Prospecto: information for the user

Zolpidem Teva-ratiopharm 5mg film-coated tablets

Zolpidem tartrate

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect.See section 4.

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

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

3.How to take Zolpidem Teva-ratiopharm

4.Possible adverse effects

5Storage of Zolpidem Teva-ratiopharm

6.Contents of the package and additional information

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 severe, debilitating, or extremely distressing sleep disturbances.

Do not takeZolpidem Teva-ratiopharm:

• If you areallergic to zolpidem or any of the other ingredientsof 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, calling, or having sex, etc.) without being fully awake after taking Zolpidem Teva-ratiopharm or other medicines containing zolpidemif you have myasthenia gravis.
• If your breathing is interrupted during short periods of time while sleeping(sleep apnea syndrome).
• If you have severe respiratory weakness(respiratory insufficiency).
• If you have severe liver damage(liver insufficiency).

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

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 Teva-ratiopharm

• if you arean elderly patient or are 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 in particular are at risk of falls and subsequent hip fractures when getting up from bed at night.

• if you haverenal insufficiency.

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

• if you havechronic respiratory problems(long duration).

Your problems may worsen.

• 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 monitored by your doctor as there is a risk of habituation and psychological dependence during treatment with Zolpidem Teva-ratiopharm.
• if you havesevere liver disease.

No should use Zolpidem Teva-ratiopharm since there is a risk of brain damage (encephalopathy). Contact your doctor.

• if you havedelirium (psychosis), depression, or anxietyrelated to depression, you should not receive Zolpidem Teva-ratiopharm as the only treatment.
• if you 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.

Zolpidem Teva-ratiopharm may cause drowsiness and decrease your level of alertness. This could cause a fall and, in some cases, 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 disease that needs to be checked. You should consult your doctor.

Altered psychomotor function the next day (see also “Driving and operating machines”)

The next day after taking Zolpidem Teva-ratiopharm, there may be an increased risk of altered psychomotor function, including altered 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.

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, abrupt discontinuation of treatment is accompanied by withdrawal syndrome.

Memory alterations (amnesia)

Zolpidem Teva-ratiopharm may cause memory loss (amnesia). This usually occurs several hours after taking Zolpidem Teva-ratiopharm. To minimize this risk, you should ensure that you sleep uninterrupted for at least 8hours (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, increased sleep disturbances, and other adverse effects on behavior may occur.

If this occurs, you should discontinue taking Zolpidem Teva-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 have 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 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.

Other medicines and Zolpidem Teva-ratiopharm

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine. 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, you may see potentiated effects such as drowsiness or altered psychomotor function the next day, including altered ability to drive.

• Medicines for some 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
• Anesthetics
• Medicines for seasonal allergic rhinitis, skin eruptions, or other allergies that may cause drowsiness (sedating antihistamines).

Zolpidem Teva-ratiopharm may interact with medicines 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 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.

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 should not be taken with fluvoxamine or ciprofloxacin.

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

TakingZolpidem Teva-ratiopharm with alcohol

You should not drinkalcoholduring treatment.Alcohol may increase the effects of zolpidem and make you sleep deeply, so you may not breathe correctly 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 if you think you may be 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 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).

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.

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 Zolpidem Teva-ratiopharm is taken for a longer period during the last months 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 baby should be closely monitored during the postnatal period.

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

Consult your doctor or pharmacist before using any medicine.

Driving and operating machines

Zolpidem Teva-ratiopharm has a significant effect on your ability to drive and operate machines. The days you take Zolpidem Teva-ratiopharm (as 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 Teva-ratiopharm and driving, operating machinery, or any work that is performed at height.

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 may affect your ability to drive, see section 4 of this leaflet.

Zolpidem Teva-ratiopharm containslactose

Zolpidem Teva-ratiopharm contains the sugar from milk, lactose. If your doctor has told you that you have alactose intolerance, consult with them before taking this medicine.

Zolpidem Teva-ratiopharm containssodium

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

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Zolpidem Teva-ratiopharm must be taken:

• as a single dose,

• just before going to bed

• Make sure to have at least an 8-hour period 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 glass of water.

The recommended dose is:

Adults

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

Elderly patients, debilitated patients, or patients with liver insufficiency

A lower dose of 5 mg per day is recommended at the beginning of treatment (one intact 5 mg tablet). Your doctor may increase your dose to 10 mg (2 film-coated tablets of Zolpidem tartrate 5 mg) if the effect is insufficient and if the medication 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.

There are 10 mg Zolpidem tartrate tablets available.

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

In certain situations, you may need to take Zolpidem Teva-ratiopharm for a longer period. 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, 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 them to your doctor.

This is so that your 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 Teva-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 Teva-ratiopharm

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

If you stop taking Zolpidem Teva-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 distant 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 questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. These side effects appear 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:

• Has an allergic reaction. Symptoms may include: hives, difficulty swallowing or breathing, swelling of the 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, alteration in 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 recent events (anterograde amnesia), ataxia (loss of muscle coordination), worsening of insomnia
• Sensation of dizziness with loss of balance (vertigo)
• Pulmonary or respiratory tract infection (respiratory infection)
• Diarrhea, feeling of discomfort (nausea), vomiting, stomach pain
• Back pain
• Fatigue

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

• Confusion, irritability
• Somnambulism, feeling of intense euphoria or confidence, feeling restless or angry,
• Difficulty speaking, alteration of attention, tremor.
• Dual vision, blurred vision
• Change in appetite (eating disorder)
• Increased liver enzymes
• Unusual or tingling sensation in the skin, skin itching or 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 damage (hepatocellular, cholestatic, or mixed)
• Rashes
• Abnormal gait (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)

• Fast inflammation under the skin in areas such as the face, throat, arms, and legs that can be life-threatening if the throat inflammation blocks the airways (angioedema)
• A drug effect that is contrary to what would normally be expected (paradoxical reaction), abnormal behavior, mental disorders (psychosis), anger, these reactions are more likely in the elderly
• Abuse of Zolpidem Teva-ratiopharm has been reported by drug abusers, 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 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 System for the Pharmacovigilance of Medicines for Human Use: https://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 that appears on the packaging and in the blister pack after CAD. The expiration date is the last day of the month indicated.

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

Medications should not be disposed of through drains or in the 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 ZolpidemTeva-ratiopharm5 mg tablets

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

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

Appearance of the product and contents of the package

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

The tablets are available in packages containing10, 14, 15, 20, 28,30, 50x1, 90and100tablets.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holderof the marketing authorization

Teva Pharma S.L.U.

C/ Anabel Segura nº 11 Edificio Albatros B, 1st floor

Alcobendas 28108 Madrid

Responsible for manufacturing

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

Last review date of this leaflet: November 2022

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