Prospect: information for the patient

Zolpidem Sandoz 10 mg film-coated tablets EFG

zolpidem tartrate

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only for you, and you should not give it to other people, even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

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

2.What you need to know before starting to take Zolpidem Sandoz

3.How to take Zolpidem Sandoz

4.Possible adverse effects

5.Storage of Zolpidem Sandoz

6.Contents of the pack and additional information

Zolpidemisused for the short-term treatment of insomnia in adults.

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

It is only used when sleep disorders are severe, incapacitating, or cause extreme distress to the patient.

Do not take Zolpidem Sandoz

-if you are allergic to zolpidem or any of the other ingredients of this medicine (listed in section 6),

-if you have a severe muscle weakness (myasthenia gravis),

-if you suffer from brief respiratory pauses during sleep (sleep apnea syndrome),

-if you have a severe and/or acute respiratory weakness (respiratory insufficiency),

-if you have severe liver problems (hepatic insufficiency),

-if you have experienced somnambulism or other unusual behaviors while sleeping after taking zolpidem or other medicines containing zolpidem. This may include driving, eating, calling, or having sex without being fully awake.

Warnings and precautions

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

General

Before starting treatment with zolpidem

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

If your sleep problems do not cease after a 7 to 14 day treatment with zolpidem, your doctor will identify, if possible, your sleep problem and the factors that cause it.

Tolerance

The repeated use of hypnotics over several weeks may cause a loss of efficacy (tolerance).

Dependence

The use of zolpidem may lead to the development of 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 disorders, or problems with alcohol, substance, or drug abuse.

Withdrawal symptoms

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

When treatment isfinished, withdrawal symptoms may temporarily appear and the symptoms that were present before treatment may reappear, including mood changes, anxiety, and restlessness. Since the risk of withdrawal symptoms or interruption is higher after sudden discontinuation of treatment, it is recommended to discontinue treatment gradually reducing the dose.

When taken according to the recommended dose and duration of use, as well as with the precautions and warnings, the appearance of withdrawal symptoms or interruption at the end of treatment is minimal.

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

Depression

Like other hypnotics or tranquilizers, zolpidem should be used with caution in patients with symptoms ofdepressionor anxiety accompanied by depression. In certain circumstances, it may increase depressive symptoms if there is no adequate treatment of the underlying disease with the appropriate medications (antidepressants). This may increase the risk of suicide in these patients. A previously undiagnosed depression 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)

Hypnotics may induce temporary limited memory loss (anterograde amnesia). This means that (usually a few hours) after taking this medicine, you may take actions that you will not be able to remember later. This may also be an inappropriate behavior. This risk depends on the dose level. To minimize this risk, 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 internal restlessness, worsening of sleep disturbances, agitation, irritability, aggression, delusions (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

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

Deterioration of psychomotor function

Deterioration of psychomotor function the next day (also see "Driving and operating machines")

Like other hypnotics or tranquilizers, zolpidem has a depressive effect on the central nervous system.

The risk of psychomotor deterioration, including the deterioration of the ability to drive, may increase if:

• you take this medicine less than 8 hours before performing tasks 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 a higher risk of falls. Falls may be caused by side effects such as coordination problems, muscle weakness, dizziness, somnolence, and fatigue. The risk of falls is higher in elderly patients and if a higher dose than recommended is used.

Deterioration of respiratory and hepatic function.

Patients with chronic respiratory insufficiency or liver 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 liver dysfunction should not receive treatment with zolpidem.

Cardiac conduction disorder

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

Elderly and debilitated patients

They 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

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

Other medicines and Zolpidem Sandoz

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

The following medicines may affect the effect of zolpidem or be affected by it:

While taking zolpidem with the following medicines, drowsiness and psychomotor deterioration the next day, including impaired ability to drive, may increase the next day after taking:

• medicines for certainmental disorders(antipsychotics),
• medicines forsleep disorders(hypnotics),
• medicines to reduce or alleviate anxiety,
• medicines for depression,
• medicines for moderate to severe pain (narcotic analgesics),
• medicines for epilepsy,
• anesthetics,
• medicines for seasonal allergic rhinitis, skin eruptions, or other allergies that may cause drowsiness (sedating antihistamines).

The concomitant use of zolpidem and opioids (potent analgesics, substitution therapy medications, and some cough medicines) increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and may put life at risk. 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, your doctor should limit the dose and duration of concomitant treatment.

Inform your doctor about all the opioid medications you are taking and follow your doctor's dose recommendations strictly. 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 analgesics (narcotic analgesics) may also lead to accelerated development of dependence.

While taking zolpidem with antidepressants such as bupropion, desipramine, fluoxetine, sertraline, and venlafaxine, you may see things that are not real (hallucinations).

Zolpidem is not recommended to be taken with fluvoxamine or ciprofloxacin.

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

Medicines that increase the activity of certain liver enzymes (in particular, the CYP3A4 isoenzyme) may weaken the effect of zolpidem (e.g., rifampicin, carbamazepine, phenytoin, St. John's wort). Zolpidem should not be used simultaneously with St. John's wort.

On the other hand, certain antifungal medications (azole antifungals, e.g., ketoconazole) and certain antibiotics (macrolide antibiotics) that 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 change and intensify the effect of zolpidem unpredictably.The ability to perform tasks that require increased concentration may also be affected. Freshly squeezed orange juice may increase the effect of zolpidem.

Pregnancy, lactation, and fertility

Pregnancy

The use of zolpidem during pregnancy is not recommended. If you are pregnant or breastfeeding, or think you may be 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 variability of fetal heart rate 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 delivery, your baby may experience muscle weakness, abnormally low body temperature, and moderate respiratory depression (respiratory depression).

If you take this medicine 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 this case, the newborn should be closely monitored after birth.

Lactation

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

Fertility

There are no available data on the effect on fertility.

Driving and operating machines

Zolpidem has a significant effect on the ability to drive and operate machines, such as "driving while asleep" or "driving while drowsy". The next day after taking zolpidem (as with other sleep aids), you should be aware of 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 decreased.

To reduce the effects mentioned above, it is recommended to have a minimum of 8 hours between the administration of zolpidem and driving, operating machines, or any work that is performed at height.

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

Zolpidem Sandoz contains lactose and sodium

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

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

Follow exactly 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 zolpidem tablet 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,
• just before going to bed.

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

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

Older adults and debilitated patients

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

Respiratory dysfunction or liver function deterioration

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

Children and adolescents

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

Administration form

Zolpidem should be taken with some liquid (water) immediately before going to bed 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, a treatment that exceeds this period may be necessary. 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, you should consult a doctor immediately.

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

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 forgot to take Zolpidem Sandoz

Do not take a double dose to compensate for the missed doses. Continue taking zolpidem as prescribed by your doctor.

If you interrupt treatment with Zolpidem Sandoz

If you want to interrupt 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 abrupt discontinuation of treatment, your doctor will advise you to end treatment by gradually reducing the dose, see section 2 Warnings and precautions, Withdrawal.

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

Like all medicines, this medicine may 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: skin rash with itching, urticaria or hives, swelling of hands, feet, ankles, face, lips or throat that may cause difficulty swallowing or breathing.

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

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

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

• drowsiness,
• increase in insomnia,
• nightmares,
• fatigue,
• headache,
• feeling dizzy,
• cognitive disorders such as temporary loss of memory (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.

Less frequent(may affect up to 1 in 100 people):

• appetite disorder,
• confusion,
• irritability,
• anxiety,
• 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 "Warnings and precautions" section).
• 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 deterioration,
• liver damage (hepatocellular, cholestatic or mixed) (see also section 2 “What you need to know before starting to take Zolpidem Sandoz” and section 3),
• hives (urticaria),
• gait insecurity,
• risk of falls (especially in elderly patients or if Zolpidem was not taken as prescribed).
• obscurationof consciousness.

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

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

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

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

Do not use this medication after the expiration date that appears on the packaging and the 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.

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and the

medicines that you do not need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and the medicines that you do not need. In this way, you will help to protect the environment.

Zolpidem CompositionSandoz

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

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

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

Product appearance and packaging contents

Coated tablets with a white shiny film coating, oblong, biconvex, and with a notch on one side.

The coated tablets are presented in PVC/Alu blisters and are packaged in a cardboard box.

The packages contain 10, 14, 20, 28, 30, 30x1, 50, 98, 100 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. Cord

Ireland

This medicine is authorized in the member states of the European Economic Area with the following names:

Bélgica:Zolpidem Sandoz 10 mg filmomhulde tabletten

Dinamarca:Zolpidem “Hexal” filmovertrukne tabletter

Alemania:Zolpidem HEXAL 10 mg Filmtabletten

Irlanda:Zolnod 10 mg film-coated tablets

Italia:ZOLPIDEM SANDOZ 10 mg compresse rivestite con film

Holanda:ZOLPIDEMTARTRAAT SANDOZ 10 MG, FILMOMHULDE TABLETTEN

Suecia:Zolpidem Hexal 10 mg filmdragerad tablett

Last review date of thisleaflet:February 2022

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es.