Zolpidem Sandoz 10 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Zolpidem Sandoz 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 or pharmacist.
• This medicine has been prescribed for you only, and you should not give it 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 or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet:

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

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

Zolpidem is used for the short-term treatment of insomnia in adults.

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

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

2. What you need to know before taking Zolpidem Sandoz

Do not take Zolpidem Sandoz

• if you are allergic to zolpidem or to any of the other ingredients of this medicine (listed in section 6),
• if you suffer from severe muscle weakness (myasthenia gravis),
• if you have brief episodes of stopped breathing during sleep (sleep apnoea syndrome),
• if you have acute and/or severe respiratory weakness (respiratory insufficiency),
• if you have severe liver problems (hepatic insufficiency),
• if you have experienced sleepwalking or other unusual behaviours during sleep after taking zolpidem or other medicines containing zolpidem. This may include driving, eating, making phone calls, or engaging in sexual activity while not fully awake.

Warnings and precautions

Talk to your doctor or pharmacist before taking Zolpidem Sandoz.

General

Before starting treatment with zolpidem:

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

If your sleep problems persist after 7 to 14 days of treatment with zolpidem, your doctor will identify, as far as possible, the nature of your sleep disorder and the factors causing it.

Tolerance

Repeated use of hypnotics over several weeks may lead to loss of effectiveness (tolerance).

Dependence

The use of zolpidem may 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 greater in patients with a history of mental disorders and/or abuse of alcohol, illicit substances, or drugs. Inform your doctor if you have ever had a mental disorder or problems with abuse or dependence on alcohol, substances, or drugs.

Withdrawal symptoms

If physical dependence has developed, abruptly stopping 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 gradually by tapering the dose. Zolpidem may cause withdrawal symptoms even within the recommended dose range.

When treatment is discontinued, withdrawal symptoms may appear temporarily, and the symptoms present before treatment may reappear and be intensified, including mood changes, anxiety, and restlessness. Since the risk of withdrawal or rebound symptoms is higher after abrupt discontinuation of treatment, it is recommended to stop treatment gradually by reducing the dose.

When zolpidem is taken according to the recommended dosage, duration of use, and with due precautions and warnings, the occurrence of withdrawal or rebound symptoms 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 tranquilizing medicines, zolpidem should be used with caution in patients with symptoms of depression or anxiety accompanied by depression. In certain circumstances, depressive symptoms may worsen if the underlying condition is not adequately treated with appropriate medications (antidepressants). This may increase the risk of suicide in these patients. Depression that was previously unrecognized may emerge during treatment with zolpidem. Some studies show a higher incidence of suicide or suicide attempts in patients taking certain sleeping or sedative pills, including zolpidem.

However, it has not been established whether this is due to the medical treatment or if other causes may be involved.

Inform your doctor immediately if you have suicidal thoughts (thoughts of harming yourself or committing suicide) or suicidal behaviour.

Memory loss (amnesia)

Hypnotic medicines may cause temporary memory impairment (anterograde amnesia). This means that (usually a few hours) after taking this medicine, actions may be taken that cannot be remembered later. This may also include inappropriate behaviour. This risk depends on the dose level. To minimize this risk, ensure 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, worsening of sleep disturbances, agitation, irritability, aggression, delirium (false beliefs), tantrums, nightmares, hallucinations (seeing, hearing, or feeling things that are not there), abnormal behaviour, and other behavioural disorders (see section 4). If this occurs, treatment with zolpidem should be discontinued (see section 4).

Sleepwalking

Cases of sleepwalking and associated behaviours have also been reported in patients who took zolpidem and were not fully awake. This includes "sleep-driving", preparing and eating food, making phone calls, or engaging in sexual activity while patients cannot recall these actions upon waking. If you notice any of the behaviours described above, stop treatment with zolpidem immediately and contact your doctor, as this sleep behaviour may pose a serious risk of injury to yourself and others. Drinking alcohol or taking other medicines that cause drowsiness at the same time may increase the risk of such sleep behaviour.

Psychomotor impairment

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

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

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

• you take this medicine less than 8 hours before performing activities requiring alertness,
• you take a higher dose than the recommended dose,
• you take zolpidem while already taking another central nervous system depressant or other medicines that increase zolpidem levels 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 may 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 when a dose higher than recommended is used.

Impairment of respiratory and liver function

Patients with chronic respiratory insufficiency or impaired liver function should 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.

Cardiac conduction disorders

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

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 use in this age group.

Other medicines and Zolpidem Sandoz

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

The following medicines may affect the action of zolpidem or be affected in their action:

When taking zolpidem with the following medicines, drowsiness and next-day psychomotor impairment, including impaired ability to drive, may increase the day after intake:

• medicines for certain mental disorders (antipsychotics),
• medicines for sleep problems (hypnotics),
• medicines to reduce or relieve anxiety,
• antidepressant medicines,
• 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).

Concomitant use of zolpidem and opioids (strong analgesics, substitution therapy medicines, and some cough medicines) increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and may be life-threatening. Therefore, 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 medicines you are taking and strictly 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.

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).

Taking zolpidem with fluvoxamine or ciprofloxacin is not recommended.

When taken simultaneously with muscle relaxants, their effect may be increased, especially in elderly patients and at higher doses (risk of falls!).

Medicines that increase the activity of certain liver enzymes (particularly 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.

Conversely, certain antifungal medicines (azole antifungals, e.g., ketoconazole) and certain antibiotics (macrolide antibiotics), which reduce the activity 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 alter and intensify the effect of zolpidem. The ability to perform tasks requiring 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, think you might 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 referred to as "hare lip" in newborns).

Reduced fetal movement and variability in 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 childbirth, your baby may have muscle weakness, abnormally low body temperature, and moderate respiratory insufficiency (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 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 data available on the effect on fertility.

Driving and use of machines

Zolpidem has a significant effect on the ability to drive and operate machinery, such as "driving while drowsy" or "driving while excessively tired" ("sleep-driving"). The day after taking zolpidem (as with other sleeping pills), 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 above-mentioned effects, a minimum interval of 8 hours between taking zolpidem and driving, operating machinery, or performing work at heights is recommended.

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

Zolpidem Sandoz contains lactose and sodium

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

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

3. How to take Zolpidem Sandoz

Follow exactly the instructions for using this medicine provided by your doctor. Consult your doctor or pharmacist if you have any doubts.

Recommended dose:

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,
• just before going to bed.

Make sure that after taking this medicine, you allow at least 8 hours to pass before engaging in activities requiring 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 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 medicine is well tolerated.

Respiratory dysfunction or impaired liver function

In patients with respiratory dysfunction or impaired liver function, the dose should be only 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 are insufficient clinical data available on its use in this age group.

Method of administration

Zolpidem should be taken with a liquid (water) immediately before going to bed or in bed.

The tablet may 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 last from a few days up to 2 weeks and should not exceed 4 weeks, including the gradual withdrawal phase.

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

If you take more Zolpidem Sandoz than you should

In case of overdose, consult a doctor immediately.

Signs of (mild) overdose 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, deep sleep up to unconsciousness, agitation, respiratory dysfunction, and circulatory collapse may occur. Cases of overdose with zolpidem (alone or in combination with other central depressants, including alcohol) have been reported, with serious consequences (including fatal events).

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

If you forget to take Zolpidem Sandoz

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

If you stop taking Zolpidem Sandoz

If you wish to discontinue treatment, speak to your doctor first. Do not stop taking the medicine 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 finish treatment by gradually reducing the dose. See section 2 Warnings and precautions, Withdrawal.

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 experiences them.

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

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

There is evidence of a dose-dependent occurrence of side effects, particularly those affecting the central nervous system. To reduce these side effects, zolpidem should be taken immediately before going to bed or while 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 adverse effects:

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

• drowsiness,
• worsening of 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 disturbance,
• confusion,
• irritability,
• restlessness,
• aggression,
• sleepwalking or other unusual behaviors during sleep, such as driving, eating, making phone calls, or having sexual intercourse while not fully awake (see section "Warnings and precautions"),
• euphoric mood,
• sensory disturbance 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,
• visual 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 when walking,
• risk of falls (especially in elderly patients or if Zolpidem was 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 or discontinuation symptoms may occur after stopping treatment),
• breathing impairment (respiratory depression).

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

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

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, 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 Sandoz

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

Do not use this medicine after the expiry date stated on the packaging and blister after "CAD/EXP". The expiry date refers to the last day of the month indicated.

Store in the original packaging to protect from light.

This medicine does not require any special storage temperature.

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

6. Contents of the pack and other information

Composition of Zolpidem Sandoz

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

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

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

Appearance of the product and contents of the pack

Film-coated tablets, shiny white, oblong, biconvex, with a score line on one side.

Film-coated tablets are supplied in polyvinylchloride/aluminum blisters and packaged in cardboard cartons.

Pack sizes contain 10, 14, 20, 28, 30, 30x1, 50, 98, or 100 film-coated tablets.

Only certain pack 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-Allee 1

39179 Barleben

Germany

or

Rowa Pharmaceuticals Ltd

Newton, Bantry

Co. Cork

Ireland

This medicinal product 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 most recent revision of this package leaflet: February 2022

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