ZOLPIDEM NORMON 5 mg FILM-COATED TABLETS

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

Do not take Zolpidem Normon

• If you are allergic to zolpidem or any of the other ingredients of this medicine (listed in section 6). The signs of an allergic reaction include: skin rash, swallowing or breathing problems, 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 or other medicines containing zolpidem. If you have severe muscle weakness (myasthenia gravis).
• If your breathing stops for short periods while you sleep (sleep apnea syndrome).
• If you have severe respiratory weakness (in which the lungs cannot take in enough oxygen) (respiratory failure).
• If you have severe liver damage (liver failure).

Children and young people under 18 years old should not take zolpidem.

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

Consult your doctor or pharmacist before starting to take this medicine:

• if you are an elderly or weak patient: You should take a lower dose (see section 3, How to take Zolpidem Normon). Zolpidem 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. Although no dose adjustment is required, caution is required. Contact your doctor.
• if you have chronic respiratory problems (long-term). 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.
• if you have severe liver disease. You should not use zolpidem as there is a risk of brain damage (encephalopathy). Contact your doctor.
• if you have delirium (psychosis), depression, or anxiety related to depression, zolpidem 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, 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 recently taken zolpidem or other similar medicines for more than four weeks.

Zolpidem 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 this medicine:

• 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.

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

The day after taking zolpidem, the risk of next-day psychomotor impairment, including impairment of driving ability, 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, illegal substances, or drug use. If physical dependence has developed, sudden interruption of treatment is accompanied by a withdrawal syndrome.

Memory impairment (amnesia)

Zolpidem may cause memory loss (amnesia). It usually occurs a few hours after taking zolpidem. 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 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 food and eating, 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 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 Normon

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 may affect other medicines. In turn, these medicines may affect the action of zolpidem.

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

• 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 relaxant 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 can cause drowsiness (sedating antihistamines).

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

The concomitant use of zolpidem and opioids (strong pain relievers, substitution therapy medicines, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), and coma and can be life-threatening. Therefore, concomitant use should only be considered when other treatment options are not possible.

However, if your doctor prescribes zolpidem tartrate 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 recommended dose prescribed by your doctor. It may be useful 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 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 with fluvoxamine or ciprofloxacin.

Medicines that greatly increase the activity of certain liver enzymes may reduce the effect of zolpidem, 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.

Taking Zolpidem Normon 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not take zolpidem during pregnancy and breastfeeding,especially during the first three months of pregnancy, as there is not enough information available to guarantee the safety of this medicine during pregnancy and breastfeeding.

Fetal movement reduction 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 delivery, your baby may show muscle weakness, a decrease in 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. If you take zolpidem 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 tremors. In this case, the newborn should be closely monitored during the postnatal period.

Zolpidem passes into breast milk in small amounts, so you should not take zolpidem during breastfeeding.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Zolpidem has a major impact on the ability to drive and use machines. On the days you take zolpidem (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 alertness may be reduced.

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

Do not consume alcohol or any other psychoactive substance while taking zolpidem, as this may increase the aforementioned effects.

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

Zolpidem Normon contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Zolpidem Normon 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 Normon

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist again.

Zolpidem should be taken:

• as a single intake;
• right before going to bed;
• make sure you have a period of at least 8 hours after taking this medicine before performing activities that require being 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 10 mg per 24 hours. A lower dose may be prescribed for some patients.

Elderly patients, debilitated patients, or patients with liver failure

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

Use in children and adolescents

Zolpidem should 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 tablets of zolpidem or one 10 mg film-coated tablet of zolpidem) per 24 hours. There are 10 mg zolpidem tartrate tablets available.

Duration of treatment

The sleep-promoting effect (hypnotic) may decrease 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 for a longer period. Your doctor will inform you when and how to stop treatment.

If you take more Zolpidem Normon 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 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 forget to take Zolpidem Normon

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 Normon

Keep taking zolpidem until your doctor tells you to stop. Do not stop taking zolpidem suddenly, but inform your doctor if you want to stop it. Your doctor should reduce your dose and stop your tablets over a period of time.

If you stop taking zolpidem suddenly, your sleep problems may come back, 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 contact 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 further questions on 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 all people suffer from 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.

Adverse effects occur more frequently in elderly patients.

Stop taking zolpidem 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.

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 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 recent past (anterograde amnesia), ataxia (loss of muscle coordination), worsening of insomnia;
• Feeling of dizziness with loss of balance (vertigo);
• Infection of the lungs or respiratory tract (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, 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 sensation or tingling in the skin, itching of 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 suddenly, you may experience withdrawal symptoms (see section 2, Warnings and precautions);
• Thinking things that are not true (delusions);
• Slower breathing (respiratory depression).

Frequency Not Known(frequency cannot be estimated from available data)

• Rapid inflammation under the skin in areas such as the face, throat, arms, and legs that can be life-threatening if throat inflammation 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 zolpidem misuse by drug addicts, being less aware of their surroundings;
• Drug tolerance, falls (mainly in elderly patients and when zolpidem is not taken as prescribed);
• Delirium (a sudden and severe change in mental state that makes a person appear confused or disoriented.

Reporting Adverse Effects

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

5. Storage of Zolpidem Normon

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

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

This medicine does not require any special storage temperature.

Store in the original packaging to protect it from light.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Zolpidem Normon

• The active ingredient is zolpidem tartrate. Each tablet contains 5 mg of zolpidem as zolpidem tartrate.
• The other ingredients (excipients) are:

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

Coating of the tablets: hypromellose, talc, and macrogol 6000.

Appearance of the Product and Package Contents

Zolpidem Normon is presented in the form of film-coated tablets, round, biconvex, white, serigraphed "Z" on one face and anonymous on the other with a diameter of 5.1 mm.

Zolpidem Normon is available in packages containing 30 tablets in aluminum/PVC blisters.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of the Last Revision of this Leaflet:August 2024

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