DALPARAN 10 mg FILM-COATED TABLETS

2. What you need to know before you take Dalparan

Do not take Dalparan

• If you are allergic to zolpidem or to the group of benzodiazepines in general or to any of the other components of this medicine (listed in section 6).
• If you have acute and/or severe respiratory difficulties.
• If you have problems breathing during sleep (sleep apnea syndrome).
• If you have weakness, muscle fatigue (myasthenia gravis).
• If you have severe liver problems (hepatic).
• As long-term treatment. Treatment should be as short as possible, because the risk of dependence increases with the duration of treatment.
• If you have experienced sleepwalking or other unusual behaviors while sleeping (such as driving, eating, making phone calls, or having sex, etc.) without being fully awake after taking Dalparan or other medicines that contain zolpidem.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Dalparan.

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

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

• If you have ever had any mental disorder or problems of abuse or dependence on alcohol or drugs.

• Risk of dependence: The use of zolpidem may lead to the development of abuse and/or physical and psychological dependence. The risk of dependence is greater 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 abuse of alcohol, illicit substances, or drugs.

• To minimize the risk of dependence, the following precautions should be taken into account:

• the intake of these medicines will only be done under medical prescription (never because they have worked for other patients) and will never be advised to other people,
• do not increase the prescribed doses by the doctor, nor prolong the treatment for longer than recommended,
• consult your doctor regularly so that he decides whether to continue treatment.

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

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

• Rebound insomnia: in some cases, after interrupting 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 that you know that there is a possibility that this rebound phenomenon may occur to minimize the anxiety that may produce the appearance of these effects when interrupting treatment. In the case of short-acting hypnotic/sedative medicines, the dose withdrawal phenomenon may appear within the dose interval. The probability of rebound insomnia is greater with sudden withdrawal. Therefore, it is recommended to gradually reduce the dose, according to the doctor's instructions.

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

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

Drinking alcohol or taking other medicines that make you drowsy along with Dalparan could increase the risk of these sleep behaviors.

The use of zolpidem with alcohol and with other medicines 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 may pose to you and others.

• This medicine may cause drowsiness and a decrease in the level of consciousness, which can cause falls and consequently cause serious injuries.

• After repeated use for a few weeks, some tolerance to the product may appear, so it may lose some of its hypnotic effects.

• If you have a history of drug or alcohol dependence, you should not take Dalparan unless your doctor indicates it.

• 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, it should be used 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 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 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 it is convenient for you to take a lower dose of Dalparan or not to take it.

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

• Do not take Dalparan at the same time as opioids (medicines used to relieve intense pain, such as morphine or codeine) unless your doctor prescribes it, due to the possible risk of suffering sedation, respiratory depression, coma, or even death (see "Use of Dalparan with other medicines"). In the event that your doctor finally prescribes zolpidem concomitantly 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 Dalparan").

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

Psychomotor alteration the next day (see also "Driving and use of machines")

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

The next day after taking Dalparan, the risk of psychomotor alteration, including the alteration of the ability to drive, may be increased if:

• You take this medicine with less than 8 hours of margin before performing activities that require a state of mental alertness.
• You take a higher dose than the recommended dose.
• You take zolpidem at the same time as another central nervous system depressant or another medicine that increases the concentration of zolpidem in your blood, combined with alcohol or with illegal 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

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine.

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

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

• If you take zolpidem with the following medicines, effects such as drowsiness or psychomotor alteration the next day, including the alteration of the ability to drive, may be increased.

• Medicines for some 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
• Anesthetic medicines
• Medicines for seasonal allergic rhinitis, skin rashes, or other allergies that can 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, it may produce an increase in euphoria that could lead to an increase in psychological dependence.

• Opioid medicines: the use of Dalparan at the same time as opioids (potent analgesics, substitution therapy medicines, and some cough medicines) increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and can be potentially fatal. Due to this, concomitant use should only be considered when no other treatment options are possible.

However, if your doctor prescribes Dalparan along with opioids, the dose and duration of concomitant treatment should be limited by your doctor.

Tell your doctor about all opioid medicines you are taking and closely follow your doctor's dosing recommendation. It may be useful to inform friends or relatives so that they are aware of the signs and symptoms indicated above. Contact your doctor when you experience these symptoms.

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

• The concomitant administration with ketoconazole (used to treat fungal infections) may increase the sedative effects.
• The concomitant administration with rifampicin (used to treat infections) and with St. John's Wort may decrease the effect of zolpidem.

• The concomitant use of zolpidem with St. John's Wort is not recommended, as it may decrease the levels of zolpidem in the blood.

• The concomitant use of zolpidem with medicines that contain alcohol is not recommended. It may increase the sedative effect.

Taking Dalparan with food, drinks, and alcohol

During treatment, avoid alcoholic beverages. The effect of alcohol may potentiate sedation, and this may affect the ability to drive or operate machinery. If you need additional 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 is not recommended during pregnancy.

If you are pregnant or 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.

A reduction in fetal movement and fetal heart rate variability may occur after taking Dalparan during the second and/or third trimester of pregnancy.

If Dalparan is taken at the end of pregnancy or during delivery, your baby may show muscle weakness, a decrease in body temperature, difficulty feeding, and respiratory problems (respiratory depression).

If you take this medicine regularly at the end of pregnancy, your baby may develop symptoms of 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, so you should not take Dalparan during breastfeeding.

Driving and use of machines

Dalparan is a medicine that produces sleep. Do not drive or use machines if you feel drowsy or if you notice that your attention and reaction capacity are reduced. Pay special attention at the start of treatment or if the dose is increased.

Dalparan has a significant effect on the ability to drive and use machines, such as "driving while drowsy". On the days you take Dalparan (as with other hypnotics), you should take into account 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 decreased.

In order to reduce the above effects, a minimum margin of 8 hours is recommended 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 Dalparan, as this may increase the above effects.

Dalparan 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.

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 administration instructions of this medication indicated by your doctor.

In case of doubt, consult again with your doctor or pharmacist.

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

• once; and
• right before bedtime.

You should ensure that you leave a minimum margin of 8 hours from when you take the medication until you perform activities that require mental alertness.

Do not take more than 10 mg every 24 hours.

• In elderly patients, in debilitated patients, and in patients suffering from some liver disorder, 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): its use is not recommended.

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

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 Dalparan right before bedtime and swallow the tablet without chewing, with water or another non-alcoholic beverage.

Under normal conditions, you should not take more than 20 minutes to fall asleep after taking Dalparan, and it is convenient to ensure that you can rest without being awakened for at least 8 hours. Otherwise, although this happens rarely, it is possible that you will 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 treatment duration is four weeks, including gradual withdrawal of the medication. Treatment extension will not be performed without a reevaluation of your condition, as the risk of abuse and dependence increases with treatment duration (see section 2).

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

If you think 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, 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 feeling of fatigue, exhaustion (lethargy). In more severe cases, symptoms may include lack of coordination (ataxia), decreased muscle tone (hypotonia), low blood pressure (hypotension), respiratory depression, cases of decreased consciousness to coma, and more severe symptoms, including a fatal outcome.

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

If you forget to take Dalparan

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

If you interrupt treatment with Dalparan

Abrupt interruption of treatment may produce withdrawal syndrome, which is manifested by 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.

4. Possible adverse effects

Like all medications, Dalparan can produce adverse effects, although not all people suffer from 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 criterion has been used for the classification of the frequency of adverse reactions:

Very frequent: may affect more than 1 in 10 patients

Frequent: 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 the available data.

A relationship between adverse effects and dose has been demonstrated. These effects should be less severe 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 localized in feet, hands, throat, lips, and respiratory tract (angioneurotic edema).

Psychiatric disorders

Frequent: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 having sexual relations, etc.), without being fully awake, see section "Warnings and precautions".

Rare:changes in sexual desire.

Very rare:dependence (treatment interruption may cause withdrawal symptoms or rebound effects).

Frequency not known:fits of rage, psychosis, abnormal behavior, delirium (a sudden and severe change in mental state that makes a person seem confused or disoriented).

Nervous system disorders

Frequent: 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: tingling sensation, numbness (paresthesia), tremor, attention disorder, 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 difficulties (respiratory depression).

Gastrointestinal disorders

Frequent: diarrhea, nausea, vomiting, abdominal pain.

Hepatobiliary disorders

Uncommon: increased liver enzymes.

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

Metabolic and nutritional disorders

Uncommon: appetite disorder.

Skin and subcutaneous tissue disorders

Uncommon: itching, skin rash, excessive sweating.

Rare: hives.

Musculoskeletal and connective tissue disorders

Frequent: back pain.

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

Infections and infestations

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

General disorders and administration site conditions

Frequent: fatigue.

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

Frequency not known: tolerance to the product.

Depression

The use of the medication may unmask existing depression. Since insomnia can be a symptom of depression, if insomnia persists, inform your doctor so that they can evaluate your situation.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for human use medications: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Dalparan

Keep this medication out of sight and reach of children.

No special storage conditions are required.

Expiration date

Do not use Dalparan after the expiration date that appears on the packaging, after CAD. The expiration date is the last day of the month indicated.

Medications should not be thrown away through the sewers or in the trash. Deposit the packaging and medications that you no longer need in the SIGRE collection point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications that you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Dalparan 10 mg film-coated tablets

• The active principle 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 (Type A) of potato, magnesium stearate, titanium dioxide (E-171), macrogol 400.

Appearance of the product and package contents

Dalparan is presented in the form of film-coated tablets, oblong, white, scored, with the inscription SN 10. The score is to divide the tablet into two equal doses.

Package with 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 last revision of this prospectus: October 2022

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