ZOLPIDEM DESGEN 5 mg FILM-COATED TABLETS

2. What you need to know before taking Zolpidem Desgen

Do not take Zolpidem Desgen

• If you are allergic (hypersensitive) to zolpidem or to the group of benzodiazepines in general or to any of the other components of this medication (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 impairment).

Warnings and precautions

Consult your doctor before starting to use Zolpidem Desgen

• Your doctor should identify the causes of insomnia whenever possible and treat the underlying factors before prescribing zolpidem.
• After taking Zolpidem Desgen, it is recommended to sleep for the entire night or have a rest period to avoid the possible appearance of anterograde amnesia (not remembering what happened while awake).
• Risk of dependence: the use of benzodiazepines can lead to physical and psychological dependence. This risk increases with the duration of treatment and with the dose. It is also higher in patients with psychiatric problems and/or a history of alcohol or drug abuse.

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

• the use of these medications will only be done under medical prescription (never because they have been effective in other patients) and will never be recommended to other people,
• do not increase the prescribed doses by the doctor, nor prolong the treatment for a longer period 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, insomnia, lack of concentration, 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, hearing problems (hyperacusis), numbness and tingling of the extremities, hypersensitivity to light, noise, and physical contact, hallucinations, or epileptic convulsions.

• In some cases, a transient syndrome may occur in which the symptoms that led to the initiation of treatment appear, 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 be caused by the appearance of these effects when stopping treatment.

• It is known that other psychiatric and "paradoxical" reactions such as restlessness, agitation, worsening of insomnia, irritability, aggressiveness, delirium, fits of rage, nightmares, psychosis, hallucinations, abnormal behavior, and other changes in behavior occur with zolpidem, and treatment should be discontinued in the event of the possible appearance of these reactions. It is more likely that these reactions will occur in elderly patients. There have been reports of somnambulism and other behaviors such as driving while somnambulant, eating, cooking, making phone calls, or having sexual relations, etc., without remembering these events in patients who had taken 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 may pose to you and others.

• This medication can cause drowsiness and a decrease in the level of consciousness, which can lead to 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 suffer from drug or alcohol dependencies, you should not take Zolpidem Desgen unless your doctor indicates it.

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

• If you have depression, it should be used with extreme caution. Consult your doctor before using this medication, as it may unmask existing depression.

• If you have liver disorders or respiratory problems, your doctor will decide whether it is convenient for you to take a lower dose of Zolpidem Desgen or not to take it.

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

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

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

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

• You take this medication 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 medication that increases the concentration of zolpidem in your blood, combined with alcohol or with illegal substances.

Take the dose once and immediately before bedtime.

Do not take another dose during the same night.

Taking Zolpidem Desgen with other medications

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

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

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

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

• Medications for some mental disorders (antipsychotics)
• Medications for sleep problems (hypnotics)
• Medications to relieve or reduce anxiety
• Medications for depression
• Medications for moderate to severe pain (narcotic analgesics)
• Medications for epilepsy
• Anesthetic medications
• Medications for seasonal allergic rhinitis, skin eruptions, 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.

Some medications 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 effect.

The administration with rifampicin (used to treat infections) may decrease the effect of zolpidem.

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

Taking Zolpidem Desgen 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 and breastfeeding

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

Pregnancy

You should avoid taking Zolpidem Desgen during pregnancy.

Before starting treatment, your doctor must know if you are or suspect you are pregnant or plan to become pregnant. The doctor will then decide whether it is convenient for you to take Zolpidem Desgen.

Children born to mothers who take sedative/hypnotic agents chronically during the late stages of pregnancy may develop physical dependence and may be at risk of developing withdrawal symptoms in the postnatal period.

Breastfeeding

This medication passes into breast milk, so you should not take Zolpidem Desgen during breastfeeding.

Driving and use of machines

Zolpidem Desgen is a medication 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 when starting treatment or if the dose is increased.

Zolpidem Desgen has a significant effect on the ability to drive and use machines, such as "driving while somnolent". On the days you take Zolpidem Desgen (as 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 or double vision
• Your state of alertness may be reduced

To reduce these effects, it is recommended to have a minimum margin of 8 hours between the administration of zolpidem and driving, using machinery, or performing any work at heights.

Do not consume alcohol or any other psychoactive substance while taking Zolpidem Desgen, as this may increase the aforementioned effects.

Zolpidem Desgen contains lactose

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

3. How to take Zolpidem Desgen

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

• The recommended dose is 10 mg (2 tablets) of Zolpidem Desgen 5 mg every 24 hours. A lower dose may be prescribed for some patients. Zolpidem Desgen should be taken:

• once; and
• right before bedtime.

You should ensure that you leave a minimum margin of 8 hours from the time 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 with liver disorders, the doctor will prescribe a lower dose.

The recommended daily dose is one 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 Zolpidem Desgen right before bedtime and swallow the tablet without chewing, with water or another non-alcoholic beverage.

Under normal conditions, you should not take longer than 20 minutes to fall asleep after taking Zolpidem Desgen, 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 Zolpidem Desgen is needed (generally not exceeding two weeks).

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

If you think the effect of Zolpidem Desgen is too strong or too weak, inform your doctor or pharmacist.

If you take more Zolpidem Desgen than you should

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

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.

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 lack of coordination (ataxia), decreased muscle tone (hypotonia), low blood pressure (hypotension), respiratory depression, cases of deterioration of consciousness to coma, and more severe symptoms, including a fatal outcome.

If you forget to take Zolpidem Desgen

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

If you stop treatment with Zolpidem Desgen

Sudden interruption of treatment may cause a withdrawal syndrome, which is manifested by headache or muscle pain, anxiety, tension, restlessness, confusion, and irritability (see "Warnings and precautions").

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

4. Possible Adverse Effects

Like all medications, Zolpidem Desgen can produce adverse effects, although not all people suffer from them.

Most patients tolerate Zolpidem Desgen well, but some, especially at the beginning of treatment, 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 adverse effects (in more than 1 in 10 patients), frequent adverse effects (between 1 and 10 in 100 patients), infrequent adverse effects (between 1 and 10 in 1,000 patients), rare adverse effects (between 1 and 10 in 10,000 patients), very rare adverse effects (in less than 1 in 10,000 patients), unknown frequency: cannot be estimated from the available data.

A relationship has been demonstrated between adverse effects and dose. These effects should be minor if zolpidem is administered immediately before bedtime or once in bed.

These effects are more frequent in elderly patients.

Immune System Disorders

Unknown frequency:allergic inflammation that can be localized in feet, hands, throat, lips, and respiratory tract (angioedema).

Psychiatric Disorders

Frequent: hallucinations, agitation, nightmares.

Infrequent: confusional state, irritability.

Unknown frequency: restlessness, aggressiveness, delirium, rage attacks, psychosis, abnormal behavior, somnambulism, dependence (discontinuation of treatment may cause withdrawal symptoms or rebound effects), changes in sexual desire, depression.

Nervous System Disorders

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

Unknown frequency: decreased level of consciousness.

Ocular Disorders

Infrequent: double vision.

Respiratory, Thoracic, and Mediastinal Disorders

Unknown frequency: respiratory difficulty (respiratory depression).

Gastrointestinal Disorders

Frequent: diarrhea, nausea, vomiting, abdominal pain.

Hepatobiliary Disorders

Unknown frequency: increased liver enzymes.

Skin and Subcutaneous Tissue Disorders

Unknown frequency: itching, skin rash, urticaria, excessive sweating.

Musculoskeletal and Connective Tissue Disorders

Frequent: back pain.

Unknown frequency: muscle weakness.

Infections and Infestations

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

General Disorders and Administration Site Conditions

Frequent: fatigue.

Unknown frequency: gait disturbances, tolerance to the product, falls (mainly in elderly patients and when the doctor's recommendations have not been followed).

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 assess 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 Zolpidem Desgen

Keep Zolpidem Desgen out of sight and reach of children.

This medication does not require any special storage temperature.

Keep in the original package.

Expiry Date

Do not use Zolpidem Desgen after the expiry date stated on the packaging, after CAD. The expiry date is the last day of the month indicated.

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

6. Package Contents and Additional Information

Composition of Zolpidem Desgen 5 mg Film-Coated Tablets

• The active ingredient is zolpidem tartrate. Each tablet contains 5 mg of zolpidem as zolpidem tartrate.
• The other components are: lactose monohydrate, microcrystalline cellulose, sodium carboxymethyl starch (type A) of potato, magnesium stearate, hypromellose, titanium dioxide (E-171), and macrogol 400.

Appearance of the Product and Package Contents

Film-coated tablet, white, oval, biconvex, and marked with "ZIM" and "5" on one of the faces.

Packages with 30 tablets and 500 tablets (Clinical Package).

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

GENERFARMA, S.L.

Ronda Isaac Peral 6, Parque Tecnológico

46980 Paterna

Valencia

Manufacturer

Synthon Hispania S.L.

Polígono Las Salinas

C/Castelló 1

08830 Sant Boi de Llobregat (Barcelona)

O

Generfarma S.L.

Los Centelles 7

46006 Valencia (Spain)

Date of the Last Revision of this Prospectus: March 2015

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