ZOLPIDEM RATIOPHARM 10 mg FILM-COATED TABLETS

2. What you need to know before you take Zolpidem ratiopharm

Do not take Zolpidem ratiopharm:

if you are allergic to zolpidem or any of the other ingredientsof this medicine (listed in section 6). The signs of an allergic reaction include: skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue.

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 Zolpidem ratiopharm or other medicines containing zolpidem.

if you have severe muscle weakness (myasthenia gravis).

if you have short pauses in breathing during sleep (sleep apnea syndrome).

if you have severe and/or acute respiratory problems (respiratory failure).

if you have severe liver problems (liver failure).

Do not take this medicine if you are in any of the above situations. If you are not sure, talk to your doctor or pharmacist.

Warnings and precautions:

Talk to your doctor or pharmacist before starting to take Zolpidem ratiopharm

• if you are an elderly or weak patient.

You should take a lower dose (see section 3, How to take Zolpidem ratiopharm). Zolpidem ratiopharm has a muscle relaxant effect. For this reason, elderly patients, in particular, are at risk of falls and consequently hip fractures when getting up at night from bed.

• if you have kidney failure.

You may take longer to eliminate Zolpidem ratiopharm. Although no dose adjustment is required, caution is needed. Contact your doctor.

• if you have chronic respiratory problems(long-term). Your problems may worsen.

• if you have ever had heart problems, including slow or irregular heartbeats (long QT syndrome).
• if you have ever had a mental disorder or have abused or been dependent on alcohol or drugs. You should be carefully monitored by your doctor as there is a risk of habituation and psychological dependence during treatment with Zolpidem ratiopharm.
• if you have severe liver disease.

You should not use Zolpidem ratiopharm as there is a risk of brain damage (encephalopathy). Contact your doctor.

• if you have delirium(psychosis), depression, or anxiety related to depression, Zolpidem ratiopharm should not be the only treatment you receive.
  • if you have had any other mental illnessin the past
  • if you have or have ever had thoughts of self-harm or suicide. 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 further medical advice.

• if you have recently taken zolpidem or other similar medicines for more than four weeks.

General

Before treatment with Zolpidem ratiopharm

• the cause of sleep disturbances should be clarified,
• any underlying disease should be treated.

If the treatment does not improve the sleep problem after 7-14 days of treatment, it may be a physical or psychiatric illness that needs to be checked. You should consult your doctor.

Psychomotor impairment the next day (see also “Driving and using machines”)

The next day after taking Zolpidem ratiopharm, the risk of psychomotor impairment, including impaired driving ability, 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 recommended
• 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.

Other considerations

Habituation (habit formation)

If after a few weeks you notice that the tablets are not working as well as when you started treatment, you should go to your doctor, as it may be necessary to adjust your dose.

Abuse and/or physical or psychological dependence

Physical or psychological dependence may develop.

The risk increases with the dose and duration of treatment and is high in patients with a history of mental disorders, alcoholism, illicit substances, or drug use. If physical dependence has developed, sudden discontinuation of treatment is accompanied by a withdrawal syndrome (see section 3 "If you stop taking Zolpidem ratiopharm").

Rebound insomnia

If treatment is abruptly interrupted, the inability to sleep may reappear more intensely. It may be accompanied by mood changes, anxiety, and restlessness (see section 3 "If you stop taking Zolpidem ratiopharm").

Memory disorders (amnesia)

Zolpidem ratiopharm may cause memory loss (amnesia). It usually occurs a few hours after taking Zolpidem ratiopharm. To minimize this risk, you should ensure that you sleep uninterruptedly for at least 8 hours (see section 4, Possible side effects).

Psychiatric and “paradoxical” reactions

Reactions such as nervousness, restlessness, irritability, aggression, delirium (psychosis), anger, nightmares, hallucinations, sleepwalking, inappropriate behavior, increased sleep disturbances, and other adverse effects on behavior are known to occur.

If this happens, you should stop taking Zolpidem ratiopharm and contact your doctor. These reactions are more likely to occur in elderly patients.

Sleepwalking and associated behaviors

Sleepwalking and associated behaviors such as "sleep-driving", preparing and eating food, making phone calls, or having sex, without memories of the episodehave been reported in patients who had taken zolpidem and were not fully awake. The use of alcohol and other central nervous system depressants with Zolpidem ratiopharm seems to increase the risk of these behaviors, or if the maximum recommended dose is exceeded. If you experience any of these events, inform your doctor immediately, as these sleep behaviors can put you and others at serious risk of injury. Your doctor may recommend discontinuing treatment.

Risk of falls and serious injuries

Zolpidem ratiopharm may cause drowsiness and decrease your level of alertness. This could cause a fall and, in some cases, cause serious injuries.

Children and adolescents

Zolpidem ratiopharm is not recommended for use in children and adolescents under 18 years of age.

Other medicines and Zolpidem ratiopharm

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines that you buy without a prescription, including herbal medicines.

Zolpidem ratiopharm may alter the effects of other medicines. These, in turn, may also alter the action of Zolpidem ratiopharm.

If you take zolpidem with the following medicines, you may experience increased effects such as drowsiness or psychomotor impairment the next day, including impaired driving ability:

• medicines for certain mental disorders (antipsychotics),
• medicines for sleep disorders (hypnotics),
• medicines to relieve or reduce anxiety,
• muscle relaxants (e.g., baclofen), as it may increase its muscle relaxant effect,
• medicines for depression,
• medicines for moderate to severe pain (narcotic analgesics),
• medicines for epilepsy,
• medicines used for anesthesia,
• medicines for seasonal allergic rhinitis, skin rash, or other allergies that may cause drowsiness (sedating antihistamines).

Taking zolpidem with opioids (strong pain relievers, substitution therapy medicines, or some cough medicines) increases the risk of drowsiness, difficulty breathing (respiratory depression), and coma and may put your life in danger. Therefore, concomitant use should only be considered when other treatment options are not possible.

However, if your doctor prescribes zolpidem hemitartrate 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 strictly follow the dose recommended by your doctor. It may be helpful to inform friends or family to alert them to the signs and symptoms described above. Contact your doctor if you experience these symptoms.

Zolpidem ratiopharm may interact with medicines to treat a variety of fungal infections, such as itraconazole and ketoconazole. Taking ketoconazole with zolpidem may increase the effect of drowsiness.

If you take Zolpidem ratiopharm 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 ratiopharm with fluvoxamine or ciprofloxacin.

Medicines that significantly increase the activity of certain liver enzymes may reduce the effect of Zolpidem ratiopharm, e.g., rifampicin (an antibiotic used to treat infections), carbamazepine, and phenytoin (medicines used, for example, for epilepsy) and St. John's Wort (a herbal medicine for mood changes and depression). Concomitant use is not recommended.

Taking Zolpidem ratiopharm with alcohol

Do not drink alcohol during treatment. Alcohol may increase the effects of zolpidem and make you sleep deeply, so you do not breathe properly or have difficulty waking up. Drinking alcohol during treatment may affect your ability to drive or operate machinery.

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 medicine.

Pregnancy

Zolpidem ratiopharm should not be taken during pregnancy, especially during the first three months.

If used during pregnancy, there is a risk that the baby may be affected.

Some studies have shown that there may be an increased risk of cleft lip and palate (sometimes called "hare lip") in the newborn baby.

Reduced fetal movement and fetal heart rate variability may occur after taking zolpidem during the second and/or third trimester of pregnancy.

If zolpidem is taken at the end of pregnancy or during childbirth, the baby may show muscle weakness, decreased body temperature, difficulty feeding, and breathing problems (respiratory depression).

If Zolpidem ratiopharm is taken for a longer period at the end of pregnancy, the 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

Zolpidem passes into breast milk in small amounts, so Zolpidem ratiopharm should not be taken during breastfeeding.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Zolpidem ratiopharm has a significant effect on the ability to drive and use machines, such as "driving while drowsy". On days when you take Zolpidem ratiopharm (as with other hypnotics), you should consider 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 level of alertness may be decreased

To reduce these effects, it is recommended to have a minimum margin 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 ratiopharm, as this may increase the aforementioned effects.

For more information on possible side effects that could affect your ability to drive, see section 4 of this leaflet.

Zolpidem ratiopharmcontainslactose

If your doctor has told you that you have an intolerance to certain sugars, contact your doctor before taking this medicine.

Zolpidem ratiopharmcontainssodium

This medicine contains less than 1 mmol of sodium (23 mg) per coated tablet; this is essentially "sodium-free".

3. How to take Zolpidem ratiopharm

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. Consult your doctor or pharmacist if you have any doubts.

Zolpidem ratiopharm should be taken:

• Once only.
• Right before going to bed.

• Make sure you have a period of at least 8 hours after taking this medication before engaging in activities that require you to be alert.

• Do not exceed 10 mg per 24 hours.
• Administer the medication orally.
• Swallow the tablet with liquid.

The recommended daily dose is:

Adults

The recommended dose is 10 mg per 24 hours. A lower dose may be prescribed for some patients.

Elderly patients (65 years), debilitated patients, or patients with mild to moderate hepatic impairment

A lower dose of 5 mg per day is recommended at the start of treatment. Your doctor may increase your dose to 10 mg if the effect is insufficient and if the medication is well tolerated.

Use in children and adolescents

The use of Zolpidem ratiopharm is not recommended in children and adolescents under 18 years of age.

Maximum dose

Do not exceed 10 mg per 24 hours.

Duration of treatment

The sleep-promoting effect (hypnotic) may be reduced after repeated treatment for several weeks.

The duration of treatment should be as short as possible. It can be from a few days to two weeks but should not exceed four weeks, including the gradual withdrawal phase.

In certain situations, it may be necessary to take Zolpidem ratiopharm for a longer period. Your doctor will tell you when and how to stop treatment.

If you take more Zolpidem ratiopharm than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. Do not go to the hospital alone, ask someone to accompany you. Bring this leaflet with you and any remaining tablets to show them to the doctor. This is so the doctor knows what you have taken.

Taking too much zolpidem can be very dangerous. The following effects may occur: feeling drowsy, confused, deeply asleep, and possibly suffering a fatal coma.

If you forget to take Zolpidem ratiopharm

Do not take a double dose to make up for forgotten doses. Take the tablet if you will be able to sleep for 8 hours. If this is not possible, do not take the tablet until you go to bed the next day.

If you stop taking Zolpidem ratiopharm

Continue taking Zolpidem ratiopharm until your doctor tells you to stop. Do not stop taking Zolpidem ratiopharm suddenly, but inform your doctor if you wish to stop. Your doctor should reduce your dose and discontinue your tablets over a period of time.

If you stop taking Zolpidem ratiopharm suddenly, your sleep problems may reappear, and you may experience a "withdrawal effect". If this happens, you may suffer some of the effects listed below.

Consult a doctor immediately if you experience any of the following effects:

• Feeling anxious, restless, irritable, or confused
• Headache
• Faster or irregular heartbeats (palpitations)
• Nightmares, seeing or hearing things that are not real (hallucinations)
• Being more sensitive to light, noise, and touch than usual
• Losing touch with reality
• Feeling distant from your body or feeling "like a puppet"
• Numbness and tingling in hands and feet
• Muscle pain
• Stomach problems
• Sleep problems get worse than before
• In rare cases, seizures (convulsions) may also occur

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

4. Possible side effects

Like all medications, this medication can have side effects, although not everyone will experience them.

These effects seem to be related to individual sensitivity and occur more frequently after taking the tablet if you do not go to bed or fall asleep immediately.

These side effects may occur mainly in elderly patients.

Stop taking Zolpidem ratiopharm and consult a doctor or go to the hospital immediately if:

• You have an allergic reaction. The signs may include: rash, swallowing or breathing problems, swelling of the lips, face, throat, or tongue that can be life-threatening if the swelling of the throat blocks the airways (angioedema). The frequency of this side effect is unknown (the frequency cannot be estimated from the available data).

Other side effects are:

Frequent(may affect up to 1 in 10 people)

• Perception of things that are not real (hallucinations), agitation, nightmares
• Depression,
• drowsiness during the next day, emotional numbness, reduced alertness, fatigue, headache, dizziness, difficulty remembering things, which may be associated with inappropriate behavior, (see section 2, Warnings and precautions), memory impairment, inability to remember recent past (anterograde amnesia), ataxia (loss of muscle coordination), worsening of insomnia
• feeling of dizziness with loss of balance (vertigo)
• lung or respiratory tract infection (respiratory infection)
• diarrhea, feeling of discomfort (nausea), vomiting, stomach pain
• back pain
• fatigue

Uncommon(may affect up to 1 in 100 people)

• state of confusion, irritability
• sleepwalking or other unusual behaviors while sleeping, such as driving, cooking, and eating, making phone calls, or having sex
• feeling of euphoria or intense confidence (euphoria), feeling restless or angry,
• difficulty speaking, altered attention, tremors.
• double vision, blurred vision
• change in appetite (appetite disorder)
• increased liver enzymes
• unusual or tingling sensation in the skin, itching of the skin or skin rash, excessive sweating.
• joint or muscle pain, muscle spasms, weak muscles, neck pain.

Rare(may affect up to 1 in 1,000 people)

• change in sexual desire (libido)
• liver damage (hepatocellular, cholestatic, or mixed)
• hives
• abnormal walking posture (abnormal gait).

Very rare(may affect up to 1 in 10,000 people)

• reduced ability to see (visual impairment)
• physical or psychological dependence. If you stop taking Zolpidem ratiopharm suddenly, you may experience withdrawal symptoms (see section 2, Warnings and precautions),
• thinking things that are not true (delusions)
• slower breathing (respiratory depression)

Unknown(the frequency cannot be estimated from the available data)

• a drug effect that is contrary to what is normally expected (paradoxical reaction), abnormal behavior, mental disorders (psychosis), anger, these reactions are more likely in the elderly
• there have been reports of misuse of Zolpidem Ratiopharm by drug addicts, being less aware of their surroundings.
• drug tolerance, falls (mainly in elderly patients and when Zolpidem ratiopharm was not taken as prescribed).

delirium (a sudden and severe change in mental state that makes a person appear confused or disoriented).

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if it is a possible side effect that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Zolpidem ratiopharm

Keep this medication out of sight and reach of children.

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

This medication does not require special storage conditions.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Zolpidem ratiopharm 10 mg

• The active ingredient is zolpidem. Each tablet contains 10 mg of zolpidem hemitartrate.
• The other ingredients (excipients) are:

Core of the tablet: lactose monohydrate, microcrystalline cellulose, sodium glycolate starch (type A), magnesium stearate, hypromellose.

Coating of the tablet: hypromellose, macrogol 400, titanium dioxide (coloring agent E171).

Appearance of the product and package contents

Zolpidem ratiopharm 10 mg is presented in the form of film-coated tablets, white, oval, biconvex, scored, and marked with "ZIM" and "10" on one side.

The tablets can be divided into equal doses.

Packaging containing 4, 5, 7, 10, 14, 15, 20, 28, 30, 50, 100, 500 tablets in blisters.

Packaging containing 30, 100, or 500 tablets in child-resistant closure bottles.

Zolpidem ratiopharm 10 mg is available in packaging of 30 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva Pharma, S.L.U.

C/ Anabel Segura, 11. Edificio Albatros B, 1ª planta,

Alcobendas, 28108 Madrid (Spain)

Manufacturer

Merckle GmbH

Ludwig – Merckle – Strasse 3

89143 Blaubeuren – Germany

This medication is authorized in the member states of the European Economic Area with the following names:

Austria Zolpidem "ratiopharm" 10 mg – Filmtabletten

Germany Zolpidem-ratiopharm 10 mg Filmtabletten

Netherlands Zolpidemtartraat ratiopharm 10 mg, tabletten

Portugal Zolpidem-ratiopharm 10 mg, comprimidos revestidos

Spain Zolpidem ratiopharm 10mg comprimidos recubiertos EFG

Sweden Zolpidem ratiopharm 10 mg flimdragerade tabletter

Date of the last revision of this leaflet: January 2024

“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/”.