Zolpidem Teva-Ratiopharm 5 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Zolpidem Teva-ratiopharm 5 mg film-coated tablets

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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you. It could harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if the side effects are not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Zolpidem Teva-ratiopharm is and what it is used for
2. What you need to know before taking Zolpidem Teva-ratiopharm
3. How to take Zolpidem Teva-ratiopharm
4. Possible side effects
5. How to store Zolpidem Teva-ratiopharm
6. Contents of the pack and other information

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

Zolpidem Teva-ratiopharm is a tablet belonging 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 prescribed only for sleep disturbances that are severe, disabling, or causing the individual extreme distress.

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

Do not take Zolpidem Teva-ratiopharm:

• If you are allergic to zolpidem or to any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction include: rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.
• If you have experienced sleepwalking or other unusual behaviors during sleep (such as driving, eating, making phone calls, or engaging in sexual activity, etc.) while not fully awake after taking Zolpidem Teva-ratiopharm or other medicines containing zolpidem.
• If you have severe muscle weakness (myasthenia gravis).
• If your breathing stops briefly during sleep (sleep apnoea syndrome).
• If you have severe respiratory weakness (in which the lungs cannot take in enough oxygen) (respiratory insufficiency).
• If you have severe liver damage (hepatic insufficiency).

Children and young people under 18 years of age must not take Zolpidem Teva-ratiopharm.

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Zolpidem Teva-ratiopharm if:

• You are elderly or physically weak.

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 are particularly at risk of falls and consequently hip fractures when getting up at night.

• You have renal insufficiency.

Elimination of Zolpidem Teva-ratiopharm may take longer. Although dose adjustment is not required, caution is advised. Contact your doctor.

• You have chronic respiratory problems (long-term).

Your condition may worsen.

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

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

• You have delirium (psychosis), depression, or anxiety related to depression; Zolpidem Teva-ratiopharm should not be the only treatment you receive.
• You have had a mental illness in the past.
• You have or have ever had thoughts of harming yourself or of suicide. Some studies have shown an increased risk of suicidal ideation, suicide attempts, 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.
• You have recently taken zolpidem or similar medicines for more than four weeks.

Zolpidem Teva-ratiopharm may cause drowsiness and reduce your level of alertness. This could lead to falls and, in some cases, serious injuries.

General

Before starting treatment with Zolpidem Teva-ratiopharm:

• The cause of the sleep disturbance should be clearly identified.
• Underlying medical conditions should be treated.

If treatment does not improve your sleep problem after 7–14 days, it may be due to an underlying physical or psychiatric illness that needs to be investigated. You should consult your doctor.

Next-day psychomotor impairment (see also “Driving and use of machines”)

The risk of next-day psychomotor impairment, including impaired ability to drive, may be increased the day after taking Zolpidem Teva-ratiopharm if:

• You take this medicine with less than 8 hours of time remaining before engaging in activities requiring mental alertness.
• You take a higher dose than recommended.
• You take zolpidem together with another central nervous system depressant or another medicine that increases the concentration of zolpidem in your blood, combined with alcohol or 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 dose and duration of treatment and is higher in patients with a history of mental disorders, alcoholism, illicit substance use, or drug abuse. If physical dependence has developed, abrupt discontinuation of treatment may be accompanied by withdrawal symptoms.

Memory disturbances (amnesia)

Zolpidem Teva-ratiopharm may cause memory loss (amnesia). This usually occurs several hours after taking Zolpidem Teva-ratiopharm. To minimize this risk, you must ensure uninterrupted sleep for at least 8 hours (see section 4, Possible side effects).

Psychiatric and “paradoxical” reactions

Reactions such as restlessness, agitation, irritability, aggression, delirium (psychosis), rage, nightmares, hallucinations, sleepwalking, inappropriate behavior, worsening of sleep disturbances, and other adverse behavioral effects may occur.

If this happens, you must 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 engaging in sexual activity, without memory of the episode, have been reported in patients who had taken zolpidem and were not fully awake. The use of alcohol and other central nervous system depressants together with Zolpidem Teva-ratiopharm appears to increase the risk of these behaviors, as does exceeding the maximum recommended dose. If you experience any of these events, inform your doctor immediately, as these sleep-related behaviors may place you and others at serious risk of injury. Your doctor may advise you to discontinue treatment.

Other medicines and Zolpidem Teva-ratiopharm

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes medicines 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, effects such as drowsiness or next-day psychomotor impairment, including impaired ability to drive, may be enhanced:

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

Zolpidem Teva-ratiopharm may interact with medicines used to treat various 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 analgesics, substitution therapy medicines, and some cough medicines) increases the risk of drowsiness, difficulty breathing (respiratory depression), and coma, and may be life-threatening. Therefore, concomitant use should only be considered when no other treatment options are possible.

However, if your doctor prescribes zolpidem hemitartrate together with opioids, the dose and duration of concomitant treatment must be limited by your doctor.

Inform 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 such 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).

Zolpidem Teva-ratiopharm is not recommended to be taken with fluvoxamine or ciprofloxacin.

Medicines that strongly 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 used for mood changes and depression). Concomitant use is not recommended.

Taking Zolpidem Teva-ratiopharm with alcohol

You must not drink alcohol during treatment. Alcohol can increase the effects of zolpidem and cause you to sleep very deeply, leading to inadequate breathing or 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 are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Zolpidem Teva-ratiopharm must not be taken during pregnancy and breastfeeding, especially during the first three months of pregnancy, because there is insufficient information available to ensure the safety of Zolpidem Teva-ratiopharm during pregnancy and breastfeeding.

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

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

Zolpidem Teva-ratiopharm must not be taken during pregnancy and breastfeeding, especially during the first three months of pregnancy, because there is insufficient information available to ensure the safety of Zolpidem Teva-ratiopharm during pregnancy and breastfeeding.

However, if the benefit to the mother outweighs the risk to the baby, your doctor may decide to treat you with Zolpidem Teva-ratiopharm. If Zolpidem Teva-ratiopharm is taken for a prolonged period during the later stages of pregnancy, your baby may develop 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.

Zolpidem passes into breast milk in small amounts; therefore, Zolpidem Teva-ratiopharm must 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 operate machinery. On days when you take Zolpidem Teva-ratiopharm (as with other hypnotics), you should keep in mind the following:

• You may feel drowsy, sleepy, dizzy, or confused
• You may experience delayed reaction time when making decisions
• You may suffer from blurred or double vision
• Your level of alertness may be reduced

To minimize the aforementioned effects, a minimum interval of 8 hours between administration of Zolpidem Teva-ratiopharm and driving, operating machinery, or performing any work at heights is recommended.

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

For further information on possible adverse effects that may affect your ability to drive, refer to section 4 of this leaflet.

Zolpidem Teva-ratiopharm contains lactose

Zolpidem Teva-ratiopharm contains lactose, the sugar found in milk. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

Zolpidem Teva-ratiopharm contains sodium

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

3. How to take Zolpidem Teva-ratiopharm

Follow exactly the dosing instructions for this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Zolpidem Teva-ratiopharm should be taken:

• as a single dose,
• just before going to bed,
• Ensure you have at least an 8-hour period after taking this medicine before engaging in activities requiring alertness.
• Do not exceed 10 mg within 24 hours.
• Administer the medicine orally.
• Swallow the tablet with a glass of water.

The recommended dose is:

Adults

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

Elderly patients, debilitated patients, or patients with hepatic impairment

A lower starting dose of 5 mg daily (one 5 mg tablet) is recommended. Your doctor may increase your dose to 10 mg (two 5 mg film-coated tablets of zolpidem tartrate) if the effect is insufficient and the medicine is well tolerated.

Use in children and adolescents

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

Maximum dose

Do not take more than 10 mg (two 5 mg film-coated Zolpidem Teva-ratiopharm tablets or one 10 mg film-coated Zolpidem Teva-ratiopharm tablet) within 24 hours.

Zolpidem tartrate 10 mg tablets are available.

Duration of treatment

The sleep-promoting (hypnotic) effect may diminish after repeated treatment over several weeks.

Treatment duration should be as short as possible, ranging from a few days to 2 weeks, and should not exceed four weeks.

In certain situations, longer-term use of Zolpidem Teva-ratiopharm may be required. Your doctor will inform you when and how to discontinue treatment.

If you take more Zolpidem Teva-ratiopharm than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested. Do not go to the hospital alone; ask someone else to accompany you. Bring this leaflet and any remaining tablets with you 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 experiencing a fatal coma.

If you forget to take Zolpidem Teva-ratiopharm

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

If you stop taking Zolpidem Teva-ratiopharm

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

If you stop taking Zolpidem Teva-ratiopharm suddenly, your sleep problems may return and you may experience a "withdrawal effect." If this happens, you may suffer some of the following effects:

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

• 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 than usual to light, noise, and touch
• Loss of contact with reality
• Feeling detached from your body or feeling "like a puppet"
• Numbness and tingling in hands and feet
• Muscle pain
• Stomach problems
• Sleep difficulties returning worse than before
• In rare cases, seizures (convulsions) may also occur

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. These effects appear to be related to individual sensitivity and seem to occur more frequently within the first hour after taking the tablet if you do not go to bed or sleep immediately.

Adverse effects occur more frequently in elderly patients.

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

• You have an allergic reaction. Signs may include: rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.

Other adverse effects are:

Frequent (may affect up to 1 in 10 people):

• Perception of things that are not real (hallucinations), agitation, nightmares
• Depression
• Drowsiness the following day, emotional numbness, reduced alertness, attention disturbance, fatigue, headache, dizziness, difficulty remembering things, which may be associated with inappropriate behavior (see section 2, Warnings and precautions), memory impairment, inability to recall recent events (anterograde amnesia), ataxia (loss of muscle coordination), worsening of insomnia
• Dizziness with loss of balance (vertigo)
• Lung or airway infection (respiratory infection)
• Diarrhea, feeling unwell (nausea), vomiting, stomach pain
• Back pain
• Fatigue

Uncommon (may affect up to 1 in 100 people):

• Confusional state, irritability
• Sleepwalking or other unusual behaviors during sleep, such as driving, cooking, eating, making phone calls, or engaging in sexual activity
• Feeling of intense euphoria or confidence (euphoria), feeling restless or angry
• Difficulty speaking, attention disturbance, tremor
• Double vision, blurred vision
• Change in appetite (appetite disorder)
• Increased liver enzymes
• Unusual sensation or tingling of the skin, itching 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 injury (hepatocellular, cholestatic, or mixed)
• Hives
• Abnormal walking posture (abnormal gait)

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

• Decreased visual ability (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)
• Believing things that are not true (delusions)
• Slowed breathing (respiratory depression)

Not known (frequency cannot be estimated from available data):

• Rapid swelling beneath the skin in areas such as the face, throat, arms, and legs, which may be life-threatening if throat swelling blocks the airways (angioedema)
• A drug effect opposite to what is normally expected (paradoxical reaction), abnormal behavior, mental disorders (psychosis), anger; these reactions are more likely in the elderly
• Misuse of Zolpidem Teva-ratiopharm reported by drug addicts, reduced awareness of surroundings
• Drug tolerance, falls (mainly in elderly patients and when Zolpidem Teva-ratiopharm is not taken as prescribed)
• Delirium (a sudden and severe change in mental state causing confusion or disorientation)

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Zolpidem Teva-ratiopharm

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

Do not use this medicine after the expiry date stated on the packaging and on the blister after EXP. The expiry date refers to the last day of the month indicated.

Store in the original packaging to protect from light. This medicine requires no special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and waste materials should be returned to the SIGRE Point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Zolpidem Teva-ratiopharm 5 mg tablets

• The active substance is zolpidem tartrate. Each tablet contains 5 mg of zolpidem tartrate.
• The other components in the tablet core are lactose monohydrate, microcrystalline cellulose (E460), sodium starch glycolate (Type A) (from potato), hypromellose (E464), and magnesium stearate (E572).

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

Appearance of the product and pack contents

Zolpidem Teva-ratiopharm 5 mg film-coated tablets are white, oval, biconvex, film-coated tablets marked with "ZIM" on one side and "5" on the other.

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

Only certain pack 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, 1st floor

Alcobendas 28108 Madrid

Spain

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

The Netherlands

or

Merckle GmbH

Ludwig-Merckle-Straße 3

89143 Blaubeuren-Weiler

Germany

or

Teva Nederland B.V.

Swensweg 5, 2031 GA Haarlem

The Netherlands

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

Ireland	Zolpidem tartrate Teva 5 mg Film-coated tablets
Netherlands	Zolpidem tartrate 5 mg PCH, film-coated tablets
Spain	Zolpidem Teva-ratiopharm 5 mg film-coated tablets

Date of the most recent review of this leaflet: October 2023

"Updated and detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/".

You can access updated and detailed information about this medicinal product by scanning the QR code included on the outer packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/75795/P_75795.html

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