Prospect: Information for the user

Zolpidem ratiopharm 10 mg coated tablets EFG

zolpidem tartrate

Content of the prospect:

1. What Zolpidem ratiopharm is and for what it is used
2. What you need to know before starting to take Zolpidem ratiopharm
3. How to take Zolpidem ratiopharm
4. Possible adverse effects
5. Storage of Zolpidem ratiopharm
6. Contents of the package and additional information

Zolpidem ratiopharm is a tablet that belongs to a group of medicines known as benzodiazepine-related drugs.

It is used for the short-term treatment of sleep disorders in adults.

Zolpidem ratiopharm should only be prescribed for severe, incapacitating, or debilitating sleep disorders that cause weakness or great discomfort.

Do not take Zolpidem ratiopharm:

if you are allergic to zolpidem or any of the other ingredients of this medicine (listed in section 6). 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 suffer from brief pauses in breathing during sleep (sleep apnea syndrome).

if you have severe respiratory problems and/or acute (short-term) respiratory failure (respiratory insufficiency).

if you have severe liver problems (hepatic insufficiency).

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

Warnings and precautions:

Consult your doctor or pharmacist before starting to take Zolpidem ratiopharm

• if you are a patient of advanced age or are weak.

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

• if you suffer from renal insufficiency.

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.

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 another mental illness in the past
• if you have or have ever had thoughts of harming yourself or committing suicide.

Some studies have shown a higher risk of suicidal ideation, attempted suicide, 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 taken zolpidem or other similar medicines for more than four weeks recently.

General

Before starting treatment with Zolpidem ratiopharm

• you should clarify what is causing the sleep disturbances,
• you should treat any underlying disease.

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

Daytime psychomotor alteration (also see “Driving and operating machines”)

The next day after taking Zolpidem ratiopharm, there may be an increased risk of psychomotor alteration, including impaired ability to drive, 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 illicit 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 do not work as well as when you started treatment, you should see your doctor, as it may be necessary to adjust your dose.

Abuse and/or physical or psychological dependence

There is a possibility of developing physical or psychological dependence.

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, abrupt discontinuation of treatment is accompanied by withdrawal syndrome (see section 3 “If you stop taking Zolpidem ratiopharm”).

Rebound insomnia

If treatment is stopped abruptly, 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 alterations (amnesia)

Zolpidem ratiopharm may cause memory loss (amnesia). This usually occurs a few hours after taking Zolpidem ratiopharm. To minimize this risk, make sure to sleep uninterrupted for at least 8 hours (see section 4, Possible side effects).

Psychiatric and “paradoxical” reactions

It is known that reactions such as nervousness, restlessness, irritability, aggression, delirium (psychosis), anger, nightmares, hallucinations, sleepwalking, inappropriate behavior, worsening of sleep disturbances, and other adverse effects on behavior may occur.

If this occurs, discontinue taking Zolpidem ratiopharm and contact your doctor. It is more likely that these reactions will occur in elderly patients.

Sleepwalking and associated behaviors

Sleepwalking and associated behaviors, such as “driving while asleep”, preparing food and eating, making phone calls, or having sex,without remembering 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 appears to increase the risk of these behaviors, or if you exceed the maximum recommended dose. If you experience any of these events, inform your doctor immediately, as these sleep behaviors can put you and others at risk of serious 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, serious injuries.

Children and adolescents

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

Other medicines and Zolpidem ratiopharm

Inform your doctor or pharmacist if you are using, have used recently, or may need to take any other medicine. This includes medicines you buy without a prescription, including herbal medicines.

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

If you take zolpidem with the following medicines, you may see potentiated effects such as drowsiness or psychomotor alteration the next day, including impaired ability to drive:

• 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 their muscle-relaxing 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 eruptions, or other allergies that may cause drowsiness (sedating antihistamines).

The concomitant use of zolpidem and opioids (strong analgesics, substitution therapy medicines, and some cough medicines) increases the risk of drowsiness, difficulty breathing (respiratory depression), and coma and may put your life at risk. 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.

Inform your doctor about all the opioid medicines you are taking and follow your doctor's recommended dose strictly. It may be helpful to inform friends or family members 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).

Zolpidem ratiopharm should not be taken with fluvoxamine or ciprofloxacin.

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

Taking Zolpidem ratiopharm with alcohol

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Zolpidem ratiopharm should not be administered 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 a higher risk of cleft lip and palate (sometimes called "hare lip") in the newborn baby.

Reduced fetal movement and variability in fetal heart rate 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 delivery, your baby may show muscle weakness, decreased body temperature, difficulty feeding, and respiratory problems (respiratory depression).

If zolpidem is taken for a longer period at the end of pregnancy, your baby may develop physical dependence symptoms 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.

Lactation

Zolpidem passes into breast milk in small amounts, soZolpidem ratiopharmshould not be taken during breastfeeding.

Consult your doctor or pharmacist before using any medicine.

Driving and operating machines

Zolpidem ratiopharm has a significant effect on your ability to drive and operate machines, such as “driving while drowsy”. The days you take Zolpidem ratiopharm (as happens with other hypnotics) you should be aware of 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 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 is performed at height.

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

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

Zolpidem ratiopharm contains lactose

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

Zolpidem ratiopharm contains sodium

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

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

Zolpidem ratiopharm should be taken:

• Once a day.
• Just before going to bed.

• Ensure you have a period of at least 8 hours after taking this medication before performing activities that require being alert.

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

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

Use in children and adolescents

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

Maximum dose

Do not exceed 10 mg per 24 hours.

Treatment duration

The hypnotic effect may be reduced after repeated treatment for several weeks.

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

In certain situations, you may need 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 Toxicological 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 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, sleeping deeply, and possibly suffering a fatal coma.

If you forgot to take Zolpidem ratiopharm

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

If you interrupt treatment with Zolpidem ratiopharm

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

If you stop taking Zolpidem ratiopharm abruptly, your sleep problems may recur and you may experience withdrawal symptoms. If this happens, you may experience some of the following effects.

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, sound, and touch than normal

• Loss of contact with reality

• Feeling detached from your body or feeling "like a puppet"

• Numbness and tingling in hands and feet

• Muscle pain

• Gastrointestinal problems

• Your sleep problems become worse than before

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

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

Like all medicines, this medicine can have side effects, although not everyone will experience them.

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

These side effects can mainly occur in elderly patients.

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

• Has an allergic reaction. Symptoms may include: hives, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue that can put your life at risk if the throat inflammation 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 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 decline, inability to remember recent events (anterograde amnesia), ataxia (loss of muscle coordination), worsening of insomnia
• sensation of dizziness with loss of balance (vertigo)
• lung or respiratory tract infection (respiratory infection)
• diarrhea, feeling of discomfort (nauseas), vomiting, stomach pain
• back pain
• fatigue

Rare(may affect up to 1 in 100 people)

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

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

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

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
• misuse of Zolpidem Ratiopharm by drug abusers, being less aware of their surroundings.
• tolerance to drugs, 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 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 Medicines and Medical Devices Agency's Website: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.

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 disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Zolpidem ratiopharm 10 mg

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

Tablet core: lactose monohydrate, microcrystalline cellulose, sodium glycinate (type A), magnesium stearate, hypromellose.

Tablet coating: hypromellose, macrogol 400, titanium dioxide (colorant E171).

Appearance of the product and contents of the package

Zolpidem ratiopharm 10 mg is presented in the form of coated tablets, white, oval, biconvex, scored, and with the mark “ZIM” and “10” on one of the faces.

The tablets can be divided into equal doses.

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

Packages containing 30, 100, or 500 tablets in bottles with child-resistant closures.

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

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Teva Pharma, S.L.U.

C/ Anabel Segura, 11. Edificio Albatros B, 1st floor,

Alcobendas, 28108 Madrid (Spain)

Responsible manufacturer

Merckle GmbH

Ludwig – Merckle – Strasse 3

89143 Blaubeuren – Germany

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

AustriaZolpidem “ratiopharm” 10 mg – Filmtabletten

GermanyZolpidem-ratiopharm 10 mg Filmtabletten

NetherlandsZolpidemtartraat ratiopharm 10 mg, tablets

PortugalZolpidem-ratiopharm 10 mg, coated tablets

SpainZolpidem ratiopharm 10mg coated tablets EFG

SwedenZolpidem ratiopharm 10 mg film-coated tablets

Last review date of this leaflet:January 2024

“Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/”.