Dalparan 10 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Dalparan 10 mg film-coated tablets

Zolpidem tartrate

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet; 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 must not give it to others, 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.

Leaflet contents

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

1. What Dalparan is and what it is used for

Dalparan is a hypnotic medicine belonging to the group of medicines known as benzodiazepine analogues.

Dalparan is used for the short-term treatment of insomnia in patients over 18 years of age, 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, since the risk of dependence increases with the duration of treatment.

Dalparan is indicated for sleep rhythm disorders and for all forms of insomnia, particularly when there are difficulties in falling asleep, either initially or after an early awakening.

2. What you need to know before taking Dalparan

Do not take Dalparan

• If you are allergic to zolpidem or to benzodiazepines 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 (hepatic impairment).
• As a long-term treatment. Treatment should be as short as possible, because the risk of dependence increases with the duration of treatment.
• If you have previously experienced sleepwalking or other unusual behaviours during sleep (such as driving, eating, making phone calls, or having sexual intercourse, etc.) without being fully awake after taking Dalparan or other medicines containing zolpidem.

Warnings and precautions

Talk to your doctor or pharmacist before taking Dalparan.

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

• After taking Dalparan, 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).

• If you have ever had a mental disorder or problems with alcohol or drug abuse or dependence.

• Risk of dependence: The use of zolpidem may lead to the development of physical and/or psychological abuse and dependence. The risk of dependence is higher when Dalparan 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.

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

• These medicines should only be taken under medical prescription (never because they worked for someone else), 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 to determine whether treatment should continue.

Once physical dependence has developed, abrupt discontinuation of treatment may lead to a 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, depersonalisation, reduced tolerance to everyday 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 in a more intense form. 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 minimise anxiety that may arise when these effects occur upon stopping treatment. For short-acting hypnotic/sedative medicines, dose-withdrawal phenomena may occur within the dosing interval. The likelihood of rebound insomnia is greater 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 behaviour, and other behavioural disturbances may occur with zolpidem. Treatment should be discontinued if these reactions occur. These reactions are more likely to occur in elderly patients.

Dalparan may cause sleepwalking or other unusual behaviours during sleep (such as driving, eating, making phone calls, or having sexual intercourse, etc.) without being fully awake, some of which have been associated with serious injuries or even death. The following morning, you may not remember anything you did during the night. If you experience any of the above symptoms, stop treatment with Dalparan immediately and contact your doctor or healthcare professional, as these sleep-related behaviours may place you and others at serious risk of injury.

Drinking alcohol or taking other medicines that cause drowsiness together with Dalparan may increase the risk of these sleep-related behaviours.

The use of zolpidem with alcohol and with other medicines acting on the central nervous system, or taking doses higher than the recommended dose, may increase the risk of these behaviours. 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 a reduced level of consciousness, which may 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 the hypnotic effect.

• If you have a history of drug or alcohol dependence, you should not take Dalparan unless instructed 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 illness (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 an existing depression.

Some studies have shown an increased risk of suicidal ideation, suicide attempt, 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 whether 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 problems or respiratory disorders, your doctor will decide whether it is appropriate for you to take a lower dose of Dalparan or not to take it at all.

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

• Do not take Dalparan 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 "Use of Dalparan with other medicines"). If your doctor does prescribe 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 Dalparan").

• Children and adolescents: Dalparan is not recommended for children and adolescents under 18 years of age.

Psychomotor impairment the following day (see also "Driving and use of machines")

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

The risk of psychomotor impairment the following day, including impaired ability to drive, may be increased after taking Dalparan if:

• You take this medicine with less than 8 hours remaining 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 Dalparan with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

This is extremely important, because taking more than one medicine at the same time may increase or decrease their effects.

Therefore, you should not use other medicines at the same time as Dalparan unless your doctor is informed and has approved it.

• If you take zolpidem with the following medicines, effects such as drowsiness or psychomotor impairment the following day, 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

• Anaesthetics

• 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).

• It is not recommended to take zolpidem with fluvoxamine or ciprofloxacin.

• If you take zolpidem with narcotic analgesics, increased euphoria may occur, which could lead to increased psychological dependence.

• Opioid medicines: Using Dalparan together with opioids (strong analgesics, substitution therapy medicines, 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 available.

However, if your doctor prescribes Dalparan 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 family members 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 Dalparan with food, drinks, and alcohol

Avoid alcoholic drinks during treatment. 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 Dalparan 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 variability in fetal heart rate may occur after taking Dalparan during the second and/or third trimester of pregnancy.

If Dalparan 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 tremor. In this case, the newborn should be closely monitored during the postnatal period.

Breastfeeding

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

Driving and use of machines

Dalparan is a medicine that causes drowsiness. 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.

Dalparan has a significant effect on the ability to drive and operate machinery, such as "driving while drowsy." On days when you take Dalparan (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 above-mentioned effects, a minimum interval of 8 hours between zolpidem administration and driving, operating machinery, or performing work at heights is recommended.

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

Dalparan contains lactose

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

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

3. How to take Dalparan

Follow exactly the instructions for administration of this medicine as given by your doctor.

If in doubt, consult your doctor or pharmacist again.

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

• as a single dose; and

• just before going to bed.

You must ensure a minimum interval of 8 hours between taking the medicine and engaging in activities requiring mental alertness.

Do not take more than 10 mg every 24 hours.

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

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

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

Treatment should begin 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 Dalparan just before going to bed, swallowing the tablet whole, with water or another non-alcoholic drink.

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

In most cases, only short-term treatment with Dalparan 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 must not stop taking Dalparan abruptly, especially if you have been taking it for a long time.

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

If you take more Dalparan than you should

If you have taken more Dalparan 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, mental confusion, and feeling tired or exhausted (lethargy). In more severe cases, symptoms may include lack of coordination in movement (ataxia), decreased muscle tone (hypotonia), low blood pressure (hypotension), respiratory depression, worsening of consciousness up to coma, and more serious symptoms, including fatal outcome.

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

If you forget to take Dalparan

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

If you stop taking Dalparan

Abruptly stopping treatment may cause withdrawal syndrome, manifested by 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, Dalparan may produce adverse effects, although not everyone experiences them.

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

The following classification has been used to describe the frequency of adverse reactions:

Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
Very rare: may affect up to 1 in 10,000 people
Frequency not known: cannot be estimated from available data.

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

These effects are more common in elderly patients.

Immune system disorders

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

Psychiatric disorders

Common: hallucinations, agitation, nightmares, depression.
Uncommon: confusional state, irritability, restlessness, aggressiveness, sleepwalking, euphoric mood. Dalparan may cause sleepwalking or other unusual behaviors while sleeping (such as driving, eating, making phone calls, or engaging in sexual activity, etc.), while not fully awake. See section “Warnings and precautions”.
Rare: changes in sexual desire.
Very rare: dependence (stopping treatment may lead to withdrawal symptoms or rebound effects).
Frequency not known: rage attacks, psychosis, abnormal behavior, delirium (a sudden and severe change in mental state causing confusion or disorientation).

Nervous system disorders

Common: somnolence, 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 behavior.
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: diarrhea, nausea, vomiting, abdominal pain.

Hepatobiliary disorders

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

Metabolism and nutrition disorders

Uncommon: appetite disturbance.

Skin and subcutaneous tissue disorders

Uncommon: itching, 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

Medication use 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 type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may 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 Dalparan

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

No special storage conditions are required.

Expiry

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

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

6. Contents of the pack and other information

Composition of Dalparan 10 mg film-coated tablets

• The active substance is zolpidem tartrate. Each tablet contains 10 mg of zolpidem as zolpidem tartrate.
• The other components are: lactose monohydrate, microcrystalline cellulose, hypromellose, sodium carboxymethyl starch (potato Type A), magnesium stearate, titanium dioxide (E-171), macrogol 400.

Appearance of the product and contents of the pack

Dalparan is presented as film-coated, oblong, white tablets, scored, with the imprint SN 10. The score allows the tablet to be divided into two equal doses.

Pack containing 28 tablets.

Marketing Authorization Holder and Manufacturer

Manufacturer

Delpharm Dijon
6, Boulevard de l’Europe
21800 Quétigny (France)

or

Sanofi Winthrop Industrie
Avenue Gustave Eiffel, 30-36
37100 Tours (France)

Date of the most recent review of this leaflet: October 2022

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