Prospecto: Information for the user

Zolpidem Aurovitas 10 mg film-coated tablets EFG

zolpidem tartrate

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

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

-If you have any questions, 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 Aurovitas and what is it used for

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

3.How to take Zolpidem Aurovitas

4.Possible adverse effects

5.Storage of Zolpidem Aurovitas

6.Contents of the package and additional information

Zolpidem belongs to a group of medications known as benzodiazepine analogs.

Zolpidem tablets are sleep aids (hypnotics) that act on the brain producing drowsiness. It is used for the short-term treatment of insomnia in adults when it is severe, debilitating, or causes great anxiety in the patient.

Do not takeZolpidem Aurovitas

•If you are allergic to zolpidem or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may include skin rash, itching, difficulty breathing, or swelling of the face, lips, throat, or tongue.

•If you have severe liver problems.

•If you have sleep apnea (a condition in which your breathing stops for short periods of time while you are asleep).

•If you have severe muscle weakness (myasthenia gravis).

•If you have severe and acute respiratory problems.

•If you are under 18 years old.

Warnings and precautions

Consult your doctor or pharmacist before starting to take zolpidem if you:

•Are an elderly patient or are weak. If you get up at night, be careful. Zolpidem may relax your muscles. This, combined with the sedative effect, increases the risk of falls and, consequently, hip fractures.

•Have any kidney or liver problems.

•Have a history of respiratory problems. While taking zolpidem, your breathing may become less intense.

•Have a history of mental illness, anxiety, or psychotic illness. Zolpidem may unmask or worsen symptoms.

•Suffer or have a history of depression (feeling sad).

•Have, or have had, a history or tendency to abuse alcohol or drugs.The risk of zolpidem dependence (physical or mental effects produced by a compulsion to continue taking the medicine) increases in these patients, and with the dose and duration of treatment.

•In patients treated with benzodiazepines or hypnotics, including zolpidem, there may be an increased risk of suicide or attempted suicide. If you ever have thoughts of harming yourself or attempting suicide, contact your doctor or go to the hospital immediately.

•In patients with long QT syndrome (a cardiac conduction anomaly, a type of arrhythmia).

Before starting treatment with this medicine

-The underlying cause of sleep disturbances should be clarified.

-Underlying diseases should be treated.

If the treatment of sleep disturbances is not satisfactory after 7-14 days, this may indicate a underlying psychiatric or physical disease that should be checked.

Zolpidem should not be taken in cases of severe liver failure because, due to liver failure, the accumulation of toxic substances in the body may cause brain function deterioration (encephalopathy).

Children and adolescents

Do not administer this medicine to children or adolescents under 18 years of age.

Other considerations

•Habituation – If after a few weeks you notice that the tablets do not work as well as when you started treatment, you should consult your doctor.

•Dependence – When taking this type of medicine, there is a risk of dependence, which increases with the dose and duration of treatment. The risk is higher in patients with a history of psychiatric disorders, dependence on medications and/or alcohol or drug abuse. However, dependence can also occur at doses used normally in treatment or in the absence of risk factors such as a history of alcohol or drug abuse.

•Withdrawal – Treatment should be discontinued gradually. After withdrawal, a short-term syndrome may occur, in which the symptoms that motivated treatment with zolpidem may worsen. This syndrome may be accompanied by other reactions, including mood changes, anxiety, and restlessness.

•Amnesia – Zolpidem may cause memory loss. To reduce this risk, ensure that you can sleep without interruptions for 8 hours.

•Psychiatric and "paradoxical" reactions – Zolpidem may cause adverse effects on behavior, such as restlessness, agitation, irritability, aggression, delusions (false beliefs), outbursts of anger, nightmares, hallucinations, psychosis (hallucinations: seeing, hearing, or feeling things that do not exist), inappropriate behavior, and increased insomnia.

•Somnambulism and other associated behaviors – Zolpidem may cause people to do things while asleep that they do not remember when they wake up. This includes somnambulism, driving while asleep, preparing and consuming food, making phone calls, or engaging in sexual activity. Alcohol and some medications used to treat depression or anxiety, or the use of zolpidem at doses higher than the recommended maximum dose, may increase the risk of these adverse effects.

•The risk and benefits of zolpidem should be carefully considered if you have long QT syndrome (a cardiac conduction anomaly, a type of arrhythmia).

•Like other hypnotic/sedative medications, zolpidem has depressive effects on the central nervous system.

•Altered psychomotor function the next day (see also Driving and operating machinery) – The next day after taking zolpidem, there may be an increased risk of altered psychomotor function, including impaired ability to drive, if:

-You take this medicine with less than 8 hours of margin before performing activities that require a state of alert mental.

-You take a higher dose than the recommended dose.

-You take zolpidem at the same time as another central nervous system depressant or another medication that increases the concentration of zolpidem in your blood, combined with alcohol or with illicit substances.

Zolpidem may cause drowsiness and a decrease in the level of consciousness, which may cause falls and, consequently, serious injuries.

Take the dose once and immediately before going to bed at night. Do not take another dose during the same night.

Other medicines and Zolpidem Aurovitas

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

Zolpidem may affect the effect and/or adverse effects of other medicines.

•Rifampicin, a medicine used to treat tuberculosis, may reduce the effect of zolpidem.

If you take zolpidem with the following medicines, you may see potentiated effects such as sedation, lethargy, or altered psychomotor function the next day, including impaired ability to drive:

•Medicines for some mental disorders (antipsychotics).

•Medicines for sleep disorders (hypnotics).

•Medicines to relieve or reduce anxiety.

•Medicines for depression, including St. John's Wort (a plant-based medicine used to treat depression).

•Medicines for moderate to severe pain (narcotic analgesics), such as codeine, morphine. They may increase the feeling of euphoria, increasing the risk of physical or mental dependence.

•Medicines used in epilepsy, such as phenytoin and carbamazepine.

•Medicines used in anesthesia. If you are undergoing a surgical procedure under general anesthesia, inform your doctor of the medicines you are using.

•Medicines for seasonal allergic rhinitis, skin eruptions, or other allergies that may cause drowsiness (sedating antihistamines).

•Muscle relaxants; the muscle-relaxing effect and the risk of falls, especially in elderly patients, may be greater.

•Medicines that inhibit liver enzymes. Ask your doctor or pharmacist which medicines have this effect (for example, ketoconazole, a medicine used to treat fungal infections).

•Orange juice may also inhibit liver enzymes.

No significant interactions have been observed when zolpidem is administered in combination with warfarin (to reduce blood clotting), digoxin (to treat heart failure), or ranitidine (to treat stomach problems).

The concomitant use of zolpidem and opioids (potent analgesics, medication for substitution therapy, and some medicines for cough) increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and may cause death. Therefore, concomitant use should only be considered when other treatment options are not possible.

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

Inform your doctor about all the opioid medicines you are taking and follow your doctor's recommended dose closely. It may be helpful to ask friends or family members to be aware of the signs and symptoms mentioned above. Contact your doctor if you experience these symptoms.

If you take zolpidem with antidepressants, including bupropion, desipramine, fluoxetine, sertraline, and venlafaxine, you may see things that are not real (hallucinations).

Zolpidem should not be taken with fluvoxamine or ciprofloxacin.

Administration of Zolpidem Aurovitas with food, drinks, and alcohol

Do not consume alcohol during treatment with zolpidem, as it may increase the sedative effect.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor before using this medicine.

Using zolpidem during pregnancy may be harmful to the fetus.

In some studies, there was a possibility of a higher risk of cleft lip and palate ("cleft lip").

After administration of zolpidem in the second and/or third trimester of pregnancy, there may be a reduction in fetal movements and changes in fetal heart rate.

Zolpidem should not be taken during pregnancy, especially during the first three months. If, for medical reasons, you take zolpidem in the last stage of pregnancy or during delivery, your baby may experience low body temperature, muscle weakness, difficulty feeding, and difficulty breathing, and may show symptoms of withdrawal, such as agitation and tremors, after birth due to physical dependence. In these cases, your baby should be closely monitored in the postpartum period.

Do not breastfeed your baby as zolpidem may pass in small amounts into breast milk.

Driving and operating machinery

Zolpidem has a significant effect on the ability to drive and operate machinery, such as "driving while drowsy". The days you take zolpidem (like with other hypnotics) 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 vision or double vision.

•Your state of 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 machinery, 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 Aurovitas contains lactose

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

Zolpidem Aurovitas contains sodium

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

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Zolpidem is a medication administered orally.

Zolpidem acts quickly and should be taken immediately before going to bed or when already in bed.

Adults:The recommended dose is 10 mg of zolpidem every 24 hours. A lower dose may be prescribed for some patients.

Zolpidem should be taken:

•once a day,

•just before going to bed.

Ensure that you leave a minimum of 8 hours between taking the medication and performing activities that require mental alertness.

Do not take more than 10 mg per 24 hours.

Senior patients (over 65 years old) or debilitated patients:The recommended dose is 5 mg. Do not exceed the recommended dose.

Patients with liver problems:The initial usual dose is 5 mg. Your doctor may decide to increase this dose to 10 mg if considered safe. Do not take zolpidem if you have severe liver problems. Special caution should be taken in elderly patients with liver insufficiency.

Patients with a history of respiratory problems (chronic respiratory insufficiency):A lower dose is recommended.

Use in children and adolescents:Zolpidem is not indicated for patients under 18 years old.

Treatment duration

The treatment duration should be as short as possible. It usually varies from a few days to two weeks. The maximum treatment duration, including the gradual withdrawal period, is four weeks.

Your doctor will establish a gradual withdrawal program based on your individual needs. In certain situations, it may be necessary to take zolpidem for more than 4 weeks.

If you take moreZolpidem Aurovitasthan you should

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

If you (or another person) ingest a large amount of tablets at once, or if you think a child has swallowed some tablets, contact your doctor immediately or go to the nearest hospital emergency room. Bring the packaging and remaining tablets with you. Do not go without a companion to seek medical help. If you have taken an overdose, you may quickly feel increasingly sleepy, and high doses may lead to a coma or even death. If zolpidem is taken with other central nervous system medications (including alcohol), it may have a severe outcome, which can also be fatal. In moderate cases, symptoms include: drowsiness, mental confusion, and a feeling of fatigue, exhaustion (lethargy). In severe cases, symptoms may include: movement coordination disorder (ataxia), muscle tone decrease (hypotonia), low blood pressure (hypotension), respiratory depression, cases of altered consciousness up to coma, and more severe symptoms, including a fatal outcome.

If you forget to takeZolpidem Aurovitas

If you forget to take the dose immediately before going to bed but remember during the night, take the missed dose only if you can sleep 8 hours uninterrupted. If this is not possible, take the next dose before going to bed the next night. Do not take a double dose to compensate for the missed doses. If you are concerned, ask your doctor or pharmacist for advice.

If you interrupt treatment withZolpidem Aurovitas

Treatment should be discontinued gradually, as otherwise, the symptoms for which you were treated may reappear with greater intensity than before (rebound insomnia). Anxiety, restlessness, and mood changes may also occur. These effects will disappear over time.

If you have developed physical dependence on zolpidem, abrupt treatment discontinuation will lead to adverse effects such as headaches, muscle pain, anxiety, tension, restlessness, confusion, irritability, and insomnia. In severe cases, other effects may appear, such as hypersensitivity to light, noise, and physical contact, abnormal hearing, and painful sensitivity to noise, hallucinations, numbness and tingling in the extremities, loss of sense of reality (feeling that the world around you is not real), depersonalization (feeling that your mind is separating from your body) or epileptic seizures (violent attacks or tremors). These symptoms may also occur between doses, especially if the dose is high.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The side effects of zolpidem, especially with regard to some effects on the central nervous system, depend on the dose and are less intense if you take the medicine immediately before falling asleep or going to bed. It is more likely that these side effects will occur in older people.

If you experience any of the following reactions, stop taking zolpidem and immediately contact your doctor or go to the nearest hospital emergency department:

•Allergic reactions, such as skin rash or itching, accompanied by swelling of the face, lips, throat, or tongue, and difficulty breathing or swallowing (angioedema).

These side effects are serious, but their frequency is unknown (cannot be estimated from available data). You need medical attention.

Inform your doctor or pharmacist if any of the following side effects occur or worsen:

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

•Upper or lower respiratory tract infections.

•Hallucinations, agitation, nightmares.

•Drowsiness, headache, dizziness, increased insomnia, amnesia (which may be associated with inappropriate behavior).

•Sensation of spinning.

•Next-day drowsiness, emotional numbness, decreased alertness, confusion, double vision.

•Diarrhea, nausea, vomiting.

•Cutaneous reactions.

•Fatigue.

•Back pain.

•Abdominal pain.

The risk of amnesia is higher at higher doses. If you can ensure uninterrupted sleep for 8 hours, the risk of amnesia is reduced.

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

•Pain or tingling without cause (paresthesia).

•Joint pain, muscle pain, muscle cramps, and neck pain.

•Involuntary tremor.

•Speech disorders.

•Attention deficit disorder.

•Appetite disorder.

•Blurred vision.

•Cutaneous eruption, itching.

•Excessive sweating.

•Double vision.

•Euphoric mood.

•Muscle weakness.

•Confusion, irritability.

•Worsening insomnia.

•Coordination disorder.

•Increased levels of some liver enzymes (which your doctor may detect in a blood test).

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

•Decreased or increased libido.

•Liver damage (hepatocellular, cholestatic, or mixed form).

•Decreased level of consciousness.

•Reduced vision.

•Urticaria.

•Changes in gait.

•Falls, especially in older people.

•Paradoxical reactions (restlessness, agitation, irritability, aggression, delirium (false beliefs), anger attacks, nightmares, hallucinations, psychosis, inappropriate behavior, and other behavioral side effects). These occur more frequently in older people.

Very rare(may affect up to 1 in 10,000 people):

•Delirium (false beliefs).

•Physical dependence: use (even at therapeutic doses) may lead to physical dependence; abrupt discontinuation of treatment may lead to withdrawal symptoms and recurrence of the problem.

•Psychological dependence: occurs when you think you will not be able to sleep without taking zolpidem.

Unknown frequency(cannot be estimated from available data):

•Various forms of liver damage.

•Difficulty breathing.

•Restlessness, aggression, anger attacks, psychosis (hallucinations: seeing, hearing, or feeling things that do not exist), inappropriate behavior.

•Depression (feeling sad)

•Somnambulism.

•Need to take increasingly larger doses of a medication to achieve the same effect.

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 prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: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 sight and reach of children.

Do not use this medication after the expiration date that appears on the blister, carton or bottle after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

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

Composition ofZolpidem Aurovitas

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

-The other components are:

Core of the tablet:lactose monohydrate, microcrystalline cellulose (PH-101), sodium carboxymethylcellulose (Type A) (from potato), magnesium stearate.

Coating of the tablet:hypromellose (5cps), macrogol 400, titanium dioxide (E171).

Appearance of the product and contents of the package

Film-coated tablets of white or off-white color, oval, biconvex, with the mark “E” on one face and “80” on the other, with a groove between the “8” and the “0”. The tablet can be divided into equal doses.

Zolpidem Aurovitas film-coated tablets are available in blister packs and HDPE bottles.

Blister pack:7, 8, 10, 14, 15, 20, 28, 30, 50, 56, 60, and 100 film-coated tablets.

Bottle:30, 100, 250, and 500 film-coated tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

O

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

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

Last review date of this leaflet:November 2022

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