Package Leaflet: Information for the User

Zolpidem DESGEN 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 and should not be given to others, even if they have the same symptoms, 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 Zolpidem Desgen is and what it is used for

2. What you need to know before you start taking Zolpidem Desgen

3. How to take Zolpidem Desgen

4. Possible side effects

5. Storage of Zolpidem Desgen

6. Contents of the pack and additional information

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

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

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

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 weakness, muscle fatigue (myasthenia gravis).

• If you have breathing problems during sleep (sleep apnea syndrome).

If you have severe liver problems (hepatic).

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 all night or have a period of rest and thus avoid the possible appearance of anterograde amnesia (does not remember 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:

• The taking of these medications will be done only under medical prescription (never because they have worked in other patients) and never advise others,
• Do not increase the doses prescribed by the doctor, nor prolong the treatment more than recommended,
• Consult your doctor regularly so that they decide whether to continue treatment.

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

In severe cases, the following symptoms may appear: alteration of the perception of reality, depersonalization, hearing problem (hyperacusia), numbness and tingling of the extremities, hypersensitivity to light, noise and physical contact, hallucinations or epileptic seizures.

• In some cases, a transient syndrome may occur in which the symptoms that led to starting treatment appear 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 in order to minimize the anxiety that may be caused by the appearance of these effects when treatment is stopped.

• 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, other alterations of conduct occur with zolpidem, and treatment should be suspended in the event of possible appearance of these reactions. It is more likely that these reactions will occur in elderly patients. Cases of somnambulism and other behaviors such as driving while asleep, eating, cooking, calling on the phone or having sex, etc. without remembering these facts in patients who had taken zolpidem and were not fully awake have been reported.

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 interrupting treatment in these cases, as it may pose a risk to both you and others.

• This medication may cause drowsiness and a decrease in the level of 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 loss of certain efficacy of the hypnotic effects.

• If you have dependencies on drugs or alcohol, do not take Zolpidem Desgen unless your doctor tells you to.

• 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 an existing depression.

• If you have liver disease or respiratory problems, your doctor will decide whether 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 old.

Altered psychomotor function the next day (see also Driving and use of machines)

The next day after taking Zolpidem Desgen, there may be an increased risk of altered psychomotor function, including altered ability to drive, 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 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 Desgen with other medications

Inform your doctor or pharmacist if you are using, have used recently or may need to use 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 Desgen unless your doctor is informed and approves it in advance.

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

• Medications for some mental disorders (antipsychotics)
• Medications for sleep disorders (hypnotics)
• Medications to alleviate 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 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.

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.

Zolpidem should not be used concomitantly with medications that contain alcohol. 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 use machinery. If you need additional information on this point, consult your doctor.

Pregnancy and lactation

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

Pregnancy

You should avoid taking Zolpidem Desgen during pregnancy.

Before starting treatment, your doctor should know if you are or suspect you are pregnant, or if you want to become pregnant. The doctor will then decide whether to take Zolpidem Desgen.

Children born to mothers who take sedatives/hypnotics chronically during the last stages of pregnancy may develop physical dependence and there may be some risk of developing withdrawal symptoms in the postnatal period.

Lactation

This medication passes into breast milk, so Zolpidem Desgen should not be taken during lactation.

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 time are reduced.

Pay special attention to the start of treatment or if the dose is increased.

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

• You may feel drowsy, sleepy, dizzy or confused
• You may take longer to make decisions
• You may experience blurred vision or double vision
• Your state of alertness may be decreased

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 Desgen, as this may increase the effects mentioned above.

Zolpidem Desgen contains lactose

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

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 Desgen per 24 hours. A lower dose may be prescribed for some patients. Zolpidem Desgen should be taken:

• once; and
• just before going to bed.

Ensure that you leave a minimum 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, that is, 5 mg of zolpidem.

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

Treatment should begin 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 Desgen just before going to bed and swallow the tablet without chewing it, with water or another non-alcoholic beverage.

Under normal conditions, it will not take more than 20 minutes to fall asleep after taking Zolpidem Desgen, 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 will not remember what happened while you were awake.

In most cases, only a short-term treatment with Zolpidem Desgen is needed (usually not exceeding two weeks).

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

If you estimate that 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 Toxicological 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: loss of coordination in movement (ataxia), decreased muscle tone (hypotonia), low blood pressure (hypotension), respiratory depression, cases of impaired consciousness leading to coma and more severe symptoms, including a fatal outcome.

If you forget to take Zolpidem Desgen

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

If you interrupt treatment with Zolpidem Desgen

Abrupt discontinuation of treatment may produce withdrawal symptoms, which manifest as headache or muscle pain, anxiety, tension, restlessness, confusion, and irritability (see "Warnings and precautions").

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

Like all medicines, Zolpidem Desgen can cause side effects, although not everyone will experience them.

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

The following criteria have been used to classify the frequency of adverse reactions:

Very common side effects (in more than 1 in 10 patients), common side effects (between 1 and 10 in 100 patients), uncommon side effects (between 1 and 10 in 1,000 patients),

Rare side effects (between 1 and 10 in 10,000 patients), very rare side effects (in less than 1 in 10,000 patients), frequency not known: cannot be estimated from available data.

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

These side 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 tracts (angioedema).

Mental and behavioral disorders

Common: hallucinations, agitation, nightmares.

Uncommon: confusional state, irritability.

Frequency not known: restlessness, aggression, delirium, outbursts of anger, psychosis, abnormal behavior, somnambulism, dependence (stopping treatment may cause withdrawal symptoms or rebound effects), changes in sexual desire, depression.

Nervous system disorders

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

Frequency not known: decreased level of consciousness.

Eye disorders

Uncommon: double vision.

Respiratory, thoracic, and mediastinal disorders

Frequency not known: respiratory difficulty (respiratory depression).

Gastrointestinal disorders

Common: diarrhea, nausea, vomiting, abdominal pain.

Hepatobiliary disorders

Frequency not known: increased liver enzymes.

Skin and subcutaneous tissue disorders

Frequency not known: itching, skin rash, urticaria, excessive sweating.

Musculoskeletal and connective tissue disorders

Common: back pain.

Frequency not known: muscle weakness.

Infections and infestations

Common: respiratory tract infections (infections of the upper and lower respiratory tract).

General disorders and administration site conditions

Common: fatigue.

Frequency not known: gait disturbances, product tolerance, falls (predominantly in elderly patients and when not following the doctor's recommendations).

Depression

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

Reporting of side effects

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

Keep Zolpidem Desgen out of the sight and reach of children.

This medication does not require any special temperature for conservation.

Store in its original packaging.

Expiration Date

Do not use Zolpidem Desgen after 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 thrown down the drains or in the trash. Dispose of the packaging and medicines that you do not need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines that you do not need. In this way, you will help protect the environment.

Composition of Zolpidem Desgen 10 mg film-coated tablets

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

Appearance of the product and contents of the packaging

Film-coated tablet, white, oval, biconvex, and marked with "ZIM" and "10" on one face.

Packaging with 30 tablets and 500 tablets (Clinical packaging).

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

GENERFARMA, S.L.

Ronda Isaac Peral 6, Parque Tecnologico

Paterna 46980

Valencia (Spain)

Responsible for manufacturing

Synthon Hispania S.L.

Polígono Las Salinas

C/Castelló 1

08830 Sant Boi de Llobregat (Barcelona)

O

Generfarma, S.L.

Los Centelles 7

46006Valencia (Spain)

Last review date of this leaflet: March 2015

The 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/