consult your doctor to discontinue treatment by gradually reducing the dose.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

The following side effects are mainly experienced when starting treatment: daytime drowsiness, emotional numbness, reduced alertness, confusion, fatigue, headache, dizziness, muscle weakness, coordination problems (ataxia), and double vision. These side effects generally disappear as treatment progresses. Other side effects that have been occasionally reported are gastrointestinal disorders, changes in libido, and skin reactions.

Common side effects (may affect up to 1 in 10 people).

• Upper or lower respiratory tract infections
• Hallucinations, agitation, nightmares, worsening of sleep disturbance (insomnia), depression
• Daytime drowsiness, numb emotion, headache, dizziness, memory loss may occur several hours after taking zolpidem (anterograde amnesia; there is a higher probability that this will happen if you sleep less than 7 or 8 hours).
• Diarrhea, nausea, vomiting, stomach pain
• Back pain
• Fatigue
• Feeling of "spinning"

Uncommon side effects (may affect up to 1 in 100 people).

• Appetite disorder
• Confusion, irritability, restlessness, aggression, sleepwalking or driving, euphoric mood
• Feeling of tingling, itching, or numbness without reason (paresthesia), involuntary tremor (tremor), attention disorder, speech disorders
• Blurred vision, double vision
• Elevated liver enzymes
• Skin rash, itching (pruritus), excessive sweating (hyperhidrosis)
• Joint pain (arthralgia), muscle pain, muscle spasms, neck pain, muscle weakness

Rare side effects(may affect up to 1 in 1,000 people).

• Changes in libido
• Decreased mental clarity, coordination problems (ataxia)
• Different types of liver damage
• Severe itching rash (urticaria) and lump development, urticaria
• Abnormal gait
• Falls (especially in elderly patients and when zolpidem is not taken according to the prescription recommendation).

Very rare side effects (may affect less than 1 in 10,000 people).

• Decreased vision (vision problems)
• Delirium, physical and mental dependence
• Suppressed breathing

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

• Sudden accumulation of fluid in the skin and mucous membranes (throat or tongue, for example), breathing difficulties, and/or itching and skin rash, often as an allergic reaction (angioneurotic edema).
• Outburst of anger, abnormal behavior, and psychosis, abuse, delirium
• Habituation

If there is a pre-existing depression that has not yet manifested, it may be unmasked with the use of zolpidem.

Reporting side effects:

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects that do not appear in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Zolpidem Vir

Keep this medication out of sight and reach of children.

Do not use after the expiration date shown on the carton and blister packaging. The first two digits indicate the month, and the last four digits indicate the year. The expiration date is the last day of the month indicated.

Keep zolpidem in its original packaging.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Zolpidem Vir composition

The active ingredient is zolpidem tartrate. Each tablet contains 10 mg of zolpidem tartrate.

The other ingredients (excipients) are:

Core:lactose monohydrate, microcrystalline cellulose, sodium starch glycolate type A, hypromellose, and magnesium stearate.

Coating:titanium dioxide (E171), hypromellose, and macrogol 400.

Appearance of the product and package contents

Zolpidem tartrate is a white, oval, biconvex, film-coated tablet with a score line on both sides and marked with "ZIM" on one side of the score line and "10" on the other. The tablet can be divided into equal doses.

Zolpidem tartrate 10 mg film-coated tablets are available in:

• Carton packages with 4, 5, 7, 8, 10, 14, 15, 20, 28, 30, 50, 100, and 500 tablets in blisters.
• Carton packages with 50 tablets (clinical package).
• Child-resistant closure packages with 30, 100, or 500 tablets.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Holder

INDUSTRIA QUIMICA Y FARMACEUTICA VIR, S.A.

Laguna, 66-68-70. Poligono Industrial Urtinsa II

28923 Alcorcón (Madrid), Spain

Manufacturer

Synthon Hispania S.L.

Polígono Las Salinas C/ Castelló 1

08830 Sant Boi de Llobregat

G.L. PHARMA GMBH

SCHLOBPLATZ, 1

A-9502 LANNACH, AUSTRIA

SYNTHON BV

Microweg, 22, P.O.Box 7071

NL-6545 Nijmegen, Netherlands

ORION CORPORATION ORION PHARMA

Orionintie 1, P.O. Box 65

02200 ESPOO, Finland

Orion Corporation

Joensuunkatu 7

24100 Salo

Finland

Industria Quimica y FCA VIR, S.A.

C/Laguna 66-70

Pol. Industrial Urtinsa II

28923 Alcorcón — Madrid

Spain

This leaflet was approved in July 2024

“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.es/”.