Prospect: information for the patient

DAGAN10mg bucodispersable tablets EFG

Zolpidem tartrate

Read this prospect carefully before starting to take this medication,because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect.See section 4.

1. What isDAGANand for what it is used

2. What you need to know before starting to takeDAGAN

3. How to takeDAGAN

4. Possible adverse effects

5. Storage ofDAGAN

6. Contents of the package and additional information

The tartrate of zolpidem is the active ingredient of DAGAN. This belongs to a group of medications known as hypnotics. It acts on the brain to help you sleep.

DAGAN is used to treat temporary sleep disorders in adults that are causing severe anxiety or affecting their daily life. These sleep disorders in adults include:in adults, among others:

• Difficulty falling asleep
• Waking up in the middle of the night
• Waking up too early

Your doctor will identify, whenever possible, your sleep problem and the factors that cause it before prescribing this medication. If your sleep problems do not cease after a treatment of 7 to 14 days, it indicates that you may have an underlying disorder, your doctor will evaluate you periodically.

DAGAN is not intended to be used every day for prolonged periods of time (the treatment should be as short as possible and not exceed 4 weeks).If you are unsure, ask your doctor for advice.

Do not takeDAGAN:

• If you are allergic to zolpidem tartrate or any of the other ingredients in this medication (listed in section 6). Signs of an allergic reaction include, among others: skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.
• If your lungs do not function properly (respiratory insufficiency).
• If you have severe liver problems.
• If you have a condition where you stop breathing for short periods of time while sleeping (sleep apnea).
• If you have a condition that causes severe muscle weakness (myasthenia gravis).
• If your doctor has told you that you have a mental illness (psychosis).
• If you are under 18 years of age.

Do not take this medication if any of the above applies to you. If you are unsure, consult your doctor or pharmacist before taking zolpidem.

Warnings and precautions

Consult your doctor or pharmacist before takingDAGANif:

• You have a history of alcohol or drug abuse.
• You have liver problems.
• You have depression or have had other mental illnesses in the past.
• You have taken zolpidem or other similar medications for more than four weeks recently.
• You have kidney problems.
• You have respiratory problems.
• You are elderly or weak.

Zolpidem may cause drowsiness and decrease your level of alertness. This could cause you to fall and sometimes suffer serious injuries.

If you are unsure whether this applies to you, consult your doctor or pharmacist before taking zolpidem.

Duration of treatment

• Once you start takingDAGAN, you should know that it is for a limited time.
• You should take zolpidem for a short period of time, not exceeding four weeks.
• You should always see your doctor as indicated to re-evaluate the situation.

Altered psychomotor function the next day (see also Driving and operating machinery)

The next day after taking zolpidem, there is an increased risk of altered psychomotor function, including altered ability to drive, if:

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

Take a single dose immediately before going to bed. Do not take another dose during the same night.

Other medications andDAGAN

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This is because zolpidem may affect the way other medications work. Similarly, some medications may affect the way zolpidem works.

Zolpidem may increase the effect of muscle relaxants.

Rifampicin, a medication used to treat tuberculosis, may decrease the effect of zolpidem.

Inform your doctor if you are taking any of the following medications:

DAGANmay increase the effect of the following medications:

If you takeDAGANwith the following medications, you may increase drowsiness and altered psychomotor function the next day, including altered ability to drive:

• Medications for some mental disorders (antipsychotics)
• Medications for sleep disorders (hypnotics)
• Medications to relieve or reduce anxiety
• Medications for depression
• Medications for moderate to severe pain (narcotic analgesics)
• Medications for epilepsy
• Medications used for anesthesia
• 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).

If you take zolpidem with narcotic analgesics, you may feel euphoric and may increase your dependence.

It is not recommended to take zolpidem with fluvoxamine.

The following medications increase the likelihood of side effects when taken withDAGAN.To reduce this likelihood, your doctor may decide to reduce your zolpidem dose:

• Some antibiotics, such as ciprofloxacin (not recommended for use)
• Some medications to treat fungal infections, such as ketoconazole or itraconazole

Administration ofDAGANwith food and drinks

• Do not drink alcoholwhile taking zolpidem. Alcohol may increase the effects of zolpidem and make you sleep so deeply that you may not breathe correctly or have difficulty waking up.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication. TakingDAGANduring pregnancy may be harmful to your child.

Zolpidem should not be administered during pregnancy, especially during the first three months. If, for medical reasons, you take zolpidem during the last months of pregnancy or during delivery, your baby may experience a drop in body temperature, muscle convulsions, and breathing difficulties, and may exhibit withdrawal symptoms after birth due to physical dependence.

Do not breastfeed while taking zolpidem, as this medication is excreted in small amounts in breast milk.

Consult your doctor or pharmacist before taking any medication if you are pregnant or breastfeeding.

Driving and operating machinery

DAGANhas a significant effect on your ability to drive and operate machinery, such as "driving while drowsy." The next day after taking zolpidem (as with other hypnotics), you should be aware that you may experience the following:

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

To reduce the effects mentioned above, it is recommended to have a minimum of 8 hours between the administration of zolpidem and driving, operating machinery, or any work that involves heights.

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

DAGANcontains:

• Lactose.If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.
• Aspartame (E951):This medication contains 5 mg of aspartame in each tablet. Aspartame contains a source of phenylalanine that may be harmful in the case of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.
• Sulfite amide caramel (E150d):This medication may cause severe allergic reactions and bronchospasm (sudden feeling of suffocation) because it contains sulfites.

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

Medication intake

• Take this medication by mouth.

• Place the tablet on the tongue and let it dissolve until it disintegrates without chewing it. Swallow the resulting suspension with saliva. You can then drink water or not.
• The recommended dose is 10mg ofDAGANevery 24hours.
• A lower dose may be prescribed for some patients.
• Zolpidem should be taken as a single dose immediately before going to bed at night.
• Ensure that you leave a minimum of 8 hours between taking the medication and performing activities that require alertness.
• Do not take more than 10mg every 24hours.
• The usual duration of treatment is 2 days to 4 weeks. The maximum treatment period, including the gradual dose reduction process, is 4 weeks.

Adults

The recommended dose is 2 tablets of 5mg or 1 tablet of 10mg (10mg) just before going to bed.Themaximum dose of 10mg should not be exceeded.

Senior citizens (over 65 years old) or weakened patients

The recommended dose is 1 tablet of 5mg just before going to bed.This recommended dose should not be exceeded.

Patients with liver problems

The initial dose is 1 tablet of 5mg just before going to bed. Your doctor will decide if the dose needs to be increased to 2 tablets of 5mg or 1 of 10mg if they consider it safe to do so.

Do not take zolpidem if you have severe liver problems.

Use in children and adolescents

Children under 18 years old should not use DAGAN.

If you take moreDAGANthan you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 5620420, indicating the medication and the amount ingested.

Carry the medication packaging with you so that the doctor knows what you have taken. Taking too much zolpidem is very dangerous. The following effects may appear:

• Sensation of drowsiness, mental confusion, hypotension, difficulty breathing, deep sleep, and possibility of falling into a fatal coma.

If you forgot to takeDAGAN

DAGAN should only be taken before going to bed. If you forgot to take the dose at bedtime, do not take it at any other time, otherwise you may feel drowsy, dizzy, and confused during the day.

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

If you forgot to take the dose immediately before going to bed but remember it during the night, simply take the missed dose if you can still sleep for 7 or 8 hours uninterrupted.

If you interrupt the treatment withDAGAN

Continue taking DAGAN until your doctor tells you to stop. Do not stop taking zolpidem suddenly, but inform your doctor if you want to stop. Your doctor will need to reduce the dose and leave the tablets you take for a period of time.

If you stop taking zolpidem suddenly, you may experience withdrawal symptoms. If this happens, you may notice the following effects.

Go to the doctor immediately if any of the following effects appear:

• Feeling anxious and tense, restless, irritable, or confused
• Headache
• Nightmares, seeing or hearing things that are not real (hallucinations)
• Increased sensitivity to light, noise, and touch
• Alteration of the perception of reality
• Feeling distant from your body or like a puppet
• Numbness and tingling in hands and feet
• Muscle pain
• Worsening of sleep disorders

In rare cases, seizures (convulsions) may also occur.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Stop taking DAGANandinform your doctor or go immediately to a hospital if:

• You experience anallergic reaction. The signs of an allergic reaction include, among others: skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue. These side effects are serious but their frequency of occurrence cannot be estimated (it cannot be calculated from the available data). You need medical attention.

Inform your doctor as soon as possible if any of the following side effects appear:

Frequent(affect less than 1 in 10 people)

• Bad memory while taking zolpidem (amnesia) and strange behavior during this time, an effect that occurs more likely a few hours after taking the medicine. After 7-8 hours of sleep after taking zolpidem, it is less likely to cause problems.
• Difficulty sleeping that worsens after taking this medicine.
• To see or hear things that are not real (hallucinations).

Rare(affect less than 1 in 100 people)

• Blurred vision or "double vision".

Frequency unknown(frequency cannot be estimated from the available data)

• To be less aware of your surroundings.
• Falls, especially in older ages.

Driving while drowsy and other strange behaviors

Some cases have been reported of people doing things while asleep and not remembering them when they wake up, after taking a sleep medicine. Among these activities include driving while asleep, sleepwalking, or having sex. Alcohol and some depression or anxiety medicines can increase the likelihood of these serious side effects.

Inform your doctor or pharmacist if any of the following side effects worsen or last more than a few days:

Frequent(affect less than 1 in 10 people)

• Diarrhea
• Feeling dizzy (nausea) or vomiting
• Abdominal pain
• Respiratory infection
• Headache
• Feeling tired or agitated
• Having nightmares
• Feeling disconnected from reality and being unable to think or judge clearly (psychosis)
• Feeling dizzy
• Feeling drowsy or sleepy
• Back pain

Rare(affect less than 1 in 100 people)

• Feeling confused or irritable
• Unusual sensations in the skin such as numbness, tingling, pinching, or burning (paresthesia)
• Tremor
• Blurred vision
• Changes in appetite or behavior related to appetite
• Muscle pain
• Muscle spasms

Very rare(affect less than 1 in 10,000 people)

• Any alteration in vision, particularly loss of vision

Frequency unknown:(frequency cannot be estimated from the available data)

• Itching or skin rash
• Excessive sweating
• Slowing of breathing (respiratory depression)
• Muscle weakness
• Feeling restless, aggressive, angry, or showing unusual behavior
• Depression
• Exaggerated feeling of happiness/confidence (euphoria)
• Thinking things that are not real (delusions)
• Changes in libido (sex drive)
• Alteration in liver enzymes (appear in blood test results)
• Change in skin color or eye white, abdominal pain (stomach) or feeling of swelling, intense itching, pale or bloody stools, extreme weakness, nausea, or loss of appetite. These signs may be due to an infection or liver injury.
• A disease in which the bile ducts from the liver are blocked (cholelithiasis).
• Signs such as jaundice (yellowing of the skin), skin rash, or fever and darkening of urine color.
• Difficulty concentrating
• Speech problems
• Changes in gait
• Zolpidem has less effect than usual
• Becoming dependent on zolpidem

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus.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 medicine.

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

This medication does not require special temperature conditions for its conservation. Store in the original packaging to protect it from light andhumidity.

Do not use this medication after the expiration date that appears on the box or blister pack after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of containers and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need.This will help protect the environment.

Composition of DAGAN 10 mg buccal dispersible tablets

- The active ingredient is zolpidem tartrate.

Cada DAGAN tablet contains 10 mg of zolpidem tartrate.

- The other components (excipients) are potassium polacrilex, mannitol, lactose monohydrate, microcrystalline cellulose, anhydrous colloidal silica, aspartame (E951), magnesium stearate, and blackcurrant flavoring (flavoring substances, cornstarch from cornstarch, triacetin, triethyl citrate, and ammonium sulfite caramel (E150d)).

Appearance of the product and contents of the packaging

The 10 mg buccal dispersible tablets are:

white to off-white, round, flat, and bisected, marked with "10" on one face and smooth on the other face, with a diameter of 10.0 mm ± 0.3 mm, thickness of 3.2 mm ± 0.3 mm, and a blackcurrant odor.

The buccal dispersible tablets are packaged in an aluminum/aluminum blister.

Components of the blister sheet - Base sheet: PVC-OPA-Aluminum-PVC; cover sheet: Aluminum-PVC

DAGAN 10 mg is presented in packaging of 28 and 30 buccal dispersible tablets.

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Meiji Pharma Spain, S.A.

Avda. de Madrid, 94

28802 Alcalá de Henares, Madrid (Spain)

Responsible manufacturer:

LAMP SAN PROSPERO S.P.A

Via della Pace, 25/A

CP 41030 San Prospero

Módena

Italy

Last review date of this leaflet: December 2020

Other sources of information:

The detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMyPS) http://www.aemps.gob.es/