ZOLPIDEM SANDOZ 10 mg FILM-COATED TABLETS

2. What you need to know before taking Zolpidem Sandoz

Do not take Zolpidem Sandoz

• if you are allergic to zolpidem or any of the other ingredients of this medication (listed in section 6),
• if you have severe muscle weakness (myasthenia gravis),
• if you have brief pauses in breathing during sleep (sleep apnea syndrome),
• if you have acute and/or severe respiratory weakness (respiratory failure),
• if you have severe liver problems (liver failure),
• if you have experienced sleepwalking or other unusual behaviors while sleeping after taking zolpidem or other medications containing zolpidem. This may include driving, eating, making phone calls, or having sex without being fully awake.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Zolpidem Sandoz.

General

Before treatment with zolpidem

• the cause of sleep disturbances should be clarified and the possibility of treating it without medication should be considered,
• any underlying disease should be treated.

If your sleep problems do not stop after 7 to 14 days of treatment with zolpidem, your doctor will identify, whenever possible, your sleep problem and the factors that cause it.

Tolerance

Repeated use of hypnotics for several weeks can lead to loss of efficacy(tolerance).

Dependence

Taking zolpidem can lead to the development of abuse and/or physical or psychological dependence. The risk of dependence is higher when zolpidem is used for more than 4 weeks. The risk of abuse and dependence is higher in patients with a history of mental disorders and/or alcohol, illicit substance, or drug abuse. Inform your doctor if you have had any mental disorder or problems with abuse or dependence on alcohol, substances, or drugs.

Withdrawal symptoms

If physical dependence has developed, sudden interruption of treatment may be accompanied by withdrawal symptoms such as headache, muscle pain, anxiety, and unusual tension, restlessness, confusion, and irritability. In severe cases, loss of sense of reality, personality disorders, auditory disturbances (hyperacusis), numbness and tingling in the limbs, hypersensitivity to light, noise, and physical contact, hallucinations, or epileptic seizures may occur. Therefore, it is recommended to discontinue treatment by gradually reducing the dose. Zolpidem may cause withdrawal symptoms even within the dose interval.

When stoppingtreatment, temporary withdrawal symptomsmay appear, and symptoms that were present before treatment may reappear, and accompanying reactions may increase, including mood changes, anxiety, and restlessness. Since the risk of withdrawal symptoms or interruption is higher after sudden interruption of treatment, it is recommended to discontinue treatment by gradually reducing the dose.

When taking zolpidem according to the recommended dosage and duration of use, as well as precautions and warnings, the occurrence of withdrawal symptoms or interruption at the end of treatment is minimal.

Zolpidem is not recommended for the basic treatment of certain mental illnesses (psychosis).

Depression

Like other hypnotic or sedative medications, 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 in these patients. Depression that was previously unrecognized may appear due to zolpidem. Some studies show a higher incidence of suicide or attempted suicide in patients taking certain sleep aids 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 committing suicide) or suicidal behavior.

Memory loss (amnesia)

Hypnotic medications can induce limited, temporary memory loss (anterograde amnesia). This means that (usually a few hours) after taking this medication, you may take actions that you will not be able to remember later. This may also include inappropriate behavior. This risk depends on the dose level. To minimize this risk, you should ensure that you can sleep uninterrupted for 8 hours.

Psychiatric and "paradoxical" reactions

Zolpidem may cause, especially in elderly patients, psychiatric reactions and so-called "paradoxical" reactions, such as inner restlessness, increased sleep disturbances, agitation, irritability, aggression, delirium (false beliefs), tantrums, nightmares, hallucinations (seeing, hearing, or feeling things that are not there), abnormal behavior, and other behavioral disorders (see section 4). If this occurs, treatment with zolpidem should be discontinued (see section 4).

Somnambulism

Cases of sleepwalking and associated behaviors have also been reported in patients who had taken zolpidem and were not fully awake. This includes "sleep-driving", preparing and eating food, making phone calls, or having sex while patients are not able to remember these actions when they wake up. If you observe any of the above behaviors, discontinue treatment with zolpidem immediately and contact your doctor, as this sleep behavior can put you and others at serious risk of injury. Drinking alcohol or using other medications at the same time that cause drowsiness may increase the risk of this sleep pattern.

Psychomotor impairment

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

Like other hypnotic or sedative medications, zolpidem has a depressant effect on the central nervous system.

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

• you take this medication less than 8 hours before performing activities that require your alertness,
• you take a higher dose than the recommended dose,
• you take zolpidem while already taking another central nervous system depressant or other medications that increase zolpidem in your blood, or while drinking alcohol, or while taking drugs or medications.

Take the full dose immediately at bedtime.

Do not take another dose during the same night.

The use of zolpidem has been associated with an increased risk of falls. Falls can be caused by side effects such as coordination problems, muscle weakness, dizziness, drowsiness, and fatigue. The risk of falls is higher in elderly patients and if a higher dose than recommended is used.

Impairment of respiratory and hepatic function.

Patients with chronic respiratory failure or hepatic function disordersshould be treated with caution, and your doctor may prescribe a lower dose of zolpidem (see also section 3).

Due to the risk of brain damage, patients with severe hepatic dysfunction should not receive treatment with zolpidem.

Conduction disorder

Patients with a certain congenital conduction disorder ("long QT syndrome") should be treated with caution. Your doctor will carefully weigh the benefits against the risks before treatment with zolpidem.

Elderly and debilitated patients

Should receive a lower dose (see section 3). In elderly patients, caution is required due to the risk of falls, especially when getting up at night.

Children and adolescents

The use of zolpidem is not recommended in children and adolescents under 18 years of age, as there are insufficient clinical data available for its use in this age group.

Other medications and Zolpidem Sandoz

Inform your doctor or pharmacist if you are taking, have recently taken, or may take any other medication.

The following medications may influence the effect of zolpidem or be influenced in their effect:

When taking zolpidem with the following medications, drowsiness and psychomotor impairment the next day, including impaired driving ability, may increase the next day:

• medications for certain mental disorders(antipsychotics),
• medications for sleep disorders(hypnotics),
• medications to reduce or alleviate anxiety,
• medications for depression,
• medications for moderate to severe pain (narcotic analgesics),
• medications for epilepsy,
• anesthetic medications,
• medications for allergic rhinitis, skin rash, or other allergies that may cause drowsiness (sedating antihistamines).

The concomitant use of zolpidem and opioids (potent analgesics, substitution therapy medications, or certain cough medications) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. Due to this, concomitant use should only be considered when no other treatment options are possible.

However, if your doctor prescribes zolpidem together with opioids, your doctor should limit the dose and duration of concomitant treatment.

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

The combination with opioid-type analgesics (narcotic analgesics) may also lead to accelerated development of dependence.

When taking zolpidem with antidepressants such as 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.

With the simultaneous administration of muscle relaxants, their effect may increase, especially in elderly patients and at higher doses (risk of falls!).

Medications that increase the activity of certain liver enzymes (in particular, the P450 CYP3A4 isoenzyme) may weaken the effect of zolpidem (e.g., rifampicin, carbamazepine, phenytoin, St. John's Wort). Concomitant use of zolpidem with St. John's Wort is not recommended.

On the other hand, certain antifungal medications (azolic antifungals, e.g., ketoconazole) and certain antibiotics (macrolide antibiotics), which reduce the effect of these liver enzymes, may increase the effect of zolpidem.

Taking Zolpidem Sandoz with food, drinks, and alcohol

You should not consume alcohol during treatment, as it may unpredictably change and intensify the effect of zolpidem. The ability to perform tasks that require increased concentration may also be affected. Grapefruit juice may increase the effect of zolpidem.

Pregnancy, breastfeeding, and fertility

Pregnancy

The use of zolpidem during pregnancy is not recommended. If you are pregnant or breastfeeding, or 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 "hare lip" 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 muscle weakness, decreased body temperature, and moderate respiratory failure (respiratory depression).

If you take this medication 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 after birth.

Breastfeeding

Since zolpidem passes into breast milk only in small amounts, zolpidem should not be taken during breastfeeding.

Fertility

There are no available data on the effect on fertility.

Driving and use of machines

Zolpidem has a significant effect on the ability to drive and use machines, such as "driving while drowsy" or driving with excessive fatigue "driving while asleep". The day after taking zolpidem (as with other sleep aids), 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.

In order to reduce the aforementioned effects, a minimum interval 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 Sandoz contains lactose and sodium

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

This medication 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 Sandoz

Follow the administration instructions of this medication as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

The recommended dose is:

Adults

The recommended dose is 1 tablet of zolpidem every 24 hours (10 mg of zolpidem tartrate). In some patients, a lower dose may be prescribed. The tablets should be taken:

• as a single dose,
• right before bedtime.

Make sure that after taking this medication, you wait at least 8 hours before engaging in activities that require your attention.

Do not exceed the dose of 10 mg every 24 hours.

Elderly and debilitated patients

A dose of 1/2 film-coated tablet (5 mg) of zolpidem is recommended for the elderly or debilitated patients who may be particularly sensitive to zolpidem. This dose should only be increased to 10 mg (1 film-coated tablet) if the effect is insufficient and the medication is well tolerated.

Respiratory dysfunction or hepatic impairment

In patients with respiratory dysfunction or hepatic impairment, the dose should be 1/2 film-coated tablet (5 mg) of zolpidem.

Children and adolescents

The use of zolpidem is not recommended in children and adolescents under 18 years of age, as there is insufficient clinical data available for its use in this age group.

Method of administration

Zolpidem should be taken with some liquid (water) immediately before bedtime or in bed.

The tablet can be divided into equal doses.

How long should you take Zolpidem Sandoz?

The duration of treatment should be as short as possible. In general, it should be from a few days to 2 weeks and should not exceed 4 weeks, including the gradual withdrawal phase.

In individual cases, treatment may be necessary for a longer period. However, this should not be done without a medical reevaluation of your condition.

If you take more Zolpidem Sandoz than you should

In case of overdose, consult a doctor immediately.

The signs of overdose (mild) may include drowsiness, dizziness, blurred vision, difficulty speaking, decreased blood pressure, unsteady gait and movement, muscle weakness, mental confusion, and hallucinations. In cases of severe poisoning, it can range from deep sleep to unconsciousness, agitation, respiratory dysfunction, and circulatory collapse. Cases of overdose with zolpidem (alone or in combination with other central depressants, including alcohol) with serious consequences (including fatal events) have been reported.

If you have taken more Zolpidem Sandoz than you should, consult your doctor immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

If you forget to take Zolpidem Sandoz

Do not take a double dose to make up for forgotten doses. Continue taking zolpidem as prescribed by your doctor.

If you stop taking Zolpidem Sandoz

If you want to stop treatment, talk to your doctor first. Do not stop the medication on your own without medical advice. Since the risk of withdrawal symptoms is higher after sudden treatment interruption, your doctor will advise you to finish the treatment by gradually reducing the dose, consult the section 2 Warnings and precautions, Withdrawal.

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 will experience them.

Stop taking zolpidem and consult a doctor or go to the hospital immediately if:

You have an allergic reaction (angioedema). These signs may include: itchy skin rash, urticaria or hives, swelling of hands, feet, ankles, face, lips, or throat that can cause difficulty swallowing or breathing.

There is evidence of dose-dependent side effects, especially those affecting the central nervous system. To reduce these side effects, zolpidem should be taken directly before bedtime or in bed, as recommended. Side effects are more common in elderly patients.

Inform your doctor as soon as possible if you experience any of the following side effects:

Common(may affect up to 1 in 10 people):

• drowsiness,
• increased insomnia,
• nightmares,
• fatigue,
• headache,
• feeling dizzy,
• cognitive disorders such as temporary memory loss (anterograde amnesia, which may be associated with inappropriate behavior),
• hallucinations,
• increased activity,
• depression,
• diarrhea,
• feeling sick (nausea) or being sick (vomiting),
• abdominal pain,
• upper respiratory tract infection,

• lower respiratory tract infection,
• back pain.

Uncommon(may affect up to 1 in 100 people):

• appetite disorder,
• confusion,
• irritability,
• restlessness,
• aggression,
• sleepwalking or other unusual behaviors during sleep, such as driving, eating, talking on the phone, or having sex during sleep without being fully awake (see the section "Warnings and precautions").
• euphoric mood,
• sensory disorder such as tingling or numbness (paresthesia),
• tremor,
• attention deficit,
• speech disorder,
• double vision,
• blurred vision,
• elevated liver enzymes,
• rash,
• itching (pruritus),
• excessive sweating (hyperhidrosis),
• joint pain,
• muscle pain,
• muscle cramps,
• neck pain,

muscle weakness.

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

• sexual dysfunction,
• vision impairment,
• liver damage (hepatocellular, cholestatic, or mixed) (see also section 2 "what you need to know before taking Zolpidem Sandoz" and section 3),
• hives (urticaria),
• unsteadiness while walking,
• risk of falls (especially in elderly patients or if Zolpidem is not taken as prescribed).
• clouding of consciousness.

Very rare(may affect less than 1 in 10,000 people):

• thinking things that are not true (delusions),
• dependence (withdrawal symptoms or interruption may occur after treatment completion),
• breathing impairment (respiratory depression).

Frequency not known(frequency cannot be estimated from available data):

• tantrums,
• abnormal behavior,
• development of tolerance,
• persistent swelling of the skin and mucous membranes (angioedema),
• abuse.

Reporting of side effects:

If you experience any side effects, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for human use medications: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Zolpidem Sandoz

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

Do not use this medication after the expiration date shown on the packaging and blister after "CAD/EXP". The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from light.

This medication does not require any special storage temperature.

Medications should not be thrown away through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. If in 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

Zolpidem Sandoz composition

• The active ingredient is zolpidem tartrate. Each film-coated tablet contains 10 mg of zolpidem tartrate.
• The other ingredients are:

Tablet core:succinic acid, sodium starch glycolate (type A), microcrystalline cellulose, lactose monohydrate, magnesium stearate, anhydrous colloidal silica.

Tablet coating:lactose monohydrate, macrogol 4000, hypromellose, titanium dioxide (E 171).

Product appearance and package contents

White, glossy, oblong, biconvex film-coated tablets with a score line on one side.

The film-coated tablets are presented in PVC/Aluminum blisters and packaged in a cardboard box.

The packages contain 10, 14, 20, 28, 30, 30x1, 50, 98, 100 film-coated tablets.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer:

Salutas Pharma GmbH

Otto-von-Guericke-Alle 1

39179 Barleben

Germany

or

Rowa Pharmaceuticals Ltd

Newton, Bantry

Co. Cork

Ireland

This medication is authorized in the Member States of the European Economic Area under the following names:

Belgium: Zolpidem Sandoz 10 mg filmomhulde tabletten

Denmark: Zolpidem "Hexal" filmovertrukne tabletter

Germany: Zolpidem HEXAL 10 mg Filmtabletten

Ireland: Zolnod 10 mg film-coated tablets

Italy: ZOLPIDEM SANDOZ 10 mg compresse rivestite con film

Netherlands: ZOLPIDEMTARTRAAT SANDOZ 10 MG, FILMOMHULDE TABLETTEN

Sweden: Zolpidem Hexal 10 mg filmdragerad tablett

Date of the last revision of this leaflet:February 2022

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.