Leaflet: information for the user

Zolpidem cinfa 10 mg film-coated tablets

Zolpidem tartrate

Read this 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. Do not give it to others even if they have the same symptoms as you, as it may harm them.

• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What is zolpidem cinfa and what it is used for

2.What you need to know before you start taking zolpidem cinfa

3.How to take zolpidem cinfa

4.Possible side effects

5.Storage of zolpidem cinfa

6.Contents of the pack and additional information

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

Zolpidem cinfa is used for the short-term treatment of insomnia in adults, in situations where insomnia is weakening or causing severe anxiety.

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

Zolpidem is indicated for sleep rhythm disorders and all forms of insomnia, especially when there are difficulties falling asleep, either initially or after a premature awakening.

Do not take zolpidem cinfa

• If you are allergic to zolpidem, the benzodiazepine group in general, or any of the other components of this medication (listed in section 6).

• If you have acute and/or severe respiratory difficulties

• If you have breathing problems during sleep (sleep apnea syndrome).
• If you have muscle weakness (myasthenia gravis).
• If you have severe liver problems (hepatic).

Warnings and precautions

Consult your doctor or pharmacist before starting to take zolpidem cinfa.

• Your doctor should identify the causes of insomnia whenever possible and treat the underlying factors before prescribing zolpidem.

• After taking zolpidem, ensure that you can have 8 hours of uninterrupted sleep to reduce the risk of anterograde amnesia (not remembering what happened while awake).

• Risk of dependence: The use of zolpidem may lead to the development of physical and psychological abuse and 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, substance, or drug abuse. Inform your doctor if you have had any mental disorders, or problems with alcohol, substance, or drug abuse.

To minimize the risk of dependence, consider the following precautions:

• The medication will be taken only under medical prescription (never because it has worked in other patients) and will never be recommended to others.
• Do not increase the prescribed doses or prolong the treatment longer than recommended.
• Consult your doctor regularly to decide if the treatment should continue.

Once physical dependence has developed, abrupt discontinuation of treatment will be accompanied by a withdrawal syndrome that may consist of restlessness, anxiety, headache, muscle pain, confusion, irritability, and tension. Therefore, it is recommended to gradually reduce the dose, according to your doctor's instructions.

In severe cases, the following symptoms may appear: altered perception of reality, depersonalization, decreased tolerance to usual sounds (hyperacusia), numbness and tingling in the extremities, hypersensitivity to light, noise, and physical contact, hallucinations, or epileptic seizures.

• Rebound insomnia: In some cases, after discontinuing treatment, a transient syndrome may occur in which the symptoms that led to starting treatment reappear, but in an increased form. They may be accompanied by other reactions such as mood changes, anxiety, sleep disorders, and restlessness. It is essential to know that there is a possibility of this rebound phenomenon occurring to minimize the anxiety caused by the appearance of these effects when discontinuing treatment. In the case of short-acting hypnotic/sedative medications, the dose withdrawal syndrome may appear within the dose interval. The probability of rebound insomnia is higher with abrupt withdrawal. Therefore, it is recommended to gradually reduce the dose, according to your doctor's instructions.

• It is known that other psychiatric and "paradoxical" reactions such as restlessness, agitation, worsening of insomnia, irritability, aggression, delirium, anger attacks, nightmares, psychosis, hallucinations, abnormal behavior, and other conduct alterations occur with zolpidem. Treatment should be suspended when these reactions appear. These reactions are more likely to occur in elderly patients.

• Cases of somnambulism and other behaviors such as driving while somnambulant, eating, cooking, calling, or having sex, etc., without remembering these events, have been reported in patients who took zolpidem and were not fully awake.

• The use of zolpidem with alcohol and with other medications that act on the central nervous system, or taking higher doses than the recommended dose may increase the risk of these behaviors. Your doctor should consider discontinuing treatment in these cases, due to the risk it poses to you and others.

• This medication may cause drowsiness and a decrease in consciousness, which may cause falls and consequently cause serious injuries.

• After repeated use for several weeks, some tolerance to the product may develop, resulting in a decrease in the hypnotic effect.

• If you have a history of drug or alcohol dependence, do not take zolpidem unless your doctor tells you to.

• If you have congenital long QT syndrome, your doctor should carefully consider the benefit-risk ratio before starting treatment with zolpidem.

• In patients with mental illnesses (psychosis), its use is not recommended as primary treatment.

• If you have suicidal tendencies and depression, use with extreme caution. Consult your doctor before using this medication, as it may unmask an existing depression. Some studies have shown an increased risk of suicidal ideation, attempt, and suicide in patients taking certain sedatives and hypnotics, including this medication. However, it has not been established whether this is caused by the medication or if there may be other reasons. If you have suicidal thoughts, contact your doctor as soon as possible for additional medical advice.

• If you have any liver disorder or respiratory problems, your doctor will decide whether to take a lower dose of zolpidem or not to take it.

• In patients with severe liver failure, zolpidem should not be taken as it may contribute to the development of encephalopathy (brain disease).

• Do not take zolpidem at the same time as opioids (medications used to relieve intense pain, such as morphine or codeine) unless your doctor prescribes it, due to the possible risk of sedation, respiratory depression, coma, or even death (see "Taking zolpidem cinfa with other medications"). If your doctor finally prescribes zolpidem with opioids, they should prescribe the minimum effective dose and for the shortest duration of concomitant use. Your doctor will monitor the appearance of signs and symptoms of respiratory depression and sedation.

• In elderly patients, the dose should be reduced. See section 3. How to take zolpidem cinfa.

• Children and adolescents: Zolpidem cinfa is not recommended for children and adolescents under 18 years old.

Altered psychomotor function the next day (see also "Driving and using machines")

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

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 medication 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.

Take the dose once and immediately before going to bed at night.

Do not take another dose during the same night.

Taking zolpidem cinfa with other medications

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

This is extremely important because the simultaneous use of more than one medication may increase or decrease its effect.

Therefore, do not use other medications at the same time as zolpidem unless your doctor is informed and approves it in advance.

If you take zolpidem with the following medications, the effects may be potentiated, such as drowsiness or altered psychomotor function the next day, including impaired ability to drive.

• Medications for some mental disorders (antipsychotics)

• Medications for sleep disorders (hypnotics)

• Medications to relieve or reduce anxiety

• Medications for depression

• Medications for moderate to severe pain (narcotic analgesics)

• Medications for epilepsy

• Anesthetics

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

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.

If you take zolpidem with narcotic analgesics, it may cause an increase in euphoria that could lead to an increase in psychological dependence.

Opioid medications: Taking zolpidem at the same time as opioids (potent analgesics, medications for substitution therapy, and some medications for cough) increases the risk of drowsiness, respiratory depression, coma, and may 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 with opioids, they should limit the dose and duration of concomitant use. Inform your doctor about all opioid medications you are taking and follow your doctor's recommended dosage. It may be helpful to inform friends or family members about the signs and symptoms mentioned above. Contact your doctor when you experience these symptoms.

Some medications that inhibit/induce certain liver enzymes (CYP450) may affect the action of zolpidem.

Concomitant administration with ketoconazole (used to treat fungal infections) may increase sedative effects.

Concomitant administration with rifampicin (used to treat infections) and St. John's Wort may decrease the effect of zolpidem.

Zolpidem should not be used concurrently with St. John's Wort as it may decrease blood levels of zolpidem.

Zolpidem should not be taken with medications containing alcohol. It may increase sedative effects.

Taking zolpidem cinfa with food, drinks, and alcohol

During treatment, avoid alcoholic beverages. The effect of alcohol may potentiate sedation, and this may affect your ability to drive or use machinery. If you need additional information on this point, consult your doctor.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

Zolpidem should not be used during pregnancy. If you are pregnant, think you may be pregnant, or intend to become pregnant, consult your doctor.

If used during pregnancy, there may be a risk of affecting the baby. Some studies have shown an increased risk of cleft lip and palate (sometimes called "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 zolpidem is taken at the end of pregnancy or during delivery, your baby may show muscle weakness, decreased body temperature, difficulty feeding, and respiratory problems (respiratory depression).

If this medication is taken regularly at 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 during the postnatal period.

Lactation

This medication passes into breast milk, so zolpidem should not be taken during breastfeeding.

Driving and using machines

Zolpidem is a medication that causes sleep. Do not drive or use machinery if you feel drowsy or if you notice that your attention and reaction time are reduced. Pay special attention to the start of treatment or if the dose is increased.

Zolpidem has a significant effect on the ability to drive and use machines, such as "driving in a somnambulant state". The days you take zolpidem (as happens with other hypnotics) you should consider the following:

• You may feel drowsy, somnolent, dizzy, or confused

• You may take longer to make decisions

• You may experience blurred vision or double vision

• Your state of alertness may be reduced

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

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

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

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

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

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

• once; and

• just before going to bed.

Make sure to leave a minimum gap of 8 hours between taking the medication and performing activities that require mental alertness.

Do not take more than 10 mg per 24 hours.

• In elderly patients, in debilitated patients, and in patients with liver disorders, the doctor will prescribe a lower dose.

The recommended daily dose is half a tablet, i.e., 5 mg of zolpidem.

• Children (under 18 years): not recommended for use.

Treatment should start with the lowest dose. Do not exceed the maximum dose.

Each individual dose should not exceed the indicated limits, and the total daily dose should not either, unless your doctor prescribes a higher dose.

Take zolpidem just before going to bed and swallow the tablet without chewing it, with water or another non-alcoholic beverage.

The tablet can be divided into equal doses.

Under normal conditions, it should not take more than 20 minutes to fall asleep after taking zolpidem, and it is advisable to ensure that you can rest without being woken up for at least 8 hours. Otherwise, although this occurs in rare cases, it is possible that you may not remember what happened while you were awake.

In most cases, only a short-term treatment with zolpidem is needed (usually not exceeding two weeks). The maximum duration of treatment is four weeks if the gradual withdrawal of the medication is included. Prolonging treatment will not be done without reevaluating your condition, as the risk of abuse and dependence increases with the duration of treatment (see section 2).

To avoid withdrawal symptoms, do not stop taking zolpidem abruptly, especially if you have been taking it for a long time.

If you estimate that the effect of zolpidem is too strong or too weak, inform your doctor or pharmacist.

If you take more zolpidem cinfa than you should

If you have taken more zolpidem than you should, consult your doctor or pharmacist immediately.

In cases of overdose involving zolpidem alone or with other central nervous system depressants (including alcohol), cases have been reported ranging from altered consciousness to coma and more severe symptoms, including death.

In moderate cases, symptoms include: drowsiness, mental confusion, and a feeling of

fatigue, exhaustion (lethargy). In more severe cases, symptoms may include discoordination in movement (ataxia), decreased muscle tone (hypotonia), low blood pressure (hypotension), respiratory depression, cases of impaired consciousness up to coma, and more severe symptoms including a fatal outcome.

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

If you forget to take zolpidem cinfa

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with zolpidem cinfa

Abruptly stopping treatment may cause withdrawal syndrome, which manifests as headache or muscle pain, anxiety, tension, restlessness, confusion, and irritability (see section “Warnings and precautions”).

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.

Most patients tolerate zolpidem well, but some, especially at the beginning of treatment, may feel a bit tired or drowsy during the day.

The following criterion has been used to classify the frequency of adverse reactions:

Very common: may affect more than 1 in 10 patients

Common: may affect up to 1 in 10 patients

Uncommon: may affect up to 1 in 100 patients

Rare: may affect up to 1 in 1,000 patients

Very rare: may affect up to 1 in 10,000 patients

Frequency not known: cannot be estimated from available data.

The relationship between adverse effects and dose has been demonstrated. These effects should be less if zolpidem is administered immediately before bedtime.

These effects are more frequent in elderly patients:

Immune system disorders

Frequency not known:allergic inflammation that can be located in feet, hands, throat, lips, and respiratory tract (angioneuritic edema).

Mental and behavioral disorders

Common:hallucinations, agitation, nightmares, depression.

Uncommon: confused state, irritability, restlessness, aggression, somnambulism, euphoric mood.

Rare:changes in sexual desire.

Very rare: delirium, dependence (discontinuation of treatment may cause withdrawal symptoms or rebound effects).

Frequency not known: outbursts of anger, psychosis, abnormal behavior.

Nervous system disorders

Common: drowsiness, headache, dizziness, worsening of insomnia, cognitive disorders such as anterograde amnesia (does not remember what happened while awake after taking the medication). Amnesia may be associated with inappropriate behavior.

Uncommon: paresthesia, numbness, tremor, alteration of attention, speech disorder.

Rare:decreased level of consciousness.

Eye disorders

Uncommon: double vision, blurred vision. Rare: visual impairment.

Respiratory, thoracic and mediastinal disorders

Very rare: respiratory difficulty (respiratory depression).

Gastrointestinal disorders

Common:diarrhea, nausea, vomiting, abdominal pain.

Hepatobiliary disorders

Uncommon: increased liver enzymes.

Rare: liver damage (hepatocellular, cholestatic, or mixed injury).

Metabolism and nutrition disorders

Uncommon: appetite disorder.

Skin and subcutaneous tissue disorders

Uncommon: pruritus, skin rash, excessive sweating. Rare: urticaria.

Musculoskeletal and connective tissue disorders

Common:back pain.

Uncommon: joint pain (arthralgia), muscle pain (myalgia), muscle spasms, neck pain, muscle weakness.

Infections and infestations

Common:respiratory tract infection (upper and lower respiratory tract infection).

General disorders and administration site conditions

Common:fatigue.

Rare: gait disturbance, falls (predominantly in elderly patients and when not following the doctor's recommendations).

Frequency not known: tolerance to the product.

Depression

The use of the medicine may unmask an existing depression. Since insomnia may be a symptom of depression, if insomnia persists, inform your doctor to evaluate your situation.

Reporting of adverse reactions

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

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

This medication does not require special storage conditions.

Do not usethis medicationafter the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of zolpidem Cinfa

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

-The other components are:

• Core:lactose monohydrate, microcrystalline cellulose (PH-101), sodium carboxymethylcellulose (type A) (from potato), talc, and magnesium stearate
• Coating:hypromellose, hydroxypropylcellulose, titanium dioxide (E-171), and talc.

Appearance of the product and content of the packaging

zolpidem cinfa is presented in the form of coated, cylindrical, scored, white tablets with the mark: Z. Each package contains 28, 30, or 500 (EC) tablets.

Only some package sizes may be commercially marketed.

Holder of the marketing authorization and responsible manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Park Areta

31620 Huarte (Navarra) - Spain

Last review date of this leaflet:July 2020

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

You can access detailed and updated information on this medication by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/65400/P_65400.html

QR code to:https://cima.aemps.es/cima/dochtml/p/65400/P_65400.html