DAGAN 5 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the Patient

DAGAN 5mg Oral Disintegrating Tablets EFG

Zolpidem Tartrate

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is DAGAN and what is it used for
2. What you need to know before taking DAGAN
3. How to take DAGAN
4. Possible side effects
5. Storage of DAGAN
6. Package Contents and Additional Information

1. What is DAGAN and what is it used for

Zolpidem tartrate is the active ingredient in DAGAN. This belongs to a group of medications called 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, among others:

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

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

DAGAN is not intended for daily use over extended periods (treatment should be as short as possible and not exceed 4 weeks). If you are unsure, consult your doctor.

2. What you need to know before taking DAGAN

Do not take DAGAN:

• if you are allergic to zolpidem tartrate or any of the other components of this medication (listed in section 6). The signs of an allergic reaction are, among others: skin rash, swallowing or breathing problems, 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 while sleeping (sleep apnea).
• if you have a disorder that causes severe muscle weakness (myasthenia gravis).
• if your doctor has informed 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 taking DAGAN if:

• 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 recently taken zolpidem or other similar medications for more than four weeks.
• 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 lead to falls and sometimes serious injuries.

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

Duration of Treatment

• Once you start taking DAGAN, you should know that it is for a limited time.
• You should take zolpidem for a short period, not exceeding 4 weeks.
• You should always consult your doctor as indicated to re-evaluate the situation.

Psychomotor Impairment the Next Day (see also Driving and Use of Machines)

The next day after taking zolpidem, the risk of psychomotor impairment, including impaired driving ability, increases if:

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

Take a single dose immediately before bedtime. Do not take another dose during the same night.

Other Medications and DAGAN

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication. This is because zolpidem may affect how other medications work. Similarly, some medications may affect how 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 take DAGAN with the following medications, it may increase drowsiness and the effects of psychomotor impairment the next day, including impaired driving ability:

• Medications for certain 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
• Medications used for anesthesia
• Medications 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).

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

It is not recommended to take zolpidem with fluvoxamine.

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

• Certain antibiotics, such as ciprofloxacin (not recommended)
• Certain medications for treating fungal infections, such as ketoconazole or itraconazole

Taking DAGANwith Food and Drinks

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

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. Taking DAGAN during pregnancy may harm your baby.

Zolpidem should not be administered during pregnancy, especially during the first three months. If, for urgent medical reasons, you take zolpidem during the last months of pregnancy or during childbirth, 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 if you are 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 Use of Machines

DAGAN has a significant effect on the ability to drive and use machines, 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 alertness may be decreased

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

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

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 2.5 mg of aspartame per tablet. Aspartame is a source of phenylalanine, which may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it properly.
• Ammonium Sulphite Caramel (E150d):This medication may cause severe allergic reactions and bronchospasm (sudden feeling of suffocation) because it contains sulphites.

3. How to Take DAGAN

Follow your doctor's instructions for taking DAGAN exactly. If you are unsure, consult your doctor or pharmacist again.

Taking this Medication

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

Adults

The recommended dose is two 5 mg tablets or one 10 mg tablet (10 mg) just before bedtime. The maximum dose of 10 mg should not be exceeded.

Elderly Patients (over 65 years) or Weak Patients

The recommended dose is one 5 mg tablet just before bedtime. This recommended dose should not be exceeded.

Patient with Liver Problems

The initial dose is one 5 mg tablet just before bedtime. Your doctor will decide if the dose needs to be increased to two 5 mg tablets or one 10 mg tablet if they consider it safe to do so.

Do not take zolpidem if you have severe liver disorders.

Use in Children and Adolescents

Children under 18 years of age 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 Toxicology Information Service, phone: 91 5620420, indicating the medication and the amount taken.

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

• Drowsiness, mental confusion, hypotension, breathing difficulties, deep sleep, and possibility of falling into a coma.

If you Forget to TakeDAGAN

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

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

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

If you Stop TakingDAGAN

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

If you stop taking zolpidem abruptly, you may experience sleep problems again and have what is known as "withdrawal symptoms". If this happens, you may notice the following effects:

Go to the doctor immediately if you experience any of the following:

• 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
• Altered 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.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

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

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

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

Frequent(affect less than 1 in 10 people)

• Poor memory while taking zolpidem (amnesia) and strange behavior during this time, an effect that occurs with greater probability 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.
• Seeing or hearing things that are not real (hallucinations).

Infrequent(affect less than 1 in 100 people)

• Blurred vision or "double vision).

Unknown frequency(frequency cannot be estimated from available data)

• Being less aware of your surroundings.
• Falls, especially in advanced 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 sleeping medicine. These activities include driving while asleep, sleepwalking, or having sexual relations. Alcohol and some medications for depression or anxiety can increase the chances of these serious effects occurring.

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 nauseous or vomiting
• Abdominal pain
• Respiratory infection
• Headache
• Feeling tired or agitated
• Having nightmares
• Having a feeling of not being in contact with reality and being unable to think or judge clearly (psychosis)
• Feeling dizzy
• Feeling lethargic or drowsy
• Back pain

Infrequent(affect less than 1 in 100 people)

• Feeling confused or irritable
• Unusual sensations in the skin such as numbness, tingling, pinching, burning of the skin (paresthesia)
• Tremors
• Blurred vision
• Changes in appetite or appetite-related behavior

• Muscle pain
• Muscle spasms

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

• Any alteration of vision, particularly loss of vision

Unknown frequency:(frequency cannot be estimated from 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 sexual desire (libido)
• Alteration in the amount of liver enzymes (appearing in blood test results)
• Change in skin or eye color, abdominal pain (stomach) or feeling of swelling, intense itching, clear 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 outlet from the liver is blocked (cholelithiasis). Signs such as jaundice (yellowing of the skin), skin rash, or fever and darkening of urine color.
• Lack of concentration
• Speech problems
• Changes in gait
• Zolpidem has less effect than usual
• Becoming dependent on zolpidem

Reporting of adverse effects

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

5. Conservation of DAGAN

Keep this medicine out of sight and reach of children.

This medicine does not require special temperature conditions for its conservation. Keep in the original packaging to protect it from light and moisture.

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

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

6. Package contents and additional information

Composition of DAGAN 5 mg oral dispersible tablets

• The active ingredient is zolpidem tartrate.

Each DAGAN tablet contains 5 mg of zolpidem tartrate.

• The other components (excipients) are potassium polyacrylate, mannitol, lactose monohydrate, microcrystalline cellulose, anhydrous colloidal silica, aspartame (E951), magnesium stearate, and blackcurrant flavoring (flavoring substances, corn maltodextrin (derived from corn starch), triethyl citrate, ammonium sulfite caramel (E150d)).

Appearance of the productand package contents

The 5 mg oral dispersible tablets are:

white to off-white, round, flat, and beveled, marked with "5" on one face and smooth on the other face, with a diameter of 7.0 mm ± 0.3 mm, thickness of 3.1 mm ± 0.3 mm, and a blackcurrant odor.

The oral 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 5 mg is available in packages of 14, 28, 30, and 56 oral dispersible tablets.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Meiji Pharma Spain, S.A.

Avda. de Madrid, 94

28802 Alcalá de Henares, Madrid (Spain)

Manufacturer:

LAMP SAN PROSPERO S.P.A

Via della Pace, 25/A

CP 41030 San Prospero

Módena

Italy

or

INPHARMASCI

ZI Nº 2 de Prouvy – Rouvignies

1 rue de Nungesser

59121 Prouvy

France

Date of the last revision of this leaflet: May 2025

Other sources of information

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