ZOLPIDEM TEVA-RATIOPHARM 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Zolpidem Teva-ratiopharm 10mg film-coated tablets EFG

Zolpidem tartrate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

1. What is Zolpidem Teva-ratiopharm and what is it used for
2. What you need to know before you take Zolpidem Teva-ratiopharm
3. How to take Zolpidem Teva-ratiopharm
4. Possible side effects

5 Storage of Zolpidem Teva-ratiopharm

1. Contents of the pack and further information

1. What is Zolpidem Teva-ratiopharm and what is it used for

Zolpidem Teva-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 Teva-ratiopharm is only prescribed for sleep disorders that are severe, disabling, or subject the individual to extreme distress.

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

Do not takeZolpidem Teva-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, difficulties in 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 Teva-ratiopharm or other medicines that contain zolpidem.
• If you suffer from severe muscle weakness (myasthenia gravis).
• If your breathing stops for short periods while you sleep (sleep apnea syndrome).
• If you suffer from severe respiratory weakness (in which the lungs cannot take in enough oxygen) (respiratory failure).
• If you suffer from severe liver damage (liver failure).

Children and adolescents under 18 years of age should not take Zolpidem Teva-ratiopharm.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Zolpidem Teva-ratiopharm

• if you are an elderly or weak patient.

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

• if you suffer from renal failure.

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

• if you suffer from chronic respiratory problems(long-lasting).

Your problems could get worse.

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

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

• if you suffer from delirium (psychosis), depression, or anxietyrelated to depression, Zolpidem Teva-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 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.

Zolpidem Teva-ratiopharm may cause drowsiness and reduce your level of alertness. This could lead to a fall and, on occasion, cause serious injuries.

General

Before starting treatment with Zolpidem Teva-ratiopharm:

• The cause of the sleep disturbance should be clear.
• Underlying diseases 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 Teva-ratiopharm, the risk of psychomotor impairment, including impairment of the ability to drive, may be increased if:

• You take this medicine with less than 8 hours of margin before performing activities that require 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.

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 interruption of treatment is accompanied by a withdrawal syndrome.

Memory disorders (amnesia)

Zolpidem Teva-ratiopharm may cause memory loss (amnesia). It usually occurs a few hours after taking Zolpidem Teva-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 Teva-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 Teva-ratiopharm appears 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 that you stop treatment.

Other medicines and Zolpidem Teva-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 Teva-ratiopharm may affect other medicines. In turn, these medicines may affect the action of Zolpidem Teva-ratiopharm.

If you take zolpidem with the following medicines, you may experience increased effects such as drowsiness or psychomotor impairment the next day, including impairment of the ability to drive.

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

Zolpidem Teva-ratiopharm may interact with medicines used to treat a variety of fungal infections such as itraconazole and ketoconazole. Taking ketoconazole with Zolpidem Teva-ratiopharm may increase the sedative effect.

The concomitant use of zolpidem and opioids (strong painkillers, substitution therapy medicines, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), and coma and can 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 members to alert them to the signs and symptoms described above. Contact your doctor if you experience these symptoms.

If you take Zolpidem Teva-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 Teva-ratiopharm with fluvoxamine or ciprofloxacin.

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

TakingZolpidem Teva-ratiopharm

You should not drink alcoholduring 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.

Zolpidem Teva-ratiopharm should not be taken during pregnancy and breastfeeding,especially during the first three months of pregnancy, as there is not enough information available to guarantee the safety of Zolpidem Teva-ratiopharm during pregnancy and breastfeeding.

Reduced fetal movement and variability of 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 childbirth, your baby may show muscle weakness, decreased body temperature, difficulty feeding, and breathing problems (respiratory depression).

However, if the benefit to the mother is greater than the risk to the baby, your doctor may decide to treat you with Zolpidem Teva-ratiopharm. If you take Zolpidem Teva-ratiopharm for a longer period during the last months of pregnancy, your baby may develop symptoms of physical dependence and may be at risk of developing withdrawal symptoms such as agitation or tremor. In this case, the newborn should be closely monitored during the postnatal period.

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

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Zolpidem Teva-ratiopharm has a significant effect on the ability to drive and use machines. On the days you take Zolpidem Teva-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 reduced

In order to reduce these effects, a minimum margin of 8 hours is recommended between the administration of Zolpidem Teva-ratiopharm and driving, using machinery, or performing any work at heights.

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

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

Zolpidem Teva-ratiopharm containslactose

Zolpidem Teva-ratiopharm contains the milk sugar lactose. If your doctor has told you that you have an intolerance to certain sugars, consult them before taking this medicine.

Zolpidem Teva-ratiopharm contains sodium

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

3. How to take Zolpidem Teva-ratiopharm

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Zolpidem Teva-ratiopharm should be taken:

• as a single intake,
• just before going to bed

• Make sure you have a period of at least 8 hours after taking this medicine before performing activities that require you to be alert.
• Do not exceed 10 mg per 24 hours.
• Administer the medicine orally
• Swallow the tablet with a glass of water.

The recommended dose is:

Adults

The recommended dose is one 10 mg tablet of Zolpidem tartrate per 24 hours. A lower dose may be prescribed for some patients.

Elderly patients, weak patients, or patients with liver failure

A lower dose of 5 mg per day is recommended at the start of treatment (half a 10 mg tablet of Zolpidem tartrate). Your doctor may increase your dose to 10 mg if the effect is insufficient and if the medicine is well tolerated.

Use in children and adolescents

Zolpidem Teva-ratiopharm should not be used in children or adolescents under 18 years of age.

Maximum dose

Do not take more than 10 mg (2 film-coated tablets of Zolpidem Teva-ratiopharm 5 mg or 1 film-coated tablet of Zolpidem Teva-ratiopharm 10 mg) per 24 hours.

5 mg tablets of Zolpidem tartrate are available.

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 range from a few days to 2 weeks and should not exceed 4 weeks.

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

If you take moreZolpidem Teva-ratiopharmthan you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine 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 your doctor.

This is so that 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 takeZolpidem Teva-ratiopharm

Do not take a double dose to make up for forgotten doses. Take the tablet if you are going to 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 treatment with Zolpidem Teva-ratiopharm

Keep taking Zolpidem Teva-ratiopharm until your doctor tells you to stop taking it. Do not stop taking Zolpidem Teva-ratiopharm suddenly, but inform your doctor if you wish to interrupt it. Your doctor should reduce your dose and suspend your tablets over a period of time.

If you stop taking Zolpidem Teva-ratiopharm suddenly, your sleep problems may reappear and you may experience a "withdrawal effect". If this happens, you may suffer from 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 getting worse than before
• In rare cases, seizures (convulsions) may also occur.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. These effects seem to be related to individual sensitivity and seem to be more frequent after the first hour of taking the tablet if you do not go to bed or sleep immediately.

Side effects occur more frequently in elderly patients.

Stop taking Zolpidem Teva-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 lips, face, throat, or tongue.

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, altered attention, fatigue, headache, dizziness, difficulty remembering things, which may be associated with inappropriate behavior, (see section 2, Warnings and precautions), memory impairment, inability to remember the recent past (anterograde amnesia), ataxia (loss of muscle coordination), worsening of insomnia
• Feeling dizzy with loss of balance (vertigo)
• Lung or respiratory tract infection (respiratory infection)
• Diarrhea, feeling unwell (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 on the skin, itching on the skin or skin rash, excessive sweating.
• Pain in the joints or muscles, muscle spasms, weak muscles, neck pain.

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

• Change in sexual desire (libido)
• Liver injury (hepatocellular, cholestatic, or mixed)
• Hives
• Abnormal walking posture (abnormal gait).

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

• Decreased ability to see (visual impairment)
• Physical or psychological dependence. If you stop taking Zolpidem Teva-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(frequency cannot be estimated from available data):

• Rapid swelling under the skin in areas such as the face, throat, arms, and legs that can be life-threatening if throat swelling blocks the airways (angioedema)
• 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 Teva-ratiopharm by drug addicts, being less aware of their surroundings.
• Drug tolerance, falls (mainly in elderly patients and when Zolpidem Teva-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 possible side effects that are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Zolpidem Teva-ratiopharm

Keep this medicine out of sight and reach of children.

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

Store in the original package to protect it from light. This medicine does not require special storage conditions.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Zolpidem Teva-ratiopharm 10 mg tablets

• The active ingredient is zolpidem tartrate. Each tablet contains 10 mg of zolpidem tartrate.
• The other ingredients in the tablet core are lactose monohydrate, microcrystalline cellulose (E460), sodium glycolate starch (Type A) (derived from potato), hypromellose (E464), and magnesium stearate (E572).

The other ingredients in the tablet coating are hypromellose (E464), titanium dioxide (E171), and macrogol 400.

Appearance of the product and package contents

Zolpidem Teva-ratiopharm 10 mg film-coated tablets are white, oval, biconvex, film-coated tablets, scored on both sides, and marked with "ZIM10" on one side.

The tablets are available in packages containing 7, 10, 14, 15, 20, 28, 30, 50x1, 90, and 100 tablets.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva Pharma S.L.U.

C/ Anabel Segura nº 11 Edificio Albatros B, 1ª planta

Alcobendas 28108 Madrid

Manufacturer

Synthon Hispania S.L.

Polígono Las Salinas

C/ Castelló 1

08830 Sant Boi de Llobregat

Spain

or

Synthon BV

Microweg 22, 6545 CM, Nijmegen

Netherlands

or

Merckle GmbH

Ludwig-Merckle-Straße 3

89143 Blaubeuren-Weiler

Germany

or

Teva Nederland B.V.

Swensweg 5, 2031 GA Haarlem

Netherlands

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of the last revision of this leaflet:October 2023

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

You can access detailed and updated information about this medicine by scanning the QR code included in the packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/75798/P_75798.html

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