Zolpidem CINFA 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

zolpidem cinfa 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, consult 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 adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Zolpidem is a hypnotic medicine belonging to a group of medicines known as benzodiazepine-like drugs.

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

Do not take this medicine 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 for all forms of insomnia, especially when there are difficulties in falling asleep, either initially or after early awakening.

2. What you need to know before taking zolpidem cinfa

Do not take zolpidem cinfa

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

• If you have acute and/or severe breathing difficulties.

• If you suffer from breathing problems during sleep (sleep apnoea syndrome).

• If you have muscle weakness (myasthenia gravis).

• If you have severe liver problems.

Warnings and precautions

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

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

• After taking zolpidem, you must ensure you will have an uninterrupted 8-hour sleep period to reduce the risk of anterograde amnesia (not remembering events that occurred while awake).

• Risk of dependence: The use of zolpidem may lead to physical and/or 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 greater in patients with a history of mental disorders and/or alcohol, illicit substances, or drug abuse. Inform your doctor if you have had any mental disorders or problems with abuse or dependence on alcohol, substances, or drugs.

To minimize the risk of dependence, the following precautions should be observed:

• These medicines should only be taken under medical prescription (never because they worked for another patient) and should never be recommended to others.
• Do not increase the dose prescribed by your doctor or extend treatment beyond the recommended duration.
• Consult your doctor regularly so they can decide whether treatment should continue.

Once physical dependence has developed, abruptly stopping treatment may lead to withdrawal syndrome, which may include 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 occur: altered perception of reality, depersonalization, reduced tolerance to usual sounds (hyperacusis), numbness and tingling in the limbs, hypersensitivity to light, noise, and physical contact, hallucinations, or epileptic seizures.

• Rebound insomnia: In some cases, after stopping treatment, a transient syndrome may occur in which the symptoms that led to starting treatment reappear, but more intensely. These may be accompanied by other reactions such as mood changes, anxiety, sleep disturbances, and restlessness. It is important that you are aware of the possibility of this rebound phenomenon to minimize anxiety that may arise when these effects occur upon discontinuation of treatment. For short-acting hypnotic/sedative medicines, dose withdrawal symptoms may appear within the dosing interval. The likelihood 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, aggressiveness, delirium, rage attacks, nightmares, psychosis, hallucinations, abnormal behavior, and other behavioral disturbances may occur with zolpidem. Treatment should be discontinued if these reactions occur. These reactions are more likely in elderly patients.

• Cases of sleepwalking and other behaviors such as driving while sleepwalking, eating, cooking, making phone calls, or having sexual intercourse, 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 medicines that act on the central nervous system, or taking doses higher 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 may pose to you and others.

• This medicine may cause drowsiness and reduced consciousness, which can lead to falls and consequently cause serious injuries.

• After repeated use over several weeks, tolerance to the product may develop, leading to a reduction in hypnotic effects.

• If you have a history of drug or alcohol dependence, you should not take zolpidem unless prescribed by your doctor.

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

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

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

• If you have liver disorders or respiratory problems, your doctor will decide whether it is appropriate to take a lower dose of zolpidem or not to take it at all.

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

• Do not take zolpidem together with opioids (medicines used to relieve severe pain, such as morphine or codeine) unless prescribed by your doctor, due to the possible risk of sedation, respiratory depression, coma, or even death (see "Taking zolpidem cinfa with other medicines"). If your doctor prescribes zolpidem concomitantly with opioids, the lowest effective dose should be prescribed for the shortest possible duration of concomitant use. Your doctor will monitor for 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 of age.

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

Like other hypnotic/sedative medicines, zolpidem has central nervous system depressant effects.

The risk of next-day psychomotor impairment, including impaired ability to drive, may be increased if:

• You take this medicine with less than 8 hours before engaging in activities requiring mental alertness.
• You take a higher dose than the recommended dose.
• You take zolpidem together with another central nervous system depressant or another medicine that increases zolpidem blood levels, combined with alcohol or 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 medicines

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

This is extremely important because taking more than one medicine simultaneously may increase or decrease their effects.

Therefore, you should not use other medicines together with zolpidem unless your doctor is informed and has approved it.

If you take zolpidem with the following medicines, effects such as drowsiness or next-day psychomotor impairment, including impaired ability to drive, may be enhanced:

• Medicines for certain mental disorders (antipsychotics)
• Medicines for sleep problems (hypnotics)
• Medicines to relieve or reduce anxiety
• Medicines for depression
• 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)

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

Concomitant use of zolpidem with fluvoxamine or ciprofloxacin is not recommended.

If you take zolpidem with narcotic analgesics, increased euphoria may occur, potentially leading to increased psychological dependence.

Opioid medicines: Taking zolpidem together with opioids (strong analgesics, medicines for substitution therapy, and some cough medicines) increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and may be potentially fatal. Therefore, concomitant use should only be considered when no other treatment options are possible. However, if your doctor prescribes zolpidem together with opioids, the dose and duration of concomitant treatment should be limited by your doctor.

Inform your doctor about all opioid medicines you are taking and closely follow your doctor's dosing recommendations. It may be helpful to inform friends or relatives so they are aware of the signs and symptoms mentioned above. Contact your doctor if you experience these symptoms.

Some medicines that inhibit or 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 reduce the effect of zolpidem.

Concurrent use of zolpidem with St. John's wort is not recommended as it may reduce zolpidem blood levels.

Concomitant use with medicines containing alcohol is not recommended. It may increase the sedative effect.

Taking zolpidem cinfa with food, drinks, and alcohol

During treatment, avoid alcoholic beverages. The effect of alcohol may enhance sedation, which may affect your ability to drive or operate machinery. If you need further information on this point, consult your doctor.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

The use of zolpidem during pregnancy is not recommended. If you are pregnant, 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 decreased fetal heart rate variability may occur after taking zolpidem during the second and/or third trimester of pregnancy.

If zolpidem is taken towards the end of pregnancy or during childbirth, your baby may show muscle weakness, decreased body temperature, feeding difficulties, and breathing problems (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 during the postnatal period.

Breastfeeding

This medicine passes into breast milk; therefore, zolpidem should not be taken during breastfeeding.

Driving and use of machines

Zolpidem is a medicine that causes sleepiness. Do not drive or operate machinery if you feel drowsy or notice that your attention and reaction ability are reduced. Pay special attention at the beginning of treatment or if the dose is increased.

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

To reduce the aforementioned effects, a minimum interval of 8 hours between taking zolpidem and driving, operating machinery, or performing any work at heights is recommended.

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

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

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

3. How to take zolpidem cinfa

Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

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

• as a single dose; and
• immediately before going to bed.

You must ensure that there is a minimum interval of 8 hours between taking the medicine and performing activities requiring mental alertness.

Do not take more than 10 mg every 24 hours.

• In elderly patients, debilitated patients, and 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 of age): use is not recommended.

Treatment should be started with the lowest dose. The maximum dose must not be exceeded.

Each individual dose must not exceed the limits indicated, nor must the total daily dose, unless your doctor prescribes a higher dose.

Take zolpidem immediately before going to bed, swallowing the tablet whole with water or another non-alcoholic drink.

The tablet may be divided into equal doses.

Under normal conditions, you should fall asleep within 20 minutes after taking zolpidem, and it is advisable to ensure that you can rest undisturbed for at least 8 hours. Otherwise, although this occurs only rarely, you may not remember what happened while you were awake.

In most cases, only short-term treatment with zolpidem is needed (generally not exceeding two weeks). The maximum duration of treatment is four weeks, including gradual withdrawal of the medicine. Prolongation of treatment should not occur without re-evaluation of your condition, as the risk of abuse and dependence increases with the duration of treatment (see section 2).

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

If you think the effect of zolpidem is too strong or too weak, tell your doctor or pharmacist.

If you take more zolpidem cinfa than you should

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

In overdose cases involving zolpidem alone or in combination 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, confusion, and feelings of tiredness, exhaustion (lethargy). In more severe cases, symptoms may include lack of coordination in movement (ataxia), decreased muscle tone (hypotonia), low blood pressure (hypotension), respiratory depression, impaired consciousness up to coma, and more severe symptoms including fatal outcomes.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take zolpidem cinfa

Do not take a double dose to make up for forgotten doses.

If you stop taking zolpidem cinfa

Stopping treatment abruptly 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 further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

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

The following criteria have 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.

A dose-dependent relationship has been established for adverse effects. These effects should be minimized if zolpidem is taken immediately before going to bed.

The following adverse effects are more common in elderly patients:

Immune system disorders

Frequency not known: allergic inflammation that may affect feet, hands, throat, lips, and respiratory tract (angioneurotic edema).

Psychiatric disorders

Common: hallucinations, agitation, nightmares, depression.
Uncommon: confusion, irritability, restlessness, aggression, sleepwalking, euphoric mood.
Rare: changes in sexual desire.
Very rare: delirium, dependence (discontinuation of treatment may lead to withdrawal symptoms or rebound effects).
Frequency not known: outbursts of anger, psychosis, abnormal behaviour.

Nervous system disorders

Common: drowsiness, headache, dizziness, worsening of insomnia, cognitive disorders such as anterograde amnesia (inability to recall events that occurred after taking the medicine). Amnesia may be associated with inappropriate behaviour.
Uncommon: tingling sensation, numbness (paraesthesia), tremor, attention disturbance, speech disorder.
Rare: decreased level of consciousness.

Eye disorders

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

Respiratory, thoracic and mediastinal disorders

Very rare: breathing difficulty (respiratory depression).

Gastrointestinal disorders

Common: diarrhoea, nausea, vomiting, abdominal pain.

Hepatobiliary disorders

Uncommon: increased liver enzymes.
Rare: liver damage (hepatocellular, cholestatic or mixed lesion).

Metabolism and nutrition disorders

Uncommon: appetite disturbance.

Skin and subcutaneous tissue disorders

Uncommon: itching, 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 physician recommendations have not been followed).
Frequency not known: tolerance to the product.

Depression

Use of this medicine may unmask an underlying depression. Since insomnia may be a symptom of depression, if insomnia persists, inform your doctor so that your condition can be evaluated.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through 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 cinfa

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

This medicine does not require any special storage conditions.

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

Medicines should not be disposed of via wastewater drains or in household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Package contents and additional information

Composition of zolpidem Cinfa

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

• The other components are:

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

Appearance of the product and contents of the pack

zolpidem Cinfa is presented as cylindrical, film-coated, scored tablets, white in colour, marked with "Z". Each pack contains 28, 30 or 500 (EC) tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of the most recent revision of this leaflet: July 2020

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/65400/P_65400.html

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